PharmaSource Podcast

“Most founders dominate organisations, spending 70-hour weeks trying to control everything. But it’s not about the hours you work – it’s about the impact. That shift in mindset transformed how I built multiple successful businesses in pharma services,” explains Raman Sehgal, reflecting on his journey from startup founder to strategic leader.

Raman Segal is the founder of ramarketing, a PE-backed life sciences marketing agency, Lead Candidate, a specialist pharma talent firm, and is host of Molecule to Market podcast.

Based in Toronto as North American President, he has scaled multiple ventures in the pharmaceutical services sector while maintaining work-life balance – a feat many entrepreneurs find elusive.

In this interview, Raman shares his framework for productive leadership, strategic growth, and building specialist businesses that command premium pricing in the pharmaceutical services sector.

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Molecule to Market is official media partner to CDMO Live, and Raman will be recording podcast episodes live from the event. Find out more and register here.

Francisco Blanco, founder of Conducta consulting, believes the human element in CDMO-sponsor relationships has been lost in the race for efficiency.

“I feel like the human component of these relationships has been lost. When I see five-star client services from CDMOs, it’s typically not because of the strength of their processes – it’s the individual.”

Francisco Blanco brings over 15 years of experience from leadership roles at Thermo Fisher and IQVIA to his consultancy Conducta, where he helps life sciences companies navigate complex supply chain transformations, with particular expertise in cell and gene therapy operations.

In this PharmaSource podcast episode, Francisco shares crucial insights on how biopharma companies and CDMOs can redesign their customer experience approach, particularly as the cell and gene therapy sector evolves.

Read the full interview

"We estimate about 8,000 metric tonnes of solvent per year are used by the industry to support solvent-based spray drying. That's a significant impact on cost, maintenance, safety and the environment," says Elizabeth Hickman, CEO of AustinPx, highlighting a critical sustainability challenge in pharmaceutical manufacturing.

Elizabeth Hickman brings extensive experience in pharmaceutical contract manufacturing to her new role as CEO of AustinPx, having worked with several CDMOs and held leadership positions focused on developing innovative pharmaceutical technologies and business strategies.

In a recent interview, Elizabeth discusses how AustinPx's innovative KinetiSol technology is eliminating the need for toxic solvents in pharmaceutical manufacturing while improving drug performance and reducing costs in the realm of amorphous solid dispersions (ASDs). She also shares insights on leadership and diversity in the pharmaceutical CDMO sector.

Read the full article on PharmaSource

“We seek long-term partnerships where our technologies can bring genuine value-add that sustains growth. It’s not about geography – it’s about matching specialties and capabilities with companies who share our vision for innovation,” says Rocco Paracchini, Director of CDMO Business Unit Morpho at Alfasigma.

Rocco Paracchini brings a blend of a biology background and extensive pharmaceutical manufacturing experience to his role as Director of Morpho at Alfasigma. After transitioning from biotech to CDMO operations in 2011 in different CDMOs across Europe, he joined Alfasigma in June 2024 to drive its Contract Development Manufacturing transformation and growth.

In the latest episode of the PharmaSource podcast, Rocco shares insights into how Alfasigma, a global pharmaceutical company founded over 75 years ago in Italy with 4,000 people across four continents, is evolving its CDMO strategy to meet growing market demands, with particular focus on customer-centric manufacturing solutions and technological innovation.

• Read the full article onPharmaSource

A perfect Storm for US Drug Manufacturing as FDA Changes, Trade Wars and M&A Surge Collide

"There's optimism… but the challenges aren't day to day - it can be minute to minute," warns Gil Roth, President of the Pharma and Biopharma Outsourcing Association (PBOA), describing a pharmaceutical manufacturing sector facing unprecedented change in 2025.

Gil Roth brings deep expertise in pharmaceutical policy and manufacturing legislation, having launched PBOA in 2014 as an essential bridge between contract manufacturers and government stakeholders.

In the latest PharmaSource podcast episode, Gil shares detailed insights into how the new administration's trade policies and leadership changes will likely create both challenges and opportunities for US pharmaceutical manufacturing.

Read the full article

Join Gil Roth and other industry experts at CDMO Live 2025

“The automotive industry was once in a similar setup to big pharma players, but they evolved through closer supplier collaboration and continuous improvement practices,” says Fabrice Le Garrec, drawing parallels between today’s pharmaceutical manufacturing challenges and the automotive industry’s transformation. “Toyota’s model of developing suppliers as an extension of your company is something pharma isn’t doing enough of.”

Fabrice Le Garrec brings extensive pharmaceutical operations experience as former VP of Global Operations at Teva and GSK, and ex-McKinsey consultant. Through OSCIS Network, he now leads a network of over 100 pharmaceutical professionals providing performance transformation services across North America and Europe.

In the latest episode of the PharmaSource podcast, Fabrice shares crucial insights about how pharmaceutical manufacturers can transform their operations by adopting Toyota’s proven approaches to supplier integration, continuous improvement, and operational excellence, including lessons learned during the COVID-19 vaccine manufacturing ramp-up.

Don’t miss Fabrice’s talk at CDMO Live 2025: 10 things I’d do differently if leading new fast-track pandemic drug launch again. Download the agenda here

Kolon Biotech's Jungjong Cho believes that the future of cell and gene therapy lies in automation, which offers unprecedented precision and cost efficiencies.

"Traditional manufacturing is prone to human error and variability among operators, affecting the quality of the product," JJ explains. "To overcome these disadvantages, our robotic manipulator significantly reduces these errors and ensures batch-to-batch consistency."

Kolon Biotech is pioneering the use of two innovative technologies that are reshaping manufacturing capabilities:

The 2D Automated Closed Platform represents a quantum leap in manufacturing precision.

The use of 3D Bioreactors further demonstrates the power of scale-up technologies.

Read the full interview

“The Americans put a man on the moon in less time than it takes us to transfer a product between countries – this has to change,” says Luiz Barberini, who leads External Manufacturing for Bayer Consumer Health across Latin America.

Luiz Barberini combines over three decades of pharmaceutical supply chain expertise from roles at Pfizer, Merck and now Bayer with academic positions at Brazil’s leading business schools. His unique perspective spans both practical implementation and theoretical frameworks for supply chain excellence.

In this exclusive interview with PharmaSource, Luiz shares why pharmaceutical companies must fundamentally transform their approach to supply chain management, offering practical insights on breaking down organisational silos, accelerating time-to-market, and building collaborative supplier relationships in an increasingly complex global landscape.

Read the full article here

The Netherlands has emerged as one of Europe's most vibrant and interconnected biotech ecosystems, home to over 1,797 life science companies, world-class pharmaceutical manufacturers, and the European Medicines Agency.

With its strategic location, exceptional infrastructure, and collaborative spirit, the country has become known as 'what industry leaders call 'Europe's connected life sciences & health metropolis'.

Ahead of CDMO Live 2025, which takes place in Rotterdam's historic World Trade Center this May, we gathered insights from three leaders at the heart of the Netherlands' biotechnology sector. Wieteke Wouters, Program Director at hollandbio, which represents over 260 biotech companies; Esther Peters, Director of Leiden Bio Science Park, the country's largest life sciences hub; and Ellen Smit, Managing Director of Rotterdam Square, the organisation behind the emerging health tech campus in Rotterdam, shared their perspectives on what makes the Dutch biotech ecosystem uniquely successful.

Read the full article

“The market for lipid nanoparticles really exploded during COVID-19,” says Alexander Aust, LNP manufacturing expert.

Alexander Aust, a consultant specialising in lipid nanoparticle (LNP) manufacturing, brings years of experience from companies like Sigma-Tau Pharmaceuticals and Exelead. His expertise spans from commercial liposomal drug products to cutting-edge mRNA and gene editing technologies.

In the latest PharmaSource podcast episode, Alexander explains why LNPs have become crucial in drug delivery, particularly for mRNA vaccines, and shares insights on manufacturing challenges, regulatory considerations, and future applications of this technology.

Read the full article

The COVID-19 pandemic didn't just disrupt pharmaceutical manufacturing—it catalysed a fundamental shift in how we approach CDMO partnerships. Johnson & Johnson's Paolo Giudici reveals how their four-year digital transformation journey is reshaping the future of external manufacturing.

Key transformations reshaping sponsor-CDMO relationships:

• Real-time manufacturing floor visibility enabling proactive process control

• Seamless ERP integration across the partner ecosystem

• Standardised quality data exchange and monitoring

• Compressed timelines from years to months

The critical challenge? Standardisation. Unlike mature industries, pharma lacks unified frameworks for digital CDMO collaboration. "Currently, if a sponsor attempts to establish digital collaboration with a CMO, they essentially start from scratch," notes Giudici.

Strategic implementation insights:

1. Secure explicit partnership agreements before technical integration

2. Focus on value creation, not job displacement

3. Establish clear cost-sharing frameworks upfront

4. Leverage industry collaboration networks

Read the article here

Paolo will be speaking about Digital Transformation of Pharma Manufacturing at CDMO Live 2025. Tickets available now

Leadership insights from our latest Women in BioPharma meetup.

"I fully expect that the industry will have multiple female CEOs in the years to come," predicts Elizabeth Hickman, Chief Executive Officer of Austin Pharmaceuticals.

However, the current state of the pharma industry is that while gender mix starts fairly even, by the time you get to the C-suite, the top table is still overwhelmingly male.

In our most recent Women in BioPharma meetup Elizabeth Hickman was joined by Nikki Whitfield, CEO of Upperton; and Hennie Zijlstra, Chief Commercial Officer at Adragos to share their perspective. Their combined experience spans research and development, commercial operations, and executive leadership, offering a comprehensive view of how women can succeed in this traditionally male-dominated industry.

Join our next meetup: 20th March 2025

Join us for an enlightening conversation with a pioneering female health startup founder, Valentina Milanova, Founder and CEO/CPO of Daye.

Valentina will explain her own personal journey in creating an innovative period care and gynae health startup and discuss the systemic issues which are harming women’s health. She will reveal the hidden gender biases she has encountered that are ingrained in the pharmaceutical industry, from research and testing, to investment, manufacturing and marketing.

Join the conversation by signing up here

Gene editing and cell therapy, they’re going to be entrenched modalities, much like small molecules and antibodies are today, that will fundamentally reshape healthcare.” says Devyn Smith.

Devyn Smith, CEO of Arbor Biotechnologies and Chairman of the Alliance for Regenerative Medicine, brings a wealth of experience to the cell and gene therapy ecosystem. With a PhD in developmental biology and eight years in strategy consulting, Devyn’s journey led him to Pfizer, where he served as COO of their cell therapy group in Cambridge, UK, before a series of board roles at various biotechs.

In the latest PharmaSource podcast episode, he shares insights on the promise of cell and gene therapy to transform lives and the operational challenges the industry must overcome to realise this potential.

Here's the full article

Stephen Sheehan of Alkermes shares their new governance framework for high-performing CDMO partnerships.

As Director of External Development & Manufacturing at Alkermes, Stephen Sheehan brings over a decade of experience in pharmaceutical development, transitioning from small to large molecules, and implementing innovative CDMO management frameworks. Based in Dublin, he’s responsible for managing CDMOs involved in development activities and manufacturing of Alkermes’ drug development candidates.

In this insightful interview, Stephen reveals how a critical batch failure led to the development of a comprehensive CDMO governance framework, and shares valuable insights on building effective CDMO relationships, establishing meaningful KPIs, and implementing sustainable practices in pharmaceutical manufacturing.

Read the full interview

Stephen will be hosting an Outsourcing Excellence Roundtable at CDMO Live about KPIs and governance frameworks for managing contract manufacturing networks.

Join the conversation: CDMO Live 2025

For us, it’s not a transaction. It really is a partnership,” says Nikki Whitfield, CEO of Upperton Pharma Solutions.

Nikki Whitfield brings over three decades of pharmaceutical development experience to her role as CEO of Upperton Pharma Solutions. A chemist by background and self-described “formulator by heart,” she has significant experience developing sterile and non-sterile dosage forms for small and mid-sized pharma companies, including a tenure at Quotient Sciences, before taking the helm at Upperton in 2021.

In the latest episode of the PharmaSource podcast , Nikki shared insights on how CDMOs can better serve small and emerging biotech companies, highlighting the importance of flexible partnerships and scientific expertise in driving successful drug development programmes. Her perspective, shaped by experience on both sides of the CDMO relationship, offers valuable insights for companies seeking manufacturing partnerships.

Read the full article

Hanns-Christian Mahler, Chief Enablement Officer at ten23 health, is redefining leadership in pharmaceutical manufacturing: “I believe collaboration at the workplace should be primarily based on trust and motivation, not on typical carrot and stick command and control models.”

Founded in 2021, ten23 health has a mission to be a human-centric and sustainable strategic partner of the pharmaceutical industry. With extensive experience at companies including Merck, Roche, and Lonza, Hanns-Christian brings a fresh perspective to the CDMO space, combining technical expertise with innovative leadership approaches.

In the latest episode of the PharmaSource podcast, Hanns-Christian shared insights into how ten23 health is revolutionising the CDMO sector through three key pillars: expertise-driven services, human-centric leadership, and sustainable operations. The company’s unique approach demonstrates how CDMOs can differentiate themselves in a competitive market while prioritising both people and planet. Read more

Connect with ten23 health at CDMO Live 2025, 7-8th May 2025 at the World Trade Center, Rotterdam. Find out more about the event here

John Childers, Director of Business Development for Wacker Biotech’s North American operations, emphasises the importance of early CDMO partnerships: “Working with an experienced CDMO partner can really help you stay on track for budget and schedule. Think long term – the investment with an external partner can substantially save you time and money.”

As part of Wacker Chemie, a century-old German chemical company, the biotech division leverages over 20 years of experience in advanced therapy manufacturing for contract development and manufacturing.

Speaking to the PharmaSource podcast ahead of CDMO Live 2025, John shares best practices for successful partnerships and explains how Wacker Biotech is positioning itself for growth in the evolving contract manufacturing landscape.

Read the full article

The pharmaceutical industry faces a significant challenge with patent expiries threatening established revenue streams of approximately $300 Billion USD.

Major brands are approaching patent expiry creating urgency for companies to identify new blockbuster opportunities. This is compounded by policy changes like the Inflation Reduction Act, which offers different exclusivity periods for biologics versus small molecules. Adam Siebert and Jeff Holder are partners at L.E.K. Consulting’s life science enablers practice, specialising in biopharma manufacturing and supply chain strategy. With backgrounds spanning operations, services, and drug discovery, they help pharmaceutical companies and CDMOs navigate emerging technology trends. In the latest episode of the PharmaSource podcast, Adam and Jeff shared insights on horizon scanning – the critical practice of forecasting drug development and manufacturing trends years in advance. Their discussion revealed key strategies for pharmaceutical companies and contract manufacturers to stay ahead of industry shifts.

Read the PharmaSource Interview

David Caron, Senior Vice-President of CMC, AL102 at Immunome, shares why choosing the right CDMO partner can make or break a biotech’s development timeline: “For biotechs, the main business challenge is to do right the first time. To do this, we need to look at the risks related to each activity.”

David Caron brings over three decades of pharmaceutical industry experience across multiple biotechs, with expertise spanning from bench formulation to senior leadership roles. His background includes extensive work with various dosage forms and regulatory requirements across EU and US markets.

In this latest episode of the PharmaSource podcast David shares crucial insights on how emerging biotechs can optimize their CDMO partnerships, manage costs effectively, and align CMC strategy with business objectives.

David Caron will be sharing advice about how to overcome biotech CMC challenges at CDMO Live 2025. Book your ticket here

• Read the interview here

Dr. Avencia Sánchez-Mejías is CEO and co-founder of Integra Therapeutics, a Barcelona-based biotech company developing next-generation gene-editing tools. With a background in molecular biology and clinical genetics, she brings over 15 years of experience in genetic therapy research across Europe, the US, and Asia.

In this exclusive interview, Avencia shares insights on transitioning from academia to entrepreneurship, building a sustainable biotech company, and leveraging strategic partnerships to bring innovative gene therapy solutions to market.

“Having a technology that can address genetic conditions and new diseases that today are not treatable, can have a huge impact. Not only for the patient but also for the cost of the health system.”, she says.

One of Integra’s most significant strategic decisions was expanding beyond being purely a platform technology company to developing their own therapeutic products. This transition required careful consideration of sustainable growth and market validation strategies.

“This is probably one of the most strategic decisions that we had to take,” Avencia explains. “We think hard and long on which first indication should be to be successful. It also changed the type of company that we were. We were very technological, and now we are building therapeutic products. So the kind of talent that you need also changes.”

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"The reality is, we have a lot of CDMOs don't they really know what they're getting into" says Herman Bozenhardt

Herman Bozenhardt, a pharmaceutical manufacturing consultant with decades of experience in facility design and operations, brings a wealth of knowledge from his work with numerous pharmaceutical companies and contract manufacturers. His expertise spans from traditional small molecule drugs to complex biologics and potent compounds.

In the latest PharmaSource podcast episode, Herman shares his candid thoughts on the challenges facing the pharmaceutical manufacturing industry, particularly in the rapidly growing field of Antibody-Drug Conjugates (ADCs). He explains why many Contract Development and Manufacturing Organizations (CDMOs) may not be adequately prepared to handle these complex and potent compounds.

https://pharmasource.global/content/podcast/adc-manufacturing-why-herman-bozenhardt-believes-only-5-cdmos-are-fit-for-purpose/

GLP-1 drugs have become a game-changer in treating obesity and type 2 diabetes, forecast to reach a $100 billion market value by 2029.

However, their rapid rise raises important questions about resource allocation in pharmaceutical development and manufacturing, as well as affecting the dynamics between patients, healthcare providers, and biopharma.

In the latest episode of the PharmaSource podcast, Ben Locwin, Chief Scientist at Black Diamond Networks, explains that GLP-1 drugs represent a significant breakthrough in the treatment of obesity and diabetes and the unintended consequences they are bringing to the industry.

Read the article here

“Treat them as a partner, not just a supplier. It’s a mindset you need to get into.” – Federica Fraschetti, MSD

Federica Fraschetti, Associate Director of External Manufacturing at MSD, brings years of experience in the pharmaceutical industry and a passion for optimising partnerships with contract manufacturing organisations (CMOs).

In the latest PharmaSource podcast episode, Federica explains why getting supplier relationship management right is a key strategy for driving efficiency and fostering innovation in the biopharma industry.

Creating an effective CMC operating model is crucial when working with external partners. Federica emphasises the importance of a clear internal structure that is visible to CMOs:

“What is really key is the structure that you have internally and then externally. So what the CMO can see of your structure when dealing with partners,” she explains.

MSD utilises a ‘virtual plant team’ model, which includes representatives from key functions such as operations, technology, quality, supply chain, and procurement. This structure provides:

• Clear supporting model for day-to-day operations with the CMO
• Established escalation paths
• Defined roles and responsibilities

While it’s ideal to match these roles with counterparts at the CMO, Federica acknowledges that this isn’t always possible. “It doesn’t mean that each function needs to be one-to-one matched at the CMO, but you do need to know where it is matched, even if it is the same person or the same function,” she advises.

Read the full interview

“Sustainability is no longer just a buzzword in the pharmaceutical industry. It’s a critical business imperative,” says Hywel Woolf, Global Sustainability Manager at Sharp Services. “

“We’re seeing it become a golden thread in who organizations are and what they intend to deliver, driven by both compliance requirements and client demand.”

Hywel Woolf brings extensive experience in environmental management to his role as Global Sustainability Manager at Sharp Services, a leader in commercial packaging, clinical services, and sterile manufacturing for pharmaceuticals. With a background spanning consultancy, construction, and heavy manufacturing, Hywel now applies his expertise to drive sustainability initiatives across Sharp’s global operations.

In a recent interview at CPHI Milan, Hywel shared insights into Sharp’ sustainability journey, highlighting the company’s strategic approach to reducing environmental impact across its diverse business units. He explains how Sharp is tackling the challenges of sustainable packaging, managing scope 3 emissions, and collaborating with suppliers and industry partners to drive positive change in the pharmaceutical supply chain.

Read the full article

“Manufacturing network strategy is about connecting the dots and seeing the interconnectivity between different brands,” explains Daniel Hurni, Director of Manufacturing Network Strategy and Business Intelligence at Bristol Myers Squibb (BMS).

Daniel Hurni brings years of life sciences expertise to his role at BMS, where he is responsible for shaping overarching manufacturing network strategies across small molecules, biologics, and cell and gene therapy business units. His experience spans technical transfer projects, incident management, and long-term strategic planning.

In a the latest episode of the PharmaSource podcast, Daniel shared invaluable insights into the complexities of developing and implementing an effective manufacturing network strategy in the pharmaceutical industry.

He explains why a robust long-term manufacturing network strategy is crucial for optimizing costs, improving margins, and ensuring supply chain resilience in an increasingly complex global landscape.

Read the full article

Live from CPHI Milan 2024, this episode is a roundup of conversations with a number of key exhibitors Recipharm, Tjoapack, Renaissance Lakewood, Ecolab and NovaCina.

As you'll hear, it was a noisy event, so written transcripts are all available on PharmaSource.

• Jon Reed, Head of Strategic Business Planning at Recipharm discussed the CDMO’s recent strategic moves, including Predictive Modeling and GLP-1 focus. https://pharmasource.global/content/podcast/recipharms-strategic-moves-embracing-predictive-modeling-and-glp-1-trends/

• Dexter Tjoa, CEO of Tjoapack, shared insights into the company’s 35 year evolution from a small Dutch contract packaging organisation (CPO) to a global player in pharmaceutical packaging. https://pharmasource.global/content/podcast/tjoapacks-global-expansion-bridging-european-and-us-pharmaceutical-packaging-markets/

• Eric Kaneps, Vice President of Sales & Marketing at Renaissance Lakewood, discussed the company’s expansion and focus on nasal spray technology. https://pharmasource.global/content/podcast/renaissance-lakewood-drives-cdmo-innovation-in-nasal-spray-technology/

• Craig Cox, Vice President of Global Sales, Bioprocessing at Ecolab, shared insights into the company’s bioprocessing solutions, and how they help support sustainability. https://pharmasource.global/content/podcast/ecolabs-bioprocessing-solutions-addressing-sustainability-and-complexity-in-drug-manufacturing/

• Peter Bullard, Senior Vice President of Manufacturing at NovaCina, shared insights into the new Australian CDMO’s unique position in the global pharmaceutical market and 50 year legacy. https://pharmasource.global/content/podcast/novacina-new-australian-cdmo-with-50-year-legacy-in-sterile-manufacturing/

"As Americans, we are very unaware of the value proposition of Poland," says Marty Henehan, highlighting the untapped potential of Central European biopharmaceutical manufacturing for North American biotechs.

Marty Henehan, Vice President of Business Development and Head of North America at Mabion sheds light on the advantages of partnering with a Polish CDMO for drug development and manufacturing services.

Speaking to the PharmaSource podcast during CPHI Milan, Marty explains how Mabion's transformation from a biosimilar company to a full-service CDMO has positioned them to offer cost-effective, high-quality solutions for biotechs worldwide, particularly those in North America.

Read the full article

Joerg Ahlgrimm brings over two decades of experience in pharmaceutical manufacturing and operations to his role as Chief Executive Officer at SK pharmteco.

His distinguished career includes leadership positions at Schering, Baxter, and Lonza, where he managed 35 facilities during a period of unprecedented growth. He was one of the founding members of the Center for Breakthrough Medicines (CBM), where he served as employee number four and helped build the operation from scratch before the CDMO was acquired by SK pharmteco.

In this exclusive interview, Joerg shares insights into SK pharmteco’s strategic vision, the future of pharmaceutical outsourcing, and why making outsourcing “easy” is crucial for success in the evolving CDMO landscape. His unique perspective comes from having experienced both sides of a major acquisition, overseeing the integration of CDM into SK pharmteco.

Joerg Ahlgrimm, CEO of SK pharmteco, believes the CDMO industry is heading for significant consolidation: “If you fast forward 10 years, there will probably be 10-15 large, multi-modality CDMOs, with many smaller and specialised ones being bought.” Read the full article on PharmaSource

"In underserved markets, there's always a challenge of reaching patients due to political and economic pressures. Through smart packaging, logistics, and distribution, we're committed to providing healthcare solutions across our network of more than 100 distributors," says Samir El Nasharty, Chief Operations Officer at Acino.

Samir El Nasharty leads an experienced global team of over 1,000 Tech Ops professionals at Acino, a Swiss pharmaceutical company established in 1836. As part of the Arcera Life Science platform, established by ADQ, an Abu Dhabi-based investment and holding company, Acino focuses on delivering high-quality pharmaceutical products to emerging markets across the Middle East, Africa, Ukraine, CIS, and Latin America.

Speaking to the PharmaSource podcast at CPHI Milan, Samir provides detailed insights into managing complex manufacturing networks, implementing digital transformation initiatives, and steering the company's strategy through challenging market conditions while ensuring consistent medical supply to underserved regions.

Read the full article

“The GLP-1 agonist market is seeing unprecedented growth, and we’re investing €900 million to capture a fair amount of that business,” says Dr Mimoun Ayoub, Senior VP and Global Head of Sales at CordenPharma, outlining the CDMO’s most ambitious expansion plan to date in response to surging demand for peptide manufacturing.

Dr Mimoun Ayoub serves as Senior VP and Global Head of Sales and Key Account Management at CordenPharma, a full-service CDMO operating an extensive network of 11 cGMP facilities across Europe and the US. With decades of experience in pharmaceutical manufacturing and a deep understanding of the CDMO landscape, he oversees the company’s global sales strategy and manages relationships with key pharmaceutical and biotech partners.

Speaking to the PharmaSource podcast at CPHI Milan, Dr Ayoub provided detailed insights into CordenPharma’s expansion plans, particularly in the rapidly growing GLP-1 market, and discussed how the CDMO is positioning itself to support pharmaceutical companies’ evolving needs across multiple technology platforms.

Read the full article on PharmaSource

“The industry is back, and we’re uniquely positioned to provide end-to-end services, including clinical trials. That’s what we mean by CDMO plus CRO – it’s a complete 360-degree set of operations,” says Dr. Anil Kane, Executive Director and Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific.

Dr. Kane leads Thermo Fisher’s technical and scientific initiatives, bringing extensive experience in pharmaceutical development and manufacturing. His expertise spans multiple modalities, from small molecules to advanced therapies, positioning him at the forefront of innovative drug development solutions.

Speaking to the PharmaSource podcast at CPHI Milan, Dr. Kane explained Thermo Fisher’s latest initiative, Accelerator™ Drug Development, which combines their Contract Development and Manufacturing Organisation (CDMO) capabilities with Contract Research Organisation (CRO) services from their PPD acquisition. This integrated approach aims to streamline the complex journey from pre-clinical development to commercialisation, offering a truly connected and customisable suite of services.

The 2021 acquisition of PPD marked a pivotal moment in Thermo Fisher’s evolution, enabling the creation of a comprehensive service offering that spans the entire drug development spectrum. This integration brings together:

• Drug substance development
• Drug product development
• Clinical trial packaging and labeling services
• Full clinical trial management
• Specialised GMP laboratory testing
• Regulatory documentation support

“This combination of services brings efficiency, reducing cost and time for our partners to run drug development from very early stage, through clinical phases, to approval and bringing medicines to patients faster,” explains Kane. “We help our clients even put documentations together for IND, NDA, and other regulatory submissions.”

Read the full interview on PharmaSource

“Customer centricity is something that is lacking in our industry, and we knew we could do it differently,” says Adragos Pharma CCO Henny Zijlstra, discussing the company’s mission to transform pharmaceutical contract manufacturing.

Henny Zijlstra serves as Chief Commercial Officer at Adragos Pharma, a rapidly expanding contract development and manufacturing organisation (CDMO) headquartered in Munich. Since its founding in 2020, the company has grown to encompass five manufacturing sites across Europe and Asia, focusing on small molecule drug products.

In this exclusive interview from the showfloor at CPHI Milan, Henny shares insights into Adragos Pharma’s ambitious growth strategy, their customer-centric approach, and how digital transformation is reshaping traditional CDMO services.

Read the full article here

“Building relationships and transparent communication are key to successful outsourcing in cell therapy manufacturing,” says Jessica Brantley, Senior Manager of External Manufacturing at Sonoma Biotherapeutics.

Jessica Brantley, Senior Manager of External Manufacturing at Sonoma Biotherapeutics, brings a wealth of experience from her roles at Novartis and a decade at Fujifilm Diosynth. Her expertise spans both sides of the outsourcing equation, having worked as a programme manager for a CDMO and now managing external partnerships for a cell therapy innovator.

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system.

In the latest PharmaSource podcast episode, Jessica explains why getting supplier relationship management right is a crucial strategy for driving down costs and improving efficiency in the fast-moving cell therapy space.

Read the interview

Quality, Integration, and Culture: Key Lessons in CDMO Selection from Firelli Alonso

Firelli Alonso, former Senior Director of External Manufacturing at Pfizer, brings over two decades of experience in the pharmaceutical industry. With a PhD in molecular virology, she has spearheaded viral vaccine development and headed Pfizer’s pre-commercial outsourcing group, focusing on biologics manufacturing.

In the latest PharmaSource podcast episode, Firelli explains how she supports biotechs in finding quality outsourcing partners they can trust to deliver.

She shares invaluable insights on selecting and managing Contract Development and Manufacturing Organisations (CDMOs), drawing from her extensive experience with complex biologics, including monoclonal antibodies, vaccines, and antibody-drug conjugates (ADCs).

Read more

“Our job is to add value, rather than sell stuff and make money.” – David Anchell, Co-Founder and Managing Director of Camida

Camida are a specialist supplier of pharmaceutical raw materials, fine chemicals and intermediates to the life sciences industry, founded in 1988.

In the latest PharmaSource podcast episode, David Anchell shares his journey and insights on the challenges and opportunities in pharmaceutical raw material sourcing, emphasising Camida’s problem-solving approach and customer-centric focus.

David explains how the pharmaceutical industry has shifted from traditional chemical synthesis to biopharmaceutical production methods. This change has created new challenges in raw material sourcing:

“Biopharmaceutical production uses products that weren’t traditionally used in pharmaceuticals, like buffers, cleaning solutions, minerals, sugars. These were previously used as commodities, but now they’re critically needed for pharmaceutical production, which upgraded the quality needs.”

He further elaborates on the pain points this creates:

“Whereas the pharmaceutical raw material needs are USP, GMP, EP, etc., these products were made in hundreds of tons. I’m talking about things like phosphoric acid and sodium hydroxide, some of the phosphates. They were manufactured in huge quantities by commodity producers, and this industry suddenly needed this high quality. I don’t think that has been solved yet.”

Read the full article

“We hide behind that hubris of science, but we still have a lot of operational challenges to really impact the lives of our patients,” warns Sanjay Srivastava, Managing Director of Accenture’s Centre of Excellence for Cell & Gene Therapy. 

This sobering assessment cuts through the hype surrounding cell and gene therapies, highlighting the critical need to address practical hurdles in bringing these revolutionary treatments to patients at scale.

Sanjay Srivastava blends academic rigour with consulting acumen. With over a decade focused exclusively on cell and gene therapy, including involvement in launching the first CAR-T therapies, Sanjay’s insights stem from hands-on experience in navigating the complex landscape of this evolving sector.

In this PharmaSource podcast episode, Sanjay unpacks the intricacies of cell and gene therapy manufacturing, offering practical solutions to key challenges in scaling production, implementing automation, and balancing innovation with regulatory requirements. 

His analysis provides a roadmap for companies striving to translate scientific breakthroughs into operational success.

Read the full interview

“Quality oversight isn’t just about compliance – it’s about building successful partnerships and driving down costs,” asserts Stephanie Gaulding, Managing Director at Pharmatech Associates.

Stephanie Gaulding, Managing Director at Pharmatech Associates, brings over 30 years of experience in quality management within the life sciences industry. Her expertise in quality systems, regulatory compliance, and supplier relationship management provides valuable insights into effective quality oversight practices.

In a recent ⁠PharmaSource podcast episode⁠, Stephanie explains why robust quality oversight is crucial for successful supplier relationships and cost reduction in pharmaceutical manufacturing.

For more insights from Stephanie Gaudling, take ⁠Outsourcing Fundamentals⁠ – a foundational eLearning course on how to master biopharma outsourcing. Use the code POD100 for a discount

“What’s in it for the CDMO? That’s the crucial question. We’re not buying a service; we’re establishing a partnership. There has to be interest for both partners.” says Eduardo da Fonseca.

Eduardo da Fonseca, Head of Supply Chain at Bioeq, brings over five years of experience in building a virtual manufacturing operation from scratch. With a background in global companies like Nestlé, Roche, and Acino, Eduardo now leads Bioeq’s innovative approach to supply chain management.

Bioeq is a new Biosimilars company with a clear vision focused on launching specific products in key markets, utilising an out-licensing strategy for commercial distribution and an outsourcing strategy for manufacturing and supply.

In the latest PharmaSource podcast episode, Eduardo explains how he’s built up their value chain from raw materials to delivery of finished products, building a network of external partners and internal teams, to get them to where they are now.

Read the full interview on PharmaSource

--- Learn the essentials of successful biopharma outsourcing.

Outsourcing Fundamentals is a new eLearning course that consolidates best practices from 100+ expert interviews into 10 engaging modules.

Podcast subscribers can use the discount code POD100 to get money off. Sign up here

“Sustainability is not just a trend; it’s integral to our DNA,” says Teva’s Global Head of Sustainability

Amalia Adler-Waxman, SVP, Global Head of Sustainability and ESG and head of Corporate Affairs of International Markets at Teva Pharmaceuticals Industries, brings a wealth of experience from her roles in government, international affairs organisations, and the pharmaceutical industry. Her unique perspective bridges the gap between public and private sectors, offering invaluable insights into the evolving landscape of corporate sustainability.

Amalia Adler-Waxman’s journey with Teva began in 2016 as a consultant. Since then, she has led the company’s transformation into one of the ‘World’s Most Sustainable Companies’, as recognised by Time magazine.

In the latest PharmaSource podcast episode, Amalia explains how Teva’s commitment to sustainability has become a key strategy for driving positive impact and improving business performance.

“Building mutual understanding and trust is the foundation for optimising performance and driving innovation with contract manufacturing organisations (CMOs),” says Guosheng Zhao, Senior External Manufacturing Lead at LEO Pharma.

Guosheng Zhao brings years of experience in procurement, management consulting at PWC, and working with contract manufacturers at companies such as Procter and Gamble and Philips to his role.

At LEO Pharma, Guosheng is responsible for external manufacturing of dermatology and thrombosis medicines, a portfolio spanning both small molecules and biologics, with a focus on maintaining stable product supply and quality across complex global supply chains.

In the latest PharmaSource podcast episode, Guosheng explains why effective supplier relationship management is crucial for reducing costs, improving margins, and ensuring consistent medicine supply for patients.

Read the full article on PharmaSource

“Supply chain leaders make things work. They get things done, but they don’t shine,” says Knut Alicke, McKinsey Partner and co-author of ‘From Source to Sold‘. 

‘From Source to Sold’ contains a series of interviews with top Supply Chain leaders, showcasing the stories of their journeys to leadership positions. Knut’s research revealed that only 11% of CEOs in the Fortune 200 had a supply chain background, highlighting the untapped potential for supply chain professionals to reach top executive positions.

• For more book recommendations, checkout the PharmaSource Book Club

In the latest episode of the PharmaSource podcast, Knut explains why recognising and developing supply chain leadership is crucial for driving strategic growth and innovation in corporates.

He explains that the ‘CHAIN’ model was developed from the interviews. It is a framework for professionals looking to enhance their supply chain management skills and advance their careers.

Read the full interview on PharmaSource

“The best CDMO is the one you haven’t worked with.” says Audrey Greenberg.”That’s really unfortunate.. it’s not that hard to be a good service provider.”

Audrey is the Founder of Centre for Breakthrough Medicines, the innovative, Pennsylvania-based Cell & Gene therapy Contract Development and Manufacturing Organization (CDMO).

Audrey launched and then sold the company to SK Pharmteco, where she is currently is Chief Business Officer for their wider CDMO business that operates facilities in United States, Ireland, France, and South Korea.

In the latest episode of PharmaSource podcast Audrey discusses her journey in launching a CDMO that put digital at the centre of operations right from the start.

“Digital infrastructure is an important piece that people underestimate.” say Audrey.

Read the full interview

“CDMO environments can often be very tough and chaotic, requiring leaders who can navigate uncertainty" says Neil Kelly, CEO and founder of Vector, a company specializing in talent solutions for the biopharma industry. 

"To succeed in this sector, you need to be able to thrive in 'grey' areas. Not all leaders can handle this kind of environment."

At CDMO Live 2024, a poll of attendees indicated that leadership skills was the most significant talent-related issue that was holding their company back from achieving growth.

“Strong leadership is critical in any organization, but it's especially vital in the fast-paced and complex world of CDMOs." says Neil, speaking on the PharmaSource podcast.

Read the full interview

Kurt Nielsen, Ph.D. shares his strategies for sponsors to extract maximum value from contract service providers, the overlooked benefits of AI, and the shifting dynamics of the global supply chain.

Kurt has an extensive background in contract development and manufacturing, having previously held senior leadership roles such as CEO at Pharmaceuticals International, Inc. (PII), President of Lupin, VP at Sandoz, SVP at Catalent, and EVP at Teva. His consultancy, Longview Leader, assists life sciences clients with continuous improvement and asset management.

“The work we do every day truly makes a difference in people’s lives,” says Kurt. “Putting aside the politics and profit debates, at its heart, the pharmaceutical industry’s mission is to improve health, cure diseases, and enhance quality of life makes it an amazing place to work.”

Read the full interview

UK Biocentre is a respected leader in sample management, high-capacity bioprocessing & analysis, and automated storage.

With the capacity to store 35 million individual sample, it is the main processor for many of the UK’s government genetics projects, including the ambitious Our Future Health project which aims to collect and analyse the genetic samples of 5 million residents.

We sat down with Dr Tony Cox OBE a molecular biologist and CEO of UK Biocentre to discuss the centre’s pivotal role during the COVID-19 pandemic, and how they have returned to supporting ambitious biopharmaceutical projects.

“I’ve always been fascinated by DNA and the concept of information moving between generations. It blows my mind that something as simple but as complex could have arisen,” says Dr Cox. “We have a vibrant life science sector in the UK. It’s a fantastic place to be doing genetics."

Read the full article

“The healthcare industry is responsible for 5% of global emissions, which is more than aviation,” says Robert Williams Director of Sustainable Procurement at AstraZeneca.

As Vice Chair of the Pharmaceutical Supply Chain Initiative (PSCI), he regularly engages with a wide cross-section of stakeholders from across the industry.

The PSCI is the leading association for pharmaceutical and healthcare companies, focused on driving an agenda for safety, environmental, and social outcomes across the global value chain.

The 81 members of the association, and the 1,000 registered suppliers, have a combined turnover of $1.3 trillion USD, representing approximately 80% of the global pharmaceutical industry (which is estimated to be $1.6 trillion USD).

Speaking to the PharmaSource podcast ahead of CDMO Live, Rob explains that working with suppliers is critical if the pharma industry is to realise its ESG and Net Zero ambitions.

“As more than 80% of PSCI member companies’ emissions are in the supply chain (97% in the case of AstraZeneca), the focus has to be on working closely with suppliers to achieve decarbonisation goals.”

“It’s clear that there is more that needs to be done globally, as we go beyond tier one and two suppliers, right back to the raw materials that we use,” he says.

Read the full article

Founded in June 2020, INCOG has secured FDA-approval and now establishes itself as a new force in contract manufacturing with a focus on sterile injectables. 

As we gear up for CDMO Live, we had the opportunity to speak with Corey Lewis, CEO, President, and Founder of INCOG Biopharma Services, about their dedicated approach to serving customers in the high-growth sterile injectable market.

Despite the company only being four years old, INCOG’s leadership team brings decades of industry experience. Cory says he has brought the ‘band back together’ by reuniting seasoned professionals to create a tier-one contract manufacturing organisation (CDMO).

“Our goal is to compete at the highest level, and that requires a seasoned executive team with a robust investment strategy.”

INCOG’s investments in vial, syringe, and cartridge filling capabilities are “just the beginning” says Lewis. “We’re also expanding into quality control, lab stability services, and eventually, auto-injector device assembly and final packaging. Our long-term site master plan outlines our ambition to not only enhance  filling capacity, but also integrate additional business units to support commercial packaging and device assembly.”

Read the full interview

UniD Manufacturing are the first global Contract Development and Manufacturing Organization (CDMO) fully dedicated to micro-implants based on sustained release and polymeric formulations.

2024 is an important year for UniD Manufacturing, their first as a CDMO open to external customers, with new projects expected to be launched by the year’s end.

Ahead of CDMO Live 2024, Chief Operational Officer Pascal Bertholet shares the company’s innovative strides in micro-implant technology and their vision for a sustainable future.

“2024 marks a significant year for us as we undergo a substantial shift in our business approach.” says Pascal. The company was originally established to develop ocular implants for sister company, EyeD Pharma, but has recently expanded to offer small implants in other therapeutic areas.

“What sets us apart is our expertise in developing both the formulation and the manufacturing process for micro-implants that release active ingredients according to a specific dissolution profile. This can range from a few hours to several years. Our formulations include biodegradable, non-biodegradable, and resorbable polymers,” explains Pascal.

Read the full article on PharmaSource

Prasfarma is a company full of experts in the manufacturing of cytostatic and highly potent products (HPAPI), with a focus on oncology.   

Ahead of CDMO Live we spoke to Diana Alarcón, Business Development Manager at Prasfarma to understand more about the services they offer by the Barcelona-based Contract Development & Manufacturing organisation, and how they have become Annex-1 ready . 

“Prasfarma has made significant investments adapting their facilities and machinery to Annex 1 requirements for the manufacturing of sterile projects. We have expanded our facilities and increased both production and analytical departments.”

Prasfarma has a reputation for working under an agile strategy. We consider our clients as our partners.

“One of our main value is our flexibility. We work on tailor-made projects and we adapted to our customer’s needs” says Diana. 

Read about their upcoming roundtable on Annex 1 here

Vitema is a fast-growing Contract Development and Manufacturing Organization (CDMO) based in Sibiu, Romania.

With one of the largest GMP-certified pharmaceutical manufacturing facilities in Europe, new management team and assets worth over €100 million, they have ambitious goals.

Ahead of CDMO Live we spoke to Diana Serban, the Head of Commercial and Business Development at Vitema.

Diana describes the company as “More than just a CDMO: we are a robust ecosystem that supports the entire pharmaceutical development lifecycle.” This includes everything from the research and development of medicines and food supplements to full-scale production. Vitema also boasts specialised capabilities for oncology products and clinical trials.

Vitema has more than 20 years experience in the pharmaceuticals market, and prides itself on its ability to assist pharmaceutical, biotech, and healthcare companies in delivering high-quality medicines and food supplements to their customers. They offer integrated services, full transparency throughout the entire manufacturing process, and highly competitive pricing data.

Read the full article

Aizon is on a mission to integrate modern computing into the complex arena of GMP manufacturing processes in life sciences.

In the latest episode of the PharmaSource podcast we sat down with Claus Abildgren, Chief Revenue Officer at Aizon, and David O’Gara, Strategic Advisor to Aizon to understand how artificial intelligence can make an impact on manufacturing in the highly-regulated industry.

“Our goal is to evolve the industry by taking pragmatic steps towards enhancing manufacturing performance through practical applications.” says Claus. “We aim to optimize the current capacity of manufacturers and utilize artificial intelligence to anticipate and mitigate the risk of adverse events with predictive capabilities.”

When producing drug products under stringent GMP conditions, “ensuring quality is fundamental. This includes securing data integrity and maintaining comprehensive audit trails—key aspects of deploying technology in a highly regulated environment.”

Leveraging the data generated at a plant leads to identifying opportunities for yield improvements, thereby ensuring high-quality production, delivered on time and at reasonable costs. says David.

“Automated quality reports can significantly reduce the workload for quality organizations and production plant chemists.”

Deploying this technology, especially at CDMOs and for their sponsors, can yield substantial returns, particularly with high-value molecules where even a 1% improvement can have a remarkable impact on return on investment.

Read the full article

“The biggest challenge for scientists to understand that it’s not just your expertise that people are buying, it’s your ability to connect with their problem.” 

Dr. Jeff Kiplinger, a former scientific leader at Pfizer, founded, scaled and sold Averica Discovery Services, a Boston-based CRO specializing in early-stage contract research and analytical development.

Now best-selling of author “Expert to Entrepreneur” and consultant, his company Selling Science advises contract service providers on how to improve their science selling techniques.

Ahead of his lighting talk at CDMO Live, we sat down with Jeff to discuss how CROs and CMOs can position themselves for success in today’s crowded marketplace, and advice for outsourcing leaders in selecting the right partner for their business.

Pfizer CentreOne is an “altogether different kind of CDMO”. Unlike a pure play contract development and manufacturing partner, they don’t own their own plants and pharmaceutical development centres. Instead their customers can leverage the wealth of expertise and state-of-the-art facilities Pfizer possesses.

Ahead of CDMO Live 2024 we sat down with Tom Wilson, VP of Global Contract Manufacturing at Pfizer CentreOne, to discuss how their integrated business model sets them apart from other contract manufacturing partners.

Pfizer CentreOne offers a comprehensive range of services including small molecule API, solid oral dose, sterile injectables, biologics, and cell & gene therapies.

“Pfizer spends over a billion dollars every year to maintain our global network of 38 plants.” says Tom.

“When we bring a client partner on board, they get access to the same manufacturing work centres, scientists, and analysts that Pfizer uses for its products. We have robust ways of controlling intellectual property, ensuring we’re protecting our clients and our own IP.”

“Pfizer’s main mission statement is ‘time is life’. We bring that patient centricity to our CDMO practice. Clients are usually surprised that we’re not talking immediately about our technology, but instead about their patient’s journey, then how can we help make a difference.”

Read the full article

“Good quality supplier data is the backbone of procurement,” says Lana Radosevic,  Global Supplier Lead in Procurement Excellence at Astellas

In her role in Procurement Excellence, Lana Radosevic’s primary focus is on improving supplier data quality across all SaaS systems used by Global Procurement and integrating supplier data. 

In the latest episode of the PharmaSource podcast she explains the importance of accurate supplier data and  shares her experience in driving improvements.

Read the full article on PharmaSource

Terumo is a mid to large size-global medical device company based in Japan, with offices in over 160 countries around the world and over 50,000 products and services.

The Terumo Pharmaceutical Solutions Division, also known as ‘PSD’, is a leading manufacturer of injectable solutions – including primary container, infusion therapy devices, general drug delivery devices – and contract development manufacturing (CDMO) services for parenteral drugs.

“2024 so far has been very good for us.” says Marco Chiadò Piat, President of Terumo Pharmaceutical Solutions Division.

“We’re seeing continuous growth this year, as we did in 2023 and 2022. Continuous growth in capabilities, the solutions we provide to our pharmaceutical customers, and hence a continued increase of the positive impact that we have on patients worldwide.”

Ahead of CDMO Live, we sat down with Marco and Anil Busimi, Vice President Strategy & Marketing at Terumo Pharmaceutical Solutions Division, to discuss the integrated CDMO services that Terumo offer to their growing, international customer base

Read the full article

Grand River Aseptic Manufacturing (GRAM), as the name suggests, is a leading sterile injectable drug manufacturer based in Grand Rapids, Michigan. Following significant investments in state-of-the-art facilities and equipment, GRAM has capacity for fill-finish biologics, small molecules, and vaccines.

Ahead of CDMO Live, we had the opportunity to sit down with David Powell, Vice President of Business Development at GRAM.

“We strive to have the latest manufacturing technology. All our equipment is always cutting-edge. But at the same time, as a good old Mid-west company, customer focus, authenticity, and transparency are the hallmarks of who we are.” say David

During the COVID-19 pandemic, GRAM helped manufacture the vaccine. “We pivoted and quickly invested in more capacity. Now, post-COVID, we have a significant amount of capacity available to our customers, with a total of three fill lines and a fourth on the way,” David explained.

With newer capabilities and facilities, GRAM has pivoted to specialize in biologics fill-finish.

“That is where our sweet spot is. We’re not into drug substance, we’re not in oral solids, we are really just focused on fill-finish and helping our customers, large or small, take their products through and get it to market.”

GRAM have announced plans for a third manufacturing facility focused on syringe and cartridge filling to complement existing capabilities.

“We’re leaving plenty of space to also get into more downstream auto injector and other device manufacturers assembly for our syringe and cartridge customers. We realize we need to continue to expand in there to match the market demand.”

• Read the full article on PharmaSource

Bayer Consumer Health heavily relies on contract development and manufacturing, maintaining a network of nearly 200 contract manufacturers that account for approximately half of their global sales.

This is set to change with the Project Martini initiative, which aims to significantly “shake up” and consolidate their network of contract manufacturers.

Speaking ahead of CDMO Live, David Buhmann, Vice President of Procurement Finished Goods, explains the new strategy and its critical importance to Bayer.  

“Contract Manufacturers are an integral part of our overall supply chain. We require top-tier partners to ensure that we fulfil our mission of helping over 1 billion people lead healthier lives with the most trusted selfcare solutions in the market. This includes every link in the supply chain, including the CMO network.”

Over the years, Bayer’s contract manufacturing network has grown organically, resulting in a situation where the company now collaborates with nearly 200 CMO sites, accounting for roughly half of the company’s revenue.

“Our priorities shifted rapidly during the COVID-19 pandemic,” says David. “Initially, our focus was on securing materials and supplies at any cost. However, more recently, we’ve shifted our attention to cost management and cash flow, right-sizing the inventories that accumulated during the pandemic.”

Read the full article on PharmaSource

Onyx Scientific is a Contract Development and Manufacturing Organization (CDMO) that specializes in process R&D, non-GMP scale-up, and GMP manufacture for clinical trials and commercial applications.

With facilities in the UK and US, their dedicated teams in chemistry, solid-state and analytical chemistry guide small molecule Active Pharmaceutical Ingredient (API) products through development and manufacturing.

In anticipation of CDMO Live, we had a conversation with Chris Atherton, the Commercial Manager of Onyx Scientific, who shed light on their business operations.

"Onyx was one of the first chemistry CDMOs to invest in solid-state, and we plan to continue investing in this area in the future." says Chris.

Established in 2000, Onyx Scientific has garnered 24 years of successful experience within the preclinical development space, completing thousands of development projects. Their pragmatic ‘fit for purpose’ approach is centred on intelligent rapid process development with an eye towards future GMP campaigns.

Connect with Onyx Scientific at CDMO Live

“Contract negotiations are often perceived as a POWER GAME but in reality, it has to be a collaboration.” says Dr Roxana Timmermans

In the latest episode of the PharmaSource podcast, Dr. Timmermans explains why contract negotiations are of critical importance in pharma outsourcing and shares her framework for success.

“Proper negotiation, is the foundation of a strong partnership. In the highly regulated world of pharma contract manufacturing, precise terms are essential."

"Negotiation skills are not just desirable; they are paramount, says Roxana. “If you not trained you will put the company in a very damaging position.”

Read the interview The Art of Contract Negotiations

While pharmaceutical companies have proven the return on investing in digital at early stages of drug discovery, manufacturing has been slower to embrace digital transformation.

To understand how pharma R&D and manufacturing can unlock more business value through adopting digital tools and technologies, we speak to Digital CMC consultant Mark Buswell.

Mark is a chemical engineer by training, with over 20 years in R&D and Manufacturing at GSK, before joining NGT BioPharma consultants to head up Digital CMC services to help pharmaceutical companies navigate digital transformation of their CMC function.

Read the full article on Digital CMC Maturity on PharmaSource

In 2024 the world of Contract Development & Manufacturing has been going through a period of major upheaval.

Since the start of the year, every day have been significant acquisitions or investments in the CDMO space. In the United States there are highly significant legislative changes working their way through Congress which will re-define the industry.

Ahead of his talk at CDMO Live, we spoke Gil Roth, President and founder of the PBOA (Pharma & Biopharma Outsourcing Association) to give us his take on all the challenges and opportunities faced by this dynamic sector.

• For more insights into the changing contract manufacturing landscape in the United States, don’t miss Gil’s expert talk at CDMO Live in June, where he will be sharing his insights on How the upcoming US Election and Legislative Changes could Impact CDMOs. Register here for your free ticket

Alcami, a contract development and manufacturing organization headquartered in North Carolina, is in a period of high growth.

With more than 50 years of experience advancing products through every stage of the development lifecycle, Alcami serves pharmaceutical and biotech companies of all sizes for small molecules and biologics – primarily in the United States.

Ahead of CDMO Live, we sat down with Kerrie Powell, Senior Vice President of Sales at Alcami Corporation, to understand more about the services that the company offers to clients, and how they help clients to navigate the the fast-changing contract manufacturing landscape in 2024.

Register today for your free ticket

Supplier Relationship Management is a ‘systematic approach to evaluating vendors that supply goods, materials, and services to an organization. It involves determining each supplier’s contribution to success and developing strategies to improve their performance’.

Anirban Mukherjee, Head of Procurement at Immunovant, argues that while Supplier Relationship Management (SRM) is crucial for achieving high performance in complex industries such as pharma and biotech, it often receives insufficient attention.

In the latest episode of the PharmaSource podcast, Anirban explains the steps to take when implementing a successful SRM programme, drawing on his experience at Ford, Becton Dickinson, and Gilead, where he served as the Global Head of Development for outsourced vendor management.

Anirban is passionate about SRM in driving business outcomes: “Over the course of your career, you realize what you deeply believe in” he says.

Read the full article here

On International Women's Day 2024, the PharmaSource community hosted an important debate, asking "how can the biopharma industry do better at supporting and elevating women into leadership roles?"

The panel included Elke Geysen, SVP Head of Global Procurement and External Supply at Grünenthal Group, Roxana Timmermans PhD, Supply Chain Procurement & Global Alliances Leader and was chaired by Alicia Ryan, Principal Consultant at Proxima.

Read the full Women in Pharma article on PharmaSource

In today’s episode we talk about real-world applications of AI and Pharma 4.0 and how it can make a difference to Pharma Manufacturing.

Our guest is Daniel O’Mahoney a Digital Transformation consultant in the Life Sciences, working for Körber Pharma, and Part-time Lecturer in Pharma 4.0 Bio-Industry 4.0 NIBRT National Institute for Bioprocessing Research and Training

In this interview, we talk about how to get started with Pharma 4.0, a concept that applies the principles of Industry 4.0 to the pharma sector, and some of the ways that technology can be used to improve the productivity of pharmaceutical manufacturing.

Read the full interview on PharmaSource

“Honesty is between sponsor and contract manufacturer is essential,” says Philip Coetzee, Director CMO Management for Daiichi Sankyo Europe.

“Be honest. I find it very difficult to work with someone who tells me ‘half-truths and whole lies’. I’d rather someone say – ‘someone messed up’ than try to hide it. It’s human. Things happen.”

In the latest episode of PharmaSource podcast Philip talks about his experience on both sides of the table - from his experience working at Catalent and now leading contract manufacturing outsourcing Daiichi Sankyo Europe

Successful partnerships thrive on trust, transparency, and genuine connections. Here are some key takeaways from Philip’s insights on optimising relationships with Contract Manufacturing Organizations:

• Build Personal Connections: Philip emphasizes the value of one-to-one relationships with key account managers. Getting to know them personally fosters better collaboration and understanding.

• Smaller CMOs can be more rewarding: Philip finds working with smaller CMOs more rewarding. It allows him to connect with key personnel, including CEOs, on a personal level.

• Appropriate Honesty: Philip advocates for sharing relevant information with CMOs. Explain why their quote wasn’t accepted, and provide constructive feedback. More information is better than too little.

Read https://pharmasource.global/content/dos-and-donts-of-managing-contract-manufacturers-interview-with-philip-coetzee-daiichi-sankyo/https://pharmasource.global/content/dos-and-donts-of-managing-contract-manufacturers-interview-with-philip-coetzee-daiichi-sankyo/

DON’T MISS!

Philip will be hosting a roundtable at #CDMOLive on the topic of how to run better RFP/RFQs. To join the session, sign up here

Bernardo Estupiñán has a career spanning chemistry and business development, and now working as a consultant to guide companies developing new biopharmaceuticals through contract manufacturing

In this interview we talk about his advice for how biotechs can successfully navigate the contract manufacturing landscape in order to bring new products into the clinic on budget.

“The biggest challenge? Money. “ says Bernardo.

Key considerations for Biotech contract manufacturing 1. Manufacturing Location Matters

2. Standardise processes to reduce costs

3. Find the right size and cultural fit

4. Document everything for a Smooth Tech Transfer

Read the full article How to navigate contract manufacturing in biotech

“Sustainability is giving more than you take.”

Fred Turco is Vice President of Enterprise Indirects and Sustainable Sourcing Lead at Pfizer.

In the latest episode of the PharmaSource podcast he explains how the company is making progress towards its targets by collaborating with suppliers.

The Enterprise Indirects team Fred manages operates across 85 countries and 300 facilities managing the majority of indirect spend, and play a key role in driving the sustainability agenda for the company.

Speaking to the PharmaSource podcast he shares his advice for how to be a successful procurement business partner and how Pfizer are making real-world progress towards a more sustainable business.

Read the full article here

“Small to midsize biotechs are the future of the biopharma industry” says Stefan Verhayden, Global Vice President of GX biological solutions and syringes at Gerresheimer. Stefan leads the company’s packaging and drug delivery services in the fast growing biopharma segment.

“They are the ones develop molecules that then afterwards, either go commercial to themselves or are being picked up by the bigger biopharma companies that then will bring them to a commercial phase.”

In the latest episode of the PharmaSource podcast, he explains some of the challenges biopharma customers face, such as personalised medication.

Read the full article

AlfaSigma, the Italian pharmaceutical company, has undergone significant changes with three acquisitions in the last 12 months.

At the same time Fabio Russo, who recently joined as the Chief Procurement Officer, is pioneering a transformation of the procurement function.

Leveraging his background in management consulting, he is introducing a new target operating model that repositions the procurement function as a strategic business enabler to support the company’s growth.

“Consulting is very much about delivering concepts and designs. I missed rolling up my sleeves and going into execution mode. I’ve joined AlfaSigma at a very exciting time,” he says.

In the latest episode of the PharmaSource podcast, Fabio breaks down his strategy, the digital journey that the team is embarking on, and how to stay aligned with the needs of an evolving business.

Read the full story on PharmaSource

Grifols Partnership, is a contract development and manufacturer (CDMO) focused on added-value injectable products for small molecules, headquartered in Barcelona, Spain.

In this episode of the PharmaSource podcast, Marga Viñes Senior Business Development Manager for Grifols contract manufacturing, explains the drug development and manufacturing services that they offer to customers.

“Grifols is mainly known in the blood-derivatives field.” says Marga. 

Additionally the company’s “contract manufacturing experience in injectable drugs led to us offering CDMO services focusing on Orphan drugs. We are very specialised in small-volume parenteral manufacturing.”

Read more on PharmaSource

Negotiating for yourself can be challenging. If you are a woman there are still implicit biases you might face, and self-doubt that can undermine your confidence and performance. Yet, knowing your worth and negotiating for it is crucial for advancing your career, increasing your income, and achieving your goals.

In the latest Women in Pharma Procurement meetup, our expert panel shared best practices for how to negotiate for yourself effectively, overcome common barriers, and close the gender pay gap.

Why it matters:

• Continuing gender pay gap: In 2021, women earned only 83% of what men earned in full-time wage and salary roles. After an MBA, the gap widened to 63% ten years later.
• The long game matters: A small difference in starting salary can have a huge impact on your wealth over time. For example, if you get a $100,000 salary and your co-worker negotiates up to $107,000, you would have to work eight years longer to be as wealthy as them at retirement.

Read the full article

Clinical research is a vital part of developing new treatments and cures for diseases. But it is also a complex and challenging process that faces many obstacles and inefficiencies.

Scott Schliebner is a Clinical Development Executive and advisor to early-stage biotech companies, helping them to design and execute clinical trials.

In the latest episode of the PharmaSource podcast, he shares his insights on some of the current problems and opportunities in clinical research, and how biopharmas can navigate the complex CRO industry in 2024.

Read the full interview here

Malik Akhtar is Vice President at Bayer Consumer Health Division, where he oversees a network of 5000 suppliers, including direct materials, APIs, and 180 contract manufacturers.

Speaking on the PharmaSource Podcast, Malik explains the “Three C” procurement strategy which defines the areas of greatest focus for Bayer in 2024 and beyond:

• Cost Containment
• Cash-Flow improvement
• CO2 De-carbonisation

Read the interview here:

“We want to be the leader in decarbonisation of the glass industry.” says Olivier Rousseau, Chief Executive Officer of SGD Pharma.

SGD Pharma is a worldwide manufacturer of molded and tubular glass for pharmaceutical primary packaging, producing 8 million vials and bottles per day.

In the latest episode of the PharmaSource podcast, Olivier sets out the company's plans for 2024 and explains how the whole company is now lazer-focused on being the most sustainable in the industry.

“2024 will be a full year of innovation” says Olivier. “We are on a growth path” with new partnerships and facilities being announced to join its existing global infrastructure of five ISO 15378 certified GMP compliant manufacturing plants.

SGD Pharma's Decarbonisation Strategy

Decarbonisation is now the company's top priority, explains Olivier.

"Our goal is to clearly lead the pharmaceutical glass primary packaging industry. We truly believe that more drug manufacturers will look to carbon levels and sustainability strategies to choose their suppliers."

"We had the ambition of reducing our CO2 emissions by 35% by 2021, and now we are working towards reducing them by 65% by 2040." he says.

“We are investing significantly in the decarbonisation of all our industrial processes and working with customers and partners across the full value chain to uncover scope one, scope two and scope three emissions to get to our goal."

Some of the decarbonisation initiatives for SGD Pharma include:

1. Hybrid furnaces

2. Re-designing industrial processes

3. Collaborating on lighter products

4. Working across the full value chain

Read the full article

“Biology is the most complex system in the known universe." says Markus Gershater, Chief Scientific Officer and Cofounder, Synthace. "The fundamental problem we're trying to solve is to how to experiment with something as complex as biology.“

In a recent survey conducted by the digital experimentation platform, 87% of scientists said their greatest challenge “keeping track of all the different elements involved” with experimentation.

Synthace’s mission is to help scientists to navigate and unpick complexity, helping them to understand what’s going on with their experiments and ultimately discover better therapeutics and biological solutions.

Read the full article on PharmaSource

BD Medical - Pharmaceutical Systems provides a broad range of parenteral drug delivery systems including glass and plastic pre-fillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure pharma meets its drug delivery goals.

An this interview with Dragana Cvijanovic, Business Director, Processability & Sustainability and Marie-Liesse Le Corfec, Business Head of B2B Medication Delivery Solutions, BD (Beckton Dickinson) we discuss BD's patient-centred innovations and why the industry must do more to achieve sustainability targets.

Read more How Realistic are Pharma’s De-Carbonisation Targets?

In an uncertain world rife with cost inflation, the pharmaceutical industry is seeking innovative solutions. René Wienmann, Chief Procurement Officer at Chr. Hansen, is leading the charge with data-driven procurement insights that are driving savings and sustainability.

René, who proudly identifies as a “procurement nerd or geek,” is leveraging technology to navigate the increasing complexity of procurement in a volatile, uncertain, complex, and ambiguous (VUCA) world.

In the latest episode of the PharmaSource podcast, René elaborates on his data-driven CPO procurement strategy. Read the full article

What is the best way to make progress towards pharma’s net zero targets? “Get started,” says Chris Shanahan, VP Global Sustainability Supply Chain at Thermo Fisher Scientific.

“Starting can be intimidating and overwhelming. There’s a lot going on, and we don’t always have all the information. But if everyone gets started, we will eventually come together. Don’t put it off.”

Chris Shanahan leads Sustainability efforts for the Thermo Fisher supply chain, following a career in life science procurement at GSK (then Haleon), BD, before joining Thermo Fisher Scientific where he spent the last 17 years as a CPO.

Chris explains why he transitioned from a procurement lead to a sustainability lead. “It’s really about creating something for the future for my own children. Climate change and unusual weather events are here and when you think about the impact we can make on supply chains, we are in a position to influence this and make things happen.”

“Climate-related issues, water waste, human rights, or ensuring fairness for workers in the workplace, these are all topics that are rapidly changing and evolving. In the last 12-18 months, I have seen a lot of change in terms of what expectations are, regulation in Europe and the US, and investors are asking about what companies are doing across sustainability ESG.”

“The way I think about my role is getting things done: executing and pulling through the commitments that companies make. That’s what we’re doing at Thermo Fisher.”

Ambition and Realism

While disruptive events like the COVID pandemic and global inflation may have changed the ability for companies to invest at a quicker rate, senior leadership at Thermo Fisher Scientific have ring-fenced their commitment to make sure that the investment is still there, says Chris.

Thermo Fisher Scientific’s net zero targets are broken down by scope and near and long-term targets

“Our ambition is net zero by 2050. My role is to say, how do we really make it happen? What are the things we must do?”

“Infrastructure needs to change, behavioural changes need to happen, you need to bring people along. It’s all about aspiration, and how quickly you can push, but also, what’s really logical and rational to get there. Some of this stuff takes time.”

Chris gives the example of sites, in countries and states where the grids and the infrastructure are not ready. “If we set a 2030 goal or 2040 goal, we know it’s not realistic because we’re dependent on so many other factors.”

“The investment cycle might get slightly delayed. Inflation is a pretty significant impact on costs, but it doesn’t take away from the actual commitments for 2030 or 2050.”

“It’s about balancing the portfolio as we go through this period. Most companies will go through this sort of pain and hurt and cycle. As you look over history, inflation happens but good times come back. It’s really about how do you flatline and balance that over periods and when you get the good times, you might need to accelerate the investment.”

Educating colleagues and the industry

Educating colleagues, peers and suppliers is critical if the industry will progress together, says Chris.

“Sustainability is something we all have to get educated on. It impacts everything – how we buy, where we place things. Education on the basics of scope one, scope two and scope three helps people to understand what sustainability really means and how to address the challenges.”

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Marketing in pharma can be tough. In the contract manufacturing space where the services of one provider might look very similar to another, it can be a challenge to build a distinctive brand and to target at customers at the right moment in their drug development process.

In the latest episode of the PharmaSource podcast, Elliott Berger – formerly Chief Marketing Officer at Catalent and currently Strategic Advisor for Orientation Marketing and Fractional CMO – shares his insights into how marketing can make a real impact in this industry.

From babies to baby molecules

Elliott has previously held a series of senior positions in J&J Consumer Group of Companies on world famous brands like Johnson’s Baby. “In consumer health we would spend literally hundreds of millions of dollars to experiment and work the best talent, best agencies, the best creatives and the biggest media companies”.

He then applied those lessons to Catalent where he led “one of the most active and aggressive marketing programmes in this industry”.

Elliott found the biggest change in moving into B2B was to “adjust from large, emotional marketing to drive impulse purchases” to targeting a business customer “who are trying to buy complex projects with multiple stakeholders, multiple influencers or large process large spending over a period of time.”

Elliott draws a direct comparison between targeting pregnant women, who are at a clear stage in the baby’s development, and targeting pharmaceutical executives who are nurturing their “baby molecule” through the drug development process.

In this interview he shares the following best practices for marketing that can cut through the noise.

Read the full article

Lonza Capsules and Health Ingredients is the global leader in the capsule manufacturing market, says Julien Lamps, Associate Director of Global Product Management.

Speaking on the PharmaSource podcast, Julien explains how Lonza support the pharmaceutical industry with a range of science-backed capsule innovations.

“We are the most well-known in the market for our Capsugel® brand products” says Julien.

“Our manufacturing footprint is well established. We have 10 manufacturing sites worldwide, in every region of the world, producing 250 billion capsules a year”

This scale means Lonza are able to deliver products worldwide to any pharmaceutical customer regardless of geography or regulatory requirements.

“We are really focused on bringing innovations to the market. We helping our customers find new ways of delivering drugs and enabling people and patients to live a better life”

Along with pharmaceutical business, Lonza have a large customer-base in the nutrition industry where their capsules are used for vitamins and minerals.

Why capsules are the patient-friendly option

The common challenges that pharmaceutical manufacturers face is to “improve the bioavailability of drugs” says Julien. “Making sure that they are delivered with the smallest amount within the body, with efficient and consistent delivery”

“Capsule are by essence the easiest dosage form. They are very convenient to store, to ship and to get into your body in a simple way.”

Julien points out that capsules are a far better patient experience than using syringes and injection, with all the complications this involves for patients and clinics.

Enteric-coated capsules

The biggest products in the Lonza portfolio are capsules that dissolve in the stomach to deliver their contents in either liquid or solid form.

Julien explains that recently they have developed a new range of Capsugel® Enprotect® capsules, which are designed for release in the intestines.

“Capsugel® Enprotect® capsules are our latest innovation in the pharmaceutical space. It is a dual-layer capsule that will withstand the acid media of your stomach and will deliver only once it has reached the small intestine.”

Enteric properties are built in, the capsule eliminates the need for additional enteric manufacturing steps such as adding solvents.

Smart Pills are on the way

Julien confirmed that ‘Smart Pills’ are a key trend he believes will become a mainstream reality in the next five years, with some projects already in progress.

“Smart capsules communicate more information to patients and healthcare professions. They can share information which can help to improve the efficacy of the treatment and ultimately improve patient adherence” he says.

Collaboration with customers

Collaborating with partners is key for Lonza Capsules and Health Ingredients, Julien says.

To help collaborate with customers, Lonza have recently launched the Lonza Capsule Application Lab, a physical facility in France where customers can visit to define their needs, develop projects and launch a proof of concept is done.

His advice is to look for parter with a strong regulatory background, who will help you understand what constraints and opportunities you face in the pharmaceutical industry, and who can prove the performance of their products with data.

“In capsules there are many players, but customers need to ensure they speak to suppliers who are backed up with scientific research” says Julien.

Read more on PharmaSource

Ray Sison is the Managing Partner for SCxCMC, connecting biotech companies with highly qualified CDMOs, strategic consultants and independent contractors.

Changing contract manufacturer is not a decision to be taken lightly, yet can be necessary to take a product to a commercial stage says Ray Sisons.

Ray Sison is the Managing Partner for SCxCMC, a consultant who specialises in connecting biotech companies with highly qualified CDMOs and independent contractors.

In his work with early stage biopharmas, Ray often finds they are managing several contract manufacturers without a formal supply chain strategy or procurement function.

"There's the supply chain you launch with, and then there's the supply chain, you actually will use in day-to-day commercial operations." he says.

"Often when we arrive we find a cobbled together set of Contract Manufacturers (CMOs) that may or may not have had the proper commercial skillset or capacity to meet the long term forecast for the product."

In the latest episode of PharmaSource podcast, Ray Sisons shares his advice on how to manage CMC and Supply Chain partnerships.

Vendor Selection

"From the very beginning, a clear project definition really sets your priorities. You need to know what it is you're trying to outsource, where you are in the business cycle and what's your exit."

"A client that is looking for a 'one stop shop' is very different to a biotech that just needs to get prototypes and preliminary stability work done."

"Bottom line, you need the right voices at the table to set the selection criteria." says Ray.

"It's not just the scientist at the bench that has the final say on who you outsource, you need to talk to your quality, compliance and regulatory. And ,if you have that function set up already, you should be talking to your commercial and supply teams about their objectives."

Ray says it's also important to take into account 'intangible' elements such as corporate culture, leadership quality when selecting a partner.

Deciding when to part company from an existing supplier

"Deciding to cut a CDMO loose may not a comfortable question asked in the presence of a CDMO", say's Ray, but it may be necessary.

"Working with a CDMO is a partnership but it's also a business transaction. If one side fails to deliver, if it does not meet its contractual obligations, timeline or deliverables, then action needs to happen."

Reviewing contractual terms

"We use all the project management and business tools that we have at our disposal before we look at the contract and start taking legal action. If we simply view there should be an exit clause, that's typically where you can get out for cause or without cause."

"The red flag is if one of the sides is no longer negotiating in good faith. If that sounds like a legal term it's because it is. It's the language we use to mean we've got to the place where one or both sides become so frustrated, that they're looking at the language of the contract to see what they're supposed to do next."

"In a functioning relationship, you don't do that - you pick up the phone, you call them and you figure out a way to work it out. But if it’s evident that one of the parties is not acting in good faith, not negotiating that looking to actually solve the problem... that for me is the moment when you decide we need to look elsewhere." says Ray.

Always have a backup

For many smaller companies having more than one CDMO working on a the same product may not be economically viable. However, there is no reason not to have backups on stand-by, says Ray.

"Always have multiples, as part of the vendor selection process. I recommend that you have a primary and you have a backup."

"You negotiate with the primary, obviously, as you want to move forward with them. Make sure to keep a relationship with the backup, even if you don't initially contract with them. That way if things go sideways you have options."

Read the full article on PharmaSource

This episode is a live recording from our first Women in Pharma Procurement meetup.

Pharma is an industry where 90% CEOs are men, and the gender pay gap is still a very real issue. In this session we learned that pay disparity is  no.1 challenge women are facing in their roles.

Since we launched PharmaSource community, it’s been clear that driving a real and meaningful change for women is an area that many of our members are passionate about. 

The panel debate you’re about to hear was chaired by Alicia Ryan, Principal Consultant  Proxima, with Tanya Momtahen,  VP Integrated Product Solutions. Thermo Fisher Scientific, Sharmeen Lalani-Fade, Global Procurement Lead: Online Media & Data, Bayer, along with contributions from members.

To find out more about this session and to get involved in future events, head to /https://pharmasource.global/content/tackling-the-gender-pay-gap-is-the-no-1-challenge-for-women-in-pharma-procurement-video/

1990’s technology stacks will not give us the supply chain that 21st century customers need and deserve, says Elouise Epstein.

Speaking to the PharmaSource podcast, Kearney partner, author and futurist Elouise Epstein explains that “Third-party data exchange is the key to the future. Above all, we need to facilitate easy data exchange with suppliers.”

In her new book, How to Hack the Supply Chain, Elouise describes an experience she had during COVID-19 when was given her vaccination record on a piece of paper. With no digital record, there was no way for her to understand the provenance of the drug she was putting into her body.

“I realised that none of these entities were integrated. There is no data exchange with the third-parties developing and distributing pharmaceuticals.”

This lack of transparency comes with real risk, says Elouise.

“When we extend supply chains we make them brittle and susceptible to risk. Our inability to exchange data has created vulnerability”

Elouise has come to the conclusion that the 21st supply chain technology platform should based around cloud technologies that are able to facilitate data exchange with third-parties, rather than the Enterprise Resource Planning (ERP) systems that currently represent the foundation of most pharma supply chains.

Read the full article on PharmaSource

How should a 100 year-old pharma company partner with a tech giant such as Google?

Sharmeen Lalani-Fade, Global Procurement Lead for online media, creative and data for Bayer explains how they are partnering with Google to bring their Advertising technology (AdTech) stack in house.

The project is designed to connects the 'demand side' (Bayer's marketing campaigns) with the online advertising 'supply side' (websites that show as such as Google, YouTube etc) - without the need of advertising agencies.

"The goal of the project is to be less reliant on agencies and more accountable" says Sharmeen.

“The holy grail of procurement is cost transparency. When you're buying everything through a media agency, however good they are, they're just not built to give you transparency. “

There were challenges with 100 year old company trying to interface with a new breed tech company.

“Not all advertisers directly contract with tech platforms." says Sharmeen "It's a decision that a company can't really take lightly. It requires a great deal of upscaling of the organisation… marketing, procurement, accounts payable all need to go on the digital journey together”

As Sharmeen explains, the project "required a great deal of due diligence. You need to be prepared for some of the common pitfalls".

7 takeaways from the Bayer / Google partnership for procurement professionals.

1. Aim for a true strategic partnership

2. Educate yourself about the tech landscape

3. Help the supplier to understand your world

4. Ensure contracting processes align

5. Marketing effectiveness has to be measured in-house

6. With great data ownership comes great responsibility

7. Stay strongly aligned with stakeholders

Read the full article here:

Avantor is a Fortune 500 company with a wide range of mission-critical products and services for the biopharma industry.

David Coorey, SVP Biopharma Business Development & Commercial Operations at Avantor spoke to the PharmaSource podcast to explain more about the services they offer.

David explains how Avantor supports biopharma companies through R&D scientific discovery, to scale up and full commercial GMP manufacturing materials including custom use excipients and single use consumables.

“Avantor’s has evolved a unique ‘systems approach’ to designing full Fluid handling solutions for customers” says David. “We work with customers to design and optimise a solution that’s tailored to their unique manufacturing process” rather than a rigid, one-size-fits-all approach.

Avantor operates in more than 30 countries, with 14,500 globally. In addition Avantor’s channel brand, VWR offers an integrated, seamless purchasing experience that is optimised for the way our customers do business.

Read the full article here

Brian Whitlock, Vice President of Global R&D Procurement at Bristol Myers Squibb shares his experience in building a high-performance operating model to support the business objectives of biopharmaceutical research.

In the latest episode of the PharmaSource podcast Brian explains how the procurement operating model had to change following 2019, when BMS announced the acquisition of Celgene.

“The acquisition was a sea change for how we think about procurement, and how to support a much larger critical R&D business unit with 9,000 scientists worldwide.” he says.

Procurement had to align with the priorities for the wider Bristol Myers Squibb business: building a world class pipeline, improving productivity and reducing development cycle times while also delivering high quality medicines to our patients.

In order for procurement to support this, Brian explains that “There has been a lot of process reengineering, both internally and with our partners, but also tapping capabilities that exist within the supplier market, that perhaps we have not made a direct investment in.”

Brian worked with leaders within R&D function to design an operating model that “not only focuses on driving the high volume, high risk and high visibility opportunities but also have individuals with unique skill sets that can drive an innovation portfolio.”

“Procurement played a very important role sitting at the table with our stakeholders to bring those new capabilities to our enterprise.”

“One of the things I absolutely love about R&D is we have very creative scientists that come up with challenging opportunities. Every day is different. Every challenge is a little bit unique. It’s that variation, and the complexity of these challenges that really motivate us day to day.”

The conversation covers the follows:

• Strategic procurement helps navigate challenging times
• Cultivate an innovation mindset to increase speed to market
• Re-designing procurement for speed
• Deep accountability for your category
• Innovation comes from smaller transactions
• One team, serving Patients
• BMS Prime: Enabling self service
• The growing importance of Computer Aided Research
• How important is having a scientific background?

Full article here

Asymchem is a large USFDA-inspected Contract Development and Manufacturing Organization (CDMO), renowned for its expertise in developing sustainable processes for late-phase to commercial small molecule and peptide Active Pharmaceutical Ingredients (APIs).

The contract manufacturer has eight manufacturing facilities spread across China, and delivers “500-600 projects a year, with 50 assets available for western markets,” says Jon Brice, Senior Vice President of Business Development at Asymchem Group.

In this interview with the PharmaSource podcast, Jon explains that what makes Asymchem unique is their two flagship technologies:

• Flow chemistry, where Asymchem is “arguably the world leader” in pharmaceutically-relevant flow chemistry.
• Biocatalysis, reactions catalysed by enzymes which are much less toxic than methods using metals.

“If you look at the suite of technology we’ve developed, it’s a toolbox you can’t find at any other CDMO,” Jon adds.

Sustainability has become the key focus for the entire pharma industry, according to Jon.

“We interact with 18 of the top 20 market cap pharma companies in the world, and the one topic that comes up at every meeting is sustainability. It’s really started to accelerate over the last 9-12 months.”

Five years ago, sustainability was more of an aspiration. Now, it’s a legitimate interest with real progress being made. Companies are now required to prove their commitment to sustainability, with each having their own scorecard and tracking metrics.

Asymchem’s flagship technologies position them perfectly to deliver value against these sustainability goals.

“1 in 2 projects we do uses a biocatalytic step with an Asymchem enzyme,” Jon explains. Biocatalysts (sometimes called nature’s catalysts) provides a legitimate avenue of progress in making processes greener.

“Flow processes are inherently less polluting as they allow for the recirculation of reactive streams on a small amount of solvent, using less polluting materials. These processes are inherently de-risked, leading to fewer accidents, less flammable material, and less risk of running foul of environmental agencies.

Last year, Asymchem were awarded the inaugural ACS Award for CMO Excellence in Green Chemistry for leveraging innovative manufacturing technologies to deliver sustainable processes.

“The client wanted us to change their existing manufacturing processes to flow chemistry.” says Jon. ” It was their insistence and their driving criteria for vendor selection move away from waste-producing methods and to do this in sustainable way.”

Read full interview

Skyepharma is a fully-integrated CDMO specialised in formulating, developing and producing complex oral dosage forms and expanding into Bioproduction with the opening of their new SkyeHub plant.

Based outside Lyon, France, the company offers their worldwide customer base a full range of services, from early stage development to industrial manufacturing and packaging.

Following a management buyout in 2021, SkyePharma is now fully owned by its management team.

In the latest episode of the PharmaSource podcast Skyepharma CEO David Lescuyer and Chief Business Officer Laurent Rigaudeau discuss the transformation journey the company is on.

“The management buyout allowed us to continue on our growth path as an independent French company.” says David.

“Now when a client meets the management team, they also meet the owners of Skyepharma. We are truly committed to the projects of our clients”.

A significant milestone for the CDMO is the recent completition of Skyehub, their new bioproduction plant, developed in partnership with MaaT Pharma.

“Skyehub was answer to something that was missing in the market.” says David, explaining how they have been working with MaaT Pharma since 2018 and together conceived a facility that could finalise the development of their product under GMP conditions for commercial use.

The plant is owned by SkyePharma, and available for other companies from early 2024.

“We had to build a brand new biotech plant with clean rooms inside, ready to build to the latest genomes. We had to implement the right quality system that allows them to produce under GMP conditions, and it all had to be delivered in in 13 months.”

Hitting these goals “was a huge challenge” says David, but the project was delivered on time and to budget.

In addition, over the last two years Skyepharma have adapted their facility to the production of Highly potent APIs (HPAPI), says Laurent.

“We have built a dedicated building for research and development of HPAPIs.  The next exciting project for us is to launch a fully dedicated new area to expand our services into more complex molecules and oncological products.”

Read the full article: https://pharmasource.global/content/supplier-spotlight/skyepharma-independent-french-pdmo-expands-to-hpapis-and-bio/

World Courier, a specialist in logistics, warehousing, and transportation services for the pharma and biopharma industry, covers the entire supply chain from preclinical stages and universities to commercial products.

With 50 years of experience in the storage and transportation of time and temperature-sensitive products, World Courier is part of the Cencora group (formerly AmerisourceBergen), allowing it to tap into a wider range of services.

Alan Runacus, UK Sales Manager, explains how World Courier supports pharma and biotechs of all sizes to access important markets.

“World Courier is not just about delivering packages; we ensure that products and samples get to where they need to be at the correct time and temperature for quality.”

As an example, World Courier holds licenses in all 52 states in America, facilitating storage and distribution.

“This makes it easier for European organizations trying to launch in the US or small Biotechs who simply don’t have the scale to apply for them all individually. World Courier can take that on and distribute direct to pharmacies.”

World Courier has been delivering direct-to-patients for over 20 years and today has a dedicated global team for personalised supply chains.

“The market has evolved significantly in recent years” says Alan. “Our network now includes more cryogenic stations around the world. We use liquid nitrogen shippers, the mode of choice for Cell & Gene therapies.”

“We were the first to introduce GPS in all our multi-use packaging systems. Clients can click into an online portal to see where their package is. “

“These therapies have made everybody look at packaging solutions to deliver safety and integrity of the product because it’s going back to a patient. “

Read the full article

SUANFARMA provides Contract Development and Manufacturing (CDMO) services for fermentation and chemical synthesis projects – both generic and innovator.

The company offers a ‘One Stop Shop’ service helping customers to achieve success in the development, scaling, manufacturing, and commercialization of APIs.

David Blanco Industrial Business Development & CDMO Director, explains the services that they offer to customers.

“SUANFARMA is more than just a CDMO, we are a real strategic partner for success in achieving customers’ final goals. We have a flexible mindset and full transparency with customers, providing them with tailored solutions to meet specific needs.”

“We specialise helping pharmaceutical, biotech and healthcare companies by delivering fully integrated services that compress timelines to market. We provide global solutions that enable customers to achieve their objectives with high quality at affordable cost, including full regulatory support for FDA and EMA.”

The pharma industry needs CDMO partners to be flexible with manufacturing due to changing market dynamics, says David.

“Our flexibility and transparency are highly valued by our customers, we adapt to changes that arise during the project accommodate, batch size requirements and guarantee the capacity on time as per the business plan.”

David explains that a key differentiator for SUANFARMA is offering a single European manufacturing plant can combine GMP, industrial processes of fermentation, purification and chemical synthesis services.

“Centralisation of commercial manufacturing processes at a single site simplifies the supply chain and thus achieves highly attractive costs, minimises risk and optimises time.”

The sustainability footprint is also improved as the site including access for full waste recycling, use of green power, and the use of green chemistry to reduce environmentally harmful processes.

Innovative solution for wastewater treatment

SUANFARMA’s ground-breaking Pharmaceutical Wastewater Treatment Project has led to them being nominated alongside their partner e-Watts have been nominated for the 2023 CPHI Awards in the Sustainability category.

“It’s the world’s first large scale installation that treats industrial volumes with a flow rate of up to 250 m3 per hour.” says David.

“Our innovative solution is an improvement of existing wastewater treatment technologies that often rely on dangerous chemicals or incineration, which can be harmful to the environment.”

“We use electro-oxidation which doesn’t require the use of dangerous chemicals and can remove non-biodegradable compounds and pollutants from volumes of wastewater, making it a much more efficient and eco friendly option.”

In addition, the plant generates green hydrogen as a by-product of the electrolysis process, which can be used as an energy source to reduce the facility’s dependency on external energy sources.

Read the full article here

West Pharmaceutical Services is a leading provider of innovative, high-quality injectable solutions and services and a trusted partner to established and emerging drug developers.

West has more than 10,000 team members across 50 sites worldwide, and supports customers by delivering approximately 47 billion components and devices each year.

“This year is our 100 year anniversary, a milestone we are very proud of.” says David Maier, Vice President & General Manager, Global Generics Market Unit at West. “Every product has a patient’s name on it.”

West’s products range from stoppers and seals for injectable packaging systems, to self-injection and reconstitution systems. The company plays a key role in supporting vaccine manufactures through supplying high performing containment systems, scalable packaging, and regulatory support.

Speaking to the PharmaSource podcast David explains that during the COVID-19 pandemic, West components were used in the majority of vaccines on the market.

“We supported the delivery of over 8 billion doses of vaccine. This required significant efforts to ramp up production and to shift priorities in order to put enough capacity online.”

Sustainability through partnerships

“Collaboration between vendors and customers is critical if the pharma industry is to address emissions, energy usage, water usage and waste reduction.” says David.

“West takes a concerted, cooperative approach with our customers and other stakeholders to work together to achieve ESG targets. This includes investigating shared power purchase agreements, researching more sustainable materials, exploring more efficient shipping methods, and studying beneficial reuses of our products.”

West have announced a new sustainable technology as part of their long-term collaboration with Corning.

West is the exclusive distributor of Corning Viridian™ Vial Technology, a drop-in solution that can reduce vial manufacturing CO2e emissions and material waste while enabling faster and safer fill-finish operations.

“Viridian Vials reduce pharmaceutical glass waste-to-landfill by 20% and vial lifecycle CO2e emissions by approximately 30%​ compared to standard vials.”

In addition, West are finalists for their FluroTec® 5-10mL Cartridge Plunger, NovaPure® Stoppers & Flip-Off® CCS Seal technology for large volume injections.

Key trend for 2024: GMP Annex 1 in Europe

David highlights that a major trend to be aware of is that regulators around the world are demanding increasing levels of quality, including changes to the GMP Annex 1 in Europe.

“The European Union is not the only territory where the bar of expectation is being raised when it comes to regulatory standards for particulates. "

A deliberate and well-documented contamination control strategy is one of the new focuses in the EU GMP Annex 1 revision. West is well-positioned to help partners prepare for these regulatory changes, says David.

Key trend for 2024: Home-Based Healthcare Market Expansion

Another major trend is the way the home-based healthcare market is expanding, driven by patient demand for more convenient treatment options.

David explains that West’s on-body platform SmartDose® was the first large-volume wearable to be approved as a combination product by the FDA and has since evolved with multiple generations and different sizes.

“SmartDose® helps to provide patients with confidence in their therapy as it is designed to reduce the need for frequent visits to infusion centres. The technology has been approved for use in four different therapies in the market.”

Read the full articles here

Clariant, the 5 billion multinational company specialising in chemicals, is releasing a range of new functional excipients

The company is a global leader in specialty chemicals and manufactures a wide range of APIs and Excipients in Germany, Spain and China.

While in the past their reputation in pharma was for manufacturing mainly Polyglycols, Vaios Barlas, Global Director Health Care at Clariant explains that they have been focused on expanding their Excipient offering.

“Excipients are ‘the vehicles of drug delivery systems’ and are growing very fast for us. Four out of ten API’s are not soluble, our body is practically all water, so you need functional excipients to be able to make them bioavailable – soluble and permeable in our organs.”

Clariant have a comprehensive portfolio of excipients including solubilizers, emulsifiers, solvents rheology modifiers, binders, humectants plasticizers and many different kinds of agents. 

Among Clariant’s standout offerings are its high-purity VitiPure® O 80 Superior, a purified Polysorbate 80 as well as the new VitiPure® CO 35 Superior, a Polyoxyl 35 Castor Oil and its low endotoxin and microbial load VitiPure® Meglumine LEX.

Clariant also offers a comprehensive selection of Polyglykols (Macrogols), which serve as universally applicable pharmaceutical polymers. Notably, these polymers boast a spectrum of molecular weights and are fortified with CEP certification and DMF documentation, underlining their quality and regulatory compliance.

Clariant are a “top-ranked” supplier for both generics and originator pharma companies, says Vaios. He highlights a recent independent survey that placed Clariant in the top five suppliers for customer loyalty, as ranked by the global pharma industry.

Greater chemistry between people and the planet

“At Clariant our motto ‘greater chemistry between people and planet’ is our raison d’etre. It’s why we exist” says Vaios.

“In the face of the global challenges of climate change and global health and nutrition issues, we feel we bear a responsibility and have to ask ourselves, what contribution we can make.”

“It’s both a company and a personal commitment to society and to the planet to innovate, find solutions to the challenges and bring technological solutions that are friendly for the people and the environment. That’s the big challenge we’re trying to live up to in Clariant”

As an example, Clariant produce bio-ethanol based ethylene oxide, which will allow them to produce Excipients and APIs with low carbon footprint in future.

“Over time this has to become an industry standard.” says Vaios.

Key Trends: Personalised Medicine and novel Drug Delivery Systems

Reflecting on key trends shaping the industry, Vaios highlights the importance of personalised medicine.

“Pharma companies are using artificial intelligence and big data to develop targeted therapies that are customised to the patient’s genome and the medical history. This is happening at rates faster than ever before.”

The delivery of complex injectables in the form of liposomes is moving the pharmaceutical industry rapidly forward, says Vaios.

“At Clariant we are participating in this, as we did with our methoxy-PEGs and the mRNA vaccines for COVID-19. I believe this has potential to address critical diseases such as cancer, HIV and infectious viruses in a way that was impossible to imagine a few years back.”

Read more

Alcami is a contract development and manufacturing organization (CDMO) headquartered in North Carolina with four-decades experience advancing products through every development lifecycle stage.

Operating across five campuses across the United States that cover 738,000 square feet, Alcami caters to pharmaceutical and biotech enterprises of all scales. The CDMO offers bespoke and inventive solutions for analytical development, clinical to commercial sterile and oral solid drug product manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services.

We spoke to Timothy Compton, Chief Business Officer Alcami to explain more.

“Biologics is a growing area for us.” says Tim. “We’ve been supporting biologic products for about 20 years. We have growing capabilities within sterile fill-finish, and a 50/50 split between a traditional small molecule and biologics products.”

“We are opening a new 65,000 square foot cGMP biostorage facility in North Carolina this year. For us, it’s about maintaining scalability for our customers, we certainly don’t want to run out of run of capacity in support of the growth of our our customers programmes.”

Unmet need for downstream capacity While there’s a tremendous amount of capacity coming online for bulk drug substance (BDS) manufacturing, Tim explains that “there is an unmet need for all the downstream activities associated with building that capacity.”

“Analytical support for the characterization or release of those bulk drug substances; sterile fill finish, drug product manufacturing of those products; the storage of materials to support the manufacturing and the BDS itself. We feel there’s a tremendous unmet need there in the industry, and one that we feel that Alcami can help fill.”

“It’s not just by adding capacity and capabilities.” says Tim. “It’s about providing a personalised  approach to customers. Everything we do is a customised approach to their needs.  We’re always pivoting to support what’s required for their programmes to be successful.”

Read the full article

Brenntag Pharma is a leading distribution partner in the pharmaceutical, veterinary and healthcare industries, offers over 10,000 products for the formulation of pharmaceuticals and the chemical synthesis of Active Pharmaceutical Ingredients.

"We are the bridge between the manufacturers of raw materials and ingredients to those that produce medicines. We develop partnerships with all types of companies from big pharma to startups" says Catarina Gil Forte, Head of Industry for Synthesis & Biopharma at Brenntag Pharma.

More than just manage the logistics and warehousing, Catarina explains that Brenntag aims to simplify the complexities of pharma and biopharma supply chain operations with a range of value-added services.

These services include:

• Customisation is a key service. "We can do repacking, refilling, analytical measurements and bindings to customise orders for customer into smaller quantity packages" says Catarina

• Regulatory and quality support is an important service for the highly-regulated pharmaceutical industry. "Everything that is related to documentation, quality agreements, audits, and compliance is covered by our expert teams." says Catarina.

• Sustainability is also a priority. Along with offering green products and green alternatives, Brenntag can now offer a CO2 management service, with a calculator that enables customers to track the emissions across the entire journey of all their supplies.

Distribution strategies to manage working capital

Reflecting on the current economic environment, Catarina notes that due to inflation some customers are struggling with getting the right balance of stock-levels.

"Working capital is an important topic at the moment and distribution can play an important role here. We can support our customers on defining their forecasts and ensuring that they receive the product on time, and do not overstock their warehouse."

"There is a big responsibility with our product managers to get the right balance between the products that we have in stock, and those that need to be supplied on time. We also support customers in managing costs by working with the best partners from supplier-side."

Read the full article on PharmaSource

Novartis has been active in the contract manufacturing space for twenty years, now under the brand name Global Biotech Cooperations.

Novartis Global Biotech Cooperations provides contract manufacturing services across various domains, including Cell & Gene Therapy, Plasmid DNA, RNA, mRNA, SiRNA, Microbial manufacturing, Mammalian cell cultures, Viral vector, and Fill & Finish.

In this episode Rathish Ravindrakumar, Business Development Director, Novartis Global Biotech Cooperations, explains how in the last 2-3 years they have been receiving more requests for newer technologies like Cell and Gene Therapy.

“These technologies represent both an opportunity and a challenge for some companies to get the required capacity. We can help these companies to manufacture their medicines as we have built our capabilities in these technologies.”

Sustainability is high on the Novartis agenda. Rathish highlights how the harmful effects of climate change are now clear to see, and will requires immediate and sustained action by all stakeholders.

“Sustainability has become the key issue for all contract manufacturers as pharma companies take proactive steps to deliver value chain emission reductions.”

“One of Novartis’ business objectives is building the green operations of the future” says Rathish “If you look at recently published analysis, Novartis is already ranked highly for its efforts to reduce greenhouse gas emissions.”

As an example of the work Novartis is undertaking, the company recent transitioned to 100% renewable energy in one of its large-scale sites. This is part of a group-wide sustainability journey to be carbon neutral across its own operations by 2025 and across its supply chain by 2030.

Full article here

C2 Pharma (C-Squared) specialises in the production and distribution of Active Pharmaceutical Ingredients (APIs) and complex chemical compounds derived from both synthetic and natural sources.

The company was founded in 2014 after the acquisition of Boehringer Ingelheim's phytochemical API product portfolio.

"In 2023 after 9 years hard work we finally reached goal of becoming the global leader in Ophthalmic APIs” says Serge Tarabay, Senior Business Development Manager at C2 Pharma.

He describes the company's ambitious plans to release two to three Ophthalmic APIs every year to expand further into the market.

C2 Pharma's extensive API product catalogue now encompasses a diverse range of compounds, such as atropine, bimatoprost, brimonidine, cyclopentolate, homatropine, latanoprost, pilocarpine, and tropicamide - and have recently received approval for Digoxin China DMF. The company serves the needs of over 200 pharmaceutical enterprises spanning across the United States, Western and Eastern Europe, South America, Asia, the Middle East, and Africa.

2024 trends: Increasing security of supply and maintain quality Serge explains that a key issue they foresee in the year ahead will be the need to increase the security of supply and minimise the risk of market shortfall.

"C2 is working closely with external operational teams to identify market needs and make sure we have sufficient stock in our warehouses in Europe to ensure continuity of supply. Customers are looking for redundancy in the supply chain to avoid any disruption in production."

Another key issue is how the industry can maintain product quality at a time when cost-pressure is on. This question has now become critical, says Serge.

"When it comes to APIs, where lives are at stake, price should not come at expense of quality. It is important to find reliable partners rather than the cheapest available in the market."

"We are seeing a lot of pressure on costs and are trying to absorb it as much as possible. We have to support customers and always be fair, but we see that quality is costing more and more these days."

Read full article

Thermo Fisher Scientific is at the forefront of providing comprehensive pharmaceutical services from drug development, clinical trial logistics to commercial manufacturing.

With a global presence spanning over 60 locations, the company offers a seamless, 'end-to-end' solution across all developmental phases, including API production, biologics, viral vectors, cGMP plasmids, formulation, clinical trial support, logistics, manufacturing and packaging.

Christy Eatmon, Global SME, Sterile Drug Products at Thermo Fisher Scientific, explains how they support pharma and biotech customers of all sizes.

“Being part of such a big company allows us to rely on a global network of people that have breadth and depth of experience. Customers benefit from reducing risk, improving timelines are often able to leverage our buying power."

“We work with all the big pharma companies, as you would expect, but the majority of our customers are actually small and emerging. " says Christy.

"I know a lot of people feel like they might get lost in such a big organisation, but our services are personalised to the needs of a specific client or programme. Supporting small biotechs has always been the heart of our business. Our goal is to enable our customers to make the world healthier, cleaner and safer."

Key trend: Home delivery of pre-filled syringes Christy says that one of the most important changes to the healthcare landscape will be increased home delivery to patients. Thermo Fisher Scientific are currently expanding their capabilities for auto injector assembly in order to anticipate the demand for what will be a “huge” market.

“Pre-filled syringes, filled with whatever drug or medicines a person might need, have the potential to be ground-breaking." says Christy. "Rather than patients having to go into clinics for intravenous infusion, they will now be able to inject themselves at home. "

“I don't see that as much different from what diabetics have been doing for years, having a vial of insulin in their fridge and then dosing themselves.  With prefilled syringes and auto injectors patients don't even have to measure how much to give themselves."

Read the full article

Established in 1942 , Lannett is a US-based pharmaceutical contract manufacturer boasting an extensive portfolio of over 100 product families currently in distribution.

In this episode Grant Brock Vice President of Operations discuss the ‘end to end’ services that Lannett CDMO offers. Lannett has a wide range of customers, says Grant, from “virtual customers looking for a home for their products, to those that have their own operations.”

Customers benefit from their expertise in the development of oral solid dosage forms of small molecules including highly potent, poorly soluble, and DEA controlled substances.

“The world is always changing, and so are we. We’re always looking for new opportunities.” says Grant.

“Our team has decades of experience, but that doesn’t mean we’re stuck in the past. We make sure we leverage that experience and knowledge, by being forward-thinking and coming up with creative solutions that apply today.”

2024: A year of consolidation?

Reflecting on the industry trends for the year ahead, Grant is expecting there to be continued consolidation both in the generic and contract manufacturing space.

That’s being driven by companies looking for opportunities to drive their plant utilisation effectively.

“When you’re operating a pharmaceutical plant, you have overhead and infrastructure costs, that that don’t go down. To combat the ever-increasing year over year costs, one way to stay competitive is to utilise the plant effectively and control your costs.”

Read the full article here

Polpharma Group is a CEE-based pharmaceutical manufacturer with 70 years of experience offering various products, including prescription drugs, consumer health care products, and generic active pharmaceutical ingredients (APIs).

David Gonzalez, Head of API Commercial, spoke to the PharmaSource podcast about their new ‘hybrid’ business model, which means they can now offer Contract Development and Manufacturing Organisation (CDMO) alongside their existing Generic API services.

“We are targeting companies with no API experience, for whom we can develop everything from pre-clinical to phase 1 and phase 2 products.”

Polpharma is one of the few companies in Central Eastern Europe that can provide these services, says David.

“Our quality and standards are all European, but (due to our location) we can offer services on a lower cost-base. It is promising and has been well-received by the customers from various markets.”

They are currently expanding their manufacturing capabilities with a $45-million investment to include High Potency Active Pharmaceutical Ingredients (HPAPI) and cryogenic technologies.

The expansion is set to begin operations from mid-2023, with full completion expected by 2026.

2024 trend: the end of big vertical integration for APIs? Reflecting on significant trends shaping the industry in the year ahead, David said the paradigm of vertical integration is changing.

“Over the last few months, we have seen many big previously back-integrated companies now selling their generic API units to private equity or independent companies,” says David. Recent announcements have included the divestment of Glenmark Life Sciences as Glenmark Pharma ‘moves up the value chain,’ Teva selling its API division as it ‘pivots to growth,’ and Lupin considering the demerger of its API business.

“Back-integration used to give big companies like this a competitive advantage. This new paradigm means that companies must be focused on fewer products but with full control of the supply chain to remain competitive.”

Read the full article

Dr. Reddy’s Laboratories, the global pharmaceutical company headquartered in Hyderabad, India, has been a key player in the industry since its establishment in 1984.

Committed to ensuring access to affordable and innovative medicines, the company operates under the mantra, ‘Good Health Can’t Wait’. Dr. Reddy’s offers a comprehensive range of products and services, encompassing APIs, generics, branded generics, biosimilars, and OTC medications.

Ahead of CPHI 2023 we interviewed Kalpesh Kumar Modi, VP and Head of Europe API Sales, Dr. Reddy’s to explain their priorities.

“We manufacture more than 200 APIs and specialise in complex APIs, including peptides, oncology, cardiovascular, and all other therapeutic categories.” says Kalpesh.

“Dr. Reddy’s is a vertically integrated pharma companies that can support customers with formulation expertise, improving development processes and timelines, and have global regulatory teams facilitating filings and early market launches..” 

In 2023, the company recently became a ‘Water Positive‘ company, beating their 2025 target by two years.

“We were among the first Indian companies to build a zero liquid discharge infrastructure into all our facilities. We are delighted to say that we are not sending a single kilogramme of waste to any landfill.”

Dr Reddy’s is committed to ESG principles, employing ‘green chemistry’ to make API processes sustainable and work with suppliers who contribute to sustainable supply chain performance.

Kalpesh explains API Plus, an initiative for emerging markets where customers don’t have their own formulation facilities.

“The core objective of API Plus is to ensure that patients of those countries can access high-quality, affordable medicines. We cooperate with local partners and support them with expertise, formulation, and technology.”

Digitalisation is another major focus for Dr. Reddy’s, says Kalpesh. “We are leveraging Industry 4.0 technologies to streamline operations and enhance data accuracy.”

As an example of this, the company has created a platform called XCEED that enables customers to manage the complete inquiry and procurement process of Dr. Reddy’s APIs in real-time.  Read full article

Christoph Staub, is CEO of allpack group ag, a Contract Packaging Organisation (CPO) based in Switzerland with an ambitious agenda for the digital transformation of the pharma supply chain.

“We are a small company but very innovative. I have confirmation from our customers that despite our relatively small size, we are at the leading-edge of digital transformation in packaging” says Christoph.

“We were one the first contract packaging partners to introduce traceability technology into our processes and have more than 12 years experience in this area.”

allpack group ag already deliver e-leaflets and e-patient information packs in Japan, a demanding market where leaflets are now mandatory.

“We provide dashboards to our customers that allows them to directly feed business-relevant information into our operations and also to monitor their products within our operations”

Why work with a dedicated Contract Packaging Organisation?

Christoph explains the benefits of working with a dedicated Contract Packaging Organisation, compared to a CDMO that includes a packaging service:

"The big challenge for a CMO is to balance two very different elements of business and technology. The business acumen between manufacturing and packaging are two different animals. It’s a challenge to keep up with the market in both areas”.

“Our experience is that if you focus exclusively on packaging, you can have much more competence in areas such as traceability, brand protection, sustainable packaging materials. Furthermore, you can be much more effective in high demanding sub-segments such as orphan drugs and highly individualised products lines."

"The classical #CDMO usually has a preference to run larger batches than what we do as a pure and focused packaging contract partner.”

🎧 Listen to the full episode here: https://pharmasource.global/content/supplier-spotlight/allpack-group-a-passion-for-digital-transformation-in-packaging/

Pfizer CentreOne, is a global contract development and manufacturing organisation (CDMO) and a prominent supplier of specialised APIs with a manufacturing network spanning over 35 sites across six continents

Ahead of CPHI Barcelona 2023 we asked Karen Lauxmann, Global Head of Marketing, Communications and Training, Pfizer CentreOne, to explain how being part of the Pfizer group makes them a different type of partner.

Karen explains how the scale and expertise within Pfizer enables CentreOne to support partners in a unique way. Whether a customer is developing complex biologics or oral solid dosage (still the lion’s share of prescriptions), they can tap into Pfizer’s network of experts.

“Pfizer is big and we’re used to making courageous decisions, if needed, to bring innovations to market.” says Karen. The Pfizer network brings substantial technical proficiency, worldwide regulatory assistance, and supply capabilities.

Finding the right contact manufacturing partner of your business is a balance between a number of factors, including price, quality and reliability to deliver on time.

“If you’re a small biotech and want to bring a breakthrough to market fast, you need to manage finance and cashflow carefully, but you also need someone you can rely on to think and plan ahead. It can’t just be about price” says Karen.

Here are her tips for finding the right CDMO for you:

1. Find a partner who is as passionate about your products as you are. “You need to work with someone who will go the extra mile to bring products to patients. Everybody in Pfizer works for the patients. Whatever we do is about the patient, and time is life. They rely on us.”
2. Agile, flexible and proactive in resolving issues. “There’s always a roadblock in the way, so find someone who can pre-empt issues”
3. Find someone with an expert network, who can bring in situational expertise, when you need it. “At Pfizer an expert on almost any topic is just a phone call away.” says Karen.

“All these will ultimately save you time and money in the long run.”

https://pharmasource.global/content/supplier-spotlight/pfizer-centreone-an-altogether-different-kind-of-cdmo/

In the face of challenging economic times, procurement leaders can emerge as the unsung heroes, helping to steer their organisations through the storm. 

One such leader is David Ward, Procurement Director at Catalent, who has leveraged his extensive experience from senior procurement roles at AstraZeneca and MSD/Merck to help guide the CDMO through challenging times. 

Catalent, along with other CDMOs, has been instrumental in the fight against COVID-19. The company played a significant role in vaccinating approximately 70% of the United States population through its partnerships with AstraZeneca, Moderna, and Johnson and Johnson. This massive undertaking saw Catalent’s largest vaccine manufacturing site in Bloomington, US, expand its workforce from around 1,500 employees to around 3,500 in just a few weeks.

David Ward describes this period as a “huge ramp up,” followed by a plateau and now a phase of ‘right-sizing.’ Throughout these stages, procurement has played a crucial role. 

In the latest episode of the PharmaSource podcast, David shares his insights on how procurement teams should operate differently during lean times and why he believes that “Procurement is the organisational Swiss Army Knife.”

The contract manufacturing sector is navigating through turbulent times as Gil Roth, Founder and President of the Pharma & Biopharma Outsourcing Association (PBOA) explains.

Caught between the after-effects of the pandemic, changing legislation, and the still-to-be fully realised promise of groundbreaking new treatments, CDMOs are showing real resilience.

“We saw the CDMO rise up heroically to help with vaccine and therapeutic production. While there was a lot of government support on the build-up side, there's been none on the drop-off". Many contract manufacturers had to scale significantly to cope with the demand but "now that things are receding, they are on their own. That's been a real challenge."

Gil says this has been a disappointing for the industry that achieved so much over the pandemic to rush out successful vaccination programmes as part of 'Operation warp speed'.

"A lot of those lessons seem to be forgotten. People start complaining about budgets, and government support starts to dissipate. "They're still arguing over reauthorizing the long standing pandemic and all hazards preparedness act here in the US." says Gil.

“R&D pipelines have been hurt, both by COVID itself or the lockdown period where a lot of research and clinical trials were disrupted. The global interest rate rises post-COVID has also led to some R&D funding drying up."

"The Inflation Reduction Act (IRA) in the US is meant to permit Medicare to begin negotiating prices on certain drugs. Some drug companies have said this is going to stymie their R&D efforts, so are leaving fields X, Y, and Z, which is also impacting funding."

“The CDMO sector is dependent on things making their way through the innovator side, so the R&D drought becomes the CDMO drought”

Cell and Gene Therapy, an area that is predominantly outsourced to startups - has experienced slower than expected growth due to speed of getting treatments approved.

“They're an incredibly promising set of technologies but building up to accommodate it is going to be tough” says Gil.

“The FDA is still working to build up the regulatory framework for a lot of the cell and gene therapies. They are in the process of hiring reviewers, build up that infrastructure and issuing guidance.Protocols that are still being developed for how to do these sorts of trials. The regulatory framework for them is still evolving.”

Gil explains some of the ways that contract manufacturing can adapting and thrive during these challenging times.

“I think they're they're in position, they're adapting. Capital is still accessible when it comes to making new investments. “

"It's worth remembering that Oral solid dosage drugs are still mighty important. In the US 90% of prescriptions are generic, small molecule drugs. That's a big savings on the US healthcare system and one that we helped contribute to by manufacturing for them.”

The onshoring movement is also creating opportunities for CDMOs based in North America and Europe. “There's more to be done for companies are looking for more supply chain security, but there's also geopolitical considerations that licence holders have and they might be interested in moving manufacturing to particular regions that aren't currently served, that might create opportunities for CDMOs in those sectors in those particular geographic regions."

There is still huge opportunities on the horizon with new treatments. “Nobody was predicting a $50 billion market in diabetes drugs that happen to cause weight loss. "

While it can be a gamble to ramp up capacity at an early stage "treatments like this create gigantic demand for certain types of manufacturing that just wasn't there before."

https://pharmasource.global/

Larger pharma companies are renown for spending a large amount on management consultants and other professionals services, due in part to the pharma industry's unique and high-risk business model.

There is a real opportunity to managing professional services better in life sciences, but it is far from straightforward, as Cameron Smith, Procurement Senior Partner for Professional Services at Novartis explains in the latest episode of the PharmaSource podcast.

“Procurement is constantly evolving” says Cameron “I don't think we're anywhere near close to scratching the surface of the value that procurement can bring.“

Professional services meets life sciences

The pharma business model comes with significantly greater risks than industries as "Pharma has to take a long-term view" says Cameron.

"If we're doing a deal with a strategy house, that strategy should help define what the business looks like for medium term, tie-in with the drug development pipeline and look at growth opportunities in market".

Another challenge is that the high-margin nature of big pharma means that a "mindset shift" is sometimes needed before stakeholders are prepared to consider alternatives to their existing suppliers.

Procurement professionals supporting business leaders is these decisions have to be aware of the importance, and politics, of these business issues. "If you're not, you're going to be left behind very quickly. Stakeholders are going to take a fairly dim view of what sort of value you can bring to the table."

7 strategies for transforming professional services procurement

Cameron details his recommendations for how procuerment professionals can manage professional services in the pharma industry.

1. Know your data down to the cent

2. Segment the existing supplier base

3. Find the category experts

4.Benchmark against the market

5. Align with your stakeholders

6. Consolidate your supply base without compromising quality

7. Measure only what is useful

Read the full article here: https://pharmasource.global/content/podcast/how-to-get-more-value-from-professional-services-in-pharma/

The pharmaceutical supply chain is undergoing major change, driven by advances in science, technology, and evolving patient expectations. 

To keep up will require fresh approaches to supply chain logistics, says Fernanda Teles, Head of Global Clinical Logistics for DHL Supply Chain. In the latest PharmaSource Podcast she explains some of the key trends from their recent report Delivering Next-Level Healthcare, and shares advice on how supply chain leaders must adapt including:

• Patient-Centric Models
• Biopharmaceuticals driving cold chain network growth
• Supply chain digitisation & sustainability
• The importance of people and technology

Read more here: https://pharmasource.global/content/podcast/pharma-supply-chain-transformation-how-to-adapt-to-the-new-era-of-healthcare/

“One of the challenges we face is trying to recruit talent in a market that is short on the skills we require.  There’s a major shortage of talent,"

Neil Kelly, founder of Vector Partners, has two decades experience in talent acquisition within life sciences, including high-growth period at Thermo Fisher and Patheon.

In the latest episode of the PharmaSource podcast Neil explains some key strategies to help bridge the talent gap in life sciences.

1. Reassess on-site vs remote talent

The great lesson from the pandemic was been the successful continuation of business through remote working.

“The supply chain is becoming more and more global - the ability to source product from anywhere in the world is just a reality now. As you think around talent and your workforce globally, then you then start realising that  it's not so much about where the product is that’s important but it's where you can source that talent, because the certain talent around the world that is really short."

However, this has presented a real challenge for HR functions and talent functions to understand which roles can go remote versus those that simply can't - such as  manufacturing or supply chain roles that physically handle products.

“Don't think about physical distance as a limitation to trade or to doing business together." says Neill.

"Start to look at your landscape globally for where do you source talent, versus where do you need to produce the product.”

2. Go deeper into a candidates' strengths and weaknesses

If it's challenging to find someone who is an exact fit, go look deeper into candidate's strengths, says Neil.

“There are very few dedicated Academic courses for sourcing, procurement and supply chain, and those that are are very dated in terms of the content that's delivered to students.  So, we have to look elsewhere."

“If particular talent doesn't exist in the market we have bypass what the label of the degree says on their resume and really start to look at who they are as an individual and their behaviours.”

3. Invest in skills development

“Skills development will continue to be paramount for organisations moving forward, certainly for the next two to three years minimum. It's not only a great retention tool, but the second is that it also allows you to create more skills within your existing resources. “

"If you take an average procurement function or supply chain function, very often, they will have a defined set of skills and a defined boundaries in terms of where they operate. 

Training can help you to get "more all-rounders in your business", says Neil, which will increase your productivity. Training "is a good thing for the employee, and a good thing for the business. "

4. Recruit from outside of the industry

"You can't train the science" says Neil, but enabling functions such as Procurement and Supply Chain - like HR and Finance - have transferable skills which you can look for outside of the pharma industry. 

"In supply chain, we look for agility, we look for speed, we look for sharpness around commerciality that generally has not come from within the pharma industry. “

"We source that talent from those industries that are really lean - telecoms, third-party logistics.These are industries that really sharpen their pencil around some of these skills. We go into these industries and pluck out the very best."

5. Use compensation to your advantage

Take the opportunity to use pay and benefits as way to attract talent from other industries.

"Compensation is generally lower within these industries (such as telecoms and third-party logistics) so you're able to attract the talent, so you've got a commercial or a compensation advantage of attracting someone.”

Listen to the full podcast for the full interview.

Olon Ricerca Bioscience is a US-based Contract Research Organisation (CRO) offering speciality chemical manufacturing capabilities.

We spoke to Alessandro Agosti, Senior Director of Scientific Operations about how they partner with customers, and some of the ways they are unique. 

The CRO was founded 1986, before being acquired by Olon SpA in 2017.   Now part of the wider Olon Group, Alessandro explains that "clients can tap into a 'One stop shop' taking them from early phase work to scaling up into full commercial manufacturing - leveraging Olon's technologies and the centre of excellence."

Speed of development is a top requirement, says Alessandro, providing the example of a recent collaboration with a US-based pharma company to develop an oncology drug. They escalated from a very early phase to full GMP manufacturing within one year.

"It was a quite a big jump in terms of scale. It was made possible because of the continuous interaction between the different teams fine-tuning the process, the analytical work, as well as the process engineering that is inevitably needed when you go from a few 100 grammes to manufacturing batches on on large scale on a chemical on a chemical plant."

"A trend that that we are seeing from many clients is the requirement to move research and manufacturing away from the Far East" says Alessandro.

While acknowledging this comes with a higher price tag, moving research to the United States is "has clear advantages in terms of control and interaction with customers", adding that it's more important than ever "to deliver first time and keep to the timeline in these very challenging times."

"We like to provide clients with a roadmap for their development, partnering from a very eary stage. This includes the way we write the proposal, the way we try to understand the client's most immediate needs. That will drives and impact the way we do the process development."

"We want to think that there might be a much larger scale, scale up required further down the road, and we believe that establishing a partnership and providing a process package rather than selling a product is the key to a successful working relationship."

“You can’t develop medicines without an ecosystem. Suppliers are probably one of the most neglected sections of the ecosystem.”

Tanya Momtahen, Vice President of Integrated Product Solutions at Thermo Fisher explains how understanding your supplier ecosystem is how to make an impact.

“The amount of money that's spent in the supplier world is daunting, to say the least” says Tanya  “yet too often key suppliers are treated transactionally.” While this attitude might make sense when procuring something that already exists “if it's services that are supporting research and development of a medicine it is crazy.”

Tanya spent nearly two decades at Sanofi, over which time she moved from research and development to becoming VP of global scientific and clinical procurement. 

She explains that she moved to procurement with a mission to champion the “neglected supplier world and truly partner with suppliers. That's how I convinced myself to go to into procurement.”

Moving to procurement Tanta faced “ many naysayers” but for her, changing how to partner with suppliers came with a moral responsibility

“I had a mission and the mission was:  if I work on a couple of products (in R&D), those are the only ones I can impact. But if I go and take over outsourcing and drive the suppliers to bring better solutions forward, I can affect many more medicines.” 

 “We owe the responsibility to the world not to waste money that can be spent on additional medicines.   It’s frustrating to see people killing products that may work because there's just not enough money to go around to develop them. Some of the products that are not so publicly known are the easiest ones to kill internally. But they also may be the ones that may work.“

Now working at Thermo Fisher and PPD, her role is to help sponsoring biopharma companies  get the most out of the wide range outsourcing services they offer. This has given her a broad perspective on how to make outsourcing work from both sides of the table.

Advice for negotiating transformational supplier partnerships

Here is Tanya’s advice for sourcing and procurement professionals to get more from their supplier ecosystem.

1. Understand the supplier’s business model

2. Move from transactional to strategic partnerships

3. Identify what’s really important for your business

4. Aim for a Win-Win 

5. Practise negotiations

6. Change come from the top

Susan Walsh, AKA the The Classification Guru about her advice on how to improve, classify and normalise ‘data data’ and why it’s so important.

“Data is the foundation of everything that you do in procurement, whether that is reviewing contracts, negotiating with supplier or looking for fraud.”

In this episode she discusses her C.O.A.T. framework for better quality procurement data, including the importance of normalisation and classification is so important for actionable procurement insights.

Normalisation vs Classification

Normalisation and classification are both important to extract usable insights from your data.

“If you don’t normalise your suppliers, you’re going to end up with10 versions of PwC, IBM or Dell. As a procurement professional, you just need to know ‘how much did I spend with Dell’ you don’t need to know the financial and financial or legal entity. “

“Normalising data means is when you go to those companies, whether that be on a global or a regional level, you have more accurate data and potentially more bargaining and leverage to get better prices, better contracts with these suppliers, because you have the right information.

If you don’t do that you could be missing out on on really good opportunities. You might think you’ve got a great deal. But your supplier on the other side is laughing because they’ve got the correct data and they know that you don’t have the right data.

It’s also important to be able to searching for company information such as ESG or Diversity, to make sure that the companies in your supply chain are ethical responsible. If you haven’t normalised you might miss out on a company, that’s actually a subsidiary of something else.

It can be quite tricky, because there’s companies like Microsoft, that also own LinkedIn. We would always normalise LinkedIn to LinkedIn, not Microsoft because otherwise inevitably ends up getting classified as software. “

Classification

The next area is to arrive at correctly classified data.

“Classification can tell you things like the number of suppliers you have per category per country per business unit. It can tell you how much you’re spending with them. For example, if you’ve got suppliers you’ve spent $50 with, do you need them on your systems at all? Or are they diverse suppliers and you need them there for a reason?

The only way you’ll know that is if you have the suppliers classification as detailed as possible. You need to have a good taxonomy”

In the latest episode of the PharmaSource CDMO Sessions, we speak Stephan Fritchi, Executive Vice President Business Units for CARBOGEN AMCIS.

Stephan is responsible for operations across all CARBOGEN AMCIS manufacturing sites worldwide, including sites in France, four in Switzerland, United Kingdom, Netherlands and China.

The contract manufacturer supports customers at all stages of drug development, from clinical trials to being released on the market as a commercial product. Their services include Highly Potent API facilities and a clean room for Antibody Drug Conjugates. 

“We are specialists in providing services in developing chemical processes and produce drugs up to the final product. Depending on the nature of the projects, we can either run our activities from a single site or using multiple sites together." says Stephan.

“We normally start our relationship with clients at a very early phase through clinical phases and then we build up a trustworthy relationship. This normally lasts five to 10 years when finally, if the product is successful on the market, we will produce commercially.”

Inside Dechra Pharma's 3-Year Procurement Transformation

Dechra Pharmaceuticals is a global specialist in the development, manufacturer and sales of veterinary pharmaceuticals worldwide.

In the latest episode of the PharmaSource podcast, we spoke to Kateryna Holovnia, Head of Procurement at Dechra Pharmaceuticals about the global transformation of the procurement function, moving from a fragmented and transactional to a unified and strategic partner to the business.

The organisation is made up of a number of acquisitions which previously operated independently, so they are in the middle of a three year strategy to harmonise and unify procurement operations.

Kateryna explains how their objective is to standardise technology and processes across the nine in-house manufacturing sites they operate, and about 70 different Contract Manufacturing Organisations (CMOs) they partner with.

“We are right now integrating our systems, and platforms, bringing all this visibility where we can consolidate where in-house manufacturing overlaps with our CDMOs, what we can leverage to get access to get one-click information."

"We have brought in global category management which has the visibility to have a helicopter view of what's going on, and what are the opportunities are regionally.”

Kateryna found moving to Dechra refreshing, finding the company open and receptive to implementing the best practices she had learned in previous roles and through her network.

Listen to the full epsiode

Len DeCandia is an award-winning Supply Chain and Procurement Executive with 40+ years of experience, most recently as Chief Procurement Officer for Johnson & Johnson, AmerisourceBergen and Roche.

In the latest episode of the PharmaSource podcast Len describes the changes he has seen in procurement, including his experience in mobilising during COVID, and explains why he believes enlightened organisations must prioritise suppliers.

Here are some of the key takeaways from the conversation: 

1. 'Enlightened' organisations prioritise and centralise supplier relationships

2. You need strong sponsorship from the board to be successful

3. The budget owner is the customer 

4. Use technology to create trust and transparency

5. Be early when finding business solutions 

6. Change the story to win hearts and minds

7. Make an impact on the world

"One of the important aspects was our commitment to purposeful spending. And so one of the commitments that we made as a team to the business was we were going to double our spend with women-owned and minority-owned suppliers.

To do that, they needed to engage the budget holder in that conversation, to prove they wouldn't have to sacrifice innovation, We had to educate them on the community impact.

Johnson and Johnson regularly publishes a Health for Humanity report which quantifies the impact they make each year. More than just numbers, Len explains that when investing in local and diverse suppliers you can see the difference yourself "They are the people you're going to church with, on Sunday, or you're seeing in the grocery store, or whose children go to school with their children, because we made it part of their community. They brought us insights and innovations that we never thought of before."

Listen to the full episode podcast for more advice and inspiration.

Laurent Bosseler is Digital Procurement and COE lead at UCB. He focused on making technology for colleagues at the pharma company as simple and seamless as possible.

In the latest episode of the PharmaSource podcast, he discussed how he is currently grappling with how to make the most of exciting Natural Language Processing (NLP) technology such as ChatGPT - but without exposing his company to preventable risk.

“The power of the tool is amazing” says Laurent but adds “you must keep your critical mind and don’t upload any company content there.

“The risk of a security breach is way too high. There have been a number cases in the press recently with Toyota and Samsung reporting security breaches”

"What you pump into the system could easily be leaked. The CEO of OpenAI even mentioned it himself.“

In March 2023, OpenAI CEO Sam Altman said he "felt awful" about leaking users' chat histories and payment details.

How to use ChatGPT responsibly

Laurent’s advice is to use chatbots to validate your thinking. 

“ChatGPT is a gamechanger in helping the professional buyer. Use it to validate your thinking. Use it to discover new ideas, to come up with new questions for your suppliers. 

If you’re not an expert in a category, it can help you write a brief for suppliers.  It really has a knowledge power that no human being can have so use it wisely to enrich your thinking.”

However, he warns against uploading confidential information. 

“Don’t upload anything! Be extremely cautious. Do not upload anything confidential such as a contract. Wait for your company to install a ChatGPT-like tool that is behind a firewall and has the necessary security.”

“The system is clever .Even if I say ‘I'm working in a Belgian pharma company, specialised in neurology and immunology’ but I've not mentioned the name, within three seconds the system will say that you work in UCB. 

Intellectual property is also an important issue to address. "Very few people read the terms and condition when you join those sites, because it's five pages but it says that everything you post is the property of OpenAI.

“I'm trying to block colleagues using ChatGPT and discussing with my IT department to see how we can have a GPT-like, way of working within UCB firewall so that you are safe to upload something.

A case study Laurent is looking at is how NLP can improve the usefulness of their intranet.

“Sharepoint is is very good for storage of document, but we are less good at removing old documents. So if you ask a question, you might find six documents which are expired but end user might not realise. A GPT would be ideal for that kind of question and could highlight all the inconsistencies between documents” 

In the latest episode of the PharmaSource podcast we spoke to  Mark Burfoot, Vice President Research Procurement at Novartis about how advances in Machine Learning allow procurement to have a more strategic role in optimising life science research.

Prior to his work at Novartis and Pfizer, Mark’s educational background is in immunology. That knowledge of the scientific process has allowed him to create new frameworks and forms of value that go far beyond cost savings.

“There are different ways of approaching procurement.” Mark says. “You can take the traditional and transactional approach –  build contracts, help your scientists gain access to the array of suppliers and services that they require in order to achieve their work.”

“But with the advent of machine learning techniques and other types of approaches, there are other ways of looking at a problem that can help redefine how we can add value. 

Rather than looking at the cheapest product, or trying to provide the widest range of options to a scientist, we can now offer tools that help the scientist to choose the products and services most likely to lead to success.“

The insight procurement provides has been proven to reduce the number of failed experiments, putting Mark and his team in a far more strategic position to steer and inform decisions about which projects to invest in.

“The nature of research is that there is a huge amount of experimentation and failed experiments. But a lot of experimental failure happens just because we haven’t picked the best reagent.”

“We are exploring tools and approaches that can help us  guide the scientists and give them insights to say, ‘“’Hey, you’re better choosing this set of reagents versus testing all these other ones that most have have a cost effective approach.'”

“There’s a cost gain to that, but it has a productivity impact because now you’re moving faster and getting less failed experiments” as a result of that. “

Mark and his team are now helping the scientists make more informed choices which are proven to increase the success rate of experiments.

“Suppliers will always tell you their product is the best and will meet all your needs. And as I know from when  I was in the lab, scientists are still very dependent on reading materials and methods and what appears in peer reviewed literature.

Procurement is now able to provide a new perspective, offering insights to suggest better ways of doing things – different materials and methods which are more likely to get the end result they are looking for.    

“It has become a very unique partnership. We are redefining the ecosystem and the supplier base and the reagents and the services that are required in order to help drive the science.“

Measuring success

“For me, driving the speed of the science more effectively is so much more valuable than just giving more choices and having the best contracts in place. “ say Mark.

“Adoption of some of the tools that we use in this space have had a 70-80% uptake, across our scientists globally. There is still a massive opportunity in this space to do more, but the desire to play, to adopt is very good.”

“By making these kind of improvements it’s possible to see savings of 10 -20 million USD over a period of a few years in a particular region or class, which you can use for reinvestment in other areas. You can keep exponentially growing.”

“We’ve seen significant increases in productivity as a result of improvements in different types of reagent classes that we purchase, for example. That has a very positive effect. I would say that there’s probably been a four-fold increase in time saved.”

“You’re getting both cost savings on one end, but you’re also getting speed and productivity gains at the other end that’s helping you accelerate the science. It is a really nice position to be in.”

https://pharmasource.global/content/how-novartis-procurement-is-cutting-failed-rd-experiments-with-ai/

The CDMO Sessions are a series of interviews with leaders at Contract Development and Manufacturing Organisations about what makes their business unique and to share advice for how to create better strategic partnerships.

We spoke to the two Vice Presidents from Olon Group responsible for their Biotech and Small Molecules businesses respectively, Andrea Conforto VP for Biotech and Roberta Pachera, VP Small Molecules.

Olon Biotech

Andrea Conforo explains how Olon use ,icrobial fermentation technology, with two anufacturing sites located in Italy. 

“We are very flexible and can offer fermentation capabilities that support the product from early clinical stages up to large commercial production with 100,000 litres of capability”

“When partnering we typically create a ‘mirror team’ to communicate directly with all the project subject matter experts a partner has. Speed is a key milestone for us, and we try to set reasonable project stages to match the customer’s timeline."

Olon Small Molecules

Roberta Pachera leads the team focusing primarily on production of Intermediates and  final APIs on behalf of innovators or generic companies, from large, mid-sized companies or startups.

Roberta highlights how Olon is able to reduce customer time to market while maintaining product quality because ” everything is under one roof”.

“We suppor customers through the entire product lifecycle, which means we don’t need to go through multiple technology transfers from one company to another. In addition we have  a technology platform which offers a toolbox of small molecules which we can offer to customers.”

Roberta gave the example of how they worked during COVID to support a small startup to go from from initial preclinical research, to producing clinical batches to face-to-face clinical studies, all within less than 18 months.

Olon have over 300 people in Research and Development, and have forged strong links with academia in Italy, Netherlands and United States which helps them to stay on the cutting-edge. 

“We have an innovative R&D team who have, amongst other things, been working on our sustainability impact with the water we use. We now measure the water quality at the start and end of the manufacturing process.”

The first step is to make sure the CDMO project team fully understand the goals and drivers of a project in detail so that they can add real value.

“We always aim to have an open environment with partners, so that we can better understand why a customer is asking for something. We are the operational experts so with the right information will often make recommendations and propose a better  solution.” says Andrea.

A two-way relationship will generally help to reduce costs. 

“Our aim is always to reduce the customer’s investment as much as possible.  For example, our Downsteam Processing (DSP) purification will work with customers to reuse as much technology as possible from what we have already in-house.  This can dramatically reduce the cost of goods. All this implies a long collaboration, moving from transactional customer relationship to partner.”

Roberta adds that there are additional savings that comes from process optimisation when manufacturing large quantities.  

“When you are manufacturing large quantities of Intermediates or Active Pharmaceutical Ingredients, it is recommended to use modern tools like Process Modelling to help you reduce production costs.” 

To find out more, check out the Olon website

“It's no secret that suppliers know that Pharma has good margins” says Alejandra Garcia, Senior Vice President, Procurement at DSM.

“We're charged a higher premium, because Pharma is considered a high margin industry.”

In the latest episode of the PharmaSource podcast Alejandra shares her initiative at DSM to protect Margins, and how she uncovered and reduced the 'Pharma Premium' suppliers were charging her business.

"Margin Protection comes down to three main levers. the supply lever, the demand lever and then the process lever.

1. The Supply lever really address a question from whom we buy

What are other sources here, how we can maximise how we can bring more diversity to our supplier base. How we can bring this diversification in terms of value performance or service with suppliers and also increase our supplier diversity.

2. The Demand Lever which is for whom we buy, This is where the work and alignment with the business is critical. Because this is where we go into strategic planning into inventory optimization and operational efficiencies in the supply chain.

3. The Process Lever. We need to have good visibility on data around cost allocation and pricing for example. We also need to assess with our suppliers if we can go to design for value or performance for value.

"Fantastic procurement should reduce the waste across the supply chain. So we have joint targets with the business, and then make sure that we have good compliance.

We can achieve this by bringing our suppliers all together to reduce waste in our supply chain, "

Alejandra explains how she worked with peers across different industries to uncover the “Pharma Premium” that suppliers were charging DSM. 

“We did is a series of different workshops, inviting companies with lower margin such as banking to benchmark certain services that we were buying with these companies. We benchmarked categories that are not highly specialised such as computer maintenance and consultancy services."

“We had a candid conversation with them and surprise, surprise, we proved the hypothesis that we were paying over-price on certain products and services because suppliers know we play in a high margin industry.”

“The premium was in the range from five to twenty percent, depending on the service and the product again, and also the region”

The benchmarking took place initially in Europe and then was rolled out in the United States and Asia. In all cases, these pilots confirmed that DSM were overpaying services.

"While some might argue that Pharma needs a unique price structure,  At the end of the day, if I have my Dell computer here, it's completely irrelevant if I use this for pharma, or for banking, or for an insurance”

The team as DSM used this information to proactively negotiate new terms and the conditions with suppliers, aligning contracts to what they discovered in the benchmarking

“With this information, we went back to our suppliers to have an open conversation, say, 'Hey, we're finding out what's going on'"

DSM were able to present suppliers with a clear framework of well-research information and use this to renegotiated agreements, reduce price or adjust payment terms. 

Alejandra acknowledges that driving an initiative like this can be uncomfortable.

“This approach may be provocative. Some of my colleagues, when I discuss these over a couple of drinks,  find it uncomfortable to challenge the status quo, because we like to think that that Pharma is a high margin industry. 

But I think that times has changed. We need to be mindful that unprecedented inflation and cost impact will stay longer and will have a permanent mark in the way that we buy. 

Customers and consumers are suffering from it. So we also need to be mindful and find new solutions and new ways to make it happen."

Virginie Mathieu has deep experience in R&D Procurement having worked at some of the world's biggest Pharmaceutical companies in France and Canada.

In the latest episode of the PharmaSource podcast she shares her experiences in supporting the experimental end of pharma and advice for partnering with scientists.

“R&D is a very specialised form of procurement. You really need to know what you're talking about, so it helps to have a scientific background."

When it comes to recruiting team members into the R&D Procurement roles Virginie says it’s hard to find people with knowledge of both (procurement and science) "so we train team members build the skills to learn about the other side “

Find out more https://pharmasource.global/

Rx360 was founded following the Heparin incident in 2008 when the drug supply became contaminated, resulting in 81 deaths in the US and left many more injured.

In response, a cross-industry consortium was formed with a mission to prevent this from happening again by protecting the pharmaceutical supply chain and ensuring the quality of materials are always at an optimum level.

In the latest episode of the PharmaSource Podcast we sat down with Rx360 CEO Jim Fries to understand how big an issue counterfeit drugs is in the supply chain today, and how procurement teams should engage with this most critical of issues.

“Let’s face it, in the pharma supply chain there are bad guys and we’re always trying to stay one step ahead. There’s a big financial gain to be made from counterfeiting drugs” says Jim.

“It only takes one incident to have it become a really bad issue again.”

Gilead vs Counterfeiters

As recently as 2022 Gilead were forced to take action to battle the counterfeit drug rings responsible for manufacturing counterfeit bottles of their HIV antiviral pills. It was a high profile case that saw more than 50 counterfeiters identified in a wide reaching investigation. 

“Law enforcement worked with legal experts in conjunction with Gilead to uncover and take down a massive counterfeiting ring. Not only did the industry identify the problem,  it was researched, the people responsible were found and it was stopped dead in its tracks.” says Jim.

“It really set a precedent moving forward that maybe scares the next people before they decide to do something like that.”

Supply contamination is not always deliberate. “Sometimes contamination is by accident. The best way to combat that is to stay vigilant and keep your eyes open”.

“ The amount of time, energy and money that pharmaceutical companies spend on quality initiatives is just immense. I think a lot of people walking down the street don’t understand the amount of audits that they do with suppliers”.

Lockdowns and supply chain disruption during the COVID-19 pandemic presented a major challenge to auditing supply chain integrity. 

“When the pandemic hit all of a sudden, literally in a 24 hour period, we went from doing on-site audits to wondering how we going to audit our suppliers. It’s not like the manufacturing of drugs stopped during the pandemic, it continued to move forward. The issue was how do we optimise and maintain that quality during the pandemic, when we can’t go on-site to do an audit of a facility?”

“In response to this the industry began to focus on remote audit programmes through the use of different technologies. It was exciting to watch it happen so quickly in order to maintain the safety of those drugs throughout the pandemic.”

Jim provides this advice for anyone sourcing pharmaceuticals to include in their process.

“It really comes down to making sure that the audit foundation is solid.” says Jim.

“Make sure that the supplier that you’re working with checks the necessary quality boxes.   Make sure the audit is recent and that it comes from the root source and wasn’t passed along from, from one auditor to another. “

“If you not conducting audits yourself, make sure you’re working with an audit partner that has a background in what you’re trying to accomplish. Get all the background and what’s included in that audit report and the timing of it. “

“If you’re a procurement person at a pharma company, make sure that you have open lines of communication with your quality departments. Those two departments have to work hand in hand to help each other. “

What advice do you have for situations where quality comes into conflict with other objectives such as cost containment or speed to market?

“I think we’d be a little bit naive if we said that internal conflict didn’t exist. But to me, it comes down to one thing: what’s good for the patient?"

Dr. Thortsen Fallisch, Head of Global R&D Procurement at Grünenthal spoke to PharmaSource about his experience in setting up a Procurement Centre of Excellence and why speed can be more important than savings.

Thorsten joined Grünenthal at an exciting time when it centralised Procurement was a  "new, mostly unshaped  function". It meant he could make a real impact on the function and see the improving results.

Establishing a Sourcing Board

One of the first areas they identified was that there was not  a standardised process for the category managers to do sourcing activities 

“Tenders sometimes only invited three or even one vendor because it was clear from the very beginning who would be the 'Chosen One', often driven by stakeholders”

Thorsten introduced a Sourcing Board council where the category managers had to present how they are planning to run that tender. 

To support that process, they introduced the governance that for any tenders over €100,000 Euros would  need to have at least three valid offers. A methodology was agreed in advance agreed for how the offers would be evaluated. For example, procurement would want 50% of the weighted criteria to be price or costs associated with the tender.

"The category manager could the run the tender, and when they had decided which vendor to take, they had to come back to the sourcing board and get the final approval."

"This framework helped to structure the process and created a lot of transparency about what was being worked on. "

To embed this required a lot of personal energy to guide and support team members through the process and communication.

With a geographically dispersed team they put a lot of efforts on our on fostering our internal community through their intranet. “This starting off with a page and a bit of content,  over time, we developed a real plan, with a fortnightly newsletters and regular Townhalls with the teams. “

How technology was used to enable change

The process started by being managed in Excel and PowerPoint documents, with sourcing mangers completing templates to present their case to the Sourcing Board.

The next step was a tool Grünenthal developed themselves specifically to manage the sourcing process, where all information previously in PowerPoint could be put in the tool. 

Finally, they implemented an E-Procurement platform. After  evaluating a number of vendors they before decided to use Jaeger,  a platform they have been using for the last two years. 

Why speed is more important than savings

Since moving into a new role focusing on R&D, Thorsten has continued to play a role in the development of the Sourcing Board so that it partners better with his new stakeholders.

His main objective has been to accelerate the process. 

“To understand the friction with R&D and Procurement you have to understand one thing…  Speed is more important than savings”

"The faster you develop a drug, the more time you have left on the market. That's why  Grünenthal as a company deliberately took the approach to to conduct some of the R&D studies in parallel and prioritise speed."

The Sourcing Board approach was perceived as delaying the process too much, so now a faster process involves the stakeholders earlier to make decisions. 

"We now call it the 'Category Council' which is now a more stakeholder-oriented way of taking vendor decisions. So it's not only the sourcing board and procurement internal council that approves a decision on the vendor, but stakeholders are closely involved throughout"

"Prioritising speed is an interesting challenge for someone in procurement to have! Not to focus on savings but on speed makes a nice change.” says Thorsten.

https://pharmasource.global/content/podcast/how-to-create-a-procurement-centre-of-excellence-a-conversation-with-dr-thorsten-fallish/

Cost savings are less important than creating business value.

In the latest episode of the PharmaSource podcast, we sat down with Jill Robbin, Fractional CPO and advisor to Biotechs at Matchbook, with a wealth of experience in leading pharma procurement teams at Eli Lilly and Elanco.

Jill offers valuable advice to anyone seeking to progress their procurement career within the pharmaceutical industry, including a warning against becoming too focussed on the bottom line.

“Savings often get lost in the shuffle. Finance can agree or not agree, or then they get added back in or taken away from budget. There’s got to be a better metric, and it has to be business value.

Instead, understand what’s important to your particular company and tie the procurement metrics to that.

A solution may cost more, but if you are delivering things faster, or you don’t have disruption in your supply, that is worth the weight in gold."

If you'd like to join a free Expert Workshop hosted by Jill Robbins, head to PharmaSource.global/events and register.

In the latest episode of the PharmaSource podcast Johannes Galatsanos, Novartis talks about how the River Rhine went from being the polluted, post-war “sewer of europe” to the swimmer-friendly river it is today, and how data quality can be improved in the same way.

Based on his experience in rolling out a global #ERP system at Novartis, this is essential listening for anyone interested in how data science - founded upon better data quality - can improve pharma business operations.

Pharmaceutical Packaging is critical for safe and stable drug delivery, and continues to be fast-growing market driven by manufacturers creating increasingly innovative products.

Founded in 1825, Bormioli is nearly 200 years old yet continues to release innovative products for the pharmaceutical industry. While they have strong roots in Italy, today Bormioli Pharma manufactures from nine plants around the globe (including United States, France, Germany and China) and have more than 890 products.

We speak to Andrea Sentimenti, Marketing and Innovation Director at Bormioli Pharma to discuss their Open Innovation programme, exploring their process for collaborating with customers, patients and healthcare professionals to prototype new packaging concepts.

The Pharma Source podcast dives into the latest trends, challenges, and commercial opportunities in the pharmaceutical and biotech industry

In each episode we'll be speaking with top executives, researchers, policy makers and other experts, who share their perspectives on the the trends that are shaping the business of pharma.

From the latest breakthroughs in drug development and manufacturing, to the impact of healthcare policy on drug pricing, we cover it all.

In this episode we interview Dr John LaMattina

John was president of Pfizer Global R&D- where he managed more than 13,000 scientists and professionals in the United States, Europe, and Asia.  Today, John is senior partner at PureTech Health, Author and Forbes contributor - Where he offer a unique perspective into the challenges and costs that come with bringing life-changing medicines to market.

His latest book Pharma and Profits - balancing innovation, medicine and drug prices, lays our the facts in a very accessible way, should be required reading for anyone in journalism before they write a story about drug prices.

In this interview we discuss:

- Unpacking the criticism and misconceptions about the Pharma industry 

- The lack of price transparency in the the US healthcare system

- The potential innovation-killing effects of the Inflation Reduction Act

- Why Gene Therapy is a particular issue for pricing

Subscribe to Pharma Source Podcast for your regular dose of pharma and biotech insight.