Send us a text

Ever wondered how the healthcare industry can leverage the power of marketing? Join us as we unravel the mysteries of programmatic marketing with the CEO and founder of Doceree, HJ. He takes us through the innovative platform that reshapes how messages are targeted to healthcare professionals. From reaching physicians, nurses, and pharmacists with personalized messages to rolling out patient savings programs, the benefits are limitless. All while staying compliant with data privacy and security guidelines. Buckle up for a deep dive into the world of automated marketing as HJ shares how their multi-tenant model disrupts the traditional process of segmentation.

But that's not all. Shifting landscapes, we get a taste of global pharmaceutical markets with HJ, a physician turned advertising expert. Navigating the choppy waters of language barriers and siloed data, HJ emphasizes the importance of market understanding before making that leap. He delivers a raw, unfiltered view of his journey in the advertising space and the critical role of market feedback in propelling growth.  Here's your chance to gain a fresh perspective on the intersection of healthcare, marketing, and technology.

Guest:

Harshit Jain 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Join us in a fascinating conversation with our special guests, Richard Nkulikiyinka, as we unravel how endpoints in trials are transforming and the significant role they play in determining trial efficiency. We also delve into innovations in oncology endpoints and discuss the challenges and opportunities in cardiovascular trials. Tune in as we explore the use of composite endpoints in heart failure trials and exciting functional endpoints that are potentially leading the way for approval studies.

We took a deep dive into the critical impacts of trial design and data collection on entire trial enterprises, emphasizing the importance of prospective validation. Richard shared intriguing insights about the changing landscape of trial design and its ripple effect on the industry. He gave an in-depth analysis of sodium-glucose co-transporter inhibitors and the revolutionary changes they brought to the standard of care through a series of trials. You wouldn't want to miss their take on the advantages of umbrella and basket trials and the essential role collaboration plays for their success.

In this riveting discussion, Richard also illuminated the transformative power of innovation and collaboration in clinical trials. We delved into the thrilling potential of cross-company collaboration in investigating the same patient population and the possible role of impartial brokers. Richard also sheds light on how AI and technological advancements could enhance clinical trial outcomes. Listen as they dissect the potential of AI in imaging, its role in streamlining assessment processes, offering real-time feedback, and reducing the burden on specialists. As we wrapped up, we examined how machine learning could make clinical trials more cost-effective by automating the adjudication of events in cardiovascular trials. This enlightening conversation is a treasure trove of insights into the dynamic world of clinical trials. 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Understand the complexities of clinical trial design from a seasoned expert. We speak to our esteemed guest, Richard Nkulikiyinka , a senior leader in clinical development. Richard illuminates the often-misunderstood world of trial design, from setting objectives and identifying target populations to the nitty-gritty like data collection, visit schedules, and maintaining quality. The spotlight shines on patient-centric approaches, as Richard persuasively argues for designing trials that are more patient-friendly without sacrificing quality.

As we go deeper into the conversation, we reveal the intriguing process of creating and accepting endpoints for various diseases. Richard presents a compelling case study of heart failure trials, debunking the notion that traditional endpoints are always the best fit. He illustrates how a novel endpoint for counting all hospitalizations was innovatively developed and accepted by health authorities — a process that holds potential for other diseases reducing exercise capacity. 

But it's not all about the technicalities. We also underscore the crucial role of collaboration in developing endpoints. To illustrate this, Richard  shares his experience charting the benefits of pre-competitive collaboration between industry partners, academic institutions, and health authorities. We also navigate the challenges of innovating clinical trials, discussing the constraints of mega trials and escalating costs, and the collective effort needed to accelerate the development of new therapies. Get ready to reimagine the future of clinical trials with this enlightening discussion!

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Join us as we talk to Pradeep Sacitharan, a serial dropout turned award-winning scientist. Starting life as a war refugee and working in London bars, Pradeep's life took a radical turn following a near-death experience, propelling him into the world of drug development. He navigates us through his fascinating journey in the biotech world, recounting his trials and triumphs in the field.

Ever considered that academia might be flawed? Pradeep exposes the cracks in the academic system, expressing the need to revamp the current structure and invest more in budding talent. He shares his unique approach to experimentation, emphasising the power of learning from rejections. As he delves into his own experiences, he offers valuable insights to help young researchers navigate the often daunting world of academia.

But Pradeep's insights don't stop at academia. He explores the relevance of practical learning, neurodiversity, and talent identification. Plus, he sheds light on the fascinating and often complex world of biotech funding, helping us understand the important details often overlooked. Pradeep's story is not just about his own journey, but it also serves as a guide for anyone looking to carve their own path in the world of science and beyond. Tune in and learn from his unique perspective on the changing landscape of biotech, academia, and talent management.

Guest:
Pradeep Sacitharan 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Ever imagined the immense potential that decentralized clinical trials (DCTs) could unlock for patients and sponsors? This week, we're going on a deep dive into the world of DCTs with our esteemed guest, Ewa Lindqvist, a trailblazer in this space. Brace yourself for an enlightening conversation about how DCTs are paving the way for increased access to new treatments and real-time data for physicians, all while slashing costs and inefficiencies.

Resistance to DCTs, stemming from technology fears and competency gaps, is a significant hurdle. However, our discussion with Ewa sheds light on how regulators have transformed into allies in this journey. We also unveil Thread, an innovative app poised to streamline DCTs, with its impressive capacity to monitor compliance, safety, efficacy, and much more. So, if you've been apprehensive about DCTs, it's time to shed those fears!

In our final segment, we touch on the pivotal role of convenience in clinical trials. Learn how Thread is leveraging technology to synchronize wearables and EDC data, thus driving efficient clinical trial processes. Also, we explore the integral role of patient advocacy organizations in ensuring DCTs are offered to patients. This conversation promises to revolutionize your understanding of clinical trials and the extraordinary potential of decentralization. Tune in and get ready to be amazed.

Guest: Ewa Lindqvist

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Prepare to uncover the transformative potential of open source software in the pharmaceutical industry! Our distinguished guest, Katja Glass, an influential open source ambassador, joins us on this enlightening journey. We'll explore the rising popularity of open source solutions in the pharmaceutical industry, its myriad benefits, and the profound impact of sharing tools, processes, and software.

Turn up the volume as we unravel the advantageous features of the Open Study Builder. This unique tool has not only helped pharma companies in embracing automation but also presents an innovative approach towards modern metadata repositories. We take a closer look at how its  properties facilitate creating protocols, bringing a refreshing twist to the traditional processes.

As we conclude, we ponder over the future prospects of the Open Study Builder, the implications and the exciting opportunities for tech vendors to engage with the Open Study Builder ecosystem. Katja shares her perspectives on the possible transformations. Tune in as we draw parallels between the pharmaceutical industry and other sectors and explore what lessons can be learned from their uptake of open source. So, buckle up and get ready for an intriguing conversation revolving around the changing dynamics of trials in the pharma industry!

Guest:
Katja Glass

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Imagine being given a shot at a cure before it's even approved. That's the fascinating world of expanded access programs for unapproved investigational interventions that we're exploring today with our esteemed guest, Patti Zettler, law professor and chair of the International Society for Cell and Gene Therapies Expanded Access Working Group. We delve into the history of these programs, the FDA's role in their regulation, and the surge of interest they've seen in the last decade. Ever wondered why a patient would be willing to be a first mover on a yet-to-be-approved drug? Patti provides enlightening insights into this unique field.

We then delve deeper into the intriguing complexities of expanded access programs within the realm of cell and gene therapy. We navigate through the potential for these programs' misuse by pharmaceutical companies, and the tension between the need for scientific evidence and a patient's desire for early access. The conversation also explores the ethical and legal dilemmas these programs present, the doctor's role, and the challenge of effectively communicating associated risks to patients. We wrap up with a contemplation on the changes we hope to see in the industry. Patti's insights, coupled with our thought-provoking discussion, will leave you with a deeper understanding of this crucial aspect of modern medicine.

Guest: Patti Zettler

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Imagine you're on an eight-year journey trying to diagnose an autoimmune disease. Suzaan Sauerman, our insightful guest today, faced this exact challenge. Sauerman, a visionary in female representation in clinical trials, uncovers the persistent gender gap in this field and posits an innovative solution—wearable technology.

We dig into the heart of Sauerman's story with a touching account of her mother's heart disease experience, a stark illustration of the gender bias in medical research. Wearable technology, Sauerman suggests, can close this gap, capturing vast data from thousands of women, while offering a more in-depth understanding of female anatomy. Our discussion touches on the potential of these wearables—earables and the like—in health tracking, the need for better design, and the importance of women's involvement in product development.

Not to be missed, Sauerman's personal tale of autoimmune disease diagnosis unfolds, setting the stage for a spirited debate on wearable technology's role in accelerating health diagnosis. We push the boundaries of this conversation, exploring how these devices could shape our awareness of health, preventative care, and even alter insurance premiums. Sauerman's passion for empowering consumers, particularly women, with these devices is infectious. Join us as we envision a future where technology seamlessly integrates into our health journey, enhancing our life one wearable device at a time.

Reach out to Suzaan Sauerman on LinkedIn

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Let's face it, executive turnover in the life sciences industry is a conundrum. Companies are offering competitive compensation, fostering positive work cultures, and providing opportunities to contribute to meaningful work, yet many executives continue to leave. In our intriguing dialogue with the insightful Federico Grayeb, we delve into why this is happening and how job embeddedness could be a key factor in predicting retention. Grayeb's perspective brings to light the deeper dynamics at play in the industry, such as the abundance of job offers executives receive and the high level of isomorphism, making it easier for them to switch roles within the industry.

But there's more to the story than just job offers and industry dynamics. Federico shares thought-provoking insights into how external events – even positive ones like pregnancy or acceptance into a prestigious school – can lead to a departure, regardless of job satisfaction. He also discusses the concept of job embeddedness, a measure of an individual’s connection to their job and outside life, and its significant role in forecasting retention. We also explore Grayeb's fascinating work on a tool that assesses job embeddedness and his approach to hiring based on psychological fit. So, join us as we navigate this complex terrain and uncover transformative ideas to tackle executive turnover in the life sciences industry. You wouldn't want to miss it!

Reach out to Federico Grayeb via LinkedIn

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we speak to Ravi Samavedam, Chief Innovation Officer for Azzur Group, about how on demand clean rooms can transform the business model for biotechs. 

We start out by exploring what the standard two choices biotech’s typically have for clinical trial manufacturing:

1. Building their own infrastructure
2. Outsourcing to a contract manufacturing organization

Both options have pros and cons. Many of the cons can be mitigated by the third option that Ravi suggests - renting the infrastructure. This enables the biotech to keep control with the manufacturing process and keep experimenting, while avoiding the upfront investment in the infrastructure that may change. 

We also dive into the compliance of the facilities, and how outsourcing the quality assurance of the facilities themselves can allow the biotech’s to focus on the production process and science. 

Even though the clean rooms for the different companies are in the same facilities, there is no exchange of air or supplies between the rooms - and also limited exchange of ideas between the individual production lines due to confidentiality. 

As a small biotech it is easy to fall into the trap of going overboard with GMP regulation adherence. And how GMP stamina is necessary to know where to draw the line of sufficient quality. 

Guest:

Ravi Samavedam

https://www.linkedin.com/in/ravi-samavedam-65a8345/ 

Azzur

https://azzur.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we speak to Leif Kuse, who is Lead Trailblazer of Drug Development Outsourcing Disruption and CEO PHARALL.

We speak about group purchasing for biotechs in clinical trials. We start out by exploring how CRO contracting usually happens for biotechs, where clinical trials are typically outsourced to CROs. 

Biotech outsourcing is especially tricky, because in especially smaller companies, there may not be competencies to handle a sudden increase of people working for the company by adding a partner to the organization.   

There are several models for collaborating with vendors - from a turnkey project, where you just “hand over the key” to a vendor, and wait for the results - to a close explorative collaboration, where the partner is basically a part of your organization. 

We discuss the difference in services and pricing that is on the table for big pharmaceutical companies and biotechs, exploring the dynamics of the market and collaboration models.

There is no ideal CRO for a biotech - it all depends on what is needed, and how a collaboration can be established. Leif provides examples of great collaborations between CROs and biotech companies - where processes, culture and contracts all meshed. 

The patient stands to benefit from successful collaboration between sponsors and CROs. The trials can be executed more smoothly and drugs can make it to market more rapidly.  

Lastly we discuss if the pharmaceutical value chain could be decentralized in general, with companies like PHARALL brokering different parts of the value chain into a coherent whole. 

Guest:

Leif Kuse

https://www.linkedin.com/in/leif-kuse-32042411/

PHARALL

https://pharall.de/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we speak to Tirrell Payton, Managing Partner at Nooma Group Consulting, about mindset in life sciences. 

We speak about how there is a disconnect between the level of risk willingness among the top levels in organizations and middle managers. Middle managers are often afraid to make a mistake - and become the “permafrost layer” where change has a tough time to take root. 

We also speak about how institutional storytelling about past failures in a company can hinder people to try new things. These stories can act as invisible guardrails that limit what can be tried in an organization. Without being actual current constraints. 


Stepping into the actual power and possibilities that each individual has in a life sciences company can foster innovation. Optimizing a single piece of technology or process step of the clinical trial value chain does not provide the benefits often promised. And you cannot solve people problems with technology or process solutions.

We speak about how remote work in life sciences worked really well during the pandemic. But that it somehow stopped working. This is in fact a well understood phenomenon, where we initially could ride on the connections created pre-pandemic: Now as teams have experienced churn, people can no longer rely on that personal connection. .And remote connection does not substitute the connections forged in person. 

Clinical trials often consist of people working for different organizations - like sponsors and CROs - who still need to gel together to do good work. To make this work, you need to be intentional to make this work. A lack of teamwork is often the root cause for poor performance in a clinical trial. 

We speak about the key challenges in pharma right now, and how companies are shifting towards rare dieseases. And how the current toolkit we have does not suit the problem. 

Guest:

Tirrell Payton

https://www.linkedin.com/in/tirrellpayton/ 

Nooma Group

https://www.noomagroup.com/  

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we speak to Philip Russmeyer, Founder & CEO of Fitfile, about the promises that true data anonymization holds for transforming clinical trials. 

We dive into the differences between tokenization, anonymization and pseudonymisation of data. And how the difference is whether individuals can ever be identified or if the data is masked with a token that can potentially be removed. 

The risk of secondary use of data that has been tokenized has held back research and data sharing between healthcare and life sciences. One of the reasons is that collecting consent from individuals costs about 400 USD per consent.

One of the downsides of anonymization is that data cannot be unified across sources for an individual to get a full picture of health data. 

We speak about the differences between US and EU attitudes and legislation about personal data protection and how these are converging towards stronger privacy protection. For good reason, since personal health data is worth 10x more on the dark web compared to financial data. 

Collection of consent also matters in the sense that 80-90% of a trial is still delayed due to longer recruitment timelines than anticipated. That can be reduced if the trial protocol rests on a larger volume of anonymized relevant data.

Anonymized data can also serve as a larger and more ethical control arm for clinical trials. Same goes for long-term follow up of clinical trials and the potential to re-use data collected once in additional trials.   

We speak about the siloed nature of health data between healthcare and life sciences and how Fitfile attempts to work end-to-end between the entire data creation lifecycle. Which is not always simple, but optimises the use of health data.  

Guest:

https://www.linkedin.com/in/philiprussmeyer/ 

Fitfile

https://www.linkedin.com/company/fitfile/ 

Notes: 

GPDPR Program of the NHS: https://digital.nhs.uk/data-and-information/data-collections-and-data-sets/data-collections/general-practice-data-for-planning-and-research 

European Journal of Human Genetics: 

https://www.nature.com/ejhg/ 

ADPPA:

https://www.congress.gov/bill/117th-congress/house-bill/8152/text 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we host Sam Ewing, who is the Global Head of Pharma Partnerships at Doccla. We speak about endpoint development in general - and digital endpoint development in particular. 

We define digital endpoints as something that happens in a patient's home, and is mediated by a smartphone with some technology associated with it. 

The benefits of digital endpoints for patients are tangible. They would not need to visit sites as often. That would make it easier to be a trial participant, and increase the diversity of clinical trial participants. That in turn would lead to better ecological validity of the data.

We also speak about how a virtual ward is analogous to decentralised trials and how some of the data collected in a virtual ward setting could be used for clinical trials - potentially reducing the scale and complexity of clinical trials in the future.  

Connecting the healthcare system and the clinical research setting could mean that we can re-use the data collected in one or the other setting.

Guest:

Samuel Ewing

https://www.linkedin.com/in/samuelewing/

Doccla

https://www.linkedin.com/company/doccla/ 

Notes:

Digital endpoint approval

https://www.clinicalresearchnewsonline.com/news/2023/02/16/a-long-time-coming-on-digital-endpoints 

Digital Medicine Initiative

https://dimesociety.org/

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we host Christian Born Djurhuus, who is a physician by training, a self-proclaimed geek and has had an impressive career in life sciences in the intersections between drug development, leadership and technology. 

We speak about how the waterfall mentality is prevalent in life sciences, where specifications are developed by one group and tossed over the fence to the next group. This creates friction and elongates development timelines. 

But there is also a challenge with developing drugs without the necessary feedback from the market - or that the market moves on from the initial dream of how a drug would perform in the market. 

We speak about how no matter how well we plan out drug development, risks will materialize. Planning may give an illusion of control, but the mentality of understanding that a plan is a nice baseline to navigate according to, but not actual reality, is crucial for navigating. 

Christian predicts that our industry will pivot towards developing patient solutions to a higher degree rather than drugs alone. These need to be tailored to the diseases they are targeting - but also patient profiles. 

We dive into how speaking to each other across professional domains is key to creating most possible value. But also that domain knowledge is essential for digitization. 

The life cycles of technology and health are very different. We speak about the example of Chat GPT and drug development lifecycles - but also those of organizations. And that life sciences needs to catch up to the speed of technology. 

Guest:

Christian Born Djurhuus

https://www.linkedin.com/in/christian-born-djurhuus-58a4395/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we speak to Simon Taylor, Head of European Solutions Consulting at Florence Healthcare. We focus on site oriented technology transformation. 

We speak about the current challenges that clinical sites face, such as the high degree of churn within the healthcare industry, the increasing complexity of protocols and the prevalence of paper as the primary recording mechanism. 

We speak about how to help sites quit their paper dependencies, and how the regulatory landscape stands in the way of adapting more digital ways of working.  

Sites have been given technologies to use by the sponsors that have not worked for them in the past - and have created an expectation that technology will not help make the process easier. 

We speak about the discrepancies between CROs, sponsors and sites. And how there is room for improvement to ensure that everyone wins from collaboration. 

Decentralized clinical trials are not well equipped to adopt additional technologies unless they can successfully move all of their processes into a more digital operating model on a more fundamental level.  

The regulatory agencies have been encouraging diversity in clinical trial recruitment. Representation in research is currently skewed, so additional focus is needed. But it translates into a new kind of work for clinical sites - of physically going to new areas to recruit patients. 

Guest:

Simon Taylor

https://www.linkedin.com/in/simon-taylor-56143638/

Florence Healthcare

https://www.florencehc.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we speak to Ole Henriksen, Associated Partner of Nordic Healthcare Group and pharmaceutical market access expert. We speak about how health technology assessments (HTA) has impacted how we conduct clinical trials. 

Health Technology Assessment (HTA) emerged first as a research area in decision aids. Later, during the 1990s, as a formal requirement for reimbursement.

Due to it being a requirement in many markets, it is often called “the 4th hurdle”.  It should be understood in addition to regulatory requirements on efficacy, safety and quality, HTA poses a 4th requirement of therapeutic value or value for money.

The main purpose of conducting an assessment in the first place is to inform decision making. The research question or decision problem is: Should we include the technology as part of standard of care (and reimburse it)?

Historically clinical trials were used to gain market access by passing regulatory requirements – efficacy, safety and quality. The emergence of HTA meant that data and information on the technologies at time of marketing should also be used to assess the value of the technology vs. existing clinical practice and in clinical practice.

This is perhaps one of the big dilemmas in medical development today that we have regulatory authorities who grant priority review/fast track and so on, but HTA authorities asking for more certain effects to be documented at reimbursement.

Guest:

Ole Henriksen

https://www.linkedin.com/in/ole-henriksen-b911705/

Nordic Healthcare Group

https://nordichealthcaregroup.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we are hosting Kimberly Tableman, Founder and CEO of ESPERO Health, and speak about how clinical trial protocols are being re-imagined in our industry. We dive into what a protocol actually is and what it describes. 

Protocols are currently being developed with a lot of manual research. WIth googling, phoning friends and re-using existing protocols in word documents. 

Trials today are being conducted in a more complex environment than before. This means that it is necessary to adapt the trial design as the trial is executed. Creating a trial and executing it unchanged is becoming more rare and requirements for additional digitization in this space are increasing. 

Trial design is also a very collaborative process involving 10-12 stakeholders. Using a system that supports collaborative creation is key to avoid the pitfalls of versioning and overwriting of comments. 

Writing the protocol with data collected from the current market can make the protocol more robust and accelerate timelines. That is what Espiro health aims to provide in their protocol platform. Making it easy is the trick to ensure adoption. 

We also speak about the dynamics that lead to rigidity in the pharmaceutical space and how having sufficient inflow of money in especially big pharma leads to containing the status quo. 

Speaking out of her experience as a founder, we dive into what it means to start a technology company in the life sciences space and how funding is key to getting off the ground. 

Guest:

Kimberly Tableman

https://www.linkedin.com/in/kimberly-tableman/

ESPERO Health

https://www.linkedin.com/company/espero-health/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we have André Chagwedera in the studio, the Founder and CEO of Fleming Protocol. We focus on health data, and what it would mean for patients to own their data. 

One of the consequences of patients owning their data would be that patient communities would have a say in which areas to conduct clinical research in as well as the design of clinical protocols.

Fleming Protocol is a patient peer-to-peer network built on the blockchain. Where Fleming Protocol focuses on providing the tooling to make this network work, they work closely with patient communities, researchers and industry to understand the currently unmet needs and funnel those into research.

Having built the solution on the blockchain builds traceability into the process of what gets funded and researched and how these priorities happen. We dive into how this would happen with the mechanisms in the blockchain as well as the needed competencies from the industry.  

Guest:

André Chagwedera 

https://www.linkedin.com/in/andrechagwedera/ 

Fleming Protocol

https://flemingprotocol.io/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

We speak to Raj Indupuri, the co-founder & CEO of eClinical Solutions, about why data plays such a key role in our industry. And dispute this being true for as long as we have had clinical trials, the recent technological advancements open up the possibilities for true data-driven decision making. 

Even though the clinical space has been digitising for many years, digitization is not necessarily transformative. Pockets of evolution have been attempted in a siloed way - not reaching all the way across the value chain. This creates a fragmented experience for the end users. 

We speak about platforms and ecosystems of platforms, and how to make the collaboration between stakeholders and technology seamless. And maintaining systems openness. This means that competing providers need to collaborate - as frenemies - for the betterment of research.

We imagine what the current transformation in the digital space means for internal IT departments in life sciences, and what kinds of skills and competencies are needed - and which are no longer required. 

This episode is a little different. Sam works for the company that Raj is the CEO of. And this time around Ivanna gets questions and answers them too. 

Guest:

Raj Indupuri

https://www.linkedin.com/in/rajindupuri/ 

eClinical Solutions

https://www.eclinicalsol.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Today we speak with Lars Rosendal, the VP of Global Clinical Operations at LEO Pharma. We speak about how clinical development is an innovation game - and how both governments and patients are willing to pay for innovation.

Patients in many major diseases are well served. That means we need to push the innovation to bring something to market that is either much safer, or has a higher degree of efficacy. 

When it comes to bringing a drug through the entire clinical value chain, there is a lot of uncertainty as it is. When you are trying to aim for innovation, the uncertainty increases. 

What this uncertainty does to a company depends on the company size. Being in a mid-sized pharmaceutical company means that there is some room for taking risks, but also a need to balance the uncertainty with the need to ensure continued operations. 

We dive into what this means for trial design in different stages of clinical trials - and how some of these stages can be outsourced, whereas others should be best kept in house to build relationships with HCPs pre-drug launch. 

We speak about leadership in the clinical area - and the benefits of understanding the entire clinical life cycle. Drug development is both an innovation game and a horse race. Leadership is what will allow your organization to run fast - but also dare to fail in pursuit of a deep purpose. 

Lars recently re-organized his leadership team to structurally ensure cross-functional collaboration and drive a competitive edge. We speak about the ideas behind this restructuring, and also how it has addressed some of the most stubborn challenges of our industry. 

Off-mic, Lars Rosendal and Ivanna Rosendal did try to figure out if there is a family relation - but there did not appear to be one.  

Guest:

Lars Rosendal

https://www.linkedin.com/in/lars-rosendal-2520a16/ 

[email protected] 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

In this episode we speak to Rebecca Godfrey, the author of The Leadership Vaccine, about transforming specialists into leaders. In The Leadership Vaccine we follow a story of how a company transforms itself - and discovers the five pillars of leadership.

We speak about how the state of leadership in life sciences is improving as the science of leadership is gaining a more prominent position. And how the regulatory requirements of our industry can bring forth creative potential in leadership.    

We discuss how leadership may not require technical expertise, and the difference between leading people and leading delivery - and why separating line management from delivery management can be beneficial for specialists. Line management should not be the only way to progress in your career.   

Another topic we discuss is how to foster cross-functional collaboration - and how creating a shared responsibility in the leadership team leads to high performance. 

Rebecca also takes us through the five pillars of leadership as she describes in the book and why they together make an organization click into place. 

Guest:

Rebecca Godfrey

https://www.linkedin.com/in/rebecca-godfrey/

The Leadership Vaccine:

https://www.amazon.com/Leadership-Vaccine-innovation-efficiency-resilience/dp/1781334536 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

 Today is World Rare Disease day. It is only fitting that we speak to Sophia Zilber who is a statistical programmer, but also Board Member & Director of Patient Registries at the Cure MITO Foundation, about bridging the gap between the life sciences industry and patient registries in rare diseases. 

Sophia has experienced first hand how rare diseases lack both data and funding. Using her personal tragedy and statistical programming skills, Sophia engaged in patient advocacy groups attempting to collect patient data for research.  

Pharmaceutical companies are often looking for data sources to understand diseases. And patient advocacy groups are eagerly collecting data in the hopes that it will make a difference for finding treatment and cures. But in many cases the data collected is not usable for actual research purposes. 

Currently there is no guidance on how to create a patient registry that will contain a high enough quality of data to be used for research. Sophia is actively working to change that through multiple efforts, such as a Phuse working group  - and shares with us her advice for how to ensure data quality. 

Guest:

Sophia Zilber

https://www.linkedin.com/in/sophiazilber/
https://sophiazilber.carrd.co/

Cure MITO Foundation

https://www.linkedin.com/company/cure-mito-foundation/ 

Phuse:

https://www.linkedin.com/company/phuse/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

We speak to Johan Lauritsen, CEO & Founder of Probe, about how clinical trials can be an alternative to treatment. 

Johan himself tried to enrol in a clinical trial for his rare chronic disease. This was an uphill battle and he never succeeded - but the experience did kindle his desire to make clinical trials available for patients.

Enrolling in a trial for a patient is not easy - even though especially chronic patients are very much willing to participate. But it is not easy for the physician to recruit patients for a clinical trial either. The problem is on both ends of the spectrum.   

There is no democratic access to clinical trials for patients. Even though a patient may be eligible, they may not enrol participants who are new to trials.

Johan discusses the moral imperative of having open access to the newest treatment options for any patient fitting the criteria - wherever the trial is running in the world. 

Johan also takes us through his solution for bridging the patients who are willing to participate - and the clinical sites recruiting for a clinical trial.

With the use of a simple apply button. But also by using the latest technology to ensure transparency of the use of data and security. 

Guest:

Johan Lauritsen

https://www.linkedin.com/in/johanlauritsen/ 

PROBE

https://www.linkedin.com/company/probe-dk/ 

Links:

https://clinicaltrials.gov/ 

https://lighthouse.ku.dk/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

We speak to Maya Zlatanova, the CEO and Founder of Trialhub and FindMeCure about trial strategy for clinical trials. We speak about the amount of information necessary to digest in order to answer the many complex questions during trial start-up, and how starting from the templates of previous trials can both be time-saving, but may also limit your perspective on what is possible with this specific trial. 

By asking the question of “what can go wrong” can help open the innovative power of clinical trial design. This can also help the understanding of patients and sites in the real world, and lead to better decisions. This question can also lead to better empathy with the stakeholders, and help anticipate some of the issues that may arise in the trial based on the design.

Finding data that can reliably support the answer for this question is another challenge yet to be solved. This is complicated further by the collaboration between the CROs and sponsors, where the responsibility to collect the data necessary to support key decisions may fall between two chairs.

Aligning your clinical trial to the real world would ideally lead to adjustments of the clinical trial as it is ongoing - but that is prohibitively expensive and difficult. When you are having trouble recruiting patients for your trial though, it may be worth the cost to pivot your trial during conduct. Here patient listening may be a way to understand what else might be possible for your trial. 

Patient recruitment slowing down may be a lagging indicator of trouble with your trial design. Having conversations with your investigators proactively can help you uncover potential issues with your trial before they manifest as recruitment problems. Understanding the entire ecosystem that the clinical trial takes place in can help you understand which alternatives to participating in a trial the patients may value more.   

Guest:

Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/ 

Trialhub and FindMeCure: https://trialhub.findmecure.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we speak to Dr. Daniel Fox, founder & CEO of Clinical Research Payment Network about how the power dynamic between sponsors and sites is shifting. We speak about the harms of “talkdown tech” and how sites can take back control over their own processes.  

We speak about the predominant model today and how sponsors in the name of efficiency introduce systems and processes to sites that may or may not work in the specific clinical setting of that site. One of the key reasons for this tendency is the information asymmetry between sponsors and sites. 

One of the problems with this approach is that it does not work. Sites are different both individually - but also according to specialities and geographies. Another issue is that it is not legally feasible in the structure between sponsors and sites. 

Site-facing technologies are bridging the gap, with the needs of the sites front and centre of the functionality. This is emerging as talk-up tech - initiated by sites, because it allows them to run clinical trials in the best possible way. 

A related term we uncover is site centricity. Physicians are the most stable element of healthcare - whether sponsors or sites exist or not. The physicians will continue to provide healthcare to patients long after the trial is completed. Optimising the clinical trial ecosystem for their needs makes sense. 

We dive into the PACT-score and how it is addressing the asymmetries between sites, CROs and sponsors - giving back control and options to sites for which trials they select to participate in.  

Guest:

Dr. Daniel Fox: https://www.linkedin.com/in/daniel-fox-mph-phd-3955b222/ 

Clinical Research Payment Network: https://www.crpaynet.com/  

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we speak to Brian D Smith, professor and author of a brand new book New Drugs, Fair Prices. In the book and on the show Brian suggests that we can have our cake and eat it too - meaning that we can have fair drug prices, yet still encourage pharmaceutical innovation. 

Brian talks us through what it means to apply a generalised Darwinian approach to the life sciences ecosystem and how considering the complex adaptive ecosystem as a whole opens up new perspectives to solving the polarising debate about drug prices on one hand and encouraging innovation on the other. 

Applying this theoretical perspective ends up with some very practical solutions to some of the ailments of our industry. Getting to the solutions, we travel through some of the habitats of the ecosystem to discover the challenges the industry faces. 

We dive deeper into the discovery habitat. The purpose of this habitat is about creating new knowledge. This is often done in universities and publicly funded labs. Predictivity is one of the challenges in this industry - meaning that it is not directly transferable to actual medicine. Understanding translational science better will help us ensure a better conversion rate between discovery and actual drugs. 

You do not solve problems in a complex adaptive ecosystem with just one solution. Like removing one weed in your garden will not create a flowerbed. You need to apply a range of solutions and react to how the ecosystem reacts. In the book, Brian suggests 27 solutions to the problems in our ecosystem - and all are interconnected. These solutions are societal projects - not just government projects or industry projects. 

Revisit Episode 8 of Season 1 where Brian first guested us: https://transformationintrials.buzzsprout.com/1906263/10832267-brian-d-smith-changing-your-dna-to-pursue-a-novel-business-model 

Guest:

Brian D Smith: https://www.linkedin.com/in/drbriandsmith/  

Who is Professor Brian D Smith video: https://youtu.be/35HFWM6tbTc

Pragmedic website https://www.pragmedic.com/  

Brian’s email for sample chapter or other questions:  [email protected] 

Book: New Drugs, Fair Prices

Book trailer video: https://youtu.be/aozQuvjMRCw

Publisher’s website with discounted book: https://www.routledge.com/New-Drugs-Fair-Prices-Managing-the-Pharmaceutical-Innovation-Ecosystem/Smith/p/book/9781032361055

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

We speak to Graham Dutfield, professor of International Governance and author of That High Design of Purest Gold on the evolution of IP regulation in Pharma and how it could be transformed in the future. 

Patents are a historic tool, but have undergone an evolution. Patents started out in the 1470’s in Venice, and as an example Christoffer Columbus had a patent to explore the new world. Only in the late 18th century did patents become associated with exclusive rights to exploit an invention in return for disclosing the recipe for it. 

The purpose of patents is to incentivise companies to take on the considerable risk and heavy investment in researching and developing drugs. Without patents, competitors could replicate a successful drug without having to take on the investment and risk. 

But even though the intention behind patents is to ensure further innovation, it also creates perverse incentives in life sciences. This is mainly because new uses of existing drugs can also be patented as well as human genes and other biologics. 

We speak about how the biotech revolution changes the patent landscape by introducing complex technologies that require multiple patents to ensure protection to reap the benefits of the investment in their development. The industry is changing with a rise in the sheer volume of patents on both the drugs themselves, but also the manufacturing methods.  

The professionalisation of invention - the intententive pursuit of invention - was in fact the greatest revolution of the pharmaceutical industry. We look back to the history of the pharmaceutical industry and how the centre of gravity changed from originally being centred in Germany, but moving to the UK and eventually the US - shaped by the world wars. 

When turning to the future, we speak about the importance of biomarkers. They have the potential to transform medicine that works mediocre in the broad population to working exceptionally well in a specific subset of the population. There are also more approvals of novel drugs than in previous decades. 

But there is still an issue with a lack of research in diseases in underserved populations as well as rare diseases, where the market for the drug may be small. The potential for technology transfer is also still unutilized, and getting this right might help us prevent another pandemic. 

Graham envisions a menu of incentive structures for different kinds of disease areas that may differ for areas like chronic pain, antibiotics or rare diseases. That would be a more precise tool for getting the kind of invention we want in areas, that may currently be outside of the reach of patents. 

Guest:

Graham Dutfield: https://www.linkedin.com/in/graham-dutfield-2013a91b5/ 

That High Design of Purest Gold: https://www.amazon.com/That-High-Design-Purest-Gold/dp/9811222479 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

This week we dive into pharmacometrics as a discipline and the potential for replacing and augmenting clinical trials with modelling. We speak to Kristin Carlsson Petri, who is a Director of Pharmacometrics. 

Pharmacometrics modelling is a range of mathematical modelling techniques that can quantify our knowledge of drug biology and disease as well as trial information. The power of the methodology lies in the integration of knowledge across drug development and different compounds. 

Even though pharmacometrics modelling is coming of age in recent years, it is not a new discipline. Its origins trace back to work conducted in the ‘50s and ‘60s, and one of the modelling programs most commonly used today were built in the 1970s in the Fortran language. The development of computers and computing power has allowed the discipline to grow, since the modelling is highly dependent technology. 

Now the regulatory bodies request pharmacometrics analysis and the FDA has its own unit that conducts pharmacometric analysis on the data provided. Both the EMA and FDA encourage inclusion of pharmacometrics analysis especially for paediatrics studies. 

In paediatrics studies pharmacometrics modelling is especially powerful. This is an area where data is usually scarce and fewer patients. But this population should still be offered evidence based medicine. By drawing on existing data from adult studies, some of the gaps can be closed without additional burden on the patients. 

There are several examples of regulatory bodies accepting label expansion into paediatrics without the need to run clinical trials - relying solely on evidence from pharmacometric models. This is an opportunity - since it takes typically 10 years from a drug being developed for adults to it being approved for children. Closing this gap will increase access to evidence-based drugs for paediatric patients.   

The area could grow even faster if data sharing across especially pharma and academia could be accelerated, and AI and machine learning could be applied to it. This is difficult, since the legal challenges of sharing data blok an efficient exchange. 

We also speak about datasets collected continuously from wearables, and how they are challenging some of the techniques developed in decades past - and how these may need to be updated to the new technological possibilities. 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

For this episode we explore the evolution of the collaboration and partnership structure between sponsors, CROs and technology vendors in life sciences with Temitope Keyes, Executive Director of Encapsia. Temitope has had a front row seat to the digitization of the clinical trial process. 

We speak about the paper handling system that used to characterise clinical processes, and how “validation” that we now use to refer to systems validation used to refer to the validation of the printed paper. An entire ecosystem of vendors was required to make the paper ecosystem function, and the debate back then was whether to in-source or out-source, say, printing. 

The evolution away from paper was absolutely necessary to get an overview of what was actually happening in the trial. The safety issues with Vioxx is an example of how data buried in paper can endanger patients. Data submitted on paper also makes it prohibitive to find trends across trials and drug profiles. 

Temitope takes us through the digitization arc of the clinical process starting from the phone-based IVR systems to manage drug supply. Next came the development of the clinical database. Pharmaceutical companies attempted to build them themselves, but the complexity also forced specialisation in the industry and the creation of many of the technology vendors we work with today.  

Clinical operations is the most expensive part of a clinical trial budget, because it is human-intensive and humans are expensive. CTMS attempts to help provide an overview of the many people involved in a clinical trial. 

As more and more systems started supporting the clinical processes, the cost became prohibitive. CROs entered the space to offer pieces of systems to sponsors for a lower price, and in that way became technology companies themselves. 

We also speak about how we brought all the technology together to end-to-end solutions that allow decentralized clinical trials. 

Guest: 

Temitope Keyes: https://www.linkedin.com/in/temitopekeyes/ 

Encapsia: https://encapsia.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

We speak to Dr. Elin Haf Davies, CEO and founder of the technology company Apartito. We dive into the topic of designing trials with especially paediatric patients in mind. Elin shares with us her perspective on this topic from her background from healthcare, regulatory authorities, pharma and now also tech. 

Elin takes us through the mindset change the industry has undergone from believing that clinical trials in children were unethical, to regulatory bodies requiring life science companies to conduct trials in children to increase treatment options for this population. 

Finding ways to make clinical trials a positive experience for children requires that you think about how you design the administration of the drug - but also how you design the trial itself. Using endpoints that were designed for adults will leave you with inconclusive results in children. Designing endpoints that are age appropriate, disease specific, passive and pain free will make all the difference for your trial. 

What is missing from the equation is the tools for making paediatric-friendly clinical trials. Developing tools that will work for children will likely benefit the adult population too - because you are forced to reduce complexity and think about ease of use. 

Measuring endpoints in a passive fashion carries the promise to make clinical trials easier to participate in for both children and adults - with tools like analysis of video recordings and wearables. We also speak about how wearables and passive means of collecting data do not replace the human element of care - especially not in a paediatric setting. 

Guest: 

Elin Haf Davies: https://www.linkedin.com/in/elin-haf-davies-414b5211/

Aparito: https://www.aparito.com/ 

Links:

EMA on mandate to conduct paediatric trials: https://www.ema.europa.eu/en/documents/other/european-paediatric-initiative-history-paediatric-regulation_en.pdf  

FDA draft guidance on paediatric trials: https://www.fda.gov/news-events/press-announcements/new-fda-draft-guidance-aims-protect-children-who-participate-clinical-trials 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Are pharmaceutical companies allowed to engage with patients and HCPs? Judging by how infrequent such interactions are, you might get the sense that it is strictly forbidden. Though such interactions are regulated, navigating these for the promise of understanding the perspective of the clinicians as well as patients is worthwhile. 

We speak to Andreas Dam, the founder and CEO of Daman, about patient empowerment in clinical trials and how pharma can come closer to patients and HCPs. 

Life sciences are impacted by two major trends: the larger consumerization trend and the shift of healthcare payer focus on outcomes. For the first, patients take greater ownership of their treatment. For the second, additional data about patients’ everyday lives are needed to determine how to prioritize the best treatment.

Patient reported outcomes are becoming an integrated part of clinical trials in part because regulatory bodies are requiring data on evaluating the value of the drug on the overall health of the patients. 

There are benefits of measuring patient health continuously rather than just at site visits. Ecological momentary assessment describes the difference between what you can measure in a controlled setting, and the actual reality. Our minds are programmed to forget the bad part of our lives and are influenced by the setting in the clinic when we recollect how the state of our health has been in the time period leading to the visit.  

Indirectly measuring the patient data from wearables rather than answering questionnaires is one of the ways that co-creating with patients creates trial design that fits more neatly into the lives of patients.  

Increased use of technology is challenging the predominant pharmaceutical business model with long lifecycles. Building software tools and wearables meant for patients require quick iteration and feedback from the end users. In this sense the digital transformation in pharma is not just about technology, but also a transformation in patient focus. 

Technology can help promote shared decision making between patients and doctors. The patient is the expert in living their life with their disease and the doctor is the medical expert. Looking at the same data can ensure a more equal conversation and improve collaboration.

Guest:

Andreas Dam: https://www.linkedin.com/in/andreasdam/ 

Daman: https://www.damandigital.com/ 

RheumaBuddy: https://rheumabuddy.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

The Life Science industry is both known for great leaps of innovation on the product side, and conservatism of process and practice on the other side. In this episode we dive into the actual state of innovation on the product side as we speak to Alexander Gray, the Chief Medical Officer of IDEA Pharma. 

The innovative potential of phase II trials in Life Sciences today is often lost, since the indication is locked in too early in the process. Instead we speak about how keeping the indication open might allow the asset to drive the research to more favorable uses. 

Especially in broad disease areas such as immunology, oncology and CNS it can pay to wait with settling on the final indication until well into the phase 2 trials. Allowing the asset to lead to the indication can lead to better asset-indication matches and better results in further clinical trials. 

We also speak about how it might be possible to keep the phase 2 trials open for longer - and the benefits of involving stakeholders from non-research areas in the development process. This can help expand the view of the asset’s potential and lead to more holistic decision making. 

That kind of holistic decision making can be difficult to achieve in especially larger companies, where the functional areas may be divided not only organizationally, but also geographically. Alexander also shares how the joining up of Commercial and R&D organisations have developed throughout the past 25 years, going from less to more collaboration - but also swinging back again occasionally. 

Specialization is both a gift and a curse in Life Sciences - leading both to highly knowledgeable people, but also makes cross-functional and cross-therapeutic thinking difficult. This sometimes means that the reasoning behind a molecule can also get lost in the mechanics of drug development later in the development process. Going back to the science can ensure a focus on the best use of the asset. 

Guest:

Alexander Gray https://www.linkedin.com/in/alexander-gray-934a653/ 

IDEA Pharma https://www.ideapharma.com/

Notes:

Link to the link between GLP-1 on addiction: https://pubmed.ncbi.nlm.nih.gov/34532853/#:~:text=Glucagon%2Dlike%20peptide%201%20(GLP%2D1)%20is%20released,a%20potential%20anti%2Daddiction%20treatment.  

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

We speak to Dr. Jack Pearson and Sofie Askervall from Natural Cycles about digital contraception and clinical trials based on data science. We explore how an app can become approved by the FDA as a contraception and the benefits of being more involved with your own reproductive health. 

Besides being used by women as a hormone-free contraceptive, Natural Cycles can use the platform to collect additional data for research purposes. Self-proclaimed “nerds with PhDs” collaborate with academic institutions to answer questions such as “does the Covid vaccine influence the menstrual cycle?”  

Having access to users already engaging with your app on a daily basis lowers the barrier for assembling additional data for clinical research - whether related to women’s health or not. This increases the speed at which clinical research can be conducted.

Besides clinical research, curious stats can also be extracted from the app - such as what day users logged as the most stressful, and how the most frequent days to have sex varies across countries. 

We also speak about how interacting with your contraceptive method on a daily basis changes the relationship with reproductive health. Both in the sense of gaining more understanding for it, involving a partner or significant others or reaching out to the support team from Natural Cycles with questions. 

Users may find Natural Cycles easier to use in the future with the announcement of the new collaboration with Oura, taking the manual task of measuring temperature each morning out of the equation.  Besides being more convenient, this collaboration provides additional data that can be incorporated into future studies. 

Guests: 

Sofie Askervall: https://www.linkedin.com/in/sofie-askervall-ba311845/ 

Jack Pearson: https://www.linkedin.com/in/jack-pearson-6a8ab190/ 

Natural Cycles: https://www.naturalcycles.com/ 

References: 

Published Research by Natural Cycles: https://www.naturalcycles.com/research-library 

Association between menstrual cycle length and covid-19 vaccination: global, retrospective cohort study of prospectively collected data: https://bmjmedicine.bmj.com/content/1/1/e000297 

FDA 510(K) pathway: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

In this episode Sam and Ivanna dive into the topic of wicked problem solving in life sciences with wicked problem wizard Nechama Katan. 

To understand wicked problems we explore complex problems as a contrast. Examples of complex problems are a game of chess or a clinical trial data submission to authorities. Both have a lot of steps involved, but in the end you know whether you succeeded or not.

Unlike complex problems the rules and outcomes of wicked problems are ambiguous. The problem itself may not be agreed upon or can be seen from multiple diverging perspectives, and the problem does not end - it ends once no more resolutions are attempted.

We speak about how the breakthrough speed of modern trials is not translatable to other clinical studies. The teams working on the recent trials were achieved by people working long hours with clear focus and direction to save the world.

Transitioning to a model where we can conduct trials in 1/100th of the time it takes today requires that we pull the common model apart, and put it back together in a radically different way. This is hard, since the “right way” of solving problems that most leaders have been taught are fit for complex problems - and many are at a loss of what to do when a problem is wicked. 

We speak about how language and psychological safety are key to being able to solve wicked problems - but that it is hard to achieve when innovation moves at the speed of meetings in life sciences. We explore which maneuvers can be taken for wicked problems and how solutions may emerge. 

Guest: 

Nechama Katan: linkedin.com/in/nechama

Blog: https://nechamakatan.wordpress.com/ 

References: 

Wicked Problems & Social Complexity: http://www.cognexus.org/wpf/wickedproblems.pdf 

PMI Wicked Problem Solving Certification: https://www.pmi.org/wicked-problem-solving 

Cynefin model: https://thecynefin.co/about-us/about-cynefin-framework/ 

Amy Edmondsen on Psychological Safety: https://amycedmondson.com/psychological-safety/ 

Living your best year ever: https://store.darrenhardy.com/products/living-your-best-year-ever 

Innovation at the speed of trust: https://www.speedoftrust.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

We speak to G.T. LaBorde, the CEO of IllumiCare about clinical trial recruitment at the point of care. Patients want to participate in clinical trials. Health care professionals are willing to refer patients. But there is a disconnect between point of care and clinical trial recruitment. 

“90% of providers say they feel comfortable talking to patients about clinical trials. Only 0.2 % actually do. That is an amazing disparity!”

• G.T. LaBorde 

G.T. talks to us about how this gap can be bridged at the point of care, making sure that providers can actually inform patients of the trials relevant to them in their geography. 

The current way of getting an eligible patient into a trial often requires heroics from the health personnel, manually reaching out to patients and remembering currently ongoing trials. 

Heroics may also be required from the patient side. For some patients, clinical trials can be the only treatment option. All existing courses of treatment may have been exhausted, and they are willing to embark on researching clinical trials on their own. 

G.T. walks us through how to embed information about clinical trials in the systems that clinicians already work in, without adding additional noise to the regular workflow. This type of seamless integration can simplify referral of the right patients to the right trials. 

This also means that patients can be recruited from a larger population base that may not search for a clinical trial on their own accord - yet the provider gets the final say. This is important to not taking patients thriving on current care off it just to participate in a trial. 

An analogy to the tool that IllumiCare built is a marketing platform at point of care to the provider who is taking care of the patient - like a marketing funnel. The study description would be like an ad, and referral would be analogous to a conversation event.

442 years of combined healthtech experience at IllumiCare is bringing this transformation to life.  

Guest:

G.T. LaBorde: https://www.linkedin.com/in/gtlaborde/ 

IllumiCare: https://illumicare.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

We speak to Savva Kerdemelidis and Nicholas Fiorenza, founders of Crowd Funded Cures about alternative financing models for clinical trials and drug development in general. 

Grants and especially patents have long been the predominant mechanisms for securing financing for novel treatment. IP law shapes the incentive structure of the life sciences industry - creating suboptimal behavior and leaving value on the table.  

We speak about unmonopolizable treatment and repurposing off-label and natural drugs. Since these do not fit into the predominant model, they do not undergo the same rigorous clinical research as patentable drugs. It is a market failure, since there are no incentives to conduct this research when no pathways exist for recovering the cost. 

The potential is large, since most of the drugs prescribed to patients are off-patent.  An example is ketamine, which is available off-label for treating severe depression and is currently more effective than it’s patented counterpart. 

Prizes, pay-for-success contracts, advance market commitments, social impact bonds and subscriptions have been debated and tested to a limited degree as alternatives to patents. 

The blockchain technology is showing promise in re-inventing IP with the emergence of Decentralized Science (DeSci) and IP Non-fungible Tokens (NFT). With blockchain technology the transaction costs are reduced and pay-for-success models are given scale.

We also speak about how the current model is disempowering for scientists, who are either forced to go into academia or join the industry. Both choices have significant drawbacks, especially considering that the low-hanging fruit for small molecules is likely already picked. 

Guests: 

Savva Kerdemelidis: https://www.linkedin.com/in/savvak/ 

Nicholas Fiorenza: https://www.linkedin.com/in/nicholascharlesfiorenza/

Crowd Funded Cures: https://crowdfundedcures.org/ 

Notes: 

DeSci  (DEcentralized SCIence) A Web3 (crypto) term for blockchain-based activities involving scientific research.

DAO decentralized autonomous organization is a system developed to distribute decision-making, management, and entity ownership.

Pay for success contracts: https://www.linkedin.com/pulse/pay-success-contracts-new-model-develop-therapies-from-/?trackingId=SKff3hMRTtcMWn3xBMFFSw%3D%3D 

Evergreening: reformulating a drug to extend patent life. 

Vita DAO https://www.vitadao.com/ 

Molecule https://molecule.to/ 

PsyDAO https://psydao.io/ 

Cherubs DAO: https://cherubsdao.com/ 

LabDAO https://www.labdao.xyz/

Enantiomers are pairs of compounds with exactly the same connectivity, but opposite three-dimensional shapes. 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Sam and Ivanna speak to Andy Yates, the Chief Scientific Officer for Artelo Biosciences about how they are tapping into the potential of the endocannabinoid system to increase treatment results for oncology patients. 

Artelo Biosciences has departed from the cannabis plant as the single source of cannabinoids to target specific parts of the endocannabinoid system, and separate the effect on the body from the brain. “You cannot get high off our drug,” Andy Yates says. 

Using the natural appetite-enhancing properties of cannabinoids, Artelo Biosciences is currently developing treatment for cancer anorexia - the accompanying loss of appetite that follows in the wake of cancer or cancer treatment. Currently there are no licensed medicines in this area. Reversing weight loss can potentially increase survival times and morbidity time with cancer. 

An increase in appetite means patients moving about more, but also joining the family at the dinner table or going out for social interactions. The increase in activity is measured through wearables according to the principle of “Keep-It-Simple-Stupid” to avoid overloading patients with notifications or commitments.  

We speak about how the stigma about targeting the endocannabinoid system has all but disappeared in the past years, and how the understanding of cannabinoids has evolved with the regulatory bodies also. The logistics requirements for clinical trials vary between countries and geographies though, making it especially difficult to navigate when multiple regulatory bodies need to be involved within the same country.  

About the our Guest:

Andy Yates: https://www.linkedin.com/in/andy-y-4985aa1/

Artelo Biosciences: https://artelobio.com/ 

Dr. Andy Yates has served as the Chief Scientific Officer for Artelo Biosciences since January 2021. Dr. Yates has more than 15 years experience in the pharmaceutical industry including 10 years as an executive at AstraZeneca. He held key roles within the medical affairs, commercial, business development and strategy functions for AstraZeneca’s in-line and development portfolio. Dr Yates has been extensively involved in the life-cycle management of key multi-billion dollar products leading to the funding and initiation of significant development programmes. Whilst in business development he led evaluations and transactions that resulted in multiple collaborative agreements with academia, biotechnology and peer pharma. Dr. Yates is a UK registered pharmacist who received his PhD in cannabinoid medicinal chemistry from the University of Nottingham.

Notes: 

The Centre for Medicinal Cannabis: https://thecmcuk.org/ 

European Medical Cannabis Association: https://eumca.org/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Imagine if all pharmaceutical companies had to re-apply for approval of all existing drugs. Crazy as it seems, this is what is happening in the medical devices space. 

Ivanna and Sam speak to Jon I Bergsteinsson, founder of Smart-Trial by Greenlight Guru. We speak about the state of clinical trials in medical devices - and the increased diligence required by the med MDR regulation by EMA. 

One of the ways medical devices differ from drugs is that it is mostly physicians and clinicians who have been interested in expanding their use for novel applications - and could do that though proving equivalence to existing devices in investigator-led trials.

With the new medical device regulation, that tendency is up for a revamping. Manufacturers of medical devices need to be able to have access to the data used to support a submission for regulatory approval. This means medical device companies are essentially being forced to conduct sponsor-led trials on their medical devices. Both the ones that are currently being developed - but also the ones that are already on the market. 

“The clinical research in medical devices is now being transformed to focus more on submission-level research, which we have seen in the pharmaceutical space for decades.”

• Jon I Bergsteinsson  

This radical change was sparked by a number of incidents in the medical devices space impacting patient safety - such as the PIP silicone breast implants scandal, where non-medical grade silicone was used.

The increase in requirements means that medical device companies will need to spend more on clinical research - and ultimately be funded better. But in some ways medical device companies have been ahead of its pharmaceutical cousins. For example patient reported outcomes have been a source of clinical data in medical devices since their inception - given the fact that often these are used by the patients themselves. 

Guest: 

Jon I Bergsteinsson:  https://www.linkedin.com/in/joningib/

Smart Trial: https://www.smart-trial.com/overview 

Greenlight Guru: https://www.greenlight.guru/ 

Notes:

The new EU MDR regulation: https://eumdr.com/ 

Medical device classification: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device 

PIP breast implants case: https://www.nhs.uk/conditions/pip-implants/ 

Medtech Europe: https://www.medtecheurope.org/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

We speak to CEO of ObvioHealth, Ivan Jarry, about how clinical trials conducted for consumer products are different from trials in pharma and biotech - and how working with these has enabled ObvioHealth to create a holistic solution for decentralised trials. 

When COVID came, ObvioHealth’s platform built for consumer products was what pharma and biotech needed to continue their ongoing trials in a decentralized environment. Starting in smaller settings and building out to more complex trials created a unique value proposition of a holistic end-to-end platform. 

Measurements at home with technology that is more accurate and less of a burden for the participant. Letting the patients enter data with a data stamp increases the accuracy of the data. But going even further, technology can measure the data on it’s own. Like measuring the crying episodes of infants by recording and analyzing sound, rather than burdening the parents with recording. Or taking a picture of stool and letting the algorithm rate it.

Augmenting clinicians with digital technology has the potential to relieve some of the strain on healthcare, and increase access to marginalised groups to clinical trials - and also help identify more narrow patient populations for certain drug modalities. 

Notes: 

Guest Ivan Jarry: https://www.linkedin.com/in/ivan-jarry-a1a09535/ 

ObvioHealth: https://www.obviohealth.com/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Sam and Ivanna speak to Mark Wheeldon, the CEO of Formedix, about that there was once a time where sponsor companies would name their trial variables whatever they wanted, and the regulatory bodies had to make sense of sponsor-specific data labelling. This made it hard to look across trials to identify potentially identical applications - and catch potential risks for patient safety.

Then along came CDISC. A cross-industry consortium collaborating to create data standards. Not only setting the standard for data labelling, but also making it easier to build standard programs to analyse the data. The models of CDISC are extendable, meaning you can build on the existing models while adding novel data sources. Despite great progress in this space, a lot of the standard technology is aging: 

“SAS transfer files are still common in our industry. Can you imagine the banking industry using technology standards from the 80’s?”

• Mark Wheeldon 

Covid challenged the study setup timelines and the frequency of data availability. The mappings were evolving. Storing mappings and spacing the mappings allows for rapid change and saves time on double coding. As the trial changes, you can easily adapt to the specification changes. But even before Covid, reacting quickly to trends in data has led to the pivot of for instance Viagra from being investigated as a cardiac drug to male impotence. 

As for Formedix’ success, Mark cites the willingness to integrate with existing EDC systems and invest in research. Even though metadata repositories are still not recognized as a separate type of solutions, the case for implementing one is clear: 

“In 6 trials you have return on investment for your metadata repository and 1,6 million of cost avoidance in regulatory submissions”

• Mark Wheeldon 

Read more: 

Guest Mark Wheeldon https://www.linkedin.com/in/markwheeldonformedix/ 

Formedix https://www.formedix.com/ 

DIA - https://www.diaglobal.org/ 

CDISC https://www.cdisc.org/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Could a chimpanzee become a business school professor? He could, if you changed his DNA. In this episode we talk about how to change the DNA of the organization to pursue a new business model - and why that is such a hard thing to do.  

In this episode we speak to a true industry expert and expert on the industry. Starting as a lab chemist in 1978 and spending 15 years in marketing and strategy and now a practicing academic, Brain D Smith is considered The World's Leading Authority on the Evolution of the Pharma and Medtech Industry.  

In this episode we take an evolutionary view and examine why the industry has such a hard time changing - but also about how much has changed already. We now speak about oncology and no longer refer to specific organ cancers as separate diseases. We no longer measure value solely in the superior efficacy to comparator drugs, but health economic value in general. 

We talk about speciation of the business models in pharma - how we have gone from having one predominant model when most drugs were based on small molecules, to now having 26 distinct business models. This creates an urgency for pharmaceutical companies to select a strategy pursuing one of these models - and change the business accordingly. 

This might have something to do with discrimination in what science is important in the industry. Whereas natural sciences are highly valued - management science is sometimes treated as something to pick up via osmosis. 

“It is difficult to be excellent at something when you do not have a common vocabulary” 

- Brian D Smith

Guest Notes

Guest Professor Brian D Smith: https://www.linkedin.com/in/drbriandsmith/ 

and his practice Pragmedic: http://www.pragmedic.com/ 

Reach out on Twitter: https://twitter.com/profbriandsmith 

or directly to [email protected] 

Books

Amazon author page with details of all 8 books 

Upcoming book ready for pre-order: New Drugs, Fair Prices: Managing the Pharmaceutical Innovation Ecosystem for Sustainable and Affordable New Medicines

Articles for download

Building the future

Back to the future

Selection pressures

Choosing destiny  

Explosive evolution

Abbre

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

After a successful career as a strategy consultant, Philip is attracted by the higher purpose of the life sciences space and takes on a quest to find solutions for why clinical trial timelines are growing longer and more complex. Even though his project is still in stealth mode, Philip takes Sam and Ivanna through some of the reasons he has uncovered so far.

We speak about the apprehension in the industry of trying new things, and how different roles in clinical trials perceive some of the same problems from different angles. We dive into recruitment of patients for clinical trials and how patient empowerment is changing how we engage with the health system. 

We imagine a fusion of research and treatment where trial treatment could be integrated into the treatment options patients are met with in the primary care - or even consider an opt-out model for contributing data for science. 

"Everyone with a condition should be able to contribute to finding a cure"
- Philip Lyng Madsen

Notes:

Guest Philip Lyng Madsen: https://www.linkedin.com/in/philiplyng/ 

Medicon Valley Alliance: https://mva.org/ 

Abbreviations: 

CRO: Clinical Research Organization 

IRB: Institutional Review Board

PI: Principal Investigator 

POC: Proof of Concept

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Matt Wilson guests the show and talks to Sam and Ivanna about how automating consent and recruitment processes can broaden the net in terms of the number of patients involved in clinical trials. A broader patient population means that underrepresented groups gain access to clinical trials and allow  a much more detailed characterization of an overall patient population.  

Removing barriers for patients to participate in trials also means using technology that is most accessible and sometimes low tech - such as the text message. Understanding your population can also help target your communication to specific groups, thereby increasing diversity in the trials participants. 

We speak about how Real World Data has evolved from databases over patient populations to electronic patient records and third party companies collecting large data sets. Using electronic health records directly means that the broken link between the actual patient and findings made in population level research is mended, meaning that the patients themselves can benefit directly from the findings in the large-scale studies. 

We also speak about the benefits of providing information to the patients about what their data has contributed to, and potentially providing them the benefits of the newly created knowledge. 

Matt encourages our industry to pursue open-mindedness to try and engage with new ideas and new ways of doing things. Not everything will work out, but the potential to unlock real value to patients is to great to ignore. 

“Patients want to help with research, and it is about providing them the means of doing that in a way that is not burdensome, and allow them to see how they have contributed. “
- Matt Wilson 

Notes

• Guest Matt Wilson : https://www.linkedin.com/in/drmattwilson/ 
• uMed: https://www.umed.io/ 
• Example mentioned of 23andMe: https://www.23andme.com/en-eu/?evr=epv 
• NHS Blood Donation Service: https://www.blood.co.uk/ 

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

“It is always fun to have some data that makes you go Wow! I didn’t know this!” 
We speak to Ulla Sofie Lønberg and Helle Hartnack about whether men are risk takers and women reluctant to experiment with health technology, and if the only difference between the male and female physiology really is the ability to bear children.

We discuss the findings in a recent registry study about gender imbalance in the use of device-aided therapies. Unconscious bias may be at play for both patients, carers and physicians when selecting treatment, but also the roles that men and women typically play in society. 

We speak about how tailoring communication might make a difference, but also the need for behavioral clinical research. Adding the behavioral element to clinical research may just be the missing link in true patient centricity. 

We also speak about how mapping the non-patient journey may help understand the biases that exist in the system and how daring to differentiate your communication to patient groups may make it easier for the patients to make decisions about treatment.  

“I found that when we discussed these findings with people, we tend to get the same kind of comments. Either that men are risk-takers or men are tech-oriented and women are not. But what we discussed in this publication is that there’s actually very little data to support this notion. And if it is true that men are risk takers and women are not, should we just accept that?”

• Ulla Sofie Lønberg

Notes

• Guest Ulla Sofie Lønberg : https://www.linkedin.com/in/mdullasofielonberg/ 
• Guest Helle Hartnack: https://www.linkedin.com/in/helle-hartnack-0345352/ 
• Publication we speak about: Henriksen T, Dalhoff KP, Hansen HE, Brenneche AW, Lønberg US, Danielsen EH. Access and Use of Device-Aided Therapies for Parkinson’s Disease in Denmark. Mov Disord Clin Pract. 2020 Jul 2;7(6):656-663. doi: 10.1002/mdc3.12988.
• Invisible women: https://www.goodreads.com/book/show/41104077-invisible-women
• Device-aided therapies and Parkinson’s disease  

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Sam and Ivanna speak to Jakob Juul Rasmussen about the stubborn prevalence of paper in clinical trials, especially in small pharmaceutical and biotech companies. Paying money up front, covering the implementation and license costs and building up internal IT functions can be prohibitive for small pharmaceutical and biotech companies. This leads many companies to outsource their entire IT landscape to CROs. As a result, control over assets becomes complicated and cumbersome, as your clinical data risks being stored in different applications with multiple data models applied.  Standard configuration is helping bridge the gap, but compliance requirements from authorities for both internal and CRO-maintained software are unchanged. Jakob suggests a radical third way of getting the set of applications needed to run the business of any biotech or pharmaceutical company, without resorting to paper or complete outsourcing, transforming both how technology companies deliver IT solutions and how IT is anchored with the sponsor companies. 

“Small companies really want to focus on science and just have the necessary tools to provide the best science”

• Jakob Juul Rasmussen

Notes

• Guest Jakob Juul Rasmussen : https://www.linkedin.com/in/jakobjuulrasmussen/ 
• PharmaIT: https://pharmait.dk/ 
• ISPE GAMP 5 https://ispe.org/publications/guidance-documents/gamp-5 
• ALCOA ++ https://www.gmp-compliance.org/gmp-news/alcoa-what-does-it-mean 
• Pharmacovigilance Signal Detection: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management 
• EMA Notice to Sponsors on Validation and Qualification of Computerized Systems used for Clinical Trials: ​​https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-sponsors-validation-qualification-computerised-systems-used-clinical-trials_en.pdfhttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-sponsors-validation-qualification-computerised-systems-used-clinical-trials_en.pdf 
• DIA Reference models: https://www.diaglobal.org/en/resources/tools-and-downloads 

Technology mentioned

• Quality Management System (QMS)
• Electronic Trial Master File (eTMF)
• Electronic Case Report Form (eCRF)
• Regulatory Information Management System (RIMS)
• Box
• Dropbox
• SharePoint
• Teams
• Word 
• Electronic Signature 

Functions mentioned

• CROs 
•  IT

Abbreviations & Definitions

eCRF: Electronic Case Report Form

eTMF: Electronic Trial Master File

EDC: Electronic Data Capture

FDA: Food and Drug Administration 

QM

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Sam and Ivanna speak to Willie Muehlhausen about how simplifying and automating patient reported outcomes is not so much complicated, as it is complex. Willie shares his perspectives on the evolution of ePRO and eCOA and how the newer trend of decentralised clinical trials is closely tied to mastering the collection of patient reported outcomes. Willie is working towards making it possible to translate a clinical protocol into configuration in 12 minutes instead of 12 weeks and hints at other possibilities yet to be explored . If Willie could change one thing in our industry it would be increasing the level of knowledge sharing and knowledge retention. 

• Willie Muehlhausen  

• Guest Willie Muehlhausen
• eCOA Consortium (formerly known as the ePRO consortium) 
• Safira Clinical Research Limited 
• Recall Bias 
• CDISC
• ODM XML 
• Guidance on Ecological Momentary Assessment
• Considering BYOD in Clinical Trials 
• eConsent

• Patient Reported Outcomes
• Electronic Patient-Reported Outcome Measures: An Implementation Handbook for Clinical Research

• ePro
• eDiary
• eCOA
• AI/ ML
• EHR
• EDC
• PDAs

• CROs 
• Clinical Sites 
• Sponsors
• Data Management
• Statistical Programming 

AI: Artificial Intelligence

API: Application Programming Interface 

BYOD: Bring Your Own Device 

BYOT: Bring Your Own Technology 

CDISC: Clinical Data International Standards Consortium

CRA: Clinical Research Associate 

DCT: Decentralized Clinical Trial

EDC: Electronic Data Capture

eDiary: Electronic Diary

EHR: Electronic Health Records

ePRO: Electronic Patient Recorded Outcomes

EMAs: Ecological Momentary A

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Sam and Ivanna speak Adam Walker about the transformation in clinical data from his experience with CROs, sites and sponsors. Adam takes us through how clinical data collection has evolved from paper forms, to being collected digitally and now fully integrated with patients’ existing devices. This shift increases the volume of data available, the quality of the data, but also puts additional pressure on the industry to make sense of the data in real time. Adam makes the point that technology companies have an advantage in identifying the value of the information collected - not only for treatment, but also to support preemptive lifestyle choices. His advice for anyone working in this field is to “not take the comfy chair” of how we used to do things. 

“The data has not changed, but how we collect it has changed” 

• Adam Walker 

Notes

• Guest Adam Walker: https://www.linkedin.com/in/adam-walker-2327951/ 
• 21st Century Cures Act: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act  
• The 100 Year Life by Lynda Gratton and Andrew J Scott: https://www.100yearlife.com/ 
• Declaration of Helsinki: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ 
• ICH: https://www.ich.org/
• GCP: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice
• CPRD: https://www.cprd.com/
• CDISC: https://www.cdisc.org/ 
• Clinical Trials overview: https://www.clinicaltrials.gov/ 
• Huxley Morton Podcast: https://www.huxleymorton.com/podcast.php 

Technology mentioned

• CTMS
• ePro
• eDiary
• RWE/ RWD
• AI/ ML
• EHR
• EDC
• Wearables
• Smartphones 
• Zoom

Functions mentioned

• Statistical Programming 
• Data Management 
• Biometrics

Abbreviations & Definitions

AI: Artificial Intelligence
CDISC: Clinical Data International Standards Consortium
CTMS: Clinical Trial Management System
CPRD: Clinical Practice Research Datalink
EDC: Electronic Data Capture
eDiary: Electronic Diary
EHR: Electronic Health Records
ePRO: Electronic Patient Recorded Outcomes
FDA: Food and Drug Administration 
GCP: Good Clinical Practice
ICH: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
MHRA: Medicines and Healthcare Products Regulatory Agency
ML: Machine Learning
NHS: National Health Service
RWD: Real-world Data
RWE: Real-world Evidence

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page

Send us a text

Sam and Ivanna speak to Angela Slocum about the difficulty in quantifying the benefits of risk based monitoring when mostly you find no issues in your data. Angela does share an example of a fraudulent site being uncovered through risk based monitoring. We speak about how having experience from multiple clinical functions enables a unique platform for innovation when new demands arise but also when implementing software in the clinical space. We also dwell on managing change in our industry, and how conquering fear is vital even when working with highly skilled experts.   

“The science is so much more sophisticated than it used to be. There is much more data than there used to be. The data types and the amount of data are vast. And the roles and skills needed to support all that have evolved” 

• Angela Slocum 
  
  

Notes

Guest Angela Slocum: https://www.linkedin.com/in/angela-slocum-160b48126/ 

Risk-based monitoring (TransCelerate): https://www.transceleratebiopharmainc.com/rbminteractiveguide/what-is-risk-based-monitoring-rbm/introduction/ 

Technology mentioned: 

• SAS 
• JReview 
• Spotfire 
• EDC
• AI/ ML
• elluminate

Functions mentioned: 

• Statistical Programming 
• Data Management 
• Clinical Operations 
• Analytics 
  
  

________
Reach out to Sam Parnell and Ivanna Rosendal

Join the conversation on our LinkedIn page