The Future of Pharma

My guest in this episode is Nathan Clark.

Nathan is the Co-Founder of Ganymede.bio, one of the fastest-growing software startups in biotech. Ganymede is the modern, data platform for life sciences companies, and its focused on integrating physical lab instruments with digital workflows. Prior to Ganymede, Nathan was the product manager at Benchling for Machine Learning and Insights Analytics. He also has a background in financial technology and trading, and notably launched affirm.com/savings. 

In this informative talk, Nathan and I talked about  - His journey from being a bond trader to a life science data entrepreneur, - Difference between Fintech and life science tech - How Genymede is doing it differently than the other companies - How to be 10% faster to the market with new drugs - Growing with a remote working team - Why he got into a life science start up - His fondness for MIT Open Courseware

You can reach out to him by email, his website or LinkedIn.

I enjoyed my chat with Nathan. Hope you do too.

I have two guests in today's episode, something I rarely do. My guests are Kyle Felmet and Jennifer Lospinoso.

Kyle Felmet serves as the Vice President of Specialty Commercialization at Two  Labs, an Envision Pharma Company, where he plays a pivotal role in ensuring that specialty drug manufacturers have the necessary distribution channel strategy infrastructure and pre-launch workstreams in place to facilitate a successful product launch with the appropriate wrap-around patient/prescriber services tailored to each unique product. His expertise spans across key therapeutic areas including oncology, rare diseases, and cell and gene therapies. Over the past decade, Kyle has been instrumental in supporting clients and vendors within these sectors, leading several successful product launches.

Jennifer Lospinoso is the Managing Director & Consulting Lead at Riparian. Jennifer brings 20 years of leadership experience in various areas of government and commercial program operations and compliance. Jennifer has extensive experience leading and delivering projects focused on U.S. government program regulatory compliance, gross-to-net forecasting and operational excellence.

In this wide-ranging talk, Kyle, Jennifer and I talk about - Cell and gene therapy (CGT) pricing in the absence of insufficient historical data - The challenges to set a price for CGT by the government and insurance companies  - Justification for high prices for CGT - Outcome based reimbursements - Expensive distribution logistics for CGT - Why the product launch preparation starts 24-36 months before the actual launch date - What start ups can do during the early phase to make product launch efficient and cost effective and - Their favorite books and topics for their potential TedTalks.

This was an interesting discussion for me because we talked about where the science ends and the commercialization begins, something I haven't done.

I enjoyed my chat with Kyle and Jenn. Hope you do to. 

Here's Kyle Felmet and Jennifer Lospinoso.

My guest today is Dr. Ben Coverdale. 

Ben is an experienced Global Account Director of Patsnap with a demonstrated history of working in the life sciences and innovation intelligence industries. Patsnap is Powered by advanced AI, where they help IP and R&D teams collaborate and accelerate the entire innovation lifecycle.

He has a strong research professional background with a Doctor of Philosophy (PhD) focused in Biomedical Materials from The University of Manchester. He developed 3D scaffold fabrication methods for the regeneration of bone tissue, gaining insight in product development and the patent landscape in the medical device and biotechnology industries.

Following 4 years at StemCell Technologies, supporting big pharma and key academic institutions to optimize their R&D workflows, he now supports innovative and disruptive life science companies to protect their IP portfolios, understand competitor movements, and innovate faster in rapidly developing markets.

In this interview, we talk about connecting the dots in drug development, what makes Patsnap different than other AI tools and gives more targeted results, his favorite author Stephen Hawking, favorite books "The brief history of time" and "Sapiens", and what the topic of his potential TedTalk would be.

I thoroughly enjoyed my chat with Ben. Hope you do too. Here's Dr. Ben Coverdale. 

My guest in this episode is Dr. Samuel Ewing. He is the Global Head of Pharmaceutical Partnerships at Doccla.

Before joining Doccla, Dr. Ewing led the development of a connected auto-injector system for Roche’s Alzheimer’s disease program at Capgemini Engineering. He also led the development of Biofourmis’s wearable vital sign monitoring platform.

At Roche, he managed remote patient monitoring across various diseases, including Parkinson’s, Huntington’s, Alzheimer’s, Multiple Sclerosis, and others. As Chief Neuroscience Officer at NeuroPro, he developed a wearable brain monitoring device for epilepsy.

Dr. Ewing's extensive experience in digital health and medical research drives his commitment to advancing treatment for challenging diseases. He believes that the scarcity of data from patients in the real world hinders progress, something he is committed to overcoming.

In this fascinating chat, we talk about our current hospital systems, and capacity, and how patients can get the hospital care in the comfort of their home in a digital hospital.  

Here’s my guest Dr. Samuel Ewing.

My guest in this episode is Greg Kunst, CEO of Aurion Biotech.

At Aurion, Greg and his colleagues are working on a regenerative treatment (corneal endothelial cell therapy) for millions of people who have partial or complete vision loss.

Greg joined Aurion Biotech with deep and varied experience in ophthalmic medical devices, drug delivery systems, diagnostics, biotechnology, and pharmaceutical products. His expertise spans global corporate development, strategy, health policy, marketing, commercialization, business development, market access and medical affairs.

Before Aurion Biotech, Greg spent 6 years at Glaukos Corporation (NYSE: GKOS) in numerous roles of increasing responsibility, most recently as vice president of global marketing.

Before Glaukos, Greg worked at Alcon, a Novartis company, as global franchise director over the Alcon glaucoma surgery and retina pharmaceutical businesses. 

Greg is a board member of Pr3vent. He received an MBA from Vanderbilt University and a BS in Economics from Brigham Young University.

In this interview, Greg talks about why he decided to dedicate his life to eye therapies, the origin of Aurion (Dr. Shigeru Kinoshita's research in Corneal Endothelial Cell Therapy), how he remains positive in spite of being a self-proclaimed news junkie, and his unequivocal commitment to making Aurion therapies affordable for everyone.

I thoroughly enjoyed my chat with Greg. Hope you do too.

My guest in this episode of The Future of Pharma is Nikhil Bhojwani. 

Nikhil is an entrepreneur, investor, strategist, and TedTalk speaker. He is a Managing Partner at Recon Strategy, a boutique consulting firm that he founded in 2010. At Recon Strategy, Nikhil works with executives and boards on strategy at the portfolio and business-unit levels for payers, hospitals, life science, and digital health companies. 

Nikhil stays close to the startup community as an investor, board member, and advisor to several companies. These have included CIC Health, a national leader in COVID testing and vaccinations, which was founded based on a blueprint set out in an HBR article Nikhil co-authored with Dr. Atul Gawande. 

Nikhil was the 2023 Dorothy R. Eisenberg Visiting Professor at Harvard Medical School/ Brigham and Women's Hospital, where for the 50th anniversary lecture of this series, he presented a lecture on the future of AI in healthcare. 

He has also lectured at Harvard Business School and the Harvard School of Public Health and is a member of the Massachusetts Governor's AI task force healthcare working group.

In this wide ranging talk, we discuss about - What AI can do that humans can't - How Moderna is using AI to respond to regulatory queries (among other things) - AI in pharma competitive landscape (and it's not just technology) - Where multiple big companies need to collaborate due to the scale - His tedtalk ("Unlock potential of Generative AI by Conquering the Spooky Mountain") - Responsible use of AI - Rational and irrational fears about AI - Why AI's growth seems scarier than other historical technological advances - Real impact in the pharmaceutical industry (and on the regulatory agencies) - And instead of writing a book, what he would do with the existing knowledge.

Hope you enjoy this informative talk with Nikhil Bhojwani.

My guest in this episode is Dr. Harsha Rajasimha, CEO/founder of Jeeva Clinical Trials.

We talked about the pharmaceutical industry's blackbox - clinical trials.

Personal tragedy inspired him to dedicate his life to make technology more efficient for healthcare solutions including AI and generative AI.

We discussed the complexities of clinical trials, its patient recruitment, and data unavailability challenges, and why we must make them more efficient

He is also the founder of a non-profit, IndoUSRare, which as the name implies bridges the rare disease treatment and awareness gap between the US and Indian diaspora. 

We also discussed the people and companies with the similar inspiring stories such as John Crowley from Amicus Therapeutics, and Terry Pirovolakis from Elpida Therapeutics.

Listen to Harsha's interview if you're looking for a doze of inspiration and motivation.

My guest today is Hon. Prof. Dr. Tom Chittenden, but he prefers to go by Tom.

He is the Chief Scientific Officer and President of R&D at BioAI Company and leads scientific research operations and ongoing development and implementation of the BioAI Health PREDICT-X Drug Discovery and Development platform.

Tom Chittenden is an Honorary Professor of AI in Biomedicine at Queen Mary University of London. His research has been published in top-tier scientific journals, including Nature and Science. Tom is regarded as one of the world’s leading authorities on causal AI in the biomedical sciences. Over the past decade, he has directed commercially successful computational teams in several globally relevant areas, including multimodal AI/ML strategies for cardio vascular disease, cancer, COVID-19, Alzheimer’s, and Parkinson’s diseases. In 2019, he was named among the top 100 Pioneers in Drug Discovery and Advanced Healthcare by Forbes Magazine. 

As a professor, he has taught at Boston Children’s Hospital, Harvard Medical School, and MIT. He holds multiple Doctorates in Molecular Cell Biology and Biotechnology and Computational Statistics. 

In this fascinating talk, Tom and I discuss the real potential and challenges in the AI space, how it's going to affect the future of the Pharmaceutical industry, and what you can do about it.

Here's Honorary Professor Tom Chittenden.

My guests today are the dynamic husband-wife duo of Alpesh and Jigisha Gandhi who jointly run Ami Polymer Pvt. Ltd. which is a leading manufacturer of silicon tubing something we use a lot in the life science industry. Starting with Alpesh and later with Jigisha, Ami Polymer is a leading silicon tubing manufacturing company in India and played an important role in COVID vaccine manufacturing.

Alpesh Gandhi did his engineering in Rubber Technology from L. D. College of Engineering, Ahmedabad, India. The same college where I did my Chemical Engineering. Then he did his MBA from Jamnalal Bajaj Institute of Management Studies. He co-founded Ami Polymer Pvt. Ltd. in the late 90s. 

Jigisha Gandhi studied commerce at the University of Mumbai and is the director of Ami Polymer Pvt. Ltd. She's been bestowed with numerous awards by Universities, magazines, and the government for her achievements in the business world, including being profiled in a book "Eves Against the Odds" featuring the most powerful women entrepreneurs in India.

Here are Alpesh and Jigisha Gandhi sharing their fascinating journey from humble beginnings to running a global company and what they think the future holds for the pharma industry.

Gareth Shaw is the President, the UK & Europe of Doceree, the first global network of physician-only platforms for programmatic messaging. Prior to joining Doceree, Gareth was the General Manager, Global Programmatic, of PulsePoint where he led the programmatic and operations divisions.

Previously, he has held roles at Yahoo! and Experian. 

Throughout his career, Gareth has gained vast experience in sales and operations across the digital media and advertising technology sectors. He has a well-regarded background in building high-performance teams and implementing strategic plans to facilitate the growth of his organizations. 

My guest in this episode is Lyndsee Manna.

Lyndsee is an EVP at Arria NLG, where along with her colleagues, she helps businesses derive actionable intelligence from data to make better decisions. That's the simplistic version and we go into a lot more details.

In this wide-ranging episode, we talk about math, words, language, writing, technology, data analytics, success, failure, and personal choices.

A standout quote from her is, "There are no failures. There are only lessons."

I had a great time talking to Lyndsee, discussing the future possibilities, and learning about AI.

My guest today is Mark Sitcoske.

Mark is the Founder & CEO of High Purity New England (HPNE), based in Northern Rhode Island, just forty-five minutes south of Boston. HPNE has grown rapidly over the last few years, expanding significantly from a small team of fewer than ten employees to a firm that anticipates reaching approximately 350 employees in 2022. Mark and his growing team of deeply-experienced professionals at HPNE are committed to supplying the biotech and biopharma industries with a variety of innovative, single-use solutions.

Currently, HPNE is one of many companies supporting the global efforts of several companies working on vaccines and therapeutics in the fight against COVID-19.

Dr. Tak received his medical degree cum laude from the Free University in Amsterdam and was trained as an internist, rheumatologist, and immunologist at Leiden University Medical Center, where he also received his PhD. He has been a Clinical Associate Professor of Medicine at the University of California San Diego. Next, he served as Professor of Medicine and founding Chair of the Department of Clinical Immunology and Rheumatology at the Academic Medical Centre/University of Amsterdam (AMC). During this time, he founded Arthrogen b.v., a biotech company focused on gene therapy.

He has published extensively in peer-reviewed journals (> 570 publications, H-index 130, >75,000 citations) and received numerous awards. He has been elected Fellow of the Academy of Medical Sciences (U.K.)

At GlaxoSmithKline he served as Senior Vice President, Chief Immunology Officer, and Global Development Leader. He oversaw the creation of a portfolio of new medicines for immune-mediated inflammatory diseases, cancer, infectious disease and pain, including anti-OSM antibody, anti-LAG3 antibody, ESM-BET inhibitor, RIP1 kinase inhibitor, anti-GM-CSF antibody, anti-CCL17 antibody, Benlysta sc, gepotidacin, molibresib (BET inhibitor), belantamab mafodotin (anti-BCMA antibody-drug conjugate), and NY-ESO1 SPEAR T cell therapy. He was the Chair of the Scientific Review Board, the governing body accountable for the scientific assessment of GSK’s R&D portfolio.

During 2018-2020 Paul Peter served as Venture Partner at Flagship Pioneering and also as President and CEO of Kintai Therapeutics, a start-up focused on enteric signaling networks, where he oversaw the creation of a portfolio of proprietary small molecules called precision enteric medicines for the treatment of obesity, neurological disease, and cancer.

In addition, he has served as President and CEO of Tempero Pharmaceuticals, Board Member of Galvani Bioelectronics, ViiV Healthcare, Sitryx Therapeutics (co-founder), Omega Therapeutics, Levicept, and Citryll.

My guest today is Amr Raafat.

Amr has over 17 years of experience combining architectural, construction, and engineering expertise and is an industry-leading technology expert. As Vice President of Virtual Design Construction & Technology at Windover Construction, he leverages the most cutting-edge technologies such as BIM, laser scanning, drone mapping, virtual and mixed reality, digital fabrication, and 3D printing to streamline the construction process for our clients and project teams.

Amr has published multiple articles on construction innovation and is a regular presenter at technology conferences throughout the country. He holds a Master’s of Architecture degree from Boston Architectural College and was recently recognized as the Autodesk AEC Innovator of the Year.

Although we mostly talked about the innovations in construction, it was also illuminating how this is affecting the life science industry considering how much new construction is going on and the cost of not doing something right the first time. If you've recently been part of a construction project, you may already have used some of the technology mentioned in this episode.

I had a lot of fun talking to and learning from Amr. I hope you enjoy this interview as well. Here's Amr Raafat.

My guest today is Francesca McBride. Francesca completed a Bachelor of Science Degree at the University of Delaware in 1985, majoring in Pre-Veterinary Science. As a pharmaceutical/ biotechnology regulatory compliance specialist Francesca works with international companies to support the design, start-up, licensing and operation of clinical and commercial product manufacturing facilities.

She has been with Jacobs (Pharmaceuticals and Biotechnology) for 25+ years and currently in her capacity as a Director, Regulatory Compliance is involved in the support of client and design teams to ensure the design meets the applicable international cGMP / cGTP requirements.

During her tenure at Jacobs she has lived and worked in the US, UK, Ireland and India. She has both presented and published papers at global conferences.

Most recently she has worked with hospitals and universities in the design and startup of new cell therapy facilities that support the treatment of cancer. Francesca's goal is to build a stronger relationship with the cell therapy facilities to advance the cancer treatment opportunities - an area which is very close to her heart and you'll understand why after listening to her story. Last but not least, she's also a Triathlete.

Some takeaways from the interview - Francesca's global journey - Say yes to new opportunities - When a new technology is introduced, everyone's learning at the same time - Regulatory 101 lesson - Which regulations apply during which stage of the drug development - How regulatory agencies' approach have changed over the years - How different regulatory agencies differ - Regulatory Dos and Don'ts at the beginning of a project - Advice for young women: Research careers to match your interest, Develop your expertise - Impact of a good professor on a student - Book she keeps going back to (given to her by her sister) : The Red Tent by Anita Diamant

Enjoy this interview with Francesca and listen how she simplifies the complicated global regulations around the life sciences for us to understand. Here's Francesca McBride.

My guest today is Brian Hagopian who's known as or at least I call him "the Kevin Bacon of the Boston life sciences industry", either you know him or you know someone who knows him. He is currently the President of Clear Water Consulting, Inc.,and received his chemistry degree from Colgate University. He has over 35 years of design, manufacturing, and operational experience and is currently a highly sought after high purity water subject matter expert. Brian is an instructor at Worcester Polytechnic Institute and is also a Massachusetts certified instructor offering licensing courses for industrial wastewater operators. Brian is the Past President of the ISPE Boston Area Chapter where he helped to lay the foundation for the Boston Chapter’s highly successful Product Show at Gillette Stadium. Not surprisingly, Brian is one of six people to have received the Hank Moes Lifetime Achievement Award for significant contributions to the Boston chapter and the life sciences industry.

Some key takeaways from the interview. - Brian's dad was an entrepreneur - You have to be in the game to win it - We underestimate how much time and money everything’s going to take - When you're an entrepreneur, say goodbye to the 40 hours per week schedule - No matter your industry, it'll continue to evolve. You must try to keep up. - Being "thrifty business owner" got him to develop a new wastewater training course - Advice to Young Professional - avoid debt, plan for big expense in advance, use credit card only for emergencies, learn to negotiate, set goals and make plans to achieve them - His potential Ted talk - General water safety  - Role models - Bill Russell (ex-Celtics player) - true team player, one of the greatest basketball players of all time  - Books recommend to others - Outliers and Tipping Point by Malcolm Gladwell, Dale Carnegie public speaking course - it helps with a lot more than just public speaking, Thinking Fast and Slow by Daniel Kahneman  - Quote he lives by - The harder I work, the luckier I get (the world is full of brilliant but lazy underachievers)

For me, he's been a friend and a mentor. In this interview, we talk about his beginning as an entrepreneur and all the excitement and challenges that come with that, how the industry has changed over the years and where it's headed. You'll also hear some nuggets about how to build your professional career, develop new skills and why hard work will outperform everything else every time. Hope you enjoy this talk from a very generous individual who's always given more than he has received. Here's Brian Hagopian.

My guest today is Dr. Andrea Adamo who is the Founder and CEO of Zaiput Flow Technologies. He also serves as the Innovation Advisor at Snapdragon Chemistry. Dr. Adamo holds a Master of Science in Engineering from the University of Palermo, Italy and a Ph.D. in Fluid Mechanics from the University Federico II of Naples, Italy in addition to a Master of Science from the Massachusetts Institute of Technology. He was also awarded the Fulbright Scholarship. After completing his graduate studies, Dr Adamo joined the laboratory of Professor Klavs Jensen, Director of the MIT Chemical Engineering Department and arguably one the world leaders in continuous flow chemistry.

In this chat with Dr. Adamo, we talk about his journey as an adolescent boy from Italy through his formative years to developing the technology that was literally tested in the outer space. I hope you enjoy my interview with this brilliant and visionary yet humble thought leader. Here's Dr. Andrea Adamo.

My guest today is Dr. Arindam Bose.

Arindam is currently an Independent Consultant in biologics process development and manufacturing following a 35-year career in bioprocess development, clinical supply manufacturing, external partnering, corporate biotechnology strategy and advocacy for science-based regulations for biologics at Pfizer Worldwide R&D from where he retired as a Vice President. He served as the Technical Lead of the Team that developed and executed Pfizer’s strategy for entry into the field of biosimilar medicines. Dr. Bose is a Member of the US National Academy of Engineering. Additionally, he was elected Fellow of AIChE, American Chemical Society and American Institute for Medical and Biological Engineering.

In this chat, Arindam and I talk about the biologics development journey from the 80s till now and what it will look like in the future and what it means for the pharmaceutical industry. Here's Dr. Arindam Bose.

My guest today is Prof Charles Cooney. Prof Cooney received his B.S. in chemical engineering from the University of Pennsylvania in 1966, and the S.M. (1967) and Ph.D. (1970) in biochemical engineering from MIT. He joined the MIT faculty as an assistant professor in 1970, becoming full professor in 1982.

Prof Cooney’s honors include the 1989 Gold Medal of the Institute of Biotechnological Studies (London); the Food, Pharmaceutical, and Bioengineering Award from the American Institute of Chemical Engineers; the James Van Lanen Distinguished Service Award from the American Chemical Society’s Division of Microbial and Biochemical Technology; and election to the American Institute of Medical and Biochemical Engineers and the Fellows of the American Chemical Society.

A consultant to multiple biotech and pharmaceutical companies, Prof Cooney has served on the boards of Genzyme, Polypore International, and Biocon, Ltd. (India), among others. His research and teaching span many aspects of biochemical engineering and pharmaceutical manufacturing. He holds more than 30 patents, has published over 250 research papers, and has co-authored or edited five books, including Development of Sustainable Bioprocesses: Modeling and Assessment.

In addition to his professional interests, Prof Cooney is a trustee of the Boston Ballet, an overseer of the Boston Symphony Orchestra, and a board member of MIT’s Community Service Fund. Other interests include rock climbing, skiing, high altitude mountaineering, scuba diving, and antique map collecting.

He's a man of many talents and interests. In this interview, we're talking about all of this and much more. Here's Prof Cooney.

My guest today is David Sullivan, Sr. Director and Global Lead of Vaccines and Biologics MSAT at Pfizer. He did his Bachelor's in Biotechnology from Worcester Polytechnic Institute and Master's in Engineering Management from Tufts University. Over the years, he's worked in process development, pilot plant, next generation technology, vaccines and biologocs MSAT. I have known Dave for over 15 years and have always been impressed with the width of his knowledge and have never had a boring conversation about anything with him. In this episode, we talk about new modalities, the current changes happening in the pharma industry landscape, the price factor, the patients first philosophy and how that's all going to impact the future of pharma.

Also, check out his book recommendation, "Trillion Dollar Coach" to learn about the leadership lessons from Bill Campbell, a revered executive who was called "Coach" by Steve Jobs, Larry Page, Sergei Brin and Eric Schmidt among others. Here's Dave Sullivan.