The Future of Pharma

My guest in this episode is Gareth Shaw. 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.

My guest today is Dr. Paul Peter Tak. 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.

My guest today is Salvatore Mascia. Sal is the Co-Founder & CEO of CONTINUUS Pharmaceuticals based in Woburn, MA. He was the former Strategic Project Manager at the Novartis-MIT Center for Continuous Manufacturing, where he led the integration of the first end-to-end continuous manufacturing process for pharmaceuticals. For his efforts, he was recognized with the “Leadership Award”. He co-founded “Professionisti Italiani a Boston” in 2009, and served as President of the “Cambridge University Technology and Enterprise Club” in 2006/07. He also ran a pharmacy business for 2 years and as you'll notice from the interview, has the ability to make a mundane seeming business like pharmacy sound interesting. Salvatore completed a post-doc at MIT in Chemical Engineering and holds a PhD in Chemical Engineering from the University of Cambridge, UK and a BS and MS in Pharmacy (summa cum laude) from University of Perugia, Italy. On a side note, you may hear the sound of emergency vehicles in the background during the interview. that's the sound of brave first-responders rushing to help someone in distress when we were recording this interview. hope you don't mind it and now, here's Salvatore Mascia from Pharmaceuticals.

My guest today is Matt Roberge. He got his Mechanical engg degree from Villanova Uni. He currently works for Pfizer and serves as a senior director of Global technology network and Emerging market. He has a truly global organization with teams in the USA, china, russia, argentina, brazil, india and i'm sure i'm forgetting a couple. I had the pleasure of working under Matt's leadership when Pfizer built the first Asian Biologics Development Center in Hangzhou, China few years back. We had a great time recording this interview. Hope you enjoy it too. Here's Matt Roberge from Pfizer.  

Dr. Mukesh Hariawala is a world-renowned heart surgeon, a highly sought after keynote speaker and Chairman of American Healthcare International (AHI). Prof Chintan Vaishnav is a professor at Sloan School of Management at MIT and Director of MIT Tata Center for Technology and Design. Mr. Jayesh Mankodi is an IT industry veteran with expertise in Infrastructure Architecture and Cloud Computing. Chintan and Jayesh are advisors to AHI. Using blockchain technology and cloud computing, Mukesh, Chintan and Jayesh at AHI are working to solve the problem of fake drugs in the market.

Episode 4 - Continuous Manufacturing and Rare Events with Prof Bernhardt Trout Professor Trout directs the Molecular Engineering Laboratory and Novartis-MIT Center for Continuous Manufacturing at Massachusetts Institute of Technology, Cambridge, MA. He is considered one of the pioneers to pave the way for the continuous manufacturing in the highly complex and regulated field of the pharmaceutical manufacturing. Find out his thoughts on how continuous manufacturing and rare events will affect the future of the pharmaceutical industry in this chat with Samir Gondalia.

Visit ispeboston.org for complete show notes of every Podcast episode. Jack Campion is Principal at the Hart Companies. He is the immediate past president of the ISPE Boston area chapter. Jack and the show host Samir have known and worked with each other for many years in their capacity as the ISPE Boston board of directors and as volunteers on other committees. Let's hear Jack's thoughts on the new and emerging developments in our industry and what it means for the future of pharma.

Visit ispeboston.org for complete show notes of every Podcast episode. Dr. Monika Weber is the Founder and CEO of Fluid Screen, a startup in Boston, MA with a revolutionary chip-on-a-technology to detect and identify bacteria in water, food and process fluids. She was inspired due to the catastrophic foodborne illness in Europe in 2011 due to the E. Coli contamination which resulted in human deaths and hundreds of millions of dollars losses. Using electric forces to control bacteria motion in water, Dr. Weber discovered a method of concentrating and identifying bacteria in fluid samples. Her technology captures and identifies bacteria in 30 minutes with greater than 99% accuracy.

Visit ispeboston.org for complete show notes of every Podcast episode. Professor Webster directs the Webster Nanomedicine Laboratory at Northeastern University, Boston which designs, synthesizes, and evaluates nanomaterials for various implant applications. To date, his lab group has generated over 9 textbooks, 48 book chapters, 306 invited presentations, at least 403 peer-reviewed literature articles, at least 567 conference presentations, and 32 provisional or full patents. Some of these patents led to the formation of 9 companies. Find out his thoughts on how nanoparticles will affect the future of the pharmaceutical industry in this chat with Samir Gondalia.

The introductory episode to launch our Podcast - The Future of Pharma with ISPE Boston. Learn about the podcast, ISPE Boston and the host, Samir Gondalia and why it's a must subscription for a pharma professional.