The Future of Pharma
The Future of Pharma with ISPE Boston. Find out where the pharmaceutical industry is headed and what it means for you. Join host Samir Gondalia as he chats with the thought leaders of the pharma world about the new technologies, innovative applications and emerging markets and how it’s going to influence the future of Pharma.
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Episode 21. Dr. Harsha Rajasimha and the Challenges and Complexities of Clinical Trials
03/25/2024
Episode 21. Dr. Harsha Rajasimha and the Challenges and Complexities of Clinical Trials
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.
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Episode 20 - Hon. Prof. Tom Chittenden and the Potential and Challenges of AI in the Pharmaceutical Industry
11/09/2023
Episode 20 - Hon. Prof. Tom Chittenden and the Potential and Challenges of AI in the Pharmaceutical Industry
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.
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Episode 19 - Alpesh and Jigisha Gandhi and The Global Supply Chain for the Pharma Industry
09/26/2023
Episode 19 - Alpesh and Jigisha Gandhi and The Global Supply Chain for the Pharma Industry
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.
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Episode 18 - Gareth Shaw and Connecting Doctors and Patients in the 21st Century
05/09/2022
Episode 18 - Gareth Shaw and Connecting Doctors and Patients in the 21st Century
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.
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Episode 17 - Lyndsee Manna on Deriving Actionable Intelligence from Data
03/31/2022
Episode 17 - Lyndsee Manna on Deriving Actionable Intelligence from Data
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.
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Episode 16 - Mark Sitcoske on Building a Company and Impact of COVID-19 on the Global Supply Chain
01/19/2022
Episode 16 - Mark Sitcoske on Building a Company and Impact of COVID-19 on the Global Supply Chain
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.
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Episode 15: Dr. Paul Peter Tak on Doing Everything With Patients in Mind
08/11/2021
Episode 15: Dr. Paul Peter Tak on Doing Everything With Patients in Mind
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.
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Episode 14 - Amr Raafat, Virtual Design Construction and Shakespeare
02/03/2021
Episode 14 - Amr Raafat, Virtual Design Construction and Shakespeare
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.
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Episode 13 - Francesca McBride, Cell Therapy and Global Regulations
01/13/2021
Episode 13 - Francesca McBride, Cell Therapy and Global Regulations
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.
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Brian Hagopian, Water Purity and Rapid Bacteria Detection
01/05/2021
Brian Hagopian, Water Purity and Rapid Bacteria Detection
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.
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Episode 11 - Dr. Andrea Adamo and the Out of This World Flow Technologies
12/14/2020
Episode 11 - Dr. Andrea Adamo and the Out of This World Flow Technologies
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.
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Episode 10 - Dr. Arindam Bose and the Evolution of the Biopharmaceuticals
07/14/2020
Episode 10 - Dr. Arindam Bose and the Evolution of the Biopharmaceuticals
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.
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Episode 9 - Prof Charles Cooney, the History and Future of Biotech and Boston Ballet
06/09/2020
Episode 9 - Prof Charles Cooney, the History and Future of Biotech and Boston Ballet
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.
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Episode 8 - David Sullivan on New Modalities, Price, Patients and the Pharma Landscape
04/08/2020
Episode 8 - David Sullivan on New Modalities, Price, Patients and the Pharma Landscape
My guest today is , Sr. Director and Global Lead of Vaccines and Biologics MSAT at . 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, "" 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.
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Episode 7 - Salvatore Mascia and Continuous Manufacturing
03/30/2020
Episode 7 - Salvatore Mascia and Continuous Manufacturing
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.
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Episode 6 - Matt Roberge and the Global Pharma Forces
03/03/2020
Episode 6 - Matt Roberge and the Global Pharma Forces
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.
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Episode 5 - Blockchain and Fake Drugs with Dr. Hariawala, Prof Vaishnav and Mr. Mankodi
06/04/2019
Episode 5 - Blockchain and Fake Drugs with Dr. Hariawala, Prof Vaishnav and Mr. Mankodi
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.
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Episode 4 - Continuous Manufacturing and Rare Events with Prof Bernhardt Trout
03/11/2019
Episode 4 - Continuous Manufacturing and Rare Events with Prof Bernhardt Trout
Episode 4 - Continuous Manufacturing and Rare Events with Prof Bernhardt Trout Professor Trout directs the and Novartis-MIT Center for Continuous Manufacturing at , 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.
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Episode 3 - ISPE Boston and Individualized Medicine with Jack Campion
11/28/2018
Episode 3 - ISPE Boston and Individualized Medicine with Jack Campion
Visit for complete show notes of every Podcast episode. is Principal at . He is the immediate past president of 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.
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Episode 2 - E. Coli Outbreak and Bacteria Detection with Dr. Monika Weber
11/28/2018
Episode 2 - E. Coli Outbreak and Bacteria Detection with Dr. Monika Weber
Visit ispeboston.org for complete show notes of every Podcast episode. is the Founder and CEO of , 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 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.
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Episode 1: Nanoparticles and the future of implants with Prof. Tom Webster
11/10/2018
Episode 1: Nanoparticles and the future of implants with Prof. Tom Webster
Visit ispeboston.org for complete show notes of every Podcast episode. directs the at , 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 .
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Episode 0 - Welcome to the Future of Pharma!
10/11/2018
Episode 0 - Welcome to the Future of Pharma!
The introductory episode to launch our Podcast - The Future of Pharma with ISPE Boston. Learn about the podcast, ISPE Boston and the host, and why it's a must subscription for a pharma professional.
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