With the patent cliff and a capital crisis, pharma companies large and small face increased performance pressures to ensure successful drug development. Yet, many people spend an entire career in drug development without ever seeing a single of their products being approved. So how do you do it? MassBio has assembled a panel who have successfully brought their drugs to market, not once but multiple times, to explore the critical elements of success in drug development. We will search for commonalities and seek to understand how different approaches worked in different situations.

Panelists include: 

• Dr. Pravin Chaturvedi, CEO of IndUS, CSO of Napo Pharmaceuticals
• Dr. Roger Tung, President and Chief Executive Officer of Concert Pharmaceuticals.
• Dr. Ene Ette, President, CEO of Anoixis Corporation

The panel will be moderated by Molly Hoult from Fletcher Spaght, Inc. a hybrid consulting and venture capital firm.

Dr. Pravin Chaturvedi

Dr. Chaturvedi currently maintains a dual role of being the Chief Executive Officer (CEO) of IndUS Pharmaceuticals and the Chief Scientific Officer (CSO) of Napo Pharmaceuticals. Dr. Chaturvedi founded of Boston-based IndUS Pharmaceuticals in 2005 and IndUS was acquired by San Francisco-headquartered Napo Pharmaceuticals in 2007 and in 2010, Dr. Chaturvedi successfully spun IndUS out. Prior to IndUS, he was a co-founder and President & CEO of Scion Pharmaceuticals, which focused on the discovery and development of a novel, first-in-class drug, for the treatment of moderate-to-severe and neuropathic pain, which was sold to Wyeth. Prior to Scion, Dr. Chaturvedi, spent several years at Vertex Pharmaceuticals as the Senior Director and Head of Lead Evaluation and before that he was in the preclinical group at Alkermes. Prior to Alkermes, he was in the Product Development group at Parke-Davis/Warner-Lambert Company (now Pfizer), where he worked on the development of new drugs for the treatment of oncology, epilepsy, pain and cognition. He has participated in the discovery and/or development of six marketed drugs for the treatment of CNS disorders, HIV and hepatitis C. He has authored or co-authored approximately 50 publications and he is an inventor or a co-inventor on several patents and patent applications. Dr. Chaturvedi holds a Ph.D. in Pharmaceutical Sciences from West Virginia University and a Bachelor’s in Pharmacy from the University of Bombay. Dr. Chaturvedi is or has served on the Boards of Scion Pharmaceuticals, IndUS Pharmaceuticals, Sindu Pharmaceuticals and Sindu Research Laboratories, as well as TiE Boston.

Dr. Roger Tung

Dr. Roger Tung, President and Chief Executive Officer of Concert Pharmaceuticals, Inc., co-founded the Company in 2006 based on research he carried out as an independent scientist.  Concert specializes in the discovery of novel deuterium-containing medicines and to date has raised over $110M from a broad base of investors.  Concert is advancing clinical programs in the areas of HIV and diabetic chronic kidney disease.

Prior to starting Concert, Roger worked in venture-backed start-up and major pharmaceutical companies, including Vertex Pharmaceuticals Inc., where he was a founding scientist and Vice President of Drug Discovery, and Merck, Sharp and Dohme Research Laboratories.  Roger co-invented and headed discovery of the commercial HIV protease inhibitor products Lexiva® and Agenerase®.  He also led the development of Agenerase, in collaboration with Glaxo, through FDA and EMEA approval. He oversaw the teams that discovered the hepatitis C drug Incivek™ and the cystic fibrosis agents VX-770 (NDA submitted) and VX-809.  Roger has published widely and has been granted over 50 U.S. patents.  He received his Ph.D. in Medicinal Chemistry from the University of Wisconsin-Madison where he studied under Professor Daniel H. Rich. He currently serves as a scientific advisor to Medivation and Verastem and a member of the Board of Visitors of the University of Wisconsin School of Pharmacy.

Dr. Ene Ette

Dr. Ette, president and CEO of Anoixis Corporation, has over 28 years of broad experience in academia, drug evaluation and regulation, and the pharmaceutical industry where he has held several senior positions, including global head/senior director of the Clinical Pharmacology Department, Vertex Pharmaceuticals, Cambridge, MA, U.S.A.  He has a Ph.D. (Clinical Pharmacology), MBA, MS (pharmacology), BS (pharmacology), and BS (pharmacy).  He is a prolific author/co-author of 92 original articles in peer-reviewed journals, book chapters, numerous conference presentations, and proceedings.  Ette is on the editorial board of many clinical pharmacology / pharmacy journals as well as a referee for many biomedical and statistical journals.  He is an invited speaker at the Food and Drug Administration (FDA) guest lectures and many international clinical pharmacology/pharmacy, pharmaceutical science, and statistical meetings.  In addition, he is the primary editor of the classic reference text, Pharmacometrics: the Science of Quantitative Pharmacology. Dr. Ette is a fellow of the American Colleges of Clinical Pharmacology and Clinical Pharmacy, and American Association of Pharmaceutical Scientists.  He was the 2006 recipient of the American College of Clinical Pharmacy’s prestigious Therapeutic Frontier Lecture Award for distinguished scientists, a consultant to the U.S. FDA from 1998 to 2001, and the 1999 recipient of the American College of Clinical Pharmacy’s Russell Miller Award for outstanding contributions to the clinical pharmacy / pharmacology literature.  In 1996, he received the Excellence in Review Science Award in CDER, FDA; and at the FDA he was the major author of the Agency’s unique Guidance for Industry: Population Pharmacokinetics.  He is an expert clinical pharmacologists/pharmacometrician, drug developer, and co-inventor on several patents and patent applications.  He has participated in the development and registration of hepatitis C, cystic fibrosis, oncology, epilepsy, and gastroenterology drugs.