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You've got that coveted accelerated regulatory pathway. Now what?

Accelerated development programs are not all fun and joy. While everyone wants a Breakthrough Therapy Designation (BTD), Fast Track or PRIME, they also add real pressure to getting the job done in the clinic. We’ll talk to several veterans of the process about the pitfalls present in any accelerated development challenge, and how to avoid them.

If you’re looking for an accelerated pathway, this is one discussion you don’t want to miss.

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Victor Vinci

Victor Vinci

VP, Product Development, Catalent Biologics

Dr. Victor Vinci is the Vice President of Product Development for Catalent Biologics with more than 25 years of technical and leadership experience in the pharmaceutical industry. Previously, he was the Vice President of Product and Process Development for Catalent Biologics’ Bloomington, Indiana facility where he oversaw product development, manufacturing sciences, and project management for the site. He joined Catalent Biologics following Catalent's acquisition of Cook Pharmica where he also served as the Vice President of Product and Process Development. Prior to his time at Cook Pharmica, Vic spent six years as an Manufacturing Science & Technology section head at Merck & Co., Inc. before moving to Eli Lilly and Company in Indianapolis. At Lilly, he was responsible for leading a range of bioprocess development efforts including: process development, tech transfer from development to large-scale clinical trial and commercial production, and process optimization and characterization to assure manufacturability. He was the company lead for the A-Mab Quality-by-Design case study which was a groundbreaking industry-FDA collaboration. Victor holds a Bachelor’s degree in both chemistry and microbiology from Bowling Green State University, and a Masters and Ph.D. in microbiology from The Ohio State University.

Eric Green

Eric Green

Senior VP & General Manager TTR, Alnylam pharmaceuticals

Accomplished biopharmaceutical professional motivated by leading teams to develop and commercialize important products for patients, most recently in ultra-rare genetic diseases and oncology. Twenty years of diverse experience spanning R&D process engineering, pharmaceutical manufacturing and operations, medical device product development, oncology program management, global strategic brand leadership, development program leadership, portfolio management and general management.

Jim Ottinger

Jim Ottinger

SVP Regulatory Affairs, UroGen Pharma

Jim is a pharmaceutical industry executive with more than 30 years of strategic regulatory experience, having supported the successful development, approval, and marketing of a number of new drugs throughout his career. Prior to joining UroGen, Jim served as Senior Vice President of Global Regulatory Affairs at Teva Pharmaceutical Industries, Ltd., where he was responsible for global regulatory oversight of Teva’s portfolio of branded, generic, and over-the-counter products. Previously, Jim was Vice President of Worldwide Regulatory Affairs of Cephalon, Inc. (acquired by Teva). Earlier in his career, Jim held a variety of senior regulatory positions with Premier Research Group Limited, and regulatory positions of increasing responsibility at Wyeth Research (acquired by Pfizer, Inc.). Jim holds a bachelor of science in pharmacy from the Temple University School of Pharmacy and is a registered pharmacist in the State of Pennsylvania.

Chris Peetz

Chris Peetz

President & Chief Executive Officer, Mirum Pharmaceuticals

Chris Peetz is a co-founder of Mirum and has served as president since December 2018 and as chief executive officer since March 2019.

Chris has been an entrepreneur-in-residence at Frazier Healthcare Partners since May 2017. Prior to joining Mirum, Chris served as the chief executive officer of Flashlight Therapeutics, Inc. From May 2014 to December 2016, he served as chief financial officer and head of corporate development at Tobira, which was acquired by Allergan plc, in November 2016. Prior to joining Tobira, Chris served as vice president, finance and corporate development of Jennerex Biotherapeutics. Prior to Jennerex, Chris held various positions at Onyx Pharmaceuticals, Inc. (now Amgen Inc.), including oversight of financial planning and analysis, corporate strategy, product lifecycle management and commercial roles. Prior to Onyx, Chris provided merger and acquisition advisory services at LaSalle Corporate Finance, a part of ABN AMRO, and held positions at Abgenix Inc. and Solazyme Inc. He has also served as a member of the board of directors of Alpine Immune Sciences, Inc., a public immunotherapy company, since April 2018.

Chris received an MBA from Stanford Graduate School of Business and a B.S.B.A. in Finance, International Business and French from Washington University in St. Louis.

John Carroll
moderator

john carroll

Founder & editor, Endpoints News

John D. Carroll is a biotech analyst and writer with decades of prize-winning experience in journalism. A co-founder of Endpoints News, he has covered biopharma for the past 15 years. Aside from his previous daily industry coverage at FierceBiotech, where he was named editor in 2003, leaving in 2016, Carroll has been a regular speaker at biotech events around the globe. He’s been quoted by The New York Times, The New Yorker, Financial Times, The Times of London and more. He’s also keynoted at biotech gatherings around the world and addressed student audiences at MIT and Harvard.