Welcome to the weekly blog contribution from our experts at YourEncore that will address "all things regulated" in life science product development.
Over the past year we have been busy assembling a world class group of professionals who have spent their careers running clinical, regulatory, safety, quality and other departments for the world’s largest pharmaceutical and medical device companies. Our virtual Who’s Who list includes former senior FDA officials and current policy thought leaders.
Now that our team is in place, we’d like to harness and share with you this remarkable brain trust.
This column is one way we can foster such knowledge sharing. Our goal is to publish refreshingly pragmatic thought leadership from our highly accomplished experts every week, so please check back regularly. You also can sign up to receive the YourEncore blog by email on the same page.
Besides myself, our regular authors include YourEncore experts:
- Joe Lamendola, Ph.D - Joe helps companies understand the FDA, how it behaves, and how to earn its trust to advance drug development. He is the former VP, U.S. Regulatory Affairs at Bristol Meyers Squibb and is responsible for 20+ drug approvals across 10+ therapeutic areas.
- Peter J. Pitts - Peter is a consultant, author and key opinion leader on food, drug and device policy. He is a former FDA Associate Commissioner, current Chief Regulatory Officer for Adherent Health Strategies, Founder/President of the Center for Medicine in the Public Interest, Founder of drugwonks.com and Associate Editor, Therapeutic Innovation & Regulatory Science.
- Don Therasse, M.D. - Don connects the dots of drug development, medical affairs, and pharmacovigilance to help companies bring products to market faster. He is the former VP, Global Patient Safety and Global Medical Affairs at Eli Lilly, where he led Lilly’s pharmacovigilance organization and played a major role in establishing Lilly’s global medical affairs, benefit-risk assessment and bioethics organizations.
Other contributing YourEncore experts include:
As members of our Regulatory Practice and Strategic Advisory Board, we (among others) have in aggregate achieved 50 first time NDA approvals, 200+ asset stage-gate decisions and portfolio reviews, and have shaped 35+ key policies or guidances, to name a few. We are poised to share that wealth of development experience with you.
We’ll write about topics that help accelerate pipelines, navigate complex regulatory environments, and drive productivity. Our topics will fall under three broad themes:
- Product Development & Commercialization - We will explore the issues involved with getting new therapies to market. Topics may include regulatory strategy, labeling and the breadth of development challenges in our industry.
- Portfolio and Asset Decisions - We will discuss issues around due diligence for stage-gate decisions on internal development projects and evaluations of external opportunities. Topics may include due diligence, drug safety and regulatory affairs.
- Power of Policy - We will provide insight into the federal, state and international policies that are shaping the regulatory environment. Topics may include: PDUFA, 21st Century Cures, EU Medical Device Directives and FDA Relations.
Please help us make this weekly column interactive. If you have a question you’d like to see addressed by one of our experts, include it in the comments section below. We look forward to hearing from you!
Next week we’ll take a look at some of the top trends impacting the biopharma industry. For a sneak peak, take a look at our recent post and infographic on “10 Pharma Trends to Navigate.”
We hope this will be a valuable addition to your week!
Authored By: Tim Franson, M.D., Chief Medical Officer at YourEncore; former VP Global Regulatory Affairs & Patient Safety, Eli Lilly and Company. Tim.Franson@yourencore.com