"The Future of the FDA Part 2: Changes to Drug Development and Approval" with Jerry Avorn, MD

WHEN: Tuesday, April 18, 12:00pm-1:00pm
WHERE: Armenise 108 (HITS Conference Room) at Harvard Medical School
HOSTED BY: GSAS Science Policy Group

Let's continue this discussion! All are welcome!

RSVP here by to ensure we have enough food :-)

We are pleased to host Jerry Avorn, MD, the Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham & Women's Hospital. Dr. Avorn is an internist, geriatrician and drug epidemiologist, and has written over 275 papers on medication use and its outcomes, the drug development paradigm and FDA policy. Dr. Avorn regularly contributes to articles on these topics written by The New York Times, The Washington Post and the Wall Street Journal. He has written a book called "Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs." Dr. Avorn has also pioneered an approach called "academic detailing," which uses evidence-based, unbiased information to educate clinicians on the efficacy and safety issues of certain drugs for various indications. 

For more information, read his bio at the Division (http://www.drugepi.org/faculty-staff-trainees/faculty/jerry-avorn/) or his Wikipedia page (https://en.wikipedia.org/wiki/Jerry_Avorn).

SETTING THE SCENE:

So far in this series, we have been fortunate to hear about the fundamentals of drug development and approval and some different perspectives regarding changes at the FDA ushered in by the 21st Century Cures Act, but there should still be lots of questions. How does this new law actually change the drug approval process at the FDA? What are the concerns? How will patients and companies be affected? How do we balance the need for a strong FDA with innovation in drug discovery and development? What are some foreseeable benefits and/or challenges with the new administration? 

Pizza will be served!

Contact Cory Gerlach (corygerlach@g.harvard.edu) with any questions.