Articles

Round Table Discussion - Friday 1/20/17

 

Click here to listen to the recording  

 

Dear friends and colleagues,you are cordially invited to join:

 

A Special Friday Call entitled—

“Wow or Yeow!?  We are now in a new era of therapeutic development and                                regulation.”

                                                                A Roundtable Discussion

 

Participants:

Timothy Franson, M.D., Chief Medical Officer, Your Encore

Infections disease specialist, highly respected advisor and commentator, industry leader. Formerly, Vice President of Global Regulatory Affairs & Patient Safety for Lilly

 

David Fox, J.D., Partner, Hogan Lovells

A leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances.  Formerly, Office of the Chief Counsel, FDA

 

Brian Harvey, M.D, PhD., Distinguished Advisor, Kinexum

Highly valued advisor, academic gastroenterologist, APSA Congressional Fellow. Formerly, senior positions at Pfizer and Sanofi and in 3 FDA Centers, Director, Division of Gastroenterology Products, CDER

Moderated by

Alexander Fleming, M.D., CEO, Kinexum

Endocrinologist and metabolic disease specialist. Formerly, CDER Division of Endocrine and Metabolic Drug Products, FDA representative to ICH and other international initiatives

 

What’s this about?

In the past, years have been required to recognize in retrospect that a new era in therapeutic development and regulation had been entered.  Not today.  The recent passage of the 21st Century Cures Act strikes the end of the beginning of the starkly different era in which we now find ourselves.  Boundless opportunities in genomic medicine, prevention of major diseases, and medical technology are offset by unprecedented economic, political and social challenges.  The discussion will barely scratch the surface of this labyrinth, but it will be a start.   

 

Who is this discussion for?

Anyone in the fields of life sciences research, therapeutic development, regulation, public policy, and commerce.

When and How:

1:00 PM EST, Friday, January 20 2017.  Call: 888-601-3595(no pin needed) and/or join us online: https://www.uberconference.com/zanfleming