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How will companies, patients, and the FDA navigate the impact of COVID-19 on Clinical Trials? A conversation with the former Director of the FDA Orphan Drug Division.

Ticker(s): IBB

Who's the expert?

Name: Dr Marlene Haffner

Institution:  Haffner Associates

  • Former Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA) for 20+ years.
  • Assisted in the development of more than 300 products in the US.
  • Credited with assisting in the development of Orphan Drug Programs in Japan, the European Union, Australia and more.

Interview Questions

Can we start with a general overview of how the FDA views rare-disease drug development, willingness to work with drug sponsors and include input from patient advocates?

Added By: joe_mccann

How is coronavirus impacting the conduct of clinical trials?

Added By: joe_mccann

How might the FDA consider clinical trials where enrollment is stopped prematurely?

Added By: joe_mccann

How might missing data be handled? Will alternative ways of collecting data, assessing patients be considered? 

  • Can visits be done remotely?

Added By: joe_mccann

What has to happen for those types of data to be collected and audited? 

Added By: joe_mccann

How flexible can the FDA be and still have reasonable assurance that data are reliable?

Added By: joe_mccann

Hi, we've heard about alternative pathways for vaccines to be licensed that have accelerated timelines vs traditional phase 1-3 pathway. (1) Are there any vaccines that have been approved using these pathways that you know of? (2) Could we see modification of these alternative pathways that may even offer an even quicker pathway to market given current pandemic? (3) Completely understanding that little to no data is available, if you have any, would be great to hear your thoughts on wide-varying opinions on hydroxychloroqine, azithromycin, BCG vaccine, other? Thanks in advance

Added By: gobind singh

What is the current status of anti-body tests? The impact on studies, interference with measures in studies and what do we know on Covid antibodies?

Added By: userccea4246

For applications or drug data sets which are boarderline on efficacy or safety due to covid issues. Say the p value on the primary isn’t stat sig but trends positive and one (the sponsor) could argue that the miss was due to covid drop outs.
Which way do you think the fda leans in that situation? Approve or not. And is it different for safety?

Added By: joe_mccann

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