Meet the Speakers: Controlled Substances Forum – Dr. Robert J. Meyer , MD

Dr. Robert J. Meyer , MD

Assc. Professor, Public Health Sciences Director

Virginia Center for Translational and Regulatory Sciences

Tell us about yourself:

I come from Connecticut originally, but have now lived in 5 other states as my training and career have led me from New England to the Northwest, to the mid-Atlantic.  Besides my interest in public health and therapeutics, I love music of almost all types, both for listening and performing.

 Tell us what a day is like in your field: 

There is no “common” day for me in academics, as I move from teaching to consulting to authoring to grant writing.  Starting a new, unique Center at a great University provides for a diverse set of activities!

Tell us what you like about working at your company: 

The University of Virginia is, at once, both very properly southern and the creation of Thomas Jefferson, as well as a modern, research University.  That duality is both a great challenge and a great opportunity.

Tell us what you would change in the industry:

I would like to see the industry be less focused on fighting regulatory expectations and more focused on creatively embracing them in a strategic manner.

Give us one best practice tip:

Effective engagement with the FDA and DEA is based on meeting expectations through robust science and then looking for wins that meet everyone’s needs, most importantly, that of the patients.  If there is a marginal signal of potential for abuse from the preclinical and clinical studies, it would be most expedient for the sponsor to propose and accept an appropriate scheduling, than to argue and resist.  While not a panacea, considering limitations with how FDA internally organizes controlled substances reviews vs. the PDUFA review activities, early, effective engagement of FDA’s review division and Controlled Substance Staff throughout development is important where abuse potential exists.  Once the data and discussion are finalized in the application, consideration should be given to a dedicated discussion in the pre-NDA setting with CSS to go over the dedicated studies and the relevant data from the clinical trials.

Controlled Substances

When: Thursday, January 16 to Friday, January 17, 2014

Where: The Washington Plaza Hotel, Washington DC

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