The regulatory field in drug development, says Biogen Idec's Nadine Cohen, "isn't black or white. It's so many shades of gray."
For Cohen, senior VP of regulatory affairs and R&D compliance, that means that deciphering the grays--considering how regulators are likely to view a new drug application--requires plenty of careful thinking. And the intricate process starts with the pre-IND meeting and runs all the way through to the final decision, gleaning information along the way and using as much regulatory feedback as you can get to design trials that will answer essential FDA questions.
Cohen and several of her colleagues in the regulatory world--from Sanofi, Human Genome Science, AstraZeneca and Acorda--will discuss how they go about the tricky business of designing a regulatory strategy for an experimental drug at our upcoming executive breakfast that will be held June 29 in conjunction with the 2011 BIO International Convention in Washington D.C.
It's no secret that the agency has raised the bar on safety, particularly in key disease arenas. Learning how to work with regulators is one of the most important tasks in the business. And this is one event you'll find helpful as you puzzle out your own regulatory strategy.
I'll be hosting a free ranging discussion on one of the most complex issues of the day for biopharma companies. And you'll have a chance to pose your own questions to our panel of experts. In the meantime, if there are any regulatory issues you're particularly interested in hearing more about, drop me an e-mail.
Please join me on June 29th at the Grand Hyatt in Washington D.C. You can register here. - John Carroll (twitter | email)