FDA-Industry IVD/Companion Diagnostic Drug Roundtable Meeting

When:  February 6, 2008- 9:00 AM - 4:30 PM

Where:  Hotel Palomar 
                2121 P Street NW, Washington, DC 20037 
                202-448-1800 

                Registration closed January 30th /  AGENDA

 In cooperation with ACLA, AACC, BIO and PhRMA, AdvaMed is pleased to invite you to attend a free (registration required as limited seating is available) roundtable discussion of issues and lessons learned around the development of drugs and companion tests used to guide selection, dosage, and safe use of those drugs.

Three real world cases representing different development scenarios will be discussed by experts bringing perspectives from industry, academic researchers, clinical practitioners, and regulators. Discussions will focus on what worked well and what could be improved. The desire is to develop further guidance to FDA and industry on the successful development of products which will fulfill the promise of “personalized medicine.”

It is anticipated this will be the first of two roundtables. Key issues and barriers identified in the case study reviews will set the agenda for the second meeting where issues will be explored in-depth and recommendations will be formulated.

Speakers will include representatives from FDA, industry, and practicing physicians. Plan on attending and learn about this important topic!

To participate in the meeting, please RSVP by email to Stacey Robertson  or (202) 434-7229 by telephone.