IMFer Mike Katz has served as a patient consultant to the FDA for a number of years. He recently received an award for his work on the Patient Consultant Telephone Lecture Series, which serves to orient new participants and provide more seasoned members an opportunity to share lessons learned.
The award was presented by Commissioner Mark B. McClellan, MD, PhD (center). Also shown to the left is Joann Minor, of the FDA's Office Of Special Health Issues. Joann is one of the leaders of the program and a key FDA resource for patients and patient advocates. Mike had a chance to speak with the commissioner and after the ceremony and thank him for the agency's fine work in streamling the approval process for innovative drugs like Velcade™ and Revimid™. The agency has recently made great strides in reducing administrative bottlenecks in the process. More importantly, though, they have brought new thinking to address the challenges of showing clinical benefit in settings such as relapsed refractory myeloma, which has sometimes been difficult to establish using traditional measures.