What 2008 Holds For Bringing Drugs To Market
It's shaping up to be a record year for drug approvals. Unfortunately for the biopharma sector and investors, it's a record low. The Food and Drug Administration is on track to grant marketing approval to 18 or fewer new drugs in 2007, and pipelines are not looking better in the coming years. For the research and development and marketing executives responsible for getting new drugs to customers, the level of unpredictability may be unprecedented. And Washington lawmakers and regulators are driving the uncertainty. Yesterday's blockbuster will not be the prototype for future drug development. Sweeping new legislation is reforming the FDA and changing how drugs are developed; Medicare is radically altering product economics; and Wall Street is looking for the next big thing.
The FDA/CMS Summit, taking place December 6-7 in Washington, D.C., will feature the key decision makers from government and industry to help biopharmaceutical executives understand what regulatory and policy developments mean for research and commercial success.
"Today may look a lot like yesterday, but the rules of the game have fundamentally changed," said Cole Werble, editor-in-chief of The RPM Report, the lead sponsor of the conference. "Industry needs to learn what recent changes to FDA law mean and what the impact might hold for drug development and marketing. The FDA/CMS Summit provides leaders in industry key insight from policy-makers who have been involved in these changes."
The FDA/CMS Summit provides health care executives with an exclusive opportunity to have face-to-face dialogues with top policymakers and executives. The Summit is aimed at industry executives in all areas of responsibility who want to create successful strategies for dealing with FDA and CMS. Attendees will get practical, real-life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles, and will also be able to benchmark their regulatory strategy against all other pharmaceutical and biotechnology companies.
Among the panels and participants scheduled for the Summit are:
- Did FDA Kill the Blockbuster?