The pressures on the FDA to scrutinize ever more closely a potential new drug's safety profile has never been greater (think Vioxx), which translates into pressure on the industry to invest ever increasing, and increasingly untenable amounts, into clinical studies and to terminate development of potential lifesaving or life-enhancing new drugs. The panel will explore this dilemma and address the "hard" questions about the impact on the launch of new drugs brought about by increasing regulatory challenges and look at the questions from the viewpoint of the FDA, the industry and, importantly, the patient.



Objectives:

Stimulate much-needed debate on a topic critical to the success of the biopharmaceutical industry and, more important, to the provision of new and efficacious treatments for undertreated diseases and unmet medical needs.

Develop new insights and recommendations for balancing the need to promote and reward the development of innovative treatments with the need to promote an awareness and acceptance that all therapeutics carry some level of risk.

Promote an understanding and awareness between the different stakeholders (patients, industry and FDA) of each other's mandates, obligations, responsibilities and needs.