Without a supportive legislative and regulatory environment, biotech companies cannot raise the funds necessary to get a product to market. The panelists explored the pressing policy issues which could have a significant impact on the industry, from the creation of a pathway for the approval of follow-on biologics, patent reform, comparative effectiveness and the implementation of the Food and Drug Administration Amendments Act (FDAAA) which was signed into law last year. The panelists also discussed health care reform in the Presidential campaigns, and the importance of selecting the right person as FDA Commissioner in the next Administration.