2011: A pivotal year for biotechnology

Biotechnology continues to hold the greatest promise to address many of the most critical issues facing our world. Continued innovation will lead to breakthrough new and improved cures and treatments for patients living with debilitating diseases such as cancer, HIV/AIDS, diabetes and Parkinson’s; enhanced agricultural products to feed a growing global population while protecting the environmental health of our planet; vaccines to protect against bioterrorism; and revolutionary biofuels. The ability of BIO members to continue our shared mission to heal, fuel, and feed the world depends on having an economic and public policy environment that supports research and development that leads to continued innovation.

In the U.S., this point was underscored throughout 2011 as continuing global economic uncertainty, critical public policy debates and the ongoing need for regulatory reform discouraged investment in our industry, making an already challenging capital formation environment even more trying. A recent National Venture Capital Association study shows that investors are increasingly pulling out of biotech. VC financing is still down 25% from its 2007 peak. Year over year, we continue to see fewer deals being done. The IPO window remains tough and selective, with companies taking a 30% haircut on their asking (filing) price to lure cautious investors.

Throughout the past year, BIO worked tirelessly to advocate for public policies designed to improve the odds for biotech companies by encouraging investment in innovation, and reforming the regulatory review process to ensure timely, science-based and patient-focused decision-making.

In 2011, BIO released our five-year plan and worked with our member companies, our allies and Congress to turn our proposals into legislation. Our recommendations are specifically designed to create new models to encourage investment in innovation and to accelerate the discovery of scientific breakthroughs. As I write this post, we expect legislation to be introduced early next year.

We also negotiated a Prescription Drug User Fee Act (PDUFA) agreement and continued to work on healthcare reform implementation, with a specific eye on the impending release of biosimilars guidance from the FDA. Additionally, we worked successfully this year to support passage of Patent Reform legislation, while fighting against reimbursement cuts by Congress, and addressing myriad appropriations issues.

Most recently, we worked with Congress to pass legislation that reauthorizes the Small Business Innovation Research (SBIR) grant program, ending the year on a high note that will provide critical funding for small companies that may not otherwise survive.