Delivering on the Promise of Biotechnology

The 2010 BIO International Convention, produced by the Biotechnology Industry Organization (BIO), will occur at a critical time for the biopharmaceutical industry. A difficult economic climate, an uncertain policy environment, and locked-up capital markets threaten to stall the biotechnology's industry's ability to deliver on the promise of providing treatments and cures for the world's most debilitating diseases.

James C. Greenwood

The convention, set for May 3–6 in Chicago, presents us with an important opportunity to refocus and re-energize our industry's mission to heal, fuel, and feed the world. The global event for biotechnology will bring us together for four days of networking, idea sharing, education, and inspiration that will pay off for years to come.

Biotech innovation has contributed to dramatic advances in healthcare during the past decade—with even more promising advances on the horizon. Last year's economic recession had a tremendous impact on the industry's ability to deliver on this promise, forcing companies to curtail projects, lay off workers, and, in some cases, close their doors.

Now, we are beginning to experience renewed signs of hope. The capital markets experienced a rebound in late 2009 and that momentum has continued into 2010.

This year started with a flurry of investor activity and interest in our industry. Investors continue to be selective, but are showing greater appetite for biotechnology. The positive outcomes of clinical trials in the past year across several key areas, including Dendreon's (Seattle, WA) cancer research and the Human Genome Sciences' work, as well as the US Food and Drug Administration's approvals of new products, are all good signals for investors.

Biotechnology's mission has never been more critical. The challenges confronting our world are enormous, but the place to look for such a momentous and meaningful achievement is among the great minds of scientists and inside the research laboratories at leading biotechnology companies.

The long-term prospects for biotechnology remain strong. Today, there are more than 250 biotechnology healthcare products and vaccines available to patients, many for previously untreatable diseases. Our companies continue to innovate at a breathtaking pace, developing medicines that are providing hope where there once was none and creating new tools to allow for more personalized and effective care.

The recent approval of Acorda Therapeutics' (Hawthorne, NY) multiple-sclerosis drug Ampyra (dalfampridine) that will help many patients walk better and Dendreon's optimism on the pending approval of the prostate cancer drug Provenge (sipuleucel-T) are promising developments.

Researching and developing new therapies is a long, expensive, and risky process. On average, the development of a new drug costs $1.2 billion over the course of 10 to 15 years from the time research begins until the drug receives FDA approval to go on the market. This amount includes the cost of dead ends and failed drug candidates along the way; only five out of every 5000 potential medicines tested ever reaches the clinical-trial stage.

Biotech innovation has always been—and always will be—a high-risk enterprise. But we can improve the odds. Even with the best scientist practicing the most cutting-edge science in the best run business, it is now more important for us to make sure that policymakers around the world create legislation that values and incentivizes innovation.

The effect of policy decisions on the ability of biotechnology companies to keep developing and delivering breakthrough science and high-quality new products is greater than ever.

Thankfully, policymakers who recognize the value of biotechnology also recognize that the right policy environment can help the industry thrive. Enacting a sound regulatory pathway for biosimilars in the United States is one important step that Congress can take to improve the policy environment for biotechnology innovation.

In the recently approved healthcare legislation, both the House and Senate followed the bipartisan votes in key Congressional committees and included an approval pathway for biosimilars that will strike the critical balance among promoting patient safety, expanding access, lowering costs and promoting continued innovation. Several patient, physician, and academic groups joined BIO in supporting this critical legislative language.

Another part of the Senate version of the legislation is the Therapeutic Discovery Project Tax Credit, which would provide a tax credit to small and emerging biotechnology companies to help offset a portion of resources spent on therapeutic development activities, including hiring scientists and conducting clinical studies. These credits would help sustain projects that promise new therapies while also creating and saving thousands of US jobs.

BIO will continue to engage with leaders in Washington, across the nation, and around the world to advocate for public policies that encourage innovation. Now is the time to bring together the entire biotechnology community to work together to find solutions for the challenges we face. Despite these challenges, biotechnology companies are dedicated to finding the next biologic-based treatment or cure.

I invite you to join me in Chicago at the 2010 BIO International Convention as we tackle some of the challenges that will shape the future and deliver on the promise and potential of biotechnology to develop preventions, treatments, and even cures, that can save lives and improve the quality of life for all of us.

James C. Greenwood is president and CEO of the Biotechnology Industry Organization (BIO) in Washington, DC, tel. 202.962.9200, james.greenwood@bio.org.