Regulatory Affairs

The 14th Annual BIO CEO & Investor Conference was held on February 13-14 in New York City at the Waldorf=Astoria

State governments in 2011 continued to see regional economic growth in the life sciences industry and in 2012 will increasingly focus attention on technology transfer and venture funding as mechanisms to increase private sector innovation related activities within their jurisdictions. Realizing that entrepreneurship is a key ingredient in economic development, states and localities are undertaking the support of programs that assist high technology businesses, and that capitalize on state regional presence of universities and federal laboratories.

BIO President & CEO Jim Greenwood and Tom Watkins, President & CEO of Human Genome Sciences and Chair of BIO’s Board of Directors, recently hosted a media briefing to recap our advocacy accomplishments in 2011 and lay out BIO’s policy priorities for 2012.

Biotechnology continues to hold the greatest promise to address many of the most critical issues facing our world.

BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for making 35 novel new treatments available to patients in FY11.

While the U.S. leads in the area of biotechnology, there is no guarantee this competitive edge will continue.

Regulatory review processes are not keeping up with rapidly advancing science and are making the environment for developing new treatments and preventions for deadly and debilitating diseases more difficult.

The biotech industry has shrunk dramatically in recent years based primarily on the continued tight capital markets and increased aversion to risk on the part of investors.

A strong Network will bolster public awareness of the industry and encourage more investment dollars.

Society has tapped just a small fraction of the many potential uses and benefits of biotechnology.

Mankind's need to cure disease, combat hunger and discover new forms of energy has never been more urgent.

BIO and five member companies – Mendel Biotechnology, Arborgen, Abengoa Bioenergy, Novozymes and BP Biofuels – along with the Biomass Power Association held a briefing on Capitol Hill this week, outlining the importance of the USDA’s Biomass Crop Assistance Program (BCAP) and related programs. Regulatory rules for the BCAP, Biorefinery Assistance Program, and Rural Energy for America Program (REAP) were finalized by USDA only during the last quarter of 2010. But Congress is considering cutting the funds for these programs before they have a chance to show their effectiveness.

To carry out military and humanitarian missions around the world, U.S. forces require reliable fuel supplies and secure supply lines. At the micro level, the military is as much at the mercy of high oil and gasoline prices as the average consumer. In addition, when you calculate the fully burdened cost of fuels, for instance a gallon of jet fuel delivered to the front lines in Afghanistan, it can be upwards of $400 per gallon. And, on a macro level, oil often comes from regions of the world that are not U.S. military allies. The need for great energy independence is therefore a very important national security issue.

Tracy Cooley talks to Renee Winsky about biotech in Maryland and the upcoming  BIO International Convention  in Washington, DC.

Letters, Testimony & Comments

May 14 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 11 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
March 1 2012
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health...
February 29 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments...
February 29 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on...

Press Releases

February 9 2012
Patient Safety Must Remain Top Priority Washington, D.C. (February 9, 2012) — Biotechnology Industry...
September 16 2011
Washington, D.C. (September 16, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
September 1 2011
WASHINGTON, D.C.(Sept. 1, 2011) – Research and development in synthetic biology is an evolution of...
June 29 2011
WASHINGTON, D.C. (Wednesday, June 29, 2011) - The Biotechnology Industry Organization (BIO) released today a summary...
June 9 2011
WASHINGTON, D.C. (Thursday, June 09, 2011) - The Biotechnology Industry Organization (BIO) announced today its...