We Are BIO

Jim's Corner

Here’s what the Biotechnology Industry Organization is doing for you.

This year, we challenged you to answer the question – What’s Your BIO? On behalf of the Biotechnology Industry Organization (BIO), I’d like to answer that question to illustrate how we advocate for federal, state and global policies to foster continued biotech breakthroughs, innovation and ingenuity.

In addition to producing the BIO International Convention, we educate and engage public policy leaders in Washington, in state capitols and around the globe to fight for policies that encourage innovation and enable our members to develop the scientific breakthrough technologies that cure disease, save lives and transform our world. Continued breakthroughs will lead to 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; innovative vaccines to protect our troops and public against the terrible threat of bioterrorism; and revolutionary sources of energy – sources that increase our energy independence.

To help grow the global biotech community, we have expanded our international activities and advocacy efforts around the world. We continue to advocate for international harmonization and consistent IP and regulatory standards, in addition to engaging in U.S. and global trade negotiations. We are well known for producing high-quality events, and in addition to our existing business development meetings in Asia and India, we hosted our first event in China last fall. We also hosted the Pacific Rim Summit, an event focused on industrial biotechnology, in Malaysia for the first time ever. Supporting business In the U.S., we help grow the industry by producing business development and investor conferences that enable companies to identify and explore partnering, dealmaking and collaboration opportunities. BIO One-on-One PartneringTM is the leading, proprietary online partnering tool designed and supported by business development and licensing professionals. It allows companies to conduct sophisticated searches for partners and licensing projects, and engage and arrange meetings with potential collaborators.

We’re also focused on helping biotech companies be more efficient and cost effective. Through BIO Business Solutions®, we have helped more than 2,700 companies save hundreds of thousands of dollars in aggregate through their participation in the cost-savings program. The program is available to U.S. and Canadian companies, and we are soon expanding its reach to the United Kingdom so our members there can take advantage of discounts and other benefits from industryleading suppliers.

A key advocacy role

BIO has your business objectives in mind as we conduct our advocacy and public policy activities in the U.S. Our overall goal is to improve the odds of success 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 fiveyear strategic plan (Unleashing the Promise of Biotechnology: Advancing American Innovation to Cure Disease and Save Lives) and worked with our member companies, allies and Congress to turn these proposals into legislation. Legislation introduced by Sen. Kay Hagan (D-NC) as the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act and by Congressman Cliff Stearns (R-FL) as the Faster Access to Specialized Treatments (FAST) Act introduce new models to encourage investment in innovation, accelerate the discovery of scientific breakthroughs, and speed cures and advanced treatments to patients.

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 pending 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.

In March of 2010, Congress enacted the BIO-supported Therapeutic Discovery Project, a critical tax program designed to stimulate investment in biotechnology research and development. Under this program, small biotech companies received a muchneeded infusion of capital to advance their innovative therapeutic projects while creating and sustaining high-paying, high-quality American jobs. The Therapeutic Discovery Project was a significant step in the right direction by Congress to invest in growing the U.S. biotech industry and ensure American companies have access to a level-playing field with our global competitors. We are currently working to ensure the program is extended and expanded.

Additionally, the Congress should be commended for reauthorizing the Small Business Innovation Research program. This too was a monumental step forward for the development of potential breakthrough products for patients by providing a critical source of funding for the early development stages of medical research. This reauthorization reinstated eligibility for a vast majority of small biotechnology companies that had been shut out of the program for the past decade due to a regulatory ruling that made many of them ineligible.

Supporting biotech crops

In our Food and Agriculture Section, we have overcome a number of significant legislative, regulatory and legal hurdles that impact our ability to feed a growing global population. We have won some significant legal cases, and we have seen USDA take some positive steps towards streamlining the petition process for plant biotech products with the goal of ultimately decreasing approval timelines by as much as 50 percent. We continue to deal with challenges – old and new – such as continuing attempts by activists set to mandate the labeling of genetically enhanced food products. But our industry is strong, and we are well-prepared to fight for a hunger- and starvation-free future.

We advocate reauthorizing the Farm Bill energy title to continue the tremendous positive impact these energy programs have had in revitalizing rural America and helping new agricultural markets emerge. In addition to putting more than 150,000 acres of underutilized farmland in over 150 counties into production raising next generation energy crops, these programs have led to an explosion of renewable chemicals innovation, demonstration and early commercialization here in the U.S.

We also advocate for maintaining the integrity of the Renewable Fuel Standard (RFS), which is the bedrock policy encouraging continued investment in the production of biofuels. Achieving American energy security requires producing domestic alternatives to all products that flow from foreign oil, and innovative U.S. companies have moved rapidly toward commercialization. These American companies rely on the RFS as they provide energy solutions today. In addition, tax policy should focus on driving innovation to reduce our dependence on foreign oil, lower gas prices, and create high quality U.S.- based career opportunities. This means an extension of current advanced biofuels tax credits and an expansion to include renewable chemicals tax credits as well, supporting the full range of biorefinery opportunities and leveling the playing field for U.S. companies.

Despite the challenging environment for capital formation, public policy and regulatory issues, our industry continues to make breathtaking scientific breakthroughs. 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 and leads to continued innovation.

We are BIO, and we are here to support and advocate on behalf of the industry. We welcome the opportunity presented by the BIO International Convention to connect with you. Please stop by the BIO Pavilion in the North Lobby to learn more about our organization and how we can put our resources and advocacy efforts to work for you.

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