Bio & Pharmaceuticals

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BIO: Innovation for Health, Food, Environment

31 Dec, 2007

By: James C. Greenwood

The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology association, representing more than 1,100 companies, academic institutions, state biotechnology centers and related organizations across the United States and more than 30 other nations. Our members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO members are leading the way toward a new era of better health, a cleaner planet and a more plentiful food supply.
 
BIO’s mission is to serve as a champion for the biotechnology industry. We provide our member companies and organizations with effective advocacy, business development programs, award-winning publications, and discounts on essential products and services. BIO produces the BIO International Convention – the global event for biotechnology – as well as the World Congress on Industrial Biotechnology and Bioprocessing and other partnering and investor conferences throughout the year. The 2008 BIO International Convention will take place June 17-20, 2008 in San Diego, California.
 
Biotechnology is a young industry that originated in the 1970s, based largely on the discovery of new recombinant DNA techniques that allowed scientists to make proteins – such as human insulin and other therapies – in cultured cells under controlled manufacturing conditions. Today we are increasing our understanding of biology at ever greater levels of precision, enabling us to manipulate not only plants and animals, but our own bodies at the cellular, genetic and molecular levels. Advances in genetics, gene sequencing, bioinformatics, proteomics, DNA microarrays, industrial enzymes and molecular pathway studies – to name just a few areas of discovery – are propelling biotech advances at an astonishing pace:
 

  • Biotechnology has created more than 200 new therapies and vaccines, including products to treat cancer, diabetes, HIV/AIDS and autoimmune disorders – with more than 400 new biotech health products now in clinical trials.

  • Biotechnology is responsible for hundreds of medical diagnostic tests that keep the blood supply safe from the AIDS virus and detect other conditions early enough to be successfully treated.

  • DNA fingerprinting, a biotech process, has dramatically improved criminal investigation and forensic medicine, as well as afforded significant advances in anthropology and wildlife management.

  • The benefits of enhanced production from biotech crops that are more resistant to pests and disease have now been realized in 22 nations, inhabited by half of the world’s population.

  • Industrial biotechnology applications are leading to cleaner manufacturing processes that produce less waste and use less energy and water in such industrial sectors as chemicals, pulp and paper, textiles, food, energy, metals and minerals.

  • Advanced biofuels refineries will come on line in the U.S. in the next two years, offering a path to greater energy independence and reduced carbon emissions as we decrease our reliance on fossil fuels and substitute clean-burning, renewable alternatives such as cellulosic ethanol and bio-diesel.

 

 
In all of these areas, innovation remains at the heart of biotechnology. Biotechnology is one of the most research intensive industries in the world. The U.S. biotech industry spent $27.1 billion on research and development in 2006. The majority of BIO’s member companies are start-up companies, or emerging companies still developing their first product, and thus depend on investor capital and other financing sources for survival.
 
The biotechnology sector is strong today, attracting more than $20 billion per year in investment, with revenues and employment growing and many new products in the pipeline. But biotech companies don’t operate in a vacuum. Our products have to compete in a global marketplace. We contend for investment capital in the financial markets. We must conduct research, develop and market products and do business within a legal and regulatory framework shaped by Congress and other government decision-makers. Maintaining a public policy environment that supports innovation is crucial to the continued success of our industry.
 
BIO has built a world-class advocacy team, attracting leaders from the ranks of Congress and federal regulatory agencies to work on the issues that matter most to the future of biotechnology. BIO is active on a wide range of issues affecting the industry, including:
 

  • Patent Law: Congress is currently considering the most significant changes to the U.S. patent system in more than 50 years. Biotechnology companies rely on strong patent protection and believe the patent system has served not only our industry, but the nation, as well. As currently written, the legislation before Congress weakens patent rights and guts the intellectual property protections that our industry relies on by weakening patent enforceability and limiting compensation for patent infringement. BIO is working closely with other innovation-intensive industries to secure true reform that strengthens and improves the patent system.

  • Follow-on Biologics: Because biologic medicines are complex molecules manufactured using living organisms, we cannot simply apply the model of generic drugs used with traditional pharmaceuticals. Follow-on biologic products will not be copies of, but rather will be similar to, life-saving, pioneering biologics. Congress is considering legislation to create a legal and regulatory pathway for the approval of follow-on biologics. BIO is working to ensure that such a pathway recognizes and addresses the differences between traditional generic drugs and follow-on products, provides sufficient protection for patient safety and the patient-doctor relationship and preserves incentives to innovate.

  • Stem Cell Research: BIO supports embryonic stem cell research that has great potential to provide new, groundbreaking therapies for diabetes, heart disease, spinal cord injuries and a host of other disabling and deadly conditions. BIO helped secure passage of bipartisan legislation to expand the limited number of stem cell lines currently available for federally-funded research. Though the resulting Stem Cell Research Enhancement Act was vetoed by the president, BIO continues to support this very promising research.

  • Food and Drug Administration and Drug Safety: BIO is strongly committed to ensuring that the FDA has sufficient resources to continue to accomplish its mission of quickly and effectively reviewing and approving novel therapies, foods and medical devices, and ensuring the safety and public confidence in those products. BIO worked for the recent reauthorization of the Prescription Drug User Fee Act, which provides the FDA with the enhanced capacity for drug evaluation with greater transparency and consistency and an active post-market surveillance system to better determine the benefits and risks of drugs and biologics. BIO also advocates for significantly increased funding for the FDA.

  • Agricultural Biotechnology: Since their commercialization over a decade ago, biotech crops have provided numerous benefits to U.S. farmers, such as increased yield, improved quality, and a reduction in pesticide applications. BIO works to ensure that laws and regulations governing plant and animal biotechnology and food safety issues reflect sound science.

  • Biofuels Research and Development: Rapid commercialization of cellulosic biofuels will require simultaneous investment in the construction of large scale biorefineries with ongoing research and development in cellulase enzymes and other biorefinery processes. BIO advocates for increased federal funding of biofuels research, as well as tax credits and other incentives for production of cellulosic ethanol and other alternative fuels.

 

 
These are a few of the many issues in which BIO is involved in ongoing advocacy. We also work closely with our affiliated state biotechnology associations to engage state and local policymakers who also make important decisions affecting our industry.
 
BIO and all of our members believe that biotechnology will help transform life in the 21st century for the better. Even in what are still the early days of the biotechnology revolution, we are saving and extending lives and improving the quality of life for millions of people. I encourage you to learn more about BIO and the biotechnology industry at www.bio.org and by joining us at the 2008 BIO International Convention in San Diego.

 

 

 

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