BIO 2003

The Biotechnology Industry Organization (BIO) is the international trade organization that represents more than 1000 biotechnology companies (start-ups, major players, and Fortune 500 firms), academic institutions, nonprofit organizations, biotechnology centers, and related organizations in all 50 US states and 33 other nations. BIO members are in the vanguard of genomics, proteomics, and informatics, as well as working in the mainstream in pharmaceuticals, food and agriculture, industrial and environmental biotech, and other fields. The common thread is the search for innovative solutions using the new tools of the life sciences.

The annual BIO meeting is the largest and most prestigious biotechnology event in the world, drawing together more than 16,000 scientists, clinicians, business professionals, policy makers, and politicians from 57 countries. The majority of delegates this year were from within the United States (approximately 12,000 delegates), but there also was strong representation from the European nations (2300 delegates), followed by nearly 900 delegates from Asia. A total of 9 US governors were in attendance (from Delaware, Iowa, Kentucky, Maryland, Massachusetts, Missouri, Pennsylvania, Virginia, and Wisconsin). Foreign dignitaries included the following:

? Lord Sainsbury of Turville, minister for science and innovation (UK)

? The Honourable Allan Rock, minister of industry (Canada)

? His Excellency Jean-David Levitte, ambassador extraordinary and plenipotentiary (France)

? The Honourable Pete Hodgson, minister of research, science, and technology (New Zealand)

? Georg-Wilhelm Adamowitsch, administrative state secretary, Federal Ministry of Economics and Labour (Germany)

? His Excellency Suwit Khunkitti, deputy prime minister, Kingdom of Thailand

? His Excellency Dr. Isaac C. Lamba, ambassador and permanent representative of the Malawi mission to the United Nations

? The Honourable Girolamo Sirchia, minister of health, Italy

BIO 2003 is a platform for learning about the biotechnology industry, launching new ventures, achieving visibility, and establishing key contacts for all types of collaborations. I had the privilege of attending this year?s event, held at the newly opened Washington Convention Center, Washington, DC, June 22-25. Support was generously provided by Pharmacy Times, the Canadian Pharmacists Association, and the University of Ottawa, Ottawa, Canada.

BIO hosted a fantastic lineup of highprofile plenary-session speakers, including George W. Bush (president of the United States); Mark B. McClellan, MD, PhD (commissioner, FDA, USA); Carl B. Feldbaum (president, BIO, USA); and Tom Ridge (secretary, Department of Homeland Security, USA).

President Bush recognized the importance and value of the biotechnology industry in health care and in the fight against infectious diseases and global hunger. Under Project Bioshield, Bush has proposed government spending of nearly $6 billion over the next 10 years to speed the research, production, and availability of effective vaccines and treatments against smallpox, anthrax, botulin toxin, Ebola virus, and other possible agents of bioterror. Bush also urged a reform of the current Medicare system, a new prescription drug benefit plan for seniors, and tort reform, as initiated with the passage of a medical liability reform bill and a class action reform bill out of the House of Representatives.

These same themes were reiterated by Dr. McClellan, who also spoke about the new FDA strategic initiative to improve the efficiency of regulatory activities. Elements of this initiative include the development of ?quality systems? for review procedures, new guidance documents for specific therapeutic areas and technology development, consolidation of review responsibilities for certain therapeutic biologics into the drug center, performance commitments in review times, and postmarket monitoring. The commissioner emphasized the need for a more efficient and effective adverse-drug-reaction reporting system in order to better manage the risks associated with a drug and to improve the quality of care. The implementation of an electronically based monitoring system that links the regulatory agency with patient medical records in real time, or near real time, was 1 goal highlighted in Dr. McClellan?s speech.

In addition to the plenary sessions, there was a choice of 25 tracks of programming that provided extensive coverage of a wide range of issues pertaining pertaining to the modern biotechnology industry. Lectures, presentations, and roundtable sessions focused on both scientific and business topics, including drug discovery and development, regulatory affairs, ethics, global health, patient advocacy, finance, business development, and technology transfer.

The topic of pharmacogenomics? the promise of personalized medicine and knowing the right medicine for the right person based on that person?s genetic makeup?was commonly discussed in the various sessions. Often touted as a revolutionary advance or paradigm shift in drug discovery and development just 5 years ago, pharmacogenetics is now recognized as just 1 more step down the path of medical progress. At Roche Genetics, no more than 5% of the total research and development (R&D) expenditure is dedicated to pharmacogenetics. Although pharmacogenetics remains a powerful tool in drug development and medical practice, how the FDA manages this new information is still a work in progress.

The break-out sessions and symposia were complemented by a huge trade show encompassing 345,000 square feet of exhibit space, with more than 1200 exhibitors from all parts of industry, government, and academia, including the large pharmaceutical companies. There were 19 state pavilions and 19 international pavilions?a reflection of the world recognition that biotechnology is receiving as the most important economic opportunity in the knowledge sector. According to Ernst & Young?s Global Biotechnology Report 2003, global biotechnology revenues sit at $41.4 billion, investments in R&D constitute $22 billion, and the industry employs approximately 194,000 employees. The United States continues to dominate biotech, accounting for 70% of revenues and more than 70% of R&D spending. The biotechnology industry has brought approximately 150 new medical products into the marketplace, with almost 1000 more in the pipeline. Pharmacists definitely need to watch this young, growing, and dynamic industry.