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BIO began 2005 with the organization's first change in leadership since its founding in 1993. Former Pennsylvania Congressman Jim Greenwood is BIO's new president, taking the reins from Carl B. Feldbaum, who retired.Greenwood brings to the organization more than two decades of experience as a state and federal legislator. In 12 years as U.S. congressman, he championed healthcare issues, and as chairman of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigation he led investigations into cloning, bioterrorism and the corporate accounting scandals of 2002.Greenwood's priorities for BIO include leadership on drug safety issues, supporting stem cell research and state-level funding for all biotechnology platforms, tax reform, and support for agricultural and industrial applications.BIO's BeginningsIn 1993, when there were but a handful of biotechnology drugs on the market and the sequencing of the human genome was pegged for completion somewhere around 2005, two small Washington-based biotechnology trade organizations merged to create the Biotechnology Industry Organization, better known as BIO. One of the founding organizations, the Industrial Biotechnology Association (IBA), primarily represented larger, established companies on Capitol Hill and before federal regulatory agencies; the other, the Association of Biotechnology Companies (ABC), represented emerging companies and universities, and focused on technology transfer issues, meetings and other business development activities.BIO united the organizations' 503 companies and 18 employees under one umbrella with a representative governing board that reserved one-third of its seats for emerging companies. The goal was to achieve a workable balance of power within the organization between the handful of large multibillion-dollar firms that launched the first wave of biotechnology products and the hundreds of startup and mid-size firms that were at the research and development stage.After conducting a multi-round search to find a leader for the nascent organization, the board hired Washington veteran Carl Feldbaum, whose background included founding a defense policy think tank called Palomar Corp. and serving as assistant Watergate special prosecutor, Defense Department inspector general and chief of staff for Sen. Arlen Specter.BIO's first order of business was to integrate the staffs and missions of the IBA and ABC, no small task given the associations' previous rivalry and their different areas of expertise. But soon everyone was on the same page - one with a BIO letterhead - and pursuing the same three-pronged mission, which has remained consistent over the years:* Advocate the industry's positions to elected officials and regulators. * Inform national and international media about the industry's progress, contributions to quality of life, goals and positions. * Provide business development services to member companies, such as investor and partnering meetings.BIO Grows with the IndustryBIO today performs many services for members, but none of them is more visible than the organization's annual convention and exhibition, the largest biotechnology event in the world. The event dates back to 1987, when the Association of Biotechnology Companies hosted an international conference in Washington, D.C., that exceeded expectations by attracting 155 attendees - the goal had been 100. Some of the session topics would become perennial themes: raising capital in the venture and public markets; FDA, USDA and EPA regulation; and patenting trends.Since then, growth has been steady - attendance hit 1,400 in 1993, the year BIO was formed, and 17,000 in 2004, with representatives from 61 nations. Press coverage has exploded as well, from a smattering of trade press reporters in the early years - even as recently as 1997, the conference drew only 61 press registrants - to 540 media registrations in 2004.Growth of the meeting, and of the organization, has paralleled that of the young, dynamic industry BIO represents. The number of approved biotechnology drug and vaccine products in the United States has soared from 22 in 1993 to 212 as of Dec. 31, 2004, while investment in the industry skyrocketed, from $3 billion in 1993 to $20.9 billion in 2004 (including a record $4.9 billion for venture-stage companies). Membership in BIO has more than doubled since the organization's founding, to 1,131 companies, academic institutions and biotechnology centers as of Dec. 31, 2004.Core issuesLocated just minutes from the Capitol and the White House, BIO's mission from its inception has centered on advocacy. In 1993, amid the clamor of a new presidency and the first party changeover in the White House in 12 years, BIO identified four major lobbying priorities:* Responding to the imminent threat of government price controls on breakthrough drugs, a threat that sent stock prices tumbling 40 percent after the election of President Clinton. * Shaping political and public reaction to the genetically modified foods that were poised to enter supermarkets. * Advocating for tax incentives that better reflected the risk and social benefit of biotech investments. * Working with Congress and the FDA to streamline the regulatory process.BIO has successfully prosecuted that agenda over the last 12 years:* Price control initiatives were beaten back repeatedly at the federal level. * The Medicare Modernization Act of 2003 largely incorporated BIO's principles for establishing coverage of outpatient drugs. The legislation also included a partial reversal of reimbursement cuts to biotech drugs used in hospital outpatient settings. * A host of genetically modified agricultural products traversed the regulatory gauntlet, including improved varieties of corn, soybeans and cotton. Biotech-enhanced crops were planted on 200 million acres worldwide in 2004. In the United States, biotech varieties accounted for 85 percent of soybeans planted (63.5 million acres), 76 percent of cotton (10.4 million acres) and 45 percent of corn (36.4 million acres). * A variety of tax incentives were enacted at the state and federal level to encourage biotech investment. * The Food and Drug Administration Modernization Act of 1997 (FDAMA) was passed, along with reauthorization of the Prescription Drug User Fee Act. In 2002, PDUFA was again renewed, with a number of BIO-supported provisions, such as the option of using of third-party expert consultants to develop Phase III trial protocols.Bioethics Comes to the ForeBioethics issues were not on the 1993 list of priorities, but have become an increasingly prominent part of BIO's agenda over the years. As early as mid-1993, BIO hosted a discussion on bioethics, focusing on genetic discrimination and gene therapy (the first clinical trials in this field had begun in 1991). BIO created a standing committee for bioethics in 1995.Bioethics concerns would gather more momentum after the unveiling of a cloned sheep named Dolly in 1997. BIO quickly responded with a statement urging a ban on human reproductive cloning and supported that position with appearances on newscasts and interviews with leading media outlets. The organization's rapid and thoughtful response to that signal event won a communications award and helped place BIO at the nexus of political and ethical controversies surrounding the industry's powerful technologies. Other cloning successes followed, and in 1998 another milestone was reached with the first-ever isolation of human embryonic stem cells, creating another bioethics debate.Responding to the controversies that have arisen on the heels cutting-edge breakthroughs, BIO addresses bioethics issues at every level of government. The organization has hired a bioethics counsel, testified before Congress, educated legislators and their staffs on the issues, written letters and op-ed pieces, and responded to thousands of media inquiries. BIO thus became the "voice" to the public for hundreds of biotech companies, large and small.Timeline1993* The Biotechnology Industry Organization (BIO) opens for business, created through the merger of the Industrial Biotechnology Association and the Association of Biotechnology Companies. * President Bill Clinton takes office, with health-care reform, including consideration of price controls, high on his agenda. BIO Chairman Kirk Raab speaks at the White House Health Care Reform Task Force's drug price control working group, and other company CEOs and BIO staff ("SWAT teams") meet throughout the year with health-care reformers in the Clinton administration, including the president himself, blasting them with the message that price controls would hurt the industry. Proposals under consideration include a Breakthrough Drugs Committee that would have the power to publicly reprimand companies whose prices are deemed excessive, and potentially to deny such companies the R&D tax credit, Medicare/Medicaid reimbursement, or full patent terms. With price controls on the table, stock prices for biotech companies plunge 40 percent. * Bovine somatotropin - bovine growth hormone - is approved and legislation is introduced to mandate labeling. BIO testifies against these proposals. There is scattered opposition to such products, but the FDA and other regulatory agencies stand by their scientific approach to regulating such products. * FDA declares that genetically engineered foods are not "inherently dangerous" and do not require special regulation. * Congress passes legislation that provides a 50 percent capital gains exemption on investments held at least five years in companies valued at $50 million or less. The measure is a welcome step toward a tax code that better reflects the risk of biotech investment, but the capitalization requirements are deemed too low. * New biotech products approved for commercial use include the first major breakthrough drug (recombinant interferon beta 1-b) for multiple sclerosis that can slow the course of the disease.1994* The threat of drug price controls in the Clinton health-care plan spooks investors and dampens biotech stock prices through most of the year. BIO leaders pull out every stop - visits to Capitol Hill, calls, letters, discussions with administration health-care reformers and reporters and editors covering the issue, testimony at hearings, op-eds - to apprise the nation's political leadership of the devastation price controls would wreak on innovation. Arid capital markets for biotech during this period of uncertainty illustrate the point vividly. BIO's efforts pay off, however, and by late 1994 price control measures are abandoned and a Republican-majority Congress is elected. * Preoccupied with partisan firefights over the federal budget and the broader Clinton agenda, Congress allows the orphan drug research tax credit to lapse at the end of 1994. * The General Agreement on Trade and Tariffs (GATT) is approved, changing the length of time patented products enjoy marketing exclusivity in the United States. In the past, the exclusivity period was 17 years from the date of issuance; under GATT, it is 20 years from the date of filing. The net result is a loss of patent term for most biotech patents due to their complexity. * The FDA gives its first approval of a whole food product developed through biotechnology, a tomato engineered for longer shelf life.1995* With the Clinton health-care reform package deep-sixed and an anti-regulation Republican majority in Congress, BIO turns its attention squarely on FDA reform, an effort that will culminate in the 1997 passage of the FDA Modernization Act (FDAMA). Many Washington, D.C.-based policy groups join BIO in the call for reform. BIO Chairman and Genzyme CEO Henri Termeer leads the effort alongside Gordon Binder, CEO of Amgen and head of BIO's FDA Reform Task Force. By November, BIO has worked with Vice President Al Gore (through his Reinventing Government program) and leaders at the FDA to eliminate two regulatory hurdles: the establishment licensing application, which required firms to obtain approval of drug manufacturing facilities separate from the product candidate itself; and lot-lease approvals, a process of continuous review of each production lot of a drug following approval. BIO seeks to codify these administrative changes and to expand the scope of FDA reform. * President Clinton establishes the National Bioethics Advisory Commission in an executive order that also calls for a review of policies and procedures surrounding human subjects research, the use of genetic information, and gene patenting. BIO is granted a nomination and selects Steven Holtzman, chief business officer at Millennium Pharmaceuticals. * The U.S. Patent Office agrees to allow applicants to meet utility requirements by submitting scientific evidence from preclinical research rather than clinical trials. Also, a new law is passed that eases the requirements for process patents covering manufacturing and allows enforcement of such patents against imported products. * The first full gene sequence of a living organism other than a virus is completed, for Haemophilus influenzae.1996* Congress reauthorizes for one year the Orphan Drug Tax Credit after an 18-month lapse and permits companies to carry forward and carry back the credit, which covers 50 percent of the cost of clinical trials for orphan drugs. The carry-forward provision allows companies not yet profitable - and hence owing no taxes - to use the credit when they become profitable. * BIO lends its support to passage of the Health Insurance Portability and Accountability Act, which prohibits insurance companies from denying coverage based on preexisting conditions when people change insurers through job changes. The original bill treats genetic information separately from other types of medical information, but BIO urges lawmakers to apply "the same standards of confidentiality and nondiscrimination for all personal medical information, whether it is gathered using genetic tests or any other diagnostic process." In the end, the bill includes genetic information in the definition of medical information. * Genetic privacy is also a hot issue on the Hill and at the president's National Bioethics Advisory Commission, which meets for the first time. BIO calls for federal standards to protect all medical information, including genetic data. * A flurry of bills are proposed to reform the FDA, including one that would turn drug applications over to private reviewers if the agency failed to render a decision after six months. In the turbulent atmosphere of a presidential election year, even the idea of privatizing the FDA is floated (a move BIO does not support). The disparate efforts keep the issue front and center but in the end do not result in legislation. Meanwhile, negotiations begin in earnest for renewal of the Prescription Drug User Fee Act, set to expire in 1997. The negotiations are complicated by the resignation of FDA Commissioner David Kessler, who opts to return to private life after six years at the agency. It will be more than a year before Jane Henney is named as the new commissioner.1997* Dolly, the first-ever mammalian cloning achieved via somatic-cell nuclear transfer, is born in late February, dramatically raising awareness - and scrutiny - of the industry. BIO immediately issues a statement opposing application of the technology to reproductive cloning of human beings. The Public Relations Society of America later gives BIO an award for excellence in crisis management. * Congress and state legislatures respond to Dolly with hearings on human cloning and bills to ban the technology; some measures would ban all applications of human cloning, pulling legitimate research into the dragnet, while others target reproductive cloning. President Clinton proposes a reproductive cloning ban with civil penalties based on NBAC recommendations. Congress adjourns without taking any action. * The Orphan Drug Tax Credit is made permanent. In addition, a new federal law is passed that allows early-stage investors in entrepreneurial businesses, including biotechnology companies, to exclude from capital gains taxation 50 percent of the gains from such investments, if held for five years. (Today, BIO is seeking a 100 percent exclusion from capital gains taxes for early biotech investors.) * The FDA Modernization Act (FDAMA) is signed into law, codifying administrative changes begun in 1995 and introducing new reforms. The law marks the most substantial reform of the agency in three decades. Provisions include the following: o Criteria for fast-track drug development. o Drug approvals allowed based on one pivotal trial. o Codification of FDA reforms implemented under Vice President Al Gore's Reinventing Government initiative. o Easier patient access to experimental drugs and medical devices, and an accessible database of clinical trials. o An end to the prohibition on manufacturer dissemination of peer- reviewed journal articles describing trials of off-label uses. o FDAMA includes a reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA), which allowed the FDA to cut the average time for a drug review in half over five years by charging companies fees in exchange for guaranteed review periods.* Rituxan (rituximab) becomes the first monoclonal antibody to win FDA approval for cancer treatment. * The first herbicide- and insect-resistant crops are introduced. * BIO membership passes the 700 mark.1998* A Chicago scientist named Richard Seed announces plans in January to clone a human being. BIO responds with a statement reiterating its position that such a procedure is unsafe and raises ethical questions that have yet to be addressed. When Congress reconvenes, House and Senate majority leaders say cloning tops their agenda. The Senate considers, and rejects, legislation that would ban human cloning, including therapeutic applications of the technology. BIO is joined in its opposition by 27 Nobel Prize winners and a multitude of scientific research and patient advocacy groups. No legislation passes at the federal level. * BIO, along with nearly 200 patient and voluntary health groups, calls for the doubling of the $13.6 billion NIH budget in five years. Congress is receptive, and as of 2001 the NIH budget stands at $20.3 billion and is on track to meet the doubling goal by 2003. * Researchers at the University of Wisconsin isolate human embryonic stem cells. In a BIO statement, Feldbaum praises the work, but notes that "these research achievements raise bioethical questions that require thorough and open national discussion … These are issues that, in some instances, involve sincerely held social and religious beliefs and perspectives." BIO calls on NBAC to review the ethical issues and make recommendations to President Clinton based on that review. * Mark Skaletsky is named BIO chairman, marking the first time the organization has been led by an executive at a small or mid-sized biotech firm. BIO's previous chairs were CEOs of the largest companies in the industry - Genentech, Genzyme and Amgen. * The first sequencing of a complete animal genome, the C. elegans worm, is achieved. * Biotech drug approvals include the first new drug for narcolepsy in 40 years and a breakthrough drug for rheumatoid arthritis (recombinant tumor necrosis factor receptor) that can slow the progression of the disease. * BIO membership passes the 800 mark.1999* BIO hosts its first CEO and Investor Conference in New York. Fifty-four CEOs make business presentations to an audience of 800 analysts, investors and other industry observers. The successful conference becomes part of BIO's annual lineup of events. * A letter published in Nature about the effects of a diet of pure Bt corn (corn genetically modified to express a pesticidal protein) on monarch butterflies sparks a media frenzy and heightened regulatory and public scrutiny of genetically modified crops in the United States and elsewhere. Later in the year, preliminary field studies fail to document the effect under real-world conditions. * The National Center for Food and Agricultural Policy releases the first-ever analysis of biotechnology's impact on crop protection and benefits to the environment, finding significant increases in crop yield, reductions in farming inputs such as pesticides, and a shift to farming practices promoting integrated pest management and conservation tillage. * Price control worries are revived as President Clinton and Congress explore various proposals to provide Medicare coverage of outpatient prescription drugs. In a Rose Garden speech, Clinton calls for voluntary coverage under which Medicare would pay half the cost of prescription drugs up to $5,000. BIO calls many aspects of the plan "laudable," particularly its stated intent to use free-market mechanisms, but laments the absence of stop-loss coverage for seniors with the highest prescription drug costs. BIO's board of directors adopts six principles that a plan must include to win the organization's support: o Reliance on private markets and competition with no price controls. o Stop-loss protection and protection of those most in need first. o Expansion of beneficiary choices among private plans. o Incentives for improved patient care through biotechnology innovations. o Continuing Medicare solvency. o Do no harm to current coverage and reimbursement.* In the late spring of 1999, Wall Street indifference to biotechnology morphs into exuberance as genomics catches the imagination of investors amid a hot race between public and private entities to complete the sequencing of the human genome. The Nasdaq Biotech Index doubles over the course of the year, and investment in new offerings soars in the fourth quarter. * The Recombinant DNA Advisory Committee at the NIH examines the gene therapy clinical trials program at the University of Pennsylvania following the death of 18-year-old patient Jesse Gelsinger in a trial of a therapy for a rare metabolic disorder.2000* A skyrocketing market for biotech stocks falls to earth when mid-March comments by President Clinton and British Prime Minister Tony Blair are widely misinterpreted as advocating restrictions on gene patents (the comments concerned keeping the human genome sequence in the public domain, a different matter). Nonetheless, the year generates a record $38 billion in new biotechnology investment, including 90 completed IPOs, also a record. * In June, the Human Genome Project and Celera Genomics jointly announce the completion of a rough-draft sequence of the human genome. * A new law is passed that increases the annual limit on H-1B work visas for skilled professionals to 195,000 over three years and exempts from the cap university and related research faculty employees. Some 15,000 biotechnology employees (almost 10 percent of the industry's workforce) have H-1B visas. * BIO launches its first TV campaign with "Biotechnology, a big word that means hope." * BIO publishes a white paper called Biotechnology's Impact on Diseases of the Elderly. The study highlights biotechnology medications in development or on the market to treat eight of the most common diseases and disabilities associated with aging: coronary heart disease, stroke, cancer, Alzheimer's and Parkinson's diseases, chronic renal failure, diabetes mellitus and osteoporosis. The study notes that, in addition to improving quality of life, some of 20 marketed drugs targeting these diseases save money by reducing hospitalizations, doctor visits and outpatient procedures. * BIO publishes a report called Economic Contributions of the Biotechnology Industry to the U.S. Economy. The report finds that in 1999 the biotech industry generated 437,000 jobs and $11 billion in research and development spending. * The BIO Editors' and Reporters' Guide wins an American Society of Association Executives Award for Excellence. * BIO membership tops 900; all 50 states are now represented. * Prescription drug coverage under Medicare becomes a hot issue in the presidential campaign, with both candidates disseminating plans. In letters and statements, BIO urges the candidates to tell the voters "not only how their plans will help seniors gain access to prescription drugs, but also how those plans will encourage innovative drug development to improve the health and quality of life of seniors." * The Environmental Protection Agency reaffirms that a review of all available scientific information indicates that monarch butterflies are at very little risk from Bt corn products. The EPA finds that widespread cultivation of Bt crops benefits the environment. * Food producers begin a massive recall of corn products when taco shells are found to contain traces of StarLink corn, a genetically engineered corn variety approved for animal feeds but not for human consumption. Regulatory agencies subsequently end the practice of so-called "split approvals." * In August, NIH releases funding guidelines for human embryonic stem cell research. Guidelines allow funding for work performed with the cells, but not for the derivation of the cells. No grants are ever provided under the guidelines, which are put on hold when President Bush takes office. * A BIO survey finds that 270 million patients have been helped by biotechnology since the industry's inception. * BIO testifies at a public hearing on reauthorization of the Prescription Drug User Fee Act, which runs through 2002. The three concerns expressed are the need for a more predictable review process that includes better communications and more timely interaction with FDA reviewers; FDA's unwillingness to agree to protocol specifications in writing; and slow, "indeed glacial," implementation of FDAMA provisions designed to guide companies in the dissemination of information about cost effectiveness and off-label uses of drugs. * The first sequencing of a complete plant genome, Arabidopsis thaliana, is achieved.2001* NIH stem cell funding guidelines are put on hold for reevaluation when President Bush takes office. After months of rancorous debate and escalating media coverage, Bush addresses the country on prime time television Aug. 10. His decision: to fund research on stem cell lines already established, which he says number 60. BIO supports the decision, but takes issue with the limitation on stem cell lines, as do many scientists and patient groups. * Moves to reform the clinical trial process kick into high gear, with NBAC issuing new recommendations and the Senate conducting hearings. Among other things, the NBAC proposal calls for legislation that would make all clinical trials subject to the same oversight as those that receive federal funding. Clinical trial rules would also be made more consistent across state lines, a move BIO endorses. BIO has harsh words, however, for an FDA proposal that would require disclosure of investigational new drug applications for gene therapy and xenotransplantation trials, calling the concept "fatally defective." BIO files comments arguing that it would be unfair to single out these two therapeutic approaches in a reversal of longstanding FDA policy against disclosing trade secrets about medical products during their development. * President Bush creates a new council on bioethics, to be headed by University of Chicago professor Leon Kass. * The House of Representatives passes a bill that would ban all applications of human somatic cell nuclear transfer (cloning), including therapeutic applications. BIO opposes the measure, arguing a ban should be limited to reproductive cloning. Debate dovetails with the controversy over stem cell research and is further inflamed when offshore scientists tell a National Academies of Sciences panel they can and will conduct reproductive cloning experiments. * BIO membership passes the 1,000 mark. * The human genome sequence is published in Science and Nature. * Rice becomes the first crop genome to be completely sequenced.2002* In June, Congress renews PDUFA, which increases FDA resources for drug and biologics reviews and incorporates BIO recommendations designed to improve first-cycle product reviews and engage third-party expert advisors on cutting-edge scientific issues. * In the late summer and fall, the FDA moves to revise good manufacturing practices and consolidate reviews of pharmaceuticals, including therapeutic biologics, at the Center for Drug Evaluation and Research. BIO works with the FDA in effecting the therapeutic biologics move in a manner least disruptive to drug development and review. * BIO succeeds in persuading the Health and Human Services Department to modify medical records rules that would have inhibited research. The new rules allow for use of de-identified information in medical research. * BIO launches a global health initiative, aimed at forging new partnerships to apply biotechnology to diseases of the developing world. The Partnering for Global Health Forum in December attracts almost 400 representatives of the industry, government and international agencies, nongovernmental organizations and the financial community. * The Farm Security and Rural Investment Act of 2002 includes pro-biotech measures such as significantly increased funding for research and risk assessment, and new programs for promoting biotechnology in developing countries. * In late November, the Securities and Exchange Commission proposes a rule recommended by BIO that would allow biotechnology companies greater investment flexibility. * BIO wages an aggressive and successful campaign to defeat the Greater Access to Affordable Pharmaceuticals Act (S. 812), which would have significantly weakened patent protections for biopharmaceutical companies. * BIO and its allies among patient and scientific groups prevent Congress from adopting a total ban on cloning, including therapeutic applications. BIO supports a more limited ban on reproductive applications of the technology. * BIO and its members develop policies for the safe development of plant-made pharmaceuticals as media coverage of this new technology heats up.2003* The Medicare Modernization Act of 2003 is signed into law. The law incorporates BIO's Medicare principles for expanded drug coverage including reliance on the private marketplace and stop-loss protection for patients facing catastrophic costs. The law also partially reversed deep cuts in reimbursement for biotech drugs used in hospital outpatient centers, a top BIO priority. * BIO 2003 convention speakers include President Bush, FDA Commissioner Mark McClellan and Secretary of Homeland Security Tom Ridge. * BIO files a citizen petition with the FDA to urge the agency to include the public in any efforts to create a pathway for approval of follow-on biologics. * Drug importation becomes a hot issue as state and local governments explore important drugs from Canada to cut costs. BIO opposes such measures. * President Bush proposes the $5.6 billion BioShield bill to overcome some of the barriers to development of biomedical protections against radiation, biological and chemical warfare. BIO supports the bill but lobbies for better liability protections. * The U.S. government files a case before the World Trade Organization, seeking an end to Europe's five-year moratorium on biotech crop approvals. * FDA releases a draft preliminary risk assessment finding no health or safety issues with food products from cloned animals or their progeny, but stops short of giving the okay to market such products. BIO hires a director of animal biotechnology to handle issues involving transgenic and cloned animals. * BIO launches a series of industrial biotechnology conferences, co-hosting with the American Chemical Society the CTO Summit to bring together biotechnology executives and chief technical officers from the world's top 50 chemical companies. * BIO launches a new television commercial titled "Biotechnology: A New Link to Hope." The spot, which features biotech researchers, airs during news and public-affairs shows in the Washington, D.C., area. * BIO's advocacy for tax reform leads to introduction of the Biotechnology Future Investment Act (H.R. 2968 and S. 1773). The bill fails to pass in the 108th Congress but is expected to reintroduced. * The U.S. Department of Commerce completes its first comprehensive survey of the biotechnology industry.2004* U.S. Rep. James Greenwood of Pennsylvania is named BIO's new president after Carl Feldbaum announces his retirement. Greenwood finishes his term in Congress, then joins BIO on Jan. 4, 2005. * The withdrawal of the pain reliever Vioxx and data linking common antidepressants to heightened suicide risk in children make improving drug safety a top priority in Washington. BIO creates a task force to develop principles for clinical trial disclosures. * In an effort to reverse a decline in approvals of new drugs, the FDA launches the Critical Path initiative, an effort to work with academia and industry to create a new suite of tools that bring cutting-edge science and technology to drug development. BIO files comments expressing support and providing suggestions, but also urges the agency to keep as a high priority timely reviews of new products. * BIO participates in a workshop on scientific issues surrounding follow-on biologics. BIO's position is that biologics should be approved only with a full complement of data, including clinical trials. * The BioShield Act becomes law, authorizing $5.6 billion over 10 years to support biodefense products. BIO supports the measure but urges a follow-up BioShield II bill to address liability and other concerns. * The Centers for Medicare and Medicaid Services develops voluminous regulations to implement drug coverage under the Medicare Modernization Act. BIO's comments seek to ensure maximum access to biotech medicines. * California voters pass a $3 billion, 10-year stem cell research initiative and other states consider following suit. * BIO hosts the first-ever BIO Emerging Company Investor Forum to provide an annual West Coast showcase for small to mid-size biotechnology companies. * Congress passes the BIO-supported CREATE Act of 2004, permitting patents on inventions jointly researched by public institutions and private entrepreneurs. * BIO opposes two-year patent-fee increases included in the Consolidated Appropriations Act of 2005 (H.R. 4818). BIO urges an end to the practice of diverting patent fees to fund other government agencies. * The Financial Accounting Standards Board moves to require public companies to expense stock options by June 15, 2005. BIO opposes the measure and urges the Securities and Exchange Commission to delay implementation.Attendance at BIO annual meeting, 1993 – 2003 Year City Total Reg. Press BIO 1993 Raleigh/RTP 1,400 n/a BIO 1994 Toronto 2,125 n/a BIO 1995 San Francisco 2,675 n/a BIO 1996 Philadelphia 3,071 70 BIO 1997 Houston 3,193 61 BIO 1998 New York 4,715 246 BIO 1999 Seattle 5,730 144 BIO 2000 Boston 10,292 452 BIO 2001 San Diego 13,740 631 BIO 2002 Toronto 15,673 388 BIO 2003 Washington, DC 16,322 534 BIO 2004 San Francisco, CA 16,901 506AwardsBiotechnology Heritage Awards Year Winner(s) 1999 George Rathmann (founder of Amgen) 2000 Robert Swanson (posthumous) and Herbert Boyer (Genentech co-founders) 2001 J. Craig Venter and Francis X. Collins (human genome sequencing pioneers) 2002 Drs. Walter Gilbert and Phillip Sharp (Nobel Laureates and Biogen Idec co-founders). 2003 William Rutter (Chiron founder) 2004 Leroy Hood (DNA sequencing pioneer and Institute for Systems Biology co-founder)Biotechnology Helix Awards Year Winner 1998 Biogen Idec 1999 Immunex 2000 Genentech 2001 OSI Pharmaceuticals 2002 CV Therapeutics and Isis Pharmaceuticals 2003 Gilead Sciences, Trimeris, and Serono 2004 Genentech, Onyx Pharmaceuticals, and Actelion Ltd