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Partner to a Dynamic Industry Coming of Age
In 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 Washington, D.C.-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 member 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 start-up and midsize firms that were at the research and development stage.
The board conducted a multi-round search to find a leader for the nascent organization and hired Washington veteran Carl B. Feldbaum as president, a position he continues to hold. An attorney and executive with an undergraduate degree in biology, Feldbaum brought a combination of science policy experience and political savvy, having founded a defense policy think tank called Palomar Corp. and having served as assistant Watergate special prosecutor and as chief of staff for Sen. Arlen Specter (R-Pa.).
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 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 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, the convention's growth has been steady. Attendance hit 1,400 in 1993, the year BIO was formed, and continued to climb each year, reaching 15,600 in 2002, with representatives from 52 nations (up from six in the late 1980s). 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 a record 631 journalists in 2001.
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 grown sixfold since 1993, to 155 as of December 31, 2002; investment in the industry has skyrocketed, from $3 billion in 1993 to $10.5 billion in 2002. Membership in BIO has more than doubled since the organization's founding, to more than 1,100 companies, academic institutions and biotechnology centers.
Core Issues
Located just minutes from the Capitol and the White House, BIO has focused from its inception on advocacy. In 1993, amid the clamor of a new presidency and the first party changeover in the White House in 12 years, Feldbaum and the board identified four major lobbying priorities:
- Responding to the imminent threat of government price controls on breakthrough drugs, a threat that sent biotech stock prices down 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 successfully prosecuted that agenda during its first decade:
- Price control initiatives were beaten back repeatedly at the federal level.
- A host of biotechnology-improved agricultural products traversed the regulatory gauntlet, including new varieties of corn, potatoes, tomatoes and cotton.
- A variety of tax incentives were enacted at the state and federal levels to encourage biotech investment.
- In perhaps BIO's most celebrated achievement, the Food and Drug Administration Modernization Act of 1997 was passed, along with reauthorization of the Prescription Drug User Fee Act in 1997 and 2002.
Bioethics issues were not on the original 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 recently begun). At that time, Feldbaum pitched to the board the idea of a standing BIO committee for bioethics, an idea that would come to fruition in 1995.
Bioethics concerns would gather momentum after the 1997 birth of a cloned sheep named Dolly. BIO quickly responded with a statement urging a ban on human reproductive cloning-but not on therapeutic applications of the technology-and supported that stance with appearances on newscasts and interviews with leading media outlets worldwide. The organization's rapid and thoughtful response to that watershed event won many communications awards 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, sparking a new bioethics debate.
Responding to the controversies that have arisen on the heels of biotech breakthroughs, BIO addresses bioethics issues at every level of government. The organization has added 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.
As a result of all these activities-lobbying, cultivating biotechnology's image, supporting scientific freedom, assisting companies with business development-BIO has emerged as the voice to the public for hundreds of biotech companies, large and small.
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