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Henri A. Termeer Genzyme, 1995-1997
In 1983, the year the Orphan Drug Act became law, pharmaceutical veteran Henri Termeer was appointed president of a fledgling Cambridge, Mass.-based venture called Genzyme. The company would ultimately become well known as one of the early orphan drug success stories, thanks to its development of two related drugs: Ceredase, a naturally derived enzyme replacement therapy for Gaucher disease, and a follow-on recombinantly produced version of the enzyme, Cerezyme. Today, Genzyme is developing enzyme-based orphan drugs for Mucopolysaccharidosis-1, Fabry disease, Pompe disease, and type B Niemann-Pick disorder.
As Ceredase/Cerezyme progressed through clinical trials, Termeer advanced to CEO in 1985 and chairman in 1988. Under his leadership, Genzyme has grown into one of the world's top five biotechnology companies, encompassing businesses that develop and market therapeutics, biosurgical products and genetic testing services.
In the early 1990s, Termeer helped bring about BIO's creation through the 1993 merger of the Industrial Biotechnology Association (IBA), on whose board he sat, and the Association of Biotechnology Companies (ABC).
The impetus for BIO was clear, said Termeer: The industry's needs had evolved since the creation of the IBA and ABC in the 1980s, when it made sense for the larger companies to belong to one organization (IBA), and the smaller start-ups and their business development support network to another (ABC).
With the election of Bill Clinton in 1992 and talk of sweeping health-care and FDA reform in the air, "it was becoming increasingly important to speak with one voice with regard to biotechnology. We were still in a very, very early educational phase, and a set of competing voices was not conducive to doing what we needed to do," Termeer said.
The decision was right for the times. "In the next 10 years, BIO flowered and expanded rapidly, with the messages becoming more complex," said Termeer. "Our industry's enormous expansion culminated with the 2000 BIO international conference in Boston. The moment was enormous."
Fast Growth, Fresh Challenges
But with prolific growth come new challenges associated with representing such a disparate group of companies, said Termeer, and so BIO created issue teams of CEOs to handle regulatory affairs and other issues. "That was helpful,"he said. During a period of rapid growth, it was important to get people together in a more focused way."
Such measures may not be enough, however, over the long run, Termeer said. "Now the organization is so large that we face another kind of danger: that we are too diluted by size to meet the challenges we face today. BIO has 1,000 members and is not an industry organization but a technology organization representing different industries. R&D, commercialization, agriculture needs-all have to be represented crisply.
"Size is not the purpose," he cautioned. "The word umbrella can really mess you up. If you keep an umbrella over you, the grass below your feet will die."
Yet even as BIO works to manage internal growth, it must expand outward to engage external constituencies, Termeer said, sharing an anecdote. "I was talking at the Houston BIO international meeting [1997]; there were 3,000 people in the room, and it struck me-this was during a very active time in health-care reform-it struck me that we had in the room all these people dedicating their lives to breakthrough innovations, to taking enormous risks. What was not there were representativesof payers and providers. I asked the audience, 'Who here is representing the payers?' There were none. It struck me that we as an organization just talk to each other, and we all agree."
BIO has responded to these concerns by initiating outreach to discover and respond to the concerns of patient groups, religious leaders and other groups with concerns about biotechnology.
FDA Reform, Other Achievements
Termeer served as chairman at the height of FDA reform efforts, which culminated in passage of the FDA Modernization Act of 1997. Among other things, the law set criteria for fast-track drug development, allowed some drug approvals based on one pivotal trial, provided easier patient access to experimental drugs and devices, and renewed the Prescription Drug User Fee program.
"The act was very, very helpful," he said. "We set up very good connections between BIO members and the FDA. I felt good about that."
Other achievements during Termeer's chairmanship included "working with the Clinton administration and the House of Representatives to make them understand the necessity of supporting R&D by expanding the NIH budget, strengthening patent law and passing tort reform," he said.
Looking ahead, he said, the industry faces regulatory, patent and other challenges in a "very multifaceted world." Termeer cautioned that "BIO is about more than lobbying. We have to think about what conditions need to be in place to bring products to the market. "
Although he is concerned about how the organization takes on specific issues such as follow-on biologics, Termeer stressed that "the big issue for BIO in the coming years will be the difficulty of staying very effective while having many members. It's difficult to stay effective, but this is a very positive challenge. We have grown to a point where the technology is truly impacting industrial behavior. We need to support that trend at so many levels, and we have to do the right thing so these technologies can come to market."
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