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Dear Members:
If you’re in the biotechnology business, you know what it means to cross the divide from Phase I to Phase II testing—the transition often means that proof of principle has been established and you’re ready to expand the program. In 2005, BIO is entering our own Phase II, undergoing a leadership change for the first time since the organization’s founding in 1993.
Over the past 12 years, a biology-based, entrepreneurial industry has grown from a small number of companies concentrated in a few cities to an industry that increasingly extends throughout society. Today, the technology’s impact has spread from health care to agriculture, mainstream manufacturing, and energy production. Nearly every state courts biotechnology development, as do countless regions around the world.With 4,000 companies in operation worldwide, the sun never sets on biotechnology research and development.
Our companies have significant challenges and promising opportunities ahead. BIO’s job is to represent the industry as a world-class advocacy operation.
These challenges include potential regulatory or legislative changes relating to drug safety, demonstrating the cost effectiveness of our products, and creating a favorable reimbursement environment. Perhaps most urgently, we face calls for FDA and clinical trial reform in the wake of the withdrawal and warnings about the risks of certain popular medications. As Congress and the Administration examine the process for improving patient safety and providing the maximum useful information to patients and physicians, it is critical that the process for drug approvals not be slowed down nor regulatory burden increased on our member companies. Our job at every step is to make sure policymakers and the public know the value of biotechnology products to patients.
In addition, we face ongoing issues in food and agriculture and environmental policies that affect many of our members. For the coming year, a critical priority is that we must continue to work with the Administration to establish science-based guidelines for the low-level, unintended presence of plant traits derived from the use of agricultural biotechnology. Furthermore, we will try to ensure that any comprehensive energy policy legislation that is passed by Congress properly recognizes the contributions and values of bio-based fuels.
On the following pages, you’ll learn about BIO’s positions on issues spanning the breadth of biomedical, agricultural and industrial biotechnology.We’ll also describe how we’re helping the industry’s youngest companies by seeking tax and grant reforms, as well as by hosting an ambitious slate of investor and partnering meetings.
In all of these efforts, we are guided by the knowledge that many of you invest more than a decade of your lives and hundreds of millions of dollars just to bring a single, but often unique, breakthrough to people around the world. Our mission is to help you reach that finish line, one product and one company at a time.
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Richard F. Pops
Chairman
Biotechnology Industry Organization
CEO, Alkermes Inc. |
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Jim Greenwood
President
Biotechnology Industry Organization
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