Foreword

Carl B. Feldbaum, JD

Among the fascinating aspects of biotechnology is the fact that this endeavor did not exist when the pioneers of the industry were growing up. Back in the day, it was not a career choice in high school or college—there were no courses you could take, no majors or minors you could elect to prepare you for what was to come. And I would be will-ing to bet that when asked what they wanted to be when they grew up, no one answered “a biotechnology entrepreneur.”

With a scant background in biology, then short careers in law, national security affairs, and politics, I was “adopted” by the biotech village in 1993, when the Biotechnology Industry Organization (BIO) was first formed. Associating with those pioneer scientists, CEOs, and financial gurus has been the best part of my professional life. Put simply, their risk-taking behavior in uncharted territory, resilience, and dedication to helping others remain both inspirational and instructive.

When BIO was established 20 years ago, our infant indus-try was struggling to apply new molecular and genetic under-standing to drug discovery, was running into financial and regulatory walls, and was attempting to adapt to proposals for comprehensive healthcare reform. Plus we encountered controversies over patents, cloning (remember Dolly?), NIH funding, GMOs, among others. Do these sound familiar?

Now, finally, we have this textbook, which serves as a roadmap and operating manual to guide the next generation of biotech entrepreneurs. The chapters that follow cover the waterfront—the whole constellation of issues you’ll confront, the hardest nuts you’ll have to crack. The authors of these chapters share their experience generously and forthrightly in a fashion that characterizes the best mentors of any industry, especially biotech.

Philosopher George Santayana’s most famous reflection is often cited but too rarely heeded. Allow me to remind you that he said “Those who do not learn from history are condemned to repeat it.” Trust me, it’s worth learning from the biotech pioneers who have authored the chapters that follow. Having been there, done that, they can help you avoid many of the pitfalls that remain particular to this endeavor. They have made their mistakes, and for the most part have learned from them. What follows is high-value, even inspirational guidance.

Read on and go forth, but this will not be the end of the story. A confident prediction: biotechnology will transform the twenty-first century well beyond what chemistry and physics accomplished earlier. There is much further uncharted territory. Those are the chapters you will write.

Carl Feldbaum grew up in Philadelphia, graduated from Princeton University with a B.A. in Biology and a J.D. from the University of Pennsylvania Law School. He served as an Assistant District Attorney in his hometown, then as a prosecutor on the Watergate Special Pros-ecution Force in Washington, D.C. He later served as Inspector General for Defense Intelligence in the Pen-tagon, president of Palomar Corporation, a national security think tank, and as chief-of-staff to U.S. Senator Arlen Specter. In 1993 he helped found the Biotechnol-ogy Industry Organization and served as its president for 12 years until his “retirement” in 2005. In 2001 he was elected to the Biotechnology Hall of Fame. Carl now serves on several public and nonprofit biotech boards of directors.

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