Beyond the Science: The Business of Drug Development
by Lynn C. Klotz
This thirteen-chapter book was written to accompany the series of online lectures that were presented until 2017 by Bridging BioScience & BioBusiness and BioPharma Dive. It is aimed at scientists, technicians, and businesspeople with no to some experience in the business of drug discovery and development. The book covers strategies, analysis, and issues for biotechnology companies in drug discovery and development. The topics are presented at a level easily understood by someone new to the business. Even if you have some experience in drug discovery and development, much of this material is not easily acquired in your day-to-day work.
Some insights unlikely to be found elsewhere include:
• Why small biotech DD&D companies can spend ten-fold less than big pharma on discovery and development
• Why the Supreme Court decision on disallowing patents on natural products will not have a major impact on development and sales of natural product drugs
• Why pharmacoeconomic considerations are important from the beginning of drug discovery through sales
• Why overpricing drugs in some disease areas can significantly hurt sales and ideas on how to price drugs to avoid the problem
• Why companies focusing on drugs for rare diseases can address only a small fraction of the market, and how drugs for most rare diseases could be developed and sold.
The book is divided into four main sections:
• Small and large drug discovery and development biotechnology companies
• The drug discovery and development process through clinical trials
• Basics of patents, and intellectual property strategy
• Pharmacoeconomics, drug pricing, and issues such as U.S. healthcare performance compared to other nations
About The Author
Lynn C. Klotz received a BA in mathematics from Princeton University (1965) and a PhD in chemistry from the University of California, San Diego (1971). He was formerly an Assistant and Associate Professor of Biochemistry and Molecular Biology at Harvard University (1971-1979) and a visiting Associate Professor at Princeton University (1979-1981). He was a founder and board member of BioTechnica International (1981-1988)-an agricultural and natural products company. Within BioTechnica, he founded BioTechnica Diagnostics, a periodontal-disease DNA-probe diagnostics company and BioTal a Wales-based environmental-remediation biotechnology company.
As a consultant, Dr. Klotz co-founded (1994) and served on the scientific advisory board of Codon, a biotechnology company focused on curing genetic diseases. He was interim Chief Executive Officer of Precision Genetics (2001-2006), an unfunded company developing gene-repair methods based on Yale and Princeton University technologies.
Dr. Klotz was a recipient of the prestigious Dreyfus Teacher-Scholar grant for teaching excellence while at Harvard University. He was also nominated for a Pulitzer Prize by the publisher Charles Scribner’s Sons, along with co-author Edward Sylvester, for the 1983 book The Gene Age: Genetic Engineering and
the Next Industrial Revolution.
In addition to his business activities, from 2003 to the present, Dr. Klotz is a Senior Science Fellow at the Center for Arms Control and Non-Proliferation where he studies and writes articles on the risk of chemical and biological weapons. From 2013 to 2015, he served as Research Scholar and Adjunct Professor at the Arizona State University’s Walter Cronkite School of Journalism and Mass Communication where he and Ed Sylvester published articles on biological-weapons risk for lay audiences.
In 2009, with co-author Edward Sylvester, the book “Breeding Bio Insecurity: How U.S. Biodefense is Exporting Fear, Globalizing Risk, and Making Us All Less Secure” was published by The University of Chicago Press, which was picked by the Press as one of its six “Best Books of 2009” in the Atlantic magazine.