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Fundamentals of Drug Development Lecture Summaries
Introduction to Drug Discovery, Development, and Commercialization
This courselet describes the steps to commercialize a new drug therapy beginning with identifying drug candidates through animal and clinical trials to manufacturing and marketing. We outline the regulatory requirements for getting a new drug approved which make drug development a long and costly process. At each stage we examine the relationships between the science and business decisions that go into developing and marketing a successful therapy, including protecting and maintaining intellectual property rights. Finally, strategies for mitigating the business and financial risks of drug development are highlighted. At the end of the courselet, students will understand the process of bringing a new drug to market and why successful drug development requires a multitude of business and technical talents.
The Regulation of Drug Development
The process of bringing a new drug to market is strictly controlled by US governmental regulations and international agreements. We start with an appreciation for the history of regulation in the US and the structure of the primary regulatory body, the Food and Drug Administration. At each stage of the drug development process, we outline the appropriate controls regarding animal use, laboratory practices, manufacturing practices and the use of humans in clinical trials. The purpose and content of the Investigational New Drug filing and the New Drug Application are explained. Finally, we examine the differences between bringing a new drug, a new biologic, and a new medical device to market. Students will appreciate the responsibilities of a new drug applicant and the regulatory complexities of bringing a drug or device to market.
Financing Drug Development
The process of drug development is long and expensive, with the ultimate payoff coming only at the end of a 12-15 year process. This dynamic imposes special challenges on organizations trying to finance the high risk, high reward process. We begin by examining the sources of (mostly) public funding for drug discovery for research and academic institutions and the impact that the Bayh-Dole law has had on the commercialization of public research. We examine the sources of financial risk in drug development and explore how large companies manage that risk. Biotechnology startups represent a special case. We discuss the sources of capital for startups and young companies, what investors are looking for, and how intellectual asset-based companies are valued. As both Big Pharma and small biotech companies turn to mutual partnerships to fund drug development and reduce risks, we explore the structure of early- and late-stage development partnerships. At the end of the class, students will appreciate how it is possible to mitigate some of the risks inherent in drug development through strategic partnerships and financing.
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