A Practical Guide to Drug Development in Academia
Description
"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology
Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed 'too early' to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest.
"I would actually welcome it if this book's intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they'll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."
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Persons
Daria Mochly-Rosen, Ph.D., is the George D. Smith Professor of Translational Medicine, the Senior Associate Dean for Research, and a Professor in the Department of Chemical and Systems Biology at Stanford University School of Medicine and the Co-director of SPARK. She received her Ph.D. from the Weizmann Institute of Science in Israel, and was a postdoctoral fellow in the department of biochemistry at UC Berkeley. She joined Stanford University in 1993 and served as the chair of her department for four years. In 2003, her lab's basic research led to the founding of KAI Pharmaceuticals, where she served as the CSO for one year, and as the chair of the Scientific Advisory Committee and a member of the Board of Directors after her return to academia. She also founded ALDEA Pharmaceuticals in 2011. In addition, Dr. Mochly-Rosen served on a variety of review groups including the Peer Review Advisory Committee of the NIH and on the Council of Councils of the NIH.
Kevin Grimes, M.D., M.B.A., received his M.D. from Brown University and his M.B.A. from Stanford University. After his training, he joined the Stanford faculty as an academic internist. He later worked in the medical device and biotechnology sectors before returning to academia. He is currently the Co-director of the SPARK Translational Research Program and Associate Professor of Chemical and Systems Biology at Stanford, where he also teaches drug discovery and development and the practice of internal medicine.
Content
Chapter 1: Getting Started
1.1 Advancing New Treatments to the Clinic within Academia
Daria Mochly-Rosen
1.2 Overview of Drug Discovery and Development
Kevin Grimes
1.3 Assessing Clinical Need
Kevin Grimes
1.4 Target Product Profile (TPP)
Robert Lum
1.5 Project Management and Project Planning
Rebecca Begeley and Daria Mochly-Rosen
Chapter 2: Discovery and Preclinical Work
2.1 Robustness of Preclinical Studies
Daria Mochly-Rosen
2.2 Repurposing Drugs
Kevin Grimes
2.3 Developing Assays for High Throughput Screening (HTS)
Bruce Koch
2.4 Medicinal Chemistry and Lead Optimization
Daniel A. Erlanson
2.5 Vaccine Development
Harry Greenberg
2.6 When to Begin Animal Studies
Daria Mochly-Rosen
2.7 In vivo pharmacology: Multiple Roles in Drug Discovery
Simeon Taylor
2.8 Pharmacokinetics and ADME Properties
Werner Rubas and Emily Egeler
2.9 Route of Administration and Drug Formulation
Terrence F. Blaschke
2.10 Preclinical Safety Studies
Michael Taylor and Kevin Grimes
Chapter 3: Preparing for the Clinic
3.1 Regulatory Considerations in Product Development
Carol Karp
3.2 Manufacturing and Quality Control
Susan Wade
3.3 Technical Development and Manufacturing of Biological Products
Mark Backer
3.4 Clinical Trial Design
Ted McCluskey
3.5 Overview of Clinical Trials
Ted McCluskey
Chapter 4: Transferring Technology
4.1 Intellectual Property
Judy Mohr
4.2 Working with the University Technology Transfer Office
Katharine Ku
4.3 Avoiding Conflicts of Interest
Emily Egeler
4.4 Working with the University Compliance Office
Jennifer Swanton Brown, Nicholas Gaich, and Steven Alexander
Chapter 5: Commercialization and Entrepreneurship
5.1 Selecting the Market for Your Drug
Lilliane Brunner Halbach
5.2 Commercial Assessments
Julie Papanek
5.3 Making a Compelling Pitch to Potential Investors
Leon Chen
5.4 Venture Capital Funding
Kevin Kinsella
5.5 Not-For-Profit Drug Development
Eugenio L. de Hostos
5.6 Legal Aspects of a Start-up Biotechnology Company
Alan C. Mendelson, Peter E. Boyd, and Christopher M. Reilly
5.7 Founder Preferred Stock
Scott M. Iyama and Stephen J. Venuto
5.8 Plan, Organize, Motivate and Control
John Walker
Chapter 6: Concluding Thoughts
6.1 A Call to Action: Changing How We Pursue Drug Discovery and Development
Steven Schow