A Practical Guide to Drug Development in Academia (eBook)

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.

Chapter 1: Getting Started1.1          Advancing New Treatments to the Clinic within Academia                Daria Mochly-Rosen1.2          Overview of Drug Discovery and Development                Kevin Grimes1.3          Assessing Clinical Need                Kevin Grimes1.4          Target Product Profile (TPP)                Robert Lum1.5          Project Management and Project Planning                Rebecca Begeley and Daria Mochly-Rosen  Chapter 2: Discovery and Preclinical Work2.1          Robustness of Preclinical StudiesDaria Mochly-Rosen2.2          Repurposing Drugs                Kevin Grimes2.3          Developing Assays for High Throughput Screening (HTS)                Bruce Koch 2.4          Medicinal Chemistry and Lead Optimization                Daniel A. Erlanson2.5          Vaccine Development                Harry Greenberg2.6          When to Begin Animal Studies                Daria Mochly-Rosen2.7          In vivo pharmacology: Multiple Roles in Drug Discovery                Simeon Taylor2.8          Pharmacokinetics and ADME Properties                Werner Rubas and Emily Egeler 2.9          Route of Administration and Drug FormulationTerrence F. Blaschke2.10        Preclinical Safety Studies                Michael Taylor and Kevin Grimes Chapter 3: Preparing for the Clinic3.1          Regulatory Considerations in Product Development                Carol Karp3.2          Manufacturing and Quality Control                Susan Wade3.3          Technical Development and Manufacturing of Biological Products                Mark Backer3.4          Clinical Trial Design                Ted McCluskey3.5          Overview of Clinical Trials                Ted McCluskey Chapter 4: Transferring Technology4.1          Intellectual Property                Judy Mohr4.2          Working with the University Technology Transfer Office                Katharine Ku4.3          Avoiding Conflicts of Interest                Emily Egeler4.4          Working with the University Compliance Office                Jennifer Swanton Brown, Nicholas Gaich, and Steven Alexander Chapter 5: Commercialization and Entrepreneurship5.1          Selecting the Market for Your Drug                Lilliane Brunner Halbach5.2          Commercial Assessments                Julie Papanek5.3          Making a Compelling Pitch to Potential Investors                Leon Chen5.4          Venture Capital Funding                Kevin Kinsella5.5          Not-For-Profit Drug Development                Eugenio L. de Hostos5.6          Legal Aspects of a Start-up Biotechnology Company                Alan C. Mendelson, Peter E. Boyd, and Christopher M. Reilly5.7          Founder Preferred Stock                Scott M. Iyama and Stephen J. Venuto5.8          Plan, Organize, Motivate and Control                John Walker  Chapter 6: Concluding Thoughts6.1          A Call to Action: Changing How We Pursue Drug Discovery and Development                Steven Schow