A Practical Guide to Drug Development in Academia - (Springerbriefs in Pharmaceutical Science & Drug Development) (Paperback)
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<p/><br></br><p><b> Book Synopsis </b></p></br></br><p>Chapter 1: Getting Started</p><p>1.1 Advancing New Treatments to the Clinic within Academia</p><p> Daria Mochly-Rosen</p><p>1.2 Overview of Drug Discovery and Development</p><p> Kevin Grimes</p><p>1.3 Assessing Clinical Need</p><p> Kevin Grimes</p><p>1.4 Target Product Profile (TPP)</p><p> Robert Lum</p><p>1.5 Project Management and Project Planning</p><p> Rebecca Begeley and Daria Mochly-Rosen </p><p> </p><p>Chapter 2: Discovery and Preclinical Work</p><p>2.1 Robustness of Preclinical Studies</p><p>Daria Mochly-Rosen</p><p>2.2 Repurposing Drugs</p><p> Kevin Grimes</p><p>2.3 Developing Assays for High Throughput Screening (HTS)</p><p> Bruce Koch </p><p>2.4 Medicinal Chemistry and Lead Optimization</p><p> Daniel A. Erlanson</p><p>2.5 Vaccine Development</p><p> Harry Greenberg</p><p>2.6 When to Begin Animal Studies</p><p> Daria Mochly-Rosen</p><p>2.7 <i>In vivo</i> pharmacology: Multiple Roles in Drug Discovery</p><p> Simeon Taylor</p><p>2.8 Pharmacokinetics and ADME Properties</p><p> Werner Rubas and Emily Egeler </p><p>2.9 Route of Administration and Drug Formulation</p><p>Terrence F. Blaschke</p><p>2.10 Preclinical Safety Studies</p><p> Michael Taylor and Kevin Grimes</p><p> </p><p>Chapter 3: Preparing for the Clinic</p><p>3.1 Regulatory Considerations in Product Development</p><p> Carol Karp</p><p>3.2 Manufacturing and Quality Control</p><p> Susan Wade</p><p>3.3 Technical Development and Manufacturing of Biological Products</p><p> Mark Backer</p><p>3.4 Clinical Trial Design</p><p> Ted McCluskey</p><p>3.5 Overview of Clinical Trials</p><p> Ted McCluskey</p><p> </p><p>Chapter 4: Transferring Technology</p><p>4.1 Intellectual Property</p><p> Judy Mohr</p><p>4.2 Working with the University Technology Transfer Office</p><p> Katharine Ku</p><p>4.3 Avoiding Conflicts of Interest</p><p> Emily Egeler</p><p>4.4 Working with the University Compliance Office</p><p> Jennifer Swanton Brown, Nicholas Gaich, and Steven Alexander</p><p> </p><p>Chapter 5: Commercialization and Entrepreneurship</p><p>5.1 Selecting the Market for Your Drug</p><p> Lilliane Brunner Halbach</p><p>5.2 Commercial Assessments</p><p> Julie Papanek</p><p>5.3 Making a Compelling Pitch to Potential Investors</p><p> Leon Chen</p><p>5.4 Venture Capital Funding</p><p> Kevin Kinsella</p><p>5.5 Not-For-Profit Drug Development</p><p> Eugenio L. de Hostos</p><p>5.6 Legal Aspects of a Start-up Biotechnology Company</p><p> Alan C. Mendelson, Peter E. Boyd, and Christopher M. Reilly</p><p>5.7 Founder Preferred Stock</p><p> Scott M. Iyama and Stephen J. Venuto</p><p>5.8 Plan, Organize, Motivate and Control</p><p> John Walker </p><p> </p><p>Chapter 6: Concluding Thoughts</p><p>6.1 A Call to Action: Changing How We Pursue Drug Discovery and Development</p><p> Steven Schow</p><p/><br></br><p><b> About the Author </b></p></br></br><p>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.</p><p> </p><p>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.</p>
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