A Practical Guide to Drug Development in Academia

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