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