A Practical Guide to Drug Development in Academia: The Spark Approach

ISBN-13: 9783319022000 / Angielski / Miękka / 2013 / 176 str.

Daria Mochly-Rosen; Kevin Grimes

Opis

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.

Spis treści

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

O autorze

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.