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Author:   Daria Mochly-Rosen ,  Kevin Grimes
Publisher:   Springer International Publishing AG
Imprint:   Springer International Publishing AG
Edition:   2nd ed. 2023
ISBN:  

9783031347238

ISBN 10:   3031347234
Pages:   217
Publication Date:   01 October 2023
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Forthcoming
Availability:   Not yet available  
This item is yet to be released. You can pre-order this item and we will dispatch it to you upon its release.

Table of Contents

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

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Author Information

Daria Mochly-Rosen, Ph.D., is the George D. Smith Professor of Translational Medicine, a Professor in the Department of Chemical and Systems Biology at Stanford University School of Medicine, and Founder and Co-director of SPARK at Stanford. She received her Ph.D. from the Weizmann Institute of Science, and was a postdoctoral fellow of biochemistry at University of California, Berkeley. She joined Stanford University in 1993 and served as the chair of her department for four years and then Senior Associate Dean for Research for seven years. She leads a multidisciplinary laboratory that includes basic researchers and clinicians, which recently focused their efforts on neurodegenerative diseases. In 2003, her lab’s research led to the founding of KAI Pharmaceuticals, where she served as CSO for one year, and as chair of the Scientific Advisory Committee and a member of the Board of Directors after her return to academia. She also co-founded two other biotech companies. In addition, Dr. Mochly-Rosen served on a variety of review groups including the Peer Review Advisory Committee of the NIH and the Council of Councils of the NIH. Kevin Grimes, M.D., M.B.A., is a Professor of Chemical and Systems Biology at Stanford University School of Medicine and Co-director of SPARK at Stanford. He received his M.D. from Brown University and after his internship and residency at Stanford, he joined the Stanford faculty as Clinical Assistant Professor of Medicine. Dr. Grimes then received his M.B.A from Stanford University and served as a White House Fellow. He later worked in the medical device and biotechnology sectors before returning to academia. He currently teaches drug discovery and development and teaches and practices internal medicine at Stanford.

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