Full Description
"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review of first edition from Nature Chemical Biology
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 start transforming their basic research discoveries into novel drugs. Often many potentially transformative basic science discoveries are not pursued because they are deemed 'too early' to attract industry interest. This comprehensive book lays out 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 discovery, optimization and preclinical studies 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.
The SPARK model has been adopted in over 60 institutions on six continents, and the program has been honored with multiple awards including the 2020 Xconomy Award for Ecosystem Development, the 2020 Cures Within Reach Award for Patient Impact Research, and the 2022 California Life Sciences Pantheon Award for Academia, Non-Profits, & Research.
The new edition updates every chapter with the latest developments since the 2014 publication of the first edition.
Contents
Preface
Acknowledgements
Contents
Chapter 1 - Getting Started
1.1 Advancing New Treatments from Academia to Biopharma
1.2 Overview of Drug Discovery and Development
1.3 Assessing Clinical Need
1.4 Target Product Profile
1.5 Project Management and Project Planning
Key Terms and Abbreviations
References
Chapter 2 - Therapeutics and Diagnostics Discovery
2.1 Finding and Validating Drug Targets
2.2 Repurposing Drugs
2.3 Developing Assays for High-Throughput Screening
2.4 Medicinal Chemistry and Lead Optimization
2.5 Natural Products
2.6 Approaching Machine Learning in Drug Development
2.7 Therapeutic Antibody Discovery
2.8 siRNA, Gene Editing, and RNA Editing
2.9 Cell and Gene Therapy
2.10 Vaccine Development
2.11 Diagnostic Biomarkers
Key Terms and Abbreviations
References
Chapter 3 On the Way to the Clinic
3.1 When to Begin Animal Studies
3.2 Robustness of Preclinical Studies
3.3 In Vivo Pharmacology: Multiple Roles in Drug Discovery
3.4 Pharmacokinetics and ADME
3.5 Pharmacogenomics
3.6 Route of Administration and Drug Formulation
3.7 Preclinical Safety Studies
Key Terms and Abbreviations
References
Chapter 4 Preparing for the Clinic
4.1 Regulatory Considerations in Product Development
4.2 Manufacturing and Quality Control
4.3 Technical Development and Manufacturing of Biological Products
4.4 Clinical Trial Design
4.5 Phase 3 Studies
Key Terms and Abbreviations
References
Chapter 5 Technology Transfer and Commercialization
5.1 Intellectual Property
5.2 Working with the University Technology Transfer Office
5.3 Navigating Conflicts of Interest
5.4 Working with the University Compliance Office
5.5 Not-For-Profit Drug Development
5.6 Personal Lessons from a Reluctant Entrepreneur
5.7 Selecting the Market for Your Drug
5.8 Commercial Assessments
5.9 Making a Compelling Pitch to Potential Investors
5.10 Venture Capital Funding
5.11 Legal Aspects of a Startup Biotechnology Company
5.12 Plan, Organize, Motivate, and Control
Key Terms and Abbreviations
References
Chapter 6 Concluding Thoughts
6.1 Addressing the Market Failure for Developing Novel Antibiotics
Key Terms and Abbreviations
References
Author Biographies
