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Springer A Practical Guide to Drug Development in Academia The SPARK Approach 2013 Edition by Daria Mochly-Rosen, Kevin Grimes
"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 from Nature Chemical BiologyWritten 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."I would actually welcome it if this book's intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they'll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form." Table of contents : - Chapter 1: Getting Started1.1 Advancing New Treatments to the Clinic within AcademiaDaria Mochly-Rosen1.2 Overview of Drug Discovery and DevelopmentKevin Grimes1.3 Assessing Clinical NeedKevin Grimes1.4 Target Product Profile (TPP)Robert Lum1.5 Project Management and Project PlanningRebecca Begeley and Daria Mochly-Rosen Chapter 2: Discovery and Preclinical Work2.1 Robustness of Preclinical StudiesDaria Mochly-Rosen2.2 Repurposing DrugsKevin Grimes2.3 Developing Assays for High Throughput Screening (HTS)Bruce Koch 2.4 Medicinal Chemistry and Lead OptimizationDaniel A. Erlanson2.5 Vaccine DevelopmentHarry Greenberg2.6 When to Begin Animal StudiesDaria Mochly-Rosen2.7 In vivo pharmacology: Multiple Roles in Drug DiscoverySimeon Taylor2.8 Pharmacokinetics and ADME PropertiesWerner Rubas and Emily Egeler 2.9 Route of Administration and Drug FormulationTerrence F. Blaschke2.10 Preclinical Safety StudiesMichael Taylor and Kevin GrimesChapter 3: Preparing for the Clinic3.1 Regulatory Considerations in Product DevelopmentCarol Karp3.2 Manufacturing and Quality ControlSusan Wade3.3 Technical Development and Manufacturing of Biological ProductsMark Backer3.4 Clinical Trial DesignTed McCluskey3.5 Overview of Clinical TrialsTed McCluskeyChapter 4: Transferring Technology4.1 Intellectual PropertyJudy Mohr4.2 Working with the University Technology Transfer OfficeKatharine Ku4.3 Avoiding Conflicts of InterestEmily Egeler4.4 Working with the University Compliance OfficeJennifer Swanton Brown, Nicholas Gaich, and Steven AlexanderChapter 5: Commercialization and Entrepreneurship5.1 Selecting the Market for Your DrugLilliane Brunner Halbach5.2 Commercial AssessmentsJulie Papanek5.3 Making a Compelling Pitch to Potential InvestorsLeon Chen5.4 Venture Capital FundingKevin Kinsella5.5 Not-For-Profit Drug DevelopmentEugenio L. de Hostos5.6 Legal Aspects of a Start-up Biotechnology CompanyAlan C. Mendelson, Peter E. Boyd, and Christopher M. Reilly5.7 Founder Preferred StockScott M. Iyama and Stephen J. Venuto5.8 Plan, Organize, Motivate and ControlJohn Walker Chapter 6: Concluding Thoughts6.1 A Call to Action: Changing How We Pursue Drug Discovery and DevelopmentSteven Schow