A Practical Guide to Drug Development in Academia The SPARK Approach /

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: Mochly-Rosen, Daria (Επιμελητής έκδοσης), Grimes, Kevin (Επιμελητής έκδοσης)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2014.
• Σειρά: SpringerBriefs in Pharmaceutical Science & Drug Development,
• Θέματα: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.

 "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 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 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.". 

 Advancing New Treatments to the Clinic within Academia -- Overview of Drug Discovery and Development -- Assessing Clinical Need -- Target Product Profile (TPP) -- Project Management and Project Planning -- Robustness of Preclinical Studies -- Repurposing Drugs -- Developing Assays for High Throughput Screening (HTS) -- Medicinal Chemistry and Lead Optimization -- Vaccine Development -- When to Begin Animal Studies -- In vivo pharmacology: Multiple Roles in Drug Discovery -- Pharmacokinetics and ADME Properties -- Route of Administration and Drug Formulation -- Preclinical Safety Studies -- Regulatory Considerations in Product Development -- Manufacturing and Quality Control -- Technical Development and Manufacturing of Biological Products -- Clinical Trial Design -- Overview of Clinical Trials -- Intellectual Property -- Working with the University Technology Transfer Office -- Avoiding Conflicts of Interest -- Working with the University Compliance Office -- Selecting the Market for Your Drug -- Commercial Assessments -- Making a Compelling Pitch to Potential Investors -- Venture Capital Funding -- Not-For-Profit Drug Development -- Legal Aspects of a Start-up Biotechnology Company -- Founder Preferred Stock -- Plan, Organize, Motivate and Control -- A Call to Action: Changing How We Pursue Drug Discovery and Development.