A Practical Guide to Drug Development in Academia : The SPARK Approach / edited by Daria Mochly-Rosen, Kevin Grimes.

Format:

Book

Contributor:

Mochly-Rosen, Daria, editor.

Grimes, Kevin, editor.

SpringerLink (Online service)

Series:

SpringerBriefs in pharmaceutical science & drug development 1864-8118

SpringerBriefs in Pharmaceutical Science & Drug Development, 1864-8118

Language:

English

Subjects (All):

Pharmaceutical technology.

Pharmaceutical Sciences/Technology.

Local Subjects:

Pharmaceutical Sciences/Technology.

Physical Description:

1 online resource (XII, 176 pages 9 illustrations, 4 illustrations in color.)

Edition:

First edition 2014.

Contained In:

Springer Nature eBook

Place of Publication:

Cham : Springer International Publishing : Imprint: Springer, 2014.

System Details:

text file PDF

Summary:

"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.".

Contents:

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.

Other Format:

Printed edition:

ISBN:

9783319022017

Access Restriction:

Restricted for use by site license.