A Practical Guide to Drug Development in Academia The SPARK Approach /
"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 Stanf...
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| Other Authors: | , |
| Language: | English |
| Published: |
Cham :
Springer International Publishing : Imprint: Springer,
2014.
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| Edition: | 1st ed. 2014. |
| Series: | SpringerBriefs in Pharmaceutical Science & Drug Development,
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| Subjects: | |
| Online Access: | https://doi.org/10.1007/978-3-319-02201-7 |
Table of 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.