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Research and Development of Vaccines and Pharmaceuticals from Biotechnology: A Guide to Effective Project Management, Patenting and Product Registration

Research and Development of Vaccines and Pharmaceuticals from Biotechnology: A Guide to Effective Project Management, Patenting and Product Registration

Jens-Peter Gregersen

ISBN: 978-3-527-61583-4 December 2007 Wiley-Blackwell 184 Pages

Description

Unique in approach, exhaustive in coverage: this book provides information usually not available to scientists.

It explains the basic scientific and technical requirements which apply to the patenting and registration of human or veterinary vaccines and therapeutic biomedicinal products. Pragmatic and practice-oriented, it helps users select and manage successfully the most attractive research and development projects.

An impressive number of topics is covered, including:

* planning and managing product development
* product development phases
* requirements for a patentable invention
* patent costs
* user safety
* ecotoxicity

The book will rapidly pay for itself by more successful fund applications,increased protection and remuneration of intellectual property, and by faster and more efficient product development.
From the Contents:
Preface

Biotechnology in Pharmaceutical Research

A Scientific Leap Forward
Biotechnology in the 1990's
Research Structures
Basic or Applied Research or Where do you want to get to?

The Aim of a Project

Defining the Aim
Creative Market Research and Other Valuable Background Information

Project Planning

The Backwards Approach to establish a Plan
Linking Project Tasks
Objectives and Milestones
Time and Task Dependencies
Project Team Approval and Refinement of the Plan
Allocation of Resources and Budget Planning
Changes to the Plan
Implementing a Project Plan
Project Management Computer Software

Product Development

Product Development Follows Different Rules
Commercial Chances and Risks of Pharmaceutical Development
Product Profile and Market Assessment of Development Products

- Planning and Managing Product Development

- Technical Aspects of Product Development

Patents for Biomedical Products

The Purpose of the Patent
Alternatives to Patents

- Basic Requirements for a Patentable Invention

- The Patent Application

- Selling an Invention, Licences and Royalties

Registration Requirements

- Three Basic Elements

- Registration Applications and Procedures




- Requirements for the Preclinical Pharmacology and Safety
Assessment

- Additional Preclinical Studies for Veterinary Products

- Annex A: Outline of Major Registration Requirements

- Annex B: References and Information Sources on Regulatory
Matters

References

Index