Idea to Product: The Process

✍ Scribed by James S. Hutchison (auth.), Nancy J. Alexander Ph.D., Anne Colston Wentz M.D. (eds.)

• Publisher: Springer-Verlag New York
• Year: 1996
• Tongue: English
• Leaves: 195
• Series: Serono Symposia USA
• Edition: 1
• Category: Library

✦ Synopsis

The young investigator with an idea has to negotiate many institutional, federal, and industrial challenges in order to get a product to market. Nowhere is described the steps in the development of new drugs, diagnos­ tics, or devices; the person with an idea has nowhere to turn for information and details. The young investigator may understand the elements of basic and clinical research, but ordinarily has no insight into novel ways of finding research funding or how to explore to find the funding opportunities that are available. The young investigator has little knowledge of the mecha­ nisms to bring an idea through the developmental phases to the market. There are other players in this complex endeavor with whom he or she has no contact, including those from industry, the Food and Drug Administration, and the legal community. Exposure to the philosophy of product develop­ ment and to procedural information would be useful to the scientific com­ munity, as would contact with those who have successfully taken an idea to a finished product. A first attempt to do this was the symposium on Idea to Product: The Process, sponsored by Serono Symposia USA and held No­ vember 17 to 20, 1994, in Washington, D.C. This book comprises the pro­ ceedings of that meeting. The editors are indebted to the many contributors to this volume, and we are especially grateful to Serono Symposia USA and to Leslie Nies and her staff for their expertise in organizing the symposium.

✦ Table of Contents

Front Matter....Pages i-xv
Front Matter....Pages 1-1
The Preclinical Research Process....Pages 3-4
The Commercial Development Process....Pages 5-6
Front Matter....Pages 7-7
What’s Involved in Clinical Research?....Pages 9-16
Product Development Partnership: Role of Academia and the NIH....Pages 17-20
Identifying Funding Opportunities at the NIH: A Grants Perspective....Pages 21-23
Identifying Funding Opportunities at the NIH: A Contract Perspective....Pages 25-31
Role of the Institution in Furthering the Young Investigator....Pages 33-44
Front Matter....Pages 45-45
Role of Toxicology in Drug Discovery and Development....Pages 47-48
Pharmacokinetics Study....Pages 49-49
Formulation of Dosage Forms....Pages 51-51
Polymeric Drug Delivery Systems....Pages 53-67
What Is a Drug, a Device, a Biological?....Pages 69-72
Front Matter....Pages 73-73
Understanding the Organization and Function of the FDA....Pages 75-79
How to Apply for an IND....Pages 81-86
What Is a 510(k) and a PMA?....Pages 87-96
Patenting and Licensing: An Overview of the Processes....Pages 97-100
Front Matter....Pages 101-101
Pharmaceutical Clinical Development....Pages 103-114
FDA Recommendations for Drug Safety Testing....Pages 115-118
Decision Strategies in Assessment of Reproductive and Developmental Toxicology: A Paradigm for Safety Evaluation....Pages 119-131
What Is Involved in a New Drug Application?....Pages 133-139
Front Matter....Pages 101-101
Institutional Review Boards and Informed Consent....Pages 141-146
Postmarketing Surveillance: A Brief Synopsis of Its History and Current Direction....Pages 147-156
Front Matter....Pages 157-157
I Had an Idea, and I Made it Work: Here’s How....Pages 159-164
Working with Companies to Market Your Discoveries....Pages 165-165
Developing Information for Health-Care Decision Makers....Pages 167-167
Getting a Medical Products Business Started....Pages 169-177
From Start-Up to Initial Public Offering....Pages 179-188
Back Matter....Pages 189-200

✦ Subjects

Medicine/Public Health, general; Biomedical Engineering