Idea to Product

The Process

  • Nancy J. Alexander
  • Anne Colston Wentz

Part of the Serono Symposia USA book series (SERONOSYMP)

Table of contents

  1. Front Matter
    Pages i-xv
  2. Introduction

    1. Front Matter
      Pages 1-1
    2. James S. Hutchison
      Pages 3-4
    3. Stan Bernard
      Pages 5-6
  3. Getting Started

  4. Details of Drug Development

    1. Front Matter
      Pages 45-45
    2. Leslie Z. Benet
      Pages 49-49
    3. Ralph F. Shangraw
      Pages 51-51
    4. Robert S. Langer
      Pages 53-67
    5. Susan Alpert
      Pages 69-72
  5. Negotiating the System

    1. Front Matter
      Pages 73-73
    2. Hanni Levi Ellis
      Pages 81-86
    3. Lillian L. Yin
      Pages 87-96
  6. Clinical Investigation

  7. Business Issues

    1. Front Matter
      Pages 157-157
    2. Elie S. Nuwayser
      Pages 159-164
    3. Elizabeth G. Posillico
      Pages 165-165
    4. Roderick L. Mackenzie
      Pages 169-177
    5. Scott Chappel
      Pages 179-188
  8. Back Matter
    Pages 189-200

About this book


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.


assessment clinical research clinical trial diagnostics drug drug delivery drug development drug discovery kinetics medicine pharmacokinetics planning research safety toxicology

Editors and affiliations

  • Nancy J. Alexander
    • 1
  • Anne Colston Wentz
    • 1
  1. 1.National Institute of Child Health and Human DevelopmentNational Institutes of HealthBethesdaUSA

Bibliographic information

  • DOI
  • Copyright Information Springer-Verlag New York, Inc. 1996
  • Publisher Name Springer, New York, NY
  • eBook Packages Springer Book Archive
  • Print ISBN 978-1-4612-6889-5
  • Online ISBN 978-1-4612-0743-6
  • Buy this book on publisher's site