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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.
Sommario
I. Introduction.- 1. The Preclinical Research Process.- 2. The Commercial Development Process.- II. Getting Started.- 3. What's Involved in Clinical Research?.- 4. Product Development Partnership: Role of Academia and the NIH.- 5. Identifying Funding Opportunities at the NIH:A Grants Perspective.- 6. Identifying Funding Opportunities at the NIH:A Contract Perspective.- 7.Role of the Institution in Furthering the Young Investigator.- III. Details of Drug Development.- 8. Role of Toxicology in Drug Discovery and Development.- 9. Pharmacokinetics Study.- 10. Formulation of Dosage Forms.- 11. Polymeric Drug Delivery Systems.- 12. What Is a Drug, a Device, a Biological?.- IV. Negotiating the System.- 13. Understanding the Organization and Function of the FDA.- 14. How to Apply for an IND.- 15. What Is a 501(k) and a PMA?.- 16. Patenting and Licensing: An Overview of the Processes.- V. Clinical Investigation.- 17. Pharmaceutical Clinical Development.- 18. FDA Recommendations for Drug Safety Testing.- 19. Decision Strategies in Assessment of Reproductive and Developmental Toxicology: A Paradigm for Safety Evaluation.- 20. What Is Involved in a New Drug Application?.- 21. Institutional Review Boards and Informed Consent.- 22. Postmarketing Surveillance. A Brief Synopsis of Its History and Current Direction.- VI. Business Issues.- 23. I Had an Idea, and I Made It Work: Here's How.- 24. Working with Companies to Market Your Discoveries.- 25. Developing Information for Health-Care Decision Makers.- 26. Getting a Medical Products Business Started.- 27. From Start-Up to Initial Public Offering.- Author Index.- Subject Inde.
