Idea to Product: The Process
Nancy J. Alexander, Anne C. Wentz
Springer Science & Business Media, Dec 6, 2012 - Medical - 200 pages
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.
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Role of Academia and
Role of the Institution in Furthering the Young Investigator
Role of Toxicology in Drug Discovery and Development
Formulation of Dosage Forms
What Is a Drug a Device a Biological?
What Is a 501k and a PMA?
An Overview of the Processes
FDA Recommendations for Drug Safety Testing
What Is Involved in a New Drug Application?
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academic adverse events agreements Alexander and Anne animals Anne Colston Wentz approval assessment BCNU bioavailability biological biotechnology CDRH Center clinical development clinical investigation clinical research clinical studies clinical trials Colston Wentz eds commercial conducted contract delivery systems determine developmental toxicity DHHS dose drug application drug product endpoints evaluation Federal funding grants Health human subjects Idea to Product identify informed consent initial institutional review board inthe investigational new drug investigator’s involved labeling laboratory licensing macromolecules manufacturing marketing Massachusetts Media New York ofthe OPRR patient pharmaceutical pharmacokinetics pharmacology Phase polyanhydrides polymer population postmarketing surveillance potential preclinical predicate device premarket product development proposed protection protocol regulations regulatory release reports reproductive risk safety and efficacy scientific scientists Serono SymposiaUSA Norwell specific sponsor Springer Science+Business Media testing therapeutic tothe toxicology volunteers York 1996 Nancy