Regulatory Affairs Case Studies
Regulatory Affairs Case Studies Regulatory affairs staff and managers should be people who look for reasons and ways to get regulatory agencies to agree with the company’s proposals, rather than…
Clinical Case Studies
Clinical Case Studies Ultimately the focus of attention in dealing with poor clinical performance must be on prevention and early detection as much as having mechanisms to deal with the…
Introduction
Introduction The case studies presented in Chapters 116, 117, 118 were originally published by the author in Case Studies in Pharmaceutical and Biotech R&D by Prous Science (www.prous. com). The…
Keys for Pharmaceutical and Development Success
Keys for Pharmaceutical and Development Success The intensity of a conviction that a hypothesis is true has no bearing over whether it is true or not. –Peter Medawar Doctor of…
Licensing Activities and Issues
Licensing Activities and Issues Underlying most arguments against the free market is a lack of belief in freedom itself. –Milton Friedman, economist. A few bad reasons for doing something neutralize…
Production Activities and Issues
Production Activities and Issues We can no longer live with commonly accepted levels of mistakes, defects, material not suited to the job, people on the job that do not know…
Patent Activities and Issues
Patent Activities and Issues Pricing is a major microeconomic factor at the time of [patent] expiry: the patent holder has the option of joining the fight with a price drop,…
Poor Development and Corporate Practices: Threats to a Pharmaceutical Organization
Poor Development and Corporate Practices: Threats to a Pharmaceutical Organization It is never too late—in fiction or in life—to revise. –Nancy Thayer, novelist. There is nothing so useless as doing…
Information Management
Information Management Information and data are the coins of the drug discovery and development realm. –Bert Spilker No amount of sophistication is going to allay the fact that all your…
Joint Medical and Marketing Activities
Joint Medical and Marketing Activities Fundamentally, there are only two ways of coordinating the economic activities of millions. One is central direction involving the use of coercion—the technique of the…
