Developing and Marketing Orphan Drugs for Rare Diseases Happiness comes from facing challenges and going out on a limb and taking risks. –Diane Frolov and Andrew Schneider. From Northern Lights…
Virtual Drug Development In the most spectacular example ever of the potential economic consequences of a careful examination of pharmacokinetics and pharmacodynamics, nifedipine XL converted a side effect-plagued immediate-release drug…
Compassionate Use Programs The good physician treats the disease; the great physician treats the patient who has the disease. –Sir William Osler Several different names are given to clinical programs…
Creating and Using Benchmarks Science is facts; just as houses are made of stones, so is science made of facts; but a pile of stones is not a house and…
Choosing Standards for Developing Drugs No house should ever be on any hill or on anything. It should be of the hill, belonging to it, so hill and house could…
Project Management: Balancing Line Function and Matrix Approaches Because change is so rapid it is not uncommon for an individual in midcareer to find that the hierarchy is passing him…
Choosing the Number and Types of Drugs to Develop We thought that if we didn’t grab the business, someone else would, and that we would never have this kind of…
International Organization and Management A few megacompanies with broad international presence will be supported by a host of small companies that are scientifically and technically highly specialized. It is argued…
Fads and Fashions in Drug Development Great things are not accomplished by those who yield to trends and fads and popular opinion. –Jack Kerouac, American writer. You go through these…
The Many Facets of Reality: Approaches to Issues and Problems There is an objective reality out there, but we view it through the spectacles of our beliefs, attitudes. –David G….
