Tag Archives: CBI
By Guest Blogger | Published: March 12, 2013
by Grant Corbett Epigenetics is the study of changes in human gene expression, in particular from environmental factors. Pharma is also experiencing epigenetic change. Human genes are formed from DNA, which are instructions much like a blueprint. Similarly, the environment is changing pharmaceutical DNA and how brand marketing is instructed.
By Jill Wechsler | Published: January 30, 2013
The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
By Ben Comer | Published: December 19, 2012
As the role and stature of the compliance officer grows, legacy senior management structures and hierarchies can accidentally pit lawyers against one another. What is strictly legal in the context of sales and marketing practices, working with government officials in global markets, and running and reporting on clinical programs, may not always be the [...]
By Ben Comer | Published: July 20, 2012
At CBI’s 7th Annual Rare Disease and Orphan Drug Leadership Congress, speakers and attendees identified areas where pharma can improve the way it approaches rare disease and treatment.
By Jennifer Ringler | Published: September 19, 2011
Pharmaceutical Executive recently spoke with David Vance, Senior Director of the Compliance Counsel at Noven Pharmaceuticals, about the birth of Expanded Access Programs and the role patient advocacy groups can play in shaping those programs.