1st Edition
Adapting to Change Federal Policy Dynamics and the Pharmaceutical Industry
Chapter 1: Introduction – Adapting to Change
Chapter 2: Key Forces Impacting Pharma
Chapter 3: Additional Emerging Policy Dynamics
Chapter 4: Small Businesses in the New Pharma Paradigm
Chapter 5: Impact of/on Compounding Pharmacies
Chapter 6: The Most Favored Nation (MFN) Drug Pricing Executive Order
Chapter 7: Medicare Part B vs. Part D Drug Coverage
Chapter 8: International Impacts on Pharma
Chapter 9: Strategic Recommendations for the Pharmaceutical Industry
Chapter 10: Conclusion – Forging the Future – Resilience and Value in Pharma's New Era
Biography
Molly Klote, MD, is the former Director of the US Department of Health and Human Services Office for Human Research Protections (OHRP). OHRP is the policy, education, and compliance office that oversees federally funded medical research for 21 federal agencies, 13,000 institutions, and over 6000 institutional review boards in the US and internationally. It is the proponent office for the policy that is called "The Common Rule" (45 CFR 46). Before joining OHRP, Dr. Klote spent six years as the research policy, regulatory, and education lead for the Veterans Health Administration, the largest integrated healthcare system in the United States. Prior to the Veterans Health Administration, she served for 30 years in the Army, with her final assignment at the rank of Colonel, working for the Army Surgeon General overseeing all US Army Human Research policy and compliance. Additionally, Dr. Klote has directed two major research program offices, served as an Institutional Official, chaired three Institutional Review Boards, and led a Research Scientific Review Board.
She recently launched her own consulting company, Klote Medical Research Advisors, LLC, to bring her over 36 years of distinguished military and civilian federal experience to those who need to better understand federal research policy.
