Adapting to Change: Federal Policy Dynamics and the Pharmaceutical Industry
Autor Molly Kloteen Limba Engleză Hardback – 22 oct 2025
Key Features
•Understand the Interconnectedness of U.S. Federal Policies.
•Analyze the Strategic Impacts of Key Legislation and Executive Actions.
•Evaluate Challenges and Opportunities in a Dynamic Regulatory Environment.
•Analyze the Interplay of U.S. Federal Actions and Industry Operations.
•Formulate Adaptive Strategies for Industry Resilience.
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Specificații
ISBN-13: 9781041159810
ISBN-10: 1041159811
Pagini: 124
Ilustrații: 32
Dimensiuni: 138 x 216 x 10 mm
Greutate: 0.47 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
ISBN-10: 1041159811
Pagini: 124
Ilustrații: 32
Dimensiuni: 138 x 216 x 10 mm
Greutate: 0.47 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Public țintă
Academic, Postgraduate, Professional Practice & Development, and Professional ReferenceCuprins
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.
Notă biografică
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.
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.
Descriere
The US pharmaceutical landscape is in the midst of impactful shifts. In this analysis, a federal policy expert unpacks the complex forces reshaping how life-saving therapies are researched, developed, manufactured, and delivered.