Value Endpoints

In this 30-minute webinar, Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation, leads a panel discussion around value endpoints and to discuss the need to demonstrate pharmacoeconomic value earlier in the development process.

View this webinar to learn more about:

  • Identifying the strategic path from functional endpoint to outcome value
  • Determining the value endpoints—functional endpoints that convert into reimbursement vehicles
  • Defining the value endpoints early to avoid difficult and costly negotiations down the road
  • Acting in the timeframe where payers are willing to listen to reimbursement proposals

Scientist Bios

Luca Pani, MD

Vice President, Regulatory Strategy and Marketing Access Innovation

Dr. Pani is former Director General of the Italian Medicines Agency (AIFA), CHMP and SAWP Member of the European Medicine Agency (EMA) and a globally recognized expert in psychiatry, pharmacology, regulatory science and market access negotiation model contracts. During his tenure as Director General of AIFA, he pioneered several new approaches to drug approval, pricing, and reimbursement strategies by using advanced informatics to follow and certify real-world data. These models have now been adopted in many other countries. As a European regulator, Dr. Pani has been a leading figure for approval and scientific advice for CNS products and served as Chair of both the European Union Board Telematics Committee and of the European Risk Management Strategy Facilitation Group. He has authored or co-authored hundreds of publications and served on the editorial boards of many scientific journals, including Clinical Neuropsychiatry. He is Professor of Clinical Psychiatry at the University of Miami and Professor of Pharmacology and Clinical Pharmacology

Kathleen Anne Welsh-Bohmer, PhD, ABPP

Vice President, Neurodegenerative Disorders

Dr. Welsh-Bohmer’s research activities over the last 25+ years have focused around developing enhanced clinical tools to reliably detect early neurodegenerative diseases across culturally diverse populations. She has lead large multidisciplinary teams focused around identifying genetic and environmental determinants of Alzheimer’s disease and developing therapeutic trials to prevent neurocognitive decline in later age. Most recently, Dr. Welsh-Bohmer was the neuropsychology lead of a Phase III global clinical trial to delay the onset of Mild Cognitive Impairment due to Alzheimer’s disease, the “TOMMORROW” study. The methods her team developed for this study continue to fill an information void in preclinical Alzheimer’s disease and have implications for improving clinical practice and accelerating global clinical \ trials to delay or prevent the disease.

Mark Skeen, MD

Senior Medical Scientist

Dr. Skeen has over three decades of clinical experience from general internal medicine to neurology subspecialty care. For the past 15 years, his focus has been on multiple sclerosis and related autoimmune conditions. Dr. Skeen is a neurologist with expansive clinical training and experience. He is board-certified in Internal Medicine, Neurology, and Clinical Neurophysiology and has broad clinical experience in neurology clinical trials in several disease states. He is recognized as a thought leader in multiple sclerosis and has been recognized for both clinical and research expertise.


Dr. Skeen also serves as an Associate Professor of Neurology at Duke University Medical Center and is the head of the division of Multiple Sclerosis and Neuroimmunology. He is a Fellow of the American College of Physicians and the American Academy of Neurology. Dr. Skeen has many longstanding partnerships throughout the pharmaceutical industry and brings a distinctly clinical neurologic perspective to VeraSci.

 

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