Phacilitate Leaders World 

Features, Workshops & Networking Agenda


Aligning regulatory, value demonstration and market access strategy to drive uptake of advanced therapies: what do executives need to know?

23 Jan 2019
Promenade Upper
Clinical Hub
The vanguard of transformative and potentially curative regenerative and advanced therapies has launched, with over 25 therapies anticipated to emerge in the next 2-3 years and a robust pipeline of 950 therapies. These therapies, while promising superior magnitude and duration of effect, must also address challenges of the complex regulatory landscape, single-administration value capture, pricing and affordability concerns. Understanding optimal routes through which to engage and approach regulatory and HTA (health technology assessment) interactions is critical to successful product development. This session will highlight best practices and lessons in aligning regulatory, value demonstration and market access efforts to optimize commercial acceptance and uptake, with case examples from North America and Europe.
Gregory Daniel, Deputy Center Director - Duke-Margolis Center for Health Policy
Eric Faulkner, MPH, Vice President, precision & Transformative Medicine - Evidera
Patricia Hurley, Senior Director - PPD Consulting
Lisa Mostovoy, Executive Director, Clinical Value, Office of Clinical Affairs - Blue Cross Blue Shield
  • Real thinking forward combining experts in the field from manufacturing, regulatory and value vision” – “great network with strong experience and sharing risks & opportunities
    Anne-Virginie Eggimann
    bluebird bio
  • Great program, great people, great venue.
    Klaus Kühlcke
  • Dynamic, interesting and highly interactive event that promotes exchange and networking in highly specialized field of gene therapy.
    Nathalie Clement
    Powell Gene Therapy Center, University of Florida
  • Phacilitate provides a unique forum, bringing together research, process development, and commercial leaders on the cutting edge of cell, gene, and immunotherapy. A great conference for anyone wanting a comprehensive view of the field.
    Dr James Trager
  • It was all business. I’ve never been to an event where over 80% of the conversations I had were constructive to my business objectives.
    Kurt Gielen
    Chemelot Campus B.V.
  • Great way to expand network with global experts in cell and gene therapy who are facing similar challenges.
    Steven Goodman