Center for Regulatory Excellence Series Kick Off

September 28, 2020 1:00 PM - 2:30 PM

Webinar, click "live-stream" button to view

Add to Calendar 9/28/2020 1:00:00 PM 9/28/2020 2:30:00 PM Center for Regulatory Excellence Series Kick Off

In collaboration with Bayer, MassBio is launching a Regulatory Center of Excellence. This is a new quarterly initiative to provide a forum for startups, biotechs, and research groups from academia to interact with experts on regulatory affairs. This event is meant to be an interactive platform for you to bring your key challenges to the discussion to better understand the evolving regulatory landscape. Our goal is to provide global regulatory insights on clinical development that will foster new innovative medicines for patients. Given the ongoing situation, our first event will be held virtually via Zoom.


Agenda:
1:00 - 1:05 pm     Welcome
1:05 - 1:15 pm     Introduction to the Center for Regulatory Excellence
1:15 - 1:35 pm     Engaging the US FDA on the Journey to Transforming Your Innovation Into a New Treatment Option
1:35 - 2:15 pm     Interactive Discussion

Moderators:

  • Chuck Wilson, President & CEO of Unum Therapeutics, and Chair, MassBio Board of Directors
  • Hanna Eilken, Strategic Alliances Director, Bayer


Bayer Panelists:

  • Max Wegner, SVP, Head of Regulatory Affairs
  • Chandra Ramanathan, Global Head, Pharma Research and Development Open Innovation
  • Todd Paporello, VP, Head Regulatory Affairs Americas

Please submit your regulatory questions to the panelists in advance. Questions to the group can be submitted to MassBio until September 18, 2020.

E-mail questions to innovationservices@massbio.org


The views and opinions expressed are those of the individual presenter and should not be attributed to any organization with which the presenter is employed or affiliated. Webinar, click "live-stream" button to view
VP, Head Regulatory Affairs Americas, Bayer
Todd Paporello is currently the Vice President & Head, Regulatory Affairs Americas and Chief U.S. Regulatory Officer for the Pharmaceuticals Division at Bayer. In this capacity, Todd is directly responsible for oversight of U.S. regulatory strategy and drug development as well as accountable for Bayer’s relationship with health authorities throughout the region. In addition to his responsibilities in Regulatory Affairs, Todd is also Bayer Pharmaceuticals U.S. Research & Development Site Head and as such is administratively responsible for R&D functions across the U.S. Externally, Todd holds the elected position of Vice Chair for PhRMA’s Regulatory Steering Group. Todd has worked in the pharmaceutical industry for over 20 years holding positions of increasing responsibility at Bayer, Hoffmann-La Roche / Genentech and Merck / Schering-Plough. Todd began his pharmaceutical industry career as a Rutgers University Post-Doctoral Pharmaceutical Industry Fellow working both at Roche and the U.S. Food and Drug Administration. Todd earned his Bachelor of Science and Doctor of Pharmacy degrees from Rutgers University and his Masters of Business Administration degree from Fairleigh Dickinson University.

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