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
Chair, MassBio Board of Directors
Charles (“Chuck”) Wilson is the former President and Chief Executive Officer of Unum Therapeutics Inc. (now named Cogent Biosciences, Inc.), a company developing novel therapies for the treatment of cancer. From 2008 to 2014, Dr. Wilson served as Vice President, Global Head of Strategic Alliances for the Novartis Institutes for BioMedical Research (NIBR), the research and early development division of Novartis. In this role he was responsible for leading partnering efforts across all disease areas up through clinical proof-of-concept. His efforts included academic and biotech collaborations, equity investing in early stage companies, in-licensing of compounds, and spin-out of assets/technologies to start ups. In 2001, Dr. Wilson co-founded Archemix, a Cambridge, MA biotech company focused on the development of aptamers as therapeutics, and served as its Chief Technology Officer where he was responsible for both developing the company’s technology platform and managing its drug discovery efforts. As part of the senior management team, Dr. Wilson helped the company raise over $100 million in equity financing and advance multiple programs into clinical development. Before moving into industry, Dr. Wilson was a professor in the Markey Center for the Molecular Biology of RNA at the University of California, Santa Cruz from 1994 to 2001. Trained in structural biology and molecular biology, Mr. Wilson received a PhD with David Agard (UCSF, HHMI) and received his postdoctoral training with Nobelist Jack Szostak (Havard University / Massachusetts General Hospital). He received a B.A. and M.A. from Boston University. In addition to serving as Board Chair for the Massachusetts Biotechnology Council, he also serves as a member of the Board for GigaGen, Inc.

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