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
Head of External Innovation, Life Sciences Innovation Group | Danaher
Chandra Ramanathan is a biopharmaceutical executive with extensive experience translating scientific ideas into treatment options & access for patients with high medical needs. He's led several initiatives across pharma, biotech, startups, & academia from early stage discovery programs to launching new products. Chandra has deep subject matter expertise across various therapeutic areas & experience in different modalities from small molecules to complex biologics including cell & gene therapy. Currently, he is the Head of External Innovation, Life Sciences Innovation Group, at Danaher Corporation. He is responsible for building and executing on external innovation strategies, including the Danaher Beacons. Previously, Chandra held various leadership positions over 12 years at Bayer. Most recently, he was the Global Head of Pharma R&D Open Innovation, where he led Open Innovation Centers (OICs) around the world (US, Europe, Japan, China, & Singapore), which focus on early access to breakthrough technologies, management of strategic alliances, & public-private partnerships. Key accomplishments include the establishment of a new innovation center & approval of a Cell & Gene Therapy Incubator in Cambridge (Investment value: $200+ Million). Chandra’s past roles at Bayer include Head of Open Innovation Center North America-East, Global Program Lead for External Innovation/Life Sciences, Global Launch Team Leader (Aliqopa), & Head of Global Oncology Pipeline Marketing. Previously, he worked at Wyeth (Pfizer) & BMS in various roles in Drug Discovery, Applied Genomics, & Business Development & Licensing. Chandra earned an MBA from Columbia Business School, a PhD in Genomics/ Bioinformatics, an MS in Medicinal Chemistry, & a BS in Pharmacy. He's an adjunct assistant professor at Tufts School of Medicine, is on the Board of Directors of MassBio, & is an Innovation, Development & Entrepreneurial Advisory Board Member at John Hopkins University.

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