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
  • Hanna Eilken
  • Strategic Alliance Director, Bayer
  • Hanna Eilken is currently a Director for Strategic Alliances and an innovation partner at Bayer Pharmaceuticals. In addition to managing strategic cardiovascular research collaborations for Bayer in Cambridge, Hanna is scouting external innovation, breakthrough technologies, new business opportunities and potential partnerships fitting various areas of Bayer’s focus. In her previous role, Hanna has been working as a lab head in Pharmacology at Bayer focusing on Ophthalmology where she led projects from early target discovery through the lead optimization phase. Hanna is a biologist by training and earned her doctoral degree from the Ludwig-Maximilians University in Munich, Germany.
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  • Todd Paporello
  • 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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  • Chandra Ramanathan, Ph.D.
  • 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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  • Max Wegner
  • SVP, Head of Regulatory Affairs, Bayer
  • Max Wegner is the Senior Vice President, Head of Regulatory Affairs at Bayer. In this role Max is responsible for oversight of all Regulatory Affairs activities in the Bayer Pharmaceuticals division. He started his career studying pharmacy at the University of Bonn and commenced his PhD in pharmacology at Bayer, starting in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also spent some time in China and the USA. Max led the Clinical Development organization in Pharmaceuticals Development for four years before re-joining the Regulatory Affairs organization in 2018 as head of the group. As a special Pharmacist for Drug Information, he is a member of the examination board of the Pharmacy Association Nordrhein-Westfalen. Additionally, Max is a college lecturer and speaker for various regulatory topics and he regularly speaks at/chairs various organizations meetings (DGRA, DIA, EFPIA, CIRS etc.).
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  • Charles Wilson
  • 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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