Navigating towards FDA approval of oncology therapeutics – regulatory considerations when bringing your oncology innovation to patients
July 21, 2021 10:00 AM - 11:30 AM
Webinar, click "live-stream" button to view
Add to Calendar
7/21/2021 10:00:00 AM
7/21/2021 11:30:00 AM
Navigating towards FDA approval of oncology therapeutics – regulatory considerations when bringing your oncology innovation to patients
Following a presentation, the Bayer Regulatory Affairs team will be available to answer questions. To help ensure robust answers from the experts, please email Dr. Hanna Eilken (hanna.eilken@bayer.com) with your questions by July 15.
About the Center for Regulatory Excellence
Webinar, click "live-stream" button to view
Small and emerging biopharma companies develop highly innovative treatment solutions for diseases but often fail when approaching a regulatory milestone. This event organized by the Bayer-MassBio Center for Regulatory Excellence will focus on the regulatory landscape unique to oncology drug development in the US.
During this interactive, virtual session, Bayer will share experiences when approaching the FDA to obtain regulatory approval for oncology therapeutics. Participants will have the unique opportunity to learn from and connect with leaders from Bayer’s Regulatory Affairs teams, who will provide:
- An overview of the FDA’s Oncology Center of Excellence, its structure, and its connections to FDA Divisions (including CDRH)
- Best practices when engaging the FDA
- Key considerations regarding Real-time Oncology Review, Breakthrough Designation, Fast-Track Designation, Orphan Drug Designation, and insight into medical devices/Companion Diagnostics
Following a presentation, the Bayer Regulatory Affairs team will be available to answer questions. To help ensure robust answers from the experts, please email Dr. Hanna Eilken (hanna.eilken@bayer.com) with your questions by July 15.
About the Center for Regulatory Excellence
The Center for Regulatory Excellence is a first-of-its-kind forum initiated by Bayer and MassBio for startups and academia to interact with and learn from regulatory experts. The Center provides formal mentorship and regular seminars to ensure early identification and mitigation of regulatory issues and optimize the chances of regulatory success.
- Chitkala Kalidas
- Vice President and Global Head of Regulatory Affairs for Oncology and In Vitro Diagnostics at Bayer
- Chitkala Kalidas, is Vice President and Global Head of Regulatory Affairs for Oncology and in vitro diagnostics at Bayer. Her organization is responsible for developing appropriate global regulatory strategies for programs across multiple platforms (Radiopharmaceuticals, Oncogenic Signaling, Immuno-Oncology and Cell Therapy) in all stages of drug development and for the registration of in vitro diagnostics as well. Programs in her group include VITRAKVI® (larotrectinib), STIVARGA® (regorafenib), XOFIGO® (radium-223), ALIQOPA® (copanlisib), NEXAVAR® (sorafenib) and NUBEQA® (darolutamide), among others. Precision medicine is an area of interest for her group as well as novel development strategies including tissue agnostic development, novel clinical trial designs, pediatric development in Oncology and drug development in special populations. Dr. Kalidas has over 20 years of experience in drug development. Prior to joining Bayer, Dr. Kalidas was at Merck & Co. Inc. where she worked across multiple therapeutic areas and geographic regions. Prior to joining the pharmaceutical industry, she was a Management Consultant at the Boston Consulting Group. Chitkala has a PhD in Microbiology from Cornell University.
- See All Sessions
- David Donne
- Vice President & Group Head, Oncology Regulatory Affairs III, Bayer
- David Donne is Vice President and Group Head of Oncology Regulatory Strategy Group 3 at Bayer focusing on early immuno-oncology projects and in vitro diagnostic development for Precision Oncology programs. Prior to Bayer, he held drug discovery, development and regulatory affairs positions of increasing responsibility at Bristol-Myers Squib, Johnson & Johnson, and GSK since 1998 and contributed to the development/approval of oncology and immunology products such as Zytiga, Dazalex, Benlysta, Nubeqa, Aliqopa, and CDx for Vitrakvi. David holds a Ph.D. in Biochemistry from Purdue University and completed post-doctoral training in Molecular Biology at the Scripps Research Institute.
- See All Sessions
- Scott Greenfeder
- Vice President & Group Head, Oncology Regulatory Affairs II, Bayer
- Scott Greenfeder is currently VP Head of Oncology Regulatory Strategy Group 2 for Bayer Pharmaceuticals. Scott has more than 25 years of pharmaceutical industry experience extending from early pre-clinical drug discovery, target identification/validation to regulatory strategy for early, late stage and post-approval clinical development programs. His expertise spans various disease states including respiratory, cardiovascular/metabolic, immunology, pain and oncology. Scott attended Rutgers University for undergraduate studies and has a PhD in molecular biology from the Graduate School of Biological Sciences of New Jersey.
- See All Sessions
- Nana Hagan
- Vice President & Group Head, Oncology Regulatory Affairs I, Bayer
- Nana Hagan is a vice president and group head in oncology regulatory affairs at Bayer, with responsibility for targeted therapies including targeted radiopharmaceuticals and cell therapies. Before joining Bayer, Nana was group director and global regulatory team lead for the gastrointestinal (GI) tumor development program at Bristol Myers Squibb, and also held US and global oncology regulatory leadership roles at Roche/Genentech. Nana began his pharmaceutical industry career at Pfizer as a senior drug discovery scientist in drug discovery. He has a bachelor's degree in biochemistry from Vassar College and a PhD in biomedical sciences from the University of Massachusetts Medical School.
- See All Sessions
- 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.
- See All Sessions
- 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.).
- See All Sessions