ML19338C224
| ML19338C224 | |
| Person / Time | |
|---|---|
| Issue date: | 12/04/2019 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| Sarah Lopas, x6360 | |
| References | |
| Download: ML19338C224 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 December 4, 2019 MEMORANDUM TO: Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards FROM: Sarah L. Lopas, Project Manager /RA/
Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
SUMMARY
OF NOVEMBER 4, 2019, CLOSED MEETING BETWEEN THE U.S. NUCLEAR REGULATORY COMMISSION AND BAYER HEALTHCARE REGARDING RADIONUCLIDE THERAPIES On November 4, 2019, U.S. Nuclear Regulatory Commission (NRC) staff met with Bayer Healthcare (Bayer) staff during a closed meeting at NRC headquarters in Rockville, Maryland.
The purpose of the closed meeting was for Bayer to present proprietary information related to their targeted radionuclide therapies, including market research, radiation safety training, and emerging technologies. Bayer discussed their recent market research data on patient access barriers to one of its radiopharmaceuticals, Xofigo (radium-223). This data was updated from a similar set of data Bayer provided to the NRCs Advisory Committee on the Medical Uses of Isotopes (ACMUI) in July 2018 (this data can be found on page 58 of the ACMUIs September 2018 public teleconference transcript, which is available at Agencywide Documents Access and Management System [ADAMS] Accession No. ML18221A170). Bayers discussion highlighted the availability of nuclear medicine physicians and patients unwillingness to travel for treatments. Bayer provided an overview of its proprietary radiation safety training program for physicians using Xofigo, as well as an update on research and development efforts in its targeted radionuclide therapy portfolio.
The enclosure lists the closed meeting attendees, including one representative from the U.S. Food and Drug Administration. No written materials were prepared or distributed by the NRC staff for this meeting.
ML19338C224 *via email OFFICE NMSS/MSST/MSEB/PM NMSS/MSST/MSEB/PM NMSS/MSST/MSEB/TL NAME SLopas MAyoade* LDimmick*
DATE 12/03/19 12/4/19 12/4/19 OFFICE NMSS/MSST/MSEB/BC NMSS/MSST/MSEB/PM NAME CEinberg* SLopas DATE 12/4/19 12/4/19
SUMMARY
OF NOVEMBER 4, 2019, CLOSED MEETING BETWEEN THE U.S. NUCLEAR REGULATORY COMMISSION (NRC) AND BAYER HEALTHCARE REGARDING RADIONUCLIDE THERAPIES November 4, 2019 Meeting Participants Name Affiliation Chris Einberg U.S. NRC, Office of Nuclear Material Safety and Safeguards, Division of Materials Safety, Security, State, and Tribal Programs, Medical Safety and Events Assessment Branch (NRC/NMSS/MSST/MSEB)
Lisa Dimmick NRC/NMSS/MSST/MSEB Maryann Ayoade NRC/NMSS/MSST/MSEB Donna-Beth Howe NRC/NMSS/MSST/MSEB Sarah Lopas NRC/NMSS/MSST/MSEB Kellee Jamerson NRC/NMSS/MSST/MSEB Libero Marzella U.S. Food and Drug Administration, Office of Drug Evaluation IV William Goeckeler Bayer Healthcare Shaemus Gleason Bayer Healthcare Ashley Cockerham Mercurie Consulting Enclosure