ML20281A547

Agenda for October 14, 2020 Collaborative Workshop FDA-NRC: Enhancing Development of Novel Technologies - Radiopharmaceutical and Radiological Devices

ML20281A547
Person / Time
Issue date:	10/07/2020
From:	Office of Nuclear Material Safety and Safeguards, US Dept of Health & Human Services, Food & Drug Admin (FDA)
To:
Sarah L Lopas
References
Download: ML20281A547 (4)

Text

Updated October 5, 2020 1

FDA-NRC Workshop: Enhancing Development of Novel Technologies: Radiopharmaceuticals and Radiological Devices Wednesday, October 14, 2020 08:00 am EST to 5:00 pm EST Virtual Workshop Objectives

1. Develop collaborative approaches among stakeholders in development of new drug products and devices with emphasis on addressing unmet medical needs for serious and life-threatening conditions.

2. Expedite regulatory reviews and increase the overall efficiency of the development process to ensure timely access for patients to novel therapies.

Welcome and Introductions 8:00am - 8:15am Louis Marzella, FDA Kevin Williams, NRC Vincent Holahan, RRS Session I: Overview of Regulatory Process for Marketing and Licensing of Radiopharmaceutical Products, Moderator: Danae Christodoulou, FDA 8:15am - 8:35am Product Jurisdiction: Devices, Drugs and Combination Products

• FDA Product Jurisdiction James Bertram, FDA

• NRC Jurisdiction: Sealed and Unsealed Materials, Generators Donna-Beth Howe, NRC

Updated October 5, 2020 2

8:35am - 8:55am Clinical Development of Radiopharmaceutical Products: Regulatory Considerations for FDA Approval and NRC licensing

• FDA Approval Frank Lutterodt, FDA

• NRC Licensing Katie Tapp, NRC Session II: Novel Radiopharmaceuticals: Standards Development, Product Quality Considerations, Supply and Demand Moderator: Danae Christodoulou, FDA 8:55am - 9:15am DOE Isotope Program Production of Radioisotopes for Medical Applications

• Marc Garland, DOE 9:15am-9:30am Development of Physical Standards for Novel Radionuclides:

Experience with Alpha-Emitters

• Denis Bergeron, NIST 9:30am - 9:40am Product Quality Considerations: FDA Perspective on Diagnostic and Therapeutic Radiopharmaceuticals

• Danae Christodoulou, FDA 9:40am - 9:50am Special Considerations for Ge-68/Ga-68 Mo-99/Tc-99m Generators

• John Amartey, FDA 9:50am - 10:20am Product Quality Considerations: Recent Experiences with Radiopharmaceuticals Approval and Licensing.

• Ge-68/Ga-68 Generators Hugh Evans, Eckert & Ziegler Radiopharmaceutical, Inc.

• Mo-99/Tc-99m Generators James Harvey, NorthStar Medical Technologies

• Ga-68 Dotatate, Lu-177 Dotatate Maurizio Mariani, Advanced Accelerator Applications 10:20am - 10:35am Break

Updated October 5, 2020 3

10:35am - 11:05am Sessions I and II Panel:

Kaye Kang, Frank Lutterodt, James Bertram, Kristina Lauritsen, Donna-Beth Howe, Katie Tapp, Marc Garland, Denis Bergeron, Danae Christodoulou, John Amartey,, Hugh Evans, James Harvey, Maurizio Mariani Session III: Safety and Efficacy Considerations for Radiopharmaceutical Products Moderator: Anthony Fotenos, FDA 11:05am - 11:15am Pharmacology and Biodistribution of Radiopharmaceuticals

• Christy John, FDA 11:15am - 11:30am Extravasation Events: Imaging Drugs and Radiopharmaceuticals

• Kish Chakrabarti, FDA 11:30am - 11:40am NRC Perspective on Extravasation

• Lisa Dimmick, NRC 11:40am - 11:50am Role of Individualized Dosimetry to Optimize Safety and Efficacy of Radiopharmaceutical Therapies

• Mitchel Anscher, FDA 11:50 am - 12:00 Role of Dosimetric Studies in Clinical Development of Radiotherapeutic Products-Industry Perspective

• Bill Goeckler, Bayer Healthcare 12:00pm - 12:45pm Lunch 12:45pm - 1:15 pm Session III Panel:

Christy John Kish Chakrabarti, Lisa Dimmick, Mitchel Anscher, Bill Goeckler, Joseph Rajendran Session IV: The Evolving LandscapeRadiological Devices Moderator: Ralph Lieto, ACR 1:15pm - 1:35pm Radiological Devices: Total Product Life Cycle

• Julie Sullivan and Mike Ohara, FDA 1:35pm - 1:45pm Sealed Sources and Device Registry

• Tomas Herrera, NRC

Updated October 5, 2020 4

1:45pm - 2:00pm Gammaknife and Microspheres-NRC Perspective

• Katie Tapp, NRC 2:00pm - 2:15pm Industry Experience in Regulatory Process for Radiological Devices Diana Thompson, Sirtex 2:15pm - 2:45pm Session IV Panel: Julie Sullivan, Mike Ohara, Diana Thompson, Tomas Herrera, Katie Tapp 2:45pm - 3:00pm Break Session V: Clinical Trial Design Considerations for Radiopharmaceuticals:

Moderator: H. Timothy Hsiao, ASTRO 3:00pm - 3:15 pm Safety Assessment for Radiotherapeutics

• Denise Casey, FDA 3:15pm - 3:30pm Efficacy Considerations for Theranostic Pairs

• Sue-Jane Wang, FDA 3:30pm - 3:45 pm Clinical Trial Considerations from Academic Perspective

• Ana Kiess, ASTRO 3:45pm - 4:15pm Patient and Physician Perspectives on Advancements in Therapeutics

• Josh Mailman

• Hossein Jadvar 4:15pm - 4:45pm Session V Panel: Denise Casey, Sue-Jane Wang, Josh Mailman, Hossein Jadvar, Ana Kiess 4:45pm - 5:00pm Closing Remarks

• Louis Marzella, FDA