ML20029F006

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M200128: Scheduling Note and Slides
ML20029F006
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Issue date: 01/28/2020
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SCHEDULING NOTE

Title:

DISCUSSION OF MEDICAL USES OF RADIOACTIVE MATERIALS (Public Meeting)

Purpose:

The purpose of the briefing is to provide the Commission with an update on the NRC's program for medical uses of radioactive materials, a status of recent activities related to the licensing and oversight of medical uses of radioactive materials, the views of stakeholders on recent NRC initiatives, and suggestions regarding transformation/innovation opportunities.

Scheduled: January 28, 2020 9:00 a.m.

Duration: Approx. 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> Location: Commissioners' Conference Room, 1st fl OWFN NRC Staff Panel 40 min.*

Steven West, Deputy Executive Director for Materials, Waste, Research, State, Tribal , Compliance, Administration, and Human Capital Programs

  • Overview of the NRC's program for medical uses of radioactive materials Kevin Williams, Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST}, Office of Nuclear Materials Safety and Safeguards (NMSS)
  • Status of recent NRC staff activities Lisa Dimmick, Team Leader of the Medical Radiation Safety Team, MSST, NMSS
  • Innovation opportunities and initiatives Katherine Tapp, PhD, Medical Radiation Safety Team, MSST, NMSS
  • Efforts to prepare for the review of emerging medical technologies Donna Janda, Chief, Medical and Licensing Assistance Branch, Division of Nuclear Materials Safety, Region I
  • Regional perspectives on licensing and oversight of medical licensees Commission Q & A 40 min.

Break 5 min.

External Stakeholder Panel 40 min.*

Murray Sheldon, MD, Associate Director for Technology and Innovation, 8 mins.*

Center for Devices and Radiological Health, U.S. Food and Drug Administration

  • Stakeholder suggestions regarding transformation/innovation opportunities for the NRC to explore :.... federal perspective Terry Derstine, Chair, Organization of Agreement States 8 mins.*
  • Emerging issues regarding the national program for the regulation of medical uses of radioactive materials Thomas Eichler, MD, President, American Society for Radiation Oncology 8 mins.*
  • Stakeholder suggestions regarding transformation/innovation opportunities - medical community perspective Vasken Dilsizian, MD, President, Society of Nuclear Medicine 8 mins.*

and Molecular Imaging

  • Perspectives on recent NRC staff initiatives related to medical uses of radioactive materials Josh A. Mailman, President, NorCal CarciNET Community 8 mins.*
  • Stakeholder suggestions regarding transformation/innovation opportunities for the NRC to explore - patient perspective Commission Q & A 40 min.

Discussion - Wrap-Up 5 min.

  • For presentation only and does not include time for Commission Q & A 2

Discussion of Medical Uses of Radioactive Materials Commission Meeting January 28, 2020

Overview of the NRCs Program for Medical Use Steven West Deputy Executive Director for Materials, Waste, Research, State, Tribal, Compliance, Administration and Human Capital Programs 2 2

NRC Panel will Address the Following Topics

  • Status of NRC Staff Activities
  • Innovation Opportunities and Initiatives
  • Efforts to Prepare for the Review of Emerging Medical Technologies
  • Regional Perspective on Licensing and Inspecting Medical Uses 3

Meeting the Medical Uses Policy Statement Objectives Regulate to provide for radiation safety of workers and the general public.

Not intrude into medical judgements, except as necessary to protect radiation safety of workers and the general public.

When justified by the risk to patients, regulate radiation safety of patients primarily to assure medical use is in accordance with the physicians directions.

In developing a specific regulatory approach, consider industry and professional standards that define acceptable approaches of achieving radiation safety.

4

Two Categories of Medical Use

  • Diagnostic

- Imaging organs, systems, and functions

- Gamma camera, PET, PET/CT, or SPECT

- Nuclear medicine, nuclear cardiology, endocrinology, diagnostic radiology 5

Two Categories of Medical Use

  • Therapeutic

- Radiopharmaceutical therapy, teletherapy, brachytherapy, gamma stereotactic radiosurgery

- Nuclear medicine, endocrinology, radiation oncology, interventional radiology 6

Status of NRC Staff Activities Kevin Williams, Deputy Director Division of Materials Safety, Security, State, and Tribal Programs NMSS 7 7

Ensuring an Effective Medical Program through Coordination

  • Training and experience
  • Patient release
  • Prevention of medical events
  • Medical AO thresholds
  • Extravasations 8

Gathering Stakeholder Input on Training and Experience Outreach for the staffs evaluation of T&E for radiopharmaceuticals under 10 CFR 35.300 included

- Three Federal Register notices

- Two public comment periods

- Six public meetings

- Five online newsletter articles published

- Four conferences attended

- Three medical list server announcements

- 200+ letters to solicit input 9

Informing the Public About Treatment with Radioactive Drugs

  • Phase 1 revision to RG 8.39, Release of Patients Administered Radioactive Material expected April 2020
  • Phase 2 update to RG 8.39 began in October 2019 10

Preventing Medical Events IN-2019-06 IN-2019-07 Patient Skin Methods to Prevent Contamination Events Medical Events with I-131 MIBG IN-2019-11 Sr-82/Rb-82 IN-2019-12 Generator Elution Y-90 Medical Events Events 11

Evaluating Medical Abnormal Occurrence Thresholds

  • Staff reviewed medical event AOs
  • Concluded that medical event AO criteria may capture events that are not significant from the standpoint of public health and safety

Evaluating Extravasations

  • ACMUI subcommittee recommendations on extravasations and infiltrations in April 2019

- Extravasation is a practice of medicine issue, not an item that needs to be regulated by the NRC

- Extravasation should not be considered a medical event unless there is unintended permanent functional damage

  • NRC staff is conducting an independent evaluation 13

Innovation Opportunities and Initiatives Lisa Dimmick, Team Leader Medical Radiation Safety Team 14 14

Reconsidering the Training and Experience Requirements

  • TASK: Determine whether and how to tailor the T&E requirements for different categories of radiopharmaceuticals
  • CHALLENGES: Current regulatory framework is prescriptive; NRC and Agreement States must review and approve T&E for AUs What if we changed the framework?

15

Thinking About Transformation 16

Proposing to Change the Regulatory Framework

  • Removal of prescriptive T&E for AUs of unsealed byproduct material
  • NRC and Agreement States no longer review and approve T&E
  • AUs must be credentialed by a recognized medical specialty board
  • Maintain high-level board recognition criteria 17

Streamlining our Process for Reviewing Emerging Technologies Medical Team Standing individual with Committee, Concur and support ACMUI, Resolve issue licensing develops Agreement comments guidance licensing States, Regions guidance review Total time 8 months (6 months savings) 18

Efforts to Prepare for the Review of Emerging Medical Technologies Katie Tapp, Ph.D., Medical Physicist Medical Safety and Events Assessment Branch 19 19

Flexible Regulatory Framework for Emerging Medical Technologies

  • Supports efficient licensing of emerging technologies 20

Evaluation Process of Emerging Medical Technologies

  • Evaluate if medical use is addressed in 10 CFR 35 Subparts D through H

- If no, staff develops recommended conditions of use and 10 CFR 35.1000 licensing guidance

- If yes, staff may still provide licensing and inspection guidance on specific radiation safety aspects 21

Effective Stakeholder Engagement on Emerging Technologies Professional ACMUI Societies Developers Professional and Early Societies Users 22

Yttrium-90 Microsphere Brachytherapy

  • Several new manufacturers developing microsphere and micro-particle devices 23

Gamma Stereotactic Radiosurgery Units

  • Original regulations developed for Gamma Knife, which treated the brain using stationary sources, helmet collimators, and a frame
  • Newer units - Perfexion, Icon, GammaPod, Infini, Galaxy, Orbiter, Vertex 24

Response to Evolving Medical Landscape

  • Updates for Emerging Medical Technologies Rulemaking would incorporate medical uses approved under 10 CFR 35.1000 into relevant subparts of 10 CFR Part 35
  • Joint NRC/OAS WG working to complete the rulemaking plan by Summer 2020 25

Alpha DaRT (Diffuse Alpha Radiation Therapy)

Check-Cap

  • Colorectal cancer screening
  • Sealed source for diagnosis (35.500 vs. 35.1000)
  • Authorized user T&E
  • Waste disposal 27

Increase in Veterinary Uses of Byproduct Material

  • Sn-117m colloid for treatment of osteoarthritis of canine elbow
  • Y-90 particles for treatment of pet sarcomas 28

Different Public Dose Limits for Animal Release

  • Higher public dose limits for the release of human patients
  • Release of animals must comply with 10 CFR Part 20 public dose limits 29

Regional Perspective on Licensing and Inspecting Medical Uses Donna Janda, Branch Chief Medical Licensing Assistance Branch Division of Nuclear Materials Safety, Region I 30 30

Regional Experiences with the Part 35 Changes 31

Inspection of Patient Release 32

Review of Medical Events 33

Coordination with Agreement States and Headquarters 34

Acronyms ACMUI - Advisory Committee on the Medical Uses of Isotopes AO - Abnormal Occurrence AU - Authorized User CFR - Code of Federal Regulations CRCPD - Conference of Radiation Control Program Directors CT - Computed Tomography DaRT - Diffuse Alpha Radiation Therapy FDA - U.S. Food and Drug Administration 35

Acronyms GSR - Gamma stereotactic radiosurgery I-131 MIBG - Iodine-131 Metaiodobenzylguanidine IAEA - International Atomic Energy Agency IN - Information Notice NRC - U.S. Nuclear Regulatory Commission OAS - Organization of Agreement States PET - Positron-emission tomography Ra-224 - Radium-224 36

Acronyms Rb Rubidium-82 RG - Regulatory Guide Sn-117m - Tin-117m SPECT - Single-Photon Emission Computerized Tomography Sr Strontium-82 T&E - Training and Experience WG - Working Group Y Yttrium-90 37

U.S. FOOD & DRUG ADMINISTRATION Transformation/Innovation Opportunities for the NRC to Explore Federal Perspective Murray Sheldon, MD Center for Devices and Radiological Health U.S. Food and Drug Administration Nuclear Regulatory Commission Discussion of Medical Uses of Radioactive Materials (public meeting)

Rockville, MD January 28, 2020

CDRH Mission and Vision 01/29/2020 2

Long-term Decline in Start-up Density Since 1988 Stark decline in Medtech since 2006 to ~600 in 2012

Makower Report (2010):

FDA Impact on US Medical Technology Innovation United States $10M $8M $40M $13M FDA Apply for Safety study Pivotal study FDA approval IDE submission Initial reimbur-Same starting sement point: Clinical 0 7 14 21 28 35 42 49 56 63 70 (months)

Development Initial reimbursement Safety study CE mark approval CE mark submission Europe $8M

$1M

~ 4 years longer to regulatory approval in US versus Europe 4

Adapted from: Josh Makower white paper, FDA Impact on US Medical Technology Innovation, November 2010

Entrepreneurs-in-Residence Program One (Oct 2011 - May 2012)

Overview: The Entrepreneurs-in-Residence (EIR) program at CDRH is a time-limited recruitment of world-class entrepreneurs and innovators to join highly-qualified internal government employees in the development of solutions in areas that impact innovation Goal: The EIR goal is to deliver transformational change by combining the best internal and external talent applying the principles of lean engineering in rapidly testing, validating and scaling new approaches Focus: To better understand the drivers for the CDRH vision and to develop a new expedited pathway to improve patient access to innovative medical devices

- ESRD Innovation Challenge (2013 - 2016)

- Breakthrough Devices Program (2018)

Source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/InnovationPathway/ucm286138.htm 5

US Medical Device Industry:

Innovation Challenges Factors cited as having the highest impact on decisions to move medical device investment outside of U.S.*

Regulatory Challenges - 38%

Reimbursement Concerns - 18%

Clinical Trial Time and Costs - 14%

  • from National Venture Capital Association/Medical Innovation & Competitiveness Coalition survey of 259 NVCA member firms investing in the healthcare sectors; 60% (156 firms responding) October, 2011 6

Entrepreneurs-in-Residence Program Two (Oct 2012 - May 2013)

Focus: The EIR teams confronted the three challenging areas identified by NVCA that have the potential to better support a more robust environment for medical device innovation:

- Streamlining clinical trials

- Streamlining FDA approval to reimbursement

- Striking the right balance between pre- and post-market requirements Source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/InnovationPathway/ucm286138.htm 7

FDA Responds to the Challenge

  • Clinical Trials Program in ODE based on recommendations from the EiR Program Early feasibility program: 17 approvals in FY 2013; 51 in FY 2019 Adaptive and Bayesian design Patient-Centric Benefit/Risk; Patient perspectives
  • Payor Communication Task Force to Streamline the path from FDA Approval to Payer Coverage (from EiR)
  • Balancing Pre and Post-market Evidentiary Requirements NEST - the use of Real-World Evidence Coordinated Registry Networks (CRNs) www.fda.gov 8

Continuous Innovation Internal Innovation

  • Training visits to innovative incubators/accelerators
  • Training visits to payors Public Private Partnerships
  • KHI - American Society of Nephrology and FDA (2012)
  • KidneyX - American Society of Nephrology and HHS (2018): Uses prize competitions to accelerate the development of innovative solution that can prevent, diagnose and/or treat kidney diseases 01/29/2020 9

Thank You 10

ASTRO AMERICAN SOCIETY FOR RADIATION ONCOLOGY 251 1s*hSt. South, s*hFloor Arlington, VA 22202 TARGF TIN G CANC F R CARF Main: 703.502.1550

  • Fax: 703.502.7852 www.astro.org
  • www.rtanswers.org Statement of Thomas Eichler, MD, FASTRO On behalf of The American Society for Radiation Oncology Before the Nuclear Regulatory Commission January 28, 2020 Good morning. Thank you very much for inviting me today. My name is Dr. Thomas Eichler and I am a board-certified radiation oncologist at the Sarah Cannon Cancer Institute in Richmond Virginia. I am also the President of the American Society for Radiation Oncology, or ASTRO for short. ASTRO is the largest radiation oncology society in the world, with more than 10,000 members who specialize in treating patients with a variety of radiation therapy techniques. We thank you for your commitment to stakeholder engagement and appreciate the opportunity to collaborate with the NRC.

Before I move on to suggestions regarding transformation and innovation opportunities from the medical community perspective, I want to take a moment to discuss the staffs recent recommendations regarding training and experience for radiopharmaceuticals. The proposal gives us cause for concern. We continue to believe that there is no need to pursue additional rulemaking, as current regulations are appropriate, protect the safety of patients, the public, and practitioners. However, if the Commission ultimately decides to pursue rulemaking, we believe the board recognition criteria must ensure that existing requirements are maintained, and that any criteria for additional boards is equivalent to existing requirements.

You asked me to speak about transformation and innovation opportunities from the medical community perspective, and I would like to highlight a 2017 ACMUI report entitled Medical Event Reporting and Impact on Medical Licensee Patient Safety Culture. In its report, the ACMUI made two important observations:

1. First, the NRCs medical event reporting criteria are set at conservative levels - which include events that rarely cause patient harm - when compared to other criteria set by The Joint Commission, the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS). This inconsistency in definitions leads to inconsistent levels of response to a patient safety event and causes confusion in the medical community.
2. Second, despite the recognition that the medical events rarely cause patient harm, a licensee is required to notify the NRC no later than the next calendar day after discovery.

After the notification, an inspection occurs looking for violations as the cause of the event.

In other words, the NRCs conservative medical event reporting requirements are inconsistent when compared to other regulatory requirements and current radiation oncology practice, and do not foster a culture of safety.

Based on these observations, as well as the need to consider other ways medical events could be evaluated, the ACMUI made the following recommendations:

The NRC should establish a program allowing a medical use licensee to evaluate medical events as described in current regulations with an approved patient safety program. The ACMUI describes an approved patient safety program as one or more of the following: a safety program that reports medical events to a Patient Safety Organization (PSO) which has medical expertise in medical use as defined in Part 35; a safety program evaluated by a CMS-approved Accrediting Organization, or; a safety program which is established as part of accreditation by a professional organization for medical use as defined in Part 35.

NRC licensees with an NRC-approved patient safety program will continue to report medical events as required with certain conditions. These conditions include the NRC not including these events in the Event Notification Report, or, if this is not possible, posting them anonymously. And probably more importantly, the NRC does not conduct a reactive inspection unless the event results in, or will result in death, unintended permanent harm, or unintended significant temporary harm for which medical intervention is required. Additionally, the licensee will write a report describing the event and corrective action taken which will be made available for the next NRC inspection.

Finally, the NRC will develop inspection procedures to support a test of this program.

The NRC should test this program with various medical practice sizes and locations, evaluating the medical event reports with the ACMUI.

After completion of the test year, the NRC should consider opening the program to all NRC medical use licensees who request approval of their patient safety program, and to Agreement States who request to implement the program with their medical licensees.

ASTRO supports the recommendations offered by the ACMUI to promote a culture of safety for medical licensees. The progressive recommendations align with ASTROs commitment to improving quality and safety in radiation oncology, and support the NRCs Safety Culture Policy Statement, while at the same time maintaining the NRCs regulatory authority to protect patients during the medical use of byproduct materials. We believe that both ASTROs Accreditation Program for Excellence (APEx) and ROILS: Radiation Oncology Incident Learning System fulfill the spirit and the requirements set forth by the ACMUI.

First, I would like to discuss APEx. APEx was launched in February 2015 and to date, has accredited more than 150 facilities. The mission of APEx is to recognize facilities by objectively assessing the radiation oncology care team, policies and procedures, and the facility. APEx supports quality improvement and patient safety in radiation therapy practices. Facilities that obtain APEx practice accreditation will have the systems, personnel, policies and procedures that are needed to deliver safe, high-quality patient care.

Obtaining APEx accreditation is a multistep process beginning with an application and contract, followed by a thorough selfassessment, including a robust medical record review and document upload of relevant processes, procedures and other documents, a facility visit by radiation oncology professionals who are trained as APEx surveyors, and finally a determination made by

ASTROs APEx committee. The APEx program is constantly evolving with regular quality assurance performed by the APEx committee.

The APEx standards represent the cornerstone of the program and identify systematic quality and safety approaches that build on and reinforce regulatory requirements to add value for practitioners and health care consumers. They are organized around five pillars: The Process of Care in Radiation Oncology; The Radiation Oncology Team; Safety; Quality Management and Assurance in Radiation Oncology; and Patientcentered Care.

Of the 16 APEx standards, the Culture of Safety standard specifically requires that the radiation oncology practice foster a culture in which all team members participate in assuring safety, capitalize on opportunities to improve safety and does not take reprisals upon staff that report safety concerns. This standard ensures that the practice fosters a culture where learning from patient safety events and unsafe conditions is a part of the process of care, and is a mandatory component of the program. We believe that the most effective way for facilities to take action on a safety event or unsafe condition is for them to take ownership of the corrective actions in a nonpunitive environment. The facilities are in the best position to make changes and improve safety since they are most familiar with their own processes and procedures. We are pleased that the ACMUI embraced this approach to safety culture, especially when it comes to medical event reporting.

Now I would like to turn your attention to RO-ILS. RO-ILS embodies these same ideals, albeit in a slightly different way. ROILS facilitates the collection and reporting of patient safety events from all participating facilities to make suggestions for change. The mission of ROILS is to facilitate safer and higher quality care in radiation oncology by providing a mechanism for shared learning in a secure and nonpunitive environment. While important legal protections prevent ROILS from sharing reported information by a facility, the facility has the ability, and is often required, to share relevant information with the NRC (and other federal and state regulators).

RO-ILS is part of an Agency for Healthcare Quality and Research (AHRQ)-approved PSO. RO-ILS has more than 500 facilities enrolled, and more than 12,000 events have been reported.

Approximately 300 of those events involve radioactive materials1. Approximately 44% of the reported events are classified by users as operational/process improvement, which is defined as a non-safety event. This suggests that practices are utilizing the system for more comprehensive quality improvement. An additional 12% of events are classified as therapeutic radiation incidents, where the radiation dose is not delivered as intended, with or without harm, with the majority of those having a less than 5% dose deviation.

The culture of safety in medicine has completely shifted from one of blame to one focused on learning. This has led to an increase in reporting. RO-ILS participants want to identify events and near misses, create interventions to prevent them from happening again, and share safety 1

Note: this number does not include events using GammaKnife because those are grouped under the broader stereotactic radiosurgery events, which include linear accelerators.

risks and solutions with others. Analyzing safety events that were caught before reaching the patient and addressing those error-prone processes is a critical aspect of incident learning in medicine. We believe the current NRC medical event reporting approach does not focus sufficiently on learning, and the ACMUI recommendation holds great promise for improving the process.

To reiterate, ASTRO believes that the NRC could play a greater role in improving safety culture in radiation therapy by implementing the ACMUIs recommendations.

Thank you, and I look forward to answering your questions.

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SOCIETY Of NUCl EAR MEDICINE & MOU:CUlAR IMAGING Vasken Dilsizian, M.D.

President, SNMMI

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SOCIETY OF NUCLEAR MEDIC1NE & MOtECULAR IMAG4NG SNMMl's History

  • Founded in 1954
  • The largest international scientific organization dedicated to nuclear medicine and radionuclide therapy
  • A multidisciplinary organization
  • Over 15,000 physicians, scientists, pharmacists and technologists

(111),&1 Valu&~ *WbJ SOCl! !AiMEDICJN

!~!!!~~!~! C urren t Path ways f or Obta1n1ng *

  • AU Stat us
1. Certification by a medical specialty board whose certificate is recognized by the NRC or an agreement state (American Board of Nuclear Medicine, American Board of Radiology, and American Board of Osteopathic Radiology)
2. Completion of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom training and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience in an ACGME accredited program (Nuclear Medicine, Diagnostic Radiology with 16 month NM/NR pathway, or Radiation Oncology)
3. Previous identification as an Authorized User on an NRC or Agreement State license of permit

NRC-2018-0230: Draft Approaches for Addressing T&E Requirements for Radiopharmaceuticals Requiring a Written Directive

  • We thank the NRC for the opportunity to provide feedback
  • Our main objective is to emphasize Patient and Public Safety, while ensuring Access to Quality of Care
  • The NRC's advisor board (ACMUI) identified no Authorized User shortage in their revised report (ACMUI July of 2018) and "strongly supported maintaining current AU pathways"
  • Thus, there seems to be no clearly defined or compelling need to develop a new tailored T&E pathway

1Blllr&1 Valu&~ *WbJ r&1D Initiative S0Clf1Y Of NUCLEAJ! MEDICJNE & MotECUlAR IMAGING NRC staff's SECY-20-0005 paper:

SUMMARY

NRC staff's SECY paper. SECY-20-0005: "Rulemaking Plan for Training & Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35)."

  • The NRC staff finds that given the expected growth in the field of nuclear medicine and uncertainties in the safety-related characteristics of emerging and future radiopharmaceuticals, such as energy level, dose, half-lives, and administration protocol, a less prescriptive and more performance-based approach to regulating T &E would be beneficial because it could cover radiopharmaceuticals beyond those currently known or 1n use.
  • In addition, increased involvement by the medical community in determining the appropriate safety criteria for radiopharmaceuticals and setting the associated T&E requirements could help accommodate the increasing "interest" of non-nuclear medicine and non-radiation oncology physicians in using radiopharmaceuticals.

While the staff considered stakeholder concerns about patient access, the availability and geographic distribution of AUs did not drive the staff's evaluation of T&E.

1Blllr&1 Valu&~ *WbJ r&1D Initiative NRC RULEMAKING PLAN - SECY-20-0005:

S0Clf1Y Of NUCLEAJ! MEDICJNE & MotECUlAR IMAGING RECOMMENDATION - 1/13/2020

  • NRC staff's recommendation to initiate a rule making to remove prescriptive T&E requirements and to eliminate the need for NRC review and approval of AUs. The staff's recommended option would require that physicians be certified by an NRC-recognized or Agreement State-recognized medical specialty board to become AUs.
  • As part of this recommended rulemaking , the NRC would revise its board recognition criteria so that certification by specialty boards other than the existing nuclear medicine and radiation oncology boards would be an acceptable T&E pathway for the use of radiopharmaceuticals.
  • The staff's recommended rulemaking option would continue to protect public health and safety, better align the NRC's T&E requirements with the Medical Policy Statement, and position the agency for more effective and efficient regulatory decision making with respect to the expected increase in the number and complexity of emerging radiopharmaceuticals.
  • The recommended option would also alleviate regulatory burden for the NRC, Agreement States, and licensees, resulting in an estimated cost savings of $2.4 million per year.

1Blllr&1 Valu&~ *WbJ r&1D Initiative S0Clf1Y Of NUCLEAJ! MEDICJNE & MotECUlAR IMAGING Other Important Views to Consider

  • Who will be training the current oncology, urology, or other medical specialties and how do we ensure that the next generation of residents and fellows in these area receive competency based training? There are no (or perhaps only a handful of) Authorized Users in these medical specialties at the present time.
  • Expansion in medical specialty training requires ACGME review committee discussion and approval in each of these medical specialties. NRC does not have iurisdiction to require changes in medical and surgical residency or fellowship training.
  • Nuclear Medicine, Radiation Oncology and Diagnostic Radiology with 16 month NM/NR pathway are the only ACGME-approved training programs that have specific goals and objectives pertaining to administration of radioactive material.

These have to be completed under the supervision of Board Certified physicians who also have been trained in this area.

1Blllr&1 Valu&~ *WbJ r&1D Initiative S0Clf1Y Of NUCLEAJ! MEDICJNE & MotECUlAR IMAGING Other Important Things to Consider

  • Independent of the medical or surgical specialty board, the AU candidate must attest to the acquisition of§ 35.390 knowledge topics & skills by successfully completing a formal competency assessment with continued formal periodic competency reassessment to maintain his/her limited-scope AU status (competency certification for radionuclide therapy).
  • Given that this type of training is not part of standardized program requirements in these medical and surgical subspecialty areas, the question arises as to which organization is best suited to ensure competency and safe administration of these agents from individuals who have sought this additional training?
  • Which subspecialty Board would be most qualified to certify these medical specialty candidates as qualified and competent for radionuclide therapy? American Board of Nuclear Medicine or Medical Specialty Boards without adequate mentors or educators to cover the§ 35.390 knowledge topics & skills?
  • Undoubtedly, organizations that have the most experience and expertise in these areas are Nuclear Medicine, Diagnostic Radiology and Radiation Oncology.

1Blllr&1 Valu&~ *WbJ r&1D Initiative S0Clf1Y Of NUCLEAJ! MEDICJNE & MotECUlAR IMAGING Release of Patients Administered Radioactive Material NRC-2019-0154: Release of Patient Administered Radioactive Material

  • We thank the NRC for the opportunity to provide feedback on the patient release criteria.
  • The SNMMI submitted comments for this patient guide in June 2017 and again in September 2019, following the current revision, to provide licensees with more detailed instructions for their patients before and after they have been administered radioactive material
  • This revision included new section on "Death of a Patient Following Radiopharmaceutical or Implants Administrations," and "Dosages of Radiopharmaceuticals that Require Instructions and Records when Administered to Patients who are Breastfeeding an Infant or Child"

1Blllr&1 Valu&~ *WbJ r&1D Initiative S0Clf1Y Of NUCLEAJ! MEDICJNE & MotECUlAR IMAGING Release of Patients Administered Radioactive Material

  • SNMMI submitted specific comments related to radiation monitoring of family members, breastfeeding interruption limits and guidance for families and children
  • SNMMI agrees that the written and oral instructions must be provided to the patient far enough in advance of treatment, without compromising patient care, to ensure that the patient has sufficient time to determine whether or not he/she can actually comply with the instructions and to make whatever arrangements may be necessary for compliance
  • SNMMI is keenly aware of the usage and impact of social media on education. Accordingly we are planning to develop a video clip that will be available on the Society's website and on YouTube for patients to view the entire radioactive material administration procedure and follow instructions in advance of their treatment.

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SOCIETY OF NUCLEAR MEDIC1NE & MOtECULAR IMAG4NG Targeted Radiopharmaceutical Therapies rowth Areas

  • Targeted Radiopharmaceutical Therapies are expected to be an area of tremendous growth in the coming years with several new agents under testing and development, in clinical trials, or in clinical use.
  • Some examples of alpha- and beta-emitting targets include:
1) FDA-approved Radium-223 therapy for metastatic prostate cancer and other cancers in bone
2) Other alpha-emitting therapeutics targeting a variety of receptors including prostate specific membrane antigen (PSMA)
3) FDA-approved Lutetium-177-labeled somatostatin analog (Lu-177 dotatate) therapy for neuroendocrine and other somatostatin receptor expressing tumors
4) Lutetium-177 PSMA therapies for metastatic or treatment-resistant prostate cancer
5) lodine-131 labeled antibodies to leukemia targets (such as CD-33)
6) Other indications in Phase 2 or 3 trials include Colorectal Cancer, Non-Hodgkin's Lymphoma and Leukemia

1Blllr&1 Valu&~ *WbJ r&1D Initiative S0Clf1Y Of NUCLEAJ! MEDICJNE & MotECUlAR IMAGING Potential Barriers to Patient Access

  • Addition of new diagnostic and therapeutic isotopes to a Radioactive Material License (RAML) can be time consuming -

up to 6 months - and can be variable from state to state

  • Isotope/agent-specific training for targeted therapeutic dosing and patient administration

1Blllr&1 Valu&~ *WbJ r&1D Initiative S0Clf1Y Of NUCLEAJ! MEDICJNE & MotECUlAR IMAGING Acronyms

  • AU - Authorized User
  • ACGME - Accreditation Council for Graduate Medical Education
  • FDA - Food and Drug Administration
  • NRC - Nuclear Regulatory Commission
  • T&E -Training and Experience
  • RAML - Radioactive Material License
  • PSMA - Prostate Specific Membrane Antigen
  • NM/NR - Nuclear Medicine/Nuclear Radiology

Innovation and Education Medica l Us e of Is otopes Pa tien t Pers pectives J os h Ma ilm a n NorCa l Ca rciNET Com m u n ity

Disclosure NorCal CarciNET receives funding for educational and s peaking events from AAA, Curium, IPSEN, Lexicon, Novartis , and Progenics .

Views expres s ed during this pres entation are s olely my own.

Thank you on behalf of patients for this opportunity to participate in this forum

Who am I ?

Diagnos ed in 2007 with a Pancreatic Neuroendocrine Tumor Firs t nuclear imaging in 2007 Firs t Ga68 PET/ CT in Germany 2008 Firs t Nuclear Medicine Therapy in Germany 2009 Selected current affiliations :

Pres ident - NorCal CarciNET Community COO - World As s ociation of Radiopharmaceutical and Molecular Therapy Inaugural pres ident of Patient Advocate Advis ory Board and Ga68 Working Group- SNMMI Treas ure and Board Member - Neuroendocrine Tumor Res earch Foundation

About Neuroendocrine Tumors (NETS)

Cons idered a Rare or Orphan Dis eas e Low incidence ~ 7/ 100k ~ 21,000 Second highes t prevalence for GI Cancer

~ 172k Aris ing from cells of the endocrine (hormonal) and nervous s ys tems . Yao, JCO 08 They can occur all over the body Often hard to diagnos e due to confus ing s ymptoms and imaging challenges (more on that later)

NETS overexpres s naturally occurring s omatos tatin receptors

Approvals for Nuclear Medicine for NET Patients J une 2016, NETSPOT - Ga68 Dotatate for Imaging J anuary 2018, Lutathera - Lu177 Dotatate for Treatment of GEPNETS J uly 2018, Azedra - I131 - Para/ Pheo J une 2019, Ga68 Dotatoc for imaging

Future Isotopes under Consideration We concur with the SNMMI, EANM and WARMTH on the promis ing us e of Alpha emitters and Copper 67 for s everal dis eas e indications beyond NETS Actinium-225 (225Ac) * -

Lead-212 (212Pb)* -

Copper-67 (67Cu) -

Thorium-227 (227Th) -

Terbium-149 (149Tb) -

Bismuth-213 (213Bi) -

Astatine-211 (211At) -

Patients Overjoyed with Availability Were des perately s eeking any Ga 68 imaging s ince 2012 Facebook on NETSPOT approval generated over 100 comments on approval date Little unders tanding of the complexity of delivery Lutathera approval has allowed a therapeutic option availability that was limited to only thos e who could afford to travel overs eas With Availability Comes New Opportunities for Education.

New Options in a New Era of Information Overwhelming res pons e is pos itive to thes e approvals - but information challenges for patient, providers , and payers are magnified by the us e of s ocial media Concerns , confus ion and mis information regarding Patient releas e ins tructions DIffers by treatment facility Fear of the unknown with Radiation Some families (and pets ) are s eparated from each other for weeks Des ire to work thos e that are trained are experienced with new drugs Mis reads or mis unders tanding of imaging Wanting to us e an experienced center Challenge of getting this paid for All magnified in the lens of Facebook, and private patient s upport portals

Areas Where the Patient Releas e Criteria NRC Ca n Help Maintaining Education Standards Managing Regulatory Challenges

Patient Release Criteria NorCal CarciNET res ponded to Docket ID-NRC-2019-0154 Our res pons e as ked the NRC to cons ider adding is otope to tables 1 and 2 even if below thres hold value with NA or

  • to indicate that the ins tructions do not apply as below thres hold.

Cons ider a patient friendly vers ion of the Releas e Criteria s o that patient can us e this in dis cus s ion with their provider Confirm all values and bes t practice with s takeholders prior to final approvals

Training and Education Standards NorCal CarciNET Community res ponded to Docket ID NRC-2018-0230 in J anuary 2019. Our pos ition was :

1. There is no s hortage in the number of Authorized Us ers (AUs ) for medical us es under 10 CFR 35.300.
2. There is adequate Geographic coverage of AUs where s ufficient demand for therapy exis ts .
3. Current NRC regulations on AU Training & Education (T&E) requirements do not limit patient acces s to procedures involving radiopharmaceuticals .
4. Current NRC regulations on AU T&E requirements do not limit res earch and development in nuclear medicine.

We are reviewing propos ed rulemaking that was is s ued on 1-17-2020

Managing Regulatory Challenges We want to again thank the NRC for updating giudice in 2017 and again in 2019 in the matter of germanium-68/ gallium-68 (Ge-68/ Ga-68) pharmaceutical-grade generators We were involved in at leas t 2 calls over 2015/ 16 in regards to Ge68 being left of one table and the impact that might have to facilities that did not currently have a decommis s ioning plan in place.

While we can not predict the next regulatory challenge we know that one will occur and s teps to mitigate the res olution time s hould be cons idered

Thank You!

J os h @n orca lca rcin et.org

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