Emerging Role of Radiopharmaceuticals for Renal Cell Carcinoma

Spencer Smith, PharmD, Clinical Nuclear Pharmacist Specialist, Michigan Medicine, University of MI

Upon completion of this activity, participants will be able to: Describe the pathophysiology, epidemiology, and treatment of renal cell carcinoma (RCC); Evaluate the results of recent radiopharmaceutical clinical trials for RCC; Discuss potential applications of adiopharmaceuticals for RCC management.

UAN: 0675-0000-25-032-H01-P/T

Hosting a USP 825 Specific Inspection     

Jessica Comstock, PharmD, BCNP, Vice President Pharmacy Quality and Regulatory, PharmaLogic Holdings

Upon completion of this activity, participants will be able to: Review key components of UPS 825 and how to respond to corresponding audit questions during an inspection; Identify differences in USP 825 and how to highlight them to inspectors who may not be as familiar with nuclear regulations; Discuss the art of hosting an inspection.

UAN: 0675-0000-25-033-H07-P/T

Enhancing Safety in Nuclear Pharmacies: A Review of Radiation Safety

Willie Regits, PhD, Senior Director, Supply Chain and Corporate Radiation Safety Officer, Clarity Pharmaceuticals

Upon completion of this activity, participants will be able to: Identify key radiation hazards and safety risks; Review best practices in radiation safety; Promote continuous education for new technologies and procedures.

UAN: 0675-0000-25-034-H99-P/T

Long-Lived Impurities in Isotopes: Impact on Waste Handling and Disposal Approaches

Yasmine Saboui, MS, Director of Process Engineering, CMC Group, Abdera Therapeutics, Consultant - Targeted Design Solutions

Upon completion of this activity, participants will be able to: List isotopes with long-lived radioactive impurities: focus on Ac 225, Pb 212 and At-211; Discuss challenges to detection and handling; Explain the impact on site licensing requirements.

UAN: 0675-0000-25-035-H01-P/T

ClinicalTrials.gov Dissected: Behind the Public Listings

Becca Segrest, PharmD, Area Manager – Nuclear & Precision Health, Cardinal Health

Upon completion of this activity, participants will be able to: Evaluate how the radiopharmaceutical research pipeline has changed over time: Number of trials by disease state, Diagnostic vs Therapeutic, •By isotope; Identify common and emerging diagnostic & therapeutic isotopes being studied; Discuss what early trends indicate about the future theranostic pairs; Discuss practical considerations for nuclear medicine department readiness and radiotherapy facilities.

UAN: 0675-0000-25-036-H01-P/T

Statistics in Nuclear Medicine       

Jonathan Baldwin, PhD, Senior BioStatistician, TigerMed BDM

Upon completion of this activity, participants will be able to: List the problems associated with low count statistics for nuclear medicine; Determine the statistical variation encountered in a typical nuclear counting experiment (precision and chi square); Explain what “sufficiently rigorous to allow statistical confidence in the results” means when applied to assigning BUD; Define Sensitivity, Specificity, Accuracy, False Predictive Fraction, and Positive Predictive Value.

UAN: 0675-0000-25-037-H99-P/T

Evolving Scope of Nuclear Pharmacists in Radiopharmaceutical Manufacturing Part 211

Jenna DeJoris, PharmD, RPh, ANP, Assistant Production Manager, Nuclear Pharmacist, SpectronRx

Upon completion of this activity, participants will be able to: Define the role of nuclear CMOs and CDMOs in radiopharmaceutical development and production; Describe the nuclear pharmacist’s contributions to compliance, quality assurance, regulatory interpretation, and documentation management; Identify career-relevant skills and responsibilities of pharmacists in manufacturing compared to traditional pharmacy practice; Examine regulatory challenges in radiopharmaceutical manufacturing, with emphasis on 21CFR Part 211 versus 21 CFR Part 212.

UAN: 0675-0000-25-038-H03-P/T

Neuroendocrine Tumors: A 2025 Update for Nuclear Pharmacists

Garcia Simon Clark, PharmD, MS, ANP, CCP, BCNP, Kindred Healthcare, Pharmacy Supervisor

Upon completion of this activity, participants will be able to: Describe the 2022 WHO classification and principal clinical subtypes of NETs; Compare and contrast Ga-68 DOTATE PET/CT and 123 I-MIBG SPECT/CT in terms of mechanism, biodistribution, sensitivity, and clinical useacross NET subtypes; Evaluate radiopharmaceutical and systemic therapies – 177 Lu-Dotate PRRT, 131 I-MIBG therapy, somatostatin analogs, targeted TKIs and their evidence base; Design an optimized diagnostic therapeutic algorithm for a given NET patient, integrating imaging choice, biomarker data, and guideline directed treatments.

UAN: 0675-0000-25-039-H01-P*