Pre-Conference Workshop Day 2024

7:30 am
Check-in & Light Breakfast

Workshop A

8:30 am MeetingYour Match: Examining Physical Properties of Isotopes to Understand Their Effect Across Varying Disease Characteristics

Synopsis

Selecting the appropriate isotope for targeted radiotherapy involves a thorough understanding of both the properties of the isotopes and the specific characteristics of the disease being treated. This requires an integration of knowledge from nuclear physics, oncology, and immunohistopathology.

In this workshop, we will delve into considerations for isotope selection to bring optimal treatment outcomes:

  • Matching isotope properties with disease properties by examining radiation type and energy from alpha, beta, and gamma emitters
  • Exploring effects of isotope half-life and decay pathways, from short-lived to long-lived isotopes
  • Assessing the optimal blend of biological half-life, physical half-life and targeting moiety
  • Navigating criteria to be considered for isotope selection such as tumour type and location and
  • microenvironmental features
  • Outlining targeting mechanisms delivering the isotope to the tumour and considerations for optimal isotope selection
  • Understanding immune profiles stimulated – activation and recruitment of immune cells at the tumor site after radionuclide therapy, and impact of the treatment on tumor immune resistance

Workshop D

8:30 am Implementing Targeted Radiopharmaceuticals into More Hospitals to Expand Access From Clinic to Approval

  • Jasminka Taleska Global Director RLT HCS Readiness & RLT Policy Strategy, Novartis AG
  • Vineet Prakash Consultant in Nuclear Medicine and Radiology, Royal Surrey County Hospital
  • Leonhard Schaetz Head Health Systems Partnership RLT international, Novartis AG
  • Luke Brzozowski Exec Dir, University Health Network Canada

Synopsis

Integrating targeted radiopharmaceuticals into hospitals involves ensuring healthcare readiness, adapting hospital infrastructure for nuclear medicine, addressing the specific requirements for handling alpha emitters, and developing strategies to increase the availability and use of radiopharmaceuticals in healthcare settings.

Expert teams will uncover:

  • What it means to have healthcare readiness from clinical integration with interdisciplinary teams and clinical protocols, training, and readiness
  • Exploring how to effectively adapt hospitals for nuclear medicine by looking at the infrastructure requirements, dedicated facilities, and radiation safety measures
  • Understanding the scope around compassionate use programs
  • Engaging with policymakers and regulatory bodies to advocate for supportive policies and regulations that facilitate the adoption and use of radiopharmaceuticals in clinical practice

10:30 am
Morning Break & Networking

Workshop B

11:00 am Expanding Radiopharmaceutical Targeting Mechanisms with Novel Moieties to Harness Enhanced Specificity, Efficacy & Safety

  • Jeremy Paull Vice President, Development and Regulatory Affairs, Starpharma Ltd.
  • Michel Afargan Head Drug Development, Starget Pharma

Synopsis

The development of novel targeting moieties for radiopharmaceuticals has seen significant advancements, particularly in the context of targeting cancer cells and supporting tissues. These novel moieties include small peptides, cyclic peptides, bispecifics and nanobodies, each offering unique advantages in terms of specificity, stability, and pharmacokinetics.

Uncovering the latest understandings and developments across novel targeting approaches, this

workshop will:

  • Reveal more novel small peptides for enhanced specificity, affinity and rapid clearance
  • Explore cyclic peptides for degradation resistance, improved binding and extended circulation time
  • Interrogate nanobodies for better tissue penetration and rapid clearance and high stability
  • Maximisebispecific antibodies for synergistic effects
  • Examine existing targeting mechanisms such as antibodies and antibody fragments to assess their viability as isotope conjugates
  • What should you be looking for to understand what makes a good targeting moiety

Workshop E

11:00 am Enhancing Excellence & Execution While Working with Different Radiopharmaceutical Supply Chain & Manufacturing Players

Synopsis

Developing and delivering radiopharmaceuticals requires seamless coordination with various supply chain and manufacturing players. This involves ensuring that all parties have the right capabilities and expertise to maintain quality, safety, and efficiency throughout the process. Both in-house teams and external players must work together efficiently to delivery high-quality radiopharmaceuticals.

This workshop will provide key learnings, case-studies and expert insights addressing:

  • Building a team of highly trained and quality supply chain and manufacturing personnel
  • Exploring best practices for CDMO selection and management
  • Drilling into technical expertise and learnings to drive strong technology transfer and regulatory navigation
  • Developing strong communications with partners to drive streamlined information-sharing

1:00 pm
Lunch Break & Networking

1:45 pm
Workshop C

2:00 pm Designing Optimal First in Human Radiopharmaceutical Trials for Translational Success: Regulatory Considerations

  • Ming Xu Vice President, Product Team Leader (PTL) for RED Oncology, Bayer
  • Francesco De Rose Head of Pharmaceutical Development, Nuclidium

Synopsis

First-in-human radiopharmaceutical trials are critical for assessing the safety, pharmacokinetics, dosimetry, and preliminary efficacy of new radiopharmaceuticals. The design of these trials must be meticulous to ensure patient safety while gathering essential data. Key components include patient monitoring duration, dose toxicity assessment, and primary readouts.

Join this workshop to:

  • Uncover pre, during and post-treatment monitoring
  • Determine your dose escalation and safety reviews
  • Exploring dosimetry from absorbed dose calculation and dose response relationships
  • Dealing with waste disposal, radiation safety and logistical challenges with alpha emitters
  • Considerations for Project Optimus

Workshop F

2:00 pm Ensuring Radiopharmaceutical Quality: Mechanistic Understandings, Safety & Measuring & Sustaining Drug Product Quality

Synopsis

Limitations in measuring alpha emitters directly requires a focus on maintaining quality control in the clinics following global shipment. Crucial to the success and safety of your drug is the analytical testing to ensure a quality product is administered to patients. Beyond maintaining drug quality, investigations are ongoing to understand what happens following radiopharmaceuticals accumulating in the target and subsequent decay pathways.

Experts will dive into discussions on:

  • Understanding how to measure drug product quality when unable to measure alpha daughters
  • Rapid identity testing of antibody-based hot targeted radionuclide therapies by bio-layer interferometry
  • Maintaining traceability
  • Exploring what innovations could help measure quality
  • Investigating potential systemic toxicity effects

4:00 pm
End of Pre-Conference Day