*All times listed are Central European Time (CET)

Conference Day One

Wednesday 4th December 2024

7:30 am Morning Check-in, Coffee & Light Breakfast

8:20 am Chair’s Opening Remarks

  • Ming Xu Vice President, Product Team Leader (PTL) for RED Oncology, Bayer

An Evolving European Market: Analysing the Growing Radiopharmaceuticals Field

8:30 am Breaking Down the Radiopharmaceuticals Landscape & Building on Learnings to Accelerate the Growing Field

  • Evrim Gurpinar Senior Director, Oncology R&D Business Development, AstraZeneca

Synopsis

  • Uncovering progress made by key European radiopharmaceutical developers and analysing the current landscape
  • Drawing comparisons to the ADC space and touching on areas where key lessons could benefit the field with commercial and market insights for future outlooks
  • Strengthening therapeutic potential of TRPs through ADC combination and sequencing approaches

9:00 am Advancing Fusion’s Targeted 225 Ac Platform- A Glimpse at What’s Clinically Advancing & What’s to Follow post the Astra Zeneca Acquisition

Synopsis

  • Outlining why 225Ac remains an attractive radioisotope for targeted therapy
  • Uncovering strategies for antibody-based radiotherapy
  • Navigating clinical strategy and updates on Fusion’s antibody and small molecule programs, including FPI-2265 (phase 2/3 study)

9:30 am Panel Discussion: Challenges and Opportunities for Securing Ongoing Funding for Radiopharmaceuticals in Europe

  • Jeevan Virk RLT Therapeutic Area Strategy Head, Novartis AG
  • Evrim Gurpinar Senior Director, Oncology R&D Business Development, AstraZeneca

Synopsis

Assessing differences in US market

Understanding nuances in European market to appreciate what investors are looking for

Hearing what investors are looking for to secure new funding

10:00 am 10:45 Speed Networking & Refreshments

Synopsis

A prime chance to make the most of in-person networking and forge new connections with an expanding community of experts in the radio-pharmaceutical field. Designed to maximise your introduction to numerous new individuals and serve as a catalyst for ongoing discussions during the summit.

Preclinical & Translational Track

Uncovering Trailblazing Preclinical Developments Opening up Novel Directions for the Radiopharmaceuticals Field

11:00 am Transforming Cancer Treatment: Advancing Radiopharmaceuticals with Nanomedicine for Enhanced Efficacy

  • Laila Quere Co-Founder & Chief Executive Officer, Aken medical

Synopsis

Revealing aKen Medical’s nanoparticles for enhance radiopharmaceutical efficacy by delivering more radionuclide payloads to the targeted tumour

Improving tumour targeting by directly coupling to vectors

Enabling simultaneous imaging and therapy, facilitating precise dosimetry to predict treatment outcomes

11:30 am Dosimetry from Preclinical to Clinical Studies: Challenges & Aspirations

Synopsis

  • Dosimetry status of preclinical research
  • Outlining pros and cons of current approaches; accuracy vs simplicity
  • Exploring dosimetry assessment from preclinical studies and translation to humans

11:45 am Chelatec – A Leading Preclinical CRO for Targeted Radionuclide Therapy

Synopsis

  • 20 + years in the radiopharmaceutical space
  • From radiolabeling to in vivo investigation
  • The way to IND application

12:00 pm Panel Discussion: Phase 0 for Radiopharmaceuticals: Benefits & Risks

Synopsis

  • Uncovering the rationale behind conducting these preliminary studies
  • Exploring the pharmacokinetic and pharmacodynamic data it can provide
  • Considerations for initiating a phase 0 trial

Clinical & Supply Chain Track

Transforming Clinical Understandings to Accelerate Radiopharmaceutical Development & Expand Treatment Efficacy

11:00 am Revealing Clinical Design & Early Data from Lead AB001 Programme

Synopsis

  • Understanding the mechanisms of action and optimising dose escalations
  • Uncovering first in human design post phase 0
  • Exploring immunological pathways stimulated

11:30 am Quality, Collaboration, and CMC: Aligning for Drug Development Excellence

  • Ashley Mishoe Vice President - Regulatory Affairs & Quality Assurance, PharmaLogic

Synopsis

  • Harmonizing drug sponsor and CDMO quality system expectations
  • Leveraging CDMO experience to expedite sponsor submissions
  • Exploring the relationship between quality, regulatory, and CMC

12:00 pm Identifying Patient Responders & Non-responders Through CXCR4 Targeted Theranostic Approaches for Central Nervous System Lymphoma (CNSL)

  • Dirk Pleimes Chief Medical & Scientific Officer, PentixaPharm GmbH

Synopsis

  • Uncovering the dose-finding clinical phase I/II study
  • Predicting treatment responses
  • Sharing clinical design

12:30 pm Lunch Break & Networking

1:15 pm
Preclinical & Translational Track

Ensuring Translational Success from Animal to Human Through Strategic Study Design & Expert Rationale

1:30 pm Industry sponsored and investigator sponsored trials: The best of both worlds

  • Jens De Vos Head of Alliance & Program Management, Precirix

Synopsis

  • Assessing safety, dosimetry and preliminary efficacy signals of novel radiopharmaceuticals
  • Aligning objectives and patient selection
  • Exploring lessons learned for future trial designs

2:00 pm Targeted Radiotherapy using CLIPS™ Macrocyclic Peptides: The case of PSV359

Synopsis

  • Discovery, development and preclinical study of [²¹²Pb] PSV359 macrocyclic peptide against FAPα protein
  • Targeting tumor receptors with an on-cell macrocyclic peptide screening platform
  • Macrocyclic CLIPS™ peptide discovery and optimization platform for radioligand therapy

2:15 pm Roundtables: Exploring Novel Radiopharmaceutical Treatment Indications through Novel Targets

  • Marika Nestor Chief Executive Officer & Co-Founder, Akiram Therapeutics AB

Synopsis

  • Future Applications & Challenges
  • From NSCLC, Ovarian Cancer, Breast Cancer, Colorectal Cancer & more
  • Outlining the opportunities in each indication and what targets are going to take us there?

2:30 pm From Innovation to Implementation: Preclinical Development & Clinical Trial Design for 177Lu-AKIR001 • Navigating the process

  • Marika Nestor Chief Executive Officer & Co-Founder, Akiram Therapeutics AB

Synopsis

  • Navigating the process of transitioning from early preclinical research to initiating clinical trials
  • Evaluating the compound’s effectiveness and safety, regulatory considerations
  • Assessing strategic considerations for designing effective clinical trials

3:00 pm Maximising Radiopharmaceutical Development Through In-silico Modelling

Synopsis

  • Outlining proprietary in-silico model
  • Identifying optimal targeting approaches to be implemented
  • Assessing isotope and chelator selection

Clinical & Supply Chain Track

Securing Radioisotope Production Capabilities to Maximise Development

1:30 pm Uncovering Novel Pb212 Isolation Technologies for Accelerated Production: High Yield Approaches

  • Daniel Rossetto Senior Vice President & Head Of Supply Chain & External Manufacturing, ARTBIO

Synopsis

  • New generator technologies among optimised protocol will accelerate production
  • Outlining processes on the forefront of development

2:00 pm Session Reserved For: RPO Scientific

Synopsis

Session Reserved For: RPO Scientific ...

2:15 pm Roundtables: Looking Toward Potential Latent Toxicities for PSMA TRPs Discussing preventative steps

Synopsis

  • As more patients are receiving PSMA radiopharmaceuticals, more monitoring is required 
  • Examining radiation dose and potential secondary malignancies 
  • Discussing preventative steps

2:30 pm Changing Manufacturing Processes to Improve Consistency of Radiopharmaceutical Drug Products

  • Vimal Patel Vice President - Chemistry Manufacturing & Controls, RadioPharm Theranostics

Synopsis

  • Understanding challenges associated with intermediates characterisation
  • Navigating regulatory challenges associated with changes in manufacturing processes
  • Assessing cost/benefit analysis of improved processes

3:00 pm Interrogating Dose Limits to Push Beyond External Beam Dosing

  • Jenny Karlsson Senior Director - Targeted Radiopharmaceuticals, Bayer

Synopsis

  • Exploring the recent FDA workshop and key dosimetry takeaways from discussions
  • How do our technologies and analytical expertise need to improve to bring new regulations?
  • Considering practical considerations for implementing in the clinic

3:30 pm Afternoon Break & Scientific Poster Session

Synopsis

This is an informal session to help you connect with your peers in a relaxed atmosphere to continue forging new and beneficial relationships. With an audience of TRP/RLT experts eager to hear the latest drug delivery innovations, you will have the opportunity to display a poster presenting your own research. Don’t miss out on the chance to connect, learn, and present.

Maximising Dosimetry Data to Optimise Dosing & Improve Patient Outcomes While Assessing European Funding

4:00 pm Panel Discussion: Integrating Dosimetry into Clinical Practice for Clinical Trials & Service

Synopsis

  • Exploring how implementing dosimetry will lead to more effective treatments and outcomes for practitioners and patients
  • Developing dosimetry methodology for new products/indications for standardised practise and maintained regulatory compliance
  • Establishing dose limits with a better understanding of the drug for enhanced patient safety and efficacy
  • Exploring personalised treatment planning

4:45 pm Global Production & Supply Potential of Alpha-emitting Radionuclides

  • Neil Quigley Team Leader & Senior Global Product Manager, ITM

Synopsis

  • Reviewing different production routes for alpha-emitting radionuclides, namely Ac-225, Pb-212 and At-211
  • Discussing each radionuclide in terms of their short and long-term sustainable supply for radiopharmaceuticals.
  • Evaluating each radionuclide in terms of their global supply potential

5:15 pm Chair’s Closing Remarks

  • Ming Xu Vice President, Product Team Leader (PTL) for RED Oncology, Bayer

5:25 pm End of Conference Day One