Conference Day One
Wednesday, July 31 2024
7:30 am Morning Check-in & Light Breakfast
8:20 am Chair’s Opening Remarks
Recapping the Busy Year for Radiopharmaceuticals: Current Status & Future Perspectives
8:30 am Panel Discussion: Reflecting on the Past Year- Discussing Current Radiopharmaceutical Trends & Assessing Our Progress
Synopsis
- Exploring PSMA updates and predictions for the future market of prostate cancer drugs
- Pricing and reimbursement considerations in a competitive market
- Discussing key future commercial challenges and opportunities for the field from advances in manufacturing to competitive demand and selection of radioisotopes, with emphasis on actinium-225, lead-212, copper-64
9:15 am Revealing Results of Phase Three Randomized NETTER-2 Novartis Trial to Explore a First Line Treatment for NET
Synopsis
- To discuss the results of the NETTER 2 clinical trial
- To review the current use of RLT in first line treatment of cancer
- To understand the role of RLT in aggressive NET disease
9:45 am Advancing the Future of Radiopharmaceutical Therapy
Synopsis
• Understanding the clinical needs for alpha, beta and auger emitting isotopes for RPT
• Exploring the past to guide future clinical trials and radiopharmaceutical development
10:15 am Exploring the Radiopharmaceutical Renaissance: What the Future Holds from Investors’ Perspective
Synopsis
• Unlocking the potential of radiopharmaceuticals while navigating challenges and opportunities facing the field
• Identifying areas on the forefront of innovation
• Pinpointing recent investors focus and interest
10:45 Speed Networking & Refreshments
Discovery & Preclinical
Exploring New Radioisotope Targeting Technologies to Optimize Your Molecule
11:45 am Overcoming Adverse Cytogenetics, TP53, Other Mutations & Treatment Resistant Disease in Relapsed/ Refractory AML Using Antibody Radiation Conjugates (ARC)
Synopsis
- Exploring Iomab-B, a CD45 I-131 ARC, enables bone marrow transplant in otherwise ineligible patients, while Actimab-A, a CD33 Ac-225 ARC, demonstrates strong anti-leukemic activity
- Outlining how responses in heavily pretreated patients for both Iomab-B and Actimab-A, including prior venetoclax treatment or TP53-mutant disease, demonstrate how targeted radiotherapies offer broad therapeutic potential as backbone regimens
- Revealing preclinical data to further show the benefits of combining Actimab-A with targeted therapies, such as FLT3 inhibitors, to enhance anti-tumor response
12:15 pm Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies
Synopsis
• Streamlining therapeutic index-focused discovery and drug development for TRTs with clinical pharmacology considerations and model-informed drug development (MIDD) concepts
• Understanding dose optimization requirements for TRT in the clinical pharmacology regulatory landscape while complying with the FDA’s Project Optimus initiative to optimize oncology drug dosage
• Discover how MIDD, including quantitative systems pharmacology (QSP) and pharmacometrics, help drive rational drug design, patient selection, and inform dosage optimization
12:45 pm Revealing Pretargeting for 177Lu/225Ac Dual-Isotope Therapy of Colorectal Cancer
Synopsis
- Pretargeting as a suitable approach for efficient and controlled tandem-radiotherapy
- Confirming co-localization of 225Ac- and 177Lu-labeled radiohaptens with autoradiography using iQID
- Pretargeted 177Lu/225Ac dual-isotope therapy can be safely administered at potentially curative doses (62.9 GBq/kg 177Lu + 2 MBq/kg 225Ac) in mice
Early-Stage Clinical
Securing Translational Success Through Forward Thinking Nuclear Clinical Design
11:45 am Considerations for Designing an Optimal First in Human Radiopharmaceutical Trial
Synopsis
• Considerations on candidate selection when working with a multidisciplinary team
• Evolving strategy and lessons learned moving from lab to clinic
• FIH study design dynamics about safety, dosimetry and PK/PD from Th227 to Ac225
12:15 pm Making Ac225 Accessible for Radiopharmaceutical Development
Synopsis
- Outlining PanTera’s Early supply through the Th-229 generator route
- Revealing PanTera’s technology perspective and timeline for the Commercial Supply
12:30 pm Advancing Field of Theranostics – Together
Synopsis
• Uncovering market trends, challenges and solutions
• Appreciating the need for multidisciplinary partnerships to advance the field of theranostics improving patient access for every patient in need
12:45 pm Outlining a Best-in-class SST2 Antagonist in SCLC & a Cancer Cell DNA Targeted- Auger-Electron Approach in Solid Tumors
Synopsis
- Using Satoreotide, aka JR11, labelled with Lu, Ac or Tb in SCLC
- Understanding the impact of changing tracer versus changing isotope
- Introducing a radioactively labelled small molecule to target tumor cell DNA using Auger emitters
Late-Stage Clinical
Late-Stage Updates & Learnings to Inform Future Radioisotope Development
11:45 am Clinical Advances of 225Ac-targeted Antibody & Small Molecule-based Agents & Revealing Preclinical Insights from Immune Checkpoint Combination Approaches
Synopsis
- Outlining why 225Ac is an attractive radioisotope for targeted therapy
- Exploring clinical strategy and updates on Fusion’s antibody and small molecule programs, including FPI-2265 (a phase 2/3 study)
- Revealing rational drug combinations for targeted alpha therapeutics
12:15 pm NextGen n.c.a. Lu-177: Developing and Scaling to Commercial Production
Synopsis
• A New Era in Lu-177 Production: Critical challenges in producing Lu-177 require an innovative approach
• Fortifying Your Lu-177 Supply: A fully integrated US-based Lu-177 supply increases reliability and provides faster delivery times
• Reimagining Clinical Trials and Beyond: The potential impact of SHINE’s new Lu-177 process on developing targeted
radiopharmaceuticals—case studies
12:30 pm Meeting Ambitious Time-To-Market Goals in a Fast- Growing TRP Market
Synopsis
• Our approach to TRP time-to-market efficiency
• Staying on course in a fast-growing environment
• Achievements and future steps in API process development & manufacturing as well as upcoming steps in the aseptic filling and freeze drying of products
12:45 pm Designing Successful Clinical Trials for Commercial Success & Patient Access
Synopsis
- Outlining key strategies to executing effective clinical trials and bringing life-changing, potentially life-saving products to market faster
- Examining why successfully executed clinical trials fail to deliver drugs to patients
- Improving clinical trial design and performance, as well as thinking beyond trial outcomes to facilitate the success of products throughout their development lifecycles
1:15 pm Lunch Break & Networking
Discovery & Preclinical
Creating the Perfect Blend of Novel Payload & Targeting Approaches to Expand Specificity
2:15 pm Panel Discussion: Examining Radiobiology & Differences in Immunological Responses Between Alpha & Beta Nuclides
Synopsis
- Discussing what responses have been observed to different isotopes and isotope combinations
- Exploring optimal use for each
- Looking toward future development opportunities
2:45 pm Towards Optimizing Tumor Retention of FAP-Targeting Theranostics
Synopsis
• Discussing the promise of FAP as a target for the imaging and therapy of various solid tumors
• Summarizing approaches used in the FAP field for optimizing tumor AUC
• Exploring insights into Actithera’s approaches and molecules
Early-Stage Clinical
Applying Dosimetry to Early Studies to Enhance Clinical Understandings
2:15 pm Panel Discussion- Integrating Dosimetry into Early-Stage Clinical Trials
Synopsis
- Exploring how dosimetry should be incorporated
- Looking at best practices for scans with treatment cycles
- Uncovering how often should scans occur?
2:45 pm Examining Dosimetry Data in Alpha Emitters: Similarities & Differences
Synopsis
• Exploring differences in alpha vs beta dosimetry analysis from clinical perspective
• Can administered activity predict the outcome?
• How to personalize the radiopharmaceuticals prescription beyond dosimetry?
Late-Stage Clinical
Supply Chain & Manufacturing- Learning from Late-Stage Production While Navigating Future Challenges
2:15 pm Advancing Isotope Evaluation & Quality Control Methods for Radiopharmaceutical Manufacturing
Synopsis
- Navigating radiopharmaceutical production with emerging isotopes
- Dealing with concatenated decay is significantly more challenging than for previous diagnostic agents
- Discussing new tools and insights that are being developed and leveraged to improve formulation and quality control for optimal use in the clinical setting
2:45 pm Panel Discussion: Scaling Up – Lessons Learned from Increasing Commercial Supply
Synopsis
- Identifying process optimization to address bottlenecks
- Expanding robust supply chain management for highly trained nuclear manufacturing professionals
- Navigating regulatory compliance
3:15 pm Afternoon Break & Scientific Poster Session
Synopsis
Take a break from the formal presentations and join your peers in the TRP field by presenting your work in our dedicated poster session.
This is the perfect opportunity to discuss, debate and display your work in the field!
Uncovering Novel Targets for Therapeutic Applications & Bridging the Gap Between Sponsors & Patient Communities
4:15 pm LRRC15-Targeted Radiotheranostic Strategies to Overcome TGFB-Driven Treatment Resistance in Cancer
Synopsis
- Exploring novel strategies for overcoming radioresistance
- Outlining novel target
- Uncovering the platform specifically designed to diagnose, monitor, and ablate immunotherapy resistance, while also significantly mitigating the development of radio-resistance
4:45 pm Sharing How to Engage the Patient Community in Research: Real World Experience Form a Research Advocate
Synopsis
- Outlining how to engage patients early on in your trial
- Using patient advocates to optimize clinical trial design
- Exploring how to approach patients for engagement
5:15 pm Chair’s Closing Remarks
5:25 pm Drinks Reception
Synopsis
Continue your conversations into the evening during our drinks reception providing your more opportunity to strengthen your industry connections!