Explore the Agenda
7:30 am Morning Check-in & Light Breakfast
8:20 am Chair’s Opening Remarks
Exploring Commercial Directions for Radiopharmaceuticals & Considerations for Company Differentiation
8:30 am Panel Discussion: Obtaining Winning Industry Partnerships to Advance Radiopharmaceutical Development
• Hearing from the experts on how to secure funding and industry partnerships
• Understanding how the process began and how to build relationships
9:00 am The Mariana Oncology Story – Advancing the Next Generation of Precision Radioligand Therapies
• Story from conception to acquisition
• Innovative Precision RLTs expanding in solid tumor indications of high unmet need
• Showing first preclinical data
9:30 am The Fractional Medical Affairs Advantage: Increasing Efficiencies & Reducing Risk in the Radiopharmaceutical Industry
• Past, Present, & Future of Medical Affairs
• De-risking medical support during uncertainty in drug development & approval
• Securing full-team support without full-team impact on resources
10:00 am Panel Discussion: Commercialization Feasibility, Reimbursement Management for Radiopharmaceutical & Engaging with Community Clinics
- Increasing the number of centers capable of administering radiopharmaceuticals
- Getting more physicians comfortable with referring patients to nuclear medicine or radiation oncology
- Managing the growth ecosystem of intermediaries and service providers
10:30 am Morning Break & Refreshments
Expanding Horizons with Novel Targeting Moieties to Optimize Radiopharmaceutical Development
11:30 am Pioneering Precision Theragnostics Through Engineered Antibody Fragments
• Exploring strategies for engineering small biologics for use as radioligand therapy
• Emphasizing how to mitigate off-target uptake of the toxic payload
12:00 pm Roundtable Discussion: A New Wave: Unlocking Novel Targeting Strategies
• Discussing drug design elements
• Understanding challenges and opportunities with each targeting molecule
12:30 pm Uncovering Pre-targeted Radioimmunotherapy for Novel Radiopharmaceutical Targets
• Sharing early preclinical therapeutic data
• Discussing compassionate use studies for speed to clinic
• Addressing unmet medical need through new targets including, oxMIF, MSLN, HER2, and Fra
1:00 pm Lunch Break & Networking
Engineering Approaches for Novel Radiopharmaceutical Delivery Innovations
2:00 pm Delivering Better Medicines Created Rapidly Through de novo Protein Design
• Creating 45 amino acid miniproteins using generative artificial intelligence
• Engineering mini proteins to bind targets with sub nanomolar affinities, and contain site-specific conjugation handles
• Small size of miniproteins enables rapid distribution and clearance
2:30 pm 21st Century Medicinal Chemistry Applied to RLT: Methodologies
• Reviewing VitsGen’s methodologies in applying AI modeling, phage display and computer aided design/medicinal chemistry design
• Using approaches to get BiC/FiC peptide based RLT molecules
• Outlining why peptide-based molecules are well-suited to the criteria for targeted radiopharmaceuticals
3:30 pm Afternoon Break & Networking
Navigating the Regulatory Environment for Radiopharmaceuticals to Streamline Development
3:30 pm Regulatory Perspectives for Radiopharmaceuticals from Diagnostics, Theranostics & Therapeutics
• Exploring key regulatory considerations for the development and marketing authorization of radiopharmaceuticals
• Touching on product type and target label claims, with a focus on the US regulatory landscape
• Uncovering future perspectives and initiatives for radiopharmaceutical regulatory affairs
4:00 pm Panel Discussion: Promoting Regulatory Harmonization for Radiopharmaceutical Clinical Research
• Discussing EMA’s concept paper and FDA’s project optimus
• Exploring how the field can harmonize regulations to streamline development