Mike Wardach

VP, Regulatory Affairs Z-Alpha Therapeutics

Seminars

Tuesday 29th July 2025
Workshop F
2:00 pm

Astatine-211 offers significant advantages for smaller organic molecules due to its similarity to iodine in chemistry, eliminating the need for a chelator. This makes it easier to attach to drug-like molecules without altering their ability to bind to targets, unlike metal-based conjugates that often face challenges with chelator incorporation. While the supply of astatine is theoretically unlimited, niche cyclotron technologies affect availability.

Join this workshop for the opportunity to:

  • Explore 211At decay properties to overcome toxicities
  • Unlocking 211At conjugation chemistry and assessing prime biological targeting vectors, strategies, and targets
  • Investigating potential of astatine development to industry-sponsored clinical trials
Thursday 31st July 2025
Panel Discussion: Promoting Regulatory Harmonization for Radiopharmaceutical Clinical Research
4:00 pm

• Discussing EMA’s concept paper and FDA’s project optimus

• Exploring how the field can harmonize regulations to streamline development

Mike Wardach