Alyssa Vito
Senior Director, Clinical Development Alpha-9 Oncology
Seminars
Tuesday 29th July 2025
Workshop A
8:30 am
Serving as a bridge between preclinical and clinical development, phase zero studies can de-risk drug development by unlocking crucial pharmacokinetic and biodistribution data to optimize radiopharmaceutical drug candidates. Patient-centricity is at the core of phase zero studies and ethical considerations must be front and center in decision-making.
- Join this discussion-based workshop to gain insights on:
- Uncovering variations in compassionate use across countries like South Africa, Australia, Germany, and India, each with unique purposes and ethical considerations
- Ensuring ethical practices in diagnostics trials and patient involvement, advocating against unnecessary patient risk
- Guiding the design of Phase 1 trials by providing insights into optimal dosing, scheduling, and safety considerations
Wednesday 30th July 2025
Panel Discussion: Streamlining your Radiopharmaceutical Preclinical Package: Working With the Regulators
11:30 am
• Understanding what’s needed and what’s not needed for a radiopharmaceutical preclinical package
• Hear interactions with the regulatory perspective
• Biodistribution, preclinical dosimetry and more
