11 min read
Monthly FDA Guidance and Regulatory News Review - June 2026
This June 2026 regulatory update focuses on advancing innovative drug development through updated guidance on...
Come join the conversation being moderated by John Balser, PhD, President of Veristat. Bring your challenging questions and be prepared to share your experiences with adaptive designs.
Have you ever wondered how biotech and pharma companies make informed decisions as to whether an adaptive design would be useful in their development programs? Do they apply suchadaptive methods early in the clinical investigation of new therapies? Or is the application of adaptive design more restricted to later phase studies?
Join Veristat at the MassBio Forum where we will explore these important questions and more including:
- Are sponsor companies using adaptive designs in Phase 1 and 2 studies more than before? Perhaps even more so than in Phase 3 confirmatory trials?
- Why are adaptive designs appropriate in early phase trials and present case studies?
- How can drug development programs optimize efficiency using these designs earlier than Phase 3?
Speakers include:
- Mark Chang, PhD, Senior Vice President, Veristat
- Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs, Brigham & Women’s Hospital, Professor, Harvard Medical School
- Yi Liu, PhD, Senior Manager, Takeda Pharmaceuticals International Co.
- Cyrus Mehta, PhD, President, Cytel
- Stella Sergiopolous, MS, MPH, Research Fellow, Tufts Center for the Study of Drug Development
Registration Details
This event is being produced by MassBio. Visit the MassBio website to register or livestream the event
2 min read
FDA Prior Knowledge Guidance: A New Framework for Natural History Evidence
Jul 2, 2026 Veristat Blog
June 22, 2026
What the FDA's prior knowledge guidance means for natural history evidence and shared datasets
On June 2,...