Archives: Agenda
PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook
- Analyzing current market dynamics and funding trends shaping biotech growth in 2025
- Addressing ongoing talent shortages and evolving workforce strategies
- Funding and investment for biotechs in and around Boston: how has this shifted in 2025?
- The impact of national political and economic changes on the biotech landscape in Boston and New England
MODERATOR: Gregg Beloff, Founder, Danforth Health
Propelling asset development through integrated regulatory, clinical, and medical expertise
- Discover the benefits this model brings to strategic asset development
- Understand the optimal timepoints for CRO engagement
- Discuss tips for maximizing your CRO’s expertise to support a comprehensive development plan
- Review real-world examples demonstrating the advantages of this approach
End of Conference
PANEL: Assessing the impact of the political and economic landscape in the US on outsourcing decisions in pharma
- 10 months in: how has the new administration affected the pharma and biotech industry in New England?
- Dealing with change and uncertainty: ensuring your clinical trial timelines stay on track
- Discussing pros and cons of running trials in the US vs overseas considering recent changes
- How have funding and resources been affected in 2025 and how has this impacted outsourcing and clinical operations?
MODERATOR Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS
During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations. Roundtables will take place in the Stream A conference room.
| ROUNDTABLE 1: Importing and exporting biological materials to or from the U.S
Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection Baljeet Kaur, Agriculture Operations Manager, U.S. Customs and Border Protection |
| ROUNDTABLE 2: Pros and cons of different outsourcing models: FSO vs FSP vs inhouse
Yolanda Wan, Head of Clinical Operations, Orna Therapeutics |
| ROUNDTABLE 3: Enabling the most inclusive approach to patient engagement
Lily Cappalletti, Director, Patient Experience, Alexion Pharmaceuticals |
| ROUNDTABLE 4: Topic TBC
Kate Tith, Vice President, Head of Clinical Operations, Dyne Therapeutics |
| ROUNDTABLE 5: Building efficient and effective relationships with sites
Peter Koefler, Director, Study Site Engagement, Takeda |
Considerations for successful third party vendor management
- What degree of oversight should you have over third party vendors?
- Risks and benefits of handing third party management to CROs
- Regulatory and quality considerations around outsourcing to third party vendors
PRIZE DRAW
Visit our exhibitors’ booths throughout the conference and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!
Diversity Action Plans: preparing, submitting, and receiving regulatory feedback
- An overview of recent US legislation around diversity in clinical trials
- Understanding requirements around DAP approval and submission: what should you include?
- Preparing documentation to demonstrate diversity in your clinical trial
- Experience with DAPs in view of the received FDA feedback