Archives: Agenda
PANEL: Fostering a strong relationship with your CRO to make your trial a success
- Technology and new developments when it comes to managing CRO relationships
- How to ensure your study is prioritized
- Maintaining a strong relationship with vendors in remote and hybrid work settings
- How to blend a CRO team with your internal team in order to foster communication and overall success of your trial
- CRO monitoring and oversight: how to make processes efficient and effective
PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets
- Ensuring your trial is cost-conscious and efficient without compromising on quality or on patient care
- Forecasting and budgeting in order to accurately predict costs and minimize unforeseen expenses
- Keeping your clinical budget on track
- Negotiating prices and contracts in order to ensure maximum benefit without going over budget
MODERATOR
Rene Stephens, Managing Director, Clinical Business Operations, Danforth Advisors
The Future of Clinical Operations with Generative AI
- Understanding Gen AI — Why it matters for clinical operations
- Trends & Barriers — What’s driving adoption or impeding progress
- GenAI in Action — Real world use cases that are transforming clinical ops
Afternoon refreshments and networking break
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 |