Archives: Agenda
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
Lunch and networking break
INTERACTIVE SESSION: What are investors looking for in a biotech or start up?
- Outline critical factors biotech investors evaluate before committing their resources, offering actionable insights to help startups stand out in a competitive market.
- Steps for biotech founders to differentiate, IP strategy and to attract funding
- Avoiding missteps in budgeting and resource allocation together with prioritization and careful planning.
- Storytelling about key milestones achieved aligned with operational activities with feasible exit strategy?
- Does the biotech investor bring strategic expertise beyond capital needs?
- Does the biotech have the appropriate team and expertise to execute?
Patient-guided by design: a framework for successful study start-up, informed protocol design and better outcomes
- Optimizing study-start up for improved timelines and site performance
- Integrating patient input into protocol design and the impact of patient motivation assessments
- Case studies: patient-informed protocol design for successful outcomes
Beyond trial participation: engaging rare disease patients in the long term
- Biopharma’s role in supporting patients with their disease once no longer study participants
- Working with advocacy groups on long term patient engagement
- Where and how can trial sponsors step in to provide long term support for rare disease patients?
- Bridging the scientific advice gap for patients with rare diseases