Science Events in Boston
Stay up-to-date with all of the life science events taking place in the Greater Boston area with the Science in Boston events calendar! From academia to industry and biotech to pharma, our events calendar is your complete source for life science conferences, symposiums, networking, and workshops in Boston. We even cover science pub nights and science fundraisers!
If you’re interested in promoting your life science event on the Science in Boston events calendar, please use our event submission form.
- This event has passed.
Challenges in Rare Disease Clinical Trials Symposium & East Training
November 6, 2019 - 9:00 am - November 7, 2019 - 5:00 pm
Description
Since 2011, the Complex Innovative Trial Design Symposium and East User Training has brought together industry experts, thought leaders and applied statisticians to discuss innovations in clinical trials and guide the development of the industry’s leading clinical trial design software, East.
This year we’re proud to be partnering with Alexion to share expertise and ideas surrounding the challenges in rare disease clinical trials.
We’re excited to share with you the full list of speakers presenting. Click here to learn more about the speakers and access the presentation abstracts.
Day 1 Symposium
8:00AM – 9:00AM
Registration and Coffee
9:00AM – 9:15AM
Welcome from the Scientific Committee
9:15AM – 10:15AM
Drug Development in Rare Diseases – Need for Innovation in Statistical Thinking
Kannan Natarajan, Pfizer
10:15AM – 11:00AM
Challenges in Rare Diseases: The PREVENT Trial for NMSOD
Amy Pace, Alexion
11:00AM – 11:45AM
Historical Control Borrowing: Overview, Advancement and New Methodologies
Jianchang Lin, Takeda
11:45AM – 12:45PM
Lunch
12:45PM – 1:15PM
Cytel Innovations/Roadmap
Geoffrey Grove, Cytel
1:15PM – 2:15PM
TBC
2:15PM – 3:00PM
Data Monitoring Committees – Behind Closed Doors
David Kerr, Axio
3:00PM – 3:15PM
Break
3:15PM – 4:00PM
The Use of Natural History Data in Clinical Trials with Rare Diseases
Clare Elkins, Alexion
4:00PM – 4:45PM
Using Historical Control for Regulatory Approvals in US – A Practical Review Focusing on Diseases in Small Population
Ziliang Li and Chenkun Wang, Vertex
4:45PM – 5:00PM
Closing Remarks
Day 2: East Software Training with Pantelis Vlachos, Principal, Strategic Consulting
8:00AM – 9:00AM
Breakfast and Introduction to East
9:00AM – 10:45AM
Phase 1 Dose Escalation (ESCALATE) with Cohort Expansion (PROGRAM)
10:45AM – 11:00AM
Coffee Break
11:00AM – 12:00PM
Phase 2: MCPMod (Design and Analysis)
12:00PM – 1:00PM
Lunch and Networking
1:00PM – 2:00PM
Phase 2/3: Multi-Arm, Multiple-Stage Designs (MAMS)
2:00PM – 3:00PM
Phase 3: Group Sequential Designs (SURVIVAL)
3:00PM – 3:15PM
Break
3:15PM – 4:15PM
Phase 3: Adaptive Designs: Sample Size Re-estimation (SURVADAPT)
4:15PM – 5:00PM
Phase 3: Adaptive Population Enrichment (ENRICH)
Email sean.cronin@cytel.com if you have any questions.
