The 2017 WideTrial Expanded Access Summit

Integrating Expanded Access Programs into the Clinical Drug Development Process

Engaging More Patients / Capturing More Data

 

September 15, 2017
Royal Sonesta Boston
Cambridge, MA

Agenda

8:30am – 8:45am

Welcome / Opening Remarks
Conference Chair
Event Team Introduction

8:45am – 9:15am

Keynote: The Landscape of Expanded Access, past and present

9:20am – 10:30am

Session 1: The State of Expanded Access: Lessons learned from the first 30 years, 1987 – 2017

  • The historical relationship between access and research
  • Dissecting the narratives; fact and fiction
  • The real ethical considerations and how they are managed
  • Success stories; how to do it right

10:30am – 11:00am

BREAK

11:00am – 12:15pm

Session 2: The Planned EAP: Operational factors and feasibility

  • How early and how big? The right Expanded Access strategy for the circumstance
  • Manufacturing, delivery, and clinical preparedness for large cohort programs
  • Site selection, IRBs, and protocol design
  • The investigator’s needs; Medicare and the role of healthcare delivery

12:15pm – 1:30pm

LUNCH

Featured Speaker: Learning from Patients; using outcomes data and molecular diagnostics to guide targeted drug development

1:45pm – 2:45pm

Session 3: Cost recovery; now and the near future 

  • Defining medical value and s.o.c. in unsolved diseases
  • Charitable partnerships, wholesale repurchase of study drug
  • Initiatives for tiered pricing of investigational products
  • CMS, group plans, and critical paths for policy change
2:45pm – 3:45pm

Session 4: A channel for Real World Evidence

  • Wider, more representative sets of patients within target population
  • Patient reported outcomes, digital clinical trials
  • Data rights and data privacy
  • Data management and application; new stakeholders
3:45pm – 4:00pm

BREAK

4:00pm – 5:30pm

Session 5: Expanded Access and adaptive clinical research 

  • The wide trial: pragmatic-design of Expanded Access trials
  • Consenting, storing, and analyzing biosamples and outcomes data
  • Discovery and validation of response-predictive markers
  • Powering computational biology with large-n clinical datasets
  • Leveraging results to design highly targeted pivotal research trials

5:30pm – 6:15pm

Reception in adjacent ballroom