Overcoming Challenges Associated with Clinical Trial
Study Start Up –A Small Biopharma
PerspectiveDr. Daina Zeng, Director of Research, Agile Sciences Inc.
Dawn Edgerton, Owner, Edgerton Data Consulting, LLC
Agile Sciences Overview• University Spin-off
• Developing small organic molecules that enhance antibiotic activity • Preclinical stage
• Scarce investment sources for early stage technology – rely on government funding and incentives
• Agile Sciences has been awarded over $10M in small business grants and contracts• Clinical trials will be funded via combination of investor and government
funding• Very small company – 4 employees
• Do not have comprehensive internal expertise!
Edgerton Data Consulting Overview
• Assist sponsors with CRO/vendor selection and oversight of successful clinical development programs
• More than 20 years of experience in
• Research computing
• Operations management at CROs
• MBA Biosciences/Services Management dual concentration
• Regulatory Affairs Certification (RAC)
• Knows the difference between oversight and micromanagement
Goal of presentation
Highlight clinical trial challenges as
they pertain to small biopharma
Showcase elements of more successful small
biopharma/vendor relationships
Topics we will cover
Building the foundation for success
Evaluating financial models
Common pitfalls unique to small biopharma
RBM approaches
Limited clinical trial experience
Success of Trial = Success of Company
Small number of employees
Priorities Change
-
-
External Funding
Small Biopharma
Poll of 5 Small Biopharmas: Top Challenges
with Clinical Trial Supply Vendors
Communication
Internal management
Alignment with other
vendors
Vendor processes
Problems with above can lead to handoff issues, wrong decisions,
increased risk to IP, subjects, and trial integrity
Building the Foundation for Success
• Know your internal team’s strengths and weaknesses
• Secure funding
• Early identification/evaluation of ALL risks
• Select vendors and tools• Ask vendor: How do you keep sponsor informed of progress,
quality, $$• Ask yourself: Does that work for my company?
• Decide how to manage vendors and processes• RACI Matrix
• Supplement internal team if needed
RACI Matrix
Task Responsible Approver Consulted Informed
Develop
RFP
Consultant CEO CTO Program
Manager
Award
contract
Program
Manager
CEO Consultant,
CTO
Rest of
Team
Evaluating financial models• Who holds contract with each vendor
• Bill by
• Milestone (FPI, database lock, etc.)
• Event (per shipment, per month, etc.)
• Changes in scope
• Approvals needed (who and what type)
• For each issue or bulk issues
• Monitoring budget vs actual spend
• Risk Sharing
What
works
best for
your
company
?
Common pitfalls
• Slow start but FPI stays same
• Choosing a vendor without vetting for
• Your protocol
• Your company culture
• Inadequate vendor(s) oversight and coordination
• Not keeping BoD informed of risks
Risk Based Monitoring Approach
Identification
Assessment
Control
Communication
Review
Reporting
ICH E6 (R2)
Vendor Selection Recommendations
Your Protocol and Company Culture
Assessment by SMEs
Turnover and Capacity
Assign Resources
Experience with Small Biopharma
Identification and Mitigation of Risks
Service Level Agreements
Vendor Oversight Recommendations
Vendor Oversight SOP
10K View Within Sponsor
Turnover and Capacity
RBM Quality Management
Build Engagement
Participate and Review
Feedback
Summary
Risk Based Approach to Everything
Stay Informed
Keep others informed
Have Fun
Questions? [email protected]