overcoming challenges associated with clinical trial … with clinical trial study start up – a...

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? dawn@Edgerton-data.com