Medical science liaison outreach led to enrolling 400+ patients across Europe in an Early Access Program (EAP), generating sufficient data to win regulatory approval.
OUR TASK
Enroll a breadth and volume of cancer patients across Europe in an Early Access Program to generate real world data for an investigational oncology therapeutic, ultimately to overturn negative CHMP opinion and win access to the European market.
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The Ask
CLIENT
U.S.
Small BioPharma
Build Relationships With Clinical Trial Sites
Work with existing clinical trial sites across Europe to spread the word about an Early Access Program (EAP).
Find + Enroll Patients
Publicize patient selection criteria and work with referring sites and KOLs to find appropriate patients for the program.
Generate Patient Data For Regulatory Approval
The project's ultimate goal was to generate sufficient data to allow the client to resubmit data to the CHMP and overturn its initial negative opinion of the therapeutic.
The Approach
TOOLS
Medical Science Liaison
Hire Experienced MSLs Across Europe
Amplity screened for, hired, and trained experienced medical science liaisons with strong relationship-building and scientific communication skills related to oncology therapeutics.
Build Relationships With Sites, Referral Centers + Patient Advocacy Groups
The team engaged in ongoing communication and high-quality scientific dialogue with existing clinical trial sites and then expanded their network to include referring physicians and other KOLs.
Attend + Speak At Congresses
The team delivered a strong presence at major European congresses and conferences, holding dozens of targeted one-on-one meetings to raise awareness of the EAP and its benefits.
The Results
OUTCOME
Business Objectives Exceeded
Client Satisfaction
Patient Enrollment Goals Exceeded
The dedicated MSL team was instrumental in driving a highly successful Early Access Program, enrolling an impressive 493 patients over just 12 months—a remarkable achievement for any EAP.
Participation Across Therapeutic Areas + Geographies
The program saw significant participation across a variety of different cancer types, with 70% of patients enrolled for non-small cell lung cancer, 24% for colorectal cancer, and 2% for pancreatic cancer.
Negative CHMP Decision Overturned
The quantity of patients enrolled and quality of data across 31 European countries played a critical role in overturning an initial negative CHMP opinion.
European Regulatory Approval
The European Medicines Agency approved the therapeutic, becoming one of only four instances where an initial negative CHMP opinion has been successfully overturned.
