Dendritic cell vaccine (oncology)
The Project
Small biotech US company developing a dendritic cell vaccine for the treatment of the Orphan indication glioblastoma in EU.
The Challenge
Client in need of expert support to align development strategy with EU authorities’ expectations. Timeline: long-term (8 years)
Support in
- Preparation and conduct
of the Scientific Advices (SA) - Medical and technical Writing
- Clinical trial Phase III
- Adaptive pathway
- Early access medicines scheme
(UK) - Hospital exemption (DE)
- Pediatric Investigational Plan (PIP)
- Pharmacovigilance: DSUR and PSUR
The Solution
Senior project lead supported by subject matter experts with know-how of special programs.
PharmaLex Project Leader as main point of contact for the customer:
- Contact point for all questions
- Provides strategic support
- Overall responsibility for all deliverables
- Coordinates the PharmaLex experts
- Fast response times
- Manages timelines and costs
Specific subject matter experts involved
Master service agreement in place with work orders for various deliverables/services
The Outcome
Positive outcome based on our 25+ years of experience with health authority interactions.
- Experts available with ATMP experience in regulatory, quality, nonclinical and clinical aspects
- Access to EU Health Authority opinion leaders via the extensive PharmaLex network
- Know-how for special programs (Hospital exemption, EAMS and Adaptive Pathway)
- Seamless integration of Development, Regulatory and PV services
- Flexible contractual framework allowing quick implementation of new work orders
