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

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
  • Hospital exemption (DE)
  • Pediatric Investigational Plan (PIP)
  • Pharmacovigilance: DSUR and PSUR
The Solution

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

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

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