The Clinical Candidate Selection Committee (CCSC) is a vital part of the EPAD application process. It is not only an evaluation committee but is also the first point of contact with EPAD for intervention owners, and a facilitator of the candidate nomination process. The CCSC may consider appointing dedicated advisers, bound by confidentiality, to help owners prepare the candidacy of their interventions. The CCSC:
- Maintains an open and transparent selection process.
- Relies on regulatory authorities to ensure that interventions have met the regulatory requirements to advance to Phase II.
- Supports de-risking the EPAD project by assuring the scientific rationale, safety, and appropriateness of using EPAD to establish PoC for a given intervention.
Who is on the CCSC?
The Clinical Candidate Selection Committee comprises of members from a number of EPAD’s partner organisations and spans expertise from across the world. The current members of the committee are:
- Professor Craig Ritchie, University of Edinburgh – CCSC chair
- Professor Philip Scheltens, VU University Medical Centre Amsterdam – EPAD member
- Dr Richard Mohs, Chief Scientific Officer for the Global Alzheimer’s Platform (GAP) Foundation – Independent industry representative.
What are the selection criteria?
All interventions are evaluated against the following nine criteria and rated accordingly.
- Scientific rationale/target validation
- Pharmacokinetics (PK)
- Pharmacology requirements
- Plans for full development/regulatory issues
- Develop-ability/CMC quality guidelines
- Biomarkers: assays available for use in the PoC
The PoC master protocol outlines our study design and requirements for all interventions. Any further requirements specific to your intervention will be mapped out in an individual appendix protocol. To discuss your individual requirements please contact the EPAD PoC team at firstname.lastname@example.org.