A regulatory science approach for morphology-based biomarkers in tissue sections
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Title: A regulatory science approach for morphology-based biomarkers in tissue sections
Short Title: TILs RS Project
WG Members: Kim Blenman (Yale), Jochen Lennerz (Harvard), Hetal Marble (Harvard), Keith Wharton (Ultivue), Esther Abels (Visopharm), Amanda Lowe (Visopharm), Aziza Nassar (Mayo Clinic), Michel Vandenberghe (AstraZeneca), Evangelos (Vangelis) Hytopoulos (iRhythm)
Addressed Parties:
All key stakeholders.
Background:
There is insufficient understanding regarding regulatory approaches for morphology-based biomarkers (e.g. TILs in H&E or IHC/IF sections). It is unclear as to what would be the “best practices for consideration”.
Approach & Objectives:
Collaboratively contribute to the creation of regulatory science approaches
Objective 1: Write a whitepaper that proposes a regulatory science approach for morphology-based biomarkers
Objective 2: Explore options for existing regulatory programs (e.g., MDDT) and pathways (e.g. CoDx) or insufficiencies or propose a new pathway
Deliverables:
(1) Produce the whitepaper (e.g., as a peer-reviewed manuscript)
(2) Share it with the TILs WG and PIcc communities
(3) Submit it to the FDA for commenting (e.g. QSub program)
Value proposition:
“How will the proposed project be valuable from each of these categories?” Address each in detail:
Regulatory: contribute regulatory science approaches to an area in which these approaches currently do not exist
Clinical: (1) benefit to regulators – provide possible “best practices for consideration” and (2) benefit to patients (in particular, low-to-middle income communities/countries) – opportunity to utilize low-cost standard H&E TILs for assessment of the immune microenvironment of tissue
R&D: enable researchers and software developers to develop compliant tools
Funding sources: if existing, please mention source or propose a funding source
Benefit to patients : technical advance, increased quality, outcome, access, affordability
References/Resources (optional):
Salgado et al., 2015 Ann Oncol https://pubmed.ncbi.nlm.nih.gov/25214542/