# BIOLOGICS SUBJECT MATTER EXPERT (SME) CONSULTING SERVICES

> **NIH NIH N02** · — · 2024 · $193,531

## Abstract

The consultants will be expected to provide feedback and guidance on scientific processes and
gap areas/needs assessments through in-person meetings, conference calls, and email. The
consultants will also be required to provide information on the ultra-rare disease space,
preferably with a focus on neurological disorders. This will assist the NIH with better
understanding the requirements for product developers to move their therapeutics through the
research and development stage into clinical evaluation studies as well as development
strategies and alternatives. Specific consulting responsibilities will depend on the expertise of
the consultants and the needs of the program.

Performance Area 1: Biologics Chemistry, Manufacturing and Controls (CMC) SME(s)
Subject matter experts in manufacturing of the various biological therapeutics platforms, including but not limited to, modalities such as therapeutic oligonucleotides (e.g., antisense oligonucleotide -ASOs, small interfering RNAs -siRNAs, etc.), AAV, lentivirus or other viral vector therapeutics, purified proteins, recombinant proteins, peptides, antibody-based and cell-based therapeutics, and ex vivo cellular therapies are required. Biologics CMC consultants will be expected to provide senior-level chemistry, manufacturing and controls expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email.

Please note that, for Performance Area 1, the Government will consider SME consultants with expertise in one or more manufacturing modalities.

The role of the CMC SME consultant may include, but is not limited to, the following responsibilities and tasks:

a)	Review and comment on the adequacy of biologic manufacturing, including scale-up, analytical method development, and process development (upstream and downstream processing) approaches proposed by Principal Investigators (PIs) and CMOs

b)	Provide guidance on delivery methods, which may include complex formulations such as polymer, liposomes, and other nanoparticle constructs
 
c)	Provide expert advice on master and working cell and viral bank development and testing

d)	Provide strategy and feedback on biologics process development and manufacturing plans proposed by the team

e)	Provide feedback on therapeutic oligonucleotide sequences and synthesis processes proposed by the team

f)	Provide feedback on proposed biologics formulations

g)	Provide feedback on critical quality attributes, release testing, etc.

h)	Evaluate CMC data on a weekly or biweekly basis

i)	Serve as the CMC expert in order to identify potential product manufacturing challenges and suggest strategies to address these challenges

j)	Accompany NIH staff or visit, at NIH staff request, CROs and CMOs under contract to the NIH.

k)	Inspect facilities and discuss appropriateness of CRO/CMO proposed methodology

l)	CMC consultant may be asked to evaluate the potential tractability (including surrounding IP space...

## Key facts

- **NIH application ID:** 11041898
- **Project number:** 75N95022P00212-P00013-0-1
- **Recipient organization:** —
- **Principal Investigator:** SUSAN BENJAMIN
- **Activity code:** N02 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $193,531
- **Award type:** —
- **Project period:** 2022-04-15 → 2024-04-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11041898

## Citation

> US National Institutes of Health, RePORTER application 11041898, BIOLOGICS SUBJECT MATTER EXPERT (SME) CONSULTING SERVICES (75N95022P00212-P00013-0-1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11041898. Licensed CC0.

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