# BIOACTIVITY ASSAY DEVELOPMENT CONSULTANT SUPPORT SERVICES

> **NIH NIH N02** · — · 2024 · $36,000

## Abstract

Bioassay Development, Qualification/Validation SME
Bioassay development consultants will be required to evaluate or develop bioassay
development plans and recommend strategies and experiments to optimize assays
and/or qualify/validate the assays, for use in a clinical and nonclinical studies. Bioassay
consultants may be asked to assist in the establishment of milestones related to assay
optimization or validation. Bioassays may be used to measure drug product in
manufacturing studies, and/or in serum or tissue samples obtained from clinical and/or
nonclinical studies. The NIH may seek guidance from consultants on the design and
interpretation of commonly used in vitro assays, such as biochemical and/or cell-based
assays. Specific consulting responsibilities will depend on the expertise of the individual
consultant and the needs of individual projects. Bioassay-related consultation services
may be required on an ad hoc basis or through LDTs.

Bioassay SME Consultants will:
1) Provide expertise in developing, qualifying/validating assays required to support
PK/PD, toxicology, and clinical safety studies, and manufacturing/release testing of
the biologic
2) Assist in the establishment of milestones related to assay optimization or validation
3) Serve as the assay development expert in order to identify potential developmental
challenges and suggest strategies to address these challenges on realistic timelines
4) In partnership with other consultants, contractors, and the NIH staff, advise,
strategically plan, and manage programs to facilitate lead optimization, IND
enabling, and clinical studies execution
5) Serve as a resource to lead development team members for assay requirements,
and logistics to conduct biologics development activities from the preclinical stage
through to the initial clinical stage
6) Collaborate on the design of investigative studies in support of biologics
development.
7) Serve as a resource to LDT for assay requirements and logistics to conduct biologics
development activities from the preclinical stage through to the initial clinical stage
The role of the Bioassay SME consultant may include, but is not limited to, the following
responsibilities and tasks:
a) Review and comment on the adequacy of bioassay approaches proposed by
Principal Investigators (PIs) and/or CMOs/CORs
b) Evaluate bioassay development and/or qualification/validation studies on a weekly or
biweekly basis
c) Serve as the team bioassay expert in order to identify potential product development
challenges and suggest strategies to address these challenges
d) Collaborate on design of studies in support of therapeutics development projects
e) In partnership with other consultants, contractors, and the NIH staff, advise,
strategically plan, and manage bioassay studies to facilitate preclinical evaluation
and safety testing, Investigational New Drug (IND) submissions, and clinical studies
f) Facilitate LDT discussions via telephone and email regarding assigned ...

## Key facts

- **NIH application ID:** 11041813
- **Project number:** 75N95022P00467-P00003-0-1
- **Recipient organization:** —
- **Principal Investigator:** WILLIAM MARTIN
- **Activity code:** N02 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $36,000
- **Award type:** —
- **Project period:** 2022-08-10 → 2025-08-09

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11041813

## Citation

> US National Institutes of Health, RePORTER application 11041813, BIOACTIVITY ASSAY DEVELOPMENT CONSULTANT SUPPORT SERVICES (75N95022P00467-P00003-0-1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11041813. Licensed CC0.

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