# PHARMACEUTICS/FORMULATION/CMC CONSULTING SERVICES FOR NINDS HEAL PROGRAM

> **NIH NIH N02** · — · 2022 · $4,140

## Abstract

“This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management.” 

The Contractor shall provide Pharmaceutics/Formulation/CMC consulting services in a collaborative
manner to the NIH HEAL Program and to other NIH neuroscience-focused drug discovery and
development programs while serving on HEAL Lead Development Teams (LDT). LDTs meet for
approximately two hours every one to two weeks via teleconference and each LDT project may require
between three and ten hours weekly, inclusive of meeting and preparation time.
Lead Development Teams (LDT) to which the Contractor is assigned may work on a number of projects
in the exploratory through preclinical safety stages. Some projects may proceed to investigational new
drug (IND) and clinical trial stages.
The Contractor’s responsibilities and tasks may include but are not limited to the following:
• Provide senior level pharmaceutics/formulation/CMC expertise, feedback, and guidance on
projects to HEAL Program staff and LDT members through conference calls and email.
• Evaluate Pharmaceutics / Formulation / CMC activities for HEAL compounds under
development in accordance with US regulatory and International Council of Harmonization for
Registration of Pharmaceuticals for Human Use [ICH] guidelines.
• Identify and assess regulatory risks for compounds under development and provide CMC
guidance to HEAL program and LDTs.
• Develop Pharmaceutics / Formulation / CMC strategies which accord with U.S. and international
guidelines.
• Provide recommendations for drug substance manufacturing, analytical method development, and
process development for small molecules.
• Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product
development for small molecules.
• Assist in ensuring timely preparation, review, and submission of chemical manufacturing and
controls documents to regulatory authorities including FDA, European Medicines Agency (EMA)
and other national authorities, to support the conduct of clinical trials and marketing applications.
• Provide expertise in activities related to active pharmaceutical ingredient (API) development.
• Recommend dose form selection and API development strategies for HEAL efforts.
• Develop plans to assist HEAL staff in strategically managing chemical manufacturing and control
pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead
optimization, formulation activities, investigational new drug (IND) enabling, and clinical
studies.
• At the request of HEAL staff, accompany NIH staff or visit Contract Research Organizations
(CRO) under contract with HEAL, inspect CRO facilities, and discuss appropriateness of CRO
proposed methodology. Submit trip reports to HEAL staff.
• Assist HEAL staff in designing investigative chemical manufacturing and controls
pharmacokinetics studies, including study st...

## Key facts

- **NIH application ID:** 10683048
- **Project number:** 75N95021P00672-P00002-0-1
- **Recipient organization:** —
- **Principal Investigator:** STEPHEN ANDERSON
- **Activity code:** N02 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $4,140
- **Award type:** —
- **Project period:** 2021-09-29 → 2023-09-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10683048

## Citation

> US National Institutes of Health, RePORTER application 10683048, PHARMACEUTICS/FORMULATION/CMC CONSULTING SERVICES FOR NINDS HEAL PROGRAM (75N95021P00672-P00002-0-1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10683048. Licensed CC0.

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