The Blueprint Neurotherapeutics Network (BPN) through the National Institute of Neurological Disorders and Stroke (NINDS) is considering developing a drug product development program for the manufacture and formulation of dosage forms suitable for administration in preclinical and clinical studies.
The goal of the product development program is to manufacture the active pharmaceutical ingredient (API), formulate the API, package, label, store, and distribute completed drug product to preclinical and clinical trial sites. The NINDS envisions awarding a contract for drug manufacturing and formulation services. The Institute is conducting market research to help determine how best to structure contracts for this work.
The BPN offers neuroscience researchers a “virtual pharma” network of contract service providers and consultants with extensive industry experience to develop promising hit compounds from chemical optimization through Phase I human clinical testing. A long term goal is to produce effective medication for a disorder of the nervous system that is currently poorly treated or untreatable. BPN will provide early chemistry knowledge and assist in technology transfer from discovery labs to the product development service provider. Services described below are important next steps for BPN contributors and quality service facilities are needed to develop and prepare drug products for human testing.
The NINDS is considering a drug product development program to assist our BPN contributors. This program is envisioned as a collaborative effort between a service facility and contributors with compounds ready to manufacture.
The service facility shall provide:
- • Chemistry scale up and process development
- • Manufacture of active pharmaceutical ingredients
- • Receipt and storage of API
- • Preformulation & Formulation of API
- • Fill and finish of formulations suitable for clinical trial
- • Packaging, labeling, and storage
- • Distribution to clinical trial sites
This Request for Information (RFI) seeks input on the design of this program from potential service contractors with staffing and equipment for drug product development studies and GMP manufacturing through Phase I and/or Phase II clinical trials.
Further details are available under Solicitation Number: NINDS-RFI-NS-13-001. Responses are due by April 22, 2013.
Read more about the network: NIH Blueprint for Neuroscience Research.
