DAIDS Preclinical Services Program to Accelerate Drug Development

Speaker: Keith W Crawford, Health Scientist Administrator at Division of AIDS,
National Institute of Allergy and Infectious Diseases, NIH

Provided a program overview with a focus on available services under Preclinical Pharmacology and Toxicology and Formulation Development and Manufacture of Clinical Dosage Forms.

The DAIDS Preclinical Services Program is a valuable resource for investigators developing next generation therapeutics for HIV and related co-infections – high priorities include longer acting ARVs, novel targets and inhibitors and novel immune-based therapies.

  • Provides preclinical support to advance promising therapeutic candidates towards clinical trials (fills critical product development and resource gaps in investigator programs). 
  • Investigators receive products, data and specialized expertise from NIAID contractors at no cost to the investigator (investigators do not receive NIAID funding).
  • Available services fall under 6 technical task areas spanning product development from initial drug discovery and lead optimization to preclinical development, including IND-directed studies and activities required for regulatory submissions and clinical trials.


Example task area 1: Formulation Development and Clinical Manufacture – available services (all studies conducted in compliance with cGMP).

  • Develop new formulations to enhance product solubility or bioavailability 
  • Develop alternative dosage forms (different strength or route of administration).
  • Develop and validate analytical assays to determine identity, strength, quality, purity, stability, and drug release methods.
  • Develop manufacturing processes and procedures.
  • Prepare reports to be included in the Chemistry, Manufacturing and Controls (CMC) section of regulatory submissions.

Example task area 2: Preclinical Pharmacology and toxicology – available services are directed towards meeting requirements to be included in the IND submission (all studies conducted in compliance with cGLP).

  • IND-enabling studies – characterize in-vitro properties (ADMET, protein binding, bioavailability and bioequivalence, potential drug interactions); pharmacology in animals, toxicology (acute, repeated dose and chronic toxicity), safety analyses in different organ systems. 
  • Develop bioanalytical methods and perform bioanalytical studies.
  • Prepare all required study reports for the IND package. 

How to access services (www.niaid.nih.gov/research/daids-services-program-accelerate-drug-develo...).

  • Submit a written request for services (specific needs, data package to support the request and overall product development plan)
  • Requests evaluated internally with a team of expert scientists according to the following criteria: 1) matches NIAID priorities; 2) soundness of development plan; 3) investigator commitment (preliminary data, concurrent studies, communications with FDA); 4) ability of NIAID contract resources to fulfill requested services; and 5) availability of funds. 
  • If approved, NIAID point of contact issues a Material Evaluation Agreement (MEA) and coordinates transfer of products and data between investigator and NIAID contractor. 
  • Resources and services listed on NIAID website with contacts.

Past projects by task area.

  • Clinical Dosage Forms Manufacture – novel formulation, delivery system or route of administration of an approved product that alters the PK.
    • Repackaged nevirapine tablets into blister packs with a 48-month stability study.
    • Manufactured methotrexate capsules and placebo with a 60-month stability study. 
    • Process development and GMP manufacture of a proprietary lipid-based product (manufactured a lipid nanoformulation).
  • Preclinical Pharmacology and Toxicology. 
    • Pharm/tox studies of proprietary ARV nanoformulation for IND filing. 
    • Safety and pharmacology studies (GLP and non-GLP) of novel formulations of existing drugs (injection, oral, and inhaled delivery in rats and dogs).
    • 6-month tox/TK study of sutezolid for mycobacterial infection. 
    • Repeat toxicity and TK studies of a novel ARV formulation in mice.
    • Reproductive tox studies of a clinical stage ARV in rats (GLP, segment I/II).
    • In-vitro mitochondrial tox studies.
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