The Preclinical Development Support Master Contract (PDSMC) supports all phases of preclinical development, including process and product development, GMP manufacturing and clinical lot production, analytical and formulation, preclinical enabling studies and associated tasks leading to the filing of investigational new drug (IND) applications.
This contract is with Advanced Bioscience Laboratories (ABL).
A large clinical trial to assess treatments for preventing people at high risk from developing multidrug-resistant tuberculosis (MDR-TB) has begun. The study is comparing the safety and efficacy of a new MDR-TB drug, delamanid, with the decades-old TB drug isoniazid for preventing active MDR-TB disease in children, adolescents and adults at high risk who are exposed to adult household members with MDR-TB.
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DAIDS offers a number of funding opportunities, including grants and contracts, to conduct translational research and development for clinical evaluation. NIAID works with funded contractors to offer services to investigator’s to manage and accelerate the product development, process development and cGMP manufacturing, and product lifecycle management to advance it into clinical trials.
The Division of AIDS (DAIDS) offers a unique venture to enable, facilitate, operationalize and translate vaccine developers’ concepts into current good manufacturing practice (cGMP)-manufactured, vialed products for clinical trials. The program manages and supports a broad portfolio of HIV vaccine assets by providing translational expertise, services, and resources in advancing HIV-vaccine development. DAIDS works closely with academic innovators, biotech, pharmaceutical companies, non-profits, vaccine trial networks, and contract manufacturing and contract research organizations (CMOs, CROs) to advance clinical HIV vaccine development. In addition, the program provides integrated quality assurance and regulatory guidance/expertise in compliance with FDA regulations by preparing and supporting regulatory filings.
DAIDS offers a number of funding opportunities, including grants and contracts, to conduct translational research and development for clinical evaluation. NIAID works with funded contractors to offer services to investigator’s to manage and accelerate the product development, process development and cGMP manufacturing, and product lifecycle management to advance it into clinical trials.
Current funding opportunities include
2019
2018
2017
These services are provided at no cost to investigators.
Liberty A. Walton, Brandie K. Taylor, Krystal A. Tomlin, Dione I. Washington, and Jane C. Lockmuller
Liberty A. Walton, Brandie K. Taylor, Dione I. Washington, Larry S. Solomon, and Jane C. Lockmuller
The HIV/AIDS clinical trials networks Funding Opportunity Announcements (FOAs) issued in January 2019 contained changes from how the NIH HIV/AIDS clinical trial networks were previously structured, particularly with regard to research on microbicides for HIV prevention and pediatric HIV research. The below questions and answers provide more information on these changes.
Why is a microbicide network absent from these FOAs?
Liberty A. Walton, Brandie K. Taylor, Krystal A. Tomlin, Dione I. Washington, Larry S. Solomon, and Jane C. Lockmuller