The Division of AIDS Awards ABL a Seven-Year Contract to Provide HIV Microbicide Research and Product Development Support
July 26 (Rockville, MD) – ABL, Inc. (ABL), a global contract research and manufacturing service provider to the Government and biopharmaceutical industry, is pleased to announce the award of contract #HHSN272201600008I for the “Comprehensive Resources for HIV Microbicides and Biomedical Prevention” (CRMP) by the Division of AIDS (DAIDS) in the National Institute of Allergy and Infectious Disease (NIAID). ABL will provide NIAID with a comprehensive suite of preclinical product development services for candidate non-vaccine biomedical prevention products to prevent sexual HIV transmission, including preclinical gap-filling services, animal models, bioanalytical support, formulation, manufacturing, and scientific and quality/regulatory support services.
Products of interest for development under this program include microbicides, pre-exposure prophylaxis (PrEP) agents, and Multipurpose Prevention Technologies (MPT’s), such as combination products for contraception and disease prevention. Candidate products for the program are the result of investigator-initiated research studies or from collaborations with industry. Products are often formulated for use in reproductive or gastrointestinal tracts where HIV is transmitted. Dosage forms ABL has worked on include gels, films, intravaginal rings (IVRs), suppositories, and long-acting injections.
Microbicides and discreet or long-acting PrEP prevention strategies are thought to provide needed methodologies to empower women and men to better protect themselves and promote adherence. According to the WHO, “a recent cost-benefit analysis conducted at the London School of Hygiene and Tropical Medicine indicates that the introduction in 73 lower-income countries of a microbicide which reduced the risk of infection by 40%, at 30% coverage, would avert approximately 6 million HIV infections over 3 years in men, women and children (Charlotte Watts, personal communication). In addition, this would reduce the health care costs (excluding the cost of antiretroviral therapy) by a staggering 3.2 billion US dollars.”
Scientists at ABL have been involved in the evaluation of antiviral agents directed toward HIV for more than 30 years, including the initial testing of AZT and identification of several compounds with potential anti-HIV-1 activity shown to interfere with multiple steps in the lifecycle of HIV-1. The microbicide field has grown in parallel with a new generation of therapeutic drugs, and these active compounds are incorporated singly or in combination in various prophylactic formulations. For the previous microbicide contracts with DAIDS, ABL has worked to provide the animal safety/toxicity testing, pharmacology, bioanalytical support services, Chemistry, Manufacturing and Controls (CMC) and other required studies and/or services for filing Investigational New Drug (IND) applications. The Principal Investigator for the program and ABL’s Director of Government Contract Research, Dr. Ranajit Pal, has been researching HIV prevention strategies for several decades and has played an integral role in the microbicide development taking place at ABL. “We are pleased to bring together our scientific core, internal research and network of experts to continue working with DAIDS on this important line of defense against the HIV pandemic,” said Dr. Pal, then adding, “The research conducted on this contract is a vital step in the full evaluation of the safety and efficacy of candidate products to more rapidly reach evaluation in clinical trials.”
The Indefinite Delivery Indefinite Quantity contract has a 7-year period with a contract ceiling of $150 million. The services of this new contract are a consolidation of two existing contracts held by ABL: “Non-human Primate Models to Evaluate Therapeutic Strategies and Topical Microbicides for HIV” (HHSN272200800020C) and “Comprehensive Resources for HIV Microbicides and Biomedical Prevention” (HHSN272201000001C).
ABL, Inc. is a global biomedical contract research and manufacturing organization dedicated to advancing therapeutics, vaccines and other biologic products. ABL has extensive experience working with diverse organizations, including industry, government and academic entities. ABL maintains U.S. and European immunological and molecular laboratories to support preclinical and GCLP clinical sample processing and testing. Additionally, with GMP facilities meeting U.S. and European regulatory standards, ABL’s manufacturing services include process and assay development, cGMP biologics manufacturing of bulk drug substance, cGMP aseptic fill and finish of drug product, and QC analytics. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally.