By Laura Powell, Managing Consultant, and Eric Jia-Sobota, Founder
CHARLESTON, S.C., Dec. 6, 2023 /PRNewswire/ -- The Rapid Response Partnership Vehicle (RRPV) Consortium is a joint initiative with the Biomedical Research and Development Authority (BARDA) to promote research and development in response to pandemics or public health emergencies. The RRPV focuses on accelerating the development, regulatory approval, commercialization, and maintenance of medical countermeasures against threats like pandemic influenza, emerging infectious diseases, and other biological threats.
RRPV seeks to address the capability gap identified by BARDA in developing therapeutics, particularly those offering protection through Pre-exposure Prophylaxis (PrEP) and treatment against new SARS-CoV-2 variants. The Consortium has released a Request for Project Proposals (RPPs) to advance the clinical development of Next-Generation Therapeutics for COVID-19, with the goal of improving COVID-19 solutions and enhancing preparedness for future health security threats. The new solicitation specifically targets the development of COVID-19 monoclonal antibody therapeutics for PrEP to licensure, with emphasis on in vitro activity against a wide range of SARS-CoV-2 variants, a high barrier to resistance, and potency suitable for intramuscular or subcutaneous administration.
The effort is expected to last up to seven years, focusing on design, manufacturing, nonclinical testing, and clinical trials, primarily in the United States. The location of these activities is negotiable, with the primary site anticipated to be the project awardee's facilities.
Eligibility criteria for proposal submissions include RRPV membership at the time of submission, a successful history of developing and conducting clinical trials for therapeutics or vaccines, and compliance with Current Good Manufacturing Practice (cGMP) standards. Additionally, preferred proposals will demonstrate in vitro potency against MERS-CoV, SARS-CoV, and SARS-CoV-2; will be at a Technology Readiness Level (TRL) of 6 or later; have reduced dosing, administration, and monitoring requirements; have a proven manufacturing process ready for clinical trials; and will be manufactured in a cGMP-compliant facility in the United States.
"EverGlade Consulting acknowledges the significant potential that RRPV offers to public health," remarked Eric Jia-Sobota, founder of EverGlade Consulting. "We're thrilled to help companies navigate this new funding opportunity."
If your company has considered applying for BARDA funding, EverGlade can help you make that determination and pursue a successful contract. Our team has helped both large and small companies prepare, submit, and win applications for federal funding. For additional information about EverGlade Consulting, visit:
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