Alliance Between Pharma and Nonprofits to Speed Development of Tuberculosis Therapies
AstraZeneca, Bayer, Sanofi, Tibotec, TB Alliance, and the World Health Organization agreed to share information on tuberculosis (TB) compounds within their respective drug pipelines, according to the Critical Path to TB Drug Regimens (CPTR). The purpose of the agreement is to promote information sharing around scientific and clinical studies so that partners can identify opportunities to test compounds in combination. Under the agreement, if two or more organizations choose to work together to further develop a regimen, they will enter into a separate arrangement that defines the rights and responsibilities of each party
AstraZeneca, Bayer, Sanofi, Tibotec, TB Alliance, and the World Health Organization agreed to share information on tuberculosis (TB) compounds within their respective drug pipelines, according to the Critical Path to TB Drug Regimens (CPTR). The purpose of the agreement is to promote information sharing around scientific and clinical studies so that partners can identify opportunities to test compounds in combination. Under the agreement, if two or more organizations choose to work together to further develop a regimen, they will enter into a separate arrangement that defines the rights and responsibilities of each party.
“Today’s announcement will accelerate efforts to simplify and improve TB drug regimens,” said Mel Spingleman, president and CEO of TB Alliance, in a press release. “It is critical that we decrease the complexity and duration of treatment, make the treatment of multidrug-resistant TB significantly easier and more tolerable, and make new regimens available to all those who need them as quickly as possible.”
CPTR is working closely with regulatory scientists at FDA, EMA, and other regulatory bodies in China, India, and African countries to develop the tools that will allow testing of new TB drugs in combination. The group’s goal is to shorten the development timeline. Under the leadership of the Critical Path Institute, CPTR’s Regulatory Science Consortium focuses on establishing consensus about preferred standards, methods, and tools for developing new TB drug regimens, and on obtaining official acceptance from international regulatory authorities. CPTR was cofounded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance with the purpose of fostering collaboration to reduce the time it takes to develop novel TB drug regimens, regardless of sponsor.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
