The University of Texas Medical Branch in Galveston and Texas A&M University have received a grant totaling around $7.5 million over five years from the National Center for Advancing Translational Sciences (NCATS) to establish a center dedicated to promoting women's and pregnancy health research.
"We are honored to receive this grant from NCATS, which will enable us to advance research in women's health and pregnancy," said Dr. Ramkumar Menon, professor in the Department of Obstetrics and Gynecology at UTMB and the center’s contact principal investigator.
This major initiative aims to advance already developed cutting-edge Microphysiological Systems, also called organ-on-a-chip, to replicate all aspects of the human female reproductive organs involved in pregnancy, into drug development tools. This approach will also reduce the use of animal models in research.
The UTMB-Texas A&M partnership is one of the four centers funded by NCATS and the only center that will conduct pregnancy and women’s health research. The grant, totaling around $7.5 million over five years, will establish the Translational Center for Microphysiological Systems Based Drug Development Tools for Pregnancy and Women's Health.
Our goal is to create reliable drug development tools, ultimately improving regulatory decision-making processes and advancing medical science in these critical areas.
UTMB will operate as the central hub for coordinating activities across a laboratory at UTMB and two others at Texas A&M University.
"Our goal is to create reliable drug development tools, ultimately improving regulatory decision-making processes and advancing medical science in these critical areas," said Menon. “Pregnant women and their fetuses are therapeutic orphans and clinical trials do not include them. With tools developed, we will work with NCATS and the FDA to accelerate clinical trials during pregnancy in the future and reduce complications like preterm birth.”
The core functions of the Translational Center for Microphysiological Systems Based Drug Development Tools for Pregnancy and Women's Health are managing administration and finances, integrating research, ensuring quality control of drug development tools, getting FDA approval for these tools, and translating research into commercial applications. The center will also focus on disseminating its knowledge to academic researchers, government agencies, and industry end-users, ensuring that the benefits of this research reach a broad audience.
"We believe this center will become a leading force in women's and pregnancy health research, providing valuable resources and expertise to the scientific community and beyond," added Menon.
Dr. Menon will be joined in the team of principal investigators by Dr. Arum Han and Dr. Ivan Rusyn, both from Texas A&M University. Dr. Lauren Richardson and Dr. Ananth Kumar Kammala are also key investigators of Dr. Menon’s team at UTMB.
With tools developed, we will work with NCATS and the FDA to accelerate clinical trials during pregnancy in the future and reduce complications like preterm birth.
Dr. Han, a professor of electrical and computer engineering at Texas A&M University, will lead the center’s activities on manufacturing of the MPS that will be advanced as drug development tools.
“Translating the MPS platforms we have developed into the hands of drug developers and pharmaceutical companies through this center will be an exciting new endeavor, truly bringing positive impacts to women's health and pregnancy, together with my long-term collaborators, Drs. Menon and Rusyn," Han said. "By supporting the qualification of MPS devices representing female reproductive systems, we hope to fill a critical gap in drug development tools.”
Dr. Rusyn, a professor of veterinary physiology and pharmacology at Texas A&M University, will lead MPS qualification efforts of the center.
“We are excited to partner with Drs. Menon and Han to utilize the experience in MPS testing and qualification that we acquired through TEX-VAL Tissue Chip Testing Consortium,” said Rusyn. “The independent verification of the performance of MPS is a critical activity for end-user confidence and we are looking forward to working with our current TEX-VAL partners in the industry and government to ensure fit-for-purpose validation.”
The National Center for Advancing Translational Sciences is part of the National Institutes of Health. NCATS focuses on improving the translational process so that new treatments and cures for diseases can be delivered to patients faster. These include scientific, operational, financial, and administrative innovations that transform the way that research is done, making it faster, more efficient, and more impactful.