TY - JOUR
T1 - Next generation strategies for preventing preterm birth
AU - Zierden, Hannah C.
AU - Shapiro, Rachel L.
AU - DeLong, Kevin
AU - Carter, Davell M.
AU - Ensign, Laura M.
N1 - Funding Information:
The work was supported by the Burroughs Wellcome Preterm Birth Initiative (grant 1015020), the National Institutes of Health (R01DK107806, U19AI113127), and a departmental grant from Research to Prevent Blindness. H.C.Z. was supported by an NSF GRFP Fellowship (DGE-1746891). K.D. was supported by a Hartwell Foundation Postdoctoral Fellowship. Figs. 1–5 were created using BioRender.com. The mucus-penetrating particle technology is licensed and in clinical development for ocular indications by Kala Pharmaceuticals. L.M.E and Johns Hopkins own company stock. Under a licensing agreement between Kala Pharmaceuticals and the Johns Hopkins University, L.M.E. and the University are entitled to royalty distributions related to the technology. These arrangements have been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. All authors contributed to the manuscript, assisted in revisions, read, and approved the submitted version.
Funding Information:
The work was supported by the Burroughs Wellcome Preterm Birth Initiative (grant 1015020), the National Institutes of Health (R01DK107806, U19AI113127), and a departmental grant from Research to Prevent Blindness. H.C.Z. was supported by an NSF GRFP Fellowship (DGE-1746891). K.D. was supported by a Hartwell Foundation Postdoctoral Fellowship. Figs. 1?5 were created using BioRender.com. The mucus-penetrating particle technology is licensed and in clinical development for ocular indications by Kala Pharmaceuticals. L.M.E and Johns Hopkins own company stock. Under a licensing agreement between Kala Pharmaceuticals and the Johns Hopkins University, L.M.E. and the University are entitled to royalty distributions related to the technology. These arrangements have been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. All authors contributed to the manuscript, assisted in revisions, read, and approved the submitted version.
Publisher Copyright:
© 2021 Elsevier B.V.
PY - 2021/7
Y1 - 2021/7
N2 - Preterm birth (PTB) is defined as delivery before 37 weeks of gestation. Globally, 15 million infants are born prematurely, putting these children at an increased risk of mortality and lifelong health challenges. Currently in the U.S., there is only one FDA approved therapy for the prevention of preterm birth. Makena is an intramuscular progestin injection given to women who have experienced a premature delivery in the past. Recently, however, Makena failed a confirmatory trial, resulting the Center for Drug Evaluation and Research's (CDER) recommendation for the FDA to withdrawal Makena's approval. This recommendation would leave clinicians with no therapeutic options for preventing PTB. Here, we outline recent interdisciplinary efforts involving physicians, pharmacologists, biologists, chemists, and engineers to understand risk factors associated with PTB, to define mechanisms that contribute to PTB, and to develop next generation therapies for preventing PTB. These advances have the potential to better identify women at risk for PTB, prevent the onset of premature labor, and, ultimately, save infant lives.
AB - Preterm birth (PTB) is defined as delivery before 37 weeks of gestation. Globally, 15 million infants are born prematurely, putting these children at an increased risk of mortality and lifelong health challenges. Currently in the U.S., there is only one FDA approved therapy for the prevention of preterm birth. Makena is an intramuscular progestin injection given to women who have experienced a premature delivery in the past. Recently, however, Makena failed a confirmatory trial, resulting the Center for Drug Evaluation and Research's (CDER) recommendation for the FDA to withdrawal Makena's approval. This recommendation would leave clinicians with no therapeutic options for preventing PTB. Here, we outline recent interdisciplinary efforts involving physicians, pharmacologists, biologists, chemists, and engineers to understand risk factors associated with PTB, to define mechanisms that contribute to PTB, and to develop next generation therapies for preventing PTB. These advances have the potential to better identify women at risk for PTB, prevent the onset of premature labor, and, ultimately, save infant lives.
KW - Drug delivery
KW - Nanomedicine
KW - Nanoparticles
KW - Pregnancy
KW - Preterm birth
KW - Vaginal drug delivery
UR - http://www.scopus.com/inward/record.url?scp=85104931019&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85104931019&partnerID=8YFLogxK
U2 - 10.1016/j.addr.2021.04.021
DO - 10.1016/j.addr.2021.04.021
M3 - Review article
C2 - 33895215
AN - SCOPUS:85104931019
SN - 0169-409X
VL - 174
SP - 190
EP - 209
JO - Advanced Drug Delivery Reviews
JF - Advanced Drug Delivery Reviews
ER -