Data-driven solutions for your most difficult CGT hurdles Cell and gene therapy research is often a high-stakes undertaking, involving incredibly complex science and constantly shifting regulatory terrain. We work diligently to minimize your development risks through our insightful regulatory support,...
Expertise: Cell & Gene Therapy 56 results
Rare Disease
Angi Robinson
Cell & Gene Therapy
Kenneth Ndugga-Kabuye, M.D., FACMG
Consulting
Greg Meyer, RAC, CQA
Cell & Gene Therapy
Jessica Merryfield
Consulting
Olu Aloba, Ph.D.
With hundreds of companies and clinical trials investigating CAR T-cell therapies, there exist opportunities to expand the applications of—and broaden access to—these novel therapeutics to address unmet medical needs.
Cell and Gene Therapy Expert Dr. Kenneth Ndugga-Kabuye to Lead Clinical Strategy With Collaboration From Operations, CMC and Regulatory Experts MORRISVILLE, N.C., April 17, 2023-- Premier Research announced today the addition of Kenneth Ndugga-Kabuye, M.D., FACMG, as VP, Cell &...
Cell & Gene Therapy
5 Tips for Operationalizing Gene Therapy Studies
Gene therapy clinical trials are logistically complex studies that require highly qualified sites and engaged patients for success. The ability to select the right sites and patients can be the difference between product failure and market approval. In this final...
Cell & Gene Therapy
Designing Robust Gene Therapy Studies
To develop a successful gene therapy, sponsors must conduct research studies that balance the need for safety oversight and robust clinical evidence with the challenges of finding the right patients, pairing them with qualified sites, providing informed consent, and confirming...