A host of factors come into play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.
By Kevin Honeycutt and Erin Graham, Alliance for Cancer Gene Therapy (ACGT)
Daniel J. Powell Jr., Ph.D., along with his research team at the University of Pennsylvania, has launched a new clinical trial to treat ovarian cancer with a pioneering therapy involving genetically modified T cells. The trial, which has treated its first patient, almost didn’t happen.
By Parrish Galliher and Brian Hubbard,GE Healthcare Life Sciences
The journey from research lab to market is a long one, and most drug candidates do not make it. For those that do progress to market there are many regulatory milestones and hurdles. Following are some tips to assist with up-front planning to prevent headaches down the road.
By Sanjay Konagurthu, Ph.D., and Tom Reynolds,Thermo Fisher Scientific
Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of formulations, and increase overall speed-to-market.