Chinese CRO GemPharmatech is building up its U.S. presence with a new San Diego space housing laboratories and a suite of genetically engineered mouse models.
The new facility is an expansion of the company’s U.S. headquarters and will provide services such as lab space rental, mouse breeding and in vivo preclinical studies, GemPharmatech announced in an April 17 release. The company’s global headquarters sit in Nanjing, China.
The expansion has been planned since 2023 as part of a long-term strategy to grow GemPharmatech’s U.S. business, a company spokesperson told Fierce Biotech in an email.
"This facility gives our clients in the U.S. the technical expertise and preclinical in vivo pharmacology solutions needed to bring new therapies to market faster, along with a direct pipeline to the largest mouse model library in the world,” Brandy Wilkinson, Ph.D., CEO of GemPharmatech’s U.S. division, said in the release.
The facility’s grand opening comes just after the April 10 announcement that the FDA plans to phase out animal testing requirements for new monoclonal antibodies.
GemPharmatech’s mouse models “are developed to help the global research community advance discoveries that impact human health,” the spokesperson said. Still, the company will “continue to follow downstream market demands” to research and develop new alternative methods.
Other CROs are also adjusting in the aftermath of the FDA’s announcement.
“We are continuously evaluating innovative approaches in drug development and have invested in virtual control groups for safety assessment studies and partnerships using AI technologies to reduce animal use,” Charles River Laboratories said in an April 17 response to the FDA’s announcement.
Charles River initially unveiled a plan to adopt new alternative methods (NAMs), like computer models and human organoids, in April 2024. The company’s stock slipped 27% in the wake of the FDA’s recent announcement, according to an April 14 report from Macquarie Equity Research.
A spokesperson told Fierce Biotech that the company does not comment on stock price but that “the overall market reaction to the FDA announcement likely reflects a general sentiment within the industry that while NAMs will play a larger role in the future, there is still a lot of work to be done to prove the safety and efficacy of full animal model replacements in drug discovery and development.”
Jim Corbett, CEO of organ chip company Emulate, fully expects the CRO industry to adapt to meet the alternative testing demands of their pharmaceutical company customers, he said at an April 15 press conference.
The FDA announcement is “a carrot to get people to move to the technology,” Corbett said. “It will take time, but I believe it will be a logical supply and demand change that's going to occur.”
In one example of this change, drug developer Certara quickly capitalized on the FDA’s decision by launching a new solution to help biopharma clients shift away from animal testing.
Certara’s service provides regulatory advice, preclinical development planning and biosimulation technology, the company said in an April 14 release.