ReciPharm and Clinical Trial Consultants are launching a new service to facilitate first-in-human trials.
Getting new drug candidates through development and into first-in-human clinical trials must be achieved as rapidly as possible in today’s competitive environment. Many pharmaceutical companies, however, “often face problems in terms of meeting timelines, adhering to changing regulations and managing trial complexity,” said Torkel Gren, General Manager at contract development and manufacturing organization (CDMO) Recipharm in Solna, Sweden. “It is our job to guide them through the process," he added.
To provide greater assistance to its customers, Recipharm has partnered with contract research organization (CRO) Clinical Trial Consultants (CLC) to launch a new service that “delivers a clear, streamlined pathway to first in human milestones.”
As a CDMO, Recipharm offers its clients support with formulation development, GMP clinical supply manufacture and bioanalysis at its sites in Solna and Uppsala, Sweden. The new service, Recipharm Pathway to Clinic, will enable the company to offer early phase formulation development support all the way through clinical trial implementation with patients. The partnership with CLC, which provides clinical trial services, including the management of Phase I trials at the Akademiska University Hospital in Uppsala, makes the end-to-end service possible. Specifically, CTC supports customers with hospital-based early phase (0/I/IIa) clinical trials, including patient recruitment, trial design, implementation and data evaluation The new service will help companies of all sizes “quickly generate data and build value in their compounds,” according to Recipharm.
"Quite simply, Recipharm’s Pathway to Clinic service means we take responsibility for the full Phase I programme, from formulation to clinical trial implementation with patients,” Gren explained. “Managing the different aspects of Phase I, while reducing risk, time and cost, requires a clear roadmap and close collaboration between the different disciplines. Through partnering with CTC, we have complete control of all the links in the chain so can adjust at each step to avoid delays, meet deadlines and build value for our customers.”
Added Anders Millerhovf, CEO at CTC: “Progressing a drug to achieve first in human results is a complex process. Together with Recipharm, we can offer a complete integrated service where all the parts have been optimised to give our customers a fast and cost-effective development programme until proof of concept.”
Recipharm and CTC plan to launch Recipharm Pathway to Clinic at the Nordic Life Science Days in Malmö, a large Nordic partnering conference that attracts more than 1000 people from Europe and the rest of the world.