CDMO Recipharm and CRO CTC To Partner And Offer Phase I Support
By Cyndi Root
Recipharm Pharmaceutical Development AB announced in a press release that it has entered into a collaboration with CTC Clinical Trial Consultants AB. The two companies have agreed to provide Phase I support to pharmaceutical companies.
Maria Lundberg, General Manager of Recipharm, said, “Together we will be able to offer customers faster and more cost-efficient phase I studies.” Bengt Dahlström, CEO of CTC, said, “CTC and Recipharm now can offer a joint service which will benefit from the companies longstanding expertise in contract development and manufacturing and early clinical research.”
Recipharm and CTC Partnership
CTC is experienced in clinical trials and has a Phase I unit at Uppsala University Hospital (Akademiska Sjukhuset). Recipharm offers manufacturing services and production of clinical trial material. The two companies plan to pool their resources and offer a set of Phase I packages for clinical studies including developing and manufacturing of clinical products. The pair hopes that an integrated approach will improve data collection and shorten clinical trials. They plan to use “adaptive design” principles in the planning, performing, and evaluation of the clinical trial.
Adaptive Trial Design
The Food and Drug Administration (FDA) has issued Guidance on adaptive trial design. The guidance covers when to consult with the FDA, trials with special considerations, what information to include in the design, and the issues to consider when designing trials. The federal agency states that clinical trials can be designed with “adaptive features” such as design changes at the interim analysis point, shorter trials, fewer patients, and designs that present the drug’s capabilities in the best light. While the FDA says that adaptive design is most suited to studies that support marketing a drug, adaptive methods are applicable to exploratory studies, such as the ones Recipharm and CTC intend to provide.
About Recipharm
Recipharm Pharmaceutical Development AB is a contract development and manufacturing organization (CDMO) based in Sweden. Recipharm employs over 1,500 employees in Sweden, the UK, Germany, and Spain. It is currently manufacturing over 200 products for small and large pharmaceutical companies.
About CTC
CTC Clinical Trial Consultants AB is a contract research organization (CRO) headquartered in Switzerland. CTC focuses on translational medicine and early stage clinical studies. It maintains a 12-bed research unit and site management organizations (SMOs) in Linköping and Uppsala, Sweden.