Recipharm, a contract development and manufacturing organization (CDMO), recently announced its new partnership with Swedish CRO Clinical Trial Consultants (CTC) for the development of a comprehensive list of services for first-in-human clinical trials. The partnership’s project, titled Recipharm Pathway to Clinic, is geared toward streamlining clinical trials and facilitating research from the early phase of formulation development to trial implementation.

Anders Millerhovf, CEO of CTC, stated, “Progressing a drug to achieve first-in-human results is a complex process.”  Therefore, the collaboration between the two companies started as a desire to provide customers with an integrated and optimized service “for a cost-effective development program until proof of concept.”

The consolidation of services offered by outsourcing organizations, which echo the mergers commonly seen among small-, medium- and large-scale pharmaceutical companies, is a rising trend that seems to be gaining momentum. As some CDMOs and CROs face increasing competition concerning costs and services offered, many are beginning to deliver a unified approach to create a simpler and cost- and time-efficient clinical trials strategy for customers. The desire to enter new markets segments and to provide end-to-end solutions represent additional reasons for many consolidations within the contract services industry.

According to the 2016 Nice Insight CRO and CDMO Outsourcing survey, more than half of pharma and biotech companies outsource clinical trial services to a CRO and CDMO. Also, almost half of companies surveyed spent approximately $50 million to $100 million on outsourcing, and roughly one-third expanded their outsourcing budget and spent greater than $100 million. As such, many companies seek strategies to optimize their outsourcing costs without sacrificing any of their research needs.

Recipharm and CTC observed a significant advantage for sponsors in purchasing clinical research services as a package, rather than separately. “This reduces the coordination burden for the sponsor,” explained Torkel Gren, general manager at Recipharm Pharmaceutical Development, “and the integrated nature of the services opens up opportunities for saving time.” The time-saving benefit, according to Gren, is essential for early phase drug development “when the focus is to achieve first in human milestones as quickly and as safely as possible.”

Ultimately, this collaboration may enable faster delivery of life-saving therapies to patients. CTC’s knowledge and experience in phase I trials, as well as Recipharm’s ability to perform mid- and post-trial bioanalysis, alongside their clinical supply manufacture offering, will potentially expedite drug-related clinical research, according to a statement by Recipharm.

The greater range of services offered to customers isn’t the only way Recipharm Pathway to Clinic may expedite clinical trials. In fact, the CRO and CDMO offices are in close geographic range to one another, which will enable faster communication and more efficient collaboration.

Gren explained that previous collaboration efforts between CTC and Recipharm in 2014 helped to fuel interest in the recent partnership. “CTC and Recipharm have previously worked together on projects for different sponsors, providing manufacture of clinical trial material, planning and performing the clinical study and bioanalysis.”

According to Gren, the collaboration between the two companies will provide a unique offering for first-in-human clinical trials and will provide services such as trial management, bioanalysis, API manufacture and manufacture of clinical trial material. Additionally, the partnership will offer the “capability to support our clients into later clinical stages and even commercial manufacture.”

Currently, there is a need for outsourcing services to create greater transparency and communication between one another. “The CRO and CDMO industries are very siloed structures, where there’s little to no integration,” according to Mark Egerton, CEO of Quotient, in a previously published statement in in-Pharma Technologist. Improved communication may provide significantly greater time advantages in respect to quickly getting vital drugs to patients who need them.

In this competitive and ever-evolving market, contract services companies must also position themselves as adding essential value to customers. Additionally, CDMOs and CROs must be able to show that they can adjust their services to the changing needs of customers if they wish to continue winning contracts. The ability of one consolidated service that offers formulation development, research supplies, recruitment of patients and implementation of clinical trials may present a unique advantage.

The newly announced partnership between the Recipharm and CTC may create a greater range of possibility and development capabilities in the area of clinical research. Gren believes that offering a comprehensive range of services may help “facilitate the activities of small virtual companies that are involved in drug development” while enabling more efficient work between pharmaceutical development experts.

“In the past, this is an area where Big Pharma had a huge advantage,” said Gren. “When the scientists in different disciplines know each other well and are used to collaborating, it is possible to provide a better service in a shorter timeframe. Now we can offer the same type of benefit to small companies that cannot afford the internal resources.”
Recipharm Pathway to Clinic will be launched September 12-14 to drug developers and manufacturers at the Nordic Life Science Days in Malmö.

This article was reprinted from Volume 21, Issue 38, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »