In its goal to advance safe, effective, and profitable drugs to market, the pharmaceutical industry has long acknowledged contract research as an essential resource. But as several CROs discussed at Select Biosciences’ recent “Pharma Outsourcing Congress”, the CRO-pharma relationship has been integrally changing in response to pharma’s new challenges and business models.
“To remain competitive, pharmas are being forced to evolve significantly or abandon traditional approaches in favor of new R&D models,” said Simone Braggio, Ph.D., director at Aptuit. “These models are the basis for a new type of relationship built on strategic partnership rather than simple customer/vendor transactions.”
Dr. Braggio noted that big pharma is increasingly partnering with CROs “for more programs and for more types of activities” that previously were conducted by pharma in-house.
Smaller pharmas, too, are benefitting from CROs, which increasingly offer “expertise and technologies not operationally or economically feasible,” allowing these small pharmas to advance molecules to a level meaningful for licensing deals or development partnerships with bigger pharmas.
Clinical Focus—In Early Development
Pharma’s growing trend to involve CROs in ever earlier stages of discovery has encouraged CROs to develop relevant expertise either in-house or through acquisitions. In July 2010, Aptuit acquired the operations of GlaxoSmithKline’s Medicines Research Centre in Verona, Italy, which has particular strengths in neuroscience, anti-infectives, and cardiovascular therapeutics. Dr. Braggio predicted an increasing move toward externalization by pharma of lead-optimization projects, either in part or entirety.
Aptuit specifically focuses its efforts on parameter assessment that will be meaningful in clinical outcomes. “Traditional lead-optimization strategies are good in designing and selecting candidates that can move adequately from the site of administration into the body—in other words, that survive to Phase 0 or Phase I—but they may not evoke a response in clinic nor be safe enough in the longer term for an adequate risk/benefit balance,” Dr. Braggio noted. “Aptuit’s approach puts a greater emphasis on clinical outcome—in particular, on clinical efficacy and safety.
Since its inception more than 60 years ago, Charles River Laboratories has seen the entire gamut of partnership agreements with pharma. In his talk, David Collins, senior manager, described the range of possibilities of commercial collaborative relationships: from transactional relationships, to preferred provider, to strategic partnering, to alliances between CROs and client pharmas. He noted that which of these is the best fit depends on the particular customer’s specific circumstances, “how mature they are, what their product pipeline is like, and how they are constituted as a company.”
The looming, industry-acknowledged patent cliff will see generics come on-stream as IP protections on branded drugs dissolve, decreasing pharma revenues by as much as 30%, according to some estimates. This is all while pharmas are seeing the “low-hanging fruit already picked,” Collins said, even as the scientific landscape becomes more complex—looking at diseases with intricate etiologies and poorly understood mechanisms while facing the technical challenges of working with complex molecules like biologicals and immunomodulators.
Still, one concern among pharmas in selecting broad-service CROs is that those suppliers may lack the nimbleness associated with focused expertise. To this, Charles River cites the strong intraorganization communication it has developed among active, global working groups with deep expertise in a number of therapeutic areas.
“We can spot trends very early according to patterns in the kinds of requests we receive from our customers. As a global network of various working groups, we can then either see where we already have that expertise or quickly identify how we will develop it.”
In response to a growing demand for earlier-stage discovery work, Charles River has been building its discovery capabilities over the last three years, with the acquisition of Piedmont Research Center and Cerebricon, augmenting its range of efficacy models. Indeed, over the last decade, Charles River has strategically made numerous acquisitions preemptively to broaden its capabilities from discovery through early-stage development.