Stephanie Wells is the Senior Vice President of the U.S.-based CRO Charles Rivers Laboratories.
Ever-growing healthcare costs mean that new drug discovery is increasingly important, but the R&D process has never been more complex. Global economics, market pressures from payors and patients and a need to reduce internal infrastructure costs are forcing pharmaceutical companies to rethink traditional drug development strategies, as well as increasingly shift spending towards the early phases of R&D. In addition, increasing development of biologics requires not only greater flexibility in R&D, but also enhanced expertise in more complex therapeutic areas and new technologies.
This changing landscape is the driving force behind a collaborative evolution within the industry, transforming traditional pharma-CRO relationships. Increasingly, CROs are evolving to become long-term partners, versus simply individual product or service vendors. They're also becoming involved earlier in the R&D process.
As pharma looks for new ways to reduce costs and gain a competitive advantage by accelerating the R&D process, there's an increasing need to break down barriers that previously separated--and in some cases still divides--the various phases of the R&D process. As traditional R&D models are challenged by top management, and procurement or Lean Six Sigma processes are applied, there is a shift towards internal, global process consistency. As a result, there is a reevaluation of internal structure, around both therapeutic areas and compound classes.
Drivers for Change
The challenges facing the pharmaceutical industry are enormous--fewer robust pipelines, rising and increasingly volatile costs and lingering patent expiration issues. There's a need for a paradigm shift. To leverage constrained internal resources, pharmaceutical companies are seeking CROs with experience not only in specific areas, but also know-how that spans the entire development process.
Drug companies are realizing that they don't have to reinvent the wheel for each new project; CROs have scientific expertise and state-of-the-art infrastructure. The industry evolution towards more comprehensive collaboration is leading to more objective CRO selection and higher expectations by pharma companies.
Changing Role of the CRO
CROs are poised to become viable, strategic partners for companies both big (to help improve productivity) and small (to help maximize licensing opportunities by achieving proof-of-concept without high infrastructure costs). Using CROs to ease the workload/workforce balancing act is becoming essential for the efficient development of new therapeutics. While still maintaining specialty programs throughout the development process, CROs can focus on the overall success of a drug candidate--versus only the success of an isolated study.
As with any strategic partnership, clearly defined roles, expectations (metrics), and governance processes--to say nothing of good communication--are the drivers for success. With joint expectations and a clear understanding of exact protocol specifications and project needs, the CRO can tailor its resources to achieve the program goals.
Transparent communication and building trust between the collaborators can overcome potential barriers to implementation. As in any evolving model, there are always obstacles--including maintaining confidentiality, building relationships based on quality outcomes and shared ownership of a program, overcoming the "not-invented-here" syndrome, internal politics and aligning of business goals. For CROs, balancing the need for efficiency through internal standardization with the clients' need for replicating their specific requirements will continue to present challenges. All must be overcome in the future to truly leverage the significant resource pool available through outsourcing.
Pharma Opportunity: Comprehensive Program Advantages
Although individual studies may be cheaper and faster to outsource in the short-term, comprehensive programs offer greater benefits by maintaining consistency and scientific oversight throughout each entire study. This allows individual studies carried out within the context of larger development goals, ultimately saving time and money.
Players should deploy a "right-fit" model. The degree of expectation of the CRO should be balanced with a stable core staff to manage the R&D planning for each compound. By engaging the CRO early in a program, pharma companies can access the scientific expertise of the CRO, strategically fill gaps and allow the CRO to influence the science objectively, through operational best practices and concurrent project management. The CRO's influence is also transferred throughout the entire drug development process, while elevating pharma resources to overall program oversight and designated scientific expertise. This process challenges both collaborative parties in an effort to achieve faster, cheaper and more accurate outcomes.
The role of CROs as a regulatory resource has grown significantly due to the current regulatory landscape. The regulatory expertise provided by CROs generally is due to broad exposure to programs, resulting in earlier insight into all aspects of the development process. Using the CRO as a regulatory resource enables pharmaceutical companies to focus on R&D.
Strategic Partner, Not Vendor
When choosing to outsource, pharma companies should consider the breadth and depth of science-based services and program management that a CRO can deliver. This will help decide which tasks it needs to keep in-house and what outside expertise they need. Because specific outsourcing needs vary, the CRO will work with the pharmaceutical company to help determine what is essential to accelerate drug development. In the current life sciences environment, it is critical to demand and expect more from the CRO. If the CRO is marginalized, only a modicum level of results can be expected. Achieving a truly innovative and more productive end result requires a new level of CRO commitment across the entire pharma R&D organization.
Ultimately then, the role of the CRO is changing from a one-off study vendor to a strategic partner in tune with the goals and objectives of their client. While maintaining a strictly fee-for-service relationship, aligning with the pharmaceutical company's overall strategic objectives not only maximizes efficiency, but allows the CRO to challenge processes and thereby help reduce the time and cost required to accelerate drug development. - Stephanie Wells