CRO Therapeutic Specialization Enhances Clinical Development Programs

With recent advances in science, new licensing and acquisition opportunities and an urgent need to increase the number of drugs in their pipelines, pharmaceutical companies may find themselves expanding their businesses into areas with which they have little or no practical experience, nor the right in-house expertise. To successfully plan and execute clinical development programs in these areas, companies are turning to a new type of contract research organization (CRO): one that is dedicated to specific therapeutic categories.

“To remain competitive, companies are expanding their pipelines into areas in which they traditionally have not performed drug development,” according to Maria V. Lopez-Bresnahan, M.D., Vice President and Global Head of i3 Medical and Scientific Affairs. “One of the challenges they face when moving into a new therapeutic area is overcoming a lack of experience in a particular field or with a particular indication,” she explained.

To bridge information gaps that emerge during therapeutic expansion, pharma companies increasingly are looking to external experts that can help them navigate unfamiliar therapeutic categories.

“In general, outsourcing is a great option when a company does not have the subspecialty resources to get the work done in-house,” Lopez-Bresnahan said. “Today, in addition to outsourcing operational activities, companies making forays into unknown therapeutic territory need to find qualified experts who have an immediate grasp of the clinical landscape in order to accelerate the clinical development of their drug,” she added.

For example, a company may have developed an antibiotic five years ago, but doesn’t have current information about the clinical trial environment in that area. This company can turn to a specialized CRO that may have developed an antibiotic program for a sponsor within the past six months and has a very timely understanding of the field.

Further, if a company’s primary therapeutic area has been development of cardiovascular products but it acquires a drug for insomnia or finds that one of its existing products has an unexplored insomnia indication, “outsourcing to a specialized CRO to spearhead its clinical drug development will not only save the company time and money but ensure a very expert program that will lead to drug approval,” she said.

Staffing, expertise deficits lead to increased reliance on CROs

Specialization is not a new concept, but it is relatively new for CROs. Pharmaceutical and biotech companies run drug development programs in highly specialized medical areas and need strong clinical development teams to ensure the successful approval of new treatments for patient care. During the past several years, however, economic, regulatory and quality pressures have made pharmaceutical companies reluctant to hire additional staff to expand those efforts, leading to the growth of the CRO industry.¹

“The growing use of CROs during the past decade to support the development enterprise has enabled pharmaceutical and biotechnology companies to build a larger drug pipeline and to complete projects faster without compromising data quality,"² according to a recent trade journal article.

As companies began leveraging “constrained internal resources” by “seeking CROs with experience not only in specific areas, but also know-how that spans the entire development process,"³ a new type of CRO is emerging: a CRO that “owns” a therapeutic space,⁴ can stand in for drug company experts and drive clinical development programs forward.

To help pharmaceutical and biotechnology companies meet their clinical research goals, i3 Research is therapeutically focused on five areas: oncology, cardiology, central nervous system, respiratory and infectious diseases, and endocrinology and metabolic diseases. “i3 Research brings together experts in these fields and assembles dedicated teams with proven experience for clients.  We’re committed to specialization throughout the organization, not just in our medical teams, but across operations and other functions,” Lopez-Bresnahan explained.

And although many specialized CROs are small, i3 Research, which is an Ingenix company – a subsidiary of UnitedHealth Group – “offers the best of both worlds,” she said, “because it has the expertise of a niche CRO, but is a large enough company with the resources to conduct large trials. In other words, we have the ability and the freedom to concentrate on key areas while having feet on the ground across the globe to execute those studies.”

Lopez-Bresnahan pointed out that although some CROs may present themselves as specialists, they either “specialize” in all therapeutic categories (an impossibility) or routinely pull their staff “specialists” to do unrelated work to ensure the full billability of their staff. At i3, staff members are committed to their areas of specialty – which is where they spend the majority of their time, she remarked. This paradigm helps i3 to both engage and retain personnel.

“The therapeutic expertise we offer permeates all levels of our organization,” she said. “The project managers, the medical directors and the clinical monitors are focused in their particular area, have a great deal of training in their specialty, and they appreciate continually building on that expertise. Because of our commitment to specialization, our professionals know that they will be able to work in their field, which is a win-win situation for them and for i3 Research.”

Another benefit of our therapeutically aligned organization is that our i3 Research structure mirrors our clients’ structure. For example, i3 physicians specializing in oncology can easily speak to their counterparts in the client company. “We match expertise to expertise and work very effectively as an extension of our clients’ organizations,” Lopez-Bresnahan said.

Specialized CRO partnerships yield short- and long-term benefits

With fewer internal resources to call on, pharma companies are relying more on CROs with therapeutic specialization to serve as true partners in their clinical research programs, a scenario that can lead to both short-term and long-term benefits. “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,” a recent trade article suggested.⁵

The role of CRO as partner is beginning to take hold, Lopez-Bresnahan added, thanks in part to therapeutically focused CROs, which by design are operating at a more hands-on level than standard CROs, Lopez-Bresnahan continued.

“The integral role now played by contract service providers and their apparent contribution to development performance suggests that we re-evaluate the conventional notion that CROs are simply vendors providing capacity on a specific project,” according to Kenneth A. Getz, senior research fellow at the Tufts Center for the Study of Drug Development.⁶

“Already a small but growing number of sponsor companies recognize the opportunity to rethink their CRO partnerships,” Getz wrote. “Companies have implemented, or plan to implement, new approaches designed to streamline contracts and initiate projects; to better match and optimize internal and external functional capabilities; and to avoid setting unrealistic and limiting budgets under which their CROs must still deliver speed and high quality."⁷

There are significant benefits to working early and often with the same therapeutically focused CRO and to regarding that CRO as a partner, Lopez-Bresnahan said. “From our perspective, the benefits are that we get to know the clients’ compounds extremely well, which allows us to craft a plan for current and future trials with a very sound foundation,” she explained. “From the client’s perspective, treating us as a partner offers continuity, consistency and efficiency, because the client does not have to educate and train a new CRO with each new research project,” she added.

“Partnership is very important to i3 Research,” Lopez-Bresnahan said. “Working with us is like having a satellite clinical research team. We become the experts on our clients’ drugs.”

Additionally, when i3 Research physicians engage in a client’s protocol early in the process and provide critical expert input, that protocol becomes easier to perform from the therapeutic area perspective, helping to avoid costly amendments down the road that slow development timelines. Moreover, the team can customize the protocol for use in specific regions. This means it will take less time and money to complete the trial and move toward registration, she said.

“At i3, we are committed to taking a close look at the sponsor’s draft protocol and making recommendations that render the trial more in line with existing clinical practice in that specialty and therefore more executable,” she said. “This early involvement of our experts adds value to that protocol immediately and helps the sponsor build the best clinical development path.” Further, when developing a case report form (CRF), the i3 team will make sure the CRF is not overcomplicated or does not ask for too little data, because both of those scenarios have an impact on time and cost, she indicated.

As part of a larger organization, i3 Research also has access to resources that most CROs do not, Lopez-Bresnahan suggested. For example, “i3 can tap into the UnitedHealth Care databases in a HIPAA-compliant fashion to determine where clinical investigators and their patients are located and to pinpoint where research can be most readily performed. Our databases allow us to ask some important scientific and medical questions related to medication use and outcomes,” she said. “The answers that we get using these tools can be quite powerful in guiding drug development.”

Bottom line, she added, pharmaceutical companies seeking a CRO partnership want to know whether a prospective CRO “has done the work before, has done it well and has hit the right metrics, and has achieved goals within the agreed targets and budgets.”

“What makes i3 Research stand out is the depth and breadth of our experience. Our people know their fields, know the players in their fields and interact successfully with investigators and opinion leaders,” Lopez-Bresnahan asserted. “When you establish a strong, collaborative partnership with i3 Research, you can be sure that we are focused on knowing your drugs, your sites, your people and your systems,” she said. “Our focus and expertise allow you to be one step ahead in your clinical development plans.”

¹ Ferguson, Robert; Pathania, Ruchira; “Emerging Contract Research Organizations – Driving Success,” Korn/Ferry International (2008).
² Getz, Kenneth A., “Insights from Today’s CRO Renaissance,” Applied Clinical Trials (June 1, 2006).
³ Wells, Stephanie, “Industry Voices: Get the most from your CRO,” FiercePharma (Sept. 30, 2008).
⁴ Ferguson, Robert; Pathania, Ruchira; “Emerging Contract Research Organizations – Driving Success,” Korn/Ferry International (2008).
⁵ Wells, Stephanie, “Industry Voices: Get the most from your CRO,” FiercePharma (Sept. 30, 2008).
⁶ Getz, Kenneth A., “Insights from Today’s CRO Renaissance,” Applied Clinical Trials (June 1, 2006).
⁷ Id.

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