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Contract Research Organizations Peter Carberry, M.D., SVP global development operations, Astellas Pharma US Peter DiBiaso, head clinical business and development operations, Vertex Pharmaceuticals Maxine Gowen, Ph.D., president and CEO, Trevena Jonathan Kfoury, VP, L.E.K. Consulting lation/resolution plan is key to ensuring that the CRO middle and senior management is fully engaged in the study's progress. Sponsors should routinely review reports on what issues were raised and how they were resolved, especially early in the trial when the learning curve is steepest. It is also important to estab- lish a dashboard with the CRO that details leading indicators for the trial each week, i.e. projected completion of enrollment based on active sites and patients enrolled to date, across sites and geographies. This ensures alignment on progress and identifies potential bottlenecks. Santosh Vetticaden,Global Drug Development Consulting: In general it is recommended that both sponsor and CRO develop a quality plan which addresses the needs of each organization. In addition, it is extremely useful to review the CRO's internal qual- ity plans which often go beyond those areas emphasized by the sponsor. The metrics for quality are too varied to cover in detail, but a few examples include qualifications and training of staff, trial metrics such as enrollment, evaluable patients, reporting time for various activities in data management, and safety reporting. WHAT NEW TRENDS DO YOU SEE TAKING PLACE WITH CROs? Maxine Gowen, Trevena: Some CROs are becoming more flex- ible in taking responsibility for their promises and often refer to this as risk-sharing, although I tend to think of it more as deliver- ing. The traditional model does not appropriately align incentives, i.e. the longer a trial takes to complete, the more a CRO is paid. This is not sustainable, particularly for loss-making companies with restricted cash availability. CROs will ultimately destroy their customer base if they do not look at their business as relationship- based vs. contract-driven. Coreen Oei, BeiGene: There has been an increase in pharma- CRO strategic partnerships, especially among the larger pharma- ceutical companies and global CROs. These have changed the rela- tionships between CROs and sponsors from tactical/transactional models to those resembling an alliance or partnership. While Big Coreen Oei, SVP of clinical operations and project management, BeiGene Marc Tokars, senior director clinical operations, Luitpold Pharmaceuticals Santosh Vetticaden, president, Global Drug Development Consulting Pharma companies benefit from strategic partnerships, small to midsize biopharma companies may be overlooked. Smaller clients may not view these CROs as having enough capacity to provide the necessary attention in light of demands from larger companies. To guarantee attention from big CROs, smaller biopharma companies need a sizable pipeline of work. HOW DO YOU GO ABOUT ASSESSING RELIABILITY FOR A CRO? DiBiaso: As with most business relationships, reliability and trust are dependent on the outcome of your last project. However, there are strategies to encourage greater success. One such approach is establishing mutual collaboration for developing and agreeing to the overall project plans. While in many cases CROs have been selected for particular expertise, this shouldn't discour- age the sponsor from contributing to or requiring transparency in the early planning process. This type of input fosters joint own- ership of plans and subsequent outcomes. Defining leading key performance indicators that enable teams to make required course corrections or deploy contingent strategies is also essential. Vetticaden: Because no two clinical programs or trials are exactly the same, it is challenging to define reliability, which may vary depending upon the areas being assessed. In general, it is impor- tant to assess the prior reputation, experience, and track record of the CRO being evaluated. Most CROs maintain metrics in areas such as trial completion on schedule and on budget which may provide useful data. Diligence of the CRO's prior experience, competence of key study personnel, organizational structure, plan to deliver, plan for contingencies, and margin of error in their esti- mates, often provide useful insights for assessing CRO reliability. HOW WOULD YOU DEFINE ACCESSIBILITY AND WHAT CAN CROs DO TO DEMONSTRATE ACCESSIBILITY AND EXECUTE ON BEING ACCESSIBLE? Oei: A key requirement during the request for proposal (RFP) process is having the sponsor's questions addressed in a compre- hensive and timely manner. I consider accessibility as my company The CRO Leadership Awards 2012 LifeScienceLeader.com 7