Life Science Leader Magazine Supplements

CRO Leadership Awards 2012

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Contract Research Organizations Expert Insight On Selecting A CRO By Rob Wright hat was once referred to as outsourcing is now commonly called strategic partnering when discussing the business of drug devel- opment. In order to successfully strengthen drug pipelines, bio and pharma companies have been increasingly turning to CROs for help. By developing stra- tegic partnerships with CROs, large and midsize companies have been able to capitalize on a reallocation of financial resources, moving from the fixed-cost internal R&D; model to one which is more variable and external to the organization. W One of the biggest examples of the implementation of this new model was demonstrated last year by Pfizer, which announced the closing of its Sandwich, UK, R&D; facility and the subsequent stra- tegic partnership with two CROs — ICON and PAREXEL. For small and virtual bio/ pharma companies, outsourcing of clini- cal trials has always been part of the business model. For sponsors, the chal- lenge remains how to best qualify, select, and partner with a CRO. But the selec- tion process is not a one-way dialogue. During recent discussions with CROs, most have expressed an interest in being more selective when developing strategic partnerships with sponsors. The goal is to not only match up with expectations and deliverables, but also to align synergisti- cally in the area of corporate culture so the strategic partnership has long-term sustainability. In an effort to help you gain a greater understanding of the CRO selection pro- cess, Life Science Leader reached out to seven experts. The resulting roundtable provides insights from highly experienced executives and consultants who can give 6 LifeScienceLeader.com perspectives from a small biotech startup to a Big Pharma company. The panel includes Peter Carberry, M.D., SVP global development operations, Astellas Pharma US; Peter DiBiaso, head clinical busi- ness and development operations, Vertex Pharmaceuticals; Maxine Gowen, Ph.D., president and CEO, Trevena; Jonathan Kfoury, VP, L.E.K. Consulting; Coreen Oei, SVP of clinical operations and project man- agement, BeiGene; Marc Tolkars, senior director clinical operations, Luitpold Pharmaceuticals; and Santosh Vetticaden, president, Global Drug Development Consulting. WHAT ROLE DOES COST PLAY IN THE CRO SELECTION PROCESS? Peter DiBiaso, Vertex Pharmaceuticals: While cost efficiency is a key selection con- sideration and a desired benefit of a CRO partnership, it is not typically a leading criterion. Of greater focus is the evalua- tion of quality and service expertise (i.e. fit for purpose) for the proposed scope of work. Cost might also play a greater or lesser role according to the type of project being supported. In a more trans- The CRO Leadership Awards 2012 actional buy — i.e. single study, low study complexity — cost might have a greater influence, whereas in a more strategically driven selection process, other factors will weigh more heavily. Marc Tokars, Luitpold Pharmaceuticals: For smaller companies, the unfortunate truth is that cost is a major consideration when selecting a CRO. Contracted tasks such as site selection, contracting, moni- toring, site payments, and data review are usually not the sole responsibility of either the CRO or sponsor and can often be shared. This provides a cost savings, as the sharing of tasks reduces the CRO's work- load while providing sponsors a greater understanding of challenges posed by a trial and faster input toward problem resolution. Some CROs seem reluctant to fully enter into this type of relationship or fail to pass on the savings to sponsors. WHAT QUALITY METRICS DO YOU UTILIZE WHEN BUILDING COLLABORATIONS WITH CROs? Jonathan Kfoury, L.E.K. Consulting: Developing an agreed upon issue esca-

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