Life Science Leader Magazine Supplements

CRO Leadership Awards 2013

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Contract Research Organizations want to hire and expend valuable internal expertise and money on conducting studies that are common, labor intensive, time consuming, and that require expensive instrumentation that is only utilized occasionally) and when studies require Good Laboratory Practice (GLP) conduct (i.e. it is too costly for us to get involved with all of the quality systems and operations and technical support required to conduct true GLP research). We do not want to have on staff dedicated pathologists, laboratory animal handlers, specialized clinical laboratory chemists, etc., and we can���t possibly afford the vivarium costs or equipment costs to conduct all research in-house. Katz: When you have a small internal staff and there are restrictions to hiring more staff, when the CRO has particular expertise suited to the project, when the project is in an early stage, or when the CRO is a trusted partner. Leslie Williams, ImmusanT: When there are noncritical aspects or ���programmed��� aspects of pre/clinical research. When the company lacks infrastructure and/or expertise, it is important to outsource. I am more apt to consider outsourcing if face-to-face meetings can be scheduled easily ��� thus ���locality��� of provider is a consideration. WHAT METRICS DO YOU USE TO DETERMINE IF YOU SHOULD OUTSOURCE PRE/CLINICAL RESEARCH? Burhop: Our primary metrics are cost and need. It is relatively easy for us to determine if it makes financial sense for us to outsource (e.g. conduct parallel studies, conduct studies requiring a large number of resources like repeat-dose toxicity testing, and if it requires capabilities we don���t have in-house, such as animal handling capabilities for primates or unique and expensive laboratory equipment). Hauske: Expense is usually the chief metric. However, on the clinical development side, experience dealing with the FDA (particularly in terms of the specific disease section, FDA expert, decision makers, key opinion leaders) is the determinant for my choice of clinical development partner. Unfortunately, in my experience, one pays a significant premium to access outsourcing providers with this sort of staff. Be willing to pay a premium since success in the clinic more than offsets budget overruns. Wessel: It is important to accurately assess the sponsor���s capacity to initiate and sustain a given project over time. For this purpose, mapping out individual steps in project execution, assessing the needs for existing or future headcount, assigning accountability, and defining timelines are essential. In my experience, it is a great advantage to have a team member with project management and budgetary authority to monitor progress and change course quickly if necessary. CRO Selection Is Personal, Not Just Business ���We must always keep in mind the people we choose to join our teams are the single most important reason we succeed or fail,��� says Jim Hauske, president and founder of Sensor Pharmaceuticals. ���Although this is true for all discovery and development programs whether insourced or outsourced, it���s particularly important to know the individuals in the company you select to place your outsourced program.��� Hauske advises you to focus on developing deep, personal business relationships with the outsourced management team, as well as those members of the outsourced team actually performing the work. Here���s why. ���As a virtual company, it is actually relatively easy to assess companies and, most importantly, people with apparently appropriate experience to perform critical experiments,��� affirms Hauske. During his 25 years of pharma ���brick and mortar��� experience, Hauske observed the Jack Welch (former CEO of GE) approach to management applied to R&D; team performance assessments, whereby teams considered to 14 The CRO Leadership Awards 2013 be the trailing 10% were summarily fired every year. He asserts that these teams consisted of top talent, as well as poor performers, and both have found their way into CROs. ���There are members of even the best drug discovery and drug development pharmaceutical organizations you would not trust to perform your critical experiments,��� he says. ���You must know the person who performs your experiment. It is no different from managing an insourced team. Take pains to assess true competency. Despite your best efforts, in some cases, a poor choice of service provider will be made. The best way to minimize such an undesirable result is to develop strong personal relationships with a number of individuals within the organization, especially those most responsible for creating the corporate culture. When something goes astray, and something always does, you need to have strong personal connections to expeditiously get things back on track without causing pain to those actually performing the work.���

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