BioPharm

28 BioPharm International eBook March 2018 www.biopharminternational.com Outsourcing Resources Analytics Outsourcing • Ensuring clarit y about what documentation is to be provided by the ser v ice prov ider and whether this is sufficient for any regulatory submissions. • Whether the service provider will provide regular updates and the format of these updates— regular telephone conferences are recommended as communication is key to a good relationship. • Whether the service provider can provide all services in-house or would parts be subcontracted. If subcontracted, does the service provider have a subcontract lab in place to perform these tasks? "There is any number of crite- ria used to select a service provider depending on the scope of work being requested," says Roger Hayes, PhD, senior vice-president, Drug Metabolism and Pharmacokinetics, MPI Research, an early stage drug development contract research orga- nization (CRO). "For example, a sponsor may have extensive in-house capabilities but lack a vivarium with non-human primates. In that case, the sponsor will seek a service pro- vider with the appropriate animal model. On the other hand, a vir- tual company may look for a service provider that has all of the services under one operational 'roof'," he says. Once the type of service required is defined, the selection criteria hierarchy is schedule, quality, and then price. For more commoditized studies, the ordering may be price, schedule, and then quality, accord- ing to Hayes. "There are certain 'table stakes' for a service provider to be considered, and those usually relate to regulatory compliance (USDA [US Department of Agriculture] and FDA), scientific knowledge/experience of the study directors, communication, and prior experience or reputation," he adds. "It's been our experience that there are two key criteria for choosing a service provider: the collaborative relationship the service provider can build and foster with the client, and the ability of the vendor to provide a wide-range of services, including analytical, bioanalytical, in vitro and in vivo services, all the way through to enabling toxicology studies," says Philip J. Kuehl, PhD, director of Scientific Core Laboratories, Lovelace Biomedical, a not-for-profit CRO. Other criteria that Kuehl points out is the responsiveness of the service provider, including having strong communicative skills to make clients feel valued, the ability to meet timelines, and the capability to review and share good or bad data quickly and efficiently. "The service provider should also be able to make a scientific contribution to the data, as it applies to the interpretation and decision-making. It is helpful if they have a breadth of experience, includ- ing small- and large-molecule capa- bilities in and around analytical and bioanalytical services," he notes. DEVELOPING RELATIONSHIPS For early phase analytical support, simple one-off service agreements or short contracts are the most common relationships, says Wood. These finite relationships fit well where the work required is reasonably well-defined and milestones are expected to be met in the near future. "This will guarantee resource availability and the analytical team can work flexibly to provide support as priorities may change and different molecules may get fast tracked ahead of other proj- ects," Wood says. The most frequently sought-after relationships on the service provider side, however, are strategic partner- ships. "No CRO would be able to sustain a business with only transac- tional fee-for-service contracts. The operational overhead involved in a competitive bid process will drive a desire for a partnership with pre- ferred pricing to entice the relation- ship," says Hayes. Hayes points out that even repeat transactions gain some familiarity with a client over time, and there is typically a period over which the relationship transitions from transactional to preferred and finally to strategic. "Somewhat uniquely, bioanalyti- cal CROs tend to attract loyal spon- sors that then require a string of poor performance before the activation barrier to seek out a new provider is broached. With that in mind, the relationships become preferred and the provider will ensure resources are always available to tend to a particu- lar client. Preferred partnerships cre- ate additional opportunities for both the sponsor and the CRO. The spon- sor has access to niche CRO talent that may otherwise go untapped if a relationship remains transactional, and the CRO has an opportunity to participate on research projects that may not typically be outsourced," Hayes says It takes time to switch over to a strategic partnership, and this is not often required given that the ser- vice being offered is commoditized, Hayes explains. "The strategic aspect could be as simple as the client pro- viding a peek into long-term needs to ensure that adequate resources are made available. Milestone dis- counting or rebates based on spend become the reciprocal enticement for the client." The success of an outsourced rela- tionship depends on the existence of a true partnership in drug develop- ment. These successful relationships involve the use of a service provider's scientific breadth of expertise and critical decision-making abilities, notes Kuehl. Also, interpretation of results and the skills to move a pro- gram along efficiently so that the ultimate goal is achieved together plays a critical role in successful part-

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