Outsourcing Analytical Services in Early Drug Development

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Criteria for choosing a partner or service provider for analytical services in early phase drug development are based on scientific skills/knowledge, resource availability, and customer needs.

An analytical service provider for early phase development studies should show that they have the necessary scientific skills and knowledge to support the program. Discussions between client and provider are needed to ensure that both parties are comfortable with what is required out of the relationship, according to John Wood, analytical account manager, Almac Group.

Wood notes that once the preliminary steps are established, other considerations should include:

• Resource availability-can the service provider provide the services within the required timeframe? A project plan should be requested detailing all activities and delivery dates.

• Ensuring clarity about what documentation is to be provided by the service provider 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 criteria 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 organization (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 provider with the appropriate animal model. On the other hand, a virtual company may look for a service provider that has all of the services under one operational ‘roof’,” he says.

Once the required service 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, according 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, including small- and large-molecule capabilities in and around analytical and bioanalytical services,” he notes.

Preferred relationships

Simple one-off service agreements or short contracts are the most common relationships in early phase analytical support. 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 projects,” Wood says.

The most frequently sought-after relationships on the service provider side, however, are strategic partnerships. “No CRO would be able to sustain a business with only transactional fee-for-service contracts. The operational overhead involved in a competitive bid process will drive a desire for a partnership with preferred pricing to entice the relationship,” 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, bioanalytical CROs tend to attract loyal sponsors that then require a string of poor performance before the activation barrier to seek out a new provider is broached. Preferred partnerships create additional opportunities for both the sponsor and the CRO.  The sponsor 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,” he says.

It takes time to switch over to a strategic partnership, and this is not often required given that the service being offered is commoditized, Hayes explains. “The strategic aspect could be as simple as the client providing a peek into long-term needs to ensure that adequate resources are made available. Milestone discounting or rebates based on spend become the reciprocal enticement for the client.”

The success of an outsourced relationship depends on the existence of a true partnership in drug development. 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 program along efficiently so that the ultimate goal is achieved together plays a critical role in successful partnership. “However, there are always times when short-term of specific one-time service agreements are suitable for a program,” he adds.

Analytical services that are typically the most sought after by clients during the early drug development phase include bioanalytical services and analytical methods to determine drug substance and drug product stability.

“For preclinical and early phase development, the most important criteria are to develop analytical methods that are suitable for release testing of the drug substance and drug product and can be used to provide early stability data,” says Wood. “Method validation is not a priority for early phase molecules, but the methods should be shown to be suitable during the development phase.”

“Bioanalytical services by far and away are the most sought-after analytical service, second only to the in-life studies that generate the PK [pharmacokinetic] samples for bioanalysis,” Hayes says. “Analysis of the dosing material is sometimes required in bridging studies and always required for the GLP [good laboratory practice] drug safety studies.  Analysis of the dosing material is most often sourced to the same laboratory providing the vivarium service, as there are significant benefits to having the dosing and the dose analysis in the same facility,” he adds.

Most researches seek three characteristics in analytical services: adaptability, responsiveness, and translatability, according to Kuehl.

“Customers look for a group that has the bandwidth to do things quickly, to be responsive and adaptive to the data as they are generated. For example, it’s great if a lab is able to start on a project relatively quickly. Then, as the data are generated, if there are changes in the assay, detection limit, matrix, or sampling process, the service provider will adapt and make changes quickly, in order to support the overall program. That’s where a strategic partnership is such a key part of the success of an analytical program--adapting to the needs of the overall program, not just a small scope of work,” Kuehl says.

In addition, customers seek translatability, which is the ability to translate methods, assays, findings, and other required information from early proof-of-concept studies through to good practices regulated validated studies, Kuehl adds.

Article Details

Pharmaceutical Technology
Supplement: Partnerships in Outsourcing 2018
February 2018
Pages: s6–s8

Citation

When referring to this article, please cite it as F. Mirasol, “Outsourcing Analytical Services in Early Drug Development," Pharmaceutical Technology Partnerships in Outsourcing 2018 Supplement (February 2018).