Product development teams getting started on preclinical exploration of a potential treatment need a certain set of specialists on board. Key roles include scientists, clinical strategist, project manager, regulatory affairs director, and a nonclinical expert, a primary authority on product safety. In fact, inclusion of a nonclinical expert is mandated by regulatory authorities to ensure that safety issues are addressed consistently throughout the development lifecycle. That said, these experts have a great deal more to contribute besides proficiency in safety, and the best practice is to include this role at the very center of a multidisciplinary team. Why?

The short answer is that the nonclinical expert, typically with highly diverse training and experience, can help guide the team toward better-informed decisions on regulatory and safety matters. While doing so, the nonclinical expert can help create an environment that facilitates collaboration and trust among the various disciplines on the team. This is because, while formally educated in a variety of life science degree programs, professionals like us tend to gain additional knowledge across technical areas via their multifaceted work experience. Quite often, after completing academic training in biomedical sciences – anatomy and physiology, biochemistry, microbiology, pharmacology, and toxicology – their career path takes them to positions in industry and government.

Essential Proficiency, from Clinical to Quality Management

In industry, they are expected to understand the key areas in each discipline where safety issues could feasibly arise. Their responsibilities involve routinely checking in with colleagues to uncover potential risks, and they work collaboratively with professionals in each these disciplines as trusted colleagues. In clinical research, their insight is essential; safety issues might arise involving dose schedule, adverse event profiles, and patient populations, just as a few examples. Their purview typically extends to supporting strategies for both clinical and nonclinical testing, regulatory meetings and submissions, as well as study design and monitoring.

Throughout the development lifecycle, nonclinical experts might support chemistry, manufacturing, and control (CMC) programs in various aspects of chemical composition or packaging that could pose safety risks. In clinical pharmacology, safety issues commonly arise related to the pharmacokinetic (PK) profile of the test article and drug interactions. In this regard, nonclinical experts help ensure that bioanalytic methods and other key PK methods employed are sound, as drug exposure (and related endpoints) is important to characterizing potential risks.

Regulatory Authority

In government, nonclinical experts serve as regulatory decision-makers and advise sponsors on their applications for drug and marketing authorization approvals. This experience affords them deep technical knowledge, along with a global viewpoint on drug development processes.

In both environments, the nonclinical expert routinely works across a wide range of disciplines and organizational levels, with management as well as individual contributors. Success depends on strong interpersonal skills and the ability to think strategically, negotiate effectively, communicate clearly, and adapt readily to the shifts in direction inherent in the drug development lifecycle. In most situations, the nonclinical expert also serves a pivotal role in transferring knowledge from one team to another and to junior staff.

Invaluable Multidimensional Insight

These are the skills that a seasoned nonclinical expert can bring to your development team. But let us add another important point based on our own experience. Nonclinical experts with tenure at a regulatory agency learn institutional knowledge that is simply not available elsewhere. In many cases, some experts at regulatory agencies might be among the few individuals in the world with insight into certain aspects of a particular product. Although this knowledge is proprietary, these experts can bring it to bear on the guidance they provide in industry settings.

One final note about why nonclinical experts should be at the nucleus of your team. Although safety issues and concerns might arise from findings made across each discipline involved in product development, these issues are typically evaluated and mitigated based on data from nonclinical studies, for ethical and practical purposes.

To learn more about CATO SMS and how we can support your drug development programs, please visit our Regulatory and Development Consulting page.

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