Guest Column | September 25, 2024

The Value Of A High-Performing Regulatory Function Within A CRO

By Pete Embley, BSc. (Hons), Dip. Reg. Aff., FTOPRA, INSTEAD, founder, Sunshine Reg Services Ltd.

Large and small-to-medium CROs offer common clinical trial services, but a perception, from some corners of the Industry, that the respective strengths of each group lie in different spaces of the clinical development cycle and with different clientele. Given their size and global reach, large CROs have the infrastructure and local presence to support multi-site, pivotal global studies, while smaller CROs are more adept at supporting early-phase, novel biotech/biopharma companies, who are often entrenched in seed-funding cycles, where cost efficiencies and value are paramount. The latter category of client/sponsors requires flexible support with efficient routes to reach major regulatory and clinical milestones.

Keeping the latter business model in mind, why is it important for such sponsors to ensure they employ a high-performing regulatory team as part of the CRO selection process? After all, a typical reg budget within a clinical study is comparatively small to the clinical operations component (approximately 5-15%, depending on the complexity of the study design and inspection requirements).

Beyond the conventional regulatory service, i.e. providing operational and submission support to health agencies and ethics committees, this article discusses the three key areas, where additional regulatory expertise may enhance the overall value of support and partnership.

Regulatory Experts “Open The Door”

Consider the small CRO whose regulatory expert attends the initial scoping call with a prospective client. From the CRO perspective, this expert can add value to the proposition, taking up a crucial role as the “door opener”. An experienced regulatory expert is conversant in quickly understanding the immediate objectives of the sponsor and anticipating their needs with the ability to probe and offer some additional insight into an early regulatory pathway. To enhance the scoping phase, the regulatory expert is often accompanied by an experienced clinical expert, creating a formidable service offering in both regulatory and clinical protocol considerations. Based on the size and the relatively flat structure of the organization, both experts can usually commit to remaining close to the development of the subsequent proposal through to the award. Offering scenarios for different types of regulatory engagements with health authorities, thereby developing a regulatory strategy, early in the consulting process to continue the partnership throughout the drug development cycle. From the sponsor perspective, say that of a new biotech company spun out from a university, this relationship can be invaluable. There is an opportunity for the sponsor to meet prominent regulatory milestones and establish a valuable regulatory pathway, which assures investors, whilst the CRO gains a potential advantage to offer their clinical trial management services that may lead to a first-in-human (FIH) study.

Regulatory oversight and client support are vital at all stages of development, starting with the discovery phase and the selection of the target indication and target product profile. Regulatory experts can also advise sponsors on specific regulatory strategies, including (but not limited to) orphan drug designation and eligibility to accelerated pathways, such as the FDA’s Breakthrough Therapy designation³. Early authority engagement, is often invaluable and often cost-efficient, such as the EMA’s SME Briefing Meetings⁴. Investors are especially keen to hear the sponsors have undertaken some form of early regulatory interaction.

“People Buy From People”

The Bob Burg quote⁵ “People buy from people” highlights the importance of CROs fostering a strong relationship with their clients as soon as they begin their drug development program. Introducing a regulatory expert into the mix early allows the CRO to begin that intimate relationship with the hopes of it continuing. And for the sponsor, the regulatory expert becomes a trusted advisor for the clinical research process.

This approach may help to stave off the tendency for sponsors, entrenched in their mid-phase clinical development program studies, to look for an alternative CRO and/or casually keep their options open if they feel the relationship with the current CRO may not have the infrastructure to manage the latter clinical development phase. The regulatory function is often crucial at this stage since a good regulatory expert can keep the partnership intact.

Regulatory Oversight Is Critical Late Phase Trials

Navigating the strategic course, especially at the crucial pivotal phase, requires intricate and complex discussions with regulatory authorities. As such, typical pivotal (Phase 3) studies usually require global reach and in-depth site relationships. Circumstances may require a regional alignment of EU and U.S. clinical development programs, validated through regulatory Scientific Advice Meetings with authorities⁶. Study sponsors also need to consider preregistration designations, such as an EU Paediatric Investigational Plan⁷. In the EU, further regulatory support will be required for the forthcoming obligatory Joint Clinical Assessment Report⁸ via the new Health Technology Assessment Regulation (HTAR), which will require careful evaluation of the final clinical package and insight. HTAR is a prime example where an evolving regulatory landscape requires constant review and insight from the regulatory team. Country submission requirements/precedence for clinical trials must be carefully monitored. The industry continues to strive for more efficiency and autonomy in conducting clinical trials and optimizing RWD. The application of AI, DCTs, and RWD/RWE continues to gather momentum and influence.

Understandably, larger CROs are often the preferred partner, given their global presence and assumed expertise in navigating various regulatory bodies and markets. However, bearing Bob Burg’s quote in mind, sponsor companies often desire regulatory oversight from a familiar service provider, one that already knows their intentions.

CROs Must Invest In Regulatory Expertise, Despite A Revenue Disparity

The impact and necessity of a high-performing regulatory team are evident to the sponsor, of course, but less so to the CRO. CROs run on a closely scrutinized profit and loss (P&L), where each operational department is individually accountable. Upon study award, the typical price tag for a Phase 1 study is approximately $4 million USD⁹, with the regulatory budget therein usually just 5%-15% of the total. The reality is that regulatory revenue is dwarfed compared to the financial income of wider clinical operations. Regulatory consultancy scopes such as holding a scientific advice meeting or writing a pediatric investigational plan typically cost $80,000 and $130,000, respectively. Again, revenue for such scopes is minor compared to the clinical operations.

It’s a stark reality, but the value of the regulatory contribution to the client’s objectives — establishing the partnership with the client and securing future studies — outweighs the initial fiscal rewards. The investment in providing early regulatory expertise, then, may yield a sizeable return if the sponsor is retained as a client. And, the sponsor wins, too, feeling confident in continuing with a partner with deep historical knowledge.

Regulatory Experts Make The Difference

The regulatory expert has a blend of strategic and operational regulatory knowledge, coupled with commercial, financial, and time management acumen. Their regulatory knowledge is reasonably broad, with inherent specialties, acquired during the formative part of an expert’s career. A regulatory expert can pivot in any client scenario with the ability to discuss, with confidence and conviction, a client’s CMC, as well as the nonclinical and clinical phases. The consultant can also opine on the direction of many evolving regulatory initiatives.

An experienced expert also can think about the client’s wider objectives and demonstrate how an agreed scope would support their goals. Commercial acumen requires consultants who can showcase their organization and be prepared to “sell” regulatory and broader clinical services, be it through a bid selection process or a networking event. Client and account management skills along with financial and time management acumen are a must and distinct from many other regulatory roles in the pharma industry. The value of the regulatory expert should not be confined to the proportion of the overall budget.

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About The Author:

Pete Embley has worked in several regulatory areas, including CROs, pharma, generic, and consulting industries for over 26 years. Working as an independent consultant, Pete provides global consulting expertise for a wide range of early to late clinical programs for start-up biotech and mid-to-large pharma.

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