There’s an old adage: “Plan your work, then work your plan.”
This statement is never more valid than in the area of regulatory strategy. Regulatory strategy encompasses the adaptations a sponsor makes to move its product from development to marketing approval and beyond. Taking the time to create a comprehensive regulatory strategy early in the product development life cycle, ideally before initiating clinical trials and alongside the clinical development plan (CDP), helps determine the fastest and highest value path to market for a product. Throughout development, the regulatory strategy and CDP should be reviewed and revised as new data (and regulations) emerge.
A regulatory strategist is a highly skilled professional with extensive experience in regulatory requirements during drug development and in-depth knowledge of the therapeutic area, enabling them to offer scientific and strategic guidance to drug development teams. These individuals have years of experience working with cross-functional teams to bring a molecule to market and bring forward the best ideas and lessons learned from a broad range of development projects.
How can a regulatory strategist help get your product to market? We highlight five distinct ways below.
Regulatory strategists evaluate development options and create a strategy based on a full understanding of key regulatory attributes and market landscape.
Regulatory strategists start with the end in mind. Therefore, a solid understanding of the key product attributes and the short-, mid-, and long-term product goals is critical. The strategist starts by speaking to key stakeholders in the cross-functional product development team to collate the product attributes with regulatory significance such as drug class and mechanism of action, intended label claim, safety profile, etc. The strategist then reviews the competitive landscape, identifies any precedents, outlines key market requirements (eg, relevant global and local guidelines), and highlights any regulatory risks. They then apply this knowledge to develop a strategy that expedites time to market and positions the product for commercial success.
Regulatory strategists identify regulatory agency programs and designations that speed approval.
An experienced regulatory strategist is intimately familiar with the various programs available that confer special designations or offer different paths to approval that may be more expeditious (eg, Fast Track, Priority Medicines [PRIME], Orphan Drug Designation [ODD], etc) for certain molecules. The strategist assesses the pathways available for the molecule, confirms data requirements meet the designation criteria, and plans when in the development program to apply for the specific designation(s). As expedited clinical development programs generally consist of fewer, smaller, or shorter clinical trials than is typical for a drug receiving traditional approval, early engagement with regulatory agencies is vital.
Regulatory strategists prioritize development issues that require agency engagement.
For all drugs in development, communication with the agencies ensures that there is agreement on the most appropriate way to generate robust evidence of the product’s risk-benefit profile. Advice meetings run throughout development, from pre-Investigational New Drug (IND) and pre-Clinical Trial Application (CTA) through to the New Drug Application (NDA), Biologic License Application (BLA), or Marketing Authorization Application (MAA). The timing of meetings is either defined in advance (eg, clients may request meetings with the Food and Drug Administration [FDA] at defined timepoints such as in advance of their investigational new drug application), or on an ad-hoc basis at any time in the drug development continuum. Based on the strategist’s in-depth understanding of regulatory issues, they will determine the best time to approach a particular agency for advice and help you prepare focused, specific questions. Their support leads to successful agency interactions that ensure your development program gets the most value from each agency interaction.
Regulatory strategists provide strategic, tactical, and operational direction.
Regulatory compliance is the cornerstone of drug development and commercialization. However, as the regulatory landscape constantly evolves to keep pace with advancements in science and technology, compliance is a moving target. The global pandemic is an extreme but recent example of where the industry has been forced into wholesale adoption of fast-changing regulations regarding the conduct of clinical research programs. As regulations change, regulatory strategists must stay abreast of the emerging and evolving regulatory framework, assess how the development program may be affected, communicate changes to the drug development team, and ensure that program milestones are met in the most efficient and compliant way.
Regulatory strategists prepare the road for approval and post-approval product access.
All pharmaceutical companies legally require marketing authorization for every product they want to commercialize, which can only be obtained once an application is submitted and approved. Choosing the right route to market and ensuring that all of the required pre-submission steps are met (eg, submission and maintenance of Pediatric Study Plans and Orphan Drug Designations, etc) is critical. A regulatory strategist guides you through the pre-submission steps for each application. They also ensure your dossier is thorough, well-written, and provides a compelling summary of the request to market, powered by the conclusive evidence presented within the dossier.
A regulatory strategist is a critical member of the drug development and post-market life cycle management team. They clearly map the regulatory options to meet product goals, note all essential milestones, define critical timepoints so sponsors can ensure sufficient staffing, and keep open communication among all functional areas involved in developing and marketing a product. Their extensive knowledge, combined with their deft people skills, enables them to share complex information with various stakeholders within the sponsor organization and keep everyone focused on the main goal—ensuring fast and sustained patient access to safe and effective medicines around the globe.
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