The importance of a 'living' Regulatory Strategy

When it comes to success or failure, strategy has a definitive role and dictates the outcome.

To create a strategy that works, first, we need to understand what it truly is.

In his Harvard Business Review article, Michael E. Porter defines strategy as the creation of a unique and valuable position involving a specific set of activities.[1]

This position suggests that, once created, the strategy remains untouched and serves only as a Microsoft project plan for business stakeholders to systematically follow.

This is an interesting take and, while it does have its merits, it makes no provision for the constantly evolving and developing nature of Regulatory Affairs.

Indeed, having worked in the field for almost three decades, it is safe to say that one of the central features of Regulatory is unrelenting change.

Because of this continual state of flux, strategy too should always be evolving and adapting to internal and external fluctuations.

It isn’t a static function that we create and file. Instead, it should be viewed as a dynamic, living organism that responds accordingly as data becomes available.

This data is a conglomerate derived from a multitude of sources, including clinical trial outcomes, industry events such as recent product approvals, emerging safety information, therapeutic area insights, best medical practice, and regulatory and market intelligence.

Good strategy is founded on an awareness of everything and anything around it and responds to changes with dynamic solutions that grow and adapt to circumstances and situations.

To achieve this, solution makers cannot work in isolation or avoid the key inputs or perspectives that may inform the development and implementation of client-specific regulatory strategy.

This stance is especially important where no Health Authority precedent is in place which can create ambiguity in current thinking or uncertainty in the clinical approach.

It is only by fostering meaningful connections with internal and external experts and embracing spirited debate and alternative opinions, that we become better equipped to anticipate issues that have a real potential to staff a client’s development program or even prove terminal to addressing vital unmet patient needs.

At its core, meaningful regulatory strategy considers other scientific disciplines and their respective strategies - such as clinical research, market insights and analytics, medical affairs, safety, and product design - to establish an effective holistic drug development program.

Overarching everything is the need for a global mindset throughout the process.

While some target their initial commercial objectives for tier 1 regions (e.g., more sophisticated Agencies in terms of regulatory policy), maintaining a weather eye on all situations and circumstances creates strategic plans that can be expansive at any point in time in the lifecycle.

Meanwhile, reverse-engineering the entire process ensures key program milestones and business catalysts are identified and visible to help capture essential investor interest and financing.

By starting with the end in mind, this approach guarantees clients optimize their resources for maximum benefit throughout the entire process and ensures that only those who are integral to the strategic discussion and development are involved, allowing precious resources to be used more efficiently elsewhere.

In viewing it as an organic process, strategy is ongoing and matures through meaningful interactions, meaning decision-making is never marked by haphazard reactions in the face of unforeseen circumstances or situations presented by Health Authorities.

Good strategic thinking requires compromise, innovation, and creativity with enough practicality to stay true to the ethical standards that are integrated within the regulations.

[1] Porter M P. Chapter 1: What is Strategy? HBR’s 10 Must Reads on Strategy. Harvard Business School Publishing Corporation. 2011.