ICON Strategic Solutions

Ines Silva is an accomplished Regulatory Affairs professional, having worked for the past 14 years in big pharmaceutical companies like Sanofi, AstraZeneca and Roche. She has worked around the globe supporting diverse therapy areas including Infectious Diseases, Immunology and Oncology, proudly contributing every day to bringing important prevention or treatment options to patients worldwide. Her role at ICON leans on expertise to support clients in achieving their mission and living their values with proficiency and excellence.

1. Why is Regulatory Strategy important in clinical trials?

Think about a prestigious orchestra, with the best musicians and instruments… but no conductor to guide them. While there is vast potential, lack of direction will certainly lead to a disastrous performance.

The same principle applies to Regulatory Strategy in clinical trials. An organisation might have the best experts and the most promising molecule at hand but, without a clear regulatory strategy, chances are it will not achieve the best possible outcome via the most efficient path to reach patients in need.

Sounds simple enough, right? Well, it is not. Regulatory Strategy encompasses 24/7 awareness and understanding of global, regional and local regulations and guidance that address all components of clinical trials and drug development. In addition, healthy and productive interactions with Health Authorities, context evaluation, multi-scenario planning and analysis, appropriate risk assessment and smart creativity are key to this demanding but fundamental work.

2. When do you need to bring Regulatory Strategy into the process?

As soon as possible is not soon enough!

To illustrate this, here are two (common) mistakes that Regulatory Strategy could avoid if involved in due time:

1. An organisation establishes their drug development plan focusing mainly on major markets like US, EU, Japan or China. They run the clinical trials as planned and a few years later they are ready to register the product across the world, only to discover that they actually can’t in some countries because specific Regulatory requirements were not considered (e.g. having sufficient data from local patients).

2. A global team including Clinical, Safety and Statistics experts develop a clinical trial design leading a few years later to irrelevant or obsolete outcomes that can’t support a filing (e.g. endpoints no longer acceptable by Health Authorities).

As soon as possible is not soon enough.

3. What is something you have been working on recently that has a significant impact on clinical trials?

Biomarkers and companion diagnostics.

Precision Medicine is the future of healthcare, by tailoring prevention and treatment options to individuals considering their specific needs and characteristics. Therefore, the importance and use of biomarkers and companion diagnostics in clinical trials has dramatically increased. As a consequence, so have regulations, guidelines and discussions around the topic. It really is a paradigm shift and again, Regulatory Strategy is at the centre.

“Regulatory Strategy is the conductor of drug development, guiding every function in harmony. Without it, even the most promising science risks missing its mark. Early, continuous strategic input ensures faster, smarter and more successful delivery to patients worldwide”

Working alongside drug product manufacturers, the clinical trial Sponsors and IVD manufacturers, I have been supporting them to understand the new regulations (e.g. EU IVDR) and their implications, as well as leading efforts to assist them in conducting their drug and/or device development accordingly.

On another level, I have been participating in relevant external debates, providing insights and learning and preparing for the future.

4. Is it only during early Drug Development that Regulatory Strategy is critical?

Absolutely not. Regulatory Strategy remains crucial during the whole development program and beyond.

Regulations are constantly changing, especially as the use of technology quickens pace. It is essential to keep abreast of not only the official requirements and registration pathways, but also the latest trends, grey zones and nuances. It is also critical to be continuously connected to Health Authorities. In doing so, strategists are best placed to pivot quickly when required and make recommendations for a positive outcome.

Likewise, evaluating the risk of unplanned mandated post-authorisation studies against the current plan is key. Furthermore, assessing the timing of key changes such as new manufacturing sites, indications or formulations, or just trying to keep a product relevant by showing its added value when the patent cliff hits ensures that Regulatory Strategy remains an essential advisor.

5. Any other considerations regarding Regulatory Strategy?

Regulatory Strategy is often times overlooked or underrated, but of utmost importance. Having Regulatory Strategy advice soon enough might dictate the difference between success and failure of a project, or even a program.

Regulatory Strategy professionals are generalists and experts at the same time, in contact with most functions within an organisation covering all aspects of R&D through to Commercial and Quality, as it all converges into a Regulatory submission before it is out the door and into the world. Attentive to details, analytical and critical by nature, good communicators and insightful, Regulatory Strategists are essential in ANY drug-related project from the start to provide guidance and direction.

At the end of the day, Regulatory Strategy is the conductor that any organisation/project needs for delivering products to patients promptly and successfully.