NeuroSense featuring the VP Regulatory Affairs

“The feeling of successfully navigating the regulatory landscape and achieving drug approval is indescribable” – Diana Shtossel, VP Regulatory Affairs

I have worked for biotech companies of all sizes in development, clinical, and regulatory affairs positions for the past twenty years or so, and I have been working at NeuroSense for two and a half years now as the VP of Regulatory Affairs. What excites me most about working for NeuroSense is our mission to help people with rare, fatal diseases like ALS, which currently have limited treatment options. This mission drives me to bring PrimeC to the market as soon as possible.

As the VP of Regulatory Affairs, my primary responsibility is to ensure that our drug development processes are conducted in alliance with regulatory authorities and in accordance with relevant guidelines. This involves constant communication with various departments within NeuroSense, where I stay updated on their progress through regular one-on-one and company-wide meetings. This open communication is essential to accurately convey our work to regulatory agencies. I also work closely with external clinical sites to ensure they follow all necessary regulations.

The regulatory mindset is crucial throughout the entire drug development process. It begins with determining the type of drug we are developing and reviewing proof-of-concept studies. We then build a development plan based on relevant guidelines, starting with preclinical and moving to early clinical stages. This plan is discussed with regulatory agencies to ensure all necessary studies are covered. As the plan is executed, we maintain constant communication with regulators to update them on our progress and ensure we are on the right track. For example, we conduct toxicology studies to initiate clinical trials and present these results to the FDA to confirm their sufficiency for patient enrollment. When dealing with new technologies, we share our development plans with the FDA to get their feedback and ensure compliance beyond marketing approval. The development stages typically progress from focusing on safety to efficacy.

One of the common challenges in small biotech startups is managing budget constraints while striving to achieve ambitious goals. We often face the delicate balance of doing as much as possible with limited resources, which can sometimes conflict with stringent regulatory requirements. To overcome this, we craft minimal yet robust plans and present them to regulatory agencies, clearly justifying why we believe they are sufficient. Navigating different regulations across countries adds another layer of complexity. For example, when registering a product in Japan, for instance, you have to convince the authorities that the clinical studies conducted in the US and EU were representative enough to proceed. My key professional tip is to never give up. If regulatory bodies like the FDA or EMA initially reject your proposal, don’t be discouraged. Instead, gather more data, refine your approach, and keep pushing forward. It’s crucial to engage with regulators positively, viewing them as partners rather than obstacles. Every meeting, whether in person or virtually, is an opportunity to tap into their expertise and move closer to your goal.

Ultimately, the journey of bringing a drug to market is immensely challenging, but the rewards are indescribable. Successfully navigating the regulatory landscape and achieving drug approval is a testament to perseverance. Despite the hurdles, knowing that you’re making a difference for patients with unmet medical needs makes every effort truly worthwhile.