Originally published by Biopharmadive.com
Teresa Nunes is responsible for overseeing the activities of the medical affairs and pharmacovigilance teams at the specialized Clinical Research Organization (CRO) leader, Allucent. Here she discusses what drives her passion for helping small and mid-sized biotechnology companies bring new therapies to light for patients around the world – and why she’s optimistic about what lies ahead.
Can you tell us a little bit about your background, and why as a medical doctor you decided to get into clinical development?
My reason for being in this field is simple – helping people. I worked in a clinical setting for several years, which I found very gratifying, but the opportunity to impact more people by being part of a team that helps bring potentially life-changing treatments to market really appealed to me.
I’ve been in clinical development for two decades now – initially within pharmaceutical companies, and then with CROs. During this time, I’ve contributed to the design and oversight of over 100 Phase I-IV studies across numerous therapeutic indications, with a particular focus on central nervous system disorders (CNS) and rare diseases.
Given your expertise in CNS, what challenges and opportunities do you see related to conducting trials in this space?
CNS drug development is highly active, with some unique considerations. A primary challenge relates to placebo response and the inherent difficulty in interpreting outcome measures that rely on patient reporting.
That’s why it’s essential to understand what kind of trials to conduct, and how to mitigate the placebo response during clinical studies. Crossover studies are one example of an approach to trial design that can help. Here, the placebo effect tends to be different since the same patients receive a placebo and an active drug sequentially. In terms of controlling for placebo response during clinical trials, one thing we do is placebo training for investigators about the nuances of clinical research and how to minimize expectations and remain neutral in all patient interactions.
At the same time, there’s a tremendous amount of opportunity in CNS. It’s a broad and varied market, with significant unmet needs across indications such as Alzheimer’s disease and other types of dementia, various psychiatric disorders, and neurological conditions like epilepsy and Parkinson’s disease, to name just a few. And, because many of these diseases are linked to aging, the need for novel therapies is only going to increase as the population gets older and people continue to live longer.
What motivates you in the work you’re doing now?
Initially, my drive came from the desire to positively impact people’s lives beyond patients in one clinical practice. That’s still the case, but it also took on a personal component when my son was born with an ultra-rare disease. I first started working in rare diseases after we received his diagnosis, and that’s when I went from feeling hopeless to seeing the real possibility of treatment for him coming relatively soon. Working close to truly groundbreaking science with the potential to take away hopelessness from others is both inspiring and humbling. It’s what motivates me every day.
That’s part of what drew me to my current role. I wanted to be in an environment where I could work directly with my team and our clients to have the greatest impact. Because of our size and our focus, I get to do just that. Some of our clients have very small in-house teams and need specialized support in navigating the various stages of development. As global CMO, I’m able to provide a holistic view and connect our partners with the right experts across our network to meet their needs. And, I get to leverage my own expertise in complex therapeutic areas to help solve their challenges.
What opportunities are you most excited about as we enter 2023?
In 2022 we’ve had the conflict in Ukraine, inflation and COVID-19 – all contributing to a challenging global economic environment with less funding for smaller biotechs where so much of today’s scientific innovation is housed. Naturally, this caused concern about what it would mean for clinical development. But we’re actually seeing the number of new clinical trials slowly picking up – particularly in rare diseases and CNS. I’m also seeing very exciting, dynamic pipelines coming from smaller companies all across the globe. Some of these companies have novel drugs that will begin trials next year. So, I’m highly energized heading into 2023, and very optimistic looking into the future.