Tell us about your background in clinical research and the inspiration behind the founding of Vertex Clinical Research.
I have over ten years of research experience in both the industry and academic settings. Our founders have over 30 years of combined research expertise. We share a passion for the central nervous system (CNS) indications and wanted our site to focus on indications in psychiatry as well as healthy memory/mild cognitive impairment and Alzheimer’s Disease trials. The US is experiencing a mental health crisis, and it is important to be part of the solution. Having a variety of treatment options available to people of all ages is critically important. We wanted to contribute using our background, knowledge, and experience. Thus, we opened Vertex Clinical Research as a dedicated CNS facility specializing in these indications. We are committed to the discovery of new treatments and to providing the highest level of care to ensure patient safety.
Can you discuss current or past development work that you are particularly proud of?
We worked with an open-label trial (guaranteed study medication/no placebo arm) for patients with moderate to severe depression/major depressive disorder. This drug has been approved in other countries but not in the USA at this time. By trial completion, many patients had received the remission of their symptoms. What was particularly rewarding was to see them functioning much better in their work, schooling, and personal/family relationships. One patient shared that she felt that she had gotten her life back. At our site for this trial, the inclusivity of underrepresented groups was over 50% based on age, race, color, disability, and sex. We were very proud to be a part of this important study.
What interested you in joining Alcanza? Why is joining now important?
Alcanza and Vertex share a common mission. The inclusion of diverse and underrepresented populations is fully aligned with our purpose. Importantly, Alcanza strives to help all people through clinical research, while maintaining the highest quality standards and exceptional integrity. Partnering with Alcanza will allow us to reach even more people together. There is no time like the present and no time to spare in helping people through clinical research!
How does Vertex reach relevant and traditionally underrepresented patient populations for clinical research participation?
This is a truly important mission for us. Patients in clinical trials should reflect US demographics, and we have a long way to go. It is our goal to provide research for all people and provide a safe space where all are welcome. We foster relationships in the community with non-profit organizations, mental health counseling groups, mental health advocacy groups, and with physician practices. In addition, community-based events in our area are very important so that we may share what we do directly with our local neighbors. We also selected Clermont, Florida, for its diversity and rapidly growing demographics.
CNS is a thriving area of drug development. What excites you about the future of this therapeutic area?
The brain is the most complex human organ, and CNS work is the final frontier. Many people know someone who has a mental/behavioral health disorder and/or someone who is experiencing cognitive decline. In addition, healthy aging and memory care are pertinent for all of us. There are so many exciting drugs coming down the CNS pipeline! New investigational products offering novel mechanisms of action are already in various stages of clinical trial testing. Some of these compounds offer different or reduced side effect burdens as compared to already approved medications. These may provide people with relief or remission from their symptoms, possibly with fewer side effects. In addition, there are also products being tested for people with chronic mental illnesses. The more we have, the better we can do to help. We are honored to be a part of this innovative field and to improve the quality of someone’s life through medical research. Mental health is physical health and should be prioritized.
Dr. Ayesha Lall, MD
Vertex Research Group