Expanding the horizons of cell and gene therapy: an interview with Nisha Durand
Nisha Durand is the GMP Director at Carolina BioOncology Institute – BioCytics (NC, USA). She oversees the implementation of GMP standards within the laboratory to ensure that manufacturing processes meet the highest quality and regulatory benchmarks. Prior to joining Carolina BioOncology Institute – BioCytics, Dr Durand was at Mayo Clinic Florida for over 12 years, where she most recently served as the Manager of Process Development and as an Assistant Professor of Regenerative Medicine.
Here, Dr Durand shares insights into her work on mesenchymal stem cell therapy for intracerebral hemorrhage and celebrates Black History Month by telling us about the people who played a pivotal role in influencing and shaping her scientific career. Read the full interview below.
What sparked your interest in cell and gene therapy?
In the spring of 2017, I completed my PhD in Biochemistry and Molecular Biology from Mayo Clinic Graduate School of Biomedical Sciences (MN, USA), and at that juncture I wanted to engage in research with more direct clinical impact. Consequently, I joined Mayo’s Center for Regenerative Biotherapeutics as a post-doctoral research fellow, and under the mentorship of Abba Zubair, I was introduced to the multifaceted and dynamic field of cell and gene therapy. Since then, I have developed a real passion for cell and gene therapy as it allows me to remain at the forefront of exciting and challenging cutting-edge research, which has direct implications for human health in critical areas such as oncology.
One of your primary focuses is research into mesenchymal stem cell therapy. You recently published findings from a preliminary Phase I trial investigating mesenchymal stem cell therapy for intracerebral hemorrhage. Could you tell us more about the study?
This was a Phase I, dose-escalation study where we evaluated the safety and feasibility of allogeneic bone marrow-derived mesenchymal stromal/stem cells (BM-MSCs) in patients with acute intracerebral hemorrhage (ICH). 9 patients were enrolled in the study and assigned to one of three treatment groups (0.5 million BM-MSCs/kg, 1 million BM-MSCs/kg or 2 million BM-MSCs/kg). Following intravenous (IV) administration of the BM-MSC product, study subjects were observed in the neuro intensive care unit to evaluate the tolerability of the stem cell infusion and potential adverse reactions. Our results from this study suggest that IV administration of allogeneic BM-MSCs in the acute ICH patient population is feasible and safe.
What are the main implications of the results and how do you think this will impact clinical practice in the future?
Although this was a Phase I study with a small patient population, the preliminary safety and tolerability data obtained from IV administration of allogeneic BM-MSCs to subjects with recent ICH serves as a crucial foundation for future large-scale, placebo-controlled clinical studies. These subsequent studies are essential for confirming and expanding upon the safety and feasibility of allogeneic BM-MSCs for ICH patients, providing a comprehensive understanding of outcomes and potential therapeutic efficacy of this therapy in the broader context of clinical practice and patient care.
What are your future research plans and what areas of cell and gene therapy do you hope to explore in the future?
A lot of my work in the cell and gene therapy field has been focused on process development and GMP-compliant manufacturing operations to support clinical applications of MSCs, and most recently immune effector cells. In the future, while I hope to continue this work, I am also deeply enthusiastic about the integration of automation in the manufacturing workflow and would like to explore how automation and novel technologies can help resolve some of the existing bottlenecks in the field.
In celebration of Black History Month, are there any black figures that have played a pivotal role in influencing and shaping your scientific career?
Yes, two people come to mind. The first is my post-doc advisor, Abba Zubair, a well-respected and highly innovative physician scientist, who introduced me to the cell and gene therapy field, which has now become the foundation of my career. It was under his mentorship and guidance that I came to learn so much about stem cells, regenerative medicine, GMP manufacturing, and so many other things. He emphasized the importance of forging my own path, directing my focus to things within my reach and most importantly he equipped me with the tools and skills essential for professional success.
Another individual who has significantly influenced my scientific journey is Phaedria Marie St Hilaire, an exceptional scientist and accomplished business leader. Like me, Dr St Hilaire is from the island of the Commonwealth of Dominica. Her remarkable achievements in the pharmaceutical industry and dedication to promoting diversity, equity and inclusion have been a source of inspiration to me. I regard Dr St Hilaire as a role model who embodies the potential and accomplishments that individuals from Dominica can achieve in the realm of science and beyond.
The opinions expressed in this interview are those of the author and do not necessarily reflect the views of RegMedNet or Taylor & Francis Group.