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In this interview, we explore the multifaceted approach of Sangamo Therapeutics through a conversation with Nathalie Dubois-Stringfellow, Sangamo’s chief development officer. Nathalie discusses the company's diverse clinical programs, strategic collaborations, including a partnership with Pfizer, and the crucial role of patient safety. Nathalie also shares insights into the future of clinical trials and the potential role of artificial intelligence, affirming Sangamo's commitment to innovation and patient-focused care.
Moe Alsumidaie: Can you provide an overview of Sangamo's current clinical programs and how these are progressing?
Nathalie Dubois-Stringfellow: At Sangamo, we're strategically focusing on our pipeline prioritization which includes our neurology portfolio platform. For instance, we recently presented the results of our Nav1.7 program at the American Society of Gene and Cell Therapy (ASGCT). This program focuses on neuropathic pain and small fiber neuropathy using our ZF-TF technology, and we're hoping to commence trials next year. For Fabry disease, we have a positive trajectory. We are escalating doses as we progress from Phase I/II trials toward a potential Phase III trial, with plans to meet with FDA on the proposed study design this summer. So, as you can see, we have a focused set of priorities the cover range of pre-clinical and clinical pipeline, each with unique challenges and exciting potential.
MA: Given the breadth and scope of Sangamo's clinical programs, what are some of the key challenges you face in managing these, and how are you addressing them?
NDS: A challenge we face is finding the right patients for our trials. Each program is designed to target a specific patient population, and we have to ensure we are reaching those patients and that they meet the specific eligibility criteria. Another challenge is the complexity of the therapies we are developing. For instance, in autologous ex vivo therapies and in vivo gene therapies, we have to deal with complex logistics and handling procedures, which require close cooperation with the clinical sites. To overcome these challenges, we work closely with experienced contract research organizations that understand the field. These partnerships help ensure we have the right operational support to execute our trials successfully. Furthermore, we operate globally with the head of our clinical operations based in London and clinical research associates all over the world. This global reach and representation enable us to effectively navigate and adapt to different clinical and regulatory landscapes. Overall, this challenge is part and parcel of the work we do. It's a complex process, but one that we approach with enthusiasm and dedication, always striving for innovation and improvement in the service of patients.
MA: I know that Sangamo has partnered with Pfizer for certain clinical programs. Can you provide some insights into the nature of this collaboration and how it's progressing?
NDS: Our partnership with Pfizer has been a strong and fruitful collaboration. Pfizer is leading the development of an investigational Hemophilia A gene therapy, and we have seen some promising results in early-phase trials. We are pleased with how our partnership with Pfizer is enabling the acceleration of this program, allowing us to advance gene therapy for Hemophilia A, which has the potential to make a significant impact on patients' lives. This collaboration has been a testament to the value of strategic partnerships in accelerating the development of novel therapies, and we look forward to seeing continued progress in our joint programs.
MA: Can you describe how Sangamo has ensured patient safety during clinical trials?
NDS: At Sangamo, we place a heavy emphasis on patient safety. One of the ways we do this is through a robust process that includes safety monitoring committees. These committees meticulously review patient safety after each cohort. They decide whether we can safely proceed to the next dosage level. Notably, we have had no safety concerns for Fabry disease, which has allowed us to escalate doses progressively.
MA: Navigating the regulatory pathway is a significant part of advancing medical products. How has Sangamo managed this?
NDS: Dealing with regulatory bodies is crucial in our work. I'm proud to say that we have successfully cleared all of our Investigational New Drug (IND) applications. We've had no holds on INDs, which is a testament to our diligence, and we maintain open lines of communication with FDA. We often hold pre-IND meetings, which provide us with a clear understanding of what they need from us for IND submission. It's an approach that has paid off.
MA: How do you see the future of clinical trials, particularly with regard to the use of artificial intelligence?
NDS: Artificial intelligence tools will greatly benefit the future of clinical trials. These tools can assist us in identifying the right patients for our trials, understanding patient accessibility based on their geographical location, and tailoring trials to minimize inconvenience for them. By making the trial process more patient-friendly, we can ensure patients are enthusiastic about being part of the trials, which ultimately leads to more successful outcomes.
MA: Can you elaborate on how you support patients and their families during the clinical trial process?
NDS: Sangamo has a strict protocol to avoid direct communication with patients; our interaction is primarily through the principal investigators (PIs). We do our utmost to support the PIs, who then relay the necessary information and assistance to the patients. Additionally, we have a travel agency that aids patients and their families with travel logistics. Our primary concern is ensuring that patients receive the necessary care.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and regular contributor to Applied Clinical Trials.