Several weeks ago, we announced that Dr. Gregory Hale joined the Medpace medical leadership team as Senior Medical Director of Medical Affairs. He is an experienced physician with clinical expertise in bone marrow transplantation, cellular therapies, and hematologic malignancies. As a well-established CRO partner for advanced therapies, the addition of Dr. Hale further strengthens Medpace’s capabilities across the full range of solid and hematologic malignancies. We were eager to sit down with Dr. Hale to learn more about what attracted him to the Medpace model and what new innovations he is most excited about.
Q: What is most attractive to you about Medpace’s approach to clinical development?
I have always enjoyed the scientific rigor, professional interaction, and investigational aspects of clinical research. While clinical research is highly regimented so that patient safety is protected and that studies are conducted in a suitable way, it is also exciting to be on the frontier of medicine, studying new drugs and devices. During my interview process, I was pleased to observe how Medpace was committed to its mission to accelerate the global development of safe and effective medical therapeutics, and it resonated with me. Medpace functions as a true partner with its clients in conducting the clinical trial, providing a full service team to support the clinical trial process. In addition, I was pleased to see how closely physicians are involved with the team throughout the entire process. As an oncologist, I understand the need for new therapies now—patients with life-threatening diseases cannot wait. As a pediatric oncologist, I have personally observed the great improvements in outcomes for many pediatric cancers due to clinical trial participation. As I have become more familiar with the Medpace team, I discovered that this organization shares this vision, emphasizing the importance of understanding the science, educating team members and focusing on delivering a high quality product. Prior to my arrival at Medpace, I knew physicians at Medpace were well-respected experts in their field, and I have been impressed with their ability to collaborate across specialties to facilitate clinical trial development The disease-specific knowledge afforded by the physicians complements the expertise present in the clinical operations, laboratory services, diagnostic imaging support, and regulatory affairs. I have really been impressed that Medpace has such a strong collaborative environment encouraging teamwork so that everyone in a variety of roles contributes leading to the best trial possible. Finally I have a strong background in patient safety and quality management and am highly impressed with the quality program in place at Medpace. The combination of expertise at all levels—but in particular in medicine and clinical research—are unique in this industry.
Q: You have a diverse background in hematopoietic cell transplantation and gene and cellular therapies. From a clinical development standpoint, what new innovations are you most excited about?
This is an exciting time in medicine, providing more novel treatments for patients with cancer blood disorders. Scientists are learning more about the human genome and its role in disease. This knowledge allows investigators to develop new diagnostic tools and therapeutic interventions to more specifically treat individual diseases. We are now identifying ways to correct disorders characterized by single gene mutations. New technologies, such as clustered regularly interspaced short palindromic repeats (CRISPR), allow scientists to excise a mutated gene and replace it with a non-mutated gene. Equally important, we are learning to harness the power of the immune system to treat cancer. We have learned that the human immune system can, in some cases, be tolerized to a patient’s malignant cells, so that it does not mount an immune response against the cancer, allowing the cancer cells to escape detection (and subsequent destruction) by the body’s immune system. New agents such as checkpoint inhibitors are showing promise in activating the patient’s immune response against the cancer. In addition, we are now developing new therapies that enhance the immune system response against cancer. Investigators are studying ways to alter hematopoietic cell grafts to alter the immunologic power of the grafts, leading to reduction of graft-versus-host disease or enhancement of anti-leukemia effects. In addition, cytotoxic T-cell therapies are increasingly utilized to treat post-transplant viral infections such as EBV and adenovirus. Natural killer (NK) cell infusions are being explored for their leukemia cell-killing abilities, especially in AML, especially when the donor and recipient are killer immunoglobulin-like receptor (KIR)-ligand mismatched. Finally, CAR-T cells, T-lymphocytes from a patient are genetically modified to express a leukemia-specific antigen, are showing great promise in patients with ALL and NHL. The first CAR-T cell products are projected to be approved by the FDA later this year. As we learn more about each of these technologies, they can be expanded to other cancers. With all of these new therapies, physicians will need to learn how to best identify which patients will benefit, how to identify and treat the new toxicities, and how to incorporate those active agents into current treatment guidelines. Taken together, these novel immunotherapy interventions expand our armamentarium of weapons against cancer, complementing or replacing existing therapies, with the ultimate goal of reducing acute and long-term toxicities and increasing survival.