New Collaboration Will Help to Expedite Medical Research to Market
A new collaboration among the University of Arizona College of Medicine – Phoenix, Dignity Health’s St. Joseph’s Hospital and the International Society for Cardiovascular Translational Research (ISCTR) is designed to speed medical advances from the bench to the bedside.
The partnership will empower entrepreneurial clinician-scientists and others to effectively translate discoveries into new medical advances, such as devices, biologics (stem cell and tissue engineering) and medications. The partnership provides the practical knowledge and real-world experience that is often the missing link for many inventors who face the dreaded “valley of death” that often prevents ideas from proceeding through the regulatory approval process.
A key component of the partnership is the creation of a Translational Research Curriculum that will provide a platform for medical product development. “Scientific discoveries are supported from initial concept to final regulatory approval by the Food and Drug Administration and other regulatory authorities. As new medical advancements become available, patients’ quality of life and chance of survival will improve,” said ISCTR President, Nabil Dib, MD, MSc, FACC, a physician and faculty member of the UA College of Medicine – Phoenix and St. Joseph’s Hospital (pictured right).
Designed specifically for biomedical technologies (initially in cardiovascular research), this program will improve how researchers bring their products into the marketplace and change the way researchers think about the commercialization process.
Getting any new product to market is challenging – but getting a biotech product currently can take anywhere from 7 to 17 years. That process delays the science to patients and increases cost. New tools and standard approaches, as well as a clear understanding of the regulatory pathways of the Food and Drug Administration, European medicine agency and others, can expedite the process, Dr. Dib said.
Phoenix was recently ranked No. 1 as a top city for entrepreneurship by Entrepreneur magazine and has risen in national and state statistics for the bioscience industry.
“Phoenix is an ideal location for our program,” said Stuart D. Flynn, MD, dean of the UA College of Medicine – Phoenix (pictured left). “We know the difficulty of taking an idea and navigating the many hurdles to actually getting it to help people. This new collaboration will be foundational in saving lives by bringing cutting edge research to those in critical need and add another expansive component of entrepreneurship in Phoenix.”
As part of the ISCTR’s commitment to innovation, they have also named the fourth scholar to enter the translational research program. Noted heart surgeon Zain Khalpey, MD, PhD, MRCS, was recently named to this post for his innovation in addressing heart failure. According to the CDC, about 5.1 million Americans suffer from heart failure, the associated costs are estimated at $32 billion each year.
Dr. Khalpey (pictured center), surgical director of the Heart Transplant and Mechanical Circulatory Support program at the UA Medical Center in Tucson, has been at the forefront of the use of stem cells to regenerate organs, such as the heart. Dr. Khalpey’s ISCTR scholarship project includes establishing a Translational Research platform to evaluate stem cell retention and distribution to improve patient outcomes.
Dr. Khalpey said patients with established heart failure might benefit from tissue repair and regeneration, using stem cells as therapy. Under the proposed project, Dr. Khalpey would study the use of a specific stem cell line and a complex mixture of protein in patients who would otherwise face a heart transplant.
“With hundreds of thousands of end-stage heart failure patients in the nation and less than 2,500 heart transplants being performed annually, other options must be found,” said Dr. Khalpey.
This type of specialized research and the resulting devices, biologics, medications and procedures are exactly the kind of advances that this partnership will help to speed from bench to bedside, said Dr. Dib.
“The Translational Research Center will support advanced medical education, medical research and ISCTR curriculum implementation. Students and scholars will have opportunities to collaborate with engineers, biologists, clinical scientists, and regulatory experts conducting pre-clinical and clinical trials,” said Dr. Dib. “The center will serve researchers, industry partners, funding agencies and regulatory authorities as a one-stop shop for innovations in Translational Research, potentially helping untold numbers of patients and creating an economic impact for our community.”
Al Bravo, UA College of Medicine – Phoenix, 602-827-2022
Lynne Reaves, St. Joseph’s Hospital and Medical Center, 602-406-4734
DeAnn Dana, ISCTR, 480-309-2884
The University of Arizona College of Medicine – Phoenix admitted its inaugural class of first year medical students in August 2007 and currently has 301 students training to be physicians. The UA College of Medicine – Phoenix inspires and trains individuals to become exemplary physicians, scientists and leaders who are life-long learners and inquisitive scholars and who will embrace professionalism, innovation and collaboration to optimize health and health care for all.