Two of the main barriers to making regenerative medicine products more widely available are high prices and the difficulty for surgeons and clinicians to implement them in their routine clinical practice, reported Nick Skaer, Ph.D., CEO of Orthox, at Regener8’s recent “Regenerative Therapies” conference in Newcastle, U.K.
“Early application and process development can greatly affect the cost of goods of these products,” added John Fisher, Ph.D., professor of mechanical engineering and director of the Institute for Medical and Biological Engineering at the University of Leeds, and executive director for Regener8.
“Currently, nobody knows how to make regenerative medicine provide economic benefit, and from the outset everyone from health economists to engineers, to scientists and clinicians, has a role to play along the innovation pathway until we get these products accepted.”
Scaling up a product for clinical use and market approval presents many technical challenges. “What works in the research lab cannot always be translated to a clinically suitable process. For example, during the production of our vascular patch, in the original research method we had used a bovine-derived nuclease and some of the buffers had BSA in them,” commented Helen Berry, Ph.D., research and technical manager of Tissue Regenix.
“When it came to developing our manufacturing process for the product to be used in the clinic, the bovine-derived nuclease was exchanged for a recombinant nuclease and the BSA was removed from the buffer to avoid the risks associated with using some bovine-derived reagents,” she explained.
“How you are going to use the product in product-development studies has to directly relate to clinical practice,” Dr. Berry added. “In our preclinical trials, the sutures used to attach our vascular patch product in the veterinary situation were different to those sutures used in humans, but clinical advice was sought on this prior to the start of the study to confirm that they were still relevant.
“In short, if you are a small medical technology company looking to design a regenerative therapy as a medical device, you should identify the clinical application as early as possible and use information on this to aid in the design of the production process and end-product. Also, seek help from established testing houses because they may identify areas that the regulators will want to know about that you may not have even considered.”
From the clinician’s point of view, Jason Wong, M.D., Ph.D., clinical lecturer in plastic and reconstructive surgery, School of Medicine, University of Manchester, explained why large numbers of regenerative medicine technologies are not being widely used.
“Hurdles exist at the developmental, pre-clinical, and, ultimately, clinical level, and it is very easy to stumble at any one of these if you do not understand the clinical application clearly. Basic scientists should really collaborate with clinicians early, at the developmental stage and throughout the development of such a project to ensure clinical translation has the slightest hope of becoming a reality.”