Interview: Richard McFarland, Chief Regulatory Officer, ARMI

Richard McFarland, Ph.D., MD joins ARMI as the Chief Regulatory Officer effective May 1, 2017.  Dr. McFarland comes to ARMI from the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) where his career spanning 16 years involved review over an extensive range of products and policy development in numerous areas both inside FDA, across the federal government, and internationally. He spent more than a decade as Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies and its predecessor office, the Office of Cellular, Tissue and Gene Therapies. In this position, he was heavily involved in policy development for tissue engineering, regenerative medicine, and alternatives to animal use in regulatory decision making. In addition to the development of risk-based regulatory oversight paradigms within FDA, his interests included broader efforts to create an interlocking network of interagency efforts to foster the growth of basic and translational science to support the maturation of the overlapping fields of tissue engineering and regenerative medicine from primarily discovery science toward a stage of commercial development.

His position at ARMI will allow him to apply the knowledge and experiences gained by over the last decade and half in the field to ARMI’s efforts to establish an industrial common, in the form of a Manufacturing Innovation Institute within the Manufacturing USA network, with the aims to coalesce the field and provide a route for nascent product concepts to reach the marketplace. Bringing these products to the market will benefit critical U.S. public health needs and will provide the economic drivers needed to create new highly-skilled jobs.

Dr. McFarland, Ph.D., M. D. received his B.S., Ph.D., and M.D. from the University of North Carolina at Chapel Hill, and completed his anatomic/clinical pathology residency and immunopathology fellowship training at UT Southwestern in Dallas. Immediately prior to joining the FDA, he was on the faculty of the Pathology Department of the University of Texas Southwestern in Dallas.  In addition to FDA policy documents, he has co-authored over 25 articles in peer-reviewed articles journals including Nature, the Proceedings of the National Academy of Science (PNAS), and Blood. Dr. McFarland will be speaking at our upcoming Boston event this July. 

Jenny: When was the first encounter you had with 3D printing?

Richard: It was probably about 10 years ago, while I was at FDA when I had my first experience with 3D printing and I began thinking about the ways that it might fit within the regulatory landscape.

Jenny: What inspired you to start your journey research in 3D printing/bio-fabrication?

Richard: It was my desire to ensure that all scientifically reasonable technologies could develop within a regulatory landscape in a way that would allow adequate safeguards for the safety of research participants and eventually patients once products were commercialized.

Jenny: Who inspired you the most along this journey in bioprinting and regenerative medicine?

Richard: There were very numerous, and as a result I am hesitant to name specific people, however I would like to specifiy three groups of people as inspirations.

First, patients with life-threatening and life-altering diseases and syndromes for which the currently available therapies fall significantly short. Those patients who must endure multiple surgeries due to the fact that current conventional medical devices cannot offer curative treatments and/or multiple surgeries with inadequate repairs fashioned from autologous tissues that also subject them to iatrogenic donor site morbidities. Patients (and parents if the patients are children) must face heart-wrenching decisions among a series of inadequate options. There is potential with bio-printing bio-fabrication to provide better clinical solutions, which may be in some cases curative if research findings can be successfully translated into medical products.

Second, I would have to say that I have been inspired by the efforts of many of the public servants across the federal government (and other governments around the world) with whom I have had the privilege to work with over my years at FDA. These individuals wrestle with difficult decisions of balancing innovation and clinical trial participant/patient safety across constantly changing fields each day, year in an year out, with full recognition essentially in anonymity without any expectation of extreme fortune or fame because, in most cases, they recognize that they are making a contribution in some way to the general wellbeing and public health. This is true of the public servants that I have worked with across the entire government, not just at my home agency- FDA, but at NIH, NSF, NIST, and DoD.

Last and most recently, I have been inspired by my colleagues at ARMI|BIoFabUSA as I have discovered the diverse, and at times very personally touching, reasons that they have chosen to contribute their talents and efforts to the Institute’s efforts to manufacture the future of biofabrication which, will in time, make good on the promises offered by biomedical research.

Jenny: What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions?

Richard: The largest obstacles in the cross-disciplinary role that I currently fill is maintaining sufficient knowledge across many adjacent files of science, engineering, medicine, manufacuticuring, business, law, politics to anticipate what needs to be aligned in sufficient time to ensure that the resources and other ingredients needed for moving the field forward are available when it is the appropriate time to make a difference.

Jenny: What do you think is (are) the biggest challenge(s) in bio-printing? What do you think the potential solution(s) is (are)?

Richard: The biggest challenge in bioprinting in terms of it being used to produce a therapeutic product is having a product developed to a sufficient stage to go into clinical trials and gain a marketing authorization. When this happens, it will demonstrate that there is a pathway to commercialization of this technology in the therapeutic realm. There are numerous technical and regulatory hurdles to address that challenge, but they are somewhat unique to the product and application, however, if the underlying scientific research is stable they are all achievable.

Jenny: What were/was the best and worst investment you made in bio-printing/bio-fabrication?

Richard: Too early to tell.

Jenny: What was/is the biggest risk you took in your career?

Richard: Probably leaving academia, and the relatively sure future of a clinician/scientist to come to work in the FDA because it had the potential (and did) change the course of my career and life.

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