Former FDA Officials Join ARMI | BioFabUSA to Help Develop Advanced Manufacturing for Engineered Tissues and Organs
Dr. Richard McFarland and Dr. Becky Robinson-Zeigler have joined ARMI/BioFabUSA to provide regulatory science expertise in support of BioFabUSA’s efforts toward developing a regenerative manufacturing industry.
Regulatory issues are of critical importance to organizations in the field of regenerative medicine, and Drs. McFarland and Robinson-Zeigler will support the BioFabUSA program in multiple ways. They will be reviewing technical project proposals with a regulatory science perspective, developing and delivering educational/workforce development offerings on regulatory review and process, and providing individualized consultations with members of BioFabUSA on their product development programs.
Richard McFarland, PhD, MD joined ARMI as its Chief Regulatory Officer in May of this year. Dr. McFarland comes to ARMI from the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) where his career of over 16 years involved review of an extensive range of products and policy development in numerous areas inside FDA, across the federal government, and internationally. He spent almost two decades at the FDA, including time as Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies (OTAT), and its predecessor office, the Office of Cellular, Tissue and Gene Therapies (OCTGT).
"I am often asked, 'How do you think about regulations for a new industry?' New regulations are not needed. One key to moving this field is demystifying the regulatory process. Many in the field claim there is no defined regulatory pathway for regenerative medicine products, including personalized medicine products. However, a process does exist and has been used successfully by others to get their product to market. We need to move away from seeing the FDA as an obstacle or hurdle to overcome and instead find ways to make the Agency a part of the product development process," said McFarland.
Dr. Becky Robinson-Zeigler, a biomedical engineer, recently joined ARMI/BioFabUSA as the Deputy Chief Regulatory Officer. With more than 6 years experience at the FDA, Robinson-Zeigler served Branch Chief of OTAT’s Pharmacology/Toxicology Branch 2 (PTB2)Pharmacology/Toxicology Branch 2 (PTB2). In this role, she was responsible for supervising a branch of five pharmacology/toxicology reviewers, and therefore was heavily involved in developing and standardizing review approaches to a wide range of regenerative medicine advanced therapies (RMATs) that were within OTAT’s jurisdiction. She also was involved in regenerative medicine initiatives across FDA’s Centers, particularly those that spanned CBER and the Center for Device Evaluation and Radiologic Health (CDRH), including serving as a preceptor in the Commissioner’s Regenerative Medicine Fellowship Program, a non-traditional post-doctoral fellowship designed to train the next generation of regulatory reviewers and scientists.
"The greatest challenge I see to the field of regenerative medicine is cooperation. Cooperation in terms of fragmentation of the field, and in terms of thinking outside of the box. For this field to move forward we must start thinking past biology and more towards engineering solutions to consistently manufacture a quality regenerative medicine product. This will necessitate people from all areas of the field - materials scientists, biologists, biomedical engineers, and physicians - and people from areas outside of the field all working together," remarked Robinson-Zeigler.