WASHINGTON, November 15, 2023/PRNewswire/ -- MCRA, LLC, a leading medical device and biologics focused clinical research organization (CRO) and advisory firm integrating seven core services [U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH)] is pleased to announce the hiring of Dr. Carolyn Yong and Dr. Iris Marklein as the Vice President and Senior Director, respectively, of Regulatory Affairs for Regenerative Medicine and Biologics Quality.
Dr. Yong and Dr. Marklein bring nearly two decades of FDA regulatory experience to MCRA – making them predominant leaders in this rapidly expanding area of medicine. Their experience and deep insight on the innerworkings of the Center for Biologics Evaluation and Research (CBER) policy and regulatory review will create tremendous opportunity for MCRA’s clients to effectively navigate this complex regulatory framework. Moreover, Dr. Yong and Dr. Marklein have diverse expertise from their previous roles at CBER and the Center for Devices and Radiological Health (CDRH), positioning them as experts in early regulatory strategy and combination products.
Carolyn Yong, Ph.D. spent over 10 years as a Biomedical Engineer and Associate Director of Policy at FDA. Dr. Yong participated in developing and advancing CBER and the Office of Therapeutic Products (OTP) policy positions as a key decision maker and Advanced Manufacturing expert. Dr. Yong also oversaw product jurisdiction and compliance-related activities in OTP. As Vice President of Regenerative Medicine and Biologics Quality Regulatory Affairs at MCRA, Dr. Yong will work closely with MCRA’s existing team of regulatory experts to manage, develop, and execute regulatory strategies and submissions for tissue establishments, regenerative medicine therapies and device companies.
Dr. Yong states, “I am thrilled to be joining MCRA at such a critical time for Regenerative Medicine. I look forward to working closely with leading and emerging regenerative medicine therapy, human tissue, and device companies to make these critical, innovative products available to those with unmet medical needs. I am also excited to serve advanced manufacturing technology innovators to navigate the evolving regulatory framework.”
Having spent over 8 years at the FDA, Dr. Iris Marklein has extensive regulatory experience with regenerative medicine products, including cell and gene therapies, human tissues, and combination products. Most recently, she was an Associate Director for Policy in the Office of Therapeutic Products in CBER, leading the development of key guidance documents on gene therapies and human tissues. Dr. Marklein also served as Device and Combination Products Team Lead in CBER, focusing on delivery devices for cell and gene therapies and devices that produce biological outputs (ex: platelet-rich plasma) at the point of care. At MCRA, Dr. Marklein will work closely with cell and gene therapy, human tissue, and device companies on regulatory strategy and submissions.
Dr. Marklein states, “By joining MCRA, I can leverage my regulatory expertise in regenerative medicine to support our clients and drive meaningful change. I'm looking forward to helping companies achieve their goals and, ultimately, advancing patient care through the application of innovative technologies.”
Kevin McGowan, VP, Regulatory Affairs – Biologics, Tissues, and Combination Products states, “The addition of Dr. Yong and Dr. Marklein to the MCRA Regulatory team deepens MCRA’s regenerative medicine and biologics expertise and will expand the scope of MCRA’s portfolio to include additional product types and therapeutic areas as well as advanced manufacturing. We are excited to welcome Carolyn and Iris to the MCRA team to foster the expansion of MCRA’s focus in the regenerative medicine space.”
Glenn Stiegman, SVP, Clinical & Regulatory Affairs says, “I am thrilled to have Dr. Yong and Dr. Marklein join the MCRA team. The regenerative medicine space is a growing and exciting market that crosscuts the entire medical industry. The skillset and experience that Carolyn and Iris bring to the regulatory team will be a great complement to our current expertise and to the other therapy verticals.”
Anthony Viscogliosi, CEO of MCRA, says “This strategic expansion of MCRA’s former FDA talent base underscores our commitment to providing best in class regulatory guidance to our clients, and ultimately better serving patients around the world. Carolyn and Iris will not only bolster MCRA’s knowledge in the field of regenerative medicine but will also unlock new opportunities to service clients in rapidly evolving areas, such as advanced manufacturing”.
About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client’s industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, the United Kingdom, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic expertise includes orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com
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