WASHINGTON, Nov. 15, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics-focused clinical research organization (CRO) and consulting 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 recruitment of Dr. Carolyn Yong and Dr. Iris Marklein as Vice President and Senior Director of Regulatory Affairs for Regenerative Medicine and Biological Quality, respectively.
Dr. Yong and Dr. Marklein bring nearly two decades of FDA regulatory experience to MCRA, making them leading leaders in this rapidly growing field of medicine. Their experience and deep understanding of the operation of the Center for Biologics Evaluation and Research (CBER) policy and regulatory review will create tremendous opportunities for MCRA’s clients to effectively navigate this complex regulatory framework. In addition, Dr. Yong and Dr. Marklein brings diverse expertise from their previous roles at CBER and the Center for Devices and Radiological Health (CDRH), positioning them as experts in early regulatory strategies and combination products.
Carolyn Yong, Ph.D. has worked for more than 10 years as a biomedical engineer and Associate Director of Policy at the FDA. Dr. Yong participated in developing and advancing the policy positions of CBER and the Office of Therapeutic Products (OTP) as a key decision maker and expert on advanced manufacturing. Dr. Yong also oversaw product jurisdiction and compliance-related activities in the OTP space. 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 institutions, regenerative medicine therapies and device companies.
Dr. Yong says, “I am thrilled to join MCRA at such a critical time for regenerative medicine. I look forward to working closely with leading and emerging regenerative medicine, therapeutics, human tissue and device companies to make these critical, innovative products available to people with unmet medical needs. I am also excited to help advanced manufacturing technology innovators navigate the evolving regulatory environment.”
After working at the FDA for more than 8 years, Dr. Marklein has extensive regulatory experience with regenerative medicine products, including cell and gene therapies, human tissues and combination products. Most recently, she served as Associate Director for Policy in the Office of Therapeutic Products at CBER, where she led the development of major guidance on gene therapies and human tissues. Dr. Marklein also served as Device and Combination Products team leader at CBER, focusing on delivery devices for cell and gene therapies and devices that produce biological outputs (e.g., platelet-rich plasma) at the point of care. At MCRA, Dr. Marklein works closely with cell and gene therapy, human tissue and device companies on regulatory strategies and proposals.
Dr. Marklein says, “Joining MCRA will allow me to leverage my regenerative medicine regulatory expertise to support our clients and drive meaningful change. I look forward to helping companies achieve their goals and ultimately advance 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 expertise in regenerative medicine and biologics and will expand the scope of MCRA’s portfolio to include additional product types and therapeutic areas, as well as advanced manufacturing. We are pleased to welcome Carolyn and Iris to the MCRA team to further the expansion of MCRA’s focus in the field of regenerative medicine.”
Glenn Stiegman, SVP, Clinical & Regulatory Affairs said: “I am pleased that Dr. Yong and Dr. Marklein to join the MCRA team. The regenerative medicine space is a growing and exciting market that cuts across the entire medical industry. The skills and experience that Carolyn and Iris bring to the regulatory team will be a great addition to our current expertise and to the other therapy verticals.”
Anthony Viscogliosi, CEO of MCRA, said: “This strategic expansion of MCRA’s former FDA talent base underscores our commitment to providing our clients with the best regulatory guidance, and ultimately better serving patients around the world. Carolyn and Iris will not only strengthen MCRA’s knowledge of regenerative medicine, but also unlock new opportunities to serve customers in rapidly evolving areas such as advanced manufacturing.”
About MCRA, LLC: MCRA is the leading private, independent Clinical Research Organization (CRO) and advisory organization for medical devices, diagnostics and biologics. MCRA delivers its client’s industry experience and integrates its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to deliver a dynamic, market-leading effort from concept of innovation to commercialization . MCRA’s integrated application of these key value-creating initiatives provides unparalleled value to its customers. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, United Kingdom, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 customers worldwide. Key areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dentistry, 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. Headquartered in New York City, VB specializes in financing venture capital, private equity and investment banking activities for the neuromusculoskeletal industry. VB is committed to financing healthcare innovation. www.vbllc.com
For more information please contact:
Alyssa Howard, vice president, business development
Phone: 215.870.3952 | Email: ahoward@mcra.com
SOURCE MCRA, LLC
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