Iris Marklein, Ph.D.
With over 9 years of experience in regulatory affairs, including 8 years at the FDA, Dr. Marklein brings extensive regulatory knowledge of regenerative medicine products; early regulatory strategy; chemistry, manufacturing, controls (CMC); and biologics and device regulatory submissions and meeting types. Dr. Marklein specializes in cell and gene therapies, delivery devices, human cells, tissues, and cellular and tissue-based products (HCT/Ps), and combination products.
As Senior Director of Regulatory Affairs for Regenerative Medicine and Biologics Quality, Dr. Marklein works closely with regenerative medicine, human tissue, and device companies on regulatory strategy, analysis, and development; submissions and meetings with FDA; and chemistry, manufacturing, and controls (CMC) documentation and testing.
Dr. Marklein received her doctorate from the University of Pennsylvania in Bioengineering with a focus on stem cells, biomaterials, and cartilage repair. She also holds a Bachelor of Science from the University of Texas, Austin in Biomedical Engineering.
Prior to joining MCRA, Dr. Marklein spent over 8 years at the FDA. Most recently, she served as an Associate Director for Policy in the Office of Therapeutic Products (OTP) in CBER, developing key guidance documents on gene therapies and human tissues and advising review teams on regulatory submissions for cell and gene therapies, combination products, and medical devices. Dr. Marklein was a designated lead in OTP on the regulatory framework for human cells, tissues, and cell- and tissue-based products (HCT/Ps), responding to 100’s of inquiries from manufacturers, healthcare providers, and patients regarding HCT/Ps and related products. Dr. Marklein also served as Device and Combination Products Team Lead in CBER, where she focused on delivery devices for cell and gene therapies and devices that produce biological outputs (ex: platelet rich plasma) at the patient’s point of care, and as a CMC Reviewer in CBER for cell therapies and devices. She also has 2 years of experience in CDRH as a Lead Reviewer for spinal and orthopedic devices.
Overview
Dr. Marklein has over 8 years of experience at FDA reviewing submissions and developing guidance for regenerative medicine products. At MCRA, Dr. Marklein primarily focuses on regulatory strategy and submissions for cell and gene therapies, delivery devices, human tissues, and combination products.