Steven S. Oh, PhD
Carolyn Yong, PhD
The Division of Cellular and Gene Therapies (DCGT) is responsible for regulatory review and oversight of cellular products, gene therapy products, tissue-engineered products, combination products, and point-of-care devices. Dr. Oh provides leadership in reaching regulatory decisions on regenerative medicine therapy products submitted to OTAT in CBER. He is actively involved in the development of regulatory policies for Regenerative Medicine Advanced Therapies. He interacts closely with the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) in FDA, and with other government agencies on cross-cutting scientific and regulatory issues and policies. Dr. Oh participates in international standards activities regarding the manufacture and testing of cellular products and tissue-engineered medical products. He is also engaged in various efforts promoting global regulatory harmonization in cellular and gene therapy products. Dr. Oh has served as a preceptor for numerous regenerative medicine fellows in the last ten years at the FDA.
Dr. Yong serves as an Associate Director of Policy in CBER/OTAT and leads policy development at the Office-level, as well as develops, advances, and represents, Center and Agency level policy positions. Her duties include management of FDA guidance document and regulation development for OTAT and liaising with other FDA Centers and external stakeholders, particularly in the advancing fields of biomanufacturing and regenerative medicine. Dr. Yong is also engaged in both FDA and standards organization activities related to tissue engineered medical products. Prior to her current role, Dr. Yong served as a Device and Combination Products Team Leader in DCGT where she conducted scientific regulatory review while providing oversight of DCGT programs related to regenerative medicine applications, and combination products containing a biological product in combination with a device and/or drug. Prior to joining OTAT in October of 2014, Dr. Yong was a Lead Scientific Reviewer in the Division of Surgical Devices in CDRH. Dr. Yong was previously a Commissioner’s Fellow (Class of 2012) and has recently served as a preceptor for two regenerative medicine fellows.
Proposed Research Project for OTAT Regenerative Medicine Fellow:
ENHANCING REGENERATIVE MEDICINE THERAPY PRODUCT DEVELOPMENT:
REGULATORY REVIEW STANDARDS FOR CELL-SCAFFOLD CONSTRUCTS
Preceptor: Steven S. Oh, Ph.D.
Co-Preceptor: Carolyn Yong, Ph.D.
Project duration: 2 years (possible 1 year extension)
Cell-based regenerative medicine products offer innovative therapeutic strategies for treating serious and debilitating conditions. One class of cell-based products is three-dimensional cell-scaffold constructs in which viable cells are combined with extracellular matrices composed of naturally derived or synthetically produced materials. To date, many cell-scaffold constructs have been described in the literature and are under clinical development to repair, replace or regenerate damaged tissues or organs. The interactions between the cells and scaffold in these constructs as well as between the host cells/tissues and scaffold component of the construct are thought to affect the biological function of the cell-scaffold constructs and consequently clinical outcomes. In fact, key attributes of cell-scaffold interactions may be specific to the types of cells and scaffolds involved and have relevant impact on the safety, quality, and effectiveness of the final construct. Therefore, understanding unique characteristics of the interactions which may have direct relevance to a functional outcome of the cell-scaffold constructs is an important part of FDA’s scientific review of cell-scaffold regenerative medicine products. However, consistent approaches to such assessments based on characteristics of cell-scaffold interactions have been challenging from the regulatory science perspective due to the complexity and diversity of the interactions.
The major goal of the proposed project is to develop scientific review standards for the characterization of cell-scaffold interactions in various types of cell-scaffold constructs for implantation into different anatomic locations in the human body. In this project, the Regenerative Medicine Fellow will focus on the following specific aims for defined cell-scaffold product types:
- research the scientific literature and regulatory submissions to FDA to evaluate the nature and complexity of various cell-scaffold interactions and identify known characteristics and important attributes in specific cell-scaffold interactions
- understand biological and functional effects of different scaffolds on exogenous and endogenous cells and maturation of the constructs based on scientific data in the literature
- survey the agency’s current regulatory review practice related to these products from internal FDA databases
- provide the latest cell-scaffold product knowledge to guide regulatory reviews in OTAT and provide insights into developing new FDA policies for stakeholders.
Deliverables from this project may include:
- development of scientific review tools and standards based on a matrix approach (final construct type, cell type, scaffold type, and atomic location/indication type) that can streamline the regulatory review of cell-scaffold products
- provide a knowledge base for developing a guidance document or white paper on cell-scaffold regenerative medicine therapy products
- contribute toward FDA’s overall efforts in facilitating the clinical development of these innovative regenerative medicine products in the U.S.
To gain broad experience within the scope of the project, the Regenerative Medicine Fellow will also participate in relevant CDRH activities through cross-center working group activities and work in CDRH with a mentor for 6-8 months.
Applicant Requirements: Ph.D. in biomedical engineering and/or biological sciences preferred. Hypothesis-driven research experience in studying or developing cell-scaffold constructs or tissue-engineered products is desirable. Hands-on experience in 3D bioprinting is a plus, but not required.