Regulatory Interests

The Cell Therapies Branch (CTB) is responsible for the regulatory review of the chemistry, manufacturing, and controls (CMC) information submitted to CBER/OTAT to support the safe use of investigational cellular therapies in human clinical trials. As a Team Leader in CTB, Carolyn Yong conducts 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. She is also engaged in both FDA and standards organization activities related to tissue engineered medical products. Prior to joining CBER/OCTGT in October of 2014, Carolyn was a Lead Scientific Reviewer in the Plastic and Reconstructive Surgery Devices Branches (PRSB) in the Division of Surgical Devices (DSD) in the Office of Device Evaluation (ODE) in the Center for Devices and Radiological Health (CDRH). Carolyn was previously a Commissioner’s Fellow (Class of 2012), where she conducted regulatory review work in both CBER/OCTGT and CDRH/ODE. Since joining OTAT, her inter-Center experiences have afforded her the opportunity to serve as a liaison between CBER and CDRH for biologic-device combination products, as well as provide mentorship and contribute to training programs related to medical device review for CBER staff.

Dr. Oh is Chief of Cell Therapies Branch (CTB) which regulates cell-based therapeutic products, tissue-engineered products, combination products, and point-of-care devices having therapeutic or regenerative indications. Dr. Oh provides leadership in reaching various regulatory decisions on medical products submitted to OTAT in CBER for marketing, clinical investigation, or product classification in the U.S. He is actively involved in the development of regulatory policies for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s) and cell-based combination products. He interacts closely with 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 in the manufacture and testing of cellular products and tissue-engineered medical products. In addition, Dr. Oh is engaged in various efforts promoting global regulatory convergence in cell-based therapeutic products.

Proposed Research Project for FDA Commissioner's Fellow

FDA Standards Activities in Regenerative Medicine: Enhancing Product Development and Regulatory Science Rotation through CDRH with ODE

Preceptor: Carolyn Yong, PhD
Co-Preceptor : Steven Oh, PhD

Standards development is an ongoing priority in FDA’s efforts to advance and promote product development in fields such as Regenerative Medicine (RM). The FDA staff acts as liaisons to Standards Development Organization (SDO) technical committees and participates in various standards working groups. In addition, FDA currently conducts standards-related research in its laboratory programs in collaboration with the National Institute of Standards and Technology (NIST). Although there have been numerous consensus standards developing activities by SDOs and other organizations for cell therapy (CT) and RM products, identifying a need for a specific standard is generally led by the industry and other stakeholders, and for this reason on-going standards development activities may not always reflect the actual needs of standards from the FDA perspective. The industry has started to coordinate their efforts through a number of approaches, e.g., Standards Coordinating Body (SCB), ISO Technical Committee 276 (Biotechnology). In light of these considerations, it is of significant importance that FDA provides input to the stakeholders with the identified needs of specific standards from the regulatory perspective through a systematic internal analysis of the technical gaps in CT and RM products.

A selected fellow will be working in CBER/OTAT and will participate in FDA activities related to standards including, but not limited to:

i. Working with FDA liaison(s) to understand the various SDO processes, participate in meetings and workshops, and support ongoing FDA efforts in established CT and RM-related standards and those in development,
ii. Internal (e.g., working with DCGT laboratory programs) and public data gathering and analysis to identify FDA’s needs for specific standards in the regenerative medicine space, particularly on cell-based products, other biologic products and single entity combination products, in collaboration with NIST
iii. Fellow will also have ample opportunities to work with CDRH Standards Staff to understand standards processes and review and provide comment, when applicable, on Work Item documents and ballots
iv. Working groups (WG), e.g., OTAT Standards WG, CBER-CDRH Intercenter focused working groups
v. Standards Coordinating Body (SCB) – Fellow will follow SCB development and priorities

The fellow will also have the opportunity to conduct review of regulatory submissions to FDA in both CBER and CDRH to gain (a) an understanding of the current use of standards in regulatory submissions, (b) gain insight into the limitations of currently employed methodologies for areas where standards are lacking, and (c) identify FDA needs for specific standards.

With the combination of these efforts, the fellow can provide valuable information on the current state of the SDO landscape as it relates to RM and will also be able to develop a set of recommendations for standards that could streamline the scientific review of RM products in FDA. Further, specific criteria may be developed for use by CBER/OTAT to systematically identify and prioritize the need for standards in the future. Together, this information would provide insight into FDA’s current and future role in RM standards development and contribute towards FDA’s continuing efforts to facilitate successful clinical development of these innovative regenerative medicine products in the U.S. and around the world.

Applicant Requirements

Ph.D. in biomedical engineering and/or biological sciences preferred; previous experience with standards, cell-based regenerative medicine and tissue-engineered products desirable, but not required.

Selected Recent Publications & Presentations

1. Yong C and Kaplan D. “Considerations for Tissue Engineered Medical Products (TEMPS): US FDA Regulatory Perspective” Cluster of Excellence REBIRTH, Hannover, Germany, September 2015.
2. Yong C. “Regulatory Considerations for Cell-Based Combination Product Development” 2016 Summer Biomechanics, Bioengineering and Biotransport Conference, National Harbor, MD June 2016.
3. Contributing author: “Hemostatic Medical Devices for Trauma Use” Discussion Paper for FDA Public Workshop – Hemostatic Medical Device for Trauma Use, September 2014.
4. Shields JD, Fleury ME, Yong C, et al. “Tumor cell homing to lymphatics is mediated by autologous chemotaxis” Cancer Cell 2007, 11(6), 526-538.
5. Lee MH, Arcidiacono JA, Bilek AM, Wille JJ, Hamill CA, Wonnacott KM, Wells MA, Oh SS. Considerations for Tissue-Engineered and Regenerative Medicine Product Development Prior to Clinical Trials in the United States. Tissue Eng Part B Rev. 2010, 16, 41-54.
6. Au P, Hursh DA, Lim A, Moos MC, Oh SS, Schneider BS, Witten CM. FDA Oversight of cell therapy clinical trials. Sci Transl Med 2012 Aug 29; 4(149):149fs31.
7. Oh SS. Regulatory Considerations for Cell-Based Combination Products. Phacilitate Cell & Gene Therapy Forum 2013, Washington, DC January 2013.
8. Oh SS. Manufacturing Cellular Products: US FDA Perspectives. 2014 APEC Harmonization Center–Health Sciences Authority: Cell- and Tissue-based Therapeutic Products Workshop, Singapore. July 2014.
9. Oh SS, FDA’s Perspectives on Cellular and Gene Therapy Regulation. International Regulatory Forum of Human Cell Therapy and Gene Therapy Products, Osaka, Japan. March 2016.
10. Oh SS. Tissue Engineering and Regenerative Medicine Initiatives across the FDA. TERMIS-AM Annual Conference, San Diego, CA. December 2016.