Mercedes A. Serabian, M.S., DABT
Chief, Pharmacology/Toxicology Branch (PTB)
Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT)
Office of Cellular, Tissue, and Gene Therapies(OCTGT)
Center for Biologics Evaluation and Research (CBER)
1401 Rockville Pike, HFM-760
Rockville, MD 20852
- B.S. (Biochemistry & Biology) Virginia Polytechnic Institute and State University
- M.S. (Toxicology) The American University
- DABT - Diplomate, American Board of Toxicology
- 1993-2002 – Toxicologist; FDA/CBER/OTRR
- 2002-Present – Branch Chief; FDA/CBER/OCTGT/DCEPT/PTB
Ms. Serabian is Chief of the Pharmacology / Toxicology Branch of CBER/OCTGT and would serve as Preceptor for this fellowship. As Branch Chief, she is responsible for overseeing the preclinical review, regulation, and policy development for all cell therapy, gene therapy, and tissue-engineered products regulated by CBER/OCTGT. She leads an experienced group of personnel with postdoctoral training in pharmacology, toxicology, biochemistry, biology, immunology, and biomedical engineering. The Branch is responsible for the regulatory review of all preclinical studies submitted to OCTGT to support the safe use of an investigational product in human trials. Ms. Serabian co-founded the CBER Pharmacology / Toxicology Working Group to facilitate interactions among CBER pharmacology/toxicology staff, and to promote discussions of scientific and regulatory issues regarding products (including preventive vaccines, blood products, and cellular and gene therapies) regulated by CBER. She also serves as a CBER representative to various committees within FDA, as well as national and international working groups; and initiated a series of interactions between CBER pharmacology/toxicology staff and members of the Special Biologics Expert Working Group of the Biotechnology Industry Organization (BIO), to discuss the preclinical testing of CBER-regulated biologics. In addition, she oversees the participation of reviewers in her Branch at intracenter, intercenter, interagency, national, and international meetings, workshops, and symposiums associated with cell therapy, gene therapy, and tissue-engineered products. Under her leadership, the draft guidance entitled, Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products was released in November 2012. She has served as a Preceptor in the Regenerative Medicine Fellowship Program and currently is a Preceptor in CBER.
Proposed Regulatory Research Project for two FDA Commissioner's Fellows:
- The Regenerative Medicine Program in the Commissioner’s Fellowship Program is cross-center collaboration between the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH). The RM Fellows will be mentored by Preceptors in both the CDRH and CBER.
Regenerative medicine products have the potential to repair, replace, restore, or regenerate diseased tissues. Although these products hold promise for the treatment of a wide variety of human disorders, they may also raise some safety concerns. Among these concerns is the risk of an adverse immune response to the administered product. Such responses may vary from mild infusion reactions to life-threatening events that preclude further development of the product.
The Fellows will investigate the potential of regenerative medicine products to elicit an immunogenic response following in vivo administration. This investigation will focus on review of data in regulatory submissions to identify regenerative medicine product classes at higher risk for immunogenic response. As part of this review, the Fellows will summarize the current testing approach for evaluation of immunogenic potential. In addition, the Fellows will review the scientific literature to identity and evaluate current methods for immunogenicity testing. An important outcome of the project will be the development of a strategy to enhance the evaluation of the immunogenic potential of regenerative medicine products, with the ultimate goal of mitigating this concern.
Regenerative medicine is a dynamic and exciting field that provides hope of restoring, regenerating, repairing, or replacing missing or damaged tissues. The potential medical applications are numerous and varied. Many regenerative medicine products are complex, in that tissue engineering can involve biologic and device combinations, for example, 3-dimensional, cell-scaffold configurations. These novel products represent the confluence of clinical medicine, engineering, and basic science. The Regenerative Medicine (RM) Program is intended to extend and enhance the ability of FDA to effectively regulate regenerative medicine products and to permit the agency to proactively participate in product development, so that safe and effective new products can become available to patients.
If you would like to apply to the program, please list Mercedes Serabian on your application. The selected RM Fellow will be trained and will participate in biologic and device regulation in both Centers and benefit from the mentoring of senior regulatory scientists from the two Centers. In addition, the RM Fellow will:
- Participate in and learn the review processes in both CBER and CDRH;
- Participate in FDA working groups such as the cross-center tissue engineering working groups;
- Provide scientific direction for Regenerative Medicine Seminar series;
- Have the potential to perform outreach activities such as writing articles for publication or presenting at public workshops;
- Have exposure to activities such as standards development and collaborations with external organizations (i.e. Multi-agency Tissue Engineering Science Interagency Working Group).
In addition to regulatory work, the RM Fellow will have the opportunity to develop a unique project under the guidance of the Preceptors listed below. The project is aimed at assessing current challenges or needs in the field of regenerative medicine, identifying and organizing the relevant applicable resources, and proposing potential solutions. The project outcomes will enhance the clinical development of regenerative medicine products and increase collaboration among CBER, CDRH, and the regulated community.
Ph.D. in biomedical science and experience in regenerative medicine are required; knowledge of immunology is recommended.
Selected Recent Publications and Presentations:
Serabian, M.A. and Y. Huang. ‘Gene Therapy Products’; in Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials, J. Cavagnaro (editor), John Wiley & Sons, Inc. 2008.
Fink DW, S.R. Bauer, P. Au, C.C. Haudenschild, M.H. Lee, B.K. McCright. “Regulatory Considerations of Stem/Progenitor Cell-Based Products: US Food and Drug Administration” In: Progenitor and Stem Cell Technologies and Therapies. A. Atala (editor), Woodhead Publishing. 2012.
Au, P., DA .Hursh, A. Lim, MC. Moos Jr., SS. Oh, BS. Schneider, CM. Witten. FDA Oversight of Cell Therapy Clinical Trials. Sci. Transl. Med. 4:149:149fs31. 2012.
M. Serabian; “IND-Enabling Studies: Preclinical Perspective”; 11th Annual Gene Therapy Symposium for Heart, Lung, and Blood Diseases; Sonoma, CA; 11/16/12.
M. Serabian; “Preclinical Considerations for Cell and Gene Therapy Products: CBER Perspective”; American College of Toxicology (ACT) Annual Meeting; Championsgate, FL; 11/07/12.
M. Serabian; “Preclinical Studies to Support Clinical Applications of Gene Therapy Products”; NIH – Gene Transfer and Rare Diseases Workshop; Rockville, MD; 9/13/12.
P. Au; “Understanding FDA/CBER Expectations for Preclinical Studies”; NIH-FDA Workshop: Pluripotent Stem Cells in Translation: Preclinical Considerations; Bethesda, MD; 7/11/12.
P. Au; “Preclinical Considerations for Imaging Technology for Cell Therapy Products”; CIRM [California Institute for Regenerative Medicine] Webinar: Imaging Technology for Cellular Therapies; 5/26/11.
M. Serabian; “Preclinical Considerations for Stem Cell-Based Therapies: CBER Perspective”; CIRM [California Institute for Regenerative Medicine] Webinar: Preclinical Animal Model Considerations for Stem Cell Therapies; 9/28/10.
Division of Small Manufacturers, International, and Consumer Assistance
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
U.S. Food and Drug Administration
- B.S. Electrical Engineering, University of Maryland at College Park
- U.S. Food and Drug Administration, 1994-present
- 1994-2001 – Electrical Engineer, Gastroenterology/Renal Devices Branch, CDRH/ODE
- 2001-2009 – Branch Chief, Cardiac Electrophysiology/Monitoring Devices, CDRH/ODE/DCD
- 2009-2011 – Policy Analyst, Office of Device Evaluation, CDRH
- 2011-present – Director, Division of Small Manufacturers, International, and Consumer Assistance, CDRH/OCER
Mr. Mallis currently serves as Director of Small Manufactures, International, and Consumer Assistance in the Center for Devices and Radiological Health. In this role, Mr. Mallis the strategic educational and advisory programs to help industry, consumer, and government stakeholders of medical devices and radiation programs to fully comprehend the policies, regulations and programs that impact them. In his first 16 years at FDA in CDRH’s Office of Device Evaluation, Mr. Mallis was responsible for the regulatory review and scientific evaluation of a variety of medical devices, which spanned the disciplines of gastroenterology, extracorporeal therapeutics, obstetrics/gynecology, cardiac diagnostic implants, and cardiac therapeutics, including novel combination products involving biologics, devices, and drugs. Mr. Mallis has previously served as a preceptor for the Regenerative Medicine Program.
Aric D. Kaiser, M.S.
Expert Biomedical Engineer
US Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
Division of Orthopaedic Devices
- B.S., Biomedical Engineering, Case Western Reserve University, 1985
- M.S., Mechanical Engineering, University of Cincinnati, 1987
- FDA experience – since 1994
Aric Kaiser, an expert biomedical engineer with experience in tissue mechanics and mechanical testing, has regulatory and scientific interests in the design and evaluation of products intended to treat orthopedic disorders. Of particular interest are tissue-engineered medical products (combination products) and devices intended to serve as functional replacements for the diseased or damaged tissue, e.g., products intended to repair/regrow damaged cartilage with functional tissue rather than implantation of synthetic materials as in total joint replacements. Recent work has focused on bone void fillers containing calcium salts, collagen and/or recombinant human proteins or synthetic peptides.
Proposed Regulatory Research Project for the FDA Commissioner's Fellow:
The Division of Orthopaedic Devices has seen an increase in the number of applications for bone void fillers used in a variety of orthopedic applications over the last several years. The complexity of these fillers, particularly those incorporating recombinant human proteins/synthetic peptides or modified manufacturing methods, would be enhanced by a review and production of a “lessons learned” and/or minimum non-clinical evaluation document based on recent applications. An example would be identification of the evaluations necessary to differentiate devices that have identical chemistry, e.g., calcium phosphate, but different final characteristics, e.g., surface topography or surface charge. In addition to these types of general documents, a guidance document describing the requirements for submissions investigating fracture healing would also be very useful to agency staff and industry.
The fellow would also participate in reviews of pre-IDEs, IDEs, 510(k)s and PMAs on these products and interact with staff from other review groups for products with dental and orthopedic uses, from OSB concerning post-market issues, as well as staff from CDER, CBER and CVM concerning pre- and post-market issues associated with these products.
FDA Fellows participating in this program will learn the basic science, regulatory science and review processes associated with the regulation of bone void fillers (with and without recombinant human proteins or synthetic peptides.) The project will include an evaluation of past applications and clearances/approvals to look for commonly resolved issues, tests and clinical study design in order to provide background for new guidance documents or other internal/external communications within FDA and with industry.
The applicant should have a Ph.D. or M.S. (with at least 3 years of research experience) in an appropriate engineering (biomedical, chemical, materials or mechanical) or scientific discipline with experience in bone biology/chemistry, tissue engineering, regenerative medicine and non-clinical testing of biological materials.
Selected Recent Publications/Presentations:
Kaiser, AD, McFarland, RD, Dawisha, SM and Leibenhaut, S: Points to Consider in the Design of Nonclinical and Clinical Evaluations of Products Intended to Repair or Replace Articular Cartilage, FDA Science Forum, April 27-28, 2005.
Kaiser, AD: Science-based Testing for Combination Devices, Proceedings from the Workshop on Science-Based Assessment – Accelerating Product development of Combination Medical Devices, Bonnie A. Scarborough, ed., The National Academies Press, 2004.
Jean, RP, Hill, GA, Kaiser, AD, Buch, BD: Hot Topics in Regulatory Science: FDA's Impact on Orthopaedic Surgeons and Their Patients, 75th Ann AAOS, 2009.
Kaiser, AD (2011) Biologics | Combination Products Are Not Solely Biological Products, Drugs, or Devices: A Regulatory Perspective. In: Moo-Young M, (ed.) Comprehensive Biotechnology, Second Edition, vol. 3, pp. 399-409. Elsevier.
Guidance document - Preparation of IDEs and INDs for Products Intended to Repair or Replace Articular Cartilage, December, 2011.
“Overview of the History of FDA Regulation of Devices Made from Bone”, FDA Open Public Meeting on: Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair, August 2, 2000.
“Medical Device Regulations—From Research to Marketing: Regulation of Bone Graft Substitutes.” Biomedical Engineering Society Annual Meeting, September 28, 2005.
"Combination Products That Include Biologics - Novel Combinations Require Novel Assessments", WCBP 2008, 12th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products, January 30, 2008.
“Orthopaedic product regulatory process today and tomorrow: The inside perspective”, Orthopaedic Research Society Annual Meeting, February 7, 2012.