Senior Consultant, Biologics Consulting Group, Inc.
Glen Burnie, MD

Expert Biologist/Product Reviewer, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation, U.S. Food and Drug Administration, Rockville, MD.

Biologist/Product Reviewer, Cell Therapy Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation, U.S. Food and Drug Administration, Rockville, MD

Biologist/Product Reviewer, Div. of Cell and Gene Therapy, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD.

• FDA expert on the characterization, manufacture, and control of novel biological products in the area of hematopoietic stem cells, umbilical cord/placental blood, cancer immunotherapy, and other cell-based therapies.
  
• Primary reviewer of over 50 active cell therapy IND, IDE, DMF files in such areas as treatments for cardiac disease, therapy for autoimmune diseases, hematopoietic stem cell transplantation, cord blood banking, and cancer immunotherapy.
  
• Provided consultation services to other centers for review of submissions of combination products containing cellular elements.
  
• Served as agency spokesperson to regulated industry and academia on issues related to hematopoietic progenitor cell products.
  
• Participated in planning and presentation of Advisory Committee meetings.
  
• Co-chaired the Cord Blood Standards subgroup of CBER Hematopoietic Stem Cell Task Group whose purpose is to develop regulatory policy for cord blood stem cells.
  
• Co-chaired FDA-CBER/NIH-NHLBI Cell Therapy Working Group for interagency discussions of regulatory and other issues regarding cell-based therapies for heart, lung and blood diseases.
  
• FDA Liaison to DHHS Interagency Working Group for Cellular Therapies
  
• Member of CBER Rapid Microbiological Methods Working Group charged with developing policy and guidance for implementation of new methods for assessing sterility of biologic products
  
• Branch representative to CBER/CDRH Cardiovascular Product Cross-Center Team whose mission is to identify and prioritize key issues for the cardiovascular cellular product area.
  
• Member of FDA Xenotransplantation IND Reviewer Focus Group, FDA Tumor Vaccine Working Group and OCTGT Comparability Working Group.
  
• FDA liaison to AABB Cellular Therapies Standards Program Unit and Cellular Therapy Certificate Program Development Subcommittee for development of standards for somatic cell therapy and cord blood products.
  
• Interacted with sponsors early in product development to facilitate the progression of clinical trials by identifying problematic areas in product safety, characterization and manufacturing.
  
• Interacted with industry, other federal and international agencies, and with other FDA reviewers to provide time-critical guidance on scientific and regulatory issues involving novel cellular therapies
  
• Developed and facilitated implementation of a tiered, risk-based approach to endotoxin release testing requirements for cellular products. Currently working on this approach for other cell therapy release testing.
  

Clinical Services Coordinator, Cell Processing Section, Department of Transfusion Medicine (DTM), National Institutes of Health, Bethesda, MD.

• Chief liaison between the Cell Processing Section and patient care personnel for coordination and management of cell processing services for stem cell transplantation
  
  • Developed and implemented processes and procedures for meeting the diverse requirements of more than 30 active investigational protocols, including donor/patient testing, cell collection, cell processing and cell administration.
    
  • Chair of the Inter-institute Cell Transplant Coordination Committee formed to facilitate communication, education and resource sharing among the various NIH transplantation and cellular therapy programs. Designed and implemented education and training materials and programs for Department and Institute patient care staff.
    
  • Consultant to investigators and patient care staff on Cell Processing Section policies and procedures, professional standards, and regulatory requirements
    
  • Primary liaison for data management between Cell Processing Section and Institutes.
    
  • Designed, tested and implemented organizational tools that supported and maximized efficient and appropriate use of departmental resources for clinical trials.
    
  • Participated in development, review and implementation of clinical research protocols and in planning of laboratory services to support those protocols.
    
• Project manager for selected research and development projects performed in collaboration with Institute investigators and/or biotechnology companies. Some examples are:
  
• Umbilical cord blood banking for siblings of sickle cell patients
  
• Evaluation of new automated cell selection systems
  
• Culture, expansion and manipulation of hematopoietic and other human cells
  
• Evaluation of novel assays for quality assessment of cellular therapy products
  
  • Actively participated in design of investigational studies.
    
  • Designed and supervised laboratory experiments and validation studies to support clinical trials.

Laboratory Manager, Pediatric Cancer and Stem Cell Research Program & Children's Cancer Group(CCG) Central Hematopoiesis Laboratory, Georgetown University Medical Center, Washington, DC.

• Directed overall operation of the Pediatric Cancer and Stem Cell Research Program and CCG Central Hematopoiesis Laboratory (housed at Georgetown University).
  
  • Participated in grant preparation and research and translational protocol development. Reviewed proposed protocols for accuracy and feasibility.
    
  • Developed personnel, supply and equipment budgets for research protocols.
    
  • Developed and implemented databases and spreadsheets for tracking and evaluating research data.
    
  • Provided technical and regulatory guidance to laboratory investigators.
    
  • Supervised flow cytometry and progenitor cell analysis, analyzed data and prepared laboratory and administrative reports for the CCG Central Hematopoiesis Laboratory.

Laboratory Manager, Georgetown University/NHLBI (COBLT) Cord Blood Bank, Georgetown University Medical Center, Washington, DC.

• Technical expert on steering committee responsible for designing, developing and implementing the NHLBI-funded Georgetown University Medical Center Cord Blood Bank
  
• Responsible for development of laboratory budget, design of laboratory space, selection of equipment, hiring and training cord blood bank laboratory staff and writing the laboratory standard operating procedures.
  
• Responsible for oversight of preparation, testing, cryopreservation, storage and shipping of cord blood units.
  
• Developed and implemented quality assurance program, including computer database that facilitated monitoring of collection and processing of cord blood units, proficiency and competency evaluation of laboratory staff and validation of laboratory processes.
  
• Responsible for supply purchases and budget management.
  
• Responsible for personnel management, including interviewing, hiring, scheduling, coaching, counseling, evaluating and terminating employees.
  
• Responsible for final review of cord blood records and release of units from quarantine.
  
• Coordinated proficiency workshops for laboratories performing COBLT flow cytometry testing.

Supervisor/Technical Specialist, Cellular Engineering/Molecular and Cellular Hematotherapy Laboratory, Georgetown University Medical Center, Washington, DC.

• Developed a laboratory support system providing cell processing services for autologous and allogeneic patients receiving bone marrow, peripheral blood stem cell and cord blood transplants.
  
• Provided oversight and coordination all Cell Processing activities including processing, culture, expansion, cryopreservation, testing and graft evaluation of bone marrow, peripheral blood stem cells and cord blood for large inpatient and outpatient transplant program.
  
• Coordinated bone marrow harvests and shipments with the donor coordinators of the National Marrow Donor Program. Georgetown University Medical Center was the largest bone marrow collection center for the NMDP.
  
• Collaborated with internal and external investigators on laboratory and clinical research protocols, including submission of Investigational New Drug applications to the FDA.
  
• Designed and implemented databases for management of clinical and research data.
  
• Developed, validated and implemented new laboratory techniques for ex vivo cellular therapy and for graft evaluation.
  
• Responsible for writing Standard Operating Procedures for the and Molecular and Cellular Hematotherapy (formerly Cellular Engineering) Laboratory and the Georgetown University Hospital Apheresis Center.
  
• Designed and managed research and development projects involving cell therapy and graft engineering.
  
• Collaborated with clinical and laboratory scientists as well as biotechnology companies to develop new techniques for cellular processing, hematotherapy and immunotherapy
  
• Provided translational laboratory support and assisted researchers in scaling up bench top experiments
  
• Developed and supervised program for external investigators and technologists to receive hands-on training in basic cell processing techniques
  
• Designed and implemented numerous innovative processes now in common use, including:
  
  • Automated procedure for concentration and purification of bone marrow mononuclear cells
    
  • Procedure for large-scale ex vivo activation of frozen/thawed bone marrow and peripheral blood stem cells with interleukin-2
    
  • System for predicting hematopoietic progenitor cell content of peripheral blood stem cell collections based on circulating peripheral blood CD34+ cells.
    
  • Real-time flow cytometric analysis of PBSC collections to optimize progenitor cell yield and minimize number and length of collections
    
  • Use of synthetic plasma substitutes to replace tissue culture media for bone marrow collection
    
• Responsible for directed donor cord blood banking program.
  
• Successfully prepared the Laboratory for inspections by the AABB, College of American Pathologists, FDA and FAHCT (now FACT).
  
• Supervised the quality assurance and preventive maintenance programs.
  

HONORS AND AWARDS:

PROFESSIONAL SOCIETIES
American Association of Blood Banks
American Society of Clinical Pathologists
International Society for Cell Therapy

PUBLIC SERVICE

• Editorial Board - Cytotherapy
  
• Reviewer: Transfusion, Bone Marrow Transplantation
  
• Abstract Reviewer: AABB Annual Meeting (2003-2005)
  
• Independent Reviewer: Institute of Medicine Study Report: "From Discord to Accord: Establishing a National Cord Blood Stem Cell Bank Program" (2005)
  
• Board of Directors: International Society for Hematotherapy and Graft Engineering (ISHAGE) (1992-1995)
  
• NIH NHLBI Special Emphasis Panel: Therapy Groups to Study T Cell Depletion in Unrelated Donor Marrow Transplantation (1993)

ADDITIONAL TRAINING

• Inspection Training for Product Specialists (10/04)
  
• CDER Pre-Market Review for CDRH and CBER Reviewers (10/04)
  
• CDRH Standards Liaison Training (8/04)
  
• CBER/CDRH Reviewer Best Practices (6/04)
  
• FDA-DIA Workshop (5/04)
  
• Ethical and Regulatory Aspects of Human Subjects Research (12/03)
  
• Security Awareness (11/03)
  
• CBER/CDER Joint PDUFA III Training (10/03)
  
• Endotoxin - Biology, Testing and Device Issues (9/03)
  
• FDA Ethics Training (9/03)
  
• CBER Medical Device Training (7/03)
  
• Economic Espionage Awareness (6/03)
  
• Introduction to Nanotechnology (5/03)
  
• Basic Food and Drug Law Course (5/03)
  
• Combination Products Training Course (4/03)
  
• MDUFMA Performance Goals (12/02)
  
• CBER Case Study Seminar Series: Specifications, Stability and Statistics (11/02)
  
• Reviewer Training Program (4/02)
  
• Common Technical Document Overview Training (1/02)
  CBER Education Forum: Assay Validation Case Study (11/01)
  

BIBLIOGRAPHY

BOOKS

Areman EM, Sacher RA, Deeg HJ (eds). Bone Marrow and Stem Cell processing: a Manual of Current Techniques. F.A. Davis, Philadelphia PA, 1992.