Public Workshop: Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products Speaker Biographies
Michael D. Strong, PhD graduated from Gonzaga University in Spokane, WA and received his PhD from The Medical College of Wisconsin, Milwaukee. He served 20 years in the Navy where he was involved in transplantation, tissue and blood banking He retired in 2007 as COO at the Puget Sound Blood Center where he founded the Northwest Tissue Center in 1988. He has served on Advisory Committees for FDA, NIH, IAEA, Canadian Blood Systems and HemaQuebec and has lectured around the world. He is the recipient of the DeGowin Lectureship in Blood Banking from the University of Iowa, the Distinguished Lectureship Award from the South Texas Blood and Tissue Bank and five lifetime achievement awards including: from AATB, ABC, APASTB, AABB and UBS. He has served as a consultant for CDC, the IAEA, the WHO and Canadian Blood Services. He is Past President of AABB and past Chair of the AABB U.S. Biovigilance Network Steering Committee. He is currently coordinating the WHO Project NOTIFY.
Bob Bollinger, MD, MPH is Founding Director of the Center for Clinical Global Health Education (CCGHE) and Professor of Infectious Diseases at the Johns Hopkins University (JHU) School of Medicine. He holds joint appointments in international health at the Johns Hopkins (JH) Bloomberg School of Public Health, and in community public health at the JH School of Nursing. He is Associate Director for Medicine of the JH Center for Global Health, Director of the JHU Fogarty India Program, and course instructor for the Global Health Intersession Course for JH medical students, which links medical students and faculty around the globe, and Director of the newly formed IMEC-JHU Partnership to advance applications in healthcare, combining JH clinical and research expertise with IMEC nanoelectronic capabilities. He is board certified by the American Board of Internal Medicine in internal medicine and infectious diseases.
Dr. Bollinger has more than 35 years of experience in international public health, clinical research, and education dealing with such global health priorities as HIV/AIDS, malaria, tuberculosis, leprosy, dengue, antibiotic resistant infections and other emerging diseases. His research interests include identifying biological and behavioral risk factors for HIV transmission; characterizing the clinical progression and treatment of HIV and related infections; and implementing science research projects to optimize healthcare capacity and delivery in resource-limited settings. He has been invited to participate in public health training programs and expert committees, and has been consulted for his expertise by more than 15 countries. He served as a member of the US Presidential Advisory Council for HIV/AIDS (PACHA), and a member of the PACHA International Sub-committee, and is a current member of the Institute of Medicine Forum on Public-Private Partnerships for Global Health and Safety. Working with partners in more than 20 countries, Dr. Bollinger and CCGHE faculty pioneered the use of distance learning and the development of their award-winning mobile health platform (emocha®) in resource-limited settings (www.emocha.com).
Dr. Bollinger is committed to improving the health of people living in resource-limited nations through clinical research, education, and leadership training. He established and has sustained programs in countries throughout Africa, South and Central America, Southeast Asia, and the Middle East. He currently leads the JHU team providing technical support to the Medical Education Partnership Initiative (MEPI) in Uganda, where he has worked for more than 15 years. In 1991, he initiated an ongoing, NIH-funded Indo-US HIV research program in Pune, India, involving the National AIDS Research Institute/ICMR and the BJ Medical College. He has served as Principal Investigator for many NIH-supported studies and clinical trials in Pune, including the SWEN study, which changed World Health Organization (WHO) guidelines for treatment of infants born to HIV/positive mothers to prevent mother-to-child transmission. Under his leadership of the Hopkins Fogarty International Program, short-term and degree training has been provided to more than 100 visiting scientists at JHU, and in-country training has been provided to more than 2000 Indian scientists. His commitment to clinician education has been honored with the Johns Hopkins Department of Medicine David M. Levine Excellence in Mentoring Award.
Dr. Bollinger is author of more than 175 peer-reviewed research publications and 15 book chapters, including the first and largest studies of risk factors for HIV transmission in India, the cloning and sequencing of the first HIV viruses from India, the only studies characterizing the primary immune response to HIV in India, and the demonstration of increased risk of HIV acquisition with recent HSV infection and lack of circumcision.
Dr. Bollinger received an undergraduate degree from Haverford College, a Doctor of Medicine from Dartmouth Medical School, and a Master of Public Health from JH Bloomberg School of Public Health. He completed his internal medicine training at the University of Maryland Medical Systems, followed by a post-doctoral fellowship in infectious diseases at JHU School of Medicine.
Mark S. Roberts, MD, MPP is a practicing internist and Professor and Chair of the Department of Health Policy and Management at the University of Pittsburgh Graduate School of Public Health and is professor of Medicine, Industrial Engineering and Clinical and Translational Science. He is also director of the Public Health Dynamics Laboratory, a mathematical modeling group in the Graduate School of Public Health. He obtained his BA in Economics from Harvard College, an MD from Tufts University, and a Master’s in Public Policy from the Kennedy School. He completed his clinical training at the Harvard Medical School, where he was a resident and fellow in general medicine.
With expertise in cost effectiveness analysis, decision analysis, mathematical optimization, simulation and health policy, he has conducted research in application of these methods to health care decisions and the delivery of care for the past 25 years. He has published over 160 peer-reviewed papers, and been funded on over 40 federally funded grants. He has examined clinical, cost, policy and allocation questions in liver transplantation, the treatment of HIV disease, hepatitis C, vaccination strategies, operative interventions, and the use of many medications. He has held leadership roles of several societies, served on multiple NIH review panels, was an associate editor of Medical Decision Making, and was that societies’ president in 2009. In 2014 he was awarded that Society for Medical Decision Making’s Lifetime Achievement Award for his contributions to decision sciences. He recently was the Chair of the “Conceptual Modeling Working Group” of the joint International Society for Pharmacoeconomics and Outcomes Research/Society for Medical Decision Making Best Modeling Practices task force, which recently published a 6-paper series of recommendations on modeling methodology.
Donald J. Brambilla PhD is a Senior Research Statistician at RTI International with over 30 years of experience in epidemiological investigations and clinical trials. His background includes numerous studies in transfusion medicine and the risk of transfusion transmission of various diseases, as well as extensive work on the development and characterization of the assays used to protect the blood supply. He was the PI for the Data Coordinating Center (DCC) for STOP and STOP II, two clinical trials of transfusion to prevent stroke in children with sickle cell anemia. Since 2011, he has been the PI for the DCC for the NHLBI-funded Recipient Epidemiology and Donor Evaluation Study - III (REDS-III). In this role, he has collaborated on numerous studies of blood donation, transfusion and the safety of the blood supply, such as a study of the risk of transfusion transmission of dengue fever in Rio de Janeiro during an epidemic in 2012. He is currently engaged in studies of the risk of transfusion transmission of Zika, Chikungunya and dengue fever in Brazil, as well as a study of the risk of transfusion transmission of Zika in the US. Through his work on REDS-III, Dr. Brambilla has gained considerable expertise in methods for estimating prevalence and incidence of infection in blood donors. He recently completed a study to evaluate seven methods for estimating disease incidence in repeat blood donors (Brambilla et al. Transfusion 2017). He has conducted similar studies to evaluate methods for estimating infection incidence in first time donors using the new Limiting Antigen (LAg)-Avidity EIA, which separates recent infections from less recent infections, and for evaluating prevalence estimates in first time and repeat donors.
Dr. Brambilla is very familiar with the assays used to detect and quantify HIV, HCV and other infectious agents in blood and other tissues. Since 1993, he has been a senior statistician for the NIAID-sponsored Virology Quality Assurance (VQA) Program. This program provides proficiency testing for laboratories conducting virologic assays in NIH-sponsored clinical trials and other studies of HIV and assistance with the development and characterization of new assays for use in these studies. Dr. Brambilla has designed and continues to analyze data from proficiency testing programs assay and characterization studies for the types of tests used for screening blood donations, including nucleic acid tests (PCR, RT-PCR, TMA, NASBA, etc.) and serologic tests by ELISA. He has collaborated in the design and execution of studies to evaluate HIV RNA assays when applied to fluids other than blood, such as saliva, semen and vaginal fluids. He has also participated in studies to characterize and compare other assays, such as culture-based assays (quantitative and qualitative HIV culture, neutralizing antibody assays and phenotypic drug resistance assays for HIV and CMV); ELISA assays for HIV p24 antigen; HIV gene sequencing; radioimmunoassays, chemiluminescent immunoassays, GC-MS, flow cytometry, and measures of cellular activity or inhibition.
Ted Eastlund, MD has 32 years of medical, administrative and executive experience in the recruitment, donation, procurement, processing, storage and use of blood transfusions, tissue allografts, organs, hematopoietic stem cells, and semen. After specialty training in internal medicine and hematology, he worked fulltime with the American Red Cross Blood and Tissue Services and the University of Minnesota Medical School. In the early 1990s, he was National Medical Director of the National American Red Cross Tissue Services and introduced good manufacturing practices into its standards.
In the early 1990s, he initiated the adoption of hospital tissue handling standards by The Joint Commission of the Accreditation of Hospitals, AATB, College of American Pathologists and the American Association of Blood Banks.
He served the American Association of Tissue Banks (AATB) as its Vice President, President and Board member and chaired and served on several committees. In the early 1990s he testified before congress on the need for federal regulation of tissue banks. After the 2001 death of a 19 yr old from Clostridium sepsis due to a contaminated cartilage allograft, he led an AATB Sentinel Task Force that discovered other disease transmission cases and led to strengthened AATB standards. He received AATB’s Kenneth W. Sell Distinguished Service Award in 2004.
He has served on the FDA Blood Products Advisory Committee representing the tissue banking profession.. He has lectured on tissue banking in 21 foreign countries and trained visiting tissue bank directors. On invitation in 1996 and 97, he evaluated tissue banking activities in Ireland and Viet Nam and made recommendations about a national approach to tissue banking.
48 of Dr Eastlund’s 102 published scientific articles, chapters and books and 33 of his 99 published abstracts, are about tissue banking topics. For over 25 years disease transmission through blood and tissues has been his main professional interest.
Marian S. Macsai, MD is the chief of the Division of Ophthalmology for NorthShore University HealthSystem and professor of ophthalmology at the University of Chicago Pritzker School of Medicine. She is the President of the Cornea Society. She is past chair of the Eye Bank Association of America and has been active in eyebanking at the national level for over 20 years.
Dr. Macsai is a board-certified ophthalmologist with fellowship training in cornea and refractive surgery. Her areas of specialties include corneal transplants, refractive surgery, cataracts, as well as medical and surgical treatment of diseases of the external eye. Dr. Macsai is a member of the American Ophthalmologic Society with thesis, and president of the Cornea Society.
Dr. Macsai is nationally recognized as an expert in the fields of corneal surgery and eyebanking and has served on the Food and Drug Administration Ophthalmic Devices Panel as a full member and consultant since 1994. She serves on the executive editorial board of the journal Cornea, and recently edited the textbooks series Rapid Diagnosis in Ophthalmology and Ophthalmic Microsurgical Suturing Techniques.
John P. Miller, MD, PhD is Vice President and Senior Medical Director of Medical, Quality and Regulatory Services at the National Donor Marrow Program/Be The Match and a Scientific Director for the Center for International Blood and Marrow Transplant Research (CIBMTR).
Dr. Miller received his bachelor’s degree in chemistry from Dartmouth College, and his MD and PhD (Biomedical Sciences/Pharmacology) degrees from the University of Connecticut School of Medicine. He completed his residency in Clinical Pathology and fellowship in Blood Banking/Transfusion Medicine at the University of Virginia. His interests include cellular therapy, adult and cord blood hematopoietic cell donation and transplantation, transfusion medicine, apheresis and quality and regulatory compliance.
Deborah J. Anderson, PhD, is a Professor in the Departments of Obstetrics and Gynecology, Microbiology and Medicine at Boston University School of Medicine. She has conducted research on various aspects of genital tract immunity and HIV transmission for over 30 years and has published over 250 scientific articles. She studied pregnancy immunology for her Ph.D., and the role of antisperm antibodies in infertility at the Oregon Regional Primate Research Center and immunogenetics of gametes at Harvard Medical School (HMS) during postdoctoral fellowships. In 1984 she joined the faculty of the Laboratory for Human Reproduction and Reproductive Biology at Harvard Medical School, where she participated in their NIH-funded Contraceptive Research Development Center and conducted research on contraceptive methods including anti-fertility vaccines. She served on the WHO Task Force for Fertility Vaccines from 1985-1990, and on the scientific advisory committees for Family Health International and the American Foundation for AIDS Research. She was the director of the Fearing Laboratory in the Department of Ob/Gyn at the Brigham and Women’s Hospital, HMS, from 1985-2005, where she conducted research in the area of infertility and started a research program on the sexual transmission of HIV. Her laboratory pioneered research on separation of HIV from sperm for use in Assisted Reproductive Technology clinics. For the past five years she has been working on a vaginal microbicide that uses a cocktail of monoclonal antibodies for contraception and the prevention of sexually transmitted infections.
Brychan Clark, MD graduated from the University of Miami, School of Medicine in 1999. She completed an internship in both Anatomic and Clinical Pathology and Internal Medicine at the University of Florida, College of Medicine, in Gainesville, FL. While serving on active duty with the United States Air Force, she completed her residency in Internal Medicine and a fellowship in Infectious Diseases at the San Antonio Uniformed Services Health Education Consortium, with training at Wilford Hall Medical Center, Lackland Air Force Base, Texas, Brooke Army Medical Center, Ft. Sam Houston, Texas, and the University of Texas Health Science Center, San Antonio, Texas. After retiring from the United States Air Force in the rank of Lieutenant Colonel in 2015, Dr. Clark then joined the FDA as a Medical Officer in the Division of Human Tissues, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research (CBER).
Michelle McClure, PhD a biologist at the FDA. In 2003, she began working at a tissue establishment as a processor of cardiovascular and orthopedic tissues. After five years of working as a technician and a team leader, Dr. McClure decided to leave the field to attend graduate school at the University of Alabama at Birmingham. Her research focused on investigating novel molecular pathways that serve as potential therapeutic targets for the treatment of Cystic Fibrosis. In 2013, she was awarded a Ph.D. in Biomedical Sciences through the Department of Genetics. She now works at the FDA in the Office of Tissues and Advanced Therapies, formerly known as Office of Cellular, Tissue, and Gene Therapies, in the Division of Human Tissues and serves as the FDA liaison to several organizations and working groups.
David J. Gocke, MD is a graduate of the University of Pennsylvania School of Medicine, trained in Internal Medicine at the Columbia-Presbyterian Hospital in New York City, in Infectious Diseases at Johns Hopkins, and in Allergy/Immunology at the National Institutes of Health. He was on the faculty at the Columbia University School of Medicine and at the Rutgers Robert Wood Johnson School of Medicine for many years where he served as Chief of Medicine and Chief of the Division of Infectious Diseases. He has a record of extensive research in viral hepatitis and HIV disease, and was Principle Investigator and Director of the AIDS Clinical Trials Unit and AIDS service at Robert Wood Johnson. He has been a Consultant and Medical Director at the Musculoskeletal Transplant Foundation since 1989 where he has reviewed 10s of thousands of donor records and participated in the remarkable evolution of tissue banking over the last 15 years. At MTF in addition to donor review he is responsible for development and maintenance of medical standards, evaluation of adverse event reports, and advice on regulatory issues.
Harry E. Prince, PhD is the Director of Scientific Affairs at the VRL Eurofins Pre-Transplant Testing Laboratory in Los Angeles, CA. In this role, he provides technical and management oversight for testing to identify infectious diseases in prospective organ and tissue donors, and provides consultative and educational services for organizations submitting samples for testing.
Dr. Prince received a Bachelor of Science degree in Microbiology from Clemson University, followed by a PhD in Immunology from the University of North Carolina at Chapel Hill. After an immunology postdoctoral fellowship at the Mayo Clinic, he completed the Medical Laboratory Immunology Fellowship Program at UCLA. Prior to joining VRL Eurofins, Dr. Prince was Scientific Director of Immunology at Focus Diagnostics Reference Laboratory, an esoteric infectious diseases testing facility within the Quest Diagnostics family of companies.
Dr. Prince is a Diplomate of the American Board of Medical Laboratory Immunology, and a Fellow of the American Academy of Microbiology. He holds a Certificate of Qualification from the New York State Department of Health in Cellular and Diagnostic Immunology, has served as an editor for Clinical and Vaccine Immunology, and has authored or co-authored over 125 publications in peer-reviewed journals.
Graham Simmons, PhD, is a senior investigator at Blood Systems Research Institute and an adjunct associate professor in the department of laboratory medicine at the University of California, San Francisco. Dr. Simmons received his PhD from the Institute of Cancer Research in London and has worked on emerging and re-emerging viruses for nearly 20 years, with a particular focus on agents with the potential for blood transfusion-transmission.
Richard A. Forshee, Ph.D. leads the Analytics and Benefit-Risk Assessment Team for the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products, vaccines, and human cell and tissue products. Before joining the FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.
William W. Tomford, MD
Medical Director, Massachusetts General Hospital Tissue Bank
Attending Orthopedic Surgeon, Massachusetts General Hospital
Professor of Orthopedic Surgery, Harvard Medical School
My clinical interest in tissue banking began when in the US Navy I served as director of the US Navy Tissue Bank at the Bethesda Naval Medical Center in Bethesda, Maryland. I continued my interest upon return to civilian life as an orthopedic surgeon at Massachusetts General Hospital, serving as the medical director of the tissue bank at MGH for more than 20 years. We no longer procure tissues. We purchase all tissues from multiple tissue banks. Surgeons in our hospital transplant approximately 300 tissues per month. These surgeons include orthopedic, general, vascular, plastic, neuro- and oral/maxillofacial surgeons. My research interests in tissue banking include transmission of diseases in allografts, storage and processing of tissues for transplantation, and development of new tissue forms.
Richard J. Kagan, M.D., FACS obtained his Bachelor of Arts from Case Western Reserve University in 1970 and his M.D. degree from St. Louis University in 1974. Dr. Kagan completed his training in general surgery at the University of Illinois Hospitals before joining the faculty as a staff surgeon in the Cook County Hospital Burn Unit in 1979. He was recruited to the Shriners Hospitals for Children and the University of Cincinnati in 1988 where he rose to become a Professor Surgery in 2003. He was the director of the University Hospital’s Adult Burn Center from 1988 to 2008 and was named Assistant Chief of Staff of the Shriners Hospital in 2000, later becoming its Chief of Staff in 2004. Dr. Kagan retired from clinical practice in 2015. Dr. Kagan’s interests are in acute and reconstructive burn care, tissue banking, skin substitutes, burn center reimbursement, and acute & chronic wound care. He has authored over 190 abstracts, 120 original peer-reviewed publications, and 19 book chapters on burn injuries and tissue banking. During his career, Dr. Kagan served as president of the American Burn Association and the American Association of Tissue Banks.
Jaime Shamonki, M.D., is a board-certified Clinical and Anatomic Pathologist, and the Executive Medical Director of California Cryobank, an industry-leading tissue bank offering comprehensive reproductive donor services and private cord blood storage. Prior to entering the tissue banking field, Dr. Shamonki spent seven years as Section Head of Breast Pathology and Medical Director of the Blood Bank at Saint John’s Health Center in Santa Monica, California, where she was jointly appointed Assistant Professor at the John Wayne Cancer Institute. She completed her residency training in Anatomic and Clinical Pathology at New York Presbyterian Hospital – Weill Cornell Medical College, and has completed fellowships in Breast Pathology (Weill Cornell) and Surgical Pathology (UCLA). Dr. Shamonki’s research career has primarily focused on women’s health, contributing numerous translational clinical inquiries within the fields of oncology and immunology. Her recent research interests have expanded to include genetic screening of reproductive tissue donors and the myriad regulatory, social, legal and clinical issues that impact the safety and utilization of reproductive tissue.
David McKenna, MD is a Professor of Laboratory Medicine & Pathology at the University of Minnesota; he holds the American Red Cross Chair in Transfusion Medicine and is Director of the Division of Transfusion Medicine. He also serves as the Scientific and Medical Director of Molecular and Cellular Therapeutics (MCT), the University’s cGMP facility, as well as Laboratory and Medical Director of the University of Minnesota Medical Center Clinical Cell Therapy Laboratory and the director of the fellowship program in Transfusion Medicine/Blood Banking. He is the current PI of the NHLBI Production Assistance for Cellular Therapies (PACT) contract awarded to the University of Minnesota in 2016. His research focuses on the translational development of novel cell therapies and quality control and optimization of product manufacturing.
George M. Gray, Ph.D. is Professor and Interim Chair in the Department of Environmental and Occupational Health and Director of the Center for Risk Science and Public Health at the George Washington University School Milken Institute School of Public Health. From 2005 to 2009 he served as the Assistant Administrator for the Office of Research and Development at the U.S. Environmental Protection Agency. Prior to joining EPA George was Executive Director of the Harvard Center for Risk Analysis and a member of the faculty of the Harvard School of Public Health. He is past President and a Fellow of the Society for Risk Analysis. George’s primary research interests are risk characterization, risk communication and the role of science in policy-making. Particular interests include the role of risk analysis in sustainability decisions, characterizing the risks of sparsely tested chemicals and improving the use of scientific information in regulatory decisions.