The Partners in Diagnostics team members leverage their decades of FDA and industry experience to make it easier for quality-assured in vitro diagnostic technologies (IVDs) to get to regulatory approval.
Elliot founded Partners in Diagnostics after 20 years of service at the US Food and Drug Administration (FDA). As Chief of the Product Review Branch in the Division of Emerging and Transfusion Transmitted Diseases at FDA’s Center for Biologics Evaluation and Research, he was responsible for the regulatory oversight of all blood donor screening tests and retroviral diagnostics, covering every facet of the regulatory review process. He served as chair or supervised the review of numerous IVD applications, as well as acting as the product expert for manufacturing facility inspections. He played key roles in the development of policy, coordinating decisions on issues such as the approval and use of the first of rapid HIV tests and the first over-the-counter HIV test system.
Known for his ability to be effective across organizations, Elliot cultivated and maintained close working relationships with colleagues at CDRH, the Centers for Disease Control and Prevention, and the Center for Medicare and Medicaid Services.
Elliot’s impact in IVD regulation has extended beyond US borders. He served as the Chair of the HIV Diagnostics Subcommittee of the Laboratory Technical Working Group in the President’s Emergency Plan for AIDS Relief (PEPFAR). He also assisted the World Health Organization in the development of its Prequalification of Diagnostics Programme. He continues to participate in global health efforts related to the regulation of IVDs and is an invited member of the International AIDS Society’s Industry Liaison Forum.
Sally joined Partners in Diagnostics as a Senior Consultant in 2016, after 12 years as the Director of the Center for Devices and Radiological Health (CDRH) Division of Microbiology Devices in the Office of In-vitro Diagnostic Device and Radiological Health at the U.S. Food and Drug Administration (FDA). In that role, she was responsible for the review and evaluation for safety and effectiveness of all IVD microbiology devices submitted to the FDA for pre-market device approval and emergency use authorization, as well as for IVD pre-market and post-market compliance actions. While at FDA, Sally maintained close working relationships with FDA CBER, CDC, NIAID, DoD, and WHO. She also represented FDA on the President’s Committee for anti-microbial resistance, served on several U.S Health and Human Services Emerging Pathogen Preparedness Committees, and on a U.S. Academy of Science Committee related to microbial diagnostic issues.
Prior to joining FDA, Sally spent 19 years in the international diagnostic device industry in various capacities ranging from R & D, On-Market Product Support, and Scientific Affairs. Sally served as the Abbott Laboratories Diagnostic Division Director of Clinical Research, managing the team of statisticians, medical writers and clinical research associates that prepared diagnostic device and blood donor screening regulatory submissions for the FDA and other international regulatory bodies. She also was Director of the Medical Affairs Quality System, Compliance, Training and Centralized Specimen Sourcing Program.
Sally has participated in IVD regulation training workshops in Europe, Africa and Asia and worked with international non-profit agency grant proposal review teams. She was also a member from 2017-2019 of the 1st WHO Strategic Advisory Group of Experts on in Vitro Diagnostics responsible for the selection and use of “Essential IVDs”. She is author and co-author of several major publications.
Tamara V. Feldblyum, MS, PhD
SENIOR REGULATORY CONSULTANT
Tamara joined Partners in Diagnostics as a Senior Regulatory Consultant in March 2021, after 15 years at FDA. She served there as a regulatory scientist and as a Branch Chief in CDRH’s Division of Microbiology Devices in the Office of In Vitro Diagnostics and Radiological Health (OIR), where she was responsible for diagnostic devices detecting respiratory viruses, HPV, and sexually transmitted infections (STIs). During her tenure, she led FDA’s efforts to reclassify influenza antigen tests and developed new approaches to evaluation of devices for STIs and HPV, providing more flexibility to device manufacturers. In collaboration with other Federal Agencies, she led the Branch in the review and Emergency Use Authorization of diagnostic tests during four declared Public Health Emergencies. Since the declaration of Public Health Emergency for COVID-19 in January 2020 until her retirement from FDA at the end of December 2020, Tamara organized a review team and managed reviews and Emergency Use Authorizations of all molecular diagnostic tests for the detection of SARS-CoV-2. Her team's efforts resulted in the authorization of over 230 molecular tests between January and December 2020.
Prior to coming to FDA in 2006, Tamara served as a director of a core sequencing facility at the Institute for Genomic Research (TIGR) and collaborated in microbial genomics research projects. She directed staff responsible for genome library construction, high throughput sequencing, genome assembly and finishing, quality control and assurance, research and development, new technology implementation, and laboratory automation. She also served as a Molecular Biology Program manager at the American Type Culture Collection (ATCC) managing staff of biologists responsible for characterization and accessioning into the ATCC collection recombinant DNA material.
Peter Kupchak, PhD
Peter received his PhD in Statistics from the University of Toronto in 2000, where his dissertation topic was the optimal design of drug interaction experiments. He has been working in the medical diagnostics industry for 21 years, and has previous experience in overseeing the day-to-day operations of the clinical affairs function within a medical diagnostics company. He currently provides statistical services, clinical consulting, and protocol development services for medical diagnostics companies. He has created clinical trial protocols and associated statistical analysis plans for exploratory and
confirmatory clinical studies, and has conducted analyses of clinical trial data to support the regulatory clearance of various medical devices, from in vitro diagnostic assays to next-generation sequencing platforms.
William FitzHugh, MS
Will FitzHugh has worked in biotechnology and bioinformatics since the early 90's. Early in his career he helped build large-scale science projects such as the Human Genome Project and microbial sequencing efforts. He has worked on technology to support drug target discovery, molecular diagnostics, machine learning and lab instrument products. Recently he has been an informatics and strategy consultant to the biotechnology and pharmaceutical industries. He has degrees in mathematics and computer science from Cornell University and Boston University.
Will has developed processes for managing, verifying and validating software requirements for IVD submissions for medical devices with software components. He has worked with companies to write and document requirements and architecture for medical device software and systems.