Expert support

John Aucott, M.D., is an Associate Professor of Medicine at Johns Hopkins University School of Medicine and the Director of the Johns Hopkins Lyme Disease Clinical Research Center. He is principal investigator for the SLICE studies of Lyme disease immunology and clinical events, a clinical research program focused on the pathophysiology, diagnosis and treatment of Lyme disease associated persistent illness. He has published over 60 articles on Lyme disease in the peer reviewed literature. An active clinician and educator, he is also the program director for the Johns Hopkins Fellowship in Lyme and Tickborne Diseases.

Liz Horn, Ph.D., MBI, serves as PI of Lyme Disease Biobank, a resource created to provide much-needed blood, urine, and tissue samples to researchers studying Lyme disease and other tick-borne infections. More than 1200 participants (representing early Lyme, later stages of Lyme, persistent Lyme, and controls) have been enrolled. Each participant’s sample donation can support up to 50 different research projects. Currently, >80 projects in academia and industry have been approved for samples. Liz is passionate about building resources to move research forward that help people, improve lives, and reduce suffering.

Mark J. Soloski, Ph.D., is a Professor of Medicine in the Division of Rheumatology at the Johns Hopkins University School of Medicine. The overarching theme of his research is understanding immune processes triggered by bacterial infection and how this encounter may trigger long-term persistent symptoms.  Currently, working with colleagues at the Lyme Disease Research Center at Johns Hopkins he has focused on developing a biorepository of human samples from subjects with Lyme Disease and on understanding how the immune system contributes to the symptoms and severity of Human Lyme disease.

Elliot Cowan, Ph.D., 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 rapid HIV tests and the first over-the-counter HIV test system.

Andrew DiMeo, Sr., Ph.D., owns and operates a health innovation consultancy, DiMeo LLC. Andrew is a health innovator, biomedical engineer, design philosopher, and social entrepreneur. He has served as a team lead in NIH programs, including RADx, ITAP, Blueprint MedTech, HIV Point-of-Care Testing, and C3i. Andrew mentors the next generation of social innovators at North Carolina State. Other notable experiences include co-founding the medical device design and manufacturing company Gilero, helping grow North Carolina’s medical device industry by starting a nonprofit trade association, helping develop Coulter College, serving as Director for Duke NeuroInnovations, and starting and selling SaaS business CanvasGT to Greenlight Guru.

Tamara V. Feldblyum, MS, Ph.D., 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.

Peter Kupchak, Ph.D., received his doctorate 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.

Rajat Mukherjee, Ph.D., is the Founder and Chief Statistical Scientist at MuSigmas Consultants. He is a statistician with over two decades of experience in multiple sectors: public health, pharma and nutrition, and academia. Rajat’s two areas of specialization are Innovative and efficient designs for clinical trials and observational studies; and applying machine learning (ML) for biomarker discoveries and diagnostics. He provides strategic consulting for products and pipeline development and regulatory statistics support to pharma, biotech, and medtech companies for market approvals. He works with both early and late-phase clinical trials and with statistical strategies using both the traditional frequentist as well the Bayesian framework. Rajat is passionate about empowering scientists to make efficient use of data while enabling robust decision-making.