Survival Analysis Expert Witnesses

Landenberg, Pennsylvania

Statistics, Medical Devices - biostatistics, FDA, Pharmaceutical Statistics, Sanofi, Edwards, Gilead, AI/ML expert, machine learning, clinical trial, Medical Device, Vaccine, Group Sequential Design, Bayesian Adaptive Design, Statistical Review of Evidence, Oncology, Epidemiological, Regulatory Submissions, Survival Analysis, Statistical Expert Witness, RWE

Lei Li, PhD, is a biostatistician and former FDA CDRH statistical reviewer with extensive experience in regulatory statistics, Real-World Evidence (RWE), medical device submissions, and pharmaceutical development. At FDA, Dr. Li evaluated statistical components of 510(k) and PMA submissions, assessed safety and effectiveness evidence for medical devices, reviewed RWE and post-market studies, and advised on complex statistical issues for regulatory decision-making. His FDA work included evaluation of study design adequacy, endpoint justification, sample-size rationale, bias and confounding, missing data robustness, and interpretation of clinical performance metrics under regulatory standards. In industry, Dr. Li served as Statistical Project Leader at Sanofi and Principal Biostatistician at Edwards Lifesciences, supporting global clinical and regulatory programs across multiple therapeutic areas, including rare diseases, inflammatory diseases, vaccines, oncology, and cardiovascular ...

Richmond, Virginia

Oncology, Hematology - Breast cancer, Lung cancer, hematologic malignancies, colon cancer, solid malignancies, lymphoma, clotting disorders, anemia, anticoagulation, life expectancy, expert witness, causation, delayed diagnosis, cancer expert, medical record review, prognosis, failure to diagnose, missed diagnosis, survival analysis, oncology expert

Dr. Khatcheressian is a board-certified medical oncologist who has been in clinical practice since 2004. He served as an Assistant Professor of Medicine at Virginia Commonwealth University from 2004 to 2008 and has since been in private practice at the Virginia Cancer Institute (VCI). Dr. Khatcheressian has served on the management committee of VCI, a physician-owned practice of more than 20 oncologists, for the past seven years, including in the role of Vice President. He has also served as Medical Director of Research at VCI and is a Fellow of the American Society of Clinical Oncology. Dr. Khatcheressian has reviewed a wide range of medical-legal matters involving standards of care, medical causation, liability, and life-expectancy. He is experienced in analyzing complex medical and causation issues and in presenting opinions in a clear, logical, and concise manner for attorneys and other legal professionals.