-
Select Expert Offerings in Product Liability Litigation & Mass Torts
Epidemiology & Biostatistics Experts
Providing in-depth epidemiological and statistical analysis of spontaneous reports safety data, clinical trials, and real-world observational data to assess claims of general causation and signal detection
Daniel Scharfstein
Professor Scharfstein is a biostatistician with expertise in the design, monitoring, and analysis of randomized clinical trials and observational studies. His research focuses on methods of reporting the results of clinical studies in which missing or censored data, non-compliance, or non-random treatment assignment may have resulted in selection bias...
Read bio
Robert Platt
Professor Platt is an expert in biostatistics and pharmacoepidemiology, with a focus on developing statistical methods for causal inference in observational studies. His recent research addresses both broad methodological topics in pharmacoepidemiology and statistical issues specific to perinatal epidemiology...
Read bio
Mei Sheng Duh
Dr. Duh, Chief Epidemiologist at Analysis Group, specializes in real-world evidence (RWE) generation for product registration, post-approval safety studies, and health economics and outcomes research (HEOR) of pharmaceuticals, vaccines, and regenerative biotherapeutics. She has led over 50 projects for new molecular entity approvals and product label expansion applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA)...
Read bio
Maral DerSarkissian
Dr. DerSarkissian’s expertise includes the application of epidemiologic methods to real-world evidence (RWE) generation in support of product registration, post-approval safety studies, and health economics and outcomes research (HEOR). She has served as an expert witness in litigation and has a wide range of experience in pharmacoepidemiology, biostatistics, and observational data analysis, including in studies on causal methods...
Read bio
Christopher Worsham
Dr. Worsham uses epidemiologic and econometric methods to perform large database research on causal associations, physician behavior, resource utilization, and health care policy. He is also a practicing physician and applies evidence-based medicine in his provision of health services and evaluation of scientific questions in health care settings...
Read bio
Lee-Jen Wei
Professor Wei is the scientific director for the program of quantitative science in pharmaceutical medicine at the Harvard T.H. Chan School of Public Health. He is an expert in biostatistics and in the development of statistical methods for the design and analysis of clinical trials, and has provided deposition and trial testimony in numerous matters regarding the effectiveness of various therapies...
Read bioClinical and Medical Experts
Analyzing and interpreting scientific evidence regarding potential associations between exposures and health outcomes and evaluate patient medical records and established risk factors to assess claims of specific causation
Christopher Worsham
Dr. Worsham uses epidemiologic and econometric methods to perform large database research on causal associations, physician behavior, resource utilization, and health care policy. He is also a practicing physician and applies evidence-based medicine in his provision of health services and evaluation of scientific questions in health care settings...
Read bio
Amol Navathe
Dr. Navathe is a health economist and practicing physician who specializes in the design and evaluation of health care payment and reimbursement models, health plan coverage, medical service and prescription drug pricing, and the application of statistical, econometric, and machine learning methods to clinical and health care decision making...
Read bio
David Chan
Dr. Chan is a practicing internal medicine physician and an economist. His research draws on industrial organization, labor economics, and applied econometric principles to study how technology and information are used in health care, and how they affect productivity and patient care. Dr. Chan’s government service includes roles as entrepreneur in residence in the White House Office of Science and Technology Policy...
Read bio
Anupam B. Jena
Professor Jena is a health economist, practicing internal medicine physician, and professor of health care policy. His work involves several areas of health economics and policy, including the economics of medical innovation, the economics of physician behavior and the physician workforce, medical malpractice, and the economics of health care productivity...
Read bio
Marguerite Brackley
Dr. Brackley is board certified in internal medicine and an expert in patient and medical safety. Her deep knowledge of clinical trial management includes clinical events committees and safety event reviews, as well as pharmacovigilance, post-market processes, field actions, and risk management. She has consulted on these issues to medical device, diagnostic, and pharmaceutical companies for over a decade...
Read bio
Fatima Cody Stanford
Dr. Stanford is a fellowship-trained obesity medicine physician-scientist who specializes in weight-related health issues, nutrition, and public health. Her expertise includes obesity treatment, health disparities in diverse populations, weight discrimination and stigma, and diagnostic criteria for clinical obesity...
Read bioDisease Area Scientific Experts
Providing insights into disease etiology and evaluate biologic plausibility of claimed causal associations
Christopher Worsham
Dr. Worsham uses epidemiologic and econometric methods to perform large database research on causal associations, physician behavior, resource utilization, and health care policy. He is also a practicing physician and applies evidence-based medicine in his provision of health services and evaluation of scientific questions in health care settings...
Read bioFatima Cody Stanford
Dr. Stanford is a fellowship-trained obesity medicine physician-scientist who specializes in weight-related health issues, nutrition, and public health. Her expertise includes obesity treatment, health disparities in diverse populations, weight discrimination and stigma, and diagnostic criteria for clinical obesity...
Read bioRegulatory Experts
Offering insights into the regulatory approval process, compliance issues, and the implications of adverse event reporting and post-market surveillance
Marguerite Brackley
Dr. Brackley is board certified in internal medicine and an expert in patient and medical safety. Her deep knowledge of clinical trial management includes clinical events committees and safety event reviews, as well as pharmacovigilance, post-market processes, field actions, and risk management. She has consulted on these issues to medical device, diagnostic, and pharmaceutical companies for over a decade...
Read bio
Mark Robbins
Dr. Robbins is a pharmaceutical and biotech executive with over 40 years of broad-based industry experience. In his role at Kodiak Strategic Consultants, he consults to a diverse group of pharmaceutical and biotech companies on clinical, regulatory, business development, and licensing issues. Dr. Robbins served as a CEO in residence at the University of Minnesota’s Office for Technology Commercialization and co-founded several biotech ventures...
Read bioMei Sheng Duh
Dr. Duh, Chief Epidemiologist at Analysis Group, specializes in real-world evidence (RWE) generation for product registration, post-approval safety studies, and health economics and outcomes research (HEOR) of pharmaceuticals, vaccines, and regenerative biotherapeutics. She has led over 50 projects for new molecular entity approvals and product label expansion applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA)...
Read bio
James Signorovich
Dr. Signorovitch partners with life sciences companies to strengthen regulatory and commercial success through evidence that informs clinical, regulatory, and economic decision making. He has extensive experience designing and implementing evidence strategies across the product lifecycle, from early clinical development through regulatory submissions, launch, technology appraisals, and post-approval settings...
Read bioPharmaceutical and Biotech Industry Experts
Evaluating industry standards, safety protocols, and product development processes
Mark Robbins
Dr. Robbins is a pharmaceutical and biotech executive with over 40 years of broad-based industry experience. In his role at Kodiak Strategic Consultants, he consults to a diverse group of pharmaceutical and biotech companies on clinical, regulatory, business development, and licensing issues. Dr. Robbins served as a CEO in residence at the University of Minnesota’s Office for Technology Commercialization and co-founded several biotech ventures...
Read bio
Denis Boyle
Dr. Boyle has over 30 years of experience in the biopharmaceutical industry, with a particular interest in commercialization, technology transfer, regulatory strategy, good manufacturing practice, recombinant protein biochemistry, and monoclonal antibodies. At CMC BioPharma, he advises biopharmaceutical clients across all stages of the biologics drug development cycle...
Read bioMarguerite Brackley
Dr. Brackley is board certified in internal medicine and an expert in patient and medical safety. Her deep knowledge of clinical trial management includes clinical events committees and safety event reviews, as well as pharmacovigilance, post-market processes, field actions, and risk management. She has consulted on these issues to medical device, diagnostic, and pharmaceutical companies for over a decade...
Read bioEconomic and Damages Experts
Analyzing the potential short- and long-term health care needs and costs of treatment associated with adverse health outcomes allegedly caused by at-issue exposures
Anupam B. Jena
Professor Jena is a health economist, practicing internal medicine physician, and professor of health care policy. His work involves several areas of health economics and policy, including the economics of medical innovation, the economics of physician behavior and the physician workforce, medical malpractice, and the economics of health care productivity...
Read bioDavid Chan
Dr. Chan is a practicing internal medicine physician and an economist. His research draws on industrial organization, labor economics, and applied econometric principles to study how technology and information are used in health care, and how they affect productivity and patient care. Dr. Chan’s government service includes roles as entrepreneur in residence in the White House Office of Science and Technology Policy...
Read bioAmol Navathe
Dr. Navathe is a health economist and practicing physician who specializes in the design and evaluation of health care payment and reimbursement models, health plan coverage, medical service and prescription drug pricing, and the application of statistical, econometric, and machine learning methods to clinical and health care decision making...
Read bio
Amitabh Chandra
Professor Chandra focuses his research on innovation, productivity, and cost growth in health care; medical malpractice; and racial disparities in medical care. He has testified before the US Senate and the US Commission on Civil Rights and served as a special commissioner on the Massachusetts Special Commission on Provider Price Reform...
Read bio
David Grabowski
Professor Grabowski specializes in health care economics, with a particular focus on insurance coverage and prescription drug markets and prices. He has testified before Congress on payment and quality issues in health care, and was the principal investigator on several research projects funded by the National Institute on Aging...
Read bio
Litigation and policy consulting in support of stakeholders navigating health care issues across industries
