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Our Expert Offerings
Scientific and Technical Experts
Specialists in biologic development, biosimilar comparability, pharmacokinetics/pharmacodynamics, manufacturing process validation, and analytical similarity assessments
Daniel O. 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...
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Michael Scott Kinch
Professor Kinch is a drug development expert specializing in cancer, immunological, and infectious diseases. His research focuses on combining cutting-edge science and entrepreneurship to improve public health. During his tenure at Washington University in St. Louis, Professor Kinch founded the Center for Research Innovation in Biotechnology (CRIB)...
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Christopher M. 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...
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Robert W. 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...
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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 bioDrug Development and Commercialization Experts
Experts in clinical and regulatory pathways for biologics and biosimilars, including trial design, manufacturing plans, approval strategies and timing, and market access challenges across global jurisdictions
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 bioMichael Scott Kinch
Professor Kinch is a drug development expert specializing in cancer, immunological, and infectious diseases. His research focuses on combining cutting-edge science and entrepreneurship to improve public health. During his tenure at Washington University in St. Louis, Professor Kinch founded the Center for Research Innovation in Biotechnology (CRIB)...
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Mark S. 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 bioDaniel O. 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 bioDenis 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 bioEconomic Experts
Professionals skilled in market modeling, damages estimation (lost profits, price erosion, royalties), competitive effects, intellectual property analyses, class certification considerations, and forecasting of biologic and biosimilar adoption trends
Justin N. McLean
Mr. McLean specializes in applying finance and economics to problems in complex business litigation, including securities, valuation, tax, and intellectual property (IP) matters. His experience spans several industries, from banking, insurance, and high tech to telecommunications and health care...
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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...
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Carla S. Mulhern
Ms. Mulhern specializes in the application of economic principles to issues arising in complex business litigation. She has served as an expert witness on damages issues in commercial litigation matters, including intellectual property (IP) and breach of contract cases, providing testimony in various district and state courts...
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Lauren R. Kindler
Ms. Kindler is an economist with extensive experience in a variety of engagements, including intellectual property disputes, contract disputes, litigation matters related to securities and finance, false advertising allegations, class action disputes, and antitrust matters. She has testified numerous times in deposition, trial, and arbitration and assisted in all phases of the litigation process...
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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...
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Robert L. Vigil
Dr. Vigil specializes in the application of economics and finance to complex commercial litigation matters. His work includes the estimation of damages and unjust enrichment in intellectual property (IP), breach of contract, and false advertising cases; the evaluation of patented drug products’ commercial success in connection with generic manufacturers’ Abbreviated New Drug Application submissions to obtain early market entry...
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Richard Mortimer
Dr. Mortimer specializes in health economics, industrial organization, microeconomic theory, and econometrics. He has extensive experience with issues involving competition, intellectual property, marketing, pricing, and valuation with a focus on pharmaceuticals and the health care industry...
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John C. Jarosz
Mr. Jarosz is an economist and director of Analysis Group’s Washington, DC office. He specializes in matters involving intellectual property (IP), commercial damages, licensing, and antitrust. His IP work focuses on evaluating lost profits, reasonable royalties, price erosion, commercial success, licensing terms, best efforts, irreparable harm, and FRAND commitments...
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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...
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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...
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David C. Chan, Jr.
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...
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Eric Sun
Dr. Sun is an anesthesiologist and health economist with expertise in perioperative and pain medicine, population health, and public health policy. His research explores issues of health through clinical and economic lenses, and has examined topics such as the influence of drug and physician pricing on medical outcomes; physicians’ responses to payment program incentives...
Read bioRegulatory Experts
Advisors with expertise in FDA and EMA guidelines on biosimilars, BPCIA litigation frameworks, and exclusivity periods (e.g., 12-year exclusivity and patent dance provisions)
Mark S. 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...
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Steven Galson
Dr. Galson is a specialist in regulatory science, drug development, and public health policy, with a focus on the evaluation, approval, and oversight of medical products and clinical research. His work addresses regulatory frameworks for safe and effective therapeutics, including drug evaluation, regulatory transparency, and the modernization of clinical trial design and approval pathways...
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William M. Zoffer
Mr. Zoffer is an expert in pharmaceutical regulatory law, risk management, and compliance. His Food and Drug Administration (FDA) experience spans nearly three decades in industry and government, including roles at GlaxoSmithKline (GSK) and the US Department of Justice (DOJ). Mr. Zoffer’s expertise as a legal practitioner, including his time at DOJ, has focused on dispute resolution...
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 bioLicensing and Contract Experts
Support for disputes involving co-development, co-marketing, contract manufacturing, supply/distribution agreements, and breach of biologics-related licensing terms, including evaluations of commercially reasonable efforts
John C. Jarosz
Mr. Jarosz is an economist and director of Analysis Group’s Washington, DC office. He specializes in matters involving intellectual property (IP), commercial damages, licensing, and antitrust. His IP work focuses on evaluating lost profits, reasonable royalties, price erosion, commercial success, licensing terms, best efforts, irreparable harm, and FRAND commitments...
Read bioMark S. 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 bioRobert L. Vigil
Dr. Vigil specializes in the application of economics and finance to complex commercial litigation matters. His work includes the estimation of damages and unjust enrichment in intellectual property (IP), breach of contract, and false advertising cases; the evaluation of patented drug products’ commercial success in connection with generic manufacturers’ Abbreviated New Drug Application submissions to obtain early market entry...
Read bioMichael Scott Kinch
Professor Kinch is a drug development expert specializing in cancer, immunological, and infectious diseases. His research focuses on combining cutting-edge science and entrepreneurship to improve public health. During his tenure at Washington University in St. Louis, Professor Kinch founded the Center for Research Innovation in Biotechnology (CRIB)...
Read bioFormer Biotech and Pharma Executives
Experts with decades of experience in biologics strategy, supply chain operations, pricing and access planning, and regulatory compliance
Laura Happe
Professor Happe is a licensed pharmacist with more than 20 years of experience as an academic and a senior executive across health care consulting, pharmaceutical research, managed care, and graduate education. Her areas of expertise include pharmacy benefit management, drug coverage policy, pricing and payment flows throughout the supply chain, pharmacoeconomics, health outcomes research, and epidemiology...
Read bioDenis 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...
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Robert P. Navarro
A managed care expert with more than 30 years of experience, Professor Navarro serves as a consultant and expert to health care, pharmaceutical company, and law firm clients on topics including drug pricing and contracting, drug formulary access and reimbursement, and drug benefit outcomes. He has practiced pharmacy in a variety of settings, including hospitals, long-term care facilities, and community pharmacies...
Read bioMark S. 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 bioMarketing and Branding Experts
Academic and practitioner experts with substantial experience analyzing firms' marketing activities
Tulin Erdem
Professor Erdem's research interests include advertising, brand management and equity, consumer choice, customer relationship management, decision making under uncertainty, econometric modeling, and pricing. She has served as a marketing and market research expert in class action and commercial litigation, including testifying on issues such as brand positioning and consumer confusion; consumer behavior and decision making; and trademark infringement...
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Punam Keller
Professor Keller is a marketing expert who specializes in the application of consumer psychology, information processing, and choice behavior to complex litigation matters involving claims of consumer confusion, false advertising, trademark infringement, and product liability, among other topics. She studies the application of social marketing principles and behavioral theory in consumer and employee contexts...
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Natalie Mizik
Professor Mizik is an expert in marketing strategy, valuation of intangibles, earnings management, and executive compensation in a range of industries, including health care. Her research centers on examining the consequences of marketing strategies and activities on financial performance, developing new metrics for marketing assets, and building empirical models to assess the value of intangible marketing assets...
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On Amir
Professor Amir is an expert on marketing and consumer behavior who uses psychological and economic principles to understand driving elements and nuances in consumer judgment and decision making across numerous products and services. His research has examined consumer judgment under risk and uncertainty as well as the impact of contextual factors on decisions throughout the consumer journey...
Read bioClinical Experts
Health care practitioners with experience using/prescribing biologics and biosimilars in various therapeutic areas
Atheendar Venkataramani
Dr. Venkataramani is a health economist and practicing physician who studies the life-course origins of health and socioeconomic inequality, both domestically and internationally. His research focuses on understanding the relationship between economic opportunities and health behaviors and outcomes, examining the health consequences of social policies, and elucidating the effects of early life interventions on adult health and wellbeing...
Read bioChristopher M. 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 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 bioAnupam 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 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...
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Litigation and policy consulting in support of stakeholders navigating health care issues across industries
