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Select Expert Offerings in Life Sciences Corporate Disputes
Scientific and Statistical Experts
Providing in-depth analyses of technologies, research and development processes, clinical trials, efficacy and safety data, and manufacturing issues in disputes involving pharmaceutical and biotech assets and medical devices
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). At Long Island University (LIU), he directed CRIB, which uses tools such as the Clinical Drug Experience Knowledgebase (CDEK) to assess trends in drug discovery and development...
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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, including process development, scale-up, manufacturing, late-stage pre-commercialization studies, contract development and manufacturing organization management, and regulatory strategy...
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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. He is actively involved with a number of startups, including GigaMune, Neuropharma Meds, and Diastol Therapeutics...
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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. He has testified at deposition and trial in a number of litigation matters involving drug and medical device safety and efficacy in and outside the US. In addition, Professor Scharfstein regularly consults to the pharmaceutical industry, advising on statistical issues related to the regulatory approval of drugs and medical devices...
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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. Since 2022, Professor Platt has served as the principal investigator for the Canadian Network for Observational Drug Effect Studies (CNODES), whose mandate is to provide high-quality evidence in response to drug safety queries generated by Canadian public health stakeholders. He was the methods lead for CNODES from 2011 to 2022...
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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. Dr. Worsham has particular research interest in the intensive care unit, for which he has received a career development grant award from the Agency for Healthcare Research in Quality. His research has been published in peer-reviewed journals including The New England Journal of Medicine, The BMJ, and JAMA Internal Medicine...
Read bioRegulatory Experts
Offering insights into regulatory approval and compliance processes in life sciences litigation, including in the US, Europe, and Asia
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. He is actively involved with a number of startups, including GigaMune, Neuropharma Meds, and Diastol Therapeutics...
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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...
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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)...
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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. He has also testified as an expert in a large pharmaceutical antitrust litigation matter, in which he explained how prescriptions are paid for. As a member of the Medicare Payment Advisory Commission (MedPAC), Professor Grabowski advised Congress on issues impacting the Medicare program...
Read bioLicensing and Business Alliance Experts
Analyzing licensing agreements, technology transfers, and revenue/cost-sharing disputes related to life sciences collaborations, including joint ventures and university partnerships
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). At Long Island University (LIU), he directed CRIB, which uses tools such as the Clinical Drug Experience Knowledgebase (CDEK) to assess trends in drug discovery and development...
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. He is actively involved with a number of startups, including GigaMune, Neuropharma Meds, and Diastol Therapeutics...
Read bioFormer Life Sciences Industry Executives
Evaluating strategic, commercial, and operational considerations in disputes involving business practices, partnerships, and competitive conduct, including analyses of the feasibility, costs, and risks associated with pharmaceutical and biotech innovation, investment, and product launches
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, including process development, scale-up, manufacturing, late-stage pre-commercialization studies, contract development and manufacturing organization management, and regulatory strategy...
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. He is actively involved with a number of startups, including GigaMune, Neuropharma Meds, and Diastol Therapeutics...
Read bioIntellectual Property Valuation Experts
Assessing the economic value of patents, trademarks, and proprietary technology in litigation and arbitration
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. Professor Chandra is a member of the Congressional Budget Office’s panel of health advisors, a research associate at the National Bureau of Economic Research, and an elected member of the American Academy of Arts and Sciences, the National Academy of Medicine, and the National Academy of Social Insurance...
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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. Ms. Mulhern’s intellectual property damages experience includes cases involving allegations of patent, copyright, and trademark infringement, as well as misappropriation of trade secrets; she has also provided expert testimony on these issues in Section 337 cases at the International Trade Commission (ITC)...
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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, including discovery, expert reports, deposition, and trial preparation. With respect to intellectual property disputes, Ms. Kindler has evaluated damages in the context of allegations of patent infringement, trade secret misappropriation, trade dress infringement, and copyright infringement...
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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. Mr. Jarosz has significant expertise testifying in patent, trademark, copyright, and trade secret tort and contract matters. He is also experienced in both US and international arbitration, often serving as an expert witness in matters involving IP rights...
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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. He has served as an expert witness, and has provided assistance in many phases of litigation, including development, presentation, and review of pretrial discovery; preparation of testimony; and critique of analyses of opposing experts...
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Keith R. Ugone
Dr. Ugone specializes in the application of economic principles to complex business disputes and is experienced in economic and damages-related analyses. He has provided financial and economic consulting services in cases involving antitrust, breach of contract, class certification, intellectual property, professional negligence, and securities-related issues. Dr. Ugone has frequently evaluated lost profits and valuation-related issues using large databases and complex computer models...
Read bioEconomic and Damages Experts
Providing lost profits, reasonable royalty, and unjust enrichment calculations; competitive analysis; and insights into the economics of innovation
John Cawley
Professor Cawley specializes in the economics of risky health behaviors, particularly those that relate to obesity. His work examines the economic causes and economic consequences of obesity, and the effectiveness of methods of obesity treatment and prevention. He has also researched a variety of topics related to nutrition and harm reduction. Professor Cawley’s publications have appeared in numerous peer-reviewed journals, including the Journal of Health Economics, Health Economics, American Journal of Health Economics, The Lancet, JAMA, Obesity, and Food Policy...
Read bioAmitabh 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. Professor Chandra is a member of the Congressional Budget Office’s panel of health advisors, a research associate at the National Bureau of Economic Research, and an elected member of the American Academy of Arts and Sciences, the National Academy of Medicine, and the National Academy of Social Insurance...
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Amol Navathe
Dr. Navathe is a health economist and practicing physician who specializes in payment model design and evaluation and applications of statistical and machine learning to clinical decision making. His research focuses on the impact of value-based care and payment models on health care value; financial and nonfinancial incentive design for clinician practices; and the intersection of clinical trials and observational data analyses. Dr. Navathe is a staff physician at the Corporal Michael J. Crescenz Veterans Affairs Medical Center and vice chair and commission member of the Medicare Payment Advisory Commission, a nonpartisan agency that advises the US Congress on Medicare policy...
Read bioJustin 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. He has served as an expert witness, and has provided assistance in many phases of litigation, including development, presentation, and review of pretrial discovery; preparation of testimony; and critique of analyses of opposing experts...
Read bioCarla 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. Ms. Mulhern’s intellectual property damages experience includes cases involving allegations of patent, copyright, and trademark infringement, as well as misappropriation of trade secrets; she has also provided expert testimony on these issues in Section 337 cases at the International Trade Commission (ITC)...
Read bioLauren 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, including discovery, expert reports, deposition, and trial preparation. With respect to intellectual property disputes, Ms. Kindler has evaluated damages in the context of allegations of patent infringement, trade secret misappropriation, trade dress infringement, and copyright infringement...
Read bioJohn 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. Mr. Jarosz has significant expertise testifying in patent, trademark, copyright, and trade secret tort and contract matters. He is also experienced in both US and international arbitration, often serving as an expert witness in matters involving IP rights...
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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. Professor Jena has been retained as an expert in several pharmaceutical and health care industry matters...
Read bioDavid 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. He has also testified as an expert in a large pharmaceutical antitrust litigation matter, in which he explained how prescriptions are paid for. As a member of the Medicare Payment Advisory Commission (MedPAC), Professor Grabowski advised Congress on issues impacting the Medicare program...
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Litigation and policy consulting in support of stakeholders navigating health care issues across industries
