Pharmaceutical Experts

Innovation in the pharmaceutical industry continues to reshape how drugs and biologics are discovered, developed, and manufactured, creating scientific and regulatory issues that often surface in complex litigation. As companies navigate questions around intellectual property, clinical evidence, safety, and compliance, legal teams increasingly rely on our pharmaceutical experts to clearly explain the science and decision-making behind these products.

DOAR represents life science experts whose experience spans pharmacology, clinical development, manufacturing, and post-market safety. They are familiar with each stage of the product lifecycle—from early research and formulation through clinical trials, regulatory submissions, scale-up, and commercialization—allowing them to address matters involving product design, labeling, risk evaluation, and market performance.

In high-stakes disputes, tour testifying experts evaluate the scientific and regulatory record, test competing narratives, and present complex pharmaceutical issues in a way that judges, juries, and regulators can understand and rely on.

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Biologics, Biosimilars & Complex Therapeutics

The rapid expansion of biologics and biosimilars has introduced sophisticated scientific and regulatory questions for manufacturers navigating development, approval, and market competition. Disputes often center on analytical characterization, comparability, immunogenicity, manufacturing variability, and exclusivity under the Biologics Price Competition and Innovation Act (BPCIA). DOAR works with experts who understand the unique challenges of producing and evaluating large-molecule therapies, including cell-line development, upstream and downstream processing, stability, and clinical performance. Through detailed technical assessments and well-structured expert reports, they help legal teams interpret complex data sets, assess regulatory positions, and present biologics-related issues with clarity in high-stakes litigation and regulatory actions.

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GSK LogoNovartis LogoHikma LogoMerck LogoRoche LogoAbbvie LogoTeva LogoAmgen LogoSanofi LogoAstraZeneca LogoEndo Logo
Areas of Expertise

We represent experts who are world-class academics, industry executives, and former government regulators who were carefully selected for their knowledge, experience, and ability to communicate effectively.

Clinical Trials

Expertise in trial design, data analysis, and interpretation of clinical evidence used to support safety, efficacy, and regulatory decisions.

Drug Safety

Experience evaluating safety signals, diversion risks, and counterfeit detection, including how quality and surveillance processes address product integrity.

Drug Types

Knowledge spanning biologics, small-molecule drugs, and OTC products, including differences in formulation, manufacturing, and regulatory pathways.

Industry Landscape

Insight into market dynamics, competitive trends, and regulatory developments that shape product strategy and commercial outcomes.

IP and Compliance

Background in patent disputes, exclusivity issues, and regulatory adherence across drug development, approval, and post-market obligations.

Manufacturing

Experience with cGMP standards, FDA inspections, and production quality systems that affect regulatory status, recalls, and related disputes.

Marketing and Sales

Understanding of labeling requirements, promotional practices, pricing strategies, and how these factors influence compliance and litigation risk.

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Learn More About Our Experts
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