Drug Development Expert Witnesses
Start Drug Development Expert Search
What is a drug development expert witness?
Drug development expert witness candidates typically have a PhD and a background in pharmaceutical chemistry, physiology, microbiology, and/or clinical pharmacology. Drug development is the process of bringing a pharmaceutical drug to the market as a result of scientific drug discovery. Experts may be a member of an industry association such as the Pharmaceutical Research and Manufacturers of America (PhRMA), or the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
What types of cases require a drug development expert witness?
The process of drug development – from concept, preclinical testing, clinical trial development to an approved drug – typically takes more than 10 years. Litigation support by drug development expert witness often involves intellectual property matters such as a patent litigation or a trade secret dispute. The expertise of a drug development expert witness will provide credibility to enable the jury to consider the scientific evidence with the weight it deserves.
Drug development expert witness case examples
Representing the plaintiff or defendant, top litigation firms call on Cahn Litigation Services to find drug development expert witnesses for a wide variety of matters including:
- toxicology (adverse effects of drugs and drug combinations),
- regulatory affairs and regulatory submissions,
- drug metabolism,
- drug safety, and
- medical malpractice.
What litigation support work might a drug development expert witness be expected to perform?
Litigation support work by a medical expert specializing in drug development could include research, literature review, and authoring expert reports, providing expert opinions and expert witness testimony at a trial. In a high-profile case, or litigation involving a significant financial stake, a law firm may request a drug development professional with prior expert witness experience.
Cahn Litigation Services has the experience required to turn a search for a drug development expert witness around quickly, providing the right balance of expertise and testimony experience.
Related Disciplines
Drug Development Expert Witness - Representative Bios
Please Note: All Cahn Litigation expert witness searches are customized to attorneys' precise specifications and preferences. Attorneys are encouraged to discuss search parameters with a Cahn search specialist.
The below expert witness bios represent a small fraction of those Drug Development experts known by Cahn Litigation Services. These bios are provided to give lawyers a sense of the Drug Development landscape.
Expert Witness #210251
This expert has many years of experience in the Cardiovascular Therapeutics and Medical Device industry, and was the Vice-President of Research for a company that developed a drug-eluting medical device. Prior to that this expert directed the Cardiovascular Therapeutics Groups at two pharmaceutical giants, and led cardiovascular drug discovery teams at others. This expert established a Cardiovascular Research Consulting Firm and serves small, mid and large pharma in many aspects of drug discovery and medical device development. This expert also has extensive IP litigation experience.
This expert is well known and has been complimented for trial presence and a clear command of science. This expert is of high integrity and supreme scientific knowledge with the ability to relate the science of the case to the jurors in a clear and understandable way. Finally, a Judge expressed publicly that this expert is one of the best expert witnesses he's ever seen at trial.
Start Drug Development Expert SearchExpert Witness #262031
This expert is a long time veteran of the pharmaceutical industry, with a career starting as an Associate Research Scientist and culminating as Chief Development Officer, Advisor and Mentor. Besides having earned a doctorate in Cellular and Molecular Physiology, this expert has significant expertise with drug development including clinical trials and bringing products to market. This expert has also been involved with intellectual property prosecutions. As an executive this expert has deep experience with investors, Board level Directors, and with grants and technology licenses. This expert has also been involved in investor presentations, Series A - C2 venture capital financings, IPO processes and SEC filings. This expert has served as a testifying expert in patent infringement and trade secret matters.
Start Drug Development Expert SearchExpert Witness #247821
This expert has had primary responsibilities in drug development, regulatory affairs and agency policy compliance. With many years of experience, this expert's consulting firm advises pharmaceutical companies on product labeling, drug safety and efficacy, analysis of clinical studies, and other compliance issues. This expert is well published with over 50 articles, and has been called to testify before Congress. This expert currently serves on two industry research journal editorial boards. This expert has expert witness experience in about a dozen matters. As is common in this field, none of these matters went to trial.
Start Drug Development Expert SearchExpert Witness #249933
With a Ph.D. in organic chemistry, post-doctoral work in molecular biology, and industrial experience combining process chemistry, organic synthesis, biotechnology, biocatalysis, plus natural product fermentation and downstream processing, this expert provides a unique combination of skills. After obtaining a Ph.D. in synthetic organic chemistry, this expert joined a company where work led to a number of patents covering the enzymatic resolution of pharmaceutical intermediates, one of which earned royalties of several million dollars. In this particular project, this expert was the chief technical witness in a patent interference suit. Following the success of the suit, this expert was invited to establish a new group within a major Chemical Process Development company. The group successfully introduced biocatalysis in over a dozen projects at scales ranging from lab-bench scale synthesis of drug metabolites for Drug Discovery groups, to GMP pilot-plant batches providing intermediates for clinical material. This included the use of a non-aqueous enzymatic step in the synthesis of an antifungal agent. Under this expert's leadership, the group filed 13 patent disclosures and produced a total of 37 public presentations and publications - an unusual accomplishment for an industrial development group. Shortly after, this expert moved to a major pharmaceutical company and became Director of Fermentation and Biocatalysis Development. This expert's group handled chemical process development, molecular biology, industrial fermentation, and GMP analytical services, supporting both Discovery and Production. This expert then established a venture, providing new and small companies with technical strategy, IP analysis, and CTO-level management across a range of disciplines covering process chemistry, molecular biology, biotransformations & biocatalysis, industrial biotech, plus fermentation of natural products and recombinant enzymes. This expert brings 40 years of experience in the field of biocatalysis and the expression of enzymes (and other proteins) as well as metabolic pathways. This expert has considerable experience in using enzymes in commercial processes, fermentation development, and co-factor recycling. This expert has appeared in both federal and State court and been deposed and crossed multiple times.
Start Drug Development Expert SearchExpert Witness #267522
This expert has many years of microbiology experience including practical proficiencies in pharmaceutical, biotech, medical device research and development, manufacturing quality and business development. This expert also brings to the table practical experience as a microbiology expert witness in patent litigation and product liability cases. This expert has successfully served as a microbiology expert witness on numerous cases, representing branded and generic drug companies, corporations and individuals, plaintiffs and defendants. This expert has supported clients during fact finding/expert discovery and claim construction in addition to providing consultation, patent review, expert opinion, deposition and trial testimony. This expert has also provided technical guidance to counsel in preparation of taking depositions.
This expert has significant education, training, skill sets and experience, and has provided legal support as a consultant and expert witness in many areas, including:
- Pharmaceutical microbiology
- Sterility assurance
- Good Manufacturing Practices (GMPs)
- FDA regulatory compliance
- Contamination control
- Sterilization
- Preservative and antimicrobial effectiveness
- Compounding pharmacy microbiology
- United States Pharmacopoeia (USP) testing
- Laboratory operations
- Ophthalmic formulations and contact lens care
This expert’s capabilities span a wide range of applications and functions, including, but not limited to:
- Manufacturing
- Sterility assurance and aseptic processing
- cGMP compliance
- Investigations of microbial excursions, presence of objectionable organisms and out-of specification findings
- Contamination control and bioburden reduction strategies for sterile and non-sterile fill-finish facilities
- Manufacturing isolator and RABS design, cycle development and microbiological validation
- Process development
- Manufacturing facility design and qualification
- Process Analytical Technology (PAT)
- Environmental monitoring (sterile and nonsterile)
- Fermentation, recovery and purification microbiological control (API, bulk drug)
- Process water monitoring and maintenance
- Disinfection and sterilization
- Cleaning validation
- Audit readiness
- Rapid microbiological method (RMM) validation and implementation
- Microbiology Laboratory
- Laboratory audits, optimization and management
- Laboratory design, qualification, optimization and automation
- Sterility test isolator design, cycle development and microbiological validation
- cGMP compliance
- Microbiology method suitability testing, including the harmonized Sterility Test and Microbial Limits Test, Antimicrobial Effectiveness testing, USP 1223 and1227
- Sterility testing (harmonized)
- Antimicrobial and preservative effectiveness testing
- Environmental monitoring
- Pharmaceutical-grade water analysis
- Bioburden and microbiological examination of nonsterile products (harmonized Microbial Limits Test)
- Disinfectant effectiveness validation
- Microbial identification strategies and instrument/method validation, including gene sequencing and MALDI
- Endotoxin analysis and method validation
- SOP and protocol development
- Method validation and technology transfer
- Pharmacopoeia (e.g., USP, Ph. Eur., JP) interpretation and compliance
- Risk assessments (e.g., objectionable organisms, microbial data deviation, bioburden excursions)
- Documentation and data management
- Rapid microbiological method (RMM) validation and implementation
- Quality, Regulatory and Product Development
- Failure investigations and root cause analysis
- Microbial data deviation investigations
- Audit response (e.g., FDA 483, warning letters, consent decree)
- Regulatory submission support associated with microbiological processes (e.g., NDA, ANDA, IND, BLA, marketing authorization)
- Pharmacopoeia (e.g., USP, Ph. Eur., JP) compliance
- Contact lens care and ophthalmic formulation development, manufacturing, stability testing and product release
- USP 797 compliance, pharmaceutical compounding of sterile preparations (compounding pharmacies)
Start Drug Development Expert SearchExpert Witness #262058
This expert's MBA makes this expert well-suited for a long year career in the business end of the pharmaceutical and ophthalmic device industries. This expert has experience bringing drugs and optical products to market and has been heavily involved in capital funding and business development. Further, this expert has intellectual property consulting experience and has been responsible for product licensing, IPO and private/public financings. This expert is new to expert witness work but has a significant consulting history.
Start Drug Development Expert SearchExpert Witness #124852
This expert is a physical analytical chemist with many years of experience in the development and characterization of a wide variety of drug-delivery systems, medical devices, and dietary supplements. This expert’s expertise also encompasses the management of formulation development, bioanalysis, and pharmacokinetics.
Much of this expert’s experience relates to oral solid dosage forms, with a significant portion of that experience in modified-release products. This expert’s professional background includes working as an innovator at generic pharmaceutical firms and in contract-research organizations. This expert is currently a consultant supporting product development, as well as consulting and testifying in civil and criminal matters. Prior to the consultancy, this expert held research and management positions with industry leaders.
This expert holds a Ph.D. in Pharmaceutical Chemistry, and a B.S. in Pharmacy. This expert is a named inventor on 4 patents in the pharmaceutical field, and is well published.
Start Drug Development Expert SearchExpert Witness #236196
This PCB/electronics expert holds a BS in Physics, an MS in Electrical Engineering, and an MS and PhD in Engineering Mechanics, and is a Professional Engineer with fellowship recognition from several prominent engineering, reliability, materials, automotive, and microelectronics packaging associations. This expert has served in editor-in-chief roles for prominent engineering and reliability publications for over 5 years, over 5 years, and over 15 years, respectively, and has also served as an editor for an electronics-related publication. This expert has served in an editor-in-chief role for a prominent engineering journal, participated in a number of national science academy studies and U.S. Congressional investigations in automotive safety, and served as an expert to a federal food and drug regulatory agency.
This expert is a university professor in both Mechanical Engineering and Applied Mathematics and has directed an engineering center funded by over 150 leading electronics companies worldwide. This expert is the author of over 30 books on product reliability, development, use, and supply chain management, as well as a series of books on the electronics industry in several Asian markets. This expert has written over 700 technical articles, holds over 10 patents, received a major award for visionary leadership in the development of physics-of-failure-based and prognostics-based approaches to electronics reliability, and was also awarded a fellowship for innovations in prognostics and systems health management. This expert has experience with PCBs and electronics, international teaching assignments and awards, and significant expert witness experience.
Start Drug Development Expert SearchExpert Witness #258306
This FDA industry expert holds a PhD and is an executive regulatory and quality consultant for drugs, biologics, and vaccines, with over 10 years of experience in senior investigator, group leader, and Chemistry, Manufacturing and Control (CMC), labeling, and compliance review roles involving Investigational New Drug applications (INDs), New and Abbreviated New Drug Applications (NDAs and ANDAs), and Biological License Applications (BLAs). The experience includes drugs, including small and complex molecules, therapeutic proteins, enzymes, monoclonal antibodies, and vaccines approved by the FDA or under clinical development for the treatment of neurological disorders, cancer, autoimmune and inflammatory diseases, and inborn errors of metabolism. This expert has conducted cGxP audits and pre-approval inspections for biologics and drug manufacturing sites as an FDA investigator and as a consultant domestically and internationally.
Experience includes U.S. FDA principal-investigator-level quality (CMC) and labeling review of biologics, biotherapeutics, drugs, and combination products.
Regulatory strategy experience includes development of briefing packages for Pre-IND, IND, 510(k), PMA, ANDA, BLA, and other technical and regulatory documents for submission to the FDA.
Inspection, compliance, and audit experience includes pre-approval inspections (PAIs), cGMP compliance, and audits of manufacturing sites for biologics, pharmaceuticals, and medical devices in compliance with 21 CFR Part 210 and 211, 21 CFR Part 820, 21 CFR Part 58, and 21 CFR Part 11, as well as FDA 483 remediation, responses to FDA Warning Letters, consent decrees, and import bans.
Additional experience includes scientific and technical due diligence audits and analysis for global investment firms, quality system development, assessment, and implementation, and product quality assessment using concepts from ICH Q8 through ICH Q11 and FDA manual references.
Start Drug Development Expert SearchExpert Witness #274276
This FDA regulatory sciences expert holds an MS, MBA, RAC, and FRAPS and leads a medical regulatory and clinical affairs consulting company specializing in FDA regulatory sciences, clinical trials, and Quality Systems for medical devices, diagnostics, and combination products.
For over 25 years, the consultancy has supported clients in attaining FDA approval or clearance for new products with innovative technologies, Quality System compliance, and achievement of company development goals. This expert holds a Master of Science in Biochemistry and has served as a Professor in a master's-level regulatory affairs program at a university.
This expert has a proven record of success in regulatory affairs and related areas across a broad range of regulated products, with over 30 years of experience in consulting and executive management teams in large and small companies. Regulatory and product development expertise includes medical devices, pharmaceuticals, and combination drug, biologics, and device products. This expert has complete familiarity with applicable FDA regulations related to raw materials, product specifications, and how regulations are promulgated, enforced, and updated.
This expert possesses deep knowledge of regulatory science and U.S. Food and Drug Law, with proficiency involving both drug and device regulators and a strong medical sciences background. This expert is an experienced expert witness and litigation consultant.
Start Drug Development Expert SearchExpert Witness #279073
This FDA regulatory/compliance expert is an FDA regulatory expert witness and FDA compliance consultant skilled in the regulations and submissions of drugs, biologics, and medical devices. This expert is a former FDA reviewer with over 30 years of experience as an independent consultant to FDA-regulated companies of all sizes and over 10 years of experience as an FDA regulatory expert witness.
This expert has broad and deep skills in all phases of drug development, including the full lifecycle of initial regulatory strategy, clinical trial planning, execution, data analysis, submission preparation, and FDA review. This expert is an authority in FDA regulations and the work required for the collection, analysis, interpretation, and presentation of information to FDA. This expert also has expertise in understanding and responding to an FDA reviewer's actions and reactions and has developed and taught classes while assisting companies with the preparation of all parts of drug submissions.
This expert has worked as an FDA regulatory expert witness in over 50 cases, has been deposed over 20 times, and has testified multiple times.
Start Drug Development Expert SearchExpert Witness #287627
This neurology/autism expert recently retired from clinical practice but remains available to pediatricians for phone consultations, maintains staff affiliations with well-regarded academic medical institutions in an honorary neurology role, and has presented on the treatment of Autism Spectrum Disorder with sulforaphane for a prominent neuroimmune institute. This expert has extensive experience with autism across patient care, research, drug development, peer-reviewed journal authorship, and leadership roles.
This expert values direct clinical care as the foundation for investigation that leads to improved clinical care, including appreciation of the importance of immune factors in autism, an area of research that continues to unfold. In recent years, this expert has focused on underlying cellular mechanisms that may contribute to autism and novel treatments. This expert co-founded a research foundation, served on its board, and conducted trials for the treatment of autism.
Start Drug Development Expert SearchExpert Witness #291799
This antimicrobial expert holds a Ph.D. in biomedical science with post-doctoral training in protein biochemistry, analytical chemistry, and pathogen genetics, and is an executive at a drug and device development translational lab specializing in wound care therapeutics and antimicrobials. This expert has over 25 years of experience in the biotech industry, working as a senior scientist, inventor, and founder of several biotech start-ups.
This expert is new to this expert witness field but holds over 60 patents and has numerous publications as a leading expert in antimicrobials.
Start Drug Development Expert SearchExpert Witness #291824
This dermatology expert is a board-certified dermatologist in private practice, holds an M.D. and FAAD credential, and serves in a medical director role for drug development strategies in dermatological clinical trials. This expert earned a B.Sc. in Nursing and Economics from a prestigious university and an M.D. from a well-regarded medical school.
In clinical practice, this expert regularly encounters hair dye allergy and has seen patients of all skin types, including African American patients, with allergies to hair dye.
This expert has experience as an expert witness and litigation consultant.
Start Drug Development Expert SearchExpert Witness #291847
This antimicrobial expert holds a B.A., M.A., and Ph.D. in Chemistry from a well-regarded university and is a department chair and professor of biochemistry, cellular, and molecular biology at a prestigious university medical school, with additional work as a visiting scientist at a federal translational science center.
The research laboratory works to elucidate mechanisms of drug resistance and to translate this knowledge toward the development of better therapy. Defects in transmembranous drug transport, ion transport, and cellular drug accumulation contribute to most examples of cellular drug resistance, so a major focus of the laboratory is to understand these phenomena in molecular terms. Current projects include cloning and expression of antimalarial drug resistance proteins, lipid kinases and other biomembrane-active enzymes, development of biochemical, immunological, and chemical biology approaches for studying their function, and design, synthesis, and testing of novel antimalarial drugs and drug combinations based on that information. There are intriguing molecular similarities between drug resistance in tumors, certain bacteria, and parasites, and this work may have broad implications.
This expert is an experienced expert witness and litigation consultant.
Start Drug Development Expert SearchExpert Witness #291885
This medical device design and development expert has more than 35 years of medical device product development experience, primarily as a project manager, and recently managed development of a combination medical device and drug product for an early-stage company.
This expert has served as an expert in a number of business disputes involving medical device product development.
Start Drug Development Expert SearchExpert Witness #300708
This international sanctions compliance expert practices law and provides strategic counsel on complex cross-border compliance and enforcement issues affected by political, policy, and legal decisions. This expert has advised domestic and international clients, including governments, multilateral organizations, financial institutions, companies facing crises, and people seeking strategic counsel on law and policy, with work spanning North America, Latin America, Europe, the former Soviet Union, the Middle East, North Africa, and East Asia.
This expert has relevant experience in international sanctions compliance and related expert work. This expert was responsible for policy development and legislation for a U.S. senator in the areas of banking and financial services, foreign relations, and law enforcement. This expert conducted numerous Congressional investigations involving international money laundering, drug trafficking, corruption, and fraud, including matters involving international political controversy, drug trafficking and money laundering in the Caribbean and Central America, and the global activities of a major international financial institution. This expert also had primary authorship responsibility for a Senate final report concerning that financial institution.
Start Drug Development Expert Search