Drug Development Expert Witnesses

drug development expert testimony

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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).

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. Litigation support work by a medical expert specializing in drug development could include expert report preparation, expert opinion 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.

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:

Cahn Litigation Services has the experience required to turn the search for an expert around quickly and provide the right balance of expertise and testimony to get the job done.

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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.

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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.

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Expert 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.

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Expert 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.

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Expert 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.

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Expert 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)

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Expert 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.  

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Expert 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.

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