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Drug Development Expert Witnesses

Drug development disputes arise across the long, heavily regulated path from early discovery through FDA approval and commercialization, and litigation frequently tracks that process. Patent disputes over formulations, drug delivery methods, or manufacturing processes are common, as are contract disputes between pharmaceutical companies and contract research or manufacturing organizations. Regulatory compliance questions, including whether a company met FDA requirements during clinical trials, submissions, or post-approval obligations, frequently underlie business disputes over licensing, partnership agreements, and product claims. Because clinical and regulatory data can be dense and highly technical, disagreements over trial design, data interpretation, or regulatory strategy require close scientific scrutiny. At the center of most disputes is whether a company's scientific, regulatory, or contractual conduct met the standards represented to its partners or to regulators.

A drug development expert helps counsel interpret clinical trial data, regulatory submissions, and pharmaceutical science to build a case a court or jury can follow. In patent and licensing disputes, experts can assess whether a formulation, delivery method, or manufacturing process meets patent claim limitations or departs from the licensing agreement's specifications. In regulatory disputes, experts can evaluate whether clinical trial design, data reporting, or FDA submissions met applicable standards, supporting both liability and rebuttal positions. Experts can also address causation questions tied to drug safety or efficacy claims, connecting clinical and preclinical data to the claims at issue. This scientific grounding allows litigators to press patent, breach, or regulatory claims with the technical credibility such cases demand.

Because drug development spans disciplines from clinical pharmacology and toxicology to regulatory affairs and process chemistry, matching an expert's specific scientific and regulatory background to the case is critical to a credible presentation. The drug development professionals Round Table Group can provide have worked as pharmaceutical executives, chemists, and pharmacologists, with experience spanning clinical trial design, the FDA drug approval process, and pharmaceutical commercialization, and several have testified extensively on patent, regulatory, and product-related matters. We've completed more than 75,000 expert searches for litigators, and we apply that experience to identify candidates whose specific scientific background fits your case. Let us help you find the right drug development expert for your case by calling us at (202) 908-4500.

Kinds of Cases We Work On

Round Table Group helps our clients find a wide variety of Drug Development expert witnesses for cases like:

01

Milestone Payment Dispute Over Trial Results.

A biotech licensor sued the pharmaceutical company it had licensed a drug candidate to, alleging the licensee wrongfully withheld a milestone payment due upon the candidate hitting a specific efficacy threshold in its pivotal trial. We identified experts with experience in clinical trial design, statistical analysis plan interpretation, and drug development milestone criteria. The experts found the trial met the pre-specified primary endpoint defined in the license agreement despite a secondary endpoint narrowly missing significance, anchoring a settlement releasing the withheld payment.
02

Licensee Accused of Lax Development Effort.

A university technology transfer office sued the pharmaceutical licensee of one of its patented compounds, alleging the licensee failed to use the commercially reasonable efforts the license required, effectively shelving the program. We identified experts with experience in drug development strategy, industry development benchmarking, and licensing diligence obligations. The experts found the licensee's budget allocation far below what comparable sponsors devoted at the same stage with no documented rationale, driving a settlement terminating the license and returning rights to the university.
03

CRO Blamed for Trial Data Integrity Lapses.

A mid-sized biopharmaceutical sponsor sued the contract research organization running its multi-site pivotal trial, alleging systemic data integrity lapses forced exclusion of a substantial share of enrolled subjects from the primary analysis. We identified experts with experience in clinical trial operations, site monitoring practices, and data integrity auditing. The experts found the CRO had missed most required monitoring visits at the affected sites during a critical enrollment period, anchoring a settlement covering the trial extension needed to reach statistical power.
04

Buyer Says Trial Failure Was Concealed.

A large pharmaceutical company sued the sellers of a biotech it had acquired, alleging the sellers withheld unfavorable interim trial data that led to a primary endpoint miss shortly after closing. We identified experts with experience in clinical trial data review, data safety monitoring board practices, and M&A diligence in drug development. The experts found the interim analysis had flagged a lower-than-expected treatment effect months before closing that never appeared in diligence materials, anchoring a substantial post-closing purchase price adjustment.
05

Tech Transfer Fails to Scale Production.

A pharmaceutical sponsor sued the contract manufacturing organization engaged to scale up production of a biologic drug substance, alleging the technology transfer failed to replicate development-scale process performance and delayed commercial launch. We identified experts with experience in biologics process development, tech transfer scale-up methodology, and batch record analysis. The experts found the CDMO deviated from several critical process parameters during scale-up without documented justification, correlating with reduced yield and purity, and drove a settlement covering remediation costs.
06

Toxicology Study Flaws Delay IND Filing.

A drug developer sued the contract toxicology laboratory engaged to conduct IND-enabling safety studies, alleging flawed conduct forced repetition of a substantial share of the studies and delayed its IND filing by roughly a year. We identified experts with experience in nonclinical toxicology, good laboratory practice compliance, and study protocol auditing. The experts found the laboratory failed to follow its own approved dosing protocol for most animals in one pivotal study, invalidating its findings and anchoring a settlement covering the repeated studies and delay.
07

Comparator Drug Shortage Stalls Clinical Trial.

A trial sponsor sued the pharmaceutical company obligated to supply an active comparator drug for a head-to-head pivotal trial, alleging repeated shortfalls forced enrollment pauses at a substantial share of sites. We identified experts with experience in clinical trial supply chain management, comparator drug logistics, and enrollment impact analysis. The experts found enrollment at affected sites effectively paused for several months due to comparator unavailability, directly extending the timeline and anchoring a settlement covering delay costs.
08

Companion Diagnostic Failure Sinks Drug Partnership.

A pharmaceutical company sued its companion diagnostic development partner, alleging the diagnostic's failure to meet the analytical validation performance specified in their co-development agreement delayed the drug's regulatory submission. We identified experts with experience in companion diagnostic validation, analytical performance standards, and biomarker assay development. The experts found the diagnostic's sensitivity for the relevant biomarker fell meaningfully short of the specified threshold across most validation samples, driving a settlement covering a replacement diagnostic developer.
09

Orphan Drug Exclusivity Rights Disputed.

Two pharmaceutical companies disputed which held valid orphan drug market exclusivity for a rare disease indication after both pursued approval for chemically related compounds. We identified experts with experience in regulatory exclusivity strategy, drug development comparative analysis, and clinical superiority criteria. The experts found the compounds differed enough to trigger the clinical superiority exception based on a lower adverse event rate in the later compound's trials, resolving the exclusivity challenge in its favor.
10

Adaptive Trial Design Blamed for Failure.

A biopharmaceutical sponsor sued the biostatistics consulting firm that designed its pivotal trial's adaptive dose-selection algorithm, alleging a flaw caused selection of an ineffective dose for the confirmatory phase. We identified experts with experience in biostatistics, adaptive trial design methodology, and dose-selection algorithm validation. The experts found the algorithm was miscalibrated to systematically favor a lower, less effective dose whenever interim enrollment lagged projections, a scenario that occurred in the actual trial, driving a settlement.

Here are a few of our favorite Drug Development Expert Witnesses:

Missouri Outsourcing Pharmaceuticals Expert #53770

This sample expert has 25 years of experience, and specializes in the field of outsourcing pharmaceuticals with specific knowledge in the areas of contract development, contract manufacturing and contract research. Testified on contract drug development, CRO, CMO, CDMO, CRMO and CRAM

 

New York Organic Chemistry Expert #50211

This sample expert has 24 years of experience, and specializes in the field of organic chemistry, cardiovascular and CNS drugs with specific knowledge in the areas of antipsychotic, anti-anxiety, analgesia, hypertension, cardiotonic agents, ion channel modulators, vaccine adjuvants and drug delivery. This expert has 80+ research articles, 55 patents, and 35 invited lectures. Testified 7 times on topics such as antipsychotic, anti-anxiety, analgesia, hypertension, cardiotonic agents, ion channel modulators, vaccine adjuvants and drug delivery.

 

North Carolina Pharmacokinetic Modeling Expert #9759

I have 30 years of experience, and specialize in the field of biostatistics and pharmacokinetic modeling with specific knowledge in the areas of statistics, pharmacokinetics and drug development. I have testified on pharmacokinetic modeling.

 

Maryland Drug Development Expert #1664

I have 40 years of experience, and specialize in the field of pharmaceutical development with specific knowledge in the areas of regulatory affairs, clinical trials and treatments. I have published on such topics as methods of drug development, development and working with the FDA. I have testified 30 times on topics such as patents, clinical trials, and drugs, devices and other treatments.

 

New York Dermatology Expert #13475

I have 20 years of experience, and specialize in the field of dermatology with specific knowledge in the areas of dermatology, drug effects, side effects and cosmeceuticals. I have published on such topics as atopic dermatitis, drug safety and drug development. I have testified on medical malpractice. I have had dual success as both a clinical and academic dermatologist and as a venture capitalist.

 

Your Case Deserves The Best Drug Development Expert Witnesses

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The right expert witnesses and consulting experts can make your case. That’s why we have spent so many hours over the past quarter century making sure our clients have just the right expert team — whether one expert or many, early-stage advice or expert reports and testimony. Across over 50,000 expert search assignments, we have honed a unique, customized approach to identifying, analyzing and connecting with expert talent so you can focus on winning your case.

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Illinois Pharmaceuticals Expert #15117

I have 19 years of experience, and specialize in the field of pharmaceuticals with specific knowledge in the areas of pharmacology, toxicology and drug development. I have published on such topics as pharmacology, toxicology, drug development and regulatory affairs. I have testified 70 times on topics such as medical and pharmacy malpractice, patent litigation and contract research organizations.

 

Ohio Drug Development Expert #17575

I have 35 years of experience, and specialize in the field of biomedical sciences with specific knowledge in the areas of pharmacology, physiology and biomedical devices. I have published on such topics as drug effects and safety, biomedical devices, blood substitutes and heart imaging agents. I have testified on drug effect on cardiovascular system, toxicity of drugs and drug-drug interactions.

 

California Drug Development, Immunity Expert #18137

I have 30 years of experience, and specialize in the field of Medicine with specific knowledge in the areas of rheumatology, allergy and immunology. I have published on such topics as drugs, steroids, treatment, food safety, lupus and arthritis. I have testified 10 times on topics such as avascular necrosis, drug toxicity, methotrexate, the biologics and asthma.

 

North Carolina Clinical Drug Development Expert #18994

I have 15 years of experience, and specialize in the field of clinical drug development with specific knowledge in the areas of metabolic diseases, arthritis, immunology and Alzheimer’s. I have published on such topics as immunology, gastrointestinal diseases and arthritis.

 

New York Synthetic Organic Chemistry Expert #19710

I have 40 years of experience and specialize in the field of organic chemistry with specific knowledge in the areas of synthetic organic, bioanalytic and pharmaceutical chemistry. I have published on such topics as natural products synthesis, synthetic methodology and bioorganic chemistry. I have testified on drug discovery, drug development, chirality, stereochemistry, medicinal chemistry, and spectroscopic and physical characterization.

 

California Oncology Expert #22455

I have 15 years of experience, and specialize in the field of oncology with specific knowledge in the areas of genitourinary cancer, drug development and global markets. I have published on such topics as prostate cancer, bladder cancer and kidney cancer. I have testified 40 times on topics such as cancer causation, missed cancer diagnosis and international drug patients.

 

Arizona Drug Development Expert #23054

I have 15 years of experience, and specialize in the field of pharmacology with specific knowledge in the areas of drug development, the drug approval process metabolism and endocrinology. I have published on such topics as atherosclerosis, LDL modulation and heart disease. I have testified on cholesterol metabolism, inflammation and atherosclerosis. I have experience in academia, the pharmaceutical industry and federal regulation.

 

Virginia Drug Development Expert #28198

I have 35 years of experience and specialize in the field of biochemistry with specific knowledge of drug development, diagnostics and drug discovery. I have published on such topics as novel human therapeutic agents, peptide structure and function, and detection and confirmation of select agent toxins. I have testified on the purification and characterization of trace plasma proteins and the immunochemical characteristics of competing protein therapeutics.

 

New York Pharmaceuticals Expert #28764

I have 30 years of experience, and specialize in the field of pharmaceuticals with specific knowledge in the areas of drug development, discovery and commercialization. I have testified on litigation, settlements and patents.

 

Kansas Pharmacology, Drug Development Expert #21777

I have 23 years of experience, and specialize in the field of pharmaceuticals with specific knowledge in the areas of neuroscience, eye research and degenerative diseases of the central nervous system. I have published on such topics as neuroscience, eye research and degenerative diseases of the central nervous system. I have testified on pharmaceuticals, drug development and eye diseases. I am involved in basic science and clinical research as well as instruction of PhDs and MDs in the areas of pharmacology, neuroscience, eye, vision, brain, stroke, Alzheimer’s and other neurodegenerative diseases. I am directing a research group and actively working…

 

New Jersey Clinical Drug Development Expert #29037

I have 10 years of experience and specialize in the field of clinical drug development, with specific knowledge of lipid metabolism, atherosclerosis and diabetes. I have published on such topics as clinical trials of novel lipid-lowering agents and the utility of biomarkers of atherosclerosis. I have testified on pharmaceutical clinical development programs.

 

Pennsylvania Drug Development, Pharmaceutical Expert #29688

I have 18 years of experience, and specialize in the field of medicine and pahrmacology with specific knowledge in the areas of cardiovascaulr disease, drug development and clinical pharmacology. I have published on such topics as coz 2 inhibitors, women’s cardiovascualr health, antioxidants, cardiovasculr risk management and dyslipidemia. I have testified on cardiovascular death, cox 2 inhibitors and PPAR agonsits.

 

Ohio Drug Development Expert #31701

I have 30 years of experience and specialize in the field of drug development, with specific knowledge of process chemistry, project management and good manufacturing practices (GMP) regulations. I have published on such topics as antibacterials, antifungals and kinases. I have testified on infringement.

 

Pharmacology, Drug Development Expert #36709

I have 15 years of experience, and specialize in the field of drug development with specific knowledge in the areas of psychopharmacology, clinical trials and minimizing placebo responses. I have published on such topics as mood disorders, imaging studies and several other areas in psychiatry. I have testified on natural health products, mood disorders and clinical development. I have an unusual combination of clinical and business experience in the pharmaceutical industry, and extensive academic expertise in psychopharmacology.

 

New Jersey Drug Development Expert #37110

I have 25 years of experience, and specialize in the field of pharmaceutical and biological drug and device development with specific knowledge in the areas of regulation, FDA approvals and post approval regulation and advertising review. I have published on such topics as human organ transplantation, cancer diagnosis and treatment and virology. I met with the president’s science advisor, worked with 6 Nobel Prize winners, have served on advisory panels and received several awards.

 

Arizona Drug Development Expert #39561

I have 12 years of experience, and specialize in the field of cancer medicine with specific knowledge in the areas of treatment and diagnostics. I have published on such topics as cancer therapy and biology.

 

Vermont Cardiovascular Disease Expert #39727

I have 30 years of experience, and specialize in the field of cardiovascular disease with specific knowledge in the areas of drug development, biotechnology, cardiac imaging, diabetes and insulin resistance. I have published on such topics as myocardial infarction, diabetes, thrombolysis, clinical trials, molecular biology, improving prognosis with novel therapeutic approaches, and coronary artery disease. I have testified on drug toxicity, pesticides, intellectual property and patent infringement.

 

Biotechnology Expert #40911

I have 25 years of experience and specialize in the field of biotechnology of complex sugars, with specific knowledge of heparin, low molecular weight heparin and heparan sulfate. I have published on such topics as heparan sulfate, heparin and glycobiology.

 

California Drug Development Expert #46679

I have 22 years of experience and specialize in the field of regulatory and drug development with specific knowledge in the areas of biotechnology, pharmaceutical development and Japanese regulations. I have published on such topics as taxol synthesis, drug development and regulatory history. I have testified 22 times on topics such as compliance issues, fraud in drug development, and company lawsuits in pharmaceutical and biotechnology development.

 

California Drug Development Expert #48632

I have 30 years of experience, and specialize in the field of clinical pharmacology with specific knowledge in the areas of pharmacokinetics, drug metabolism and bioequivalence. I have published on such topics as pharmacokinetics, drug metabolism and bioequivalence.

 

New York Drug Development Expert #51341

I have 20 years of experience and specialize in the field of pharmaceutical science with specific knowledge in the areas of formulation, controlled and modified release, and solubility and stability. I have published on such topics as stability of amorphous dosage forms, pulsatile microdialysis and transdermal drug delivery. I have testified on solid solutions in dosage forms and the effects of water in the formulation process.

 

Virginia Gastroenterology Expert #42504

I have 25 years of experience, and specialize in the field of gastroenterology with specific knowledge in the areas of ulcerative colitis, Crohn’s disease and irritable bowel syndrome. I have published on such topics as diarrhea, constipation and irritable bowel syndrome. I have testified on bile duct perforation and Crohn’s disease. I have been uniquely positioned at the level of translational medicine between drug discovery, drug development, and clinical medicine. I have served not only as a professor of medicine and researcher, but also experienced biotech and pharmaceutical executive, bridging these two worlds.

 

Washington D.C. Organic Synthesis Expert #42770

I have 27 years of experience, and specialize in the field of organic chemistry with specific knowledge in the areas of synthesis, drug development, polymorphs, bioequivalence and oral formulations. I have published on such topics as new synthetic reactions and methods, new formulations and process development. I have testified on intellectual property and drug development. I co-organize and teach a series of four 2-week courses in drug development for African pharmaceutical professionals (Moshi, Tanzania). We recently graduated our first class and these individuals are, with their home companies, writing submissions for approval to the US FDA and WHO pre qualification…

 

Ohio Hematology and Oncology Expert #43435

I have 23 years of experience, and specialize in the field of hematology and oncology with specific knowledge in the areas of genitourinary, melanoma, sarcoma, gastrointestinal malignancies, breast cancer, lung cancer, leukemia and lymphomas. I have published on such topics as cancer cell biology, IL-2 treatment in renal cell carcinoma, a variety of cancer agents in clinical trials and preliminary data on a new serum marker for prostate cancer. I am a seasoned cancer clinician and clinical investigator. I have extensive training and expertise in the area of cancer drug development, clinical trials and requirements for FDA approval of anti-cancer…

 

Virginia Drug Development Expert #46538

I have 27 years of experience, and specialize in the field of drug development with specific knowledge in the areas of clinical drug development, regulatory affairs, clinical trials and GCP. I have published on such topics as clinical trials in HIV infection and the late cutaneous response in allergy. I have testified on drug development related cases. I chose to develop my career in drug development after obtaining significant hands-on experience in patient care during my internship, residency and fellowship. As a result, I have a broad clinical hands-on patient experience that enhances my ability to advise clients regarding all…

 

Pennsylvania Clinical Pharmacology Expert #48129

I have 30 years of experience, and specialize in the field of clinical pharmacology with specific knowledge in the areas of forensic toxicology, clinical research and drug development. I have published on such topics as drug interactions, toxicology; phase 1 clinical studies, pain management, pharmacokinetics, and drug overdose. I have testified 12 times on topics such as blood alcohol, drug overdose, drug interactions and medical malpractice. I can authoritatively discuss a broad range of topics from the most basic science aspects of organic chemistry and mechanistic toxicology to the most clinical aspects of primary care and intensive care medicine.

 

Utah Antiviral Chemotherapy Expert #50228

I have 32 years of experience, and specialize in the field of antiviral chemotherapy with specific knowledge in the areas of pre-clinical drug development in cell culture and animal models, working with pharmaceutical companies and evaluating scientific data pertaining to this field. I have published on such topics as anti-herpes compounds related to acyclovir and ganciclovir, the anti-influenza compounds related to oseltamivir and zanamivair and antiviral compounds related to ribavirin. I have testified on anti-herpes approved Federal Drug Administration drug. I have professional experience in industry, academia, and working for the government. My field of expertise is applied, i.e., to…

 

California Pharmacology and Toxicology Expert Witness #5686

I have 40 years of experience, and specialize in the field of basic medical science, non-clinical medicine with specific knowledge in the areas of toxicology, pharmacology, medical biochemistry, drug toxicity, adverse drug reactions, illicit drugs, nutritional supplements and drug interactions. I have published on such topics as toxicology, forensic toxicology, drug metabolism, drug developments, toxic reactions to drugs and chemicals, bacterial infections and antibiotics. I have testified 50 times on topics such as toxicity of chemicals, pharmaceuticals illicit drugs, prescribing errors, drug overdoses, wrongful deaths and drug interactions. I have been a practicing toxicologist for 44 years with experience in…

 

Put Our Drug Development Expert Network to Work for You

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Our huge network of experts – eminent university professors and practitioners who have achieved renown as thought leaders in their fields – combined with unparalleled research capabilities puts the experts you need at your disposal when and where you need them.

If you’re a litigator or general counsel, we want to put this network to work for you and your clients. Let us know how we can help by calling us at (202) 908-4500 or filling out the form on this page. We’re so confident you’ll love what we do that unless you retain an expert we present there’s no charge!

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Questions Attorneys Ask About Drug Development Expert Witnesses:

Counsel typically need a drug development expert when a case involves patent claims over formulations or delivery methods, contract disputes between pharmaceutical companies and their research or manufacturing partners, or regulatory compliance questions tied to FDA submissions and clinical trial conduct. These experts are also valuable in commercial disputes over licensing agreements and product performance representations. Early engagement helps counsel frame discovery around the specific scientific and regulatory record at issue.
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