Drug Development Expert Witnesses

Denver, Colorado

Pharmaceutical Research, Infectious Diseases - Molecular biology, Microbiology, Science, Scientific research, Life Sciences, Drug development, Medicine, Literature review, Bacteria, Fungus, Medical chart review, Data analysis, Scientific advisor, Medical scientist, Biotech, Startup, Biomedical, infection

Education M.D. - University of Colorado School of Medicine Ph.D. - Molecular Biology, University of Colorado Anschutz Medical Campus B.A. - Summa cum laude Integrative Physiology, University of Colorado Boulder Awards Catalyst Awardee, National Academy of Medicine, Healthy Longevity Global Competition Molecular Pathogenesis of Infectious Diseases National Institute of Allergy and Infectious Diseases T32 Awardee Sobel Scholar, American Society for Investigative Pathology Howard Hughes Medical Institute Undergraduate Research Awardee I have spent the past 15 years immersed in science and medicine, building expertise across both research and clinical disciplines. Throughout my training, I developed the ability to analyze complex subjects and translate them into clear, actionable insights for diverse audiences. I take pride in making technical material accessible and useful, helping clients understand and apply complex information with confidence. My consulting career began as a scie...

Bethesda, Maryland

Pharmaceutical Research, Pharmaceutical Regulation - FDA, Biotechnology, Analgesia, Drug Development, Regulatory, Clinical Research, Neurology, Anesthesiology, Psychiatry, Medicine

Christopher D. Breder, MD, PhD is a physician-scientist with extensive experience in both the pharmaceutical industry and the U.S. Food and Drug Administration (FDA). As a former FDA Medical Officer and Lead Medical Officer, he contributed to the review of numerous INDs and multiple NDA/BLA approvals across neurology, anesthesiology, and rare diseases. In industry, he has served in senior clinical development leadership roles at Sunovion, Supernus, and Bristol Myers Squibb, and now consults widely across biotech, investment, and legal sectors. Dr. Breder brings deep expertise in clinical trial design, regulatory strategy, safety assessment, and product development from early-stage programs through approval, and into life cycle management. He has taught drug development, safety analysis, and pharmaceutical project management at the FDA, NIH, and Johns Hopkins University. His dual perspective from within the FDA and as an executive in drug development makes him uniquely valuable as a ...

Bethesda, Maryland

Pharmaceutical Research, DNA - Drug development, Gene therapy, Oligonucleotide, Drug manufacturing, Bioprocessing, Biologics, Biopharmaceuticals, Monoclonal antibodies, Peptides, Drug discovery, Biotechnology, Business valuation, Due diligence, Drug regulation, Therapeutics, Cell therapy, Drug research, Research and development, RNA therapeutics, Drug research

Management consultant and fractional management services to biopharma companies providing a broad set of services. Hands on management experience from Big Pharma, biotech companies, and as consultant COO for biotech companies. Consulting experience from Boston Consulting Group. Large industry network. Over 25 years broad experience in US, EU, Japan and Australia. Doctor of Science from MIT in Biochemical Engineering with minor in Management. Master of Science in Chemical Engineering from Royal Institute of Technology, Sweden. Consulting Experience from Boston Consulting Group, Arthur D. Little and IBM. Biopharma experience from Pharmacia, BASF Pharma and several biotech companies. Fulbright scholar. Member of the Umbrex, BiotechExcec and Alacrita consultant networks. Uniquely broad and deep experience both as a hands-on manager and consultant, in drug discovery, preclinical and clinical development (including IND filings and clinical trial management), biologics and gene thera...

Baltimore, Maryland

Pharmaceutical Regulation, Infectious Diseases - Food and Drug Administration (FDA), drug/biologics safety/labeling/post-marketing surveillance, FDA drug/biologics regulations/procedures/applications (INDs/NDAs/BLAs), clinical trials, drug development, pharmacy compounding, HIV, MRSA, antibiotics, hepatitis, osteomyelitis, influenza, C. difficile

Dr. Ross is a Yale fellowship-trained, board-certified infectious disease physician with expertise in clinical medicine, pharmaceutical development and regulation, and public health . An active clinician in practice for over 30 years, he provides patient care in the areas of infectious disease and primary care. Dr. Ross received his undergraduate degree in Molecular Biophysics and Biochemistry from Yale University and his medical degree from New York University School of Medicine. He completed his internal medicine residency training at NYU Medical Center and infectious disease fellowship training at Yale University. Dr. Ross also holds a M.S. and Ph.D. in Biochemistry from NYU, and a Master’s Degree in Biomedical Informatics from Oregon Health & Sciences University. Dr. Ross spent 10 years at the FDA’s Center of Drug Evaluation and Review (CDER) as a medical officer, senior medical reviewer, medical team leader, and new drug review office management official. He has extremely br...

Blue Bell, Pennsylvania

Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use

Ethical Full Lifecycle Labeling/Prescribing Information That Never Cuts Corners For Pharmaceutical Giants Merck, Shire, and J&J: Labeling strategy and leadership that brings product labeling and products to market supporting vaccines and treatments for infections, internal medicine, oncologic, and rare diseases. These include life-saving, ground breaking, and first-of-its-kind products. Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World. Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?” Provide leadership in support of label development for new applications, supplemental appl...

Lovettsville, Virginia

Pharmaceutical Research, Infectious Diseases - pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, medical microbiology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro, IP

25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense. Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs. As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...