Biologics Expert Witnesses

Biologics expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on biologics. The biologics expert witness listings on this page are typically from fields/areas of expertise such as: Biomedical Engineering, Dermatology, DNA, Infectious Diseases, Internal Medicine, Nurse Practitioner, Pharmaceutical Research, Physician Assistant, Products Liability, Rheumatology, and Wound Care.

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Jeffrey Brown, PhD

Finding the cause of biomedical product failures

Compass Consulting Engineers

Westminster, Colorado
Products Liability, Biomedical Engineering - Medical device, Biologics, Manufacturing, Risk Management, Design History File, FMEA, Stem Cells, Biomaterials, Product Liability, Intellectual Property, Implant, Collagen, Device testing, Design Controls, Product labeling, CDMO, Quality/Regulatory, Allograft, Forensic Science
10+ years in medical device/biologics design, development, and manufacture 15 years in design and operational engineering Inventor on two biomedical patentsQualified Nuclear Engineering Officer in the US Navy First author for 3 peer-reviewed original scientific research articles
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Lidia Pomaville, PA-C, MPAS

Dermatology PA Expert Witness

Chicago, Illinois
Physician Assistant, Dermatology - skin cancer, skin infections, wounds, medication side effects, chemical peels, melanoma, psoriasis, physician assistant scope of practice, skin surgery, biopsies, cosmetics, atopic dermatitis, physician assistant standard of care, laser, cysts, fillers, pigmentation, biologics, Accutane, burns
Lidia Pomaville is a board-certified PA with over 24 years of healthcare experience. She began her medical training at the prestigious Mayo Clinic in Rochester, MN, where she earned a Bachelor's degree while working at the hospital. Lidia completed her Master of Science degree in PA studies at Wichita State University in Kansas in 2011 and currently practices medical and cosmetic dermatology at Forefront Dermatology in Berwyn, IL. She holds an Adjunct Assistant Clinical Professor position with Marquette University and University of Dubuque. In addition, she maintains a clinical site for precepting PA students for Rush University, Rosalind Franklin University, Dominican University, Marquette University and University of Dubuque. She has co-authored multiple articles for medical publications and lectured on dermatology topics locally and nationally. Lidia is a member of the American Academy of PAs, IL Academy of PAs, IL Society of Dermatology PAs, and a Diplomate Fellow of the Society...
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Donald E Thomas, MD, FACP, FACR, RhMSUS

Rheumatology Expert Witness | 30+ yrs Experience

Arthritis and Pain Associates of Prince George's County

Greenbelt, Maryland
Rheumatology - Lupus, Sjogren's, Rheumatoid Arthritis, Autoimmune Disease, Connective Tissue Disease, Immunosuppressants, Biologics, Psoriatic Arthritis, Osteoarthritis, Fibromyalgia, Gout, Joint Injections, Osteoporosis, Accident-related Arthritis, Rheumatology, Rheumatology Patient Evaluation, Rheumatology Exam, Neck Pain, Back Pain
Qualifications • Practicing rheumatologist with 30+ years of clinical experience • Board-Certified Rheumatologist • Clinical Professor of Medicine • Author: The Lupus Encyclopedia (Johns Hopkins University Press) • Expert witness since 2010 with extensive deposition and case review experience • Chair Emeritus, Chair Medical and Scientific Council, Lupus Foundation of American, DC/MD/VA • Past Chair, Sjögren’s Foundation Board Why Retain Dr. Thomas • Clear, effective communicator skilled at explaining complex medical issues • Time-efficient: prioritizes expert cases, meets deadlines, and produces thorough reports • Experienced at reviewing complex cases and basing conclusions on objective evidence • Responsive: direct access via cell and email, with prompt turnaround on calls and requests • Available nationwide for medical record review, deposition, and testimony Contact: (202) 431-6909 Email: donthomasj@proton.me www.LupusEncyclopedia.com/about LinkedIn: www.linkedin.com/in/donald...
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Per Lindell, Sc.D.

Expert on biopharmaceutical industry, MIT Sc.D.

Novadigm Consulting Group

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...
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Seana Rutherford, DNP, MSN, APRN, FNP-C, CWS, WCC

Board Certified Wound Specialist NP

Legal Wound Care Consulting

Cleveland, Ohio
Wound Care, Nurse Practitioner - pressure injuries, vascular wounds, non-healing wounds, burns, atypical ulcer, nursing homes, arterial ulcers, biologics, osteomyelitis, diabetic ulcers, venous ulcers, negative pressure wound therapy, wound infection, decubitus ulcers, lymphedema, surgical wounds, wound debridement, stasis ulcers
Dr. Seana Rutherford is a board-certified Nurse Practitioner and nationally recognized wound care expert with nearly 20 years of nursing experience and advanced clinical practice since 2015. She holds dual certifications as a Certified Wound Specialist (CWS®) through the American Board of Wound Management and as a Wound Care Certified (WCC) clinician through the National Alliance of Wound Care and Ostomy. Dr. Rutherford’s expertise spans the continuum of care, with direct clinical experience in hospital, home health, long-term care, and domiciliary settings. She is the founder of Healix Wound Care, a practice dedicated to the treatment of complex wounds in post-acute environments. Through master-level wound care certifications and first-hand clinical experience, Dr. Rutherford and her team at Legal Expert Wound Care Consultants provide comprehensive wound case reviews, expert witness statements, depositions, and testimony at trial. With astute knowledge of Minimum Data Set (MDS) d...
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Mary Abraham, MD, MBA

Board Certified Rheumatologist w/ Academic Experti

Corvallis, Oregon
Rheumatology, Internal Medicine - Rheumatology, Autoimmune diseases, Medication Adverse effects, Biologics, lupus, fibromyalgia, psoriatic arthritis, rheumatoid arthritis, DMARDS, osteoarthritis, Central pain sensitization , Gout, Pseudogout, Ankylosing spondylitis, Sjogrens, Dermatomyositis, Interstitial lung disease, scleroderma, MCTD, osteoporosis
Professional Summary Board-certified rheumatologist with over 8 years of experience managing complex autoimmune and inflammatory disorders, including lupus, vasculitis, rheumatoid arthritis, fibromyalgia, and IgG4-related disease. Extensive experience in interpreting longitudinal medical records, evaluating treatment appropriateness, and providing evidence-based opinions on standard-of-care and medication adverse events. Experienced lecturer and mentor, recognized for clear communication, analytical rigor, and professional judgment. Available for expert consulting, medical record review, depositions, and testimony. Licensure & Certification • Medical Licensure: Oregon (#MD211734), New York (#290534) • Board Certification: Internal Medicine (2015), Rheumatology (2018) Education • Doctor of Medicine (MD) — Albany Medical College, Albany, NY (2008–2012) • MBA, Health Administration — Union Graduate College of Union University, Schenectady, NY (2006–2008) • BS in Biology & Sociology...
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Peter Coderre, PhD

Antimicrobial Regulatory Consulting

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...