Drew N. Kelner, PhD, is a classically trained Biochemist with 30 years of experience in the Biopharmaceutical Industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment.
During his long tenures at Bayer and Amgen, Dr. Kelner had the privilege of participating in the development, registration and/or lifecycle management of 15 biological drugs (9 BLAs), including Epogen, Neupogen, Aranesp, Neulasta, Prolia, Kogenate (Factor VIII), and Vectibix. He has deep experience in the development of biologicals for oncology and immune disorders, including Imlygic, the first licensed oncolytic virus for melanoma, and Blincyto, the first licensed immunotherapy (for leukemia) using a bifunctional ("BITE") antibody. His experience covers all aspects of biopharmaceutical product development, with proven expertise in the commercialization of manufacturing and quality operations for biopharmaceuticals, as well as extensive experience with global regulatory filings at all stages of the product lifecycle. Dr. Kelner’s development and commercialization experience cover both innovator (including first-in-class) therapeutics as well as multiple biosimilars.
Litigation Support - As President of Colorado Biotechnology Consultants, Dr. Kelner has experience as an expert consultant for Biopharmaceutical Patent Infringement and Trade Secrets litigation. He has written multiple declarations (U.S.) and Affidavits (Canada), largely around issues related to biosimilar patent infringement, leveraging his vast knowledge of the scientific literature and experience as a process development leader in both establishing intellectual property while designing ways around existing patents to enable unencumbered process and product development (where feasible).
Areas of Expertise: Dr. Kelner's scientific expertise covers all aspects of bioprocess development and commercialization, including extensive expertise in regulatory filings on a global basis. His areas of expert knowledge include Protein Biochemistry, Cell Biology, Immunology, and Protein Pharmacokinetics.
Ideal Client Engagement:
Case Experience Includes:
Increased quality and integrity of written expert reports, based on an expanded knowledge base Time savings by only having to coordinate and discuss a case with one expert as opposed to two or more Since there is so much overlap between fields in the medical profession it is often hard to determine where one scope ends and another begins. This ambiguity is dramatically decreased , and scope increased by combining physician, pharmacist, and pharmacologist into one Communication skills of a pharmacist and experience dealing directly with the lay-public, in addition to the knowledge and background of a physician is extremely beneficial describing technical details to a jury Practicing in different realms within the healthcare field has allowed Dr. Lee to integrate the multiple facets giving him a unique and distinct perspective that no other expert has
Criminal and Civil Cases Anaphylactic Reactions Overdosel Wrongful Death Cardiac Arrest Respiratory Arrest Fentanyl Overdose Dilaudid Overdose Pharmacist Mis-Fills Pharmacist Dispensing Errors Pharmacy Standard of Care Medication Adverse Effects Falls Related to Medications (in and out of hospital) Toxicology/Toxic Reactions Medical Marijuana Positive Drug Screens in the Workplace Workplace Safety Fit for Duty Testing
Howard S. Robin, MD, has over 40 years of experience in the field of Pathology. He is Board Certified in Anatomic, Clinical, and Immunopathology.
Dr. Robin has been the Medical Director of hospital, commercial, and specialty laboratories for over 4 decades. He has performed over 1,500 forensic autopsies for coroner systems. Dr. Robin has served as a Medical Director of continuing medical education for integrated health systems for 25 years, as well as blood bank Medical Director for 30 years.
Consulting - Dr. Robin helps biotechnology companies commercialize research assays as laboratory developed tests (LDTs) through the CLIA approval process. As a member of the College of American Pathologists and an inspector for the CAP, he is well versed in the preparation steps required for CAP accreditation.
Litigation Support - Dr. Robin has extensive experience as an Expert Pathologist in medical legal, product liability, medical group billing, laboratory medicine, and drug overdose cases. He has testified over 30 times in the last several years. Dr. Robin's services are available to attorneys representing both Plaintiff and Defendant and include autopsy interpretation and review, deposition, and trial testimony.
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Dr. James C. Norris, Ph.D., DABT, EURT is an Expert Witness in Toxicology and Pharmacology. He has Litigation and Arbitration experience in the United States, United Kingdom and Hong Kong. Dr. Norris has given testimony to government agencies, has acted as a consultant for the media (BBC) and is an Industrial Site Crisis Team Member. He is avaliable for both Plaintiff and Defense.
Areas Of Expertise:
Tracy L. Skaer, PharmD, FASHP, FASCP is a Professor Emeritus of Pharmacotherapy with over 30 years of pharmaceutical experience; 5 years as an expert witness. She is a licensed pharmacist in California, Idaho, and Washington. Dr. Skaer is a Fellow of the American Society of Health-Systems Pharmacists, the American Society of Consultant Pharmacist, and a Member of the American College of Clinical Pharmacist's (ACCP) Pain and Palliative Care Practice and Research Network (PRN). Dr. Skaer's research interests include chronic pain, comorbid mental illness in chronic disease, depression, anxiety disorders, insomnia, mindfulness, complementary and alternative medicine, and pharamcoeconomics and pharmacoepidemiology. Her research has been supported by over $3.2 million in grants from foundations and pharmaceutical industry. Litigation Support - Dr. Skaer has completed several expert cases across the United States. Her services are available to attorneys representing plaintiff and defendant and include record review, written reports, deposition, and trial testimony. Dr. Skaer's cases involve: