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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:
Dr. Yadin B. David has over 35 years experience in Managing Medical Technologies from Pre-Purchasing Evaluation phase, to Installation, Training, Servicing and Incidents Investigation. His expertise includes wide variety of medical devices and accessories including infusion pump, laser, electrosurgery unit, monitors, X-ray, defibrillators, implants, monitors, warmers, surgical instruments and catheters. Dr. David is also an expert in Electromagnetic interferences (EMI) medical devices and in Telemedicine and TeleHealth systems. His experience includes review and analysis of patent infringements allegation and validity. Dr. David serves a Consultant for industry and institutions including the Food and Drug Administration (FDA), General Hospital and Personal Use Devices Panels, World health Organization (WHO)and medical devices manufacturers. His services include testing, adverse events investigation, engineering reports, equipment management program review and risk assessment. Dr. David has given many national and international presentations about medical technology management, telemedicine and medical devices regulations.He authored manuscripts, chapters and books.
Biomedical Business Resources LLC is a network of experts in the Medical Device Industry. With over 35 years of industry experience, their services include:
Mr. Crosby's product experience includes implantable devices (cochlear implants, cardiac pacemakers, implantable defibrillators, artificial heart, neurostiumulation), in vitro diagnostics, imaging (ultrasound and X-ray), software, AEDs, and patient monitoring. His clinical domain experience includes ophthalmology, otolaryngology, cardiac surgery, cardiology, orthopedics, pain management, anesthesia and intensive care.View Peter Crosby's Expert Witness Profile.