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
Dr. Stein is Adjunct Assistant Clinical Professor St. Louis University Emergency Medicine / Critical Care Physician at Mercy Hospital South. Has lectured nationally on Pain Management, In litigation support Dr. Stein furnishes an unbiased opinion on medical malpractice and negligence cases, not guaranteeing a favorable outcome but providing an honest assessment.
Over 400 cases reviewed.
Testified over 150 times (Deposition and trial)
Expert Services Include:
Richard M. Sobel, MD, DFAPA, has over 30 years of experience practicing Adult Psychiatry and Pain Management / Medicine. His specialty focus is in Pain Medicine, for which he has sub-specialty board certification, Psychotherapy, and Psychopharmacology. Dr. Sobel is currently a Clinical Assistant Professor in the Department of Psychiatry at Jefferson Medical School. A Distinguished Life Fellow of the American Psychiatric Association, Dr. Sobel is immediate Past President and continues to serve on the board of the Greater Philadelphia Pain Society, one of six regional chapters of the American Pain Society. He is a Representative of the Pennsylvania Psychiatry Society to the Safe and Effective Prescribing Practices and Pain Management Work Group of the Pennsylvania Department of Drug and Alcohol Programs. In 2014, Dr. Sobel was the recipient of the Dean's Award for Excellence in Education at Jefferson Medical College and, in 2013, was nominated Practitioner of the Year by the Philadelphia Psychiatric Society. Litigation Support - Dr. Sobel offers expert witness services to counsel representing both plaintiff and defendant. Dr. Sobel's services include Independent Medical Exams (IMEs), medical record review, utilization review, written reports, depositions, and trial testimony as needed. Areas of Expertise:
William Santoro, MD is Board Certified in Addiction Medicine and Family Medicine. In addition to being the Chief of the Section of Addiciotn Medicine at Tower Health and Medical Director at the Reading Hospital & Medical Center detoxification/rehabilitation program, Dr. Santoro is also the Medical Director at New Directions, Methadone Treatment center where he is responsible for all admission physical exams and for prescribing methadone to approximately 950 opiate dependant patients. Dr. Santoro is the Addictionist on staff at The Reading Hospital & Medical Center within the Department of Psychiatry. He is consulted by hospitalists to care for patients admitted to the hospital with addiction complicating their condition. Dr. Santoro runs a Medication Assisted Recovery Clinic, an outpatient program treating over 200 patients with buprenorphine (Suboxone) or Vivitrol maintenance. With an interest in Sports Medicine in 2001, he served as a volunteer physician for the U.S. Olympic Training Team in Lake Placid, New York. Dr. Santoro has been deposed more than a dozen times in the past several years. He has testified in court numerous times on behalf of the plaintiff as well as for the defense. He has testified in Federal Court and been involved in cases concerning the pharmacuetical industry.
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: