Pharmacy / Pharmacology / Pharmaceuticals Consultants

Tracy L. Skaer, PharmD, FASHP, FASCP is a Professor Emeritus of Pharmacotherapy with over 30 years of pharmaceutical experience. Dr. Skaer's research and professional experience includes pharmacy practice, chronic pain, mental health, substance abuse, and complementary and alternative medicine. She is licensed pharmacist in California, Idaho, and Washington. Dr. Skaer’s current research involves the use of mindfulness and multiple family group problem solving for the Treatment of Chronic Pain in those with high risk of Opioid Use. Her plans are to expand this intervention to manage chronic insomnia and post-traumatic stress disorder in children and adolescents, American Indians, veterans, and other populations. Other 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. Dr. Skaer has published 110 professional abstracts, 82 research papers, 43 review articles, and 6 book chapters. She serves on the editorial boards of 3 medical professional journals, Clinical Therapeutics, Journal of Sleep Medicine and Disorders, and Pain Studies and Treatment. Dr. Skaer's publications have appeared in numerous journals including, Drugs, Clinical Drug Investigation, PharmacoEconomics, Journal of Clinical Pharmacy & Therapeutics, American Journal of Medicine, Harvard Review of Psychiatry, and the New England Journal of Medicine among others. View Dr. Skaer's Expert Witness Profile.

Alan J. Waldman, MD, has practiced Forensic Neuropsychiatry and Forensic Psychiatry for over 20 years. He specializes in the evaluation of head injuries, dementia, any type of post accident cerebral neuropathy, and any neuropsychiatric / psychiatric disorder. The learning and honing of Dr. Waldman's skills progressed through his stint as full time faculty at the University of Florida, his subsequent private practice, the neuropsychiatric consultant to a head injury rehabilitation and residential facility, and the medical directorship of a 217 bed State of Florida forensic psychiatric institution. While at the institution, he did consultations on the head injured patients and those suspected of malingering. Litigation Support - Dr. Waldman has evaluated over 400 respondents or potential respondents, for the state and defense in Florida's post incarceration sex offender program. He has testified in approximately 50 hearings and trials (again for both sides) and has been qualified as an expert in the prediction of sex offender recidivism risk. He has a great deal of experience in the detection of Embellishment and Malingering. Dr. Waldman has been qualified as an expert witness in circuit, county, and federal courts through out Florida. He was retained by the Office of the Attorney General of Texas in Austin for a case involving questions of malingering by a death row inmate whose case was remanded back to the Federal District Court in Austin by the U.S. Supreme Court. Dr. Waldman has testified in courts in California, Illinois, New Jersey, Ohio, Maryland, New Hampshire, and Texas. Areas of Expertise:

Sexually Violent Predator Evaluations Brain Injury Criminology Competence to Proceed (Stand Trial) Forensic Psychiatry Forensic Psychology IMEs Malingering Embellishment Neurophysiology Neuropsychiatry

Neuropsychology Neuropsychopharmacology Impaired Driver Post Traumatic Stress Disorder Sanity / Trial Competency Sexual Abuse Cognitive Impairments Sexual Harassment / Discrimination Spousal Abuse Stalking Suicide

TOXICULL Associates provides technical support to industries involving Chemical, Drug and Alcohol, and Environmental Toxicology issues. TOXICULL Associates provides the following consulting services:

• Therapeutic and Environmental Chemical Exposure Evaluations
• Site Inspections
• Health and Environmental Data Acquisition
• Fire- Assoicated Health Assessments
• Technical In-service Development

Dr. John P. Bederka, PhD, Director at TOXICULL, has over 30 years of experience as a Toxicologist with specialized knowledge of Chemistry, Pharmacology, and Neuropharmacology. Dr. Bederka served as Section Head of Toxicology and Therapeutic Drug Monitoring for the Abraham Lincoln School of Medicine at the University of Illinois Medical Center. His practice covers Occupational Exposure, Residential Exposure, Adverse Health Effects, and Chemical Substances of Abuse.

Dr. Bederka has written extensively on the subjects of chemical, drug and alcohol, and environmental toxicology. His consulting services were called upon for the Exxon Valdez oil spill and his recent work involves chemicals in Hydrofracking Fluids in Shale Gas extraction.

View Dr. Bederka's Expert Witness Profile.

Mohan Nair, MD, trained at the University of California (Irvine) and Harvard and is board certified by the American Board of Medical Specialties in:

Brain Injury Medicine Psychiatry Child Psychiatry Forensic Psychiatry

Addiction Medicine Pain Medicine Psychopharmacology Behavioral Neurology / Neuropsychiatry

Dr. Nair brings his extensive training, clinical experience, and formal board certifications to provide in-depth and nuanced medico-legal analysis of cases for both adults and children involving brain injury, frequently and tragically combined with chronic pain and severe psychological trauma (PTSD). He is committed to comprehensive and accurate forensic examinations, quality neuropsychological assessment, and use of the most up to date technology available in the field. Litigation Support - Dr. Nair has provided extensive trial testimony in defense and plaintiffs cases. With cases primarily involving Traumatic Brain Injury and PTSD - Post Traumatic Stress Disorder, he provides and coordinates medical, psychological, neuropsychological, toxicological, and imaging experts for complex civil litigation.

Dr. Nair is familiar with the milieu of the courtroom and its adversarial nature that can be intimidating for non-forensic scientists. He will provide timely and jargon free IME reports when needed and prepare for and withstand forceful cross examinations. He provides the full spectrum expert witness services for personal injury/civil litigation, criminal cases, private disability, medical board investigations, and employment litigation, including confidential consultations, record reviews, litigation support for IME, depositions, witness preparation, and trial testimony.

EDUCATION:

• 1970-75 Doctor of Medicine, University of Bombay
• 1981-83 Clinical Fellow in Child Psychiatry, Harvard University; McLean Hospital / Massachusetts General Hospital
• 1978-81 University of California at Irvine: Residency in Psychiatry

LICENSES:

• Board Certified: Brain Injury Medicine, Psychiatry, Child & Adolescent Psychiatry, Forensic Psychiatry, Addiction Medicine, Behavioral Neurology & Neuropsychiatry, Clinical Psychopharmacology, Pain Medicine
• Board Certification: United Counsel for Neurologic Subspecialties, Behavioral Neurology & Neuropsychiatry
• American Society of Clinical Psychopharmacology

Ted W. Simon, PhD, DABT, is an award winning Environmental Toxicologist and Scientist. His expertise is in toxicology, risk assessment, mathematical modeling, statistics, neuroscience, and environmental / ecological health issues.

Dr. Simon has over 10 years of experience as a toxicologist employed by the Environmental Protection Agency (EPA). He served as EPA’s senior toxicologist in the waste management division working on risk and soil cleanup.

Teaching Experience - Since 2001, Dr. Simon has served as an Instructor / Adjunct Professor in the Department of Environmental Health Science, College of Public Health, at the University of Georgia.

Public Speaker - Well published, including the author of a textbook on toxicology and environmental risk assessment, Dr. Simon has extensive national and international public speaking experience. Since 1996, he has been delivering seminars and lectures to universities and national institutes on many subjects within his area of expertise. In 2016, he delivered a lectures on “Bayesian Methods for Application of Uncertainty Factors,” to the Society of Toxicology Annual Meeting, New Orleans, LA, and “Quantitative Prediction of Phenotypic Change from High Throughput Assay Results,” to the EPA's Workshop on In Vitro to In Vivo Extrapolation, Research Triangle Park, NC.

Litigation Support - Dr. Simon has over 15 years of experience offering expert witness services to counsel representing both plaintiff and defendant. He has been retained over 20 times since 2000 for cases involving environmental risk, drug and alcohol cases, DUI, accidental poisoning, and intellectual property. Dr. Simon has particular expertise in dioxin-like chemicals and polychlorinated biphenyls (PCBs). His services include consulting, reports, deposition, and trial testimony when necessary.

Areas of Expertise:

Dioxins PCBs Drugs Alcohol Poisoning DUI / DWI Water Contamination Soil Contamination Environmental Risk Assessment

Environmental Toxicology Carcinogenicity Food Contamination Pesticides Fracking Lead Marijuana Polychlorinated Biphenyls Intellectual Property

Justina E. Ogbuokiri, BSc, RPh, PharmD, FASCP, is an associate professor of Clinical Pharmacy at Xavier College of Pharmacy and the Consultant Clinical Pharmacist at the HIV Outpatient Clinic of the Medical Center of Louisiana in New Orleans. She has over 30 years of experience in her field of expertise.

Dr. Ogbuokiri designed community-based population focus care delivery models and curricula for adults living with HIV / AIDS and developed peer-to-peer relationships with physicians and drug therapy management services in the clinical management of patients with HIV / AIDS for the past decade and previously in tropical diseases.

Dr. Ogbuokiri has presented over 50 HIV workshops and traineeships to providers locally within the tri-state area and nationally since 1996. She has provided medication management services in HIV / AIDS to the HIV Outpatient Program (HOP) in New Orleans, with a patient load of 3,000-plus registered patients, the largest HIV ambulatory care clinic in the Southeastern Region of the United States.

Consulting - Dr. Ogbuokiri currently serves as a researcher and consultant to the World Health Organization Tropical Diseases Research Programme in Onchocerciasis, a clinical pharmacy specialist and consultant to the HIV Outpatient Program, and Co-principal investigator to the National Minority AIDS Education and Training Center. She also offers technical support and consultant to the HIV / AIDS pharmaceutical industry and Health Resources Service Administration (HRSA) in the area of HIV / AIDS, mental disorders, and other co-morbidities.

Specific Areas of Expertise:

• Pharmacokinetic studies of drugs used in onchocerciasis and malaria
• Operational research in key tropical diseases such as malaria and onchocerciasis
• Preceptorships and workshops in the pharmaceutical care process in HIV / AIDS
• Development of web-based teaching strategies and a web-site for HIV student preceptorship
• Design and development of workshop curricula based on provider needs assessment
• Capacity building for community-based AIDS service organizations (ASOs)
• Pharmacy and Therapeutics (P&T) committee and drug formulary management

View Dr. Ogbuokiri's Expert Witness Profile.

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:

• Carcinogenicity and Chemicals
• Combustion or Fire Toxicolog
• General and Inhalation Toxicology
• Pesticides, and Pharmaceuticals (pharmacology)

Professional Affiliations:

• American Association of Pharmaceutical Scientists
• British Toxicology Society
• Society of Toxicology
• Editorial Boards of Inhalation Toxicology and Journal of Fire Sciences

MRK Medical Consultants provides Medical-Legal Evaluations to help legal and insurance professionals reach appropriate conclusions about their client's situations. MRK provides a wide array of medical experts that offer objective review and analysis of personal injuries. Each stage of the process—research to review, analysis to opinion—is addressed in a comprehensive manner in order to help legal and insurance professionals reach appropriate conclusions about their client’s situations. MRK has over forty board certified physician specialists and many with subspecialty certifications. MRK provides physician experts to the entire State of California, the Reno/Lake Tahoe area and Las Vegas, and we travel to many areas of the United States. Physical therapy, registered nurses, physician assistant and billing review consultants are available services MRK provides. Oncall MD's in office daily to discuss your needs if you are unsure of what expert you need.

Edward W. Younger, III, M.D., Medical Director of MRK Medical Consultants, specializes in Orthopedic Surgery. He has extensive experience in total joint replacement, as well as reconstructive surgery of the knee, hip and shoulder. He was instrumental in bringing computer navigation technology to his hospital. He has served on the orthopedic trauma staff at Mercy San Juan Medical Center and serves on the Medical Executive Committee at Mercy San Juan. He is a member of Alpha Omega Alpha National Honor Society and is a Diplomate of the American Board of Orthopedic Surgery, a member of the American Medical Association, the American Academy of Orthopedic Surgeons and the California Orthopedic Association.


Dr. Michael R. Klein, Jr., M.D., specializes in Orthopedic Surgery and is a founding member and the first Medical Director of Northern California Orthopedic Centers. He is a senior member of the medical staff at Mercy San Juan Medical Center and was involved with the development of the orthopedic section of the Level II Trauma Center.

Dr. Klein is a clinical instructor at University of California, Davis, Medical Center, a Fellow of the American College of Surgeons and American Academy of Orthopedic Surgeons and a member of the American Medical Association and the California Medical Association.

MRK's Areas of Expertise:

Orthopedics Neurosurgery / Neurology Rheumatology General surgery / trauma Emergency Medicine Internal Medicine Cardiology Geriatrics Sports Medicine RN Physical Therapy Chiropractic Orthopedics

Neuropsychology Podiatry Vascular Surgery Family Practice Anesthesiology Ophthalmology Optometry Urology Gastroenterology Infectious Disease Pulmonary Medicine Critical care Otolaryngology

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.

Areas of Expertise:

Pathology Autopsy Toxicology Immunology Pharmacology - Drugs of Abuse DUI Alcohol / Intoxicants

Cancer Diagnosis / Prognosis Predictive Laboratory Testing Transfusion Medicine Blood Banking Issues Adverse Drug Reactions Liver and Kidney Pathology

David Clay Griffin, RPh, has over 30 years of experience in Retail and Community Pharmacies and still actively working as a pharmacist and pharmacy manager. Well-versed in practice standards and pharmacy operations, including controlled substance laws and policies, as well as financials, inventory, sales.

Throughout his Pharmacy Management career, Mr. Griffin also served as a pharmacist for the United States Department of Health and Human Services in Dallas, Texas (2002/2017). He worked with the Texas 4 Disaster Medical Assistance Team and was the Pharmacy Unit Leader with NDMS over several missions.

Mr. Griffin consults and serves as a pharmacy expert witness for attorneys representing both plaintiff and defense. His services include medical record review, thorough reports, depositions, and trial testimony.

Areas of Expertise:

Pharmacy Practice Standards Retail Pharmacies Community / Independent Pharmacies Drug / Medication Errors Pharmacy Drug Interactions Medication Overdose and Under-dose Medication Interaction / Drug Utilization Review

Pharmaceuticals Adverse Reactions Pharmacy Safety and Counseling Pharmacist Duty to Warn Pharmacy Operation Staff Supervision and Training Controlled Substance Laws and Policies DUI / DWI

Dr. Matthew Lee is a Physician, Pharmacist, Pharmacologist and Toxicologist who also practices as an Expert Witness and Legal Strategy Consultant.

Specific Benefits Include:

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

Case Experience Includes:

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

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:

• A small to mid size biotechnology company that needs consulting expertise in organizational management, process and product development, and regulatory affairs. Dr. Kelner specializes in solving the most difficult process and product development challenges
• An attorney who is involved in biopharmaceutical patent infringement and trade secret litigation

Richard Stripp, PhD, is a nationally recognized expert in Toxicology providing services in all aspects of a Clinical and Forensic Toxicology. He has served as an expert consultant in 100’s of cases in the field of toxicology and pharmacology for attorneys, investigators, and physicians involved in forensic and clinical toxicological evaluations associated with ethanol, drugs of abuse, prescription medications and chemical exposure.

Dr. Stripp provides unbiased expert case reviews involving drug effect on human performance, toxicity of iatrogenic/ therapeutic agents, lead and other toxic metals, carbon monoxide and environmental/occupational hazards. These services include, impartial evaluations involving drug impairment, overdose, toxic chemical exposure, medical issues associated with drug therapy, poisoning, and the role of drugs, alcohol, or chemical exposure in civil and criminal litigation. This covers a full breath of forensic medical-legal cases including:

• Analytical Toxicology and Laboratory Operations
• Review and Interpretation of Toxicology Reports
• Assessment of Impairment and the Role of Drugs/Alcohol in fatalities, accidental injury, overdose, MVA / DWI / DUI, criminal and civil litigation
• Insurance Claims
• To Serve as an Expert Witness: Experienced in Depositions and Court testimony
  • Forensic Toxicology Case Reviews
  • Litigation Support
  • Workers' Compensation
  • DUI/DWI
  • Drug and Alcohol Effects
  • Pharmacology Evaluations
  • Environmental/Occupational Chemicals & Toxic Chemical Exposure
  • Interpretation of Analytical Results and Drug Testing Cases
  • Continuing Education and Lectures
  • Chemical and Product Safety