Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.
As a consultant in his own pharmaceutical development advisory firm for over 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors.
Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.
Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more
Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness and consultant to litigation in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Anti-trust, Patent, and Product Liability.
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.
The willingness to view risk as part of daily life has vanished. A risk-averse mindset among environmental regulators engenders confusion between the ethics of intention and the ethics of consequence, leading to the elevation of the precautionary principle with unintended and often unfortunate outcomes. Environmental risk assessment is conservative, but the actual level of conservatism cannot be determined. High-end exposure assumptions and current toxicity criteria from the USEPA, based on linear extrapolation for carcinogens and default uncertainty factors for systemic toxicants, obscure the degree of conservatism in risk assessments. Ideally, one could choose a percentile of the target population to include within environmental standards, but this choice is complicated by the food, pharmaceutical and advertising industries, whose activities, inadvertent or not, often promote maladaptive and unhealthy lifestyle choices.
Dr. Olen R. Brown, PhD is a board certified Diplomate in Toxicology and member of the standards of knowledge committee. He has the PhD in Microbiology With over 35 years of experience in Life Sciences and more than 150 publications. Dr. Brown specializes in complex, multidisciplinary cases, and he focuses on Human Medicine using the disciplines of bacteriology, virology, immunology, epidemiology, biochemistry, physiology, analytical chemistry, toxicology, and environmental sciences.
Dr. Brown has provided litigation support services for 180+ cases in 25 states and 1 in Canada. Dr. Brown has served in Plaintiff/Defense, and Criminal/Civil cases. He has testified in 20 trials and 31 depositions. Dr. Brown's expertise include: cause-and-effect determination after medical record review; risk assessment and causation determination from toxic exposure; evaluation of the therapeutic and harmful effects of ethical drugs, antibiotics, alcohol, and drugs of abuse; the toxicity of solvents, pesticides, heavy metals, ozone, carbon monoxide, particulates, and most organic chemicals for most organ systems including the lung (Asthma, COPD, RADS) and the brain (Parkinson's), Dr. Brown has evaluated human medical and veterinary medical devices and pharmaceuticals for safety.
Attorneys use experts in two ways. First is the traditional use of an expert as a witness in court. In this role, scientists, business people, or others with technical knowledge are retained by attorneys primarily for their opinions (oral, written, or both), ultimately to be given at deposition and in civil and criminal courts. Second, the expert may be used as a pre-trial consultant or more specifically as an undisclosed consultant
"Miracles" reveals truth from Scripture, science and life. Everything that is or was or is to come is part of God's miracle. Science says that nothing is miraculous- Time and Chance created the universe with no meaning or purpose. God's universe has great meaning extending from the stars to atoms and to you. What we believe about miracles can be a source of great joy or missed joy in our lives. Dr. Brown, a Christian and author of over 100 scientific papers, has coined a new word, synscicretism, to call attention to the doctrine that today elevates science above religion. Science works best for the great "how" questions, but poorly for the great "why" of all things.
This authoritative guide is designed to achieve a synthesis of understanding and effort between case science and case law. It examines all stages of attorney/expert interaction from the initial interview to post-trial evaluation.