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.
James P. Langley is an independent Energy Consultant with over 45 years of experience in his field. His practice focuses on business analysis related to Refining, Transportation, and other facets of the Downstream Industry. Mr. Langley holds a BA in Chemical Engineering and an MA in Business, with emphasis in marketing and finance. He has worked extensively on the international scene, traveling to over 40 countries
Background Experience: Building on hard core plant operations, Mr. Langley's career moved into operations planning and strategic analysis. The money side of the industry analysis led into mergers and acquisitions, CFO of a specialty refining and chemical company, and, for many years, the industry subject matter expert for the financial services firm PricewaterhouseCoopers. In that role, Mr. Langley traveled the world to guide PwC consultants and auditors in the nuance of the petroleum industry. Critical in that assignment was bridging knowledge between functional expertise in many areas, including litigation and arbitration support.
Later, Mr. Langley provided engineering, operations, and maintenance knowledge to the benchmarking of natural gas pipelines and processing facilities in Europe, Asia, the Middle East, South America, and Africa.
Litigation Support: Jim Langley has worked and consulted in almost every aspect of the downstream industry, and can explain past and current practices. He has worked in operations, supply and trading, marketing, finance, accounting,and taxation.
Mr. Langley has been successful in helping attorneys quickly understand the commercial, technical, operational, and broad business practices of their clients' industry. He provides a detailed analysis of strengths and weaknesses of the opposition's position, and includes suggested interrogatories. In written reports, he offers insights that clarify underlying issues in the dispute, and quantify the economic impact on clients. In deposition and testimony, Mr. Langley explains these issues in a way that is easily understood by the judge or jury.
He has spoken on industry issues on several occasions and taught an annual symposium course for 18 years at UT Dallas to international oil company finance and accounting executives.
Joel Coats, PhD, is Distinguished Professor of Entomology and Toxicology in the Department of Entomology at Iowa State University. Specializing in Insecticide Toxicology and Environmental Toxicology, he has been on the faculty at Iowa State University since 1978 and served as Department Chairman for seven years.
Dr. Coats’ research program includes two main areas: (1) insect toxicology and (2) environmental toxicology and environmental chemistry of Agrochemicals. His research in the insect toxicology area is focused primarily on natural products as insecticides and insect repellents, including investigations of their spectrum of activity, mechanisms of action, metabolism, synthesis of biorational derivatives and analogs, quantitative structure-activity relationships.
Dr. Coats is familiar with all types of pesticides and insect repellents, including synthetic and botanical insecticides, acaricides, fumigants, and repellents; toxicity, mechanisms of action, environmental and comparative toxicology, ecological risk assessment, persistence of pesticides, movement in the environment, and residue analysis.
Litigation Support - Dr. Coats provides expert witness services to counsel representing both Plaintiff and Defense. He has been deposed and testified on numerous occasions. Dr. Coats offers opinions regarding pesticide cases of many types, including:
Non-target / Off-target Effects
Efficacy of Products
Dr. Coats has received the International Award for Research in Agrochemicals from the American Chemical Society Agrochemical Division, and he is a Fellow of the American Association for the Advancement of Science, and a Fellow of the Entomological Society of America. In October he received the Alumni Achievement Award from the University of Illinois College of Liberal Arts and Sciences.
Resistance to conventional pesticides has been growing rapidly among all pests. Furthermore, there is increased public concern about the safety of conventional pesticides, and increased governmental restrictions have resulted in the need to identify new compounds that are safe and effective in controlling pests that are of concern to agriculture as well as to public and animal health. Biopesticides may aid in the control of such pests with fewer deleterious effects to the environment, people and animals.
This volume and the contributed chapters therein are a result of the Natural Products for Pest Management symposium held at the 244th ACS National Meeting in Philadelphia, PA August 19-23, 2012 to honor the late Horace (Hank) Cutler and his contributions in the field of natural products chemistry. The symposium introduced recent discoveries and applications of natural products from insect, terrestrial plant, microbial, and synthetic sources for the management of insects, weeds, plant pathogenic microbes, and nematodes.
The first compilation of research on microbial degradation of contaminants in the rhizosphere. Discusses the interactions between microorganisms, plants, and chemicals in the rhizosphere. Examines the degradation of industrial chemicals, including polycyclic aromatic hydrocarbons, pentachlorophenol, and trichloroethylene, as well as the degradation of pesticides in the rhizosphere.
This new volume offers comprehensive information on microbial adaptation for pesticide degradation. Among the many topics covered in its 20 chapters are a general description of enhanced biodegradation as it occurs in an agricultural context; the microbial aspects of enhanced biodegradation, including the genetics, biochemistry, and ecology of pesticide-degrading microorganisms; and the potential impact of enhanced degradation on pesticide fate in aquatic systems and groundwater.
Toxicology Medical Environmental Sciences Expert Witness Olen Brown
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.