24 Pharmaceutical Development Expert Witnesses Found

Results Sorted Below by State

Lucy H Fraiser, PhD, DABT Lucy Fraiser Toxicology

Fayetteville, Arkansas
Toxicology, Environmental - risk assessment, public health, air quality, NAAQS, risk-based corrective action, ozone (O3), nitrogen oxides (NO2), sulfur dioxide (SO2), hydrogen sulfide (H2S), particulate matter (PM), chemicals
...Lucy Fraiser is a board-certified toxicologist with over 25 years of experience in the areas of exposure and risk assessment, health effects and toxicology evaluations, development of quantitative toxicity criteria, development of risk-based air quality guidelines and soil cleanup criteria, and risk communication. Dr. Fraiser has conducted hundreds of exposure assessments for chemicals used in pharmaceutical laboratories and industrial processes, chemicals applied to control pests and unwanted vegetation, and chemicals released as unwanted by-products of chemical and product manufacturing, combustion of fossil and waste-derived fuels, generation of electricity, petroleum refining, smelting, rock crushing, and activities at military installations. Dr. Fraiser has been qualified as an expert, deposed, and has provided expert testimony in contested case hearings, criminal case hearings, Federal Civil suits, and toxic tort litigation on numerous occasions.

Andrew F. Calman, MD, PhD Premier Eyecare

San Francisco, California
Ophthalmology, Optometry - Cataract,Glaucoma,Diabetic Retinopathy,eye,vision,eye injury,eye injuries,retina,eye surgery,vision loss,patent,antitrust
...Calman has served as an Ophthalmology Expert for the Medical Board of California, Associate Examiner for the American Board of Ophthalmology,and has developed national eye care policy with the Medicare Carrier Advisory Committee and the American Academy of Ophthalmology. He has an active private practice in San Francisco's Mission District, treating a wide variety of medical and surgical eye problems. Dr. Calman has 20 years of experience as an expert witness, including eye injuries, medical malpractice, independent medical examinations, and patent infringement and antitrust disputes involving ophthalmic pharmaceuticals. He has been qualified as an expert in state and Federal courts, and never disqualified. References, including multiple AmLaw 100 and corporate clients, are available upon request. He can be reached directly by email or at his cell number above.

Christopher J Heckman, M.D., M.S. Expedient Medicolegal Services

Norwalk, California
Psychiatry - Standard of Care, Traumatic Injury, PTSD, Sexual Offender Risk Assessment, Testamentary Capacity, Intentional Infliction of Emotional Distress, Mental Impairment, Disability, Adjustment Disorder, Depression, Psychosis, Personality Disorders, Anxiety, Inpatient Care, Institutional Care, Suicide Risk
...The Clinical Operations Division facilitates the development, evaluation, and maintenance of clinical standards for California’s Department of State Hospitals (DSH). At the heart of the DSH Clinical Operations Division is the Clinical Operations Advisory Council (COAC), an interdisciplinary team of clinicians from the state hospitals who are devoted to the quality of clinical care and therapeutic services that the DSH provides. Dr. Heckman represents the Department of Psychiatry on the COAC. COAC works closely with clinical leaders to identify best practices within DSH facilities, as well as facilities outside of California and in the current academic literature. While conducting onsite reviews of clinical services, COAC gathers data to design data collection methodologies. These methodologies are used to better understand our patients, identify patterns and trends and create tools for mentoring clinical staff....

John Horst, CISSP®-ISSAP® Xanesti Technology Services, LLC

San Diego, California
Computers, Cybersecurity - Computer, Digital Forensics, Discovery, Databases, Class Action, Hacking, Breach, Encryption Safe Harbor, Health Care Data, Digital Medical Records, HIPAA, PII
...John has provided expert information technology consulting across several lines of business such as pharmaceutical development, medical billing, general liability insurance, clinical laboratory systems, mortgage financing, and automotive aftermarket products. John has provided cybersecurity engineering, software development, installation and training, and troubleshooting for 11 years in support of multiple U.S. Navy programs of record, including programs operating at both unclassified and secret levels. John maintains an active national security clearance at the SECRET level. John has taught information technology courses for the University of Phoenix (San Diego and Online campuses) and Coleman University (San Diego) where John pioneered the development of computer game software development instruction, now a core part of the Coleman curriculum. John has also taught philosophy courses for the University of Phoenix, including critical thinking....

John J Hosier John Hosier Healthcare Consulting, LLC

California
Marketing, Management - Bio-similar drugs, Biotech & Pharma Marketing, Operations, Branded Promotion, CNS Products, Medicare, Oncology Products, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE
...He has provided insights to small molecule & biotechnology companies across multiple therapeutic areas but has maintained a heavy concentration in oncology and specialty pharmaceuticals. He has led brand launch; corporate, franchise, and strategic brand planning; commercial integration; organizational design; and operational effectiveness from multiple perspectives (as the client, as the independent consultant, and as an agency lead). Mr. Hosier’s firm has architected the launch of rare disease and oncology business units for multiple pharmaceutical clients (large and small); led development of the managed markets, trade, and distribution strategy for the launch of new chemical entities (NCEs) and 505(b)2 assets for various organizations; and provided commercial assessment and recommendation of various licensing and co-promote deals between organizations. Mr....

Walter Sujansky, MD, PhD Sujansky & Associates, LLC

San Carlos, California
Health Informatics, Software Engineering - Electronic Health Records, EHR, Electronic Medical Records, EMR, Interoperability, Health Information Exchange, Health Data Exchange, Internet, Database, Medical Apps, User Interface, Artificial Intelligence, AI, Machine Learning, Probability, Statistics, Bioinformatics, Intellectual Property
- A seasoned health I.T. professional with a medical degree, medical informatics doctorate, and 30 years of research and development experience in industry. - Adjunct faculty member at Stanford Medical School in the Center for Biomedical Informatics Research. - A track record of innovation in product-development roles, as well as consulting to health I.T. firms, healthcare provider organizations, pharmaceutical companies, government agencies, and litigators in intellectual property and medical malpractice cases. - Has consulted as an expert witness on 11 cases since 2011, with 3 depositions since 2019. - Published author and experienced speaker....

Stephen L. Newman, MD, MBA, FACP, FCCP, FAASM

Denver, Colorado
Pulmonary Disease, Occupational Medicine - Asbestos, Silicosis, Cancer,Certified Grade B reader NIOSH, IMEs, Internal Medicine, Occupational Pulmonary Disease, Sleep Disorders
...I am a consultant to industry in both medical device and pharmaceutical product development.

Jonathan D Hurwitz iDiscovery Solutions

Washington, District Of Columbia
Legal, Technology - data analysis, data analytics, data, analytics, structured data, database, SQL, data science, data scientist, complex data
...While at Deloitte, he helped lead an award-winning project team that developed and deployed a data analytics enterprise fraud detection platform for a large federal agency. Before his time at Deloitte, Jon spent 5 years working at FTI Consulting within their Life Sciences practice. While there, Jon worked on a variety of data intensive projects related to high profile litigation impacting healthcare and pharmaceutical clients. Jon has a Bachelor of Science in Commerce from the University of Virginia McIntire School of Business, and a Master of Science in Business Analytics from the George Washington University School of Business.

Joshua Herskovic, MD HealthAdvise

Boca Raton, Florida
Anesthesiology - Difficult intubations, airway trauma, airway management, obstructive sleep apnea, intraoperative codes, code blue, cpr, cardiac arrest, hypoxia, hypotension. anesthetic drug interactions, toxicities, patient positioning, intraoperative burn injury, central lines, arterial line, allergies
...Herskovic is a Board Certified Physician Anesthesiologist with background in medical device development. He has over 15 years of experience as a practicing anesthesiologist in a busy private practice. Prior to medicine he worked in the medical device industry as a mechanical engineer. He continues to use his engineering background to provide assistance to start up medical device companies. This assistance includes medical device R&D, CAD design, rapid prototyping & 3D printing, and low volume manufacturing techniques. He also provides consulting services to established medical device & pharmaceutical companies. Having worked in the medical device industry as a mechanical engineer he understands engineering limitations a device may have; while, as a physician and end user he understands how the device will be used along with the need to efficiently utilize a physician's time....

Tim Kamerzell, MD, PhD

Overland Park, Kansas
Hospitalist, Internal Medicine - Hospital Medicine, General Internal Medicine, Telemedicine, Perioperative Medicine, Medical Devices, Pharmaceutical Research and Development, Pharmaceutical Regulation, Chemistry, Biochemistry,
...Kamerzell received a PhD in Pharmaceutical Chemistry from the University of Kansas and has extensive experience working in the pharmaceutical industry as a research scientist at Genentech, Inc. Dr. Kamerzell completed research fellowships at Harvard Medical School and Mount Sinai School of Medicine in the areas of drug discovery and design, cardiovascular disease, and electrophysiological mechanisms of cardiac arrhythmias. He remains active in research and works as a consultant to multiple pharmaceutical and biotechnology companies. Dr. Kamerzell has several patents related to the design of novel therapeutics and has published extensively in peer reviewed chemistry journals. He remains an active adjunct professor of Pharmaceutical Chemistry at The University of Kansas in Lawrence, KS and is a section editor for the journal Protein and Peptide Letters and Scientific Advisor to the Editor of the Journal of Pharmaceutical Sciences. Dr....

Christopher M Byrd, PhD BSquared Consulting, LLC

Bethesda, Maryland
DNA, Laboratories & Testing - Forensic Science, Pharmaceutical Research, Bioengineering, Biomedical Engineering, Biochemistry, Chemistry, Bacteria, Infection, DNA, Biological Engineering, Testing and Laboratories, Infectious Disease research, Laboratory, Vaccine, Vaccine development
...His areas of expertise include: ➢ Bioengineering ➢ Biochemistry ➢ Forensic Science ➢ Microbiology ➢ DNA and Nucleic Acids ➢ Vaccine Development ➢ Research and Development ➢ Biotechnology ➢ Pharmaceutical Development ➢ Bacteria and infection ➢ Laboratory documentation and research review

Stuart G Levy SGL Chemistry Consulting, LLC

Arlington, Massachusetts
Pharmaceutical Research, Chemistry & Chemicals - API process development, API manufacturing, Solid state and physicochemical characterization, enabled formulation development, drug product development, drug product manufacturing, stereochemistry, process impurity identification, control, synthetic route selection, preformulation, polymorphism
HIGHLIGHTS • Twenty-eight years of industrial experience in all aspects of chemical development • Twenty-four years of experience in oversight of external vendors performing chemical development, custom starting material production and API manufacturing, preformulation, formulation development, drug product manufacturing, and all associated CMC activities • Eighteen years of experience in devising and executing integrated CMC development programs • Hands-on, results-oriented leadership of CMC development and multidisciplinary teams • Innovation in the conception of practical synthetic routes to pharmaceuticals, development and implementation of chemical processes for the manufacture of APIs and chemical process troubleshooting....

Ilonna J. Rimm, MD PhD CFA Rimm Healthcare Capital Advisory LLC

Newton Center, Massachusetts
Financial, Pediatric Hematology Oncology - Appraisal and Valuation, Banking, Business Valuation, DNA, Financial, Securities and Investments, Biotechnology, Medical Devices, Healthcare Services, Life Science Tools , Pharmaceuticals , Entrepreneurial Companies, Start-up companies
...Ilonna's advisory skills were developed during twenty years of Financial Services work on the Buy and Sell side of public equity, the Buy side of private equity and in the pharmaceutical industry. Her Linked In page is here: https://www.linkedin.com/in/ilonna-rimm-md-phd-cfa/

Chris Scott, PhD Material Answers LLC

Weston, Massachusetts
Chemical Engineering, Failure Analysis - polymer, plastic, rubber, coating, materials, material science, material engineering, thermoplastic, thermoset, composite, design, manufacturing, adhesive, ink, automotive, medical device, aerospace, packaging, accident, defect
...He has extensive experience with manufacturing, product development, product design, and failure analysis. Systems investigated include plastics, composites, coatings, paints, adhesives, rubbers, fibers, suspensions, emulsions, and pastes. In particular, Dr. Scott has published extensively on the topics of polymer processing and structure relationships, compounding and mixing in multiphase polymer systems, and structure and morphology development during polymer processing. He is the inventor on 11 U.S. patents, author of more than 30 articles in peer reviewed journals, author of 40 conference proceedings, and has presented more than 50 seminars to industry and government organizations. Dr. Scott has conducted failure analysis investigations and developed product designs in a broad range of applications, including: automotive components, consumer products, medical devices, aerospace, pharmaceuticals, coatings, prints, construction materials, and packaging....

Magdy M. Abdel-Malik, Ph.D. Quaestio Global Partners LLC

Chester, New Jersey
Pharmaceutical Research, Chemistry & Chemicals - Analytical chemistry , Drug delivery systems , Natural products chemistry, Oral cavity health, Chemicals characterization, Hair care, Smoking cessation, Cosmetic products, innovation assessment, Organic chemistry, Dietary supplements, Intellectual property (IP) , Over the counter (OTC) medicines
...His expertise lies in the intersection of R&D and business development in the life sciences, particularly in pharmaceuticals and consumer products. PHARMACEUTICALS AND CONSUMER PRODUCTS: AREAS OF EXPERTISE Dr. Abdel-Malik has developed comprehensive expertise across diverse therapeutic areas within pharmaceuticals and consumer products....

John J Hosier John Hosier Healthcare Consulting, LLC

West New York, New Jersey
Marketing, Management - Bio-similar drugs, Biotech & Pharma Marketing, Operations, Branded Promotion, CNS Products, Medicare, Oncology Products, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE
...He has provided insights to small molecule & biotechnology companies across multiple therapeutic areas but has maintained a heavy concentration in oncology and specialty pharmaceuticals. He has led brand launch; corporate, franchise, and strategic brand planning; commercial integration; organizational design; and operational effectiveness from multiple perspectives (as the client, as the independent consultant, and as an agency lead). Mr. Hosier’s firm has architected the launch of rare disease and oncology business units for multiple pharmaceutical clients (large and small); led development of the managed markets, trade, and distribution strategy for the launch of new chemical entities (NCEs) and 505(b)2 assets for various organizations; and provided commercial assessment and recommendation of various licensing and co-promote deals between organizations. Mr....

John J Hosier John Hosier Healthcare Consulting, LLC

New York
Marketing, Management - Bio-similar drugs, Biotech & Pharma Marketing, Operations, Branded Promotion, CNS Products, Medicare, Oncology Products, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE
...He has provided insights to small molecule & biotechnology companies across multiple therapeutic areas but has maintained a heavy concentration in oncology and specialty pharmaceuticals. He has led brand launch; corporate, franchise, and strategic brand planning; commercial integration; organizational design; and operational effectiveness from multiple perspectives (as the client, as the independent consultant, and as an agency lead). Mr. Hosier’s firm has architected the launch of rare disease and oncology business units for multiple pharmaceutical clients (large and small); led development of the managed markets, trade, and distribution strategy for the launch of new chemical entities (NCEs) and 505(b)2 assets for various organizations; and provided commercial assessment and recommendation of various licensing and co-promote deals between organizations. Mr....

Gary S. Barach, CPA, CFE, CFF, CVA BCG Forensics, LLC

West Chester, Pennsylvania
Business Damages, Economics - fraud, business valuation, business interruption, lost profits, product recall, personal injury, employment cases, discrimination, contract disputes, dispute resolution, economic damages, construction defects, insurance claims, class action, shareholder disputes, bankruptcy, commercial litigation.
...Barach’s 40 years of experience includes diverse industries such as telecommunication; hospitality; health care; sport franchises; construction; retail; pharmaceutical manufacturing and distribution; and oil, gas and mining. Examples of cases are as follows: Intellectual Property and Valuation: Determination of Fair Market Value of the Brand “Platinum”, arising from a dispute between two national software developers. Product Liability: Economic damages to an international manufacturer of diesel locomotives due to defects in supplied engine components. Economic damages arising from the recall of pet food due to contaminated wheat gluten imported from China. Construction: Economic damages to a resort from defects in structural material resulting in additional costs to construct and lost profits due to delay in opening. Fraud and Arson: Amounts embezzled by a bank manager and methods used....

John J Hosier John Hosier Healthcare Consulting, LLC

Pennsylvania
Marketing, Management - Bio-similar drugs, Biotech & Pharma Marketing, Operations, Branded Promotion, CNS Products, Medicare, Oncology Products, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE
...He has provided insights to small molecule & biotechnology companies across multiple therapeutic areas but has maintained a heavy concentration in oncology and specialty pharmaceuticals. He has led brand launch; corporate, franchise, and strategic brand planning; commercial integration; organizational design; and operational effectiveness from multiple perspectives (as the client, as the independent consultant, and as an agency lead). Mr. Hosier’s firm has architected the launch of rare disease and oncology business units for multiple pharmaceutical clients (large and small); led development of the managed markets, trade, and distribution strategy for the launch of new chemical entities (NCEs) and 505(b)2 assets for various organizations; and provided commercial assessment and recommendation of various licensing and co-promote deals between organizations. Mr....

Debra Leibold, MD, PhD Consultant

Blue Bell, Pennsylvania
Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use
Ethical Full Lifecycle Labeling/Prescribing Information That Never Cuts Corners For Pharmaceutical Giants Merck, Shire, and J&J: Labeling strategy and leadership that brings product labeling and products to market supporting vaccines and treatments for infections, internal medicine, oncologic, and rare diseases. These include life-saving, ground breaking, and first-of-its-kind products. Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World. Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?”...

Eileen E. Ming, MPH, ScD, FISPE Epi Excellence LLC

Garnet Valley, Pennsylvania
Public Health, Pharmaceutical Research - epidemiology, pharmacoepidemiology, outcomes research, observational research, real world evidence
...Ming, MPH, ScD, FISPE, is an epidemiologist, pharmacoepidemiologist, outcomes researcher, and leader in the pharmaceutical industry. She served as an outcomes researcher at Merck, an epidemiologist at AstraZeneca, and the head of global epidemiology and pharmacoepidemiology at Shire Pharmaceuticals. Dr. Ming founded Epi Excellence, an epidemiology consulting practice, in 2014. She has worked across a variety of therapeutic areas, from pre-clinical through post-marketing phases, providing epidemiologic strategic and tactical expertise to commercial, clinical development, market access, medical affairs, regulatory, and pharmacovigilance activities. Dr. Ming is an Adjunct Scholar of the Center for Clinical Epidemiology and Biostatistics, and an Adjunct Investigator of the Center for Pharmacoepidemiology Research and Training, at the Perelman School of Medicine at the University of Pennsylvania. She is a Fellow of the International Society for Pharmacoepidemiology. Dr....

Paul Abato, Ph.D.

Providence, Rhode Island
Pharmaceutical Research, Chemistry & Chemicals - Drug Formulation, Biotechnology, liquid formulation, medicinal chemist, organic chemist, pharmcokinetics, stability studies, dietary supplements, tetracyclines, synthetic biology, breathalyzer, drug tests
...Dr Abato has testified in high stakes litigation cases at the International Trade Commission and federal courts for major players in the pharmaceutical industry. He has experience with ANDA, trade secret, trademark infringement, patent infringement and contract law cases relating to pharmaceuticals. Upload Dr Abato’s CV, which includes a complete list of case numbers and Law Firms that he has represented. PHARMACEUTICAL EXPERIENCE Dr. Abato is a Medicinal Chemist. His expertise includes drug research, medicinal chemistry, organic chemistry, drug formulation for; IT, IV, IP, ICV, IN, IM and oral dosing routs, stability studies, extensive structure-activity relationships, efficacy, pharmacokinetics, as well as all pre-clinical testing required for IND submission to the FDA....

Lucy H Fraiser, PhD, DABT Lucy Fraiser Toxicology

Texas
Toxicology, Environmental - risk assessment, public health, air quality, NAAQS, risk-based corrective action, ozone (O3), nitrogen oxides (NO2), sulfur dioxide (SO2), hydrogen sulfide (H2S), particulate matter (PM), chemicals
...Lucy Fraiser is a board-certified toxicologist with over 25 years of experience in the areas of exposure and risk assessment, health effects and toxicology evaluations, development of quantitative toxicity criteria, development of risk-based air quality guidelines and soil cleanup criteria, and risk communication. Dr. Fraiser has conducted hundreds of exposure assessments for chemicals used in pharmaceutical laboratories and industrial processes, chemicals applied to control pests and unwanted vegetation, and chemicals released as unwanted by-products of chemical and product manufacturing, combustion of fossil and waste-derived fuels, generation of electricity, petroleum refining, smelting, rock crushing, and activities at military installations. Dr. Fraiser has been qualified as an expert, deposed, and has provided expert testimony in contested case hearings, criminal case hearings, Federal Civil suits, and toxic tort litigation on numerous occasions.

Ronald J Graf, MD MultiCare

Tacoma, Washington
Diabetes, Endocrinology - Type 1 diabetes, Type 2 diabetes, endocrine disorders, thyroid disease, hyperthyroidism and hypothyroidism and other disorders of the adrenal, pituitary, parathyroid and reproductive glands, osteoporosis, metabolic disorders, obesity, male hypogonadism.
...Graf has served as a principal investigator for dozens of clinical research trials involving the development and evaluation of numerous pharmaceuticals related to the care of patients with diabetes and other endocrine disorders. Dr. Graf is experienced in records review, report writing, depositions and testimony.