Expert 514225 - FL

Expertise Description

My background in the nutraceutical and pharmaceutical industry has spanned over 30 years. My areas of expertise include formulation development and analytical development. I also have a successful track record of managing people, processes, and projects for the pharmaceutical industry by creating, maintaining, and developing products for specialty products and services. I have also spent more than a decade as a pharmaceuticals expert witness in FL by providing consultations, as well as courtroom testimony and deposition.

Expert 520396 - CO

Expertise Description

With more than 25 years experience as an attorney, I specialize in environmental health issues and legislation. I perform legislative analysis and outreach on state and federal environmental, health and trade laws; focusing on the delegation and authorization of federal and state laws; and providing legal and technical assistance to state legislators and agency staff on state, federal and international environmental, environmental health, and trade policies. I have provided consultations, deposition, and courtroom testimony as an environmental health expert witness in Colorado.

Expert 519871 - AL AK AZ AR BC CA(N) CA(S) CO CT DE DC FL GA HI IA ID IL IN KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA QC RI SC SD TN TX UT VT VA WA WV WY WI

Expertise Description

As a patent law expert witness, I have more than 5 years experience as a physician, attorney, and acupuncturist, specializing in health care financing and regulation, intellectual property, and public health. I have additional experience in the challenges big data and artificial intelligence pose to patent law; the role of comparative effectiveness research in drug regulation; and the intellectual property implications of innovations related to human biological processes. My career also includes offering my services in Southern California as an expert witness with consultations and courtroom testimony.

Expert 519450 - MA

Expertise Description

My career has spanned more than 25 years in Massachusetts as a Food Safety and Food Science expert. I have worked with a wide range of food and safety-related issues, including biofilm formation and removal; bioactive food components, rapid detection methodology and food fermentations. I have additional knowledge in rapid bacteria detection methods, media formulation, and dairy starter cultures, among other biological disciplines pertaining to the food and beverage industries.

Expert 519562 - DE TX VA

Expertise Description

My background of over 25 years in the field of Food Safety has been focused on the regulatory, foodservice, and manufacturing sectors. As a food safety expert witness, I also have experience in nutrition and well being, regulatory compliance, business strategy, and consumer surveys. I am well-versed in HACCP, food quality, nutrition, FDA, food processing, food service, sanitation, restaurants, grocery, dietitian, and food technology. I have provided courtroom testimony, deposition, and consultations as a food safety expert witness.

Expert 518694 - MD

Expertise Description

I have more than 40 years in the Pharmaceutical industry with expertise on health policy, technology transfer, medico-legal, and health economics issues. I have more than 25 years experience as a former official for the Food and Drug Administration (FDA). I have managed multiple drug regulatory activities and large staffs and have extensive experience in outreach to government agencies and organized medicine. I have additional experience with private practice of family medicine and geriatrics. I have prior deposition and testimony experience, and over 10 years as an expert witness.

Expert 518592 - MA

Expertise Description

My 35 years of experience in the hospitality industry includes working as a Hotel Administrator and Food and Beverage Sanitation Instructor. I founded a consultant firm that has provided design, diversity, food safety, management consulting, marketing, quality assurance, and training, as well as development support to the service industries with a concentration on the hospitality industry. My experience includes the analysis of recipes and suggestions for recipe changes to make foods healthier; developing business plans with financial projections for new or relocated restaurants; mystery shopping for regional chains and independent restaurants, as well as extensive experience providing customer service, food safety, responsible beverage and anti-discrimination training in the United States, Canada, Europe, Middle East, and Asia. I have prior expert witness experience.

Expert 518552 - NJ NY

Expertise Description

I have more than 35 years of experience in Immunology, Virology, and Biochemistry, with over 25 years of regulatory affairs and drug development experience (drugs, biologics, devices). This experience includes CMC, clinical, promotion and advertising, cGMP, cGCP, and success interacting and negotiating with FDA and international health authorities. I am a monoclonal antibody expert. I have founded a pharmaceutical and medical device consulting company to assist companies in strategic planning, FDA liaison and negotiation, FDA meetings, regulatory submissions and formation and execution of plans, and to help meet unanticipated needs and challenges. I have over 5 years of expert witness experience with consultations and deposition.

Expert 518266 - TX

Expertise Description

I have more than 35 years in Pharmacology and more than 25 years in senior management within the industry. My expertise is in drug safety, drug and device development, regulatory, clinical and technical sciences associated with drug and device approval, QA/QC of clinical research services, health outcomes research, and health policy. My company has provided regulatory program development and operational management for drugs and devices, as well as safety and efficacy programs in support of drug approval and postmarketing surveillance, label development and warnings, and label comprehension studies. I also have experience with clinical site management, including QA/QC facility audits of clinical sites and CROs and renovation of quality management systems. I have over 10 years of expert witness experience with consultation, deposition, and courtroom testimony.

Expert 518320 - NJ

Expertise Description

I have over than 25 years of experience in drug development, clinical manufacturing and drug delivery systems. I have been Principal of a firm that provides guidance in all aspects of drug product development. These subjects include: sterile product subject matter, peptide and protein formulation, drug delivery, aseptic processing, sustained release parenteral, excipients, inter partes patent review, technology transfer, injection devises, solubilization, and patent infringement and validity. I also have substantial GMP, FDA R&D and manufacturing experience. I have prior expert witness experience with consultation, deposition, and courtroom testimony.

Expert 518341 - CA(S)

Expertise Description

I have more than 15 years of Pharmaceutical experience. My focus is regulatory affairs, of which my experience includes: drafting and filing IDE and IND applications, preparing correspondences and annual reports to FDA and IRBs, as well as responding to FDA audits, attending meetings, monitoring clinical trials, and training interns for regulatory compliance monitoring or auditing. I have developed regulatory strategies for innovative products, including drugs, biologics, devices and dietary supplements. I also have intellectual property experience, having acted as liaison for legal, bioinformatics, cloning, and screening departments regarding updates of existing inventions and the discovery of new genes, as well as participated in patent drafting and prosecution.

Expert 518240 - CA(S)

Expertise Description

I have more than 35 years of experience in Chemistry and Organic Chemistry. As a Professor, I have taught and done research on topics such as: radical reactions of transition metal-complexed unsaturated systems; synthetic methodologies in organic and organometallic chemistry; novel therapeutic agents for a breast cancer treatment; enzymatic chemistry; cancer drug development; aromatase metabolism; hormonal chemistry; food chemistry; antioxidants; supplements; cosmetics; environmental chemistry, consumer product chemistry, environmental laws. As a Consultant, I have provided support to consumer protection groups, and handled cases involving consumer product torts (cosmetics; foods; electronics; petrochemicals); and supported non-profit organizations in the “failure to warn” litigations and the state actions initiated under the California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). I have over 10 years of expert witness experience with consultations, deposition, and courtroom testimony.

Expert 515811 - CA(S)

Expertise Description

I have more than 40 years of experience in the Pharmaceutical industry with expertise as a Registered Pharmacist. I have served on a pharmacy board for over 8 years and through this experience I have been part of committee panel that is presented with pharmacists’ defense of their disciplinary cases, and as a committee we enforced disciplinary actions, and if accusations should be dismissed. This has provided a broad perspective for me and has helped me to be fair and objective.

Expert 506990 - AL AK AZ AR BC CA(N) CA(S) CO CT DE DC FL GA HI IA ID IL IN KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA QC RI SC SD TN TX UT VT VA WA WV WY WI

Expertise Description

I have more than 20 years of experience in the field of Medicine with expertise in Gastroenterology and Endoscopy. My educational background brings together multiple graduate degrees in clinical medicine, basic science, epidemiology, biostatistics and law. By the time I began my Residency Training in Internal Medicine, I had completed a Master Degree in Cell Biology (MS), Master Degree in Public Health (MPH) and Doctorate in Medicine (MD). I have performed a significant amount of research in diseases of the gastrointestinal tract and have successfully publishing multiple papers on the diagnosis and treatment of gastrointestinal disease, including a distinguished Medical Progress Review on this subject. I have focused experience on Colonoscopy, Advanced Endoscopy, Liver and Pancreatic Disease. I have helped develop a Center for Pancreatic Disease at a medical school; performed basic science research in a laboratory focused on Acute Pancreatitis in Rat/Mice models; and published dozens of peer reviewed papers, chapters and abstracts on research topics in Acute and Chronic Pancreatitis. As Division Chief and Director of Medical Education and Research, I have been responsible for the medical education of dozens of fellows in gastroenterology, medical residents and medical students. Under my leadership, we have maintained an active Clinical Research Program, publishing over 200 abstracts, papers, books, and book chapters. While maintaining a busy clinical practice, I have also served on committees for Gastroenterology. I am recognized as one of the top experts in Acute and Chronic Pancreatitis. I have over 20 years of expert witness experience with consultation, deposition, and courtroom testimony.

Expert 508401 - VT

Expertise Description

I have more than 30 years experience in the Food Safety industry. My experience is across all food groups, with significant emphasis with microbiological pathogen control in dry powder factories. I am expert at implementing hygienic zoning, sanitation programs, environmental sampling programs, and microbiological troubleshooting. I have prior expert witness experience with consultations, deposition, and courtroom testimony.

Expert 500361 - AL AK AZ AR CA(N) CA(S) CO CT DE DC FL GA HI IA ID IL IN KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WY WI

Expertise Description

I have more than 30 years of experience in the Food Science industry with expertise in explaining complex scientific matters in simple terms that people having no scientific background can understand. For example, in a bench trial involving theft of trade secrets for a biological process, I was able to explain both the biochemistry and engineering aspects of the process to the satisfaction of a judge who had no background in these areas. In a similar fashion, I use “cartoon chemistry” and simple analogies in expert opinions that support natural claims for common food ingredients. In a consulting capacity, using my broad scientific background, I helped a client build safety into a new product and generate data that resulted in FDA approval that exempted the food from the severe processing that would otherwise be required. I have over 15 years of expert witness experience with consultation, deposition, and courtroom testimony.

Expert 321554 - NY

Expertise Description

I have over 25 years experience as a Medicinal Chemist and Pharmaceutical Drug Discovery expert. I have experience in multiple therapeutic areas including oncology, inflammation, women’s health, and diabetes. I have a comprehensive understanding of the drug discovery process, enzyme inhibitors, including high throughput screening, hit to lead development, lead optimization, and late stage discovery / clinical. My expertise includes a thorough understanding of composition of matter and intellectual property law as an inventor on more than 35 pharmaceutical patents and patent applications.

Expert 107522 - CA(S)

Expertise Description

I have 25 years of experience in the Pharmaceuticals and Medical Device Industry. My experience as a Laboratory Director includes product development, analytical chemistry, organic chemistry, inorganic chemistry, wet chemistry, laboratory testing, environmental sample testing, materials testing, complaint investigations, FDA investigations, quality assurance, manufacturing, facilities system audits, preventative actions, US-FDA / EMEA issues, warning letters, remediation, Therapeutic Goods Administration (TGA) inspection, Millennium Challenge Corporation (MCC) inspection, analytical method development, method validation, internal and external laboratory audits, optimized equipment usage, use of developmental software, consumer products, extensive knowledge in active pharmaceutical ingredient (API) synthesis, active pharmaceutical ingredient (API) and dosage form analysis, stability programs, non-conformance investigations, quality engineering, process optimization, laboratory training, stability study protocols, and pharmaceutical lawsuits. I have prior expert witness experience.

Expert 96660 - CA(S)

Expertise Description

Doug Schoon, M.S. (Dana Point, CA)  – I have over 35 years’ experience working in the cosmetic, personal care and beauty industry focused on organic and polymer chemistry, including materials testing and ingredient toxicology.  I specialize in cosmetics, salon products, salon safety, and best practices for the professional beauty industry, as well as retail cosmetic and beauty products. My expertise includes: beauty industry regulations and standards; cleaning, disinfection, sterilization, communicable diseases, infections related to hair, nail, skin, eye lashes; cuts, burns, adverse skin reactions such as irritations or  allergies, standard of care, state board regulations, federal regulations, marketing claims, education and nail and cosmetology schools. 
 
I have expertise in European Union and Canadian cosmetic regulation and standards; as well as, salon chemical safety issues, to include injuries, damage, illness, as well as cosmetic / personal care product development and testing, safe handling, air quality and testing, personal protection equipment, product labeling, product warnings and quality control and/or assurance.  I am an internationally recognized author of books/articles, presenter and educator with a large amount of expertise in both natural and artificial nail products, salon practices and services in cosmetology, hair, lashes, nail anatomy and skin care, manicure and pedicure procedures/practices/standards/equipment.  I have over 25 years expert witness experience with consultations, depositions, and courtroom testimony.

Expert 59053 - FL

Expertise Description

I have over 30 years experience in pharmaceuticals and am currently a pharmaceutical executive, with extensive knowledge of all phases of drug development, including product approval, manufacturing, labeling, marketing, and distributing. My areas of pharmaceutical expertise include: biotechnology; clinical development; compound evaluation; dosage forms; drug regulatory affairs; facility compliance; FDA approval process; laboratory and manufacturing audits; licensing; medical devices; medicine in the media; microbiological development; microbiology; national and international pharmaceutical projects; patent infringement; pre-clinical / clinical studies; production monitoring; quality control; and regulatory parameters. I have additional expertise in budgeting, financial controls, and strategic planning. I have more than 20 years expert witness experience with consultations, deposition, and courtroom testimony.

Expert 34333 - CA(S)

Expertise Description

I have more than 40 years in the field of Chemistry. My areas of expertise encompass water, food, and drug analysis; organic and inorganic chemical testing on water and wastewater; coliform bacteria analysis in water; and compliance testing for water utilities. My consultations further include qualitative and quantitative chemical analysis on diverse matrices for a variety of other cosmetic and hazardous substances. I have extensive experience in various spectrophotometric and chromatographic techniques. I have over 20 years expert witness experience with consultations, deposition, and courtroom testimony.

Expert 501488 - CA(S) DC FL IL MI NV NY WA

Expertise Description

I have more than 30 years of experience in the Biomedical field with expertise in Bioengineering and Advanced Surgical Technologies. I have experience with a variety of mechanical and energy-imparting devices used to manipulate and modify tissues within the body without the need for large incisions. I have investigated a variety of laser applications for cardiovascular, ophthalmologic, orthopedic, urologic, and neurosurgical procedures. I serve on several study sections, evaluating state-of-the-art medical imaging technology, cancer therapeutics, and a wide range of medical devices. I am an expert on image-guided therapies, imaging equipment, minimally invasive surgical procedures, and medical device development. I have over 25 years expert witness experience with consultation, deposition, and courtroom testimony.

Expert 500453 - OH

Expertise Description

I have 27 years of experience, and specialize in the field of disposable diapers with specific knowledge in the areas of manufacturing, product design and intellectual property. I have published on such topics as industry trends, product benchmarking and raw material issues. I have testified on patent infringement, product design and manufacturing process. Extensive connection with diaper industry executives. I have clients in 26 countries and have audited diaper factories everywhere, from large to small. I am also well connected with OEM's and raw material suppliers

Expert 41691 - CA(S)

Expertise Description

I have more than 15 years experience in Pediatric Infectious Diseases, particularly HIV, other viral, and fungal infections. I have experience with therapeutic drug monitoring and adherence to long-term anti-infective therapy. I have additional experience with Clinical pharmacometrics (the application of population pharmacokinetic and pharmacodynamic modeling and simulation to the optimization of dosing in individual patients), pharmacology, and pediatrics drug development and infectious diseases. I have over 10 years expert witness experience.

Expert 427826 - CA(S)

Expertise Description

I have more than 25 years in the field of Cosmetic Chemistry. My extensive experience includes research and development, product development, business development, operations, sales and marketing for personal care, skin conditions, cosmetic procedures, OTC, Nutraceuticals and pharmaceutical industries.

Expert 460263 - AL AK AZ AR CA(N) CA(S) CO CT DE DC FL GA HI IA ID IL IN KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WY WI

Expertise Description

I have more than 20 years of experience in practicing Dentistry with expertise as a Dental Malpractice expert. I have served as Chief Scientific Officer and was elevated to the dual position of CSO and Chief Medical Officer in a Laser R&D and Infectious Disease R&D photobiology company. I have written and been granted US, Canadian, European and Chinese patents on multiple light based medical devices and have run R&D teams for multiple classes of medical laser and optical devices. I have served as plaintiff, defendant and expert witness in patent litigation, patent infringement litigation with experience in patent analysis and claims construction. I am also a Biochemist, Dentist and Photo-Biologist. I have designed and completed human clinical testing on many laser based technologies for use in potentiating generic antimicrobial drugs in the treatment of multi-drug resistant bacterial and fungal infections such as MRSA and CRE. My devices have received FDA 510(k), Health Canada, and CE Mark approvals. I have over 10 years of experience in writing medical device patents, as well as in assisting with Intellectual property litigation for laser and medical device patents, including claims construction and patent analysis; with over 15 years of expert witness experience with consultations, deposition, and courtroom testimony.

Expert 460318 - GA

Expertise Description

I have more than 30 years in the Packaging and Beverage Industries with expertise in developing plastic closures for soft drink bottles and managing corporate package testing labs. I have additional experience in quality glass bottles, consumer behavior, primary and secondary packaging, production equipment and breakage, and distribution channels on 6-continents. I have additional experience with support in product liability, extortion, counterfeiting, and regulatory cases. I have prior expert witness experience with consultations and deposition.

Expert 128368 - NJ NY

Expertise Description

I have more than 25 years experience in the field of Oncology with expertise in internal medicine, Hematology, clinical research, independent medical examinations, case and utilization review, reimbursement policies, producing policies and guidelines, advising on FDA submissions, high-level medical writing and strategic planning. I have additional experience with strategic planning, fundraising and grants, recruitment and human resources, and policies and procedures. I have over 10 years expert witness experience with consultations, deposition, and courtroom testimony.

Expert 440376 - IL

Expertise Description

I have more than 35 years of experience in the field of Pharmacology and Drug Regulation. My extensive experience includes tracking, controlling, summarizing and reporting submissions to the FDA, drug reviews, clinical studies, drug activity in humans, human risk assessment, regulatory affairs, dispensing, and clinical pharmacy. I have over 30 years expert witness experience with consultations, deposition and courtroom testimony.

Expert 426295 - NY

Expertise Description

I have more than 20 years experience in the field of Dermatology. My experience includes skin conditions, pediatric dermatology, dermatologic surgery, dermatopharmacology, cutaneous mycology, psoroasis, therapeutics / FDA, clinical pharmacology, dermato-venereologica, dermatologic surgery, and current drug delivery. My teaching experience consists of biology, molecular genetics, diagnosis, and chemistry topics. My dermatologist research interests are directed toward treatment of uncomplicated skin and superficial skin, benefits of concomitant use of mild cleansing bar, facial contact dermatitis, treatment of acne, salicylic acid, ameliorate ashy skin, secondarily-infected dermatoses, acne vulgaris, actinic keratoses, and efficacy of other medications and dermatologic drugs. I have over 10 years expert witness experience with consultations, deposition, and courtroom testimony.

Expert 149592 - CA(S)

Expertise Description

I have more than 40 years experience in Engineering and Medical Devices. My areas of expertise consists of hydroculators, moist heat pads, thermal cooling pads and cooling apparatus; laser and thermal hair removal devices, dermabrasion equipment; luggage and costume jewelry; patient beds, transport gurneys; failure of Pilates exercise devices; surgical staples; surgical fluid warmers; pedicle screw failure; absorbable shoulder tacs; suture failure; chiropractic devices; dental burr and drill failures; defibrillator mechanical design issues; surgical laser power cord design reliability, and much more. My additional experience includes engineering and management focused on research and development, design, and manufacturing in the medical device, packaging, toy, consumer product, and aerospace industries. My responsibilities have ranged from original product conception through high volume manufacturing, including plastic extrusion, injection molding, assembly, decorating, labeling, and packaging. I have experience with FDA requirements and Good Manufacturing Procedures (GMP’s); producing prototype models; performing computer aided plastic part design (SolidWorks) and failure; and hazard analysis including Failure Mode Effects Analysis (FMEA). I have over 10 years expert witness experience.

Expert 142953 - CA(N)

Expertise Description

I have over 40 years experience in Rheumatology / Allergy and Clinical Immunology. I also specialize in internal medicine. My expertise includes environmental health, including food, safety, mold, and allergens. My clinical interests also consist of autoimmunity and nutrition / immunity. I have more than 35 years expert witness experience with consultations, deposition, and courtroom testimony.

Expert 343607 - GA

Expertise Description

I have more than 35 years experience in the Pharmaceutical and Pharmaceutical Packaging industries. I have extensive experience in the areas of Laboratory Management and Food and Drug Administration Regulations. My experience also includes various technical management positions in Quality Control, Technical Service, Labeling, and as a Director of Research and Development in Pharmaceutical Packaging. I have over 10 years expert witness experience.

Expert 350457 - KS

Expertise Description

I have more than 35 years experience in Food Science. My expertise includes: control of E. coli O157:H7 in raw ground beef and other processed beef products; control of salmonella in various food products; and Listeria monocytogenes in processed meats. I have additional experience in USDA and FDA food regulations and in the design and implementation of food safety systems, including HACCP. I have over 20 years expert witness experience with consultations, deposition, and courtroom testimony.

Expert 345649 - TX

Expertise Description

I have more than 15 years experience in Bio-medical Engineering. My expertise includes medical devices, medical implants, surgical implants, surgical devices, biomechanics, biological tissues; orthopedics, biomaterials, biochemistry, implants, devices, quality control, FDA approval, failure analysis, immunology, and laboratory safety. I have prior expert witness experience.