Regulatory Affairs Expert Witnesses

This expert has over 10 years of experience in risk management and regulatory compliance in the financial services industry, with a focus on identifying compliance issues and implementing solutions to mitigate risk. In his work with the CFPB, he identified millions of dollars in remediation for consumers. Formerly, he worked in consumer protection roles with the Consumer Financial Protection Bureau and the California Department of Financial Institutions, as well as in compliance and risk management roles at San Diego County Credit Union and Union Bank. Currently, he is a compliance advisor with a national financial services group and is based in California.

This highly qualified check fraud specialist and certified anti money laundering specialist has over 21 years of service in the industry. He spent 10 years as a Nevada law enforcement official in the field of corrections, and reserve work and became the president of the Nevada Check Cashing Association and board member of the National Check Cashers Association. He is currently a member of the Nevada Fight Fraud task force and Consumer Affairs Investigator Reserve as well as previous member Anti Money Laundering MSB task force. He currently provides anti-fraud consulting services nationally as well ad AML training, drafting of AML programs and independent reviews and written risk assessments.

This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods verification of New Drug Applications and Abbreviated New Drug Applications, Drug Product Surveys, and Research Projects. Currently, this expert is an independent consultant in which he assists pharmaceutical firms in technical, regulatory, and management areas to ensure their clients' products hit the market in a timely manner. He assists attorneys as an Expert Witness/Subject Matter Expert in Pharmaceutical cases.

This Nutrition industry professional has an advanced degree in nutrition, and several years of experience involving the technical aspects of regulatory affairs, scientific affairs, product labeling, and research & development. His specialties: 21 CFR 101 (Food Labeling), 21 CFR 111 (cGMPs for dietary supplements), FTC advertising guidelines, regulatory compliance review, product substantiation, ingredient research and product development. In his current role as Manager at a Vitamin research company he is responsible for reviewing products, labeling and marketing materials for FDA and FTC compliance.

This highly qualified expert has extensive knowledge of regulatory and legislative issues relating to the healthcare industry and of eHealth governance. He received both his MAS and PhD degrees focusing in health policy and law and global health from the University of California, San Diego, and has worked as a consultant or expert for various organizations including the World Health Organization, US Department of State, US Department of Justice and others. He is a member of various professional organizations, including the American Public Health Association and is the current program chair of the APHA Trade and health forum. He lectures both nationally and internationally and has received multiple honors for his outstanding research. He has published 100+ peer-reviewed journal articles and serves on the editorial board at BMC Medicine and is an associate editor at BMC Public Health. He is the former senior research associate at the California Western School of Law's Institute of Health Law Studies and the former senior legal and compliance specialist at ResMed Inc. Currently, he is the director of a major health policy research institute and an assistant professor of global public health at a major school of medicine, where he also directs the master's degree program in health policy and law.

This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.

This expert received his undergraduate and doctoral degrees in Biomedical Engineering from Iowa State University. He has worked for and consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the FDA, Health Canada, the US & European Patent Offices, the Centers for Medicare and Medicaid Services, and other regulatory agencies around the world. As an internationally recognized expert, he presents frequently on cutting-edge medical technologies and conducts seminars for medical device, pharmaceutical and biotechnology companies.

This highly qualified expert has more than 40 years of international experience in the development and implementation of occupational health, safety, and environmental (HSE) management systems within the petroleum, petrochemical,manufacturing, and construction industries. He is an advisor to management on regulatory compliance with worldwide agencies such as BSEE, EC, OSHA, HSE, PSA, SSM, DEA, USCG, MSHA, MMS, NOPSA and other applicable industry standards and codes. He is experienced with ISO, ISM, Injury Incident Free (IIF) culture building, root cause analysis, and behavior based safety; including 24 years experience with stringent safety requirements of the North Sea regulatory agencies.

This certified Regulatory Affairs Professional has more than 20 years of experience ensuring compliance with the FDA. Throughout his career, he has managed 510(k) submissions, reviews, appeals, and clinical trials for a multitude of devices with applications ranging from dentistry to cardiology and neurology. Prior to launching his current consultancy, he served as a Director of Regulatory Affairs at medical device firms that manufacture class II and class III products. Have experience with: Catheters/Stents: IV administration sets, peripheral perfusion/infusion catheters, coronary perfusion/infusion catheters, thoracic catheters, chest drains and blood bags, embolectomy catheters, thrombus aspiration catheters, PTA, PTCA, CVC, ECMO, retrograde and antegrade hemodialysis catheters, urethral and ureteral catheters/stents, insulin administration, Closed System drug Transfer Devices (CSTD), non-roller cardiopulmonary bypass pumps and catheters, coronary and peripheral BMS, peripheral covered stents, aortic covered stents, DES, ureteral stents, urological stents, esophageal stents, intracranial aneurysm stents, pericardium covered stents, vascular grafts and vascular grafts with helix or nitinol reinforcement, and vascular patches. Biomaterials: bone void fillers, resorbable implants, hydroxyl appetite, hyaluronic acid, dental impression materials, PEEK, calcium carbonate, Beta TCP, imaging contrast agents, hydrogel dressings, lubricious coatings, artificial saliva, contact lenses and contact lens solutions, antimicrobial coatings, antithrombotic coatings, IIb/IIIa inhibitors, mTOR inhibitors, and omega3 coatings, injectors and pens, antimicrobial wound cleanser and bandages. Orthopedic/Dental: ACL/PCL screws, suture anchors, tacks, staples, spinal cages, trauma plates and screws, CMF, approximation pins and rods, dentures, veneers, dental implants/abutments, impression material, autoclave equipment, dental units, limb lengthening systems, and intra-oral x-ray equipment. Accessories: tunnelers, suture wings, convenience kits, stylets, peel away dilators, cannulas, scalpels, suture, guidewires, sheathes, extension sets, repair kits, luer valves, needle/syringes, blood vacuum tubes, needle safe devices, O2 regulators, radiation therapy patient positioning systems, radiation range compensators, sterilization biological and chemical indicators, and fiber wire docking stations. Hardware/Software: neonatal clinical trial software, firmware, RIS software, image repository software, ECG analyses software, TENS, MIRS, MMA, MDDS, EMC therapy, PACS, stereotactic tracking system, stereotactic software, patient monitors, ventilators, lift beds, TMS (transcranial magnetic stimulator), active tinnitus implants, Holter monitors, phototherapy devices, data fusion software, hyperbaric chambers, autoclave sterilizers, powered muscle stimulators, cryosurgical units, MDM workflow software, Doppler and GPS ultrasound scanners, GPS needle sensors, vascular access needles, RF, nerve block needles, fiber optical lasers, neuron stimulators, and therapeutic massagers, MIMS, viewing monitors, body contouring devices. Reusables: nasopharyngoscope, colonoscope, colposcope, neurological endoscope, sinuscope, arthroscope, and laparoscopes, instruments, tunneler rods, irrigation systems, therapeutic mattresses, OB/GYN scopes, patient cables and electrodes, scooters, vein graft tunneling systems, confocal optical imaging devices, and cannulae, 3DHD endoscopes, IR fluorescence and Indocyanine green endoscopes, measuring microscopes. General Surgery: surgical film, pressure mattresses, cryo-biopsy needle, surgical mesh, plugs, anal fissure drug suppository and delivery plunger, anorectic Nifedipine CTD, red light therapy dermatology lasers, surgical lasers, and Continuous Low Irradiance Photodynamic Therapy (CLIPT) for phototherapy drug activation, collection and transport media, disinfecting swabs and wipes, gastrostomy tubes.

This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and regulatory due diligence. Her experience includes serving as a member of the Management Team (SVP RA) for three small companies developing novel drugs and biologics, and building and leading a product compliance organization (RA, QA and CQA) for a small biotech company, including approval of their first monoclonal antibody product, while serving in a leadership role on the Management Team. Prior to that, have led regulatory activities for several NDAs (leading to marketed products), INDs and post-marketing regulatory activities in 3 large pharmaceutical companies. She has 5 years experience in small molecule API process development and a PhD in medicinal chemistry and is a frequent contributor to various Industry programs. Specialties: All aspects of Regulatory Affairs for entire product lifecycles for small molecules and biologics, including: -IND/NDA/BLA submission management, prosecution and strategy -FDA meetings -Regulatory Liaison activities -Ad/Promo review and advising -CMC

A 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal Investigations (OCI) and as an analytical regulatory microbiologist. During his last three years at FDA he spearheaded the agency's integration efforts with Customs and USDA on crosscutting interagency enforcement and operational issues; served as the FDA's point-person in managing the intersection of imports and FDA's new bioterrorism regulations; established joint agency and industry working groups to evaluate counterfeiting and tampering risks to food and drug distribution supply chains; was the agency lead in its strategic planning efforts to reinvent the FDA's import programs; wrote the initial statement of work and acted as program manager over the FDA's new PREDICT, risk-based electronic entry screening system; and directed the development of the FDA's agency-wide Risk-based Import Strategic Plan designed to improve compliance of foods, dietary supplements, drugs, medical devices, cosmetics, and biological products imported into the U.S. As CEO of a FDA consulting firm and Founder of an affiliated law firm, he currently represents domestic and foreign companies of all sizes, assisting them in identifying USDA, FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and state requirements. He focuses his practice on FDA matters, including but not limited to: matters relating to FDA inspections, FDA criminal, regulatory and administrative enforcement actions for medical devices, drugs, cosmetics, alcohol, tobacco, dietary supplements, and foods.

This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.

This former New York DMV manager has decades of experience working for the Department of Motor Vehicles. He held positions as a Clerk and Operations Manager in the White Plains and Albany offices in the 1980s and became Office Manager of the New York District Office in 1993. For 12 years, he served as the District Director in charge of operations in the MetroNorth District, and he finished his career in the DMV as the Regional Director in charge of the Metropolitan Region from 2008 until 2012. After leaving the DMV, the expert briefly served on a county legislature; he now works in the insurance industry.

This expert regularly counsels clients on regulatory, transactional and legislative issues affecting the broadcasting, wireless and wireline industries. He is an active member of the Federal Communications Bar Association, for which he has served on the Executive Board since 2013. He also authors a monthly column in Radio Magazine, is editor of a telecom blog, and speaks regularly on panels, including the National Association of Broadcasters, state broadcast associations, and the National Association of Regulatory Utility Commissioners.

This extremely qualified expert is a certified pharmacist with years of experience in community pharmacy management and regulatory affairs. He received both his BS degree in pharmacy and his MBA degree from the University at Buffalo. He is a member of multiple professional associations, including the American Association of Colleges of Pharmacy, the American Pharmacists Association and the American Society for Pharmacy Law. He has given 100+ lectures statewide in NYS. His outstanding work has earned him several honors, including the Pharmacists Society of the State of New York's "Faculty Excellence Award" the Pharmacists Association of Western New York's "Pharmacist of the Year" award and the national Bowl of Hygeia award. He is the former coordinator of pharmacy services at the Community Health Center of Buffalo. He is also the former director of pharmaceutical care services at the University of Buffalo. Currently, he is a clinical associate professor of pharmacy practice and administration at a major university, where he also serves as the senior associate dean of the pharmacy school's student, professional and community affairs.

This expert is the president of a healthcare government relations and regulatory policy consultancy firm that she founded after an extensive career in healthcare and government. She was the Vice President for Government Relations and Public Policy at Celgene and was the Vice President for Regulatory Policy at GE Healthcare. She served in the administration of President George H.W. Bush as Special Assistant for Legislative and Public Affairs in the Office of the Commissioner, US Food and Drug Administration. She is a certified Regulatory Affairs specialist and is the author of numerous reports and is currently on the Board of Directors of the FDA Alumni Association. Her formal education includes a BA in Government from Georgetown University and an MS in Science and Technology Commercialization from The University of Texas at Austin.

This expert received his BA from Cornell University, and his MD and PhD from Albert Einstein College of Medicine. He completed his residency in Psychiatry at UCLA Neuropsychiatric Institute/Brentwood VA Medical Center. He is also a member of numerous academic societies including American Society of Addiction Medicine, American Academy of Addiction Psychiatry, Society of Biological Psychiatry, College of Problems of Drug Dependence and American Psychiatric Association. He has been highly prolific in his career with over 170 publications. He is a currently a Professor of Psychiatry at an academic medical center.

This qualified expert received his BA from Valparaiso University and is a licensed OSHA trainer for numerous courses. He has managed various construction safety projects including the installation and modification of industrial equipment valued at over a billion dollars. Formerly, he served as a night safety manager for Gallagher Kaiser at General Motors and as a safety manager for NKC American at Toyota Motor Manufacturing. He currently is the safety manager for a prominent aluminum manufacturer overseeing the installation of a new stamping bed.

This highly-qualified expert in arbitration and mediation has over 25 years of experience. She earned her BA in philosophy at College of William and Mary and her JD at the University of Richmond. She is a certified mediator with the Florida Supreme Court and a certified arbitrator with AIDA Reinsurance & Arbitration Society. She is active in her field as a member of the Association of South Florida Mediators and the Chartered Property Casualty Underwriter Society. She has formerly served as the chair of the tort and insurance practice section for the American Bar Association and as an attorney in the insurance transactional and regulatory practice at Adorno & Zeder, P.A. In addition, she spent nearly 20 years working for the National Council on Compensation Insurance, where she served in several legal business positions. She currently serves as the owner of her own firm that provides arbitration, mediation and consulting in Florida.

This highly qualified expert has over 30 years of experience as an insurance regulator and consultant. He earned his BS in commerce from Rider College. He is an accredited insurance examiner and is a member of the Statutory Accounting Working Group and NAIC Financial Analysis Working Group. He was formerly an assistant chief insurance examiner for the financial analysis unit, at the New Jersey Department of Banking and Insurance. Additionally, he was an assistant commissioner and the chief insurance examiner for the office of solvency regulation at the New Jersey Department of Banking and Insurance. He is currently a managing member of an insurance regulation and compliance service company.