Pharmaceutical Regulation Expert Witnesses
The SEAK Expert Witness Directory contains a comprehensive list of pharmaceutical regulation expert witnesses who testify, consult and provide litigation support on pharmaceutical regulation and related issues. Pharmaceutical regulation expert witnesses and consultants on this page may form expert opinions, draft expert witness reports, and provide expert witness testimony at deposition and trial. The issues and subjects these pharmaceutical regulation expert witnesses testify regarding may include: FDA, Drug Development, Regulatory Compliance, Clinical Trials, Commercially Reasonable Efforts, Drug Formulation, Fda Compliance, Fda Regulations, Medical Device Product Liability, Medical Devices, Pharmacology, Product Liability, 505(b)(2), Abuse, and Active Pharmaceutical Ingredient.
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John J Hosier
Pharmaceutical & Biotechnology Marketing and Sales
John Hosier Healthcare Consulting, LLC
California
Marketing, Pharmaceutical Regulation
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Bio-similar drugs, Biotech & Pharma Marketing, Operations, Promotion, CNS Products, Medicare, Launch delay, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE, Pharmaceuticals , Promotional compliance
Mr. Hosier is a strategic advisor to the life sciences industry drawing on 30 years of sales, marketing and managed markets experience in commercial healthcare organizations. 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; advised on commercially reasonable effort (CRE); and provided commerci...
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Timothy A Anderson
Chemistry and Manufacturing Controls (CMC), FDA
The AquaMarine Group, Inc.
Redding, Connecticut
Pharmaceutical Regulation, Manufacturing
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Current Good Manufacturing Practice, ANDA, cGMP, CMC, Active Pharmaceutical Ingredient, Food and Drug Administration, 505(b)(2), NDA, New Drug Application, NCE, Regulatory compliance, BLA, Drug Master File, Method validation, CRL, Due diligence, FDA, Chemistry and Manufacturing Controls, API, label
Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely inter-disciplined 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 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), 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...
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Willa L Carter
CQG
Conyers, Georgia
Chemistry & Chemicals, Pharmaceutical Regulation
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Medical devices, pharmaceutical research, patents, drug formulation, quality control, laboratories, manufacturing, drug packaging, cosmetics, food, ISO, International Standards of Harmonization (ISO), environmental conditions, compliance, sterilization, chemical synthesis, fermentation, components
Experienced Chemist with 25+ years of experience in quality control, raw materials, manufacturing, validation, and stability. Experience in pharmaceutical, medical device, cosmetics, and food industries. Former odor panel scientist at Proctor & Gamble as a contractor. Extensive teaching experience. International inspector.
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Dennis A. Wichern
DEA Compliance Expert - Former DEA Agent in Charge
Prescription Drug Consulting LLC
Carmel , Indiana
Pharmaceutical Regulation, Pharmacist
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DEA, DEA Expert, DEA Compliance, DEA Compliance Expert, DEA Pharmacy Compliance, DEA Red Flags Expert, DEA OTP Expert, DEA Pharmacy, DEA Ketamine , Opioid prescribing , DEA ASC Compliance, DEA Opioid Compliance, DEA Pain, DEA Recordkeeping Compliance, DEA Opioid Prescribing, Veterinaran Compliance, DEA EMS, Fentanyl
Dennis Wichern is a partner in PDC, where he focuses his efforts on DEA compliance initiatives, drug diversion prevention, and training to protect healthcare organizations, providers, pharmacies, ASC’s, OTP’s, and DVM’s nationwide. His experience includes 30 years of public service as a DEA Special Agent retiring in 2018 as the Special Agent in Charge of the Chicago Field Division where he directed all criminal enforcement and diversion control operations in the states of Illinois, Indiana, Wisconsin, Minnesota and North Dakota with a team of approximately 550 employees.
Dennis was the first to develop DEA compliance, diversion prevention, and training relating to pain and prescription opioids, SAMHSA OTP’s regulations, hospital, pharmacy, ketamine therapy, ASC, and DVM drug protocols. Dennis is a recognized expert on the dangers of the opioid epidemic and routinely speaks to healthcare organizations, pharmacies, providers, ASC’s, OTP’s, and DVM’s to identify methods to better safe...
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David B Ross, MD, PhD, MBI
Infectious Disease Physician & Former FDA Reviewer
David B Ross MD PHD MBI LLC
Baltimore, Maryland
Pharmaceutical Regulation, Infectious Diseases
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Food and Drug Administration (FDA), drug/biologics safety/labeling/post-marketing surveillance, FDA drug/biologics regulations/procedures/applications (INDs/NDAs/BLAs), clinical trials, drug development, pharmacy compounding, HIV, MRSA, antibiotics, hepatitis, osteomyelitis, influenza, C. difficile
Dr. Ross is a Yale fellowship-trained, board-certified infectious disease physician with expertise in clinical medicine, pharmaceutical development and regulation, and public health . An active clinician in practice for over 30 years, he provides patient care in the areas of infectious disease and primary care.
Dr. Ross received his undergraduate degree in Molecular Biophysics and Biochemistry from Yale University and his medical degree from New York University School of Medicine. He completed his internal medicine residency training at NYU Medical Center and infectious disease fellowship training at Yale University. Dr. Ross also holds a M.S. and Ph.D. in Biochemistry from NYU, and a Master’s Degree in Biomedical Informatics from Oregon Health & Sciences University.
Dr. Ross spent 10 years at the FDA’s Center of Drug Evaluation and Review (CDER) as a medical officer, senior medical reviewer, medical team leader, and new drug review office management official. He has extremely br...
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Joshua Sharlin, PhD
SHARLIN CONSULTING
STEVENSVILLE, Maryland
Pharmaceutical Regulation, Medical Devices
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FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability
Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times.
Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries.
Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions.
Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it?
Provide FDA related ...
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Paul A. Arpino, PharmD
Newton, Massachusetts
Pharmacist, Pharmaceutical Regulation
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Hospital, Outpatient Retail Pharmacy Practice, Standards of Pharmacy Practice, Medication Errors, Medication Safety, Adverse Drug Reactions, Drug Interactions, Standard of Care, Anticoagulation, Controlled Substances, Pharmacy Standards, Therapeutic Drug Monitoring, Pharmacy regulations
Extensive knowledge in pharmacy practice, regulatory compliance, medication management and standards of pharmacy practice across a variety of patient care settings. Board Certification in Pharmacotherapy (BCPS). Available as a consultant for both plaintiff and defense cases.
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John J Hosier
Pharmaceutical & Biotechnology Marketing and Sales
John Hosier Healthcare Consulting, LLC
West New York, New Jersey
Marketing, Pharmaceutical Regulation
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Bio-similar drugs, Biotech & Pharma Marketing, Operations, Promotion, CNS Products, Medicare, Launch delay, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE, Pharmaceuticals , Promotional compliance
Mr. Hosier is a strategic advisor to the life sciences industry drawing on 30 years of sales, marketing and managed markets experience in commercial healthcare organizations. 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; advised on commercially reasonable effort (CRE); and provided commerci...
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Frank Breve, PharmD, MBA, CCP
Mid Atlantic PharmaTech Consultants, LLC
Ventnor City, New Jersey
Pharmacist, Pharmaceutical Regulation
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Geriatrics, Addiction, Opioids, Hospitals, Dialysis, Behavioral Health, Drug Distributors, Drug Companies, Long Term Care, Assisted Living, Pharmacies, Professional Practice, Regulatory Compliance, Duty of Care, Duty to Warn, Product Liability, Pharmacology, Toxicology, Abuse, Overdose
Dr. Frank Breve is an independent contractor consultant pharmacist. He is President and CEO of Mid Atlantic PharmaTech Consultants, LLC, a for profit company. Dr. Breve is also President and CEO of Opioid Consulting Educational Solutions, a 501(c)(3) non-profit corporation. He is adjunct faculty at Temple University School of Pharmacy in Philadelphia, and at University of Colorado Skaggs School of Pharmacy in Denver. Dr. Breve has authored over sixty scientific publications in peer reviewed journals. Dr. Breve is past president of the New Jersey Pharmacists Association, and a member of various professional societies and committees. He has been the recipient of many awards in his field of practice. Dr. Breve has served as an expert witness for roughly twenty years, and has worked on numerous cases, representing both plaintiffs and defendants.
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John J Hosier
Pharmaceutical & Biotechnology Marketing and Sales
John Hosier Healthcare Consulting, LLC
New York
Marketing, Pharmaceutical Regulation
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Bio-similar drugs, Biotech & Pharma Marketing, Operations, Promotion, CNS Products, Medicare, Launch delay, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE, Pharmaceuticals , Promotional compliance
Mr. Hosier is a strategic advisor to the life sciences industry drawing on 30 years of sales, marketing and managed markets experience in commercial healthcare organizations. 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; advised on commercially reasonable effort (CRE); and provided commerci...
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Dr. Ediuska Laurens, M.S, EngD.
Medical Device FDA Regulation & Quality Expert
Genius Shield LLC
New York City , New York
Medical Devices, Pharmaceutical Regulation
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Medical Device FDA Regulation, Biologics FDA Regulation, FDA Compliance, FDA Warning & Labels, Product Liability, FDA Regulations, Medical Device Product Liability, Clinical Trials FDA Regulation, Medical Device FDA Approvals-Clearance, Medical Device Recalls, Medical Device Complaints, Biomedical Engineering
Dr. Ediuska Laurens is a highly credentialed biomedical engineer and expert in FDA regulation, compliance, and product liability for medical devices and biologics. She provides expert witness services to both plaintiff and defense counsel in litigation involving medical device and biologics FDA approval and clearance, labeling and warnings, quality systems, adverse event reporting, clinical trials, and post-market surveillance.
Dr. Laurens brings over 20 years of combined industry, research, and regulatory experience. She has led regulatory and quality efforts across the entire medical device lifecycle, from concept through commercialization, supporting product development, regulatory submissions, and quality compliance for a wide range of technologies, including cranial and orthopedic implants, spinal and neural devices, tissue engineered-biologics and combination products, hydrogel biomaterials, as well as pediatric and women’s health innovations, among others. Attorneys rely on...
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John J Hosier
Pharmaceutical & Biotechnology Marketing and Sales
John Hosier Healthcare Consulting, LLC
Pennsylvania
Marketing, Pharmaceutical Regulation
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Bio-similar drugs, Biotech & Pharma Marketing, Operations, Promotion, CNS Products, Medicare, Launch delay, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE, Pharmaceuticals , Promotional compliance
Mr. Hosier is a strategic advisor to the life sciences industry drawing on 30 years of sales, marketing and managed markets experience in commercial healthcare organizations. 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; advised on commercially reasonable effort (CRE); and provided commerci...
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Debra Leibold, MD, PhD
Consultant
Blue Bell, Pennsylvania
Pharmaceutical Regulation, Warnings & Labels
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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?”
Provide leadership in support of label development for new applications, supplemental appl...
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Frederick H Hausheer, MD, FACP
Oncology Drug R & D, ICH GCP, Drug Patent Validity
HAUSHEER BIOMED, LLC USA
Austin, Texas
Oncology, Pharmaceutical Regulation
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Oncology Drug Development, Patent Validity, ICH GCP, Written description, Enablement, Obviousness, Anticipation, Pharmacology, FDA, EMA, NMPA/China, PMDA/Japan, Drug formulation, Medical Safety, Phase 1-3 Clinical Trials, Drug Product Safety, Medical Oncology, Breach of Contract - Pharma/Biotech, Commercially Reasonable Efforts, Damages
Dr. Frederick (Fred) Hausheer is a physician-scientist with over 37 years of executive leadership and management experience in US and international (EU, JP, China, others) commercial pharmaceutical research and development (Phase I-III), preclinical translational and clinical medicine, clinical pharmacology, ICH GCP compliance and commercial development strategy and risk management of novel cancer therapeutics. His commercial research and development experience includes cytotoxic agents, targeted agents, immuno-oncology therapeutics, cell therapies (BMT, CAR-T), and supportive care medicines. He is an inventor/co-inventor on more than 400 issued United States and international pharmaceutical patents, and author/co-author of more than 200 scientific/medical publications.
He is an experienced former CEO and Chief Medical Officer with several biopharma companies and a former NCI-Designated Clinical Investigator, NCI-Institutional Review Board voting member, and NCI-Experimental Ther...
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Peter Coderre, PhD
Antimicrobial Regulatory Consulting
Lovettsville, Virginia
Pharmaceutical Research, Infectious Diseases
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pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, medical microbiology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro, IP
25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science.
Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense.
Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs.
As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...
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Connecticut, Georgia, Indiana, Maryland, Massachusetts, New Jersey, New York, Pennsylvania, Texas, and Virginia
