- Regulatory, Food and Drug Administration (FDA)-related provisions and cases providing support to legal clients in areas: Death or injury caused by drugs, biologics or medical devices, (patents, insurance claims, wrongful termination, trade secrets, merger and acquisitions.
- Develop and present more than 40 FDA related technical, regulatory and compliance topics to over 50,000 participants.
- Develop case-specific information from FDA databases of safety information about medical devices and drugs.
- Critique adverse event reporting.
- Perform statistical analysis.
- In-depth understanding of the FDA approval process for drugs, and medical devices.
- Identify, prevent and solve FDA compliance problems for drug and medical device companies.
- Expert in data integrity and software development.
- Author safety expert reports and FDA compliance.
- Vast experience auditing companies for FDA compliance.
- Author FDA submissions, standard operating procedures (SOPs), and study reports
- Speaker at FDA meetings with drug and medical device companies.
- Testify as an FDA expert witness in drug, biologic, and medical device cases.
- FDA reviewer.
Expert Witness Experience
Expert FDA Witness Activities
- Food and Drug Administration (FDA)-related regulatory support to attorneys in cases involving; death or injury caused by drugs, biologics or medical devices, patents, insurance claims, wrongful termination, trade secrets, merger and acquisitions.
- Expert in data integrity and software development.
- Provide testimony and depositions.
- Hands-on experience in the entire lifecycle of FDA-regulated product development, from developing an initial regulatory strategy, thru data collection and analysis, to review and approval at FDA.
- Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies.
- Specialist in analyzing FDA compliance information targeting areas:
- What did the company know and when did they know it; What should the company have known and when should they have known it; What should the company have done and when should they have done it?
Undisclosed Company, Development Leadership Advisor: Regulatory, 2016 - Present
- Advise senior Department of Defense leadership on changes to tactical and strategic regulatory actions that improve the path to FDA approval of 19 products (drugs, vaccines and medical devices) under development intended as defense against biological weapons.
- Attend all meetings with FDA. Write white papers for all programs identifying regulatory strengths, weaknesses and risks affecting progress toward FDA approval.
- Develop and implement recommendations for improving regulatory strategy.
S.C. Consulting, Washington, D.C., Consultant & Principal, 1994 - Present
- Expert witness in court for matters related to FDA’s regulatory process for drugs, biologics, and medical devices.
- Audit drug companies, contract research organizations (CROs), clinical sites, labs and software vendors for good clinical practice (GCP) compliance.
- Identified and closed compliance gaps in anticipation of an audit by FDA..
- Write, review and improve INDs, NDAs, IDEs, PMAs, 510(k)s, SAPs, protocols and SOPs.
- Solve compliance problems identified by FDA auditors and answer questions posed by FDA reviewers.
- Develop and present more than 40 FDA-related technical, regulatory and compliance topics to over 50,000 people.
- Assist drug companies and CROs in FDA compliance of electronic records, software products, databases and software development.
- Investigate, analyze and improve data quality and data integrity in FDA-related activities.
- Prepare information for, and present information at FDA meetings with drug, biologic, and medical device companies.
Food and Drug Administration (FDA), Rockville, MD, Drug Reviewer, 1992 - 1994
- Manage the drug review process. Instruct firms on how to proceed with drug approval.
- Summarize outstanding problems and issues with protocols and studies.
- Determine if deficiencies were adequately addressed. Review statistical methodology of studies.
- Author all written communication to the sponsoring firm and integrate comments from other reviewers.
Expert Witness Activities
- Analyze FDA’s medical device safety database to show a company failed to report incidents about their medical device resulting in death.
- For a hip implant, identify pre- and post-approval actions and inactions by the medical device manufacturer that were noncompliant with FDA’s regulatory requirements.
- Explain how a drug company’s inadequate Medication Guide fulfillment processes failed to meet FDA’s regulatory requirement for supplying a Medication Guide with every drug prescription.
- Explain how a drug company’s manufacturing compliance failure negated their business loss insurance claim made after physical damage to their manufacturing facility.
- For a hip implant, describe the medical device manufacturer’s lack of FDA compliance in their efforts to obtain a 510(k) approval.
- Conduct an FDA regulatory review of medical device company’s actions after the installation of their implantable pulse generator (intended to relieve pain) caused harm.
- For a hip implant, describe the medical device company’s non-compliance with FDA’s labeling and reporting requirements for adverse event information.
- Write a report explaining why the Warning Section in the label for a generic version of sulindac was deficient.
- Write a report confirming a drug manufacturer’s processes for establishing the stability of a drug product met FDA’s compliance requirements.
- Review a clinical study intended to compare the effectiveness of two drugs. Show the study’s design was manipulated to mask the weakness of one drug over the other.
- Find weaknesses in a defense expert’s report on the adverse event reporting of fentanyl.
- Evaluate FDA compliance in reporting adverse event information about Actos.
- Deposed about the responsibilities of an Institutional Review Board in a wrongful firing case.
- Testify for the defendant in a fertility clinic damages case. Explain the process and predictability of FDA approval of a drug under development.
- Analyze the content of a drug IND submission to identify trade secret content.
- Identify FDA regulatory deficiencies in the adverse event reporting of a breast cancer drug and the describe the resulting deficiencies in the drug’s label.
- Analyze the adverse event reporting for a drug that treats Attention Deficit Hyperactivity Disorder (ADHD) to determine if the drug’s label meets FDA regulatory requirements.
- For a schizophrenia drug, analyze the growing body of scientific literature about the drug and determine if the company’s updates to the drug label’s safety information were FDA compliant.
- Support a medical device company’s claim for monetary damages by showing how infringement of their patent solved a regulatory compliance problem of the Defendant.
- Explain how achieving drug development milestones triggered a disputed $100 million dollar payment in a merger agreement.
Honors & Publications
- Author of numerous expert reports recognized in active litigation and regulatory bodies.
- Ph.D. Physiology, University of Georgia, Athens, GA
- M.S. Physiology University of Maryland, College Park, MD
- B.A. Biology, University of Iowa, Iowa City, IA