Expert Details
Chemistry, Manufacturing, and Controls Drug Development & Regulatory Expert
ID: 740400
Kansas, USA
Expert also serves as the President and CEO of a startup focused on acquiring and developing technologies and drug products for commercialization. Earlier in her career, she held leadership roles at companies such as Cypress and Hawthorn Pharmaceuticals, where she directed product development teams, liaised with the FDA, and oversaw product launches.
Her expertise extends to global regulatory affairs, where she has guided clients through submissions to foreign Ministries of Health, managed complex GMP documentation, and ensured compliance with regulatory standards worldwide. Her skills have been sought after as an expert witness in pharmaceutical litigation, where she has contributed expert reports and depositions in high-profile cases involving antitrust disputes and intellectual property.
Expert is a certified Regulatory Affairs professional and an active member of professional organizations such as the Pharmaceutical Technical Exchange Association (PTEA), the Regulatory Affairs Professional Society (RAPS), and the American Association of Pharmaceutical Scientists (AAPS). Her thought leadership is further evidenced by her invited presentations at international seminars and her contributions to industry panels on biologics, small molecules, and regulatory practices.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1986 | Degree: BS | Subject: Chemistry | Institution: Quincy University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2013 to Present | Employer: Undisclosed | Title: CEO | Department: |
Responsibilities:Consulting for new and generic drug product development, strategy planning,and life-cycle management; FDA application submissions (ANDA/NDA/IND/DMF); FDA interactions; submissions to foreign Ministries of Health; technical project management; GMP documentation review; prescription drug labeling; US Agent duties; and expert witness services. Small, medium, and large pharma clients with products in varying stages of development and/or post-approval. |
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| Years | Employer | Title | Department |
| Years: 2019 to Present | Employer: Undisclosed | Title: President & Chief Executive Officer | Department: |
Responsibilities:Start-up pharmaceutical company interested in acquiring technology, molecules or drug products for development for future commercialization. |
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| Years | Employer | Title | Department |
| Years: 2006 to 2013 | Employer: Cypress Pharmaceutical, Inc. / Hawthorn Pharmaceuticals, Inc. | Title: Director of Product Development | Department: Divisions of Pernix Therapeutics |
Responsibilities:• Led the Product Development team in the development and approval of new and genericproducts from conception to post-approval. • FDA liaison for all Cypress and Hawthorn development and approved products. • Provided the strategy for submission and approval of NDAs and ANDAs. • Provided the strategy for submission of INDs and DMFs. • Prepared meeting packages and participated in numerous pre-IND meetings with FDA. • Preparation, submission, and review of FDA applications in electronic and CTD formats. • Performed technical and regulatory review of GMP documents, including manufacturing batch records, raw material and finished product release specifications, test methods and validations; and determined appropriate Change Control, as necessary. • Provided leadership and guidance regarding the launch of products to the U.S. market. • Created, reviewed and approved product labeling for submission to FDA. |
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| Years | Employer | Title | Department |
| Years: 2002 to 2006 | Employer: Beckloff Associates, Inc. | Title: Director, Pharmaceutical Sciences | Department: |
Responsibilities:• Project lead for INDs, CTAs, CEPs, NDAs, ANDAs and MAAs• Preparation, review, submission, and maintenance of CMC sections of INDs, CTAs, NDAs, ANDAs, MAAs, and DMFs in traditional paper and electronic formats • Preparation, review, and submission of briefing documents for FDA, Health Canada and European Union Agency meetings • Training of client companies’ representatives in on-site seminars for U.S. regulatory requirements |
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| Years | Employer | Title | Department |
| Years: 1988 to 2002 | Employer: Aventis Pharmaceuticals | Title: Chemist & Quality Assurance Regulatory Liaison | Department: |
Responsibilities:• Liaised between the various Regulatory departments within Aventis, the external manufacturers of Aventis products, and the foreign Aventis manufacturing sites to ensure drug products and APIs were registered with consistent data• Authored numerous product applications submitted to FDA • Setup and implementation of regulatory change-control system for multi-million dollar and billion-dollar products manufactured at multiple sites around the world and approved in multiple countries • Provided regulatory assessments of post-approval changes in the U.S. • Responsible for development and testing of R&D products |
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Career Accomplishments
| Associations / Societies |
|---|
| • Regulatory Affairs Professional Society (RAPS) • Pharmaceutical Technical Exchange Association (PTEA) • American Association of Pharmaceutical Scientists (AAPS) • BioKansas |
| Licenses / Certifications |
|---|
| Regulatory Affairs Certification (RAC-US) |
| Professional Appointments |
|---|
| Former President & VP, Pharmaceutical Technical Exchange Association |
Additional Experience
| Expert Witness Experience |
|---|
| Expert has worked on 5 cases in pharmaceutical litigation and has experience with expert reports, supplemental reports, deposition, and rebuttals. |
| Training / Seminars |
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| Multiple FDA trainings and seminars, as well as various speeches, presentations, and panels. |
Fields of Expertise
new drug application, abbreviated new drug application, Drug Master File, small molecules, drug discovery litigation, antitrust, FDA approval, CMC writing, drug product approval, investigational drug, investigational drug procedures, active pharmaceutical ingredient, injectable pharmaceutical product, pharmaceutical capsule, pharmaceutical chemistry, pharmaceutical containers, pharmaceutical industry, pharmaceutical launch, pharmaceutical life cycle management, pharmaceutical manufacturing, pharmaceutical manufacturer, pharmaceutical operations, pharmaceutical packaging process, pharmaceutical product development, pharmaceutical product formulation, pharmaceutical product shelf life testing, pharmaceutical quality assurance, pharmaceutical quality control, Pharmaceuticals, solid pharmaceutical product, pharmaceutical scale-up, pharmaceutical research and development, pharmaceutical regulations, pharmaceutical dissolution, FDA audit