Expert Details
Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
ID: 730734
Florida, USA
Among my activities are:
1. Designing preclinical, clinical and bioequivalence studies.
2. Filing INDs, ANDAs, NDAs and MAAs
3. Handling pre-approval inspections and all FDA relations
4. Quality auditing of vendors, manufacturing operations, and clinical sites
5. Laboratory operations
6. Technical expert for pharmaceutical partner alliances
Consulted for a medical device company on a device/drug combination.Have consulted for a start-up transdermal company on regulatory and quality issues.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1976 | Degree: B.S. | Subject: Biological Science | Institution: Florida State University |
| Year: 1976 | Degree: | Subject: | Institution: |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2003 to Present | Employer: Undisclosed | Title: Vice President of Regulatory & Technical Affairs | Department: |
Responsibilities:Leads all operational infrastructure services, regulatory affairs, and business development activities for this breakthrough technology with broad applications across therapeutic categories, pharmaceutical segments, formulations, and combinations. Serves as a key contributor in driving the organization forward. Develops and refines regulatory strategies to ensure compliance and resolves regulatory issues. Conducts GMP inspections of pharmaceutical companies engaged to manufacture or co-develop products. Member of the Board of Directors (BOD). Managed a staff up to 10 team members on a matrix basis including accounting, legal, clinical research, and business development. |
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| Years | Employer | Title | Department |
| Years: 1987 to 2003 | Employer: Noven Pharmaceuticals, Inc | Title: Executive Director of Medical & Regulatory Affairs | Department: |
Responsibilities:• Designed and conducted preclinical/clinical studies for the entire company product portfolio. Submitted protocols to IRB and responded to issues. Selected and inspected CROs for specific trials and personally led the evaluation of clinical sites and investigators for other studies.• Conducted vigorous research and prepared detailed technical documents necessary for filing approximately 10 INDs, 1 ANDA, 4 NDAs, and 3 MAAs with the FDA and European Regulatory Agencies. Ensured seamless and timely regulatory processing by proactively anticipating and addressing inquiries, evidenced by minimal regulatory follow-up questions, including the chemistry, manufacturing and control (CMC) section. • Designed, researched, and drafted the compliant Current Good Manufacturing Practices documentation system, incorporating the standard operating procedures (SOP) and standard testing procedures (STP), which is still used today. Inspected frequently as a new company, passing all FDA visits with minimal observations. • Attained FDA approval on four transdermal products currently being marketed and one transmucosal product. Collaborated with two Big Pharma licensing partners to gain MAA (Marketing Authorization Application) approval on three products. Led negotiations for product approvals with the FDA and MAA. • Formed the company’s first Clinical Advisory Board for psychotropic medications and women’s health specialties. Identified and recruited industry and academic experts, including a leader in women’s health who convinced the FDA to approve Noven Pharmaceuticals’ hormonal replacement patch, which became the lowest dosage available on the market. |
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| Years | Employer | Title | Department |
| Years: 1984 to 1987 | Employer: Key Pharmaceuticals, Inc | Title: Quality Control Supervisor | Department: |
Responsibilities:Led all quality initiatives related to the company’s product portfolio that included transdermal, solid dose, and liquids. Managed a staff of 30 in conducting microbiology/raw material/tablets and transdermal testing. |
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| Years | Employer | Title | Department |
| Years: 1979 to 1984 | Employer: Cordis Dow Corporation | Title: Quality Assurance Department Head | Department: |
Responsibilities:Developed cell culture and hemolysis assays for determining the biocompatibility of polymers to be used in medical devices. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2006 to Present | Country / Region: India | Summary: Technical expert advising on business development efforts, contract negotiations, and product development. |
| Years: 1992 to 2003 | Country / Region: Europe | Summary: Served as liaison with the European Health Authorities and global partners. |
Career Accomplishments
| Associations / Societies |
|---|
| Regulatory Affairs Professionals Society |
| Professional Appointments |
|---|
| Accu-Break Pharmaceuticals Inc, SoLapharm Inc, PharmaNet Development Group Inc, Appointed to the Audit, Compensation and Nominating Committees |
| Publications and Patents Summary |
|---|
| Multiple. |
Additional Experience
| Training / Seminars |
|---|
| I have conducted training sessions on transdermal development for marketing personnel. |
| Vendor Selection |
|---|
| I have experience in identifying and qualifying active pharmaceutical ingredient and excipient suppliers. I have also recruited and inspected clinical sites. |
| Marketing Experience |
|---|
| I have been a resource on regulatory issues for a medical device company and a start-up transdermal company |
| Other Relevant Experience |
|---|
| I can advise companies how to write the CMC section of their applications to minimize questions from the FDA and other regulatory agencies. |
Language Skills
| Language | Proficiency |
|---|---|
| English |
Fields of Expertise
abbreviated new drug application, active pharmaceutical ingredient, adverse drug reaction, animal drug testing, biocompatibility, bioequivalence, Chemistry, Manufacturing and Controls, clinical study, clinical trial, clinical trial design, clinical trial documents generation, Current Good Manufacturing Practice, documentation process, drug bioavailability, drug clinical trial, drug development, drug dosage form development, drug product approval, Federal Food, Drug, and Cosmetic Act, Food and Drug Administration, Food and Drug Administration drug registration, Food and Drug Administration new drug code, Food and Drug Administration regulation, Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, investigational drug procedures, new drug application, pharmaceutical life cycle management, pharmaceutical manufacturing facility auditing, pharmaceutical product development, pharmaceutical quality assurance, pharmaceutical quality control, pre-approval inspection, preclinical research, transdermal patch, pharmaceutical scale-up, pharmaceutical research and development, medical device auditing, pharmaceutical product formulation