Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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Expert Details

Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence

ID: 730734 Florida, USA

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I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments.
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.
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.

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.
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.

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

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