Pharmaceutical Consultant

PROJECTS
Critical Due Diligence
- Preformulation, Formulation, Analytical Development, and Manufacturing (CMC) issues for:
  - ULTRAM® tramadol extended release internal formulation development, (Johnson & Johnson Legal), prior to external in licensing
  - REVLIMID® lenalidomide, polymorph patents for investors (Anonymous)
  - Fenfluramine, in licensing, CMC for new indication, orphan status (Anonymous)
  - OTC Softgels, in license, CMC review for Regulatory Submission suitability (Anonymous)
  - L-Glutamine, in license, CMC for claim of source having superior quality to vitamin store sourced (Anonymous)

Ferring USA
- Managed CRO outsourced development of 3 Development Projects for Ferring USA over a 16 month period.
- ENDOMETRIN® progesterone effervescent vaginal tablets from Pre-clinical support through Phase III CTM/Registration Batches of Drug Product. Authored issues free complete IND CMC Section, and NDA Dosage Form Development History Report.
- Human Chorionic Gonadotropin (HCG) sterile injection containing a more highly refined HCG drug substance formulated to comply with current cGMP and ICH/FDA guidelines.
- Decapeptide iontophoretic delivery system to initiate ovulation. • >$6 Mil budget each. Developed budgeting models for each novel product development project.

Advancis
- MOXITAG® amoxicillin extended release tablets.
  - Authored all Analytical Development Department Reports for NDA except for dosage form Stability Report.
  - Critically Reviewed Analytical Methods Validation Reports for compliance with current ICH Guidelines and internal SOPs.
  - Provided critical/feasibility assessments of APIs/NCEs for pulsatile, ER and IR applications, data, projects, presentations, personnel and facilities.

J&J Merck
- PEPCID AC® famotidine gelcap NDA CMC Section.
  - Authored complete NDA CMC Analytical Section.
  - Critically reviewed preliminary Analytical Methods Validation Report, identified and resolved problems, errors and inconsistencies, and recommended and applied successful solutions.
  - Authored every CMC supportive report document including Methods Development History, Analytical Methods Validation, and Dissolution Method Rationale.
  - Assignment completed on time in 5 months free of regulatory issues. •
- Product Analytical Methods Reorganization
  - Analytical Methods and Acceptance Criteria Documents for Commercial Products were converted into one SOP.

ALZA
- Analgesic Combination, Acetaminophen + Narcotic 24 Hour Extended Release Product
  - Created finished Process Validation Reports for individual manufacturing steps (e.g. compression, coating, laser drilling etc.) for Regulatory Submission.

Oscient
- Fenofibrate
  - Supported CDMO production of fenofibrate tablets with reviews and reports.
  - Reviewed manufacturing data and authored reports.

University of California, Irvine
- Laboratory Chemicals
  - Created SOPs for handling/using individual chemicals in laboratories in response to court order.

Avendro Inc. (Client/Sponsor) and K & L Gates (attorneys).
- Rejected Regulatory Batches of CDMO Manufactured Sterile Product
- Reviewed Batch Records and Laboratory Test Results determine the cause(s) of the rejection.

George Kontonatos vs. Hygrosol, Spiridon Spireas, et.al • Liquisolid Systems, George Kontonatos.
- (Contract Dispute)
  - Served as the only Expert and Consultant.