Pharmaceutical Consultant
· Due Diligence
· ULTRAM® tramadol extended release internal formulation development review performed prior to in‑licensing product developed by an external CMO (Johnson & Johnson Legal)
· 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 review for claim of source having superior quality to vitamin store sourced (Anonymous)
Projects
Ferring USA
· Managed CRO outsourced development of 3 Ferring USA projects over 16 month period.
§ ENDOMETRIN® progesterone effervescent vaginal tablets
· Managed development from Pre-clinical through Phase III CTM/Registration Batches of Drug Product.
· Authored issues free 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 cGMP, ICH and FDA guidelines. Co-developed with Argentinian Company.
§ Decapeptide iontophoretic topical delivery system to initiate ovulation, co-developed with Becton-Dickinson& Company.
§ >$6 Mil budget each. Developed budgeting models specific for each novel product development project.
Advancis MOXITAG® pulsatile extended release once a day amoxicillin tablets.
· Author of the Analytical Development History Report for Amoxicillin and critical reviewer of all of the Analytical Development Reports prepared for NDA submission.
· Performed Literature Search regarding feasibility of formulating amoxicillin and in pulsatile extended release dosage forms.
· Reviewed construction plans for Analytical, Preformulation and Formulation Laboratories
Johnson & Johnson Joint Venture and McNeil Consumer Products Companies
· PEPCID® AC famotidine acid controller gelcaps
· Authored famotidine drug product Analytical Development History Report, famotidine Analytical Method Validation, and complete Analytical Section of the NDA CMC.
· Performed 100 % QA review of data supporting Famotidine Analytical Method Validation Report.
· Reorganization of Analytical Methods and Specifications from two documents to one.
· Review of all Analytical Method Validations for compliance with current FDS, ICH and internal SOPs. .
ALZA Corporation 24 hour Hydrocodone/acetaminophen osmotic delivery dosage form
· Created Process Validation Reports from the notes and first drafts of laboratory personnel from several processing steps for a Regulatory Submission to the FDA.
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Johnson & Johnson Pharmaceutical Research and Development: OC + vitamin(s) combination products
· Created Formulation Development History Reports for several products from the first draft of the formulator.
PC-International:
· Taught 2 day cGMP training course in various locations (Boston, Raleigh, San Juan, Washington DC) for 3 years. .
· Published three articles related to Preformulation: Vendor-client mismatched SOPs, utility of SOPs in the Preformulation Laboratory, and the current state of Preformulation.