Request Expert

As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for analysis are defined. Expert has written several of these validation reports.

At a start-up drug delivery system organization, Expert had responsibility for establishing a cGMP compliant Pilot Plant and establishing a cGMP compliance state of mind. The staff using the facility included Engineering which built the fabrication device, R&D personnel, and Quality Control and Assurance. He was responsible for training, establishing, and writing SOPs, providing vendor services such as cleaning, sterilization, and components. He was also an instructor for cGMP training by an international provider of training.

As a pharmaceutical scientist who worked for big Pharma J&J, consultant to several small Pharma companies, Expert has had experience with the development of the following: Tablets, capsules, parenteral products, controlled release, immediate release, enteric/polymeric, and pulsatile delivery systems; oral solutions, topical products, vaginal suppositories, tablets and creams, transdermal delivery systems; medical device containing drug; pulsatile iontophoresis; HCG, steroids, anti-cancer agents; CNS, CVS; antimicrobials; sublingual tablets.

Expert has supported their development and for some such as oral and parenteral solutions, iontophoretic and vaginal non-oral effervescent delivery; He has been an actual formulator or project manager.

Expert has over 30 years of experience in the development of pharmaceuticals. He has an undergraduate degree in Pharmacy, a pharmacy license in NJ (active), and an MS and Ph.D. in Pharmaceutics, the science of drugs.

Expert has been in Pharmaceutical Development for over 30 years. He has supported the development of practically every type of drug product at McNeil Pharmaceutical/The RW Johnson Pharm Research Institute (Ortho-McNeil) merger. He has sat on development teams that have moved NCEs from discovery to finished products, ACEON(R)Perindopril erbumine, LEVAQUIN(R) levofloxacin, ULTRAM(R) tramadol, TOPAMAX (R) topiramate, (Ortho) Oral contraceptive combinations, HALDOL (R) Halopperidol DECONATE inj; failed projects such as cetiedil citrate, fenobam, xilobam, fenoctimine sulfate, fenretinide, transdermal delivery systems containing an opiate.

Expert has done feasibility studies for experimental dosage/delivery systems, formulated sub-lingual dosage, NCE in oil/water IV emulsions for drug safety studies. Modeled partitioning to predict transdermal penetration in human skin.

As a consultant to a small virtual company, Expert managed the development of an effervescent steroid vaginal tablet for aid in pregnancy, iontophoretic pulsatile delivery of a peptide, and an intramuscular or sc delivery of a human female hormone derived from urine. All work was performed by contract vendors.
He formulated several injectable and oral solution products at McNeil for human use as well as several for animal pre-Clinical Safety and Pharmacokinetic studies.
Expert was responsible for establishing a cGMP attitude at the company. He taught cGMP compliance and several times for PT-International. Expert worked for J&J, an industry leader. As a consultant, Expert has seen other organizations' compliance.

Expert trained colleagues and new hires, including Engineering, R&D, and Control in cGMPs. He has 20 years of experience at J&J, a leader in cGxP training and practices. He was a trainer for PT International, cGMP.

Expert is experienced with Controlled Release, Immediate Release, Delayed Release, Tablets, and Capsules.

Expert was developing 9 OTC flash dosage forms that contained cough and cold combinations. He has consulted at a major OTC Big Pharma Company several times, including writing documents for and parts of the CMC NDA.

Expert has over 30 years in the industry, developing pharmaceuticals. He has worked with small and medium-sized pharma companies as a consultant. He has worked with J&J big Pharma. He is a former chair of the Pharmaceutical Technologies Section of the American Pharmaceutical Association.

At J&J, Quality Assurance meant that all written reports and documents were reviewed for compliance to notebook entries and written SOPs. Changes in the processing and scale-up of NCE synthesis and recovery during development can result in the creation of polymorphic forms. Pharmaceutical processes that involve the addition of energy such as milling, dissolution such as in granulation can also create new polymorphic forms. Polymorphic forms have the same chemical structure but differ in crystallinity and crystalline form. They can have differences in solubility, chemical stability, color, and bioavailability. Occasionally, pharmaceutical scientists deliberately try to create new forms to take advantage of these types of differences, particularly in a positive fashion.

Identification and characterization of polymorphic are performed by X-ray powder diffraction (XRD) and solid-state NMR. DSC and hot stage microscopy are secondary tools for the characterization of these forms. Expert has experience with several NCEs such as fenretinide and fenoctimine sulfate, where XRD methods for quantization and identification were developed.

Expert managed CRO development of three products, a solid dosage form for nonoral delivery; a sterile biological hormone, human origin; and an iontophoretic delivery system; for the virtual company over 16 month period, >$6 Mil budget each. Pre-clinical support through Phase III CTM/Registration Batches of Drug Product. Developed budgeting models. Authored issues-free IND CMC. Provided critical/feasibility assessments of APIs/NCEs for pulsatile, ER, and IR applications; data, projects, presentations, personnel, and facilities. Wrote Pharmaceutical Development Reports and Analytical Development Reports for regulatory submissions. Reviewed Corporation’s Analytical Methods Validation Reports for compliance to ICH Guidelines and internal SOPs. Reorganized Analytical Methods.

For several clients authored reports for regulatory submissions
a) Authored 70% and critically reviewed 30% of reports from Analytical Development Dept. for inclusion in antibiotic NDA
b) Critically reviewed data/initial draft for all Analytical Dev Dept. Reports for an Rx to OTC switch NDA. validation, Chem. Development and the analytical section of the CMC in the NDA. Identified and resolved problems, errors, and inconsistencies, and recommended and applied successful solutions.
c) Authored Pharm Dev History Reports for clients, effervescent steroid for non-oral delivery, and OC combination for NDAs.

a) Reviewed projects with clients, where project venting was necessary to move forward.
b) Recommended contacts at FDA and other service providers to several clients.