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Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
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…
Biotechnology, Pharmaceuticals,
Expert in Biopharmaceutical molecule development and licensure. Experience with top Biotech companies (BMS, sanofi, MedImmune, AZ, Adello, etc.). Designed successful Analytical strategy for 100s of IND and many BLA submissions in multiple countries. Expert in the following areas: Scientific writing…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Chemical and Pharmaceutical Development – Comprehensive CMC
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…
Embedded System Software, Storage, Processor development, Software, Firmware, File Systems, networking and Telecommunications, Android, IOS
Expert has had many years of experience programming Access, Filemaker and SQL databases. He has developed a multi-user, multi-site manufacturing control system using Access. The system included remote synchronization of the databases. Using FileMaker Expert has built and sold complete…
Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition…
Pediatrics, Adolescent, & Young Adult & Administrative Medicine, Medical-Legal Issues, Public Health
Strong background since establishing the first student internship program in bioehtics at the Kennedy Bioethics Institute in 1972 - mentor Andre Helligers, then director of the CEnter. Published in medical ethics journals. Hospital ethics committee experience. Licensed to practice law…