Chemistry – University of Chicago
Manufacturing and Regulatory Strategies and Pharmaceutical Stability
Manufacturing Troubleshooting; Pharmaceutical Stability; Innovative, Compelling Regulatory Strategies; Leadership of Complex Programs; New Product Conception/Evaluation; IP Analysis/ Expert Witness
Headed Chemistry R&D department at Baxter; Baxter Distinguished Scientist; Devised major drug delivery platform, used for 6 HIV drugs in development by major pharma; Conceived and developed rapid testing approach expediting change control, reducing stability testing, showing compliance with Good Distribution Practices, and minimizing testing for elemental impurities, and leachables, endorsed by MHRA.
Troubleshot complex corrosion issue affecting manufacturing process, implemented for key product line; Improved manufacturing processes resolving pH and particulate issues, retiring imminent product recall issues for major, strategic product lines; Developed industry position/white paper and presented to FDA on storage labeling, saving millions of dollars in unnecessary costs. Expert reports, depositions, and trials in generic drug cases, and misappropriation of trade secrets.