Drug Development Expert 518320 NJ


Expertise Description

I have over than 25 years of experience in drug development, clinical manufacturing and drug delivery systems. I have been Principal of a firm that provides guidance in all aspects of drug product development. These subjects include: sterile product subject matter, peptide and protein formulation, drug delivery, aseptic processing, sustained release parenteral, excipients, inter partes patent review, technology transfer, injection devises, solubilization, and patent infringement and validity. I also have substantial GMP, FDA R&D and manufacturing experience. I have prior expert witness experience with consultation, deposition, and courtroom testimony.

Areas of Expertise


Expert Witness

My expert witness experience includes working with cases on patent litigation.


Consulting Experience

My consulting experience includes acting as a consultant for pharma, legal and investment firms.


Professional Experiences

My professional experience includes working in a leadership role in development of 9 marketed products, and as the Head of Sterile Clinical Manufacturing with 7 successful Pre-Approval Inspections. I have a very high success rate for providing clinical batches on time. I have worked with extensive FDA interactions, and as an FDA trainer, for Biopharmaceutical Formulation and Stability.


Relevant Experiences

I have worked in parenteral development and manufacturing for over 25 years. I have consulted in a number of patent litigation cases over the last 3 years, been deposed and testified in court.

I am a Subject Matter Expert in parenteral development and manufacturing. Since most of the products that were brought to market by my group were peptides and proteins a special focus was given to aseptic processing. I managed a cGMP sterile facility as well as a GLP sterile facility for 17 years and conducted international technology transfer for over 20 years for parenteral formulations.


Education

Degree Subject Institution
Ph.D. Pharmaceutical Sciences Long Island University Brooklyn NY
B.S. Pharmacy New York University New York NY

Licenses Certifications

Registered Pharmacist, New York State

Awards & Affiliation

American Association of Pharmaceutical Scientists
American Pharmacy Association
Parenteral Drug Association

Primary Affiliation

American Association of Pharmaceutical Scientists



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