Biotech, Chemist Expert — Dr. Paul Abato

My services have been retained in a high-profile ANDA case. I was deposed, wrote an opening report, reply report and participated in pretrial preparation.  

I have also previously been retained by a generic drug company involved in an ANDA dispute

My services have also been retained by a major generic drug company regarding a contract dispute involving pharmaceutical degradation and 21 CFR.   I wrote the opening report prior to a settlement being reached.       

I have also consulted for H3-Biomedicine, where I oversaw radio-labeled syntheses, of active pharmaceutical ingredients (API) for pharmacokinetic studies as well as the design of stability studies and formulation of the API in support of CMC efforts. 

Presently I am consulting for the Gates foundation in the development of new drug combinations for resistant TB infections.

A Ph. D. Medicinal Chemist with over 29 years of experience in the discovery and development of novel human therapeutics in the areas of cancer, anti-infective, anti-inflammatory and neurodegenerative diseases.  Awarded the Heroes of Chemistry Award by the American Chemical Society in August 2019 for my contribution to a new antibiotic, NUZYRA.

I also, contributed to the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis and Spinal Muscular Atrophy.

I have been involved in all aspects of drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy, pharmacokinetics and pharmacodynamics) testing, dosing routs, drug formulation, stability studies and the management of CROs.   I have co-authored a pre-IND proposal for SMA that had a favorable review by the FDA.