Speakers

Shashank Upadhye
Shashank Upadhye

Shashank Upadhye, Esq.

Founding Partner

Amin Talati Upadhye, LLP

shashank@amintalati.com 

Shashank Upadhye is a partner at Amin Talati Upadhye, LLP and is one of the foremost authorities on US pharmaceutical patent and FDA law. For 20+ years, he has focused on pharmaceutical and biosimilars law, with an emphasis on IP and FDA issues. He also spent many years as the chief of legal/IP/FDA inside counsel at Apotex, Sandoz, and Eon Labs, so he brings key business savvy to client help. He is a prolific speaker and recognized leader in the Hatch Waxman/Para. IV and biosimilars fields. He counsels both brand companies [505(b)(2) applicants] seeking to strategically patent and launch their brand name products in the long term; and to generic companies seeking to challenge patents (opinions and litigation), maximize 180-day exclusivity, and with FDA GMP compliance (483’s, Warning Letters, and enforcement). He provides input at every stage of the product lifecycle from product selection, R&D, regulatory affairs, product launch, and ongoing marketing/sales. Shashank is also the author of the key legal text on pharmaceutical and FDA law called Pharmaceutical Patent & FDA Law. He can be reached at: shashank@amintalati.com and his bio is here: http://amintalati.com/professionals/shashank-upadhye/
  
  

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