Nandkishor Nere

Company: AbbVie

Job title: Volwiler Research Fellow/Director

Bio:

Nandkishor Nere, Ph.D., is an adept techno-strategic leader with exemplary experience of more than a decade in both drug substance (API) and drug product process engineering for small and large molecules. He has proven experience in late-stage development, control strategy development, NDA filing, clinical and commercial manufacturing through commercialization of Viekira Pack, Mavyret, Orilissa and Rinvoq and the optimization of processes for multiple commercial assets including Humira, Skyrizi, Creon and Duodopa. In addition to heading the critical cross-functional Center of Excellence (CoE) team CoExIST (Center of Excellence for Isolation and Separation Technologies) responsible for API crystallization process development for the entire small molecule pipeline of AbbVie, Dr. Nere was the founder-leader of highly impactful AbbVie wide Cross-functional Modeling Forum (CMF). The CMF has been instrumental in developing various modeling platforms for the key CMC processes spanning small and large molecules. The CMF team was recognized as the winner of the 18th Chicago Innovation Award under Healthcare Category in 2019. Dr. Nere has authored more than 50 publications, been leading multiple industry-academic collaborations, serves on board of directors of Enabling Technologies Consortium and is a steering committee member of the Association of Crystallization Technology. He also teaches an interdisciplinary graduate course on biopharmaceutical process development and manufacturing at University of Illinois, Chicago as an affiliate faculty member.

Seminars:

Harnessing Modeling for Efficient Bio-Pharmaceuticals Process Development 9:15 am

• Platform approach to understand key CMC processes for both the small and large molecules • Pragmatic modelling to troubleshoot and optimize processes • Utility of digital twins across various modalities including continuous processingRead more

day: Day Two

Panel Discussion: Measure Vs Model in CM Validation & Approval 9:45 am

• What measurements can be replaced with a model, whilst retaining product quality and regulatory compliance? • How can regulatory approval for CM differ across the world? • Key differences between traditional bath processing vs continuous in regulatory submission, e.g. continuous process validation • Inspection preparedness as we move into commercial spaceRead more

day: Day Two