Dr. Nancy Sever from AbbVie will present a seminar on Applying engineering concepts in Pharmaceutical Development and Manufacturing, detailed information is given below:
Speaker: Dr. Nancy Sever, AbbVie
Title: Applying engineering concepts in Pharmaceutical Development and Manufacturing
Abstract
The objective of Pharmaceutical Development is to enable the consistent manufacture of an efficacious and stable drug product that meets appropriate quality controls. The development cycle can take several years as a compound moves from a discovery candidate to a commercial drug product. Along the way, the synthesis and isolation of the drug substance is optimized, the composition of the drug product is tailored to achieve the desired pharmacokinetic profile, the drug product manufacturing process is scaled-up and transferred to the commercial plants, and devices are designed to address key stakeholder (I.e. Patients, caregivers, Healthcare providers) needs while delivering the drug product accurately and consistently. Engineering principles play an integral part in all these processes and examples will be highlighted during the presentation. From crystallization to packaging, theoretical and empirical concepts are employed by cross-functional teams to develop and commercialize a new pharmaceutical drug product. Opportunities for better predictions and process controls still remain and can allow for flexibility after regulatory approval.
Biography
Nancy Ekdawi Sever joined Abbott/AbbVie in 2002 as Research Pharmacist in Global Pharmaceutical Research and Development. She has held several positions at Abbott/AbbVie, including Associate Director in Formulation Sciences in GPRD. In addition to project responsibilities, she lead efforts in Process Analytical Technology, Continuous Manufacturing, and Process Simulation. Nancy assumed her current role as CMC Scientific Director in Global Pharmaceutical R&D in 2014. Nancy received a PhD in Chemical and Biological Engineering from University of Wisconsin – Madison and a B.S. in Chemical Engineering from Northwestern University.
Date & Time: Thursday, November 19th 9:00 am – 10:00 am
Location: Tech LR4 (refreshments will be available at 8:45am)