Speakers

Speakers

Dr Craig Harris, Head of Small Molecule Development & Scientific Advisor, Galderma

photo of Dr Craig Harris

Craig currently leads the small molecule development for Galderma, operating out of the offices of Lausanne, Switzerland. During his 9 years at Galderma, Craig has contributed to the delivery of 10 development candidates on a variety of targets linked to skin diseases such as psoriasis, acne, skin cancer, atopic dermatitis and in the aesthetic and corrective field. Prior to joining Galderma, Craig was responsible for driving the synthesis for the Oncology iMed in Reims, AstraZeneca, France where he contributed to many discovery programs including 3 clinical candidates as well as to several continuous improvement projects.

Presentation Title: Transitioning towards a Virtual CMC Operation for the Sourcing of API and Drug Products, Showcasing Highly Collaborative Outsourcing Partnerships

Abstract: Over the few years, Galderma has undergone a huge transition from having internal R&D, supporting drug discovery and early development up to Phase II, to a fully externalized or virtual pharmaceutical company model. This talk will focus on how we adapted to this new operating model and optimized our workflows in the CMC department through a science-driven and highly collaborative approach with our supporting contract research and manufacturing organizations. Highlighted is a very recent example of a highly successful collaboration across 5 sites and 6 countries to identify compendial impurities E and F in lymecycline after a recent investigation.

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