Speakers

Dr Craig Harris, Founder and CEO, CMC Innov

photo of Dr Craig Harris

In a nutshell, I am a NCE (new chemical entity) drug development leader and scientific advisor with more than 25 years’ experience in small molecule drug discovery & development working in big pharma alongside 5 years' experience in HA-based dermal filler R&D.

Throughout my career, I have been priviledged to have driven excellent discovery and CMC teams on >20 small molecule drug NCE discovery and development projects resulting in 14 transitions including 6 clinical candidates in the Oncology, Dermatology and Aesthetic & Corrective fields. In the past 8 years, I also expanded my horizons to trouble-shooting established products (eg., impurity management strategy, second sourcing of APIs, route improvement while remaining in the scope of DMF, CEP etc) resulting in several success stories, avoiding market recalls through sound scientific position papers and costly re-processing.

I am not afraid to innovate within the scope of the project or task in hand and have a strong track record of tangible creativity spanning from enabling access to hard-to-make design space in a drug discovery setting all the way to significantly improving established API routes permitting net commercial gain.

Presentation Title: Early Chemical Development and Optimization of A Novel Macrocyclic PKC Theta Inhibitor

Abstract: The link between psoriasis and protein kinase C theta (PKCθ) inhibition lies in the role PKCθ plays in the immune response, particularly in T cell activation and inflammation, which are central to psoriasis pathogenesis. PKC Theta was Galderma’s first oral medchem project and probably the most challenging of the three small molecule projects we transferred from our R&D facility in Sophia-Antipolis, France, to our offices in Switzerland to be ran in a fully outsourced manner. This talk will focus upon the CMC challenges we encountered during the transfer and scale-up of our development candidate to be ready for Phase I.

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