An increasing number of therapies obtain designations with accelerated and priority reviews. The need to streamline the pathway from development to commercialization path for these drug products is of crucial importance. Lonza will share practical Chemistry, Manufacturing, and Controls (CMC) experience on how to navigate regulatory, development, manufacturing and packaging requirements critical for  accelerated clinical pathways and commercialization. We will discuss strategy, timing, process, practical and execution aspects to be considered in order to achieve a target  outcome. Case studies will be presented that demonstrate each of these challenges and the considerations necessary to meet fast-track timing requirements of clinical trials and registration applications.

Featured Speakers

Jacqueline Hargis, PhD 

Head of Supply Chain and Program Management, Tampa Drug Product Site 
Lonza Pharma & Biotech

Jacqueline has six years of experience in oral solid dosage CMC  program and supply chain management at Lonza where she has overseen products to commercial approval. Before joining Lonza, Jacqueline worked as a postdoctoral research fellow in computational biochemistry and drug design at the University of South Florida after completing her PhD in computational quantum chemistry at the University of Georgia. 

Jakob Bonde, MSc

Head of Regulatory Affairs Small Molecules (DS & DP) / Associate Director Regulatory Affairs
Lonza Pharma & Biotech

Jakob has over 15 years of experience within a broad field of regulatory affairs including global clinical trials, scientific advice, change control, CMC and marketed products variations and NDA/MAA’s; and has worked in large pharmaceutical companies such as Novartis, Grunenthal, J&J and Pfizer, consultancies such Clinipace and Medpace as well as smaller biotech ventures. He joined Lonza in November 2018 working out of Visp, Switzerland office.

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