Process chemistry plays a pivotal role in various stages of the pharmaceutical R&D cycle. However, support for preclinical and early clinical phases demands a delicate balancing act different from late clinical phases and commercialization. Early stage 'fit-for-purpose' development activity prioritizes several key areas which support GLP tox batches and adhere to initial GMP Production. To effectively bolster IND investigations, featured speaker Qixuan Lu, VP of Global CMC Solutions at BioDuro-Sundia, delves into key topics surrounding process chemistry roles and interventions to harmonize in-depth research with the time, cost, and compliance aspects of IND filing programs.

Join us as we explore critical process chemistry issues that commonly arise during IND filings, such as route selection, impurity profile controls, and essential setup criteria for RSM/API. Unlock the secrets to streamline drug development and pave the way to successful IND submissions.

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Qixuan Lu

VP of Global CMC Solutions (APAC) Business Unit, Head of Process R&D

Over his 20+ years pharma sector experience, Qixuan Lu has led 100+ different types of process R&D projects in support of IND filing, by driving innovation in the design and synthesis of organic small molecules, process route development and optimization, and quality controls for drug production under GMP conditions.

Qixuan graduated with a degree in Pharmaceutical Engineering from East China University of Science and Technology in Shanghai and joined BioDuro-Sundia in 2007. Advancing into his current role as VP of Global CMC Solution (APAC) Business Unit and Head of Process R&D, Qixuan has built an outstanding 15+ years track record partnering with biotechnology and pharmaceutical companies across the globe to optimize processes and meet regulatory requirements.