Establish Early Development Strategies For Therapeutics Proteins

Presented by

Sorina Morar-Mitrica, Principal Fellow at Novartis and Bernardo Cordovez, PhD, Chief Science Officer & Founder, Halo Labs

About this talk

Presented by Sorina Morar-Mitrica, Principal Fellow Sr Drug Product Lead Early Phase Biologics at Novartis The protein therapeutics field has expanded considerably in number and diversity of protein formats. Along come higher expectations for patient-centric products. And the clinical and regulatory landscapes are ever-evolving. All these have significant implications for the early CMC development strategies for protein products. In this webinar we explore early-phase development strategies, covering both fundamentals (successful approaches such as platforms) and specialized considerations (what to consider when faced with novel constructs) as follows: drivers for the early-phase development strategy, and challenges typically encountered at this stage previously-established successful strategies for early-phase development desirable tools and expertise to enable early-phase development transforming our perceptions of early-phase risks into innovation opportunities Follolwed by an Industry perspective presented by Bernardo Cordovez, PhD, Chief Science Officer & Founder, Halo Labs

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