Establishing Early Development Strategies For Therapeutics Proteins
21st October 2020 | 10:00 am EST | Thorsten Lorenz, Head Early Drug Substance Development and Sorina Morar-Mitrica, Principal Fellow Sr Drug Product Lead Early Phase Biologics at Novartis and Renee Tobias, Director of Marketing, Halo Labs |BOOK FREE SEAT FOR THIS WEBINAR
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
Presented by Thorsten Lorenz, Head Early Drug Substance Development at Novartis
Thorsten Lorenz studied Biochemistry at the University of Bochum in Germany. He performed his PhD work at the Max Planck Institute for Medical Research in Heidelberg and afterwards joined Novartis as postdoctoral fellow. In 2011, he took the lead for the buildup of a laboratory for protein characterization and pre-formulation assessment. After taking roles of increasing responsibility in the unit, Thorsten was appointed Team Head Developability Assessment in 2017, responsible for the assessment of molecular properties, downstream process and stability characteristics as well as immunogenicity and in vivo stability risks for the Novartis Biologics pipeline at the transition from Research to Development.
Since April 2019, Thorsten has been leading the Early Drug Substance Development group in Novartis Technical Development New Biologics Entities.
And Sorina Morar-Mitrica, Principal Fellow Sr Drug Product Lead Early Phase Biologics at Novartis
Sorina Morar-Mitrica is currently a Principal Fellow Senior Scientific Lead Drug Product in Biologics Early Phase Pharmaceutical Development at Novartis. By training, she is a Protein Chemist and received her Ph.D. from the University of North Carolina at Chapel Hill. She has been working in the biopharmaceutical industry for the past 18 years, developing protein drug products in both early and late phases of clinical trials. Her previous appointments include GlaxoSmithKline and Diosynth Biotechnologies. She has a special interest in formulation and delivery of protein therapeutics, and a passion for biophysical characterization and high-throughput formulation. More recently, she has been focused on the development of high-risk proteins such as novel constructs, for which innovative solutions are required to solve the unique formulation, manufacture and clinical administration challenges.
Followed by Renee Tobias, Director of Marketing, Halo Labs
After earning her Masters in Cell and Molecular Biology, Renee worked several years in drug discovery research at companies like Tularik (Amgen), Bayer, and Schering-Plough. She eventually left the bench to pursue more customer-facing roles in applications and product management for life science analytical tools. She is passionate about promoting new, innovative solutions to accelerate biopharmaceutical development, and her current role as Director of Marketing at Halo Labs enables her to do just that.
Sponsored by Halo Labs
Halo Labs is a venture-backed scientific instrumentation and consumable company that commercializes high-throughput biopharmaceutical formulation and quality control tools for particle analysis using state-of-the-art custom optics and image processing techniques.
Halo Labs knows particles. The HORIZON, our flagship product, detects, counts and characterizes subvisible particles. A simple, plate-based approach enables low-volume (25 µL), high-throughput (96 samples) particle imaging and analysis at any stage of the biologics workflow from developability assessment through formulation and quality control.
Halo Labs’ core mission has been to provide researchers with unprecedented insights into the particles present in their processes by leveraging our core scientific competency: optical imaging on membranes. Over the years, Halo Labs has been the recipient of many prestigious awards, and has received over $6M in research grants from agencies including DARPA, FDA, NSF, NIST and NIH. Today, we dedicate our collective experience and novel technology to empower formulation researchers to learn more about the stability and quality of their biological drugs faster and with more accuracy than ever before.
Our institutional partners include Research Corporation Technologies (RCT), BioAdvance, Broad Oak Capital Partners, and Ben Franklin.