Establishing Early Development Strategies For Therapeutics Proteins
21st October 2020 | 10:00 am EST | Sorina Morar-Mitrica, Principal Fellow Sr Drug Product Lead Early Phase Biologics at Novartis and Bernardo Cordovez, PhD, Chief Science Officer & Founder, 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 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 Protein or Not? Advanced High Throughput Aggregate Analysis with the Aura
In protein-based formulations, distinguishing aggregated API from other particle types is important for understanding the root cause of instability. Until now, existing methods have been either unreliable or too cumbersome and difficult to use in many workflows. Here we introduce the Aura, a 96-well low-volume aggregate and particle imaging system that can rapidly size, count, and characterize particles and identify them as proteins, non-proteins, hydrophobic, or other types of molecules.
Presented by Bernardo Cordovez, PhD, Chief Science Officer & Founder, Halo Labs
Bernardo leads application and business development and is one of the Halo Labs’ founders. He was previously CEO and CTO and played a pivotal role in bringing over $6M in federal grant funding. Prior to starting Halo Labs, Bernardo was a Postdoctoral Associate at Cornell University, where he also obtained his M.S. and Ph.D. degrees in Mechanical Engineering. His wide range of technical experience includes particle analysis, detection and manipulation, drug delivery devices, microfluidics, nanophotonics and bioenergy production. In 2012, Bernardo was named one of Philadelphia’s top 30 under 30 entrepreneurs, the same year Halo Labs was named Philadelphia Life Science Startup of the year by the Greater Philadelphia Alliance for Capital and Technologies.
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 Aura, the company’s flagship product, can count and characterize subvisible particles – and tell you whether they are proteinaceous or non-proteinaceous. A simple, plate-based approach enables low-volume, high-throughput, fully automated particle imaging and analysis at any stage from developability assessment through 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 technology development grants from DARPA, FDA, NSF, NIST and NIH. Today, Halo Labs’ products have been adopted by the top biopharmaceutical companies in the world because they empower formulation researchers to learn more about the stability and quality of their biological drugs faster and with more accuracy than ever before.