Analytical Stream
The 2020 coronavirus pandemic has thrown academic and industry research groups into a rapid and unexpected pivot to the search for new diagnostics, vaccines and therapeutics, and the discovery and analytical functions must support these efforts. The PEGS Virtual Analytical Stream examines the state of the art in new analytical methods, their application for novel molecules and formats, and how these tools can be rapidly deployed to support accelerated R&D programs.
Week 1: June 4 Characterization for Novel Biotherapeutic Modalities
Week 2: June 11 Novel Biophysical Methods
Week 3: June 18 Cell and Gene Therapy Analytics
Week 4: June 25 Rapid Lead Selection and Developability Analysis
CHARACTERIZATION FOR NOVEL BIOTHERAPEUTIC MODALITIES
THURSDAY, JUNE 4 | 10:00 AM - 1:15 PM (ET)
With new (and sometimes very new) product formats progressing through development and into the regulatory process, the role of analytical characterization is taking on new meaning. New modalities present challenges to both analytical scientists and regulatory agencies alike, and this steep learning curve requires a near-constant cycle of adaptation and innovation. The Characterization for Novel Biotherapeutics session explores the analytical challenges of new modalities and considers the tools needed to support rapid development for emerging vaccines and treatments.
10:00 Chairperson's Opening Remarks
George Bou-Assaf, PhD, Scientist, Analytical Development – Product & Technology Development, Biogen
10:10 Keynote Presentation: Applying State-of-the-Art Methods to Study Novel Therapeutic Modalities with Altered Flexibility
Ivan Correia, MBA, PhD, Head, Global Protein Sciences, AbbVie
10:55 State of the Science for Cutting-Edge Chromatographic, Electrophoretic and Mass Spectrometry Analysis of mAbs, Fc-Fusion Proteins and ADCs
Alain Beck, PhD, Senior Director, Biologics CMC and Developability, Pierre Fabre Laboratories, France
11:30 Refreshment Break
11:35 The Experience of a Protein Biochemist Transitioning to Gene Therapy: The Interfaces of Instrumentation and Analytical Methods
George Bou-Assaf, PhD, Scientist, Analytical Development – Product & Technology Development, Biogen
12:15 Interactive Q&A Session with Speakers and Audience
12:45 Close of Day
NOVEL BIOPHYSICAL METHODS
THURSDAY, JUNE 11 | 10:00 AM - 1:15 PM (ET)
As emerging markets and pandemics fuel a need for next-generation biotherapeutics and vaccines, biophysical analytical methods are playing an increasingly important role at different stages of R&D. New informatics and instruments are increasingly allowing these methods to be used in a quantitative, rather than qualitative way – and biophysical studies now play a key role in regulatory filings. Our Novel Biophysical Methods session explores the latest technologies and methods for problem-solving in this dynamic field.
10:00 Chairperson's Opening Remarks
Iain D. G. Campuzano, Principal Scientist, Discovery Attribute Sciences, Amgen
10:10 Keynote Presentation: Integrating Experimental and Computational Methods for Rapid Developability Analysis
Peter Tessier, PhD, Professor, Pharmaceutical Sciences and Chemical Engineering, University of Michigan
10:55 Denaturing and Native-MS in Pharma: A Selection of Interesting Case Studies
Iain D. G. Campuzano, Principal Scientist, Discovery Attribute Sciences, Amgen
11:35 Refreshment Break
11:40 Microfluidic Technology for the Characterization of Antibodies and Therapeutic Proteins
Paolo Arosio, PhD, Professor, Biochemical Engineering, Department of Chemistry and Applied Biosciences, ETH Zurich, Switzerland
12:20 Interactive Q&A Session with Speakers and Audience
12:50 Close of Day
CELL AND GENE THERAPY ANALYTICS
THURSDAY, JUNE 18 | 10:00 AM - 1:15 PM (ET)
Research and development efforts for cell and gene therapies are underway throughout the industry, but significant advances in analytical and process technologies are required to support preclinical and clinical development, quality control strategies and progression through the regulatory steps needed to reach the market. The Cell and Gene Therapy Analytics session features leading scientists sharing their experiences with new tools, lessons and learnings – and what works and doesn’t work.
10:00 Chairperson's Opening Remarks
Eric S. Alonzo, PhD, Scientist, Process and Analytical Development, bluebird bio
10:10 Keynote Presentation: Emerging Tools for In-Process Cell Therapy Analytics and Control Systems
Jan Joseph (Jos) Melenhorst, PhD, Adjunct Associate Professor, Pathology & Laboratory Medicine, University of Pennsylvania
10:50 Leveraging High-Dimensional ‘-omics’ Technologies for Comprehensive Profiling of CAR T Cells to Resolve Drug Product Complexity
Eric S. Alonzo, PhD, Scientist, Process and Analytical Development, bluebird bio
11:25 Watch your AAV Capsid Leak and Pop with Uncle’s Tools for Viral Characterization
Kevin Lance, PhD, Marketing Manager, Unchained Labs
AAV genomes leak out when capsids get stressed – well before protein unfolding occurs. Uncle uses 9 µL of sample to give insights on AAV stability by tracking DNA ejection from capsids, in addition to capsid protein unfolding and overall aggregation. See the story of your escaping DNA with Uncle.
11:40 Refreshment Break
11:45 Overcoming the Limits and Variability of Gene Therapy Potency Assays
Win Cheung, PhD, Associate Director, Analytical Development, REGENXBIO
12:15 Interactive Q&A Session with Speakers and Audience
12:45 Close of Day
RAPID LEAD SELECTION AND DEVELOPABILITY ANALYSIS
THURSDAY, JUNE 25 | 10:00 AM - 12:40 PM (ET)
The screenings and studies that comprise a company's lead selection process are essential in ensuring that the best quality molecules are chosen for advancement – and that these match target profiles for efficacy, safety and pharmacology. New rapid development programs and corporate efficiency initiatives have added the dynamic of accelerated timelines. The Rapid Lead Selection session explores solutions coming from the intersection of new high-throughput technologies, computational power and new assays to support the push for success in the clinic.
10:00 Chairperson's Opening Remarks
Andrew R.M. Bradbury, MB BS, PhD, CSO, Specifica, Inc.
10:10 Keynote Presentation: Best Practices for Developability Risk Assessment
Jonathan Kingsbury, PhD, Senior Director, Developability & Preformulation Science, Sanofi
10:30 Predicting Antibody Developability Profiles through Early Stage Discovery Screening
Laurence Fayadat-Dilman, PhD, Senior Director, Merck
11:10
Protein or Not? Advanced High Throughput Aggregate Analysis with the Aura
Rick Gordon, Vice President, Sales, Halo Labs
Distinguishing aggregated API from other particle types is important for understanding the root cause of instability. Existing methods are unreliable, too cumbersome and difficult to use in many workflows. With Aura, you can now finally count, size, and characterize aggregates and identify them as proteins, non-proteins, or other molecules.
11:25 Refreshment Break
11:30 Quantitative Pharmacology in Support of Design, Selection and Development of Biologic Modalities
Mohammad Tabrizi, PhD, Senior Director, Pharmacology, Ascendis Pharma A/S
12:10 Interactive Q&A Session with Speakers and Audience
12:40 Close of Day
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