Choose from more than 20 problem-solving breakout discussions
TUESDAY, 13 NOVEMBER 09:35 – 10:30
Grasping the Full Analytical Domain
Moderator: Jose C. Menezes, PhD, CEO & Founder, 4Tune Engineering
- The importance of long-term thinking when building Analytical Protocols
- How risk-based approaches build analytical flexibility and robustness
- How to measure similarity along lifecycle
Biophysical Characterization in Antibody Discovery
Moderator: Fang Yi, PhD, Principal Scientist, Biologics Discovery Sciences, Janssen Biotherapeutics, Johnson & Johnson
- Which strategy is better? Large immunization campaigns coupled with early HTP screening OR small/moderate campaigns coupled with downstream optimizations.
- What biophysical attributes are most important to ensure good developability?
- Which assays are most efficient to funnel down large panel of candidates?
- How predictive are the early HTP screening assays, and strategies to improve the robustness of the developability assessment?
- New biophysical techniques and their potential impact
Moderator: Michele Vendruscolo, PhD, Professor, Chemistry, University of Cambridge
- Which are the most reliable developability assays?
- Which is the optimal way to combine different developability assays?
- Can in silico methods replace in vitro developability assays?
- At which stage should these assays be used in the development pipeline?
Cell-Free Protein Synthesis to Change the Paradigm of Biomanufacturing Processes
Moderator: Fernando López-Gallego, PhD, ARAID Tenured Scientist, Institute of Synthetic Chemistry, University of Zaragoza
- How can we compare cell-free protein synthesis to classical production systems in living cells?
- Is this strategy a new path to implement GMP production systems at the point of care (i.e., hospitals)?
- Is cell-free protein synthesis the solution to make orphan drugs available for patients of rare diseases?
Recombinant Production of Multi-Protein Complexes
Moderator: Arnaud Poterszman, PhD, Research Director, Integrated Structural Biology, IGBMC (CNRS/INSERM/UdS)
- Which targets: antibodies, hard-to-produce binary or ternary kinase complexes, other?
- Which expression system: microbial, insect baculovirus, transient or stable mammalian, other?
- What are the main bottlenecks: solubility, stockiometry, yield, cost, other?
- Quality control?
- Emerging technologies?
TUESDAY, 13 NOVEMBER 10:05 – 10:30
Phage and Yeast Antibody Libraries
Moderator: Andrew R.M. Bradbury, MB BS, PhD, CSO, Specifica, Inc.
- How to make them
- Synthetic or natural?
- Yeast or phage or both?
WEDNESDAY, 14 NOVEMBER 18:45 – 19:45
Computational Protein Strategies
Moderators: Philip M. Kim, PhD, Associate Professor, Donnelly Centre, University of Toronto and
Samuel Coulbourn Flores, Docent, Dean, Swedish National Graduate School in Medical Bioinformatics, Biochemistry and Biophysics, Stockholm University
- Roles for machine learning/AI
- Free energy methods vs. rosetta or other forcefields
- Future of computational design vs. screening methods
Optimization Strategies for Generation of Engineered Antibodies
Moderator: Christopher Mann, Director, Field Applications Scientist, Maxcyte
- Benefits and Pitfalls of targeted genome-editing
- Current challenges to transient protein production
- Transient versus stable expression
- What are the main bottlenecks?
- Emerging technologies?
Development of Effective Combination Therapies for Immuno-Oncology
Moderator: Eric Smith, PhD, Director, Bispecific Antibodies, Regeneron, Inc.
- What makes for a good combination therapy?
- Strategies for conducting preclinical studies with combinations and how to translate the results to humans
- Determination of optimal dosing regimens and schedules for combination therapies
- Measures to ensure safety
- How to examine combination approaches that are not well tolerated
- Addressing potential long term safety concerns
Overcoming the Challenges of CD3 Bispecifics
Moderator: Catherine J McMahan, PhD, Senior Director, Pharmacology and Cell Sciences Research and Non-Clinical Development, Aptevo Therapeutics
- Sharing of experiences regarding cytokine release and toxicity and means of overcoming this
- Benefits of Fc engineering
- Selection procedures to use
- Measures to enhance potency and specificity
- Means of enhancing manufacturing
- Preclinical models to use
Stability Strategies for Large Molecules
Moderator: Declan Lowney, MSc, Associate Director, Analytical Development, Janssen R&D
- Design of studies
- Influence of Tg’ on stability strategy
- Stability strategy for self-administered products
- Statistical modelling and extrapolation
CAR Versus TCR
Moderator: Hans J. Stauss, MD, PhD, Director & Professor, Tumor Immunology, Infection & Immunity & Transplantation, Royal Free Hampstead NHS Trust
- Profile of effector function
- T cell persistence
Common Issues with Transient Protein Production
Moderators: Richard Altman, MS, Scientist, Protein Technologies, Amgen
Henry C. Chiou, PhD, Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
- Scalable and rapid transient protein production in mammalian cells continues its evolution as an integral part of the biotherapeutic drug discovery process as well as an important tool to generate recombinant proteins for a variety of other applications. What are the current challenges to transient protein production?
- What are the keys to optimizing expression?
- How do we optimize the whole protein expression process?
- How can we maintain volumetric yields while scaling transient expression up or down?
- What cell line(s) should we use and when?
- What parameters can impact the quality or physical attributes of transiently produced proteins?
How to Express Physiologically Relevant Intracellular Target Proteins for Small Molecule Drug Discovery
Moderator: Rick Davies, PhD, Associate Director, Discovery Biology, AstraZeneca Pharmaceuticals
- Most work in the industry is focused on secreted proteins. For drug discovery, expressing complex intracellular proteins is critical. Expressing complex, multi-domain proteins in mammalian/insect/bacterial systems is very challenging. Why is this?
- What are the blockers for intracellular expression?
- What can we do to develop new systems to enable this work?
The Past and Future of TGE
Moderator: Florian M. Wurm, Dr. rer. nat., Professor Emeritus, Swiss Federal Institute of Technology Lausanne (EPFL); Founder, Chairman, ExcellGene SA
- What yield for what protein – past and present?
- Manufacturability – a question to be answered by TGE
- What scale for what type of goals?
- Future of cGMP TGE – is it coming for protein pharmaceuticals?
- What are the regulatory challenges – are the FDA and the industry ready for it?
FRIDAY, 16 NOVEMBER 12:05 – 13:00
Key Features of Bispecific Antibody Platform
Moderator: Ulrich Brinkmann, PhD, Expert Scientist, PRED, Roche
- Best use of Bispecific antibodies
- Bispecific antibody platforms, strengths and challenges
- Criteria for selecting bispecific antibody leads
- Emerging issues with bispecific antibodies
Strategy for Engineering and Design of Bispecific TCR-Based Products
Moderator: Yoram Reiter, PhD, Head, Molecular Immunology, Technion-Israel Institute of Technology
- The differences and similarities in TCR-based bispecific vs. conventional antibody-based bi-specific
- Measures to increase tumor specificity
- Balancing the affinities of the bispecific tumor antigen and CD3
- Potential of CD3 bispecifics for the treatment of solid tumors
- Optimal PK properties for CD3 bispecific products
- Getting the right potency / toxicity balance
Immune Recognition of Cancer Cells
Moderator: Mar Valés-Gómez, PhD, Spanish National Research Council, CSIC; Spanish National Center for Biotechnology
- The involvement of NK cells in tumour immune recognition and evasion
- Extracellular vesicles as markers for tumour progression or diagnosis
Will Standard Monoclonal IgG Drugs Someday Become Obsolete as Cancer Therapeutics?
Moderator: Daniel Emerling, PhD, Senior Vice President, Research, Atreca, Inc.
- What do antibodies do really well as drugs?
- What are the likely advantages and limitations of next generation therapies as cancer therapeutics?
- Are there things which standard monoclonal antibodies do well that may never be replaced by other formats?
Freezing, Thawing and Storage of API Solutions of Therapeutic Proteins – A Practical Exchange
Moderator: Karoline Bechtold-Peters, PhD, Senior Strategy and Technology Leader, Biologics Technical Development & Manufacturing, Novartis Pharma AG
- What are adequate long-term storage conditions, minus 20°C, minus 30°C, minus 40°C, minus 80°C?
- How can we achieve controlled freezing and thawing in various containers? Are some better/worse? Does it matter?
- Do newer formats of proteins constitute further challenges?
- Container closure integrity under frozen condition?
Protein Aggregation Mechanisms for mAbs, ADCs and Multivalent Antibodies
Moderator: Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
- Interaction energetics control aggregation
- Both protein and solvent contribute to the energetics
- What you can do to control aggregation
- Excipients and interaction impact on interactions energetics
Enhancing Tumor Response to Antibodies
Moderator: Alison Betof Warner, MD, PhD, Medical Oncology Fellow, Memorial Sloan Kettering Cancer Center
- What do recent successes and failures from combination trials teach us about sensitization to checkpoint inhibitors?
- How can we therapeutically modulate tumor microenvironment to improve success with antibodies?
- What role do patient selection, stratification, and biomarkers play?
- Are there strategies to enhance tumor response to antibodies without significantly increasing immune-mediated adverse events?
Agonist Discovery and Human Efficacy
Moderator: Bryan Glaser, PhD, Vice President, Research, Invenra, Inc.
- How does the desired agonist mechanism of action and target biology impact discovery strategy?
- What is the optimal format (ligand-fusion, fc-modified, bispecific, etc) of the final candidate and how is it determined?
- How do we best judge activity using in vitro and in vivo models?
- What is the best way to evaluate agonists that lack mouse cross-reactivity?
Application of Structural and Biophysical Methods in the Development of Biopharmaceuticals
Moderator: Ray Owens, PhD, Professor, Molecular Biology and Head, Oxford Protein Production Facility, University of Oxford
- What are the best methods for assessing the impact of post-translational modifications on higher order structure of biopharmaceuticals?
- Does structure determination by either X-ray crystallography or cryo-electron microscopy have a role to play in the development of biopharmaceuticals?
- What properties, that can be analysed by biophysical methods, are relevant to the stability, and/or aggregation propensity of biopharmaceuticals?
Challenges with Protein L -- Let’s Exchange Experiences and Ideas
Moderator: Oliver Spadiut, PhD, Assistant Professor, Chemical, Environmental and Biological Engineering, Integrated Bioprocess Development, Technische Universität Wien (TU Wien)
- Is protein L the way to go to capture Fabs?
- What about recombinant Fabs from microbials?
- How stable is the ligand? And how pure is the product?