Breakout Discussions

Engage in in-depth discussions with industry experts and your peers about the progress, trends and challenges you face in your research!

Interactive discussion groups play an integral role in networking with potential collaborators. They provide an opportunity to share examples from your work, vet ideas with peers, and be part of a group problem-solving endeavor.

MONDAY, MAY 4TH
2:20 - 3:20 PM

Display of Antibodies

TABLE: Can Mammalian Display Compete with Yeast and Phage? Challenges and Benefits of Mammalian Selection Systems for Protein Engineering

Moderator: Jennifer Maynard, PhD, Henry Beckman Professor, McKetta Department of Chemical Engineering, Cockrell School of Engineering, The University of Texas at Austin

  • What are the trade-offs among reported mammalian systems?
  • What proteins are right for mammalian display? (GPCR, transport proteins and intramembrane proteases)
  • How can we design selections based on protein activity?
  • How to introduce and maintain a library – retroviral elements, CRISPR or others?
  • Can we simultaneously engineer glycosylation and proteins for desired functions?
  • How can we maximize library size, ensure just one variant per cell and maximize the dynamic range to separate populations of interest?

TABLE: Enabling Technologies to Enhance Selections Based on Immune Function

Moderator: Jamie Spangler, PhD, Assistant Professor, Biomedical and Chemical & Biomolecular Engineering, Johns Hopkins University

  • Interfacing new flow cytometry tools with directed evolution to facilitate functional selections
  • Yeast biopanning techniques to improve recognition of active signaling proteins
  • Choosing readouts to couple with selection process
  • Designing selection strategies to evolve proteins that enact therapeutic mechanisms of interest

Antibodies for Cancer Therapy

TABLE: What is the Best?

Moderator: Daniel Vallera, PhD, Lion Scholar and Professor; Director, Section on Molecular Cancer Therapeutics; Professor of Therapeutic Radiology, University of Minnesota Masonic Cancer Center

  • Best target for solid tumors
  • Best route of delivery
  • Best way of minimizing adverse reactions
  • Best way of prolonging half-life of therapeutics

Improving Immunotherapy Efficacy and Safety

TABLE: Combination Therapies and the Tumor Microenvironment

Moderator: Allison Betof Warner, MD, PhD, Assistant Attending Physician, Melanoma Service, Memorial Sloan Kettering Cancer Center

  • What are recent combination trials telling us about the mechanism of action of combinations in the microenvironment?
  • What role does the microbiome play and how do we harness this to improve outcomes?
  • Strategies for immune system priming and activation
  • Control of immune-related adverse events

TABLE: CAR T Safety

Moderator: Saad Kenderian, PhD, Assistant Professor, Medicine and Oncology, Mayo Clinic College of Medicine

  • CART cell therapy efficacy and safety balance
  • CART cell engineering
  • CART cell application

Characterization of Novel Biotherapeutics

TABLE: Co-formulation of Therapeutic Proteins

Moderator: Dennis Krieg, PhD, Researcher, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximilians-University Munich, Germany

  • Analytical challenges (deconvolution of chromatographic and spectroscopic data, systematic and efficient method development
  • Formulation challenges (DoE approaches, setup of stability studies for co-formulations)
  • Regulatory challenges (demands for co-formulation characterization by the regulatory authorities, use of single formulation stability data for co-formulations)
  • Clinical challenges (setup of PK studies for flexible or fixed dosing ratios, extrapolation of clinical data from single to co-formulations)

TABLE: Challenges Associated with Analytical Method Development for the Characterization of AAV-Based Therapeutics

Moderator: George Bou-Assaf, PhD, Scientist, Analytical Development, Product & Technology Development Biogen

  • Similarities and differences between AAV and protein-based challenges
  • Transferability of methods from proteins to AAV-based molecules
  • Sample limitations and design of experiments to take into account this limitation
  • Simplified and streamlined approaches to method development that still meets ICH guidelines and regulatory expectations
  • New tools and instrumentations that enable analytical method development of AAV based therapeutics

Difficult to Express Proteins

TABLE: Experiences with Using Different Binder Types as Crystallization Chaperones or Cryo-EM Handles

Moderator: Susanne Gräslund, PhD, Principal Investigator, Structural Genomics Consortium, Karolinska Institute

  • What binder types/scaffolds have the participants worked with?
  • Has any comparisons of different binder types have been made?
  • What type of antigens, soluble proteins, complexes, integral membrane proteins?
  • Different methods of immobilizing the antigens during selections?

TABLE: Cell-Free Approaches to Difficult Proteins

Moderator: Matthew Coleman, PhD, Senior Scientist & Group Leader, Biosciences and Biotechnology Division, Lawrence Livermore National Laboratory

  • Eukaryotic versus prokaryotic cell-free expression systems
  • Variants of cell free expression (batch versus dialysis)
  • Additives for screening and producing membrane bound proteins

TABLE: Optimising Protein Production Strategies for Multi-Protein Complexes Within Drug Discovery

Moderator: Saleha Patel, PhD, Senior Research Scientist, Protein Science, Discovery Biology, AstraZeneca

  • Obtaining high-quality homogeneous protein samples, at high yields, are often a pre-requisite for a successful drug discovery campaign
  • What are the current challenges for protein production in drug discovery?
  • What are the best protein production strategies for recombinant multi-protein complexes?
  • Are there any new technologies available to help with the increasing complexity of protein targets/antigens?
  • How do we ensure protein reagents are fit-for-purpose for downstream applications?

Immunogenicity Case Studies and Clinical Management

TABLE: Immunogenicity of PEG: Impact and Analysis

Co-Moderators: Johanna Abend, PhD, Senior Scientist I, Immunogenicity Assessment, Translational Sciences, BioMarin Pharmaceutical Inc.

Madhukar Aryal, MS, Senior Research Associate, BioAnalytical Sciences, BioMarin Pharmaceutical Inc.

  • How is our understanding of anti-PEG responses evolving (eg, pre-existing PEG antibodies, drug-induced anti-PEG responses)?
  • Can dosing regimens affect the anti-PEG response (eg, is desensitization / tolerance possible)?
  • Can other strategies be used to overcome the effect of anti-PEG response (eg, administration of free PEG)?

TABLE: How to Optimize Sample Pretreatment Methods

Moderator: Lynn Kamen, PhD, Senior Scientist, BioAnalytical Sciences, Genentech Inc.

  • ACE vs BEAD vs SPEAD
  • How much positive control antibody recovery is sufficient?
  • How to optimize assay sensitivity while maintaining drug tolerance?
  • What is the best sample pretreatment method for cellular assays?

Emerging Indications for Therapeutic Antibodies

TABLE: Biotherapeutics for Respiratory Indications

Moderator: Bas van der Woning, PhD, Research Fellow, arGEN-X, Belgium

  • What are the biggest unmet medical needs in respiratory diseases (asthma, cystic fibrosis, COPD, idiopathic pulmonary fibrosis, etc.)
  • Systemic versus local administration of biotherapeutics
  • Challenges of local administration of biotherapeutics
  • Methods to measure an effect on lung function (spirometry, CT, 3He MRI, airway resistance, ect.)
  • Biomarkers (eosinophils, neutrophils, IgE, FeNO, ..any new biomarkers?)

TABLE: Antibody Targeting and Delivery Strategies for CNS Indications

Moderator: Charles Glabe, PhD, Professor, Molecular Biology and Biochemistry, University of California, Irvine

  • Do antibodies that modulate inflammation or complement activity have potential therapeutic activity in CNS diseases?
  • Does immunotherapy hold promise for other amyloid related neurodegenerative diseases? If so, is it possible to have a broad spectrum or universal antibody for neurodegenerative diseases?
  • What parameters are important for making immunotherapy more effective?
  • Does amyloid structural polymorphism mean that immunotherapy needs to be personalized according to specific conformational strain?

TABLE: Strategies for Modulating, Targeting and Directing T Cell Activity for Therapeutic Gain

Moderator: Elissa Leonard, PhD, Postdoctoral Fellow, Biomedical Engineering, Johns Hopkins University

  • What are the most viable emerging or established strategies for directing T cell specificity? Engineered TCRs? Expansion of endogenous populations? CARs?
  • Other stimulatory signals that can direct lineage and suppressive/inflammatory activity
  • Engineering or controlling persistence
  • Therapeutic viability in terms of cost and scale

WEDNESDAY, MAY 6TH
5:00 - 6:00 PM

Engineering Antibodies

TABLE: Mammalian Cell Display for High-Throughput Engineering of Immune Receptors

Moderator: Rodrigo Vazquez-Lombardi, PhD, Postdoctoral Fellow, Biosystems Science and Engineering, ETH Zurich, Switzerland

  • Advantages and limitations of mammalian cell display platforms relative to traditional display methods
    • Design and development of mammalian display platforms using CRISPR-Cas9 genome editing
    • Deep mutational scanning as a key method for the design of highly focused combinatorial libraries
  • Orthotopic introduction of immune receptor libraries into the genome of mammalian cells using CRISPR-Cas9
  • Selection of desired variants using flow cytometry coupled with deep sequencing and enrichment analysis

TABLE: Modulating the Dynamic and Subcellular Trafficking Behavior of Antibodies for Therapy

Moderator: Sally Ward, PhD, Professor, Molecular Immunology, University of Southampton, United Kingdom

  • How can microscopy inform the design of therapeutics?
  • Targeting FcRn to clear pathogenic antibodies
  • Half-life extension technology
  • Modulating endosomal trafficking of ADCs to enhance drug delivery to lysosomes

TABLE: Big Data Challenges in Protein Engineering

Moderator: David Gifford, PhD, Professor, Computer Science and Biological Engineering, MIT

  • The role of machine learning in the discovery and optimization of biologics
  • What quantity of data is required to build effective machine learning models
  • What experimental designs are necessary to get optimum machine learning performance
  • Error correction and processing of data for machine learning

Advancing Bispecific Antibodies and Combination Therapy to the Clinic

TABLE: Pre-Clinical Mouse Models to Examine Immunotherapeutics

Moderator: Alison Crawford, PhD, Senior Staff Scientist, Oncology & Angiogenesis, Regeneron Pharmaceuticals

  • Xenogenic versus syngeneic models
  • Read-outs examining T cell activation
  • Combination therapy in pre-clinical models

TABLE: Pros and Cons of Assays to Predict the Half-Life of Antibodies in Primates

Moderator: Gundo Diedrich, PhD, Director, Antibody Engineering, MacroGenics, Inc.

  • FcRn affinity chromatography
  • Cell-based assays with FcRn-expressing cell lines (transcytosis assays, recycling assays)
  • In vitro plasma stability assays

CAR-Ts, TCRs and TILs

TABLE: Present and Future of Genetically Engineered T Cells in Oncology

Moderators: Adrian Bot, MD, PhD, Vice President, Translational Sciences, Kite, a Gilead Company

  • Current results and limitations of CAR-T therapy
  • Innovative receptor designs
  • Desired features of T cells: potency and controllability
  • Manufacturing optimizations to scale out, diminish cost, and fully utilize this platform technology
  • Beyond blood cancers and beyond cancer: what is next?

TABLE: Mirror, Mirror on the Wall, Who is the Finest CAR T Phenotype of Them All?

Moderator: Peggy Sotiropoulou, PhD, Director, Research & Development, Celyad

  • What is the ideal memory phenotype for CAR T cells?
  • Is the ideal memory phenotype the same for autologous and allogeneic CAR T cells?
  • Does CD4/CD8 ratio matter?
  • Does the optimal CD4/CD8 ratio depend on the cancer type (heme vs solid – hot vs cold) and therapy type (autologous vs allogeneic)?

Biophysical Methods

TABLE: The Role of Denaturing and Native-MS in Pharma: From mAbs to Membrane Proteins and Beyond

Moderators: Iain D. G. Campuzano, Principal Scientist, Discovery Attribute Sciences, Amgen

Wendy Sandoval, Principal Scientist, Genentech

  • LCMS in pharmaceutical research: can it be improved upon?
  • Native-MS in pharma: is it established or still niche? What needs to improve?
  • Required improvements for native-MS to become main-stream in pharma
  • LC-MS and native-MS in membrane protein analysis: what role does it have?

TABLE: High Throughput (HT) Analytical Data Management to Enable Machine Learning

Moderator: Marc Bailly, PhD, Associate Principal Scientist, Merck

  • Enabling HT data generation through efficient data capture, processing, storage and streaming
  • Identifying meaningful data related to the specific project/question asked to the machine learning algorithm
  • Building a relevant and accurate training data set to enable machine learning (identify test and validation data sets)

TABLE: Biophysical Methods to Drive Protein Decisions: What Matters and How Do We Measure It?

Moderator: Andrew Urick, PhD, Senior Scientist, AbbVie

  • Assessing different types of protein stability
  • Informing biophysical techniques with computational modeling
  • How do we leverage biophysical methods for increasingly complex therapeutic formats?
  • What new assays do we need?

TABLE: Structural Mass Spectrometry (SMS): Tools for the Future of Therapeutic Discovery and Development

Moderator: Brandon Ruotolo, PhD, Professor, Chemistry, University of Michigan

  • What are the options for SMS platforms, and what plans are there for adopting SMS technologies into future projects?
  • What are the main barriers for adopting SMS tools into existing projects?
  • What are the deficits in existing SMS capabilities that would add immediate value to current discovery/development efforts?
  • What targets are most amenable to SMS-based analysis and screening capabilities?

Optimizing Protein Expression

TABLE: Non-Standard Amino Acid Incorporation in Recombinant Proteins

Moderator: Jesse Rinehart, PhD, Associate Professor, Cellular & Molecular Physiology, Systems Biology Institute, Yale University School of Medicine

  • Non-standard amino acids have been incorporated in a variety of protein expression systems
  • Each non-standard amino acid, the choice of cellular host, and incorporation strategy brings with it a host of unique challenges
  • From basic set up/trouble shooting to mass spectrometry/proteomics of non-standard amino acid containing proteins
  • Bacterial systems using non-standard amino acids and proteomics

TABLE: Challenges in Cell Therapy Manufacturing Development

Moderator: Zhimei Du, PhD, Director, Process Development, Merck and Co., Inc.

  • How to mitigate the variability during cell therapy manufacturing?
  • What are the practical strategies to reduce COGS of cell therapy manufacturing?
  • Is current the list of critical quality attributes sufficient to define product and process control?
  • What is the next generation manufacturing strategy for cell therapy?

TABLE: Prepping Endogenous Protein Complexes for Downstream Analysis

Moderator: John LaCava, PhD, Group Leader, Laboratory of Macromolecules and Interactomes, European Research Institute for the Biology of Aging, University Medical Center Groningen

  • Quality assurance / quality control
  • Affinity capture, best practices
  • Intermediate readout - which tool for the job?
  • End game - routine structural analysis of endogenous complexes

Immunogenicity Assessment and Regulatory Approval of Biologics

TABLE: Strategies and Considerations for Developing Immunogenicity Assays for Novel Modalities

Moderator: Hao Jiang, PhD, Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb

  • Novel modalities such as bispecific Abs, probodies and lipid nanoparticle siRNA pose lots of challenges in clinical immunogenicity assay development
  • What are the major considerations for developing ADA and NAb assays, such as assay formats and cell lines?
  • What are the potential risks from regulatory perspective?

TABLE: Fully Automated Cell-Based Binding Neutralizing Antibody Assay on MSD Platform

Moderator: Weifeng Xu, PhD, Principal Scientist, PPDM, Regulated Immunogenicity and Molecule, Merck

  • NAb assay development: when to have an assay, which format: cell or non-cell?
  • How to overcome drug interference;
  • Interpretation of new 2019 Jan FDA Immunogenicity guidance

Engineering Antibody-Drug Conjugates

TABLE: Understanding Heterogeneity of Antibody Distribution in Human Tumors and Implications for Antibody Drug Conjugates

Moderator: Eben Rosenthal, MD, Cancer Center Medical Director, Otolaryngology, Stanford University

  • What tumor-related biomarkers are associated with modulation of antibody delivery
  • How can interventions be designed to increase the delivery of antibodies and antibody drug conjugates to target site(s), but avoid off-target effects?
  • What is the relationship between tumor burden/size or vessel fraction with the antibody delivery?
  • What aspects of tumor heterogeneity are the most important to determining delivery of antibodies and antibody drug conjugates

TABLE: Antibody Engineering Approaches to Improve the Therapeutic Index of ADCs

Moderator: Dhaval K. Shah, PhD, Assoc Prof, Pharmaceutical Sciences, University of Buffalo

  • Is 150 kDa size of mAb the best to conjugate drug molecules, or fragment-drug conjugates may provide more/different benefits?
  • What are different antibody engineering approaches evaluated to improve ADCs (e.g. bi-specific etc.), and which one seems more superior.
  • Does the site of drug conjugation (e.g. specific amino acid, glycan etc.) matter dramatically for ADCs?
  • What are learnings from application of ADCs beyond oncology? Is it a viable targeted drug delivery approach for other disorders?

TABLE: ADC Targets and Payloads: When Friends Become Foes

Moderator: Rakesh Dixit, PhD, DABT, President & CEO, Bionavigen

  • Navigation of targets and payloads for ADCs
  • Wrong pairing of targets and payloads: turning friends into foes
  • Strategies for selection of targets and payload for improving the therapeutic index
  • Translational medicine strategies to maximize TI

Gene Therapy

TABLE: Challenges During Gene Therapy Development for Neurological Diseases

Moderator: Gabriele Proetzel, PhD, Director, External Neuroscience Innovation, Neuroscience Drug Discovery Unit, Takeda Pharmaceuticals

  • Choice of animal models
  • Usefulness of reporter gene biodistribution studies
  • AAV capsid choices
  • Biopotency assay development

TABLE: Cell and Gene Therapy Development in Europe: Navigating the Regulatory Framework

Moderator: Alex Bloom, PhD, Vice President, Regulatory Affairs and Quality Assurance, Gyroscope Therapeutics

  • Clinical trial and GMO applications in the EU
  • Opportunities for accelerating ATMP development
  • Interacting with regulators in the EU and optimising scientific advice

TABLE: CQA Identification and Assessment in Gene Therapy Products

Moderator: Lin Liu, PhD, Principal Scientist, Biologics Development, Sanofi

  • Identification of pCQAs for AAV based gene therapy products
  • Design structure-functional study specific to gene therapy CQA assessment
  • Role of forced degradation study in CQA assessment
  • Potency assay used for structure-function studies

* The program is subject to change without notice, due to unforeseen reason.

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Update History
2020/03/04
Agenda,Sponsor updated
2020/02/13
Agenda,Speaker,Sponsor updated
2020/01/08
Agenda,Sponsor updated
2019/12/09
Event Information updated
2019/11/25
Sponsor updated



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