MONDAY, APRIL 8
2:20 - 3:20 PM
Phage-Display of Recombinant Affinity Reagents
Moderator: Brian K. Kay, PhD, Professor, Department of Biological Sciences, University of Illinois, Chicago
- Two-site capable affinity reagents are challenging to discover
- Pair discovery can be built into phage-display through MegaSTAR
- Millions of pair-wise combinations can be created and easily screened
- MegaSTAR yields 5-15 pairs per target
- Bispecific reagents have affinities < 22 nM
Cyclic Peptides – Going from Hits to Leads and to the Clinic
Moderator: Ali Tavassoli, PhD, Professor, Chemical Biology, University of Southampton
- Several methods available for identifying cyclic peptide hits
- The path from hit to lead is less clear
- We will discuss strategies for converting cyclic peptide hits into leads
Phage Display for Biomarker Discovery
Moderator: Lobelia Samavati, MD, Associate Professor of Medicine, Department of Medicine, Center for Molecular Medicine and Genetics, Wayne State University School of Medicine
- T7 phage display as novel nexus for biomarker discovery of inflammatory diseases
- Biomarkers as expression of disease pathogenesis
- Biomarkers for the development of targeted therapy
Getting from NGS Data to Testable Clones in in vitro Antibody Discovery?
Moderator: Fortunato Ferrara, PhD, Vice President, Specifica, Inc.
- Importance of NGS to isolate lead candidate after in vitro selections
- Will NGS completely replace high throughput screenings?
- Novel and future NGS platforms and their use in guiding recombinant antibody discovery
Engaging Innate and Adaptive Immunity
Moderator: Paul M. Sondel, MD, PhD, Reed and Carolee Walker Professor of Pediatrics, Human Oncology, and Genetics, and Director of Research, UW Division of Pediatric Hematology, Oncology and BMT, UW Carbone Cancer Center and American Family Children’s Hospital, University of Wisconsin
- Tumor reactive mAbs can have activity against small amounts of solid tumor in vivo, likely via innate immunity
- Induction of Innate Immunity can help trigger subsequent adaptive immunity
- This may enable an existing tumor to function as an in situ vaccine
Clinical Development, Early Phase Studies, Immunotherapy Combinations, and Engineering Cancer Immunotherapy
Moderator: Daniel Chen, MD, PhD, CMO, IGM Biosciences
- We face specific challenges in developing next generation cancer immunotherapy
- Improved immunotherapy must start by reversing specific immune escape mechanisms – or bypass them
- Engineered cancer immunotherapy may target biologic modification more specifically – improving efficacy and safety, or bypass endogenous immune biology
- Rational combinations for cancer immunotherapy are likely necessary to obtain optimal outcomes and durable responses
- Assessing contribution of parts and optimal dose/schedule in cancer immunotherapy Phase I studies require attention to specific study design features
Anti-B Cell Maturation Antigen Chimeric Antigen Receptor T Cell therapy for Multiple Myeloma
Moderator: Dexiu Bu, MD, PhD, Investigator III, Exploratory Immuno-Oncology, Novartis Institute for Biomedical Research
- How to best target the low level of Antigen
- The stemness of Antigen: Escape mechanisms after treatment
- Therapeutic modality: Cell therapy vs therapeutic Abs (ADC, or bispecific)
The Emerging Profile of Immunotherapy in Acute Leukemia
Moderator: Naval G. Daver, MD, Associate Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center
- Immune therapy toxicity management in AML/MDS
- Biomarkers for response to immune therapy in leukemia
Predicting and Mediating CAR, TCR, and TIL Toxicities
Moderator: Saad J. Kenderian, Assistant Professor of Medicine and Oncology, Mayo Clinic College of Medicine
- Recognize expected toxicities after CART cell therapy
- Preclinical modeling of cytokine release syndrome after CART cell therapy
- Management of toxicities after CART cell therapy
- Strategies to develop novel approaches and prevent cytokine release syndrome after CART cell therapy
New Targets and Technologies for CAR T cells
Moderator: Michael Würzburg, PhD, Program Leader, Max Eder Research Group‚ CAR T-Cell Engineering, Department of Medicine II, University Hospital Würzburg
- Rational CAR design to enhance antitumor activity
- Defined subset composition of CAR-T cell products to augment safety and efficacy
- Novel CAR target antigens in hematologic and solid tumors
- Virus-free CAR gene transfer and genome editing strategies
Challenges of Producing Integral Membrane Proteins
Moderator: Nicola Burgess-Brown, PhD, Principal Investigator, Biotechnology, Structural Genomics Consortium, University of Oxford
- Construct design: preferred tags, proteases, how many constructs to screen?
- Challenges of expressing integral membrane proteins: which expression host?
- Problems of scale of production for structural biology: resource and cost issues.
- Strategies to improve purification and stability of membrane proteins: detergents, lipids, affinity reagents, liposomes, nanodiscs, SMALPs.
Why are we Stuck with HEK and CHO? What New Eukaryotic Expression Systems are Ready to Use? Are We Making the ‘Right’ Proteins?
Moderator: James Love, PhD, COO, Institute for Protein Innovation
- Engineering cell lines or find new cell lines with enhanced properties?
- Opportunities for purification from natural sources?
- What proteins can’t be made?
Next Generation of Biotherapeutics: Challenges to Express Complex Format Proteins (Host vs. Titer vs. Product Quality)
Moderator: Shahram Misaghi, PhD, Senior Scientist, Early Stage Cell Culture, Genentech, Inc.
- Therapeutic molecules are becoming increasingly more complex (no longer just antibodies).
- Many of these molecules are highly potent (especially the ones that elicit immune cells), requiring lower dosage but very consistent product quality.
- Are we, as an industry, prepared to express these increasingly more complex molecules?
- Are we, as an industry, focusing enough on product quality besides productivity?
- What innovations (engineering, media, hosts, etc.) should we focus on to address these issues?
- Have new large-scale manufacturing approaches being adequately developed and tested to consistently manufacture these complex molecules?
Characterization Issues for Cell Therapy Products
Moderator: Kuldip Sra, PhD, Director, QC, Kite Pharma, Inc.
- Lot release of cell therapy products
- Stability program for cell therapy products
- Raw material testing strategy
Impact of HPLC-MAM-MS Workflows to the Analytical Drug Development Process
Moderator: Jennifer F. Nemeth, PhD, SCPM, Director, Biophysics, Structural Characterization, Biologics Discovery Sciences, Janssen Research & Development
- What assays are being replaced by HPLC-MAM-MS Workflows?
- What assays have people tried to replace and have run into difficulties?
- Is the vendor software meeting compliance needs for GLP / GMP environments?
- What could vendors be doing better to help our industry execute MAM workflows?
Development Issues for CAR-Ts
Moderator: Zhimei Du, PhD, Director, Bioprocess, Merck & Company, Inc
- What are major COGs during CAR-T cell therapy and how to reduce it?
- How to improve process consistency during CAR-T cell therapy?
- How to apply the experience of biologics development to CAR-T cell therapy?
- Scale up vs scale-out
Best Practices for Assessment of Critical Quality Attributes (CQAs) for Antibody-Drug Conjugates
Moderator: Lisa Zhou, Senior Scientist, Protein Analytics, AbbVie
- Application of platform vs. product-specific attribute knowledge in CQA assessments for ADCs
- CQAs assessment and determination of specifications, early stage and late stage strategies
- Analytical methods used for the release vs. characterization
- CQAs and process characterization
Immunogenicity Risk Assessments for Complex Biotherapeutics
Moderator: Theresa J Goletz, PhD, Global Head of NBE Drug Disposition, QPD, BIOPHARMA, R&D, Global Early Development, EMD Serono Research & Development Institute Inc.
- How Immunogenicity Assessments differ (or not) for complex multi-domain biotherapeutics versus traditional mAbs or therapeutic proteins
- Immunogenicity Risk Assessments during clinical development
How Can We Translate, Integrate and Implement ADA Testing in Clinical Routine in the Most Efficient Way?
Moderator: Anna Fogdell-Hahn, PhD, Associate Professor, Clinical Neuroscience, Clinical Neuroimmunology, Center for Molecular Medicine (CMM)
- Can we transfer ADA methods from industry to clinical routine (challenges versus benefits)?
- What type of data is missing to convince clinicians to integrate ADA testing in treatment decisions?
- What would be the consequences of routine testing for ADA in the clinic for the pharma industry, health care, patients, clinicians and society?
Novel Formats and Platforms for Fusion Proteins
Moderator: Dario Neri, PhD, Professor, Chemistry and Applied Biosciences, Swiss Federal Institute of Technology (ETH Zurich)
- Fusions based on full IgG vs. antibody fragments
- Monovalence vs. multivalence
- Tissue penetration and half-life
Fusion Proteins as Immunotherapy Agents
Moderator: Oliver Hill, PhD, Vice President, Molecular Biology/Protein Engineering, Apogenix AG
- Evaluation of immunotherapeutic formats - Fusion proteins, Antibodies, Antibody-fragment based fusion proteins and Multiformats:
- Is there superiority of a specific format regarding agonistic versus antagonistic signaling approaches?
- Are there target-structure based preferences for certain formats?
- Performance of multidomain fusion proteins to locally override an immune checkpoint:
- Are there enabling formats?
- Which targets to address (ECM, immune cell, tumor cell)?
- What are useful therapeutic combinations?
Preclinical Development Strategies for Antibody Therapeutic Candidates
Moderator: An Song, PhD, Senior Vice President, Development Sciences, Immune-Onc Therapeutics, Inc.
- Pros and cons of technologies for generating antibody therapeutic candidates
- What antibody affinities do you usually target and when would you do affinity maturation?
- Assessment and design of Fc effector functions for IND?
- Pros and cons of using single clone material for IND-enabling studies or pooled clone material
- Approaches to pilot studies prior to GLP and IND-enabling studies
Emerging Technologies for Antibody Discovery and Engineering
Moderator: Juan Carlos Almagro, PhD, Founder and Director, GlobalBio, Inc.
- Human content and immunogenicity
- Diverse phage display libraries, advantages and limitations
- Engineering novel properties in the antibodies, for instance, pH-dependent binding
- Novel transgenic platforms for antibody discovery, for instance, transgenic chickens
Alternate Conjugation Strategies
Moderator: Ahuva Nissim, PhD, Professor, Antibody and Therapeutic Engineering, Biochemical Pharmacology, Queen Mary University, United Kingdom
- Synthetic scaffolds in oncology
- Biological scaffold in oncology: vesicles shaded scaffolds and liposomes
- Biological scaffold in auto-immune diseases
- What can we learn for future combined treatment development?
WEDNESDAY, APRIL 10
4:45 - 5:45 PM
Biochemical Analysis of Complex Antigens and Antibody-Antigen Interactions
Moderator: Kathryn Hastie, PhD, Staff Scientist, Immunology and Microbiology, The Scripps Research Institute
- How to assess the mass and oligomeric state of complex proteins (particularly glycoproteins) using light scattering – necessary information for down-stream analyses
- Epitope binning using Octet
- Kinetics and affinity using Octet
- Kinetics, affinity and stoichiometry analysis using light scattering
The Application of Machine Learning in Antibody Discovery
Moderator: Sai Reddy, PhD, Assistant Professor, Biosystems Science and Engineering, ETH Zurich, Switzerland
- Difference between machine learning and deep learning
- Concepts of machine/deep learning in drug discovery
- How can machine/deep learning be used for antibody therapeutics?
- What are major challenges for implementing machine/deep learning strategies?
Bispecific Antibodies: The Road Less Traveled and the Road Up Ahead
Moderator: James L. Gulley, MD, PhD, FACP, Chief, Genitourinary Malignancies Branch, Head, Immunotherapy Group, GMB Director, Medical Oncology Service, Center for Cancer Research, NCI, NIH
- Cancer immunotherapy approaches and opportunities in solid tumors
- Why combination approaches in immunotherapy are the next big thing
- Why bispecific proteins are an important rational approach to combination immunotherapy
- Concentrating immune activity within tumor
- Drug development strategies
- Examples of bispecifics (M7824, NHS-IL12, N-809)
Developability of Bispecific Antibodies
Moderator: Nimish Gera, PhD, Director, Research and Development, Mythic Therapeutics
- Format Selection
- Developability Assays
- Other Considerations
Bringing Novel Bispecific Antibodies to the Clinic: Challenges and Solutions
Moderator: Charlotte Russell, MD, PhD, CMO, Alligator Bioscience AB
- Translating non-clinical data to the human setting
- Limited availability of non-clinical data due to lack of relevant models
- Justification of first-in-human starting dose and escalation
- Design of studies with combinations, e.g. Standard of care + novel compound and/or novel + novel compound
- Selection of patients for first-in-human trials
Building Better T Cell- and NK Cell-Engaging Bispecifics
Moderator: Gundo Diedrich, PhD, Director, Antibody Engineering, MacroGenics
- Targets on T and NK cells that induce stimulation/co-stimulation
- Can T cell stimulation be uncoupled from cytokine release?
- T cell- vs. NK cell-engagers: What are their advantages and disadvantages?
- What can we learn from CAR T cell designs?
Integrating Bispecifics with Emerging Mechanisms of Resistance to IO Therapies
Li Peng, PhD, Vice President, Biotherapeutics Discovery, Palleon Pharmaceuticals
- Discuss potential targets for bispecifics from emerging mechanisms of resistance to current IO therapies
- How different formats of bispecifics impact biological activities, PK, and toxicity
- Emerging stories of bispecifics with potentials increase IO response rates
Advances in Allogenic Cell-Based Therapies
Moderator: Barbra Sasu, PhD, CSO, Allogene
- Limitations and Novel approaches for CAR-T therapy Differences between autologous and allogeneic cell therapy
- Generation of a renewable source for large scale manufacturing of cellular therapeutics
- Challenges of cell therapy for solid tumors
- Combinations for cell therapy
Present and Future of Genetically Engineered T Cells in Oncology
Moderators: Adrian Bot, MD, PhD., Vice President, Translational Sciences, Kite, a Gilead Company
Marco Ruella, MD, Clinical Instructor, Associate Director, Dr. June’s Laboratory, Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania
- 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?
The Future of Cell Line Development: Random Integration, Targeted Integration or Both? Pros and Cons
Moderator: Ulrich Goepfert, PhD, Principal Scientist, Cell Line & Molecular Development, Roche Innovation Center Munich
- DNA cloning efforts
- Quality of stable pools
- Diversity of clones
- Production stability
Transient Cell Lines for CHO and Stable Pools
Moderator: Samuel Ellis, Vice President, Thomson Instrument Company
- Which cell lines are best to work with
- Which cell lines are best for scaling up for commercial use
- Pros/Cons of different cell lines
Strategic Outsourcing in Cutting-Edge Biologics Development
Moderator: Ian Wilkinson, PhD, CSO, Absolute Antibody, Ltd.
- What drives developers to outsource? Is this the future or a fad; will development gradually be brought back in-house? What might drive that?
- What processes can be readily outsourced? Is there anything that should never be outsourced?
- What measures could CDMOs and CROs take to make themselves more useful for biologics developers?
Multi-Attribute Method for Product Quality Attribute Understanding in Biotherapeutics
Moderator: Kristin Boggio, PhD, Senior Scientist, Protein Mass Spectrometry, Pfizer
- What does MAM mean to you?
- Attributes to be monitored
- Correlation between MAM and early release methods
- Technical and practical limitations of implementing MAM
What are the Applications and Limitations of the Assays Used for Measuring Higher Order Structures?
Moderator: Jihong Wang, PhD, Principal Scientist, MedImmune
- What kind of data should be included or not to be included in regulatory filings?
- What assays needed to be included in comparability?
- How HDX MS and NMR are used during protein drug development?
- What’s new and high throughput assays can be used to evaluation higher order structures?
The Role of Denaturing and Native-MS in Pharma: From mAbs to Membrane Proteins and Beyond
Moderator: Iain D. G. Campuzano, Principal Scientist, Discovery Attribute Sciences, Amgen
- Native-MS in pharma: is it established or still niche?
- 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?
- Specific MS improvements which would highly benefit pharmaceutical research
- Which deconvolution algorithm is optimal for use in biopharma?
Solutions for a Drug-Tolerant Neutralizing Antibody Assays
Moderator: Zhandong Don Zhong, PhD, Associate Director, Specialty Bioanalytics, Teva Pharmaceuticals
- A risk-based approach to developing a drug tolerant neutralizing antibody (NAb) assays
- The implication of the NAb positive controls
- Pros and cons of various methods for improving detection of NAb
Acid Dissociation for ADA Assays: Is it as Useful as Assumed?
Moderator: Eric Wakshull, PhD, Principal Scientist/Group Leader, Bioanalytical Sciences, Genentech
- Acid dissociation is used to increase drug tolerance, and is often insisted upon by regulators
- Acid dissociation has the potential to alter a sample in an unknown way
- Does using acid dissociation methods bring added value to clinical immunogenicity assessment?
Solid Tumor Resistance Mechanisms to Antibody-Drug Conjugate Therapeutics and Strategies to Overcome Them
Moderator: Anton Neschadim, PhD, MBA, CEO, ImmunoBiochem Corporation
- Target-based resistance mechanisms: target heterogeneity; target loss and selective pressures acting against target; poor tumor penetration.
- Payload-based and multifactorial resistance mechanisms: drug transporters and payload efflux; altered ADC trafficking and processing; mutations in cytotoxic drug target.
- Lessons from the clinic, and congruence between clinical data and preclinical models.
- Strategies to overcome resistance and their translation: novel targets; improved linkers and payloads; dual-payload design; small-molecule drug conjugates; bystander effects; bispecific and biparatopic ADCs, enzymatically- or environment-activated ADCs; combination therapies.
Designing Optimum ADCs- Linkers and Conjugation Technologies
Moderator: James Baker, PhD, Associate Professor, Chemistry, University College London
- Site-selective methods vs stochastic conjugation, the importance of controlling the attachment chemistry.
- Serum stable linkers, with/without controlled cleavability. Leading approaches and new opportunities.
- Strategic linker design, to offer the opportunity to increase the DAR/reduce hydrophobicity.
Novel Payloads and New Platforms for ADCs
Moderator: Hans-Georg Lerchen, PhD, Chief Scientist, R&D Pharmaceuticals, Bayer AG
- Experience and lessons learned from current effector chemistries utilized in ADCs in clinical trials
- Is there a particular need for novel payload classes?
- What are the criteria transforming toxophore moieties into payloads successfully employed in ADCs?
- What are the desired profiles of payloads for treatment of solid tumors and hematological malignancies, resp.?
Strategies to Maximize Potential of Oncolytic Viruses
Moderator: Caroline Breitbach, PhD, Vice President, R&D Programs and Strategy, Turnstone Biologics
- What makes a better oncolytic virus? A more potent oncolytic backbone? Greater inducer of anti-tumor immunity?
- Oncolytic virus engineering strategies
- Rational combination therapy approaches
Combining Virotherapy with Immunothearpy: Challenges and Opportunities
Moderator: Smita Nair, PhD, Professor, Surgery, Neurosurgery and Pathology, Duke University School of Medicine
Development Issues for High Concentration Monoclonal Antibody Drug Products
Moderator: Chaitanya Sudrik, PhD, Postdoctoral Associate, Molecular Engineering, Massachusetts Institute of Technology
- Novel excipients for viscosity reduction in liquid high concentration formulations
- Novel drug formats like antibody particle suspensions: opportunities and challenges
- Drug delivery device solutions like on-body injectors.: opportunities and challenges
- Fill-finish and other manufacturing challenges with high concentration mAb formulations
Definition of Clinically-Reliable Specifications
Moderator: Gerald Gellermann, PhD, Senior Fellow, Novartis, Switzerland
- What is a clinically-reliable specification?
- How is it defined in ICHQ6 and what are the consequences?
- Do we need to test every variant at its maximal level in clinical trials to back-up specifications anticipating future process variability e.g. during process/capacity improvements?
- What is a clinical reliable specification for a non-critical product variant?
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