Basel, 9 - 11 November 2021

Schedule

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Nov 909:05
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Opening Remarks

Antibodies Opening Keynotes
Alain Beck, Senior Director, Centre d'Immunologie Pierre Fabre
Nov 909:10
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10 years of biosimilars in Europe – current challenges and opportunities

Biosimilars Opening Keynotes
  • Uptake and access
  • Identifiability and safety
  • International collaboration to move forward
Ana Hidalgo-Simon, Biosimilars Lead, European Medicines Agency
Nov 909:10
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The latest advances in antibody discovery and design

Antibodies Opening Keynotes
Peter Senter, Vice President Of Chemistry, Seattle Genetics Inc
Nov 909:10
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Translational Learnings from BCMA and CD19 CAR-T trials

Immunotherapy Opening Keynotes
Anne Kerber, Senior Vice President, Head Cell Therapy Development, Bristol Myers Squibb
Nov 909:30
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Current Biosimilar Landscape

Biosimilars Opening Keynotes
Chad Pettit, Executive Director, Marketing, Global Biosimilars Commercial Lead, Amgen
Nov 909:35
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Evolving Manufacturing Strategies for Monoclonal Antibody Therapeutics

Antibodies Opening Keynotes
  • Monoclonal antibody (mAb) based therapies now account for nearly a fifth of the FDA’s new drug approvals each year, with increasing numbers of novel antibody formats also progressing in development pipelines
  • The global pandemic has highlighted the pivotal nature of vaccine and mAb manufacturing supply chains.
  • New and emerging technologies are also providing more processing options than was previously the case.
Nov 909:50
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Keynote Panel Discussion: Regulatory lessons learnt from the past 15 years and what can regulatory guidelines do to improve access going forward? 

Biosimilars Opening Keynotes
Martin Schiestl, Head of Regulatory Affairs, Sandoz (Novartis)
Ana Hidalgo-Simon, Biosimilars Lead, European Medicines Agency
Nov 910:00
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Keynote panel discussion: What does the future of Immunotherapy hold for Oncology and Infectious Diseases?

Immunotherapy Opening Keynotes
Nov 910:00
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Next generation antibody therapeutics: discovery, development and beyond

Antibodies Opening Keynotes
Panellists TBA
Paul Parren, EVP, Lava Therapeutics
James Crowe, Director, Vanderbilt Vaccine Center
Arne Skerra, Professor - Biological Chemistry, TU Munich
Nov 911:30
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Antibodies Roundtable 4: Applying AI and machine learning to antibody development

Antibodies Roundtables
Nicolás Lopez Carranza, Deepchain Product Lead, InstaDeep
Nov 911:30
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Antibodies Roundtable 8: investing in biologics

Antibodies Roundtables
Shyam Masrani, Principal, Medicxi
Nov 911:30
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Approaches to conjugation – advancing ADCs

Antibodies Roundtables
Nov 911:30
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Approaches to conjugation – advancing ADCs

Antibodies Roundtables
Nov 911:30
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Biosimilars Roundtable 3 - Accelerating Development of Biosimilars: Current Bioprocessing Challenges and Opportunities

Biosimilars Roundtables
Nov 911:30
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Combination therapies with Cell therapies

Immunotherapy roundtables
Nov 911:30
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Developability of multispecifics

Antibodies Roundtables
Nov 911:30
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Gene-engineering and combinatorial therapy approaches for tacking solid tumors

Immunotherapy roundtables
Nov 911:30
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Immune cells as biomarkers of response or resistance to antibody immunotherapies

Immunotherapy roundtables
Nov 911:30
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Roundtable 6: Tracking Social Determinants of Health During the COVID-19 Pandemic. Why Partnering With Healthcare Organizations Overcomes Barriers In Healthcare Presented by SOMOS Community Care

Antibodies Roundtables
The COVID-19 pandemic exposed a number of cracks in health ecosystem, but none so wide as the one separating the health haves from the have-nots. By catapulting deep-seated disparities into the spotlight, the pandemic and the disproportionate rates of infection in Black, Latino, Chinese and other minority communities. During the pandemic, we have seen what can be achieved when stakeholders in healthcare work together. Data indicate the shares of people experiencing hardships peaked in December 2020 but have otherwise remained largely stable. Trends across all measures have improved since December 2020, reaching lows during the pandemic in March and April 2021, likely reflecting the roll-out of the COVID-19 vaccines and new federal funding available during that period. However, differences in rates of hardship among certain populations has remained largely stable throughout the pandemic and to some extent reflect longstanding disparities that existed even before the pandemic.While Covid-19 pandemic fundamentally disrupted our health care system, it also opened our eyes to better strategies to manage everyday health. In this roundtable panel discussion, we’ll explore the ways in which we have rethought how healthcare works, from wellness visits and checkups and chronic disease in low population communities.
  • Transforming access for patients while preparing for future population healthcare needs
  • Partnerships and collaborations to address healthcare systems challenges
  • Delivering better patient outcomes by bringing medicines to patients in a way that is as innovative as our science
  • What are some of the challenges that get in the way of successful partnerships and how can they be addressed
Nov 911:30
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Selection of immunomodulatory payloads to OV therapeutics

Immunotherapy roundtables
Nov 911:30
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Table 1 - Analytical and structural characterization of mAbs, biosimilars, ADCs, BsAbs, and Fc fusion proteins

Antibodies Roundtables
Nov 911:30
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Table 2 - Antibody Manufacturing - How does the Future Look?

Antibodies Roundtables
Nov 911:30
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TABLE 5: IP and Legal Considerations for Biosimilars

Biosimilars Roundtables
Andrew Roberts, Chief Portfolio Officer, Alvotech
Nov 911:30
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Targeting innate immunity in solid cancer therapy

Immunotherapy roundtables
Nov 911:30
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Title TBA

Immunotherapy roundtables
Nov 911:30
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Title TBA

Immunotherapy roundtables
Nov 911:30
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Title TBA

Immunotherapy roundtables
Nov 911:30
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TNFRSF-Agonists: Is site-specific engagement by multiformats/bi-specific biologics the right strategy?

Immunotherapy roundtables
Which formats are promising? Whom to activate? CD40? 4-1BB? OX40? CD27? GITR? LIGHTHow to achieve TME based enrichment and activity of the agonist? Which target dependency to be implemented for local but effective signaling?
Nov 914:00
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Aggregates formation after mixing biopharmaceuticals with human plasma and blood: comparison of originator and biosimilar products

Biosimilars Manufacturing, Analysis, Research and Development
Tudor Arvinte, President And Chief Executive Officer, Therapeomic Inc
Nov 914:00
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Bispecific gamma-delta T cell engagers

Bispecifics & Multispecifics
  • Next generation T cell engager platform
  • Mechanism of action of LAVA’s CD1d gamma-delta bsTCE
  • Progress towards the clinic
Paul Parren, EVP, Lava Therapeutics
Nov 914:00
Conference pass

Cell line development for innovative antibody formats at Ichnos Sciences

Manufacturing & Bioprocessing
  • Description of CLD platform process currently established at Ichnos Sciences
  • Presentation of selected process improvements to current platform process
  • Evaluation of selected external technologies
Martin Bertschinger, Deputy Cell Sciences Director, Ichnos Sciences
Nov 914:00
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Clone and process optimization – Combining productivity with quality goals

Technology Showcase
  • Cell line selection to meet quality and quantity perspectives
  • Media and process optimization to tune quality and quantity
  • High end protein and glycan analytics for quality control
Lars Stockl, Division Manager, FyoniBio – Service Branch of Glycotope
Nov 914:00
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Co-stimulatory single-chain TNFSF ligands as building blocks for bispecific fusion proteins

Innate & Adaptive Checkpoint Inhibition
  • The engineering concept of scTNFSFligands in different bispecific formats will be presented
  • Immune-stimulatory scTNFSF-ligands can be combined with any antibody of interest in a bispecific drug compound
  • Examples demonstrating the biological activity of scCD40L or sc4-1BBL in combination with anti-PD-L1 will be shown
Nov 914:00
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Designing antibodies for treating infectious diseases

Infectious Disesaes
Andreas Hougaard Laustsen, Postdoctoral, Technical University of Denmark
Nov 914:00
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Novel 10 kDa scaffold libraries for selection of peptide inhibitors - case studies in GPCR and amyloid therapeutic development with phage display

Protein Engineering
  • Synthesis and selection of newly designed 10kDa scaffolds will be described
  • Case studies of novel bindersin two key therapeutic areas poorly served by mAbs
  • Disseminationplan of patented libraries for basic research and commercial projects introduced
David O'Connell, Associate Professor, School Of Biomolecular And Biomedical Science, University College Dublin
Nov 914:00
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Phase I/II clinical data using LOAd703 in pancreatic cancer

Oncolytic Viruses
  • LOAd703 is a virus expressing CD40L and 4-1BBL in the tumor microenvironment to stimulate anti-tumor immunity
  • Results demonstrating immune changes in the tumor microenvironment in different solid tumors post treatment will be presented
  • Results from a Phase I/II clinical trial in pancreatic cancer will be presented
Angelica Loskog, Chief Executive Officer, Lokon Pharma
Nov 914:00
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Strategies to improve manufacturing robustness & scale of TCR-T products

Manufacturing, Commercialisation & Market Access
  • Immatics is a clinical-stage company focused on the development of TCR-based immunotherapies
  • Novel tumor-specific TCRs are used to generate TCR-engineered T cells in various ongoing clinical Adoptive Cell Therapy programs
  • The talk will focus on innovations and improvements implemented in the manufacturing of these products
Ali Mohamed, Vice President, CMC, Immatics Inc
Nov 914:00
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The challenges of global commercialisation for a biosimilars player

Biosimilars Commercialisation and Market Access
Jenny Hao, Pharma Operating Partner, Convergence Partners AG
Nov 914:00
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T-SIGn tumor reengineering: reprogramming the tumor microenvironment to drive anti-tumor immunity

Cell & Gene Therapy
Nov 914:20
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Accelerating bioprocess workflows with microfluidic, immunoassay-based parallel impurity analysis

Manufacturing & Bioprocessing
  • Product titer and impuritieslevels are critical quality attributes (CQA) in biotherapeutic and viral vector manufacturing.
  • Gyrolab® systems perform automated immunoassays within nanoliter-scale microfluidic structures, increasing throughput and reducing sample volumes dramatically as compared to plate-based ELISA.
  • We will present data from different case studies in which biotherapeutic bioprocess samples and adeno-associated viral (AAV) samples were assessed for titer as well as impurities using Gyrolab and ready-to-use kits. Results demonstrate dynamic range, precision, dilutional linearity, and spike data that fulfills key regulatory bioanalytic method requirements.
Nov 914:20
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Biosimilars in Denmark. High Uptake and Low Prices. What’s the Story?

Biosimilars Commercialisation and Market Access
  • Belief in Science
  • Health Authorities
  • Procurements, tenders and pricing
  • Stakeholder participation
  • Information to patients
  • A miracle-or just common sense and cooperation?
Peter Jorgensen, Director of the Industrial Ass, Danish Generic and Biosimilar Medicines Industry Association (IGL)
Nov 914:20
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Development and novel administration approaches of SARS-CoV-2 neutralizing antibodies

Infectious Disesaes
  • Icosagen’s antibody development pipeline
  • Characterization of ultra-potent and cross-neutralizing SARS-CoV-2 antibodies
  • Inhalation based delivery of antibodies
Mart Ustav, CSO, Icosagen Cell Factory OU
Nov 914:20
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Expanding the therapeutic window of CD3-engaging DART® and TRIDENTTM molecules

Bispecifics & Multispecifics
CD3-engaging bispecifics mediate potent redirected T-cell killing in vitro and anti-tumor activity in vivo. However, their dosing is often limited by systemic cytokine release or off-tumor activity. Examples will be shown how modulating the affinity of CD3 engagement or bi-epitopic targeting of CD8 T cells might improve the activity and safety profile of next-generation CD3-engaging DART molecules.
Gundo Diedrich, Senior Director, MacroGenics
Nov 914:20
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Exploring new approaches to antibody engineering

Technology Showcase
Nov 914:20
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Identification of Novel pHLA Targets to Enable Targeting of Solid Tumors with High Potency Compounds

Cell & Gene Therapy
  • Advantages of intracellular targets (pHLAs) versus conventional cell surface antigens
  • Start with the end in mind: TCRs and targets from patients responding to CPI treatment
  • Strategies to find the most prevalent and immunogenic targets in CPI responders
  • Selection of pHLA targets with highest tumor vs normal tissue rations to avoid off-tumor target toxicities of ADCs, Bispecifics, TCR-T and CAR-T cell therapies
Hanspeter Gerber, CSO, 3T Biosciences
Nov 914:20
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State-of-the-art analytical methods for originator and biosimilar characterization

Biosimilars Manufacturing, Analysis, Research and Development
  • Critical Quality Attributes ranking
  • Multi-dimensional analytical workflows
  • Multi-levelmAbsand Fc-fusion proteins characterization
Alain Beck, Senior Director, Centre d'Immunologie Pierre Fabre
Nov 914:20
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Twist Biopharma: Writing the Future of Biologics to Discover and Optimize Single Domain Antibodies

Protein Engineering
Utilizing its proprietary DNA technology to write synthetic libraries, Twist Biopharma provides end-to-end antibody discovery and optimization solutions including a panel of highly diverse synthetic naïve single domain antibody phage display libraries. In this presentation, Aaron will give an overview of these libraries and present several case studies.
Nov 914:20
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Unique cancer and anti-infective immunotherapy platforms

Oncolytic Viruses
  • ValoTx has developed novel, uniquely flexible and broadly applicable immunotherapy platforms targeting multiple disease specific antigens
  • PeptiCRAdis an oncolytic adenovirus based cancer immunotherapy platform entering clinical testing in 2021
  • PeptiVAXis a vaccine platform for infectious disease - preclinical proof of principle data has been generated
Nov 914:40
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A Global Intercompany Precision and Robustness Validation of icIEF methodology for the Analysis of NIST-mAb and a Fusion Protein

Manufacturing & Bioprocessing
The presentation will cover a global study with 21 sites including pharmaceutical and IVD companies, along with a regulatory agency that compared the precision and robustness of an imaged cIEF method. The NIST mAb and a fusion protein were analyzed on the iCE3 and the Maurice instruments. Information on the comparability of the results obtained by these two instruments has been widely requested. It will help companies to better understand how to evaluate the instruments with these key parameters and in transition to the newer technology. Attendees will learn about:How the iCE3 and Maurice compare relative to precision and robustness for a mAb and a fusion protein.
Minna Mattila, Technology Manager, Medix Biochemica
Nov 914:40
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An Integrated Development Approach to Bispecifics: A Portfolio Review

Bispecifics & Multispecifics
Bispecific antibodies and Fc-fusions, molecules that are able to engage two distinct targets at the same time, have continued to grow in the market as next generation modalities. KBI has carried out over 40 development and cGMP manufacturing projects to date for bispecifics, leveraging our deep analytical expertise to inform process decisions. This seminar will review how KBI approaches CMC development bispecific antibodies, sharing details on production facility design, CMC strategy, and pitfalls of bispecific development in a CDMO environment.
Nov 914:40
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Development of glyco-humanized neutralizing polyclonal antibodies against SARS-CoV-2

Infectious Disesaes
  • Glyco-humanization of heterologous polyclonal antibodies allow safe administration in humans.
  • XAV-19 is a polyclonal antibody against SARS-CoV-2 showing potent neutralizing activity against Wuhan, UK and SA strains.
  • POLYCOR and EUROXAV clinical trials are ongoing to evaluate safety and efficacy of XAV-19 in moderate to severe hospitalized and outpatients presenting with COVID-19.
Bernard Vanhove, COO, Xenothera
Nov 914:40
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Fast Scale Up of Your Shake Flask Results

Biosimilars Commercialisation and Market Access
  • Supportanalyzingthe shake flask conditions
  • Presenting scale up examples
Nov 914:40
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Multidimensional personalized response assessment to microglia modulators in glioblastoma bioreactors

Innate & Adaptive Checkpoint Inhibition
  • Using CODEX technology, we provide an indepth characterization of the umor microenvironment in different regions of the same tumor
  • To evaluate the effect of TAM-modulating therapies in combination with T-cell checkpoint inhibitor approaches, we generated 3D GBMbioreactor cultures from patient-derived samples
  • We report patient-tailored, tumor region specific response assessment to microglia modulators and checkpoint inhibitors using multidimensional fluorescent microscopy techniques (CODEX), and multiplexed cytokine release
Gregor Hutter, Research Group Leader, University Hospital Basel
Nov 914:40
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New perspectives on antibody manufacturing

Manufacturing & Bioprocessing
Senior Representative, Bio-Techne: Digital Solutions
Nov 914:40
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One-Stop Customized Service for Recombinant Protein Expression and Antibody Development

Protein Engineering
  • Largest validated recombinant protein bank supporting comprehensive research fields
  • Customized service for recombinant protein and antibody production
  • Customized service for antibody development (monoclonal- and polyclonal antibody)
Nov 914:40
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Overcoming the most common challenges in cell & gene therapy development using Droplet Digital PCR

Cell & Gene Therapy
The number of cell and gene therapy trials has rapidly grown in recent years, promising to deliver solutions to diseases that were previously considered untreatable.There are however several challenges facing the developers of these therapies, including low vector concentration, empty capsids, contaminating host cell DNA and mycoplasmas and the common thread amongst these is the need for rigorous quality control.Here we will look in more detail at how ddPCR can be used to overcome some of these challenges and help guarantee safe and effective gene therapies.
Rosario Tizzone, Genomics Specialist, BIO-RAD
Nov 914:40
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Strategies to enhance systemic antitumor immunity elicited by oncolytic viruses

Oncolytic Viruses
Christophe Queva, Chief Scientific Officer, Oncorus
Nov 914:40
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The Puncher platform - Antibody discovery and Cell line generation

Technology Showcase
  • Efficient, flow-based sorting of thousands of single cells into microwell chips
  • Rapid single cell secretion detection, DNA analysis, RNA analysis, and selection of single cells for clonal expansion
  • Image-based assurance of monoclonality
Nov 914:40
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Title TBA

Protein Engineering
Senior Representative, Sino Biological
Nov 914:40
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Value Based Agreements and Biosimilars - innovative contracting and new payer perspectives with biosimilars

Biosimilars Commercialisation and Market Access
  • Payer trends and global drivers for innovative contracting
  • Uptake of biosimilars and payer strategies for successful implementation
  • New tactics and drivers from branded parent innovators and payer offerings on value trade offs
  • VBA & biosimilars - case examples
Nov 915:00
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Access & VBC strategy to enable Acceleration of Biosimilar Commercialization

Biosimilars Commercialisation and Market Access
Nov 915:00
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Addressing unmet patient needs in immune-inflammatory diseases through monoclonal / bispecific antibodies

Bispecifics & Multispecifics
Almirall is a mid-size pharm dedicated to medical dermatology. Primary focus is on providing treatment options to patients suffering from severe skin diseases and help them to get closer to a healthy life. This presentation analyses current therapeutic antibody concepts targeting potential immune-mediated inflammatory diseases drivers. Some of those concepts validated in the clinic others showed rather low efficacy or failed. Thus, high unmet medical needs remain, in particular for more heterogeneous diseases. We share how we think about understanding and tackle the remaining unmet medical needs with monoclonals and bispecific antibodies.
Thomas Huber, Research director, ALMIRALL
Nov 915:00
Conference pass

Antibodies with on/off switches: Engineering strategies for fine-tuning of antibody activity

Protein Engineering
  • Target binding and effector functions of antibodies can be conditionally blocked
  • Protein engineering enables installation of antibody blocking and activation modules
  • Examples for generation of conditionally active antibodies and application options are provided
Anti-tumor antibodies often suffer from a narrow therapeutic window due to expression of the antibody target on non-tumor tissue or insufficiently controlled effector functions. We developed several routes for modulating antibody activity in the tumor microenvironment that rely on pH and/or tumor protease-dependent antibody activation. This is achieved by implementing pH-dependent target binding, thereby generating high affinity binding in the acidic tumor microenvironment. Alternatively, efficient conditional paratope blockade can be installed by tailor-made anti-idiotype shark-derived vNAR modules. In addition, a novel antibody format is presented, where a Fc masking unit conditionally blocks effector function, which is regained in the TME. These generic strategies pave the way to fine-tune antibody activities aimed at widening the therapeutic window.
Harald Kolmar, Head of department applied biochemistry, TU Darmstadt Biochemie
Nov 915:00
Conference pass

Bioinformatics made simple!

Technology Showcase
  • Pipe | bio enables scientists to analyse antibody sequence data themselves, without the need for bioinformaticians or programmers.
  • We provide a single platform where scientists can perform their analyses and manage their data in one place.
  • We are the friendliest team in the world!
Jannick Bendtsen, CEO, PipeBio
Nov 915:00
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Converging synthetic biology and rational combinations for next generation T-cell therapies

Cell & Gene Therapy
Melita Irving, Group Leader T-Cell Engineering, University of Lausanne
Nov 915:00
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Human B cell responses to emerging infections

Infectious Disesaes
  • New single-cell technologies that enable rapid discovery
  • Rapid functional testing facilitates early antibody lead selection
  • New capabilities to discover broadly reactive antibodies
Nov 915:00
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Multi-quadrupole-ICP-MS Analysis of the Elemental Composition in Cell Culture Media

Manufacturing & Bioprocessing
Senior Representative, Perkin Elmer
Nov 915:00
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Multi-quadrupole-ICP-MS Analysis of the Elemental Composition in Cell Culture Media

Manufacturing & Bioprocessing
Controlling the composition and quality of raw materials and culture media as well as understanding their impact on the production yield is becoming important with an increase in the number of biologic modalities such as mAbs and vaccines as therapeutics in the pharmaceutical end market. Inductively coupled plasma–mass spectrometry (ICP-MS) for multi-element analysis is an excellent analytical tool for understanding of the impact of elements in the biologics yield, and has the potential to serve as a powerful technology in biopharmaceutical upstream process development and batch quality control in manufacturing. In this work we demonstrate a validated methodology that can tolerate high-matrix samples while simultaneously quantifying the high- and low-level elemental species using the NexION 5000 multi-quadrupole ICP-MS in raw materials and culture media used in vaccine production. We will discuss sample preparation, instrument optimization, and validation data in various culture media and ingredients. Particular focus is presented on difficult interferences where the resolving power of a multi-quadrupole, using two <0.7 amu resolving quadrupoles, and taking advantage of the Dynamic Reaction Cell to control ion-molecule reactions. These results show the capability of the NexION 5000 ICP-MS to monitor both trace and major elements with high sensitivity and specificity in various industrial culture media.
Nov 915:00
Conference pass

Panel discussion: Affordability of cell & gene therapies

Manufacturing, Commercialisation & Market Access
Ali Mohamed, Vice President, CMC, Immatics Inc
Lakshmikanth Gandikota, Vice President, Innovation Sciences, Intas Pharmaceuticals
Nov 915:00
Conference pass

Preclinical development of NI-1801, a CD47xMesothelin bispecific antibody to treat solid tumors

Innate & Adaptive Checkpoint Inhibition
  • Tumor specific CD47 targeting with a bispecific antibody strategy
  • Preclinical efficacy of the NI-1801 in comparison with an anti-mesothelin mAb
  • Preclinical safety of NI-1801
Nov 915:00
Conference pass

Process Control in Continuous Manufacturing

Biosimilars Manufacturing, Analysis, Research and Development
  • Novel strategies for effective control of continuous processes.
  • Statistical process control and monitoring of protein refolding, from buffer preparation to refold quenching.
  • Traditional offline HPLC for online analysis using a 2 way/6 port valve to facilitate simultaneous automate sampling of product stream eluting form a process column and fractionation.
  • A single NIR flow cell used before the inlet of the loading column to measure the concentration ofmAbin the harvested broth.
Nov 915:20
Conference pass

Accelerating Immunotherapy Drug Development Targeting Checkpoints with Robust MOA-Based Assays

Technology Showcase
  • Case studies on ready-to-use cell-based assays for therapeutics targeting checkpoint receptors
  • Development and qualification strategy to ensure assay is fit-for-purpose for characterization and lot release
Nov 915:20
Conference pass

Antibody engineering to fight infectious diseases and cancer

Protein Engineering
  • Human antibodies to infections diseases, e.g. neutralizing SARS-CoV-2
  • Ultra fast development of a therapeutic antibody from the scratch to clinic
  • Antibody engineering tricks to improve efficiency and safety
Nov 915:20
Conference pass

Cysteine in cell culture media induces acidic IgG1 species by disrupting the disulfide bond network

Manufacturing & Bioprocessing
  • In this study, the promoting effect of cysteine on monoclonal antibody (mAb) acidic charge variants is demonstrated in in vitro and in cell culture based experiments.
  • The presence of cysteine was linked to ruptured and modified disulfide bonds, leading to enhanced levels of acidic species.
  • The data highlights cysteine in cell culture media as key player for manipulating mAb charge during the fermentation process.
Nov 915:20
Conference pass

Enhancing Efficacy and Safety of 4-1BB Agonism with PRS-343, a Tumor-Targeted Bispecific

Innate & Adaptive Checkpoint Inhibition
  • PRS-343 is the first bispecific to enter the clinic which is engineered to specifically activate 4- 1BB in the tumor microenvironment
  • PRS-343 demonstrated durable anti-tumor activity in heavily pre-treated patient populationacross multiple tumor types, including those usually not responsive to immune therapy; novel and non-redundant MoA among HER2- targeting therapies and checkpoint inhibition
Shane Olwill, Vice President Of Development, Pieris Pharmaceuticals
Nov 915:20
Conference pass

Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability

Infectious Disesaes
Marit van Gils, Associate Professor, Amsterdam UMC
Nov 915:20
Conference pass

The Next Generation of Generics: Biosimilars & Enabling Market Access in the United States

Biosimilars Commercialisation and Market Access
  • Favorablepolicies to grow biosimilar market access in the United States, along with how the market has evolved so far since the passage of the Affordable Care Act.
  • How a growing U.S. biosimilars market will increase affordability for all biologic medicines through increased competition and access.
  • Predictions (or forward-looking thoughts) on this market moving forward for industry professionals in the audience, as several patents are scheduled to end in the coming years providing ample opportunity for market growth.
Meaghan Smith, Executive Director, The Biosimilars Forum
Nov 915:20
Conference pass

The Rise of the Next Generation of T-cell Engagers

Cell & Gene Therapy
  • The holistic approach to designing multispecifics
  • Designing T-cell engager platforms for better therapeutic windows
  • Targeting solid tumors with TCEs
Nov 915:20
Conference pass

Three arms are better than two: avidity driven selectivity for T-cell bispecifics

Bispecifics & Multispecifics
  • Identified a pair of antigens coexpressed on breast cancer cells but not on normal tissue
  • Demonstrated a high affinity T-cell bispecifics versus one of the antigens drives both tumor regression and on-target toxicity
  • Showed trispecific Abs with optimized affinities and other attributes are able to reduce on-target toxicity while maintaining efficacy
Nicholas Agard, Scientist, Genentech
Nov 915:20
Conference pass

Title TBA

Bispecifics & Multispecifics
Nov 915:20
Conference pass

US Pharmacopeia Biological Performance Standards

Biosimilars Manufacturing, Analysis, Research and Development
  • Brief history of USP
  • Biologics analytical testing
  • mAbPS
Alessandro Slama, General Manager and Senior Director EMEA at US Pharmacopeia, US Pharmacopoeia
Nov 916:30
Conference pass

A bispecific antibody agonist of the IL-2 heterodimeric receptor promotes in vivo expansion of CD8 and NK cells

Bispecifics & Multispecifics
  • Development and activity of bispecific antibodies that simultaneously bind and activate IL-2Rβγ
  • Bispecific anti-IL-2Rβγ antibodies avoid IL-2Rα and toxicities associated with the trimeric receptor
  • IL-2Rβγ agonist antibodies expand T and NK effector cells both in vitro and in vivo and avoid preferential expansion of Tregs
Nov 916:30
Conference pass

A Breakthrough Cell Count and Viability label-free method for High-Throughput Cell Culture Monitoring in bioreactors

Technology Showcase
  • From cell line to process development
  • Small volume of unprepared samples
  • Integrated to High-Throughput microbioreactors: a fully automated solution
Nov 916:30
Conference pass

Blood-Brain Barrier Delivery in Non-Human Primates by Single Domain VNAR Antibodies to TfR1

Protein Engineering
  • Development of BBB shuttles using single domain VNAR antibodies
  • Efficient delivery of biologic payloads to the brain – PoC studies in mice
  • Successful translation to non-human primates
Pawel Stocki, Reseach Director, Ossianix, Inc.
Nov 916:30
Conference pass

Enabling Biosimilars Market Access

Biosimilars Commercialisation and Market Access
Caroline Boulliat, Governor, Chelsea And Westminster Hospital Nhs Foundation Trust
Nov 916:30
Conference pass

Gene therapy of blood disorders

Cell & Gene Therapy
Lakshmikanth Gandikota, Vice President, Innovation Sciences, Intas Pharmaceuticals
Nov 916:30
Conference pass

Immunogenicity and Immunotoxicity of biologics

Immunogenicity
  • Adverse effects of biologics mediated by the immune system
  • How immunogenicity affects the outcome of the therapeutic response
  • Mechanisms of biologics immunogenicity
Marc Pallardy, Professor and head of the Department of Toxicology, Universite Paris Sud
Nov 916:30
Conference pass

Orphan drug biosimilars: when a copy could cost more than the innovator

Biosimilars Manufacturing, Analysis, Research and Development
Nov 916:30
Conference pass

Rapid discovery and development of antibodies for Covid-19

Infectious Disesaes
Blaine Stine, Director, Global Biologics Discovery, AbbVie
Nov 916:30
Conference pass

The CD47-SIRPα innate immune checkpoint in cancer

Innate & Adaptive Checkpoint Inhibition
  • Enhancing anti-cancer antibody efficacy by targeting CD47-SIRPα
  • Clinical progress
  • Development of BYON4228 anti-SIRPα
Timo van den Berg, Senior Director Immuno-Oncology, Byondis
Nov 916:30
Conference pass

Viral Backbone and the design of Oncolytic Viral therapies for intravenous delivery

Oncolytic Viruses
Nov 916:50
Conference pass

Biosimilars in Canada – Public and Private Drug Plan Developments

Biosimilars Commercialisation and Market Access
  • Biosimilars have been approved in Canada since 2015
  • Dozens of biosimilars have been approved, with market uptake varying significantly by molecule
  • This talk will explore recent trends in biosimilar uptake including efforts by provincial governments to mandate biosimilar transitioning
  • Recently approved Adalimumab biosimilar dynamics will be explored
Ned Pojskic, Leader, Pharmacy And Health Provider Relations, Greenshield Insurance Brokers LLC
Nov 916:50
Conference pass

Developing Immunotherapies with Axion BioSystems Maestro Z Platform for Impedance-Based Cellular Assays

Technology Showcase
Axion BioSystems is a world leader manufacturer and provider of electrode-based technologies for the life sciences. Our solutions for cell analysis allow label-free, non-invasive recordings for continuous long-term recording of cell behaviour in multi-well plate formats.Our Maestro Z cell analysis platform enables the measurement of cell impedance, a well-established technique for monitoring the presence, changes in morphology and behaviour of cells in culture proving to be a suitable assay to study cell proliferation, strength of cell-cell coupling, cell signalling, cytotoxicity of chemotherapy agents and efficacy of cell therapies.Here I will discuss how our next generation cell analysis platform, the Maestro Z and our latest product, the Maestro Z-HT have been designed to be versatile to the scientists needs in both research and manufacturing environments.We will discuss the advantages of Axion Maestro Z and Z-HT and show examples of selected applications including how the platform can be used for developing immunotherapies.
Nov 916:50
Conference pass

Discovery of a potent human antibody that neutralizes SARS-CoV-2 and its variants

Protein Engineering
As the pandemic continues, more transmissible SARS-CoV-2 variants that evade COVID-19 treatments have emerged. As part of its ongoing pandemic response, AbCellera discovered a highly potent monoclonal antibody, bebtelovimab (LY-CoV1404) from a convalescent COVID-19 patient sample that could present a long-term solution to the ongoing pandemic. Bebtelovimab targets a rarely-mutated epitope on the SARS-CoV-2 spike protein and potently neutralizes variants of concern, including the Delta variant.
Nov 916:50
Conference pass

IgG-like bispecific antibody design and discovery for multiple immuno-oncology target pairs

Bispecifics & Multispecifics
  • Design of a developable IgG-like bispecific antibody format
  • Simultaneous multiple target antibody discovery
  • mAb and bsAb characterisation and early development
Christopher Plummer, Antibody Selections Team Leader, GSK
Nov 916:50
Conference pass

Non-clinical immunogenicity assessment : an update of the T cell response specific for therapeutic antibodies

Immunogenicity
  • Methologies and their outcomes
  • Location and function of T cell epitopes
  • Improving affinity while reducing T cell epitope content
Bernard Malliere, Head of laboratory, CEA
Nov 916:50
Conference pass

Panel Discussion: The importance of clinical streamlining and how to achieve this.

Biosimilars Manufacturing, Analysis, Research and Development
Alain Beck, Senior Director, Centre d'Immunologie Pierre Fabre
Andreu Soldevila, Chief Executive Officer, Syna Therapeutics
Nov 916:50
Conference pass

Perspectives from Sino Biological on mAb design for treating infectious diseases

Infectious Disesaes
Reserved for Sino Biological
Nov 916:50
Conference pass

The impact of immune environment on checkpoint blockade

Innate & Adaptive Checkpoint Inhibition
  • Antibody drug classes have different Fc requirements for optimal activity
  • The local immune environment can impact immune checkpoint blocker efficacy
  • Can a suboptimal environment be overcome to enhance responses?
Nov 916:50
Conference pass

Unleashing the Titans: the GEN-011 Neoantigen-targeted Peripheral T cell Therapy for Solid Tumors

Cell & Gene Therapy
  • Adoptive T cell therapies have resulted in unprecedented efficacy against solid tumors
  • Prioritizing neoantigens with the ATLASTM bioassay identifies the right targets and avoids pro-tumor InhibigensTM
  • The GEN-011 neoantigentargeted peripheral T cells(NPTs) have broad specificity and are nonexhausted, polyfunctional, cytolytic cells
  • The TITAN-1 clinical trial is ongoing (NCT04596033)
Nov 917:10
Conference pass

Advances in bispecific engineering

Bispecifics & Multispecifics
Senior Representative, Biocytogen
Nov 917:10
Conference pass

Affibody molecules as aggregation inhibitors for neurodegenerative disorders

Protein Engineering
  • Affibody molecules are small alternative affinity proteins that are currently evaluated in clinical trials with encouraging results
  • Generating binders for the amyloid ß peptide yielded variants with 60-pM affinity and with unique mode of binding, sequestering the peptide in a tunnel-like cavity
  • Similar binders for other aggregation-prone peptides have been engineered, demonstrating structural rearrangements of both affibody and peptide upon binding and efficient inhibition of aggregation
John Lofblom, Professor in Combinatorial Protein Engineering, K.T.H. Royal Institute of Technology
Nov 917:10
Conference pass

At the interface with Contract Manufacturers: the key for effective relationship management

Manufacturing, Commercialisation & Market Access
  • Contract manufacturing of products at all stages and of all kinds is a trend across the pharmaceutical industry
  • While it offers clear advantages in terms of cost and resource allocation, at times maintaining a productive relationship with the CMO is challenging
  • This presentation will cover real life examples and learnings of years of interactions with CMOs, while transferring a process or overseeing regular commercial activities
Nov 917:10
Conference pass

Epitope profiling of coronavirus-binding antibodies using computational structural modelling

Infectious Disesaes
  • Here, we describe a novel computational method for epitope profiling based on structural modelling and clustering. We apply it to a large database of antibodies all shown experimentally to bind coronaviruses.
  • Our approach functionally links antibodies based on similar predicted structure, transcending genetic lineage, species origin and coronavirus specificity. The resulting structure-function relationships yield new opportunities to identify repertoire functional convergence hitherto missed by sequence-only analysis.
  • These results also demonstrate the value of large virus family-specific antibody databases both for pandemic preparedness and for understanding the full diversity of antibodies that can engage a given antigen binding site.
Matthew Raybould, Postdoctoral Researcher, University of Oxford
Nov 917:10
Conference pass

Evaluating the Stability of Bispecific Antibodies using High Throughput Platforms

Technology Showcase
As the complexity of engineered antibodies increases, flexible and innovative methods for functionally evaluating and characterizing the stability of bispecific antibodies (bsAb) are necessary during both discovery and development stages. Here, we describe the development of two different high throughput no wash homogenous immunoassays to evaluate the binding activity and to show if both sites on the bsAb bind the target proteins. We also developed a single homogeneous multiplex assay for simultaneous measurement of the two separate binding events. We utilized the no wash immunoassays to evaluate stability and degradation and confirmed our results using a high throughput SDS PAGE microfluidic capillary electrophoresis assay to look for fragmentation of the antibody. The combination of these robust high throughput techniques can give a more complete picture of the stability of a bispecific antibody.
Nov 917:10
Conference pass

Immunogenicity risk assessment

Immunogenicity
Vibha Jawa, Executive Director, BMS
Nov 917:10
Conference pass

Next-Generation In Vivo Models To Streamline Discovery of Antibody Therapeutics

Bispecifics & Multispecifics
  • We have generated fully human antibody transgenic mice, including a strain harboring a common light chain, for mono- or bispecific/multispecific antibody discovery applications, respectively.
  • Human antibodies generated from these transgenic mice have a higher chance of clinical success due to thein vivonatural selection and affinity maturation of antibody-secreting B cells.
  • Knockout of relevant target genes in fully human antibody transgenic mice elicits robust immune responses and is highly advantageous for antibody discovery campaigns against challenging or highly homologous targets.
  • Target KO/KI humanized mouse models will further accelerate antibody lead selection via in vivo efficacy studies
Nov 917:10
Conference pass

Notch-dependent Myeloid Cell Regulation

Innate & Adaptive Checkpoint Inhibition
  • Notch-signalling is a highly conserved pathway often involved in cell-fate decisions
  • Notch signalling plays a role in development and homeostasis of immune cells
  • Targeting the Notch pathway could be employed to affect myeloid cell composition
Nov 917:10
Conference pass

Opportunities and Challenges for Biosimilar Uptake Across Europe

Biosimilars Commercialisation and Market Access
Moderator: Peter Jorgensen, Director of the Industrial Ass, Danish Generic and Biosimilar Medicines Industry Association (IGL)
Marcin Czech, Professor, Institute Of Mother And Child
Nov 917:10
Conference pass

Title TBA

Oncolytic Viruses
David Pyrce, Senior Vice President of Strategy and Innovation and Chief Commercial Officer, DevaCell, Inc.
Nov 917:30
Conference pass

A Practical Approach to Mitigating Immunogenicity Concerns in Novel Biotherapeutics

Immunogenicity
  • Overview of current methodologies
  • Use cases for in silico or in vitro methods
  • Effectively implementing a mitigation strategy
Samuel Pine, Head of Bioanalysis and Immunogenicity, Ablynx, a Sanofi company
Nov 917:30
Conference pass

Bispecific CARs using Crescendo VH

Protein Engineering
  • Crescendo’s proprietary transgenic mouse generates highly diverse fully human VH domain (‘Humabody’) building blocks
  • Humabody VH can be combined in various formats which lack the constraints of traditional mAbs, enabling multifunctional molecules to be constructed which deliver enhanced therapeutic benefit
  • VH are ideally suited to being the antigen binding moiety of a CAR-T due to their small size and lack of a light chain. Data presented will illustrate the superior antitumour effect of Crescendo VH CAR-Ts in mono- and bispecific formats
Colette Johnston, Senior Director, Early Discovery, Crescendo Biologics Ltd
Nov 917:30
Conference pass

COR-101 – fast track development of a SARS-CoV-2 neutralizing antibody

Infectious Disesaes
  • COR-101 is a potent SARS-CoV-2 neutralizing antibody endowed with a novel safety design
  • COR-101 was developed in less than 11 months from target to first patient
  • COR-101 is currently investigated in a phase 1b/2 trial of patients with moderate to severe COVID-19.
Nov 917:30
Conference pass

Developing Next Generation Programmed T Cell Therapies

Manufacturing, Commercialisation & Market Access
Nov 917:30
Conference pass

Development of a T-cell centred oncolytic virus against solid tumors

Oncolytic Viruses
  • TILT-123 is an oncolytic adenovirus developed after a number or optimization rounds to achieve best inclass Pharmacokinetic and Pharmacodynamic properties.
  • Conclusions from human data were taken back to the lab for validation and showed the promise of use of TILT-123 to enable immune checkpoint inhibitors, CAR T-cell therapy and ACT-TIL therapy.
  • Clinical development is ongoing where the use of TILT-123 with different T-cell therapies is being studied for different solidtumorindications.
Nov 917:30
Conference pass

FAP-Activated Prodrugs and Antibody-Drug Conjugates: TME Targeting of Innate Immune Activators

Innate & Adaptive Checkpoint Inhibition
Matthew Vincent, VP of Business development & Therapeutic strategy, Avacta
Nov 917:30
Conference pass

iNKT-based cell therapy for treatment of tumors

Cell & Gene Therapy
  • iNKT cells, a powerful vehicle for cell therapy
  • Enhancement of iNKT killing using CARs
  • CARDIS: a novel platform for discovery of specific, highly functional CARs
Nov 917:30
Conference pass

Multispecific MATCH antibodies – novel therapeutics with tumor targeted immunomodulatory functions and beneficial safety profile

Bispecifics & Multispecifics
  • Therapeutic approaches based on Numab’s MATCHTM platform aim at multispecific designs with superior efficacy and favorable safety.
  • NM21-1480 is a trispecific scMATCH-3 currently in phase 1 clinical testing that potently stimulates anti-cancer immune responses by tumor-localized activation of the immune stimulatory receptor 4-1BB and concomitant blockade of the immune suppressive PD-L1 pathway.
  • Relevance of molecular formats, 4-1BB epitopes and relative affinities to each target protein to exploit the full synergistic potential of dual pathway modulation and at the same time to avoid systemic activity/toxicity.
Tea Gunde, Chief Research Officer, Numab Therapeutics AG
Nov 917:50
Conference pass

A Proprietary Tumor Filtrating Lymphocytes (TIL) Platform for Treatment of Solid Tumors

Cell & Gene Therapy
Nov 917:50
Conference pass

A role of biosimilars in the Polish reimbursement system

Biosimilars Commercialisation and Market Access
  • P&R decision making in Poland
  • Biosimilar status and importance
  • Examples, benefits and challenges
Marcin Czech, Professor, Institute Of Mother And Child
Nov 917:50
Conference pass

Cost effective development of biosimilars, what is enough?

Biosimilars Manufacturing, Analysis, Research and Development
  • Cost effective development of Biosimilars
  • Orthogonal characterisation of biologics
  • Biosimilarityassessment
Andreu Soldevila, Chief Executive Officer, Syna Therapeutics
Nov 917:50
Conference pass

Designing Tech Transfers for Success

Manufacturing, Commercialisation & Market Access
Dan Bright, Senior Global Project Manager, Ferring Pharmaceuticals
Nov 917:50
Conference pass

Enabling discovery of broadly-neutralising antibodies: Venom toxin clustering and unravelling snake venom complexity

Immunogenicity
Next-generation antivenoms comprised of recombinant monoclonal antitoxins are on the horizon. They carry substantial therapeutic potential for the development of safer and more effective treatment of the 2 million annual envenomations. However, such antivenoms are challenging to develop due to the high diversity and number of toxins that require neutralisation. To enable feasible biomanufacture, it is critical to keep the number of monoclonal antibodies in a therapeutic product low. This feat is only possible if one deconvolutes venom complexity and identifies groups of similar toxins that can potentially be neutralised by the same broadly-neutralising antibody. Therefore, in this project we clustered all currently published snake venom toxins from medically relevant toxin families using sequence-based clustering approaches. However, sequences might be insufficient predictors of cross-neutralisation potential as antibodies recognise structural, not sequence, features. As such we also investigated structural similarity by retrieving all available toxin 3D structures, as well as computationally predicting the over 1600 structures for all remaining toxins via a bioinformatic tool developed in house. This allowed us to identify clusters of toxins that share substantial sequence and/or structural similarity, possibly allowing for the prediction of which clusters can be neutralised by a single broadly-neutralising monoclonal antibody. In turn, such a prediction may enable a more targeted discovery strategy that can be employed to identify a minimum set of broadly-neutralising monoclonal antibodies that can cross-neutralise one or more whole venoms. We hope that this approach will act as a roadmap and subsequently lead to a significant acceleration of the discovery of broadly-neutralising antibodies against snake venom toxins.
Timothy Jenkins, H.C. Orsted Postdoctoral Fellow, Technical University of Denmark
Nov 917:50
Conference pass

Human monoclonal antibodies as therapeutics against SARS-COV-2 and related viruses

Infectious Disesaes
  • Rapid identification of human antibodies by phage display
  • High affinity/avidity to SARS-CoV-2 S glycoprotein and mutants found in patients (Li W et al PNAS, Cell; Sun Z et al mAbs, 2020; Zhu X et al PLOS Biology, Sun Z et al bioRxiv, 2021) as well as to bat coronavirus S receptor binding domains.
  • Potent and specific neutralization of SARS-CoV-2 in hACE2 expressing transgenic mice and hamsters as well as mouse ACE2 adapted SARS-CoV-2 in wild type BALB/c mice at doses as low as 2 mg/kg.
Nov 917:50
Conference pass

Robust, modular approaches to binder valency engineering and receptor agonism

Protein Engineering
  • Robust, site-specific covalent capture of proteins on biocompatible hydrogels
  • Modular post-translational covalent assembly of binder constructs of defined valencies
  • Spatiotemporal control of capture and release through in-built photocleavable linker proteins
  • Significantly improved agonism of TRAIL-R1 and TRAIL-R2 pro-apoptotic receptors through valency engineering of monomeric scFv and nanobody building blocks.
Thomas Fryer, Industrial Postdoc, Technical University of Denmark
Nov 917:50
Conference pass

Targeting of tumor-specific peptide antigens with bispecific T Cell-Engaging Receptor (TCER®) molecules

Bispecifics & Multispecifics
  • Update on Immatics’ T cell-engaging receptors (TCER®) pipeline
  • Development and preclinical validation of bispecific molecules equipped with soluble, high-affinity T cell receptors

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Nov 1009:00
Conference pass

Chair's Opening Remarks

Biosimilars Day 2 Opening Keynotes
Antonella Cardone, Director, European Cancer Patient Coalition
Nov 1009:00
Conference pass

Opening Remarks

Antibodies & Immunotherapy Keynotes
Lamine Mbow, CSO, Arena Pharmaceuticals
Nov 1009:05
Conference pass

Novel approaches for antibody cancer immunotherapy

Antibodies & Immunotherapy Keynotes
Dr Christian Klein, Dept Head, Roche Pharmaceutical Research and Early Development
Nov 1009:05
Conference pass

Regulatory Considerations for Biosimilars

Biosimilars Day 2 Opening Keynotes
Nov 1009:30
Conference pass

Accelerating Novel Immunotherapeutic Modality Discovery through Digitalization

Antibodies & Immunotherapy Keynotes
The advent of novel immunotherapeutic modalities, including next-generation antibodies, cell & gene therapies and RNAs, has resulted in massive amounts of complex R&D data needing to be systematically structured and interpreted. We present case studies showing how biopharma and biotech organizations digitalize and automate their bi- and multi-specific antibodies, AAV, CAR-T, and TCR-T workflows and how they leverage having full traceability and data integrity for data sciences and ML approaches.
Nov 1009:30
Conference pass

The Evolution of the Regulatory Biosimilar Pathway

Biosimilars Day 2 Opening Keynotes
  • Development of regulatory requirements for biosimilar approval in Europe and the US
  • Current hot topics in enabling further streamlining biosimilar development
  • Outlook to the future
Martin Schiestl, Head of Regulatory Affairs, Sandoz (Novartis)
Nov 1009:55
Conference pass

PD-1 antibodies either as precision medicine informed monotherapy or combinations are transforming cancer care

Antibodies & Immunotherapy Keynotes
Roy Baynes, Senior Vice President And Head Global Clinical Development, Chief Medical Officer, Merck Research Laboratories
Nov 1009:55
Conference pass

Promoting Equitable Access of Biosimilars Across Therapeutic Areas

Biosimilars Day 2 Opening Keynotes
Nov 1010:20
Conference pass

Accelerating Biopharma R&D: Merging Automation & Data Management to Enable Collaboration and Innovation

Antibodies & Immunotherapy Keynotes
  • Digitalization strategies – challenges & successes
  • Automation - instrument integration, workflow and process automation
  • Enabling collaboration & innovation through digitalization
  • Future trends and AI approaches
Moderator: Jana Hersch, Scientific Consultant, Biologics, Genedata AG
Soraya Hölper, Project Lead for Portfolio and Strategy, Sanofi - Biologics Research
Björn Hüber, Team Leader Data Management NIBR Biologics Center, Novartis
Uwe Wittenberg, Merck KGaA
Markus Enzelberger, Partner, Versant Ventures
Alexander Jung, Head of Digitalization Biologicals Development CMC, Boeringer Ingelheim Pharma
Ezio Bonvini, Chief Scientific Officer, MacroGenics
Nov 1010:35
Conference pass

The sustainable future of biosimilars

Biosimilars Day 2 Opening Keynotes
Mark Levick, Chief Executive Officer, Alvotech
Nov 1011:30
Conference pass

Clinical Efficacy Testing of Biosimilars is not Necessary--an FDA perspective?

Biosimilars Sustainability
  • Is it possible to design a meaningful clinical efficacy testing for biosimilars?
  • Does the history of clinical efficacy testing supportbiosimilarityclaims beyond what is already established?
  • Is indication extrapolation possible if clinical efficacy is required for approval of biosimilars?
Sarfaraz Niazi, Professor, University of Illinois
Nov 1011:30
Conference pass

Oxidative post translational modification (oxPTM) and autoimmune diseases

Non-Oncology Immunotherapy
  • Humoral response tooxPTMin rheumatic disease
  • Humoral response tooxPTMin autoimmune diabetes
  • T cell response tooxPTMneoepitopes
Ahuva Nissim, Professor, William Harvey Research Institute
Nov 1011:30
Conference pass

The WHO SBP guideline revision: a chance to build on experience to achieve a more efficient regulatory landscape

Biosimilars Regulation and Policy
  • The WHO is currently revising its Similar Biotherapeutics Products (i.e.biosimilar medicines) guidelines, which were first published in 2009. The input of biosimilar medicines manufacturers will be essential in ensuring fit-for-purpose guidance.
  • This important revision happens as discussions are intensifying worldwide on how to achieve regulatory streamlining. Among the necessary steps to reach this goal, embracing regulatory science advances, increased international convergence among regulators, and a concerted global roadmap for implementation of clinical trial tailoring will be key.
  • The role of the WHO in achieving a more efficient regulatory landscape for biosimilar medicines spans beyond standard setting and guidance issuance.
Nov 1011:30
Conference pass

Using allogeneic dendritic cell biology to develop novel cancer immunotherapies

Cell & Gene Therapy
Nov 1011:40
Conference pass

An update on protein engineering from the University of Zurich

Protein Engineering
Pascal Egloff, Platform Leader, University of Zurich
Nov 1011:40
Conference pass

Efficient NK cell redirection by targeting natural cytotoxicity receptor NKp30

Bispecifics & Multispecifics
  • Activating NK cell receptors represent promising targeting structures to elicit potent anti-tumor immune responses
  • Novel NK cell engagers were constructed by bridging EGFR on tumor cells with NKp30 on NK cells
  • Different formats for NK cell redirection will be discussed
Stefan Zielonka, Associate Director, Protein Engineering And Antibody Technologies, Merck KGaA
Nov 1011:40
Conference pass

Homocitrullination of lysine residues mediated by MDSCs in the tumour environment makes an excellent target for cancer Immunotherapy

Neoantigens & Therapeutic Vaccines
  • Homocitrullinationis the post-translational modification (PTM) of lysine by cyanate derived from MPO expressed by MDSC
  • We have shownhomocitrullinationcreates neo-epitopes that are excellent targets for T cell mediated anti-tumour immunity
  • In addition we show that a repertoire of T cells exists in humans capable of responding tohomocitrullinatedvimentin and aldolase peptides that would support the targeting ofhomocitrullinatedproteins for cancer therapy
Nov 1011:40
Conference pass

Optimizing DNA Damaging Payload ADCs

Armed Antibodies
  • Improving calicheamicin ADCs through linker innovations
  • Modulating PBD potency depending on the target
  • Efficacy and safety data supporting candidate progression
Thomas Pillow, Senior Scientist, Genentech
Nov 1011:40
Conference pass

Preclinical models to evaluate potent off-the-shelf combination treatment for T cell redirection against tumors

Combination Therapies
  • Introduction into the preclinical model platform for CIT evaluation developed at the Roche Innovation Center Zurich (part of Roche pharma Research and Early Development, pRED)
  • Key features of the T cells engagers and targeted immunocostimulators platforms developed in Roche pRED Oncology Discovery
  • Preclinical in vivo profiling of immunotherapy combination to optimally stimulate anti-tumor T cell responses
Nov 1011:40
Conference pass

State of the art characterization of antibody based products

CMC & Developability
  • LC and LC-MS improvements (ultra-short columns, additives) and CE-MS
  • Native MS, Ion Mobility, Collision-Induced Unfolding, PASEF
  • mAbs, biosimilars, Fc-fusion proteins and peptides, BsAbs and ADCs
Alain Beck, Senior Director, Centre d'Immunologie Pierre Fabre
Nov 1011:50
Conference pass

Active immunization against a-synuclein for the prevention and treatment of Parkinson’s disease and other synucleopathies

Non-Oncology Immunotherapy
  • Vaxxinity’smodular vaccine platform
  • Preclinical evidence supporting UB-312 as a candidate vaccine
  • Safety and immunogenicity of UB-312 in healthy individuals
Nov 1011:50
Conference pass

Fostering Sustainable Access to Biosimilars

Biosimilars Sustainability
  • How to support biologic competition and reinvestment in healthcare?
  • What can we learn from front runners: Key differentiation & success factors in biosimilar policy?
  • Emerging challenges: Healthcare system makeover and better patient care
Julie Marechal-Jamil, Biosimilars Policy & Science, Medicines for Europe
Nov 1011:50
Conference pass

Global policies enabling access through substitution

Biosimilars Regulation and Policy
Joseph McClellan, Chief Scientific Officer, Alvotech
Nov 1011:50
Conference pass

The development of Vdelta1 Gamma Delta T cell platforms for use in next generation allogeneic CAR therapies

Cell & Gene Therapy
  • Characterization of gamma delta T cells as allogeneic pipeline products
  • Novel methods to enable manufacturing of blood and tissue resident gamma delta T cell products
  • Unique gene engineering tailored to gamma delta T cells to enable next generation CAR technologies
Oliver Nussbaumer, VP, Immunology, GammaDelta Therapeutics
Nov 1012:00
Conference pass

Beyond Antibodies – Developing Robust CMC Approaches for Next Generation Modalities

CMC & Developability
  • Emerging drug candidates/platforms
  • Analytical considerations and challenges
  • Standard vs. orthogonal methods
Nov 1012:00
Conference pass

Cell-antibody binding kinetics analyzed with an automated biosensor

Bispecifics & Multispecifics
  • A novel method to analyze the association and dissociation of molecules binding to targets on (cancer) cell surfaces
  • On- and off-rate measurements and discrimination of affinity vs. avidity binding modes of multi-valent and multi-specific antibodies
  • Single-cell analyses with automated workflows
Nov 1012:00
Conference pass

Development of new protease-sensitive masked antibodies

Protein Engineering
  • Masked antibodies are only activated in the tumor by specific proteases
  • Such antibodies have decreased off-site effects
  • An efficient way to generate masked antibodies is here reported
Benjamí Oller-Salvia, Assistant Professor, Ramon Llull University (URL)
Nov 1012:00
Conference pass

Innovative lab-on-a-chip platform facilitates CAR-T efficacy and off-target assessment in 3D with combination therapy

Combination Therapies
  • Microfluidic CAR-T assays
  • Miniaturised combination therapy screening
  • 3D tumour co-culture models
Nov 1012:00
Conference pass

Late-stage clinical development of a personalized vaccine platform technology for cancer and COVID-19

Neoantigens & Therapeutic Vaccines
  • A pan antigenic approach, protecting against mutation-associated loss of function
  • A personalized medicine, which minimizes adverse events and maximizes efficacy
  • A scalable and readily available platform
Nov 1012:00
Conference pass

Novel approaches to native antibody modification by exploiting native disulfides

Armed Antibodies
  • Functional disulfide re-bridging
  • Cysteine-to-lysine transfer reagents
  • Reversible covalent conjugation
  • Use of chemical linkers to form bi- and tri-specifics.
Vijay Chudasama, Reader, UCL
Nov 1012:00
Conference pass

TubTecans: P5-labelling for technology-enabled payload solutions targeting topoisomerase-I

Armed Antibodies
  • P5-labeling enables a rapid generation of stably linked, hydrophilic ADCs from native antibodies
  • Topoisomerase-I-inhibitors have become the prime payload class for ADCs in solid tumor indications
  • With the combination of P5 and Topo-I, we were able to develop a superior linker-payload platform for the efficient and steady delivery of the API to malignant cell
Marc-André Kasper, Tubulis GmbH
Nov 1012:10
Conference pass

Analytical Tools to help the production of your Gene Therapy products

Cell & Gene Therapy
  • Understand how new analytical tools are helping to optimize your cell culture media
  • Learn how to characterize viral proteins in your gene therapy products to get a better understanding of their potency
  • Discover how to profile empty vs full viral particles using less than 5 μL of sample in under an hour
Nov 1012:10
Conference pass

Implementing Biosimilars and the Role of Specialist Pharmacists

Biosimilars Sustainability
Kalveer Flora, Lead Rheumatology And Biosimilars Specialist Pharmacist, London North West University Healthcare NHS Trust
Nov 1012:10
Conference pass

INO-4800 – A DNA based vaccine against COVID-19 Efficacy in an

Non-Oncology Immunotherapy
  • Efficacy in animal challenge models
  • Phase 1 immunogenicity and safety profile
  • Thermo stability of DNA vaccines
  • Enhanced delivery through electroporation
Nov 1012:10
Conference pass

Novel Regulatory Strategies for Biosimilars and Validation Guideline Review

Biosimilars Regulation and Policy
  • Points-to-consider for compliance when validating advanced analytics.
  • Review of the world’s first SPR Assay Validation Guideline for potency assays.
  • Industry case-study: Novel validation approach for comparability assessment and QC.
Nov 1012:20
Conference pass

A novel IL12-based immunocytokine targeting Fibroblast Activation Protein (FAP) for the treatment of cancer

Armed Antibodies
  • A novel FAP-specific pan-tumoral monoclonal antibody has been generated
  • The antibody selectively localizes to FAP-positive, but not to FAP-negative tumors in pre-clinical models
  • The antibody-IL12 fusion protein cures tumor-bearing mice as single-agent
Nov 1012:20
Conference pass

Accelerating Antibody Engineering with Modern Informatics

Protein Engineering
  • Antibody engineering is now more streamlined than ever, but several factors contribute to its complexity such as persistent concerns around immunogenicity, increasing diversity of antibody formats, and the need for comprehensive characterization.
  • There is a need for a modern informatics solution that can adapt to the complex science and provide meaningful insights to make critical program-level decisions.
  • This presentation will highlight some of the critical considerations in evaluating an informatics solution to accelerate antibody engineering.
Nov 1012:20
Conference pass

CMC & developability at Merck

CMC & Developability
Horst Bierau, Senior Scientific Advisor - Head CMC Science & Intelligence, Merck Serono
Nov 1012:20
Conference pass

intein-mediated high throughput screening of bispecific antibodies

Bispecifics & Multispecifics
  • Split inteins enable reconstitution of bispecific antibodies on the protein level
  • Comparability to genetically fused bispecifics and automation are discussed
  • Broad combinatorial screening for identification of optimal bispecific antibodies
Nov 1012:20
Conference pass

Novel approaches to TNF superfamily antagonism

Combination Therapies
  • New antibody designs for TNF Superfamilies
  • TNFR2 for cancer
  • CD40 for autoimmunity
Nov 1012:30
Conference pass

Evidentiary Consistency and Regulatory Efficiency in Development of Biosimilars

Biosimilars Regulation and Policy
  • The endpoint of comparability is the critical indistinguishability of the clinical properties of the compared products.
  • To be efficient, regulators should apply consistent evidentiary requirements and logic to both biosimilars and manufacturing changes of all biologics.
  • Approval of biosimilars through regulatory reliance is a logical outcome that would enhance regulatory efficiency and access for patients.
Nov 1012:30
Conference pass

Sustaining Uptake in Rheumatology Biosimilars

Biosimilars Sustainability
Nov 1012:40
Conference pass

ADCITMER®, an ADC for neuroendocrine carcinoma

Armed Antibodies
  • McSAF Inside®, disulfide rebridging technology for ADCs
  • ADCITMER® product targeting CD56 (NCAM)
  • Proof of concept in a Merkel Cell Carcinoma model
Nov 1012:40
Conference pass

Boosting immuntherapy efficacy with epidrugs in oncology

Combination Therapies
  • Immunotherapy has been a breakthrough in oncology buthas efficacy in small proportion of patients
  • Epigenomic modulation has been shown to impact immunotherapy efficacy
  • Ongoing clinical trials evaluate the combination of epidrugs with immunotherapy
Nov 1012:40
Conference pass

Development of UB-612; The First Multitope Protein/Peptide Vaccine Against COVID-19

Neoantigens & Therapeutic Vaccines
Farshad Guirakhoo, CSO, Vaxxinity
Nov 1012:40
Conference pass

New Opportunities in AI and Protein Design

Protein Engineering
Nicolás Lopez Carranza, Deepchain Product Lead, InstaDeep
Nov 1012:40
Conference pass

Using mass spectrometry for release testing in a quality control laboratory: points to consider for user-friendly data evaluation

CMC & Developability
  • Quality control identity testing using mass spectrometry
  • Automated and user-friendly data evaluation
  • Multi-attribute monitoring with low-resolution mass spectrometry
Patrick Bulau, Senior Principal Scientist, Roche Pharma
Nov 1014:20
Conference pass

Biosimilar breakthrough: China to Global

Biosimilars Emerging Regions
  • Quality by design
  • Globalization strategy
  • China's journey of globalization
Nov 1014:20
Conference pass

Biosimilars: Improving patient access and the sustainability of healthcare systems

Biosimilars in Oncology
  • Biosimilar cancer medicines present a necessary and timely opportunity for patients in Europe. They may increase access to medicines by improving the financial sustainability of our healthcare systems.
  • Increased availability of effective biosimilars translates directly into driving down the costs of biological medicines as the market becomes more competitive and potentially allowing more cancer patients to access the medicines they need
  • The switching and substitution still present a challenge, and we strongly believe that patients must have an active role in the decision-making concerning their treatment. It is important to highlightthat patientsmust be prescribed the safest and most efficacious treatment possible and be closelymonitored at all times.
Antonella Cardone, Director, European Cancer Patient Coalition
Nov 1014:20
Conference pass

Bispecific anti-PD1/IL7 preclinical evaluation

Antibodies for Immunotherapy
  • Optimized format for improve PK/PD profile
  • Preclinical efficacy in syngeneic orthotopic tumor models and humanized mice
  • Selective activation of PD1+ CD127+ progenitor T cells
Nicolas Poirier, CSO, O.S.E. Immunotherapeutics
Nov 1014:20
Conference pass

Combination Therapy to Fight Cancer

Combination Therapies
  • Combining different modalities of epigenetic therapy
  • Combining epigenetic therapy with chemotherapy to reverse chemo resistance
  • Combining epigenetic therapy with immunotherapy
Nov 1014:20
Conference pass

Creating a sustainable future for Biosimilars

Biosimilars Sustainability
Philip Schneider, Advisory Board Chair, Alliance for Safe Biologic Medicines
Isabell Remus, Head Biosimilars & Specialty Business, Europe, Sandoz
matthew turner, Head government affairs Europe, ROW, Fresenius Kabi
Nov 1014:20
Conference pass

Empowering LC-MS characterization of therapeutic proteins in early phase development

CMC & Developability
  • In-depth characterization of therapeutic proteins in forced degradation and stability studies
  • Monitoring multi-quality attributes on peptide level of drug products
  • Building knowledge of liabilities and potential CQAs in an early development stage
Nov 1014:20
Conference pass

Enhancing Therapeutic Efficacy of Cell Therapy in Solid Tumors

Cell & Gene Therapy
Nov 1014:20
Conference pass

Leveraging antibody & T cell immunity with IV administrable glycopeptide cancer vaccines

Neoantigens & Therapeutic Vaccines
Nov 1014:20
Conference pass

Linker matters: highly stable and efficient ADCs made with native antibodies and peptide linkers

Armed Antibodies
  • ADCs are generated from native antibodies ‘off-the-shelf’ in one step using various payloads
  • Resulting ADCs are very well defined and show favorable biophysical properties
  • Araris ADC shows improved efficacy vs. FDA-approved ADC in head-to-head studyin mice
Philipp Spycher, Psi Founder Fellow, Paul Scherrer Institut
Nov 1014:20
Conference pass

Structural lessons from antibodies developed against disordered peptide antigens as tools for the clinical application of PASylation technology

mAbs
  • PASylation is a biological alternative to PEGylation to generate biopharmaceuticals with extended plasma half-life
  • Structurally disordered (poly)peptides such as PAS sequences composed of Pro, Ala and/or Ser represent "difficult antigens"
  • High affinity anti-PA(S) MAbs reveal peculiar ways to achieve molecular recognition of such feature-less PAS sequences
Arne Skerra, Professor - Biological Chemistry, TU Munich
Nov 1014:40
Conference pass

B cells and antibodies in patients with solid tumours

Antibodies for Immunotherapy
Cell-based and genomic evaluations reveal an active B cell immune surveillance and a B cell compartment with distinct immunoglobulin isotype profiles in cutaneous melanoma and breast cancer. Inflammatory Th2-biased conditions promote B cell class switching as a mechanism to divert the humoral response. Dissecting the humoral response and immunoglobulin profiles may uncover new insights into immunosuppressive forces in the tumour microenvironment.
Nov 1014:40
Conference pass

From Unknown Biosimilar Developer to Biosimilar Partner of Choice

Biosimilars Emerging Regions
Bert Thomas, Senior Vice President Of Business Development, Bio-Thera Solutions
Nov 1014:40
Conference pass

Innovative Biosimilars Adoption Strategies and post COVID-19 Healthcare Recovery

Biosimilars in Oncology
  • COVID-19 has caused a serious global public health and economic crisis.
  • Large molecule biologic medications are the driving force behind high drug costs.  Innovative formulary management can help reduce drug costs without compromising patient care.
  • Biosimilar products are highlysimilar tobrand name biologics and are a fraction of the cost.  100 billion dollars can potentially be saved via the utilization of biosimilars.  Thus, biosimilars can help alleviate financial burdens during this challenging time.
Sophia Humphreys, Director of System Pharmacy, Providence Health System
Nov 1014:40
Conference pass

Leading Strategies for Antibody Discovery Against GPCRs – Genetic Immunization and Berkeley Lights Beacon®

mAbs
Traditional hybridoma and phage display methods have shown limited success in delivering therapeutic antibodies against difficult targets like most GPCRs and ion channels. Amelie Kutschera will present case studies of how Genovac has overcome this challenge by leveraging their core genetic immunization technology and Berkeley Lights’ Beacon OptoFluidic system to rapidly discover antibodies against challenging targets, focusing on GPCRs, from a variety of different animal species.
Nov 1014:40
Conference pass

Multi-Attribute Monitoring (MAM)” for process development of Nanobody and Synthorin drug candidates

CMC & Developability
  • An end-to-end automated LC-MS methodology to assess CQAs in Nanobodies and Synthorins is presented
  • Different examples for the analyses of multiple CQAs of both new Biologic modalities during process development are demonstrated
  • The presentation will provide insights into MAM method development from identification of pCQAs to the fully established automated LC-MS approach including software driven data analysis
Udo Roth, Laboratory Head MS, Sanofi Pasteur
Nov 1014:40
Conference pass

New class of cancer vaccine based on an off-the-shelf Antigen Presenting Cell line (PDC*line)

Neoantigens & Therapeutic Vaccines
  • PDC*line is a new potent and scalable therapeutic cancer vaccines based on a proprietary allogeneiccell line of Plasmacytoid Dendritic Cells
  • PDC*line is much more potent to prime and boost antitumor antigen, including neoantigens, specific cytotoxic T-cells than conventional vaccines and improves the response to checkpoint inhibitors
  • The technology can be applied for any cancer
Nov 1014:40
Conference pass

Novel monoclonal antibody design

mAbs
Senior Representative, Genovac
Nov 1014:40
Conference pass

Pan-tumoral Small Molecule-Drug Conjugates targeting Fibroblast Activation Protein in solid lesions

Armed Antibodies
  • OncoFAP is a clinically validated small organic ligand targeting FAP in solid tumors
  • OncoFAP-drug conjugates selectively target tumors in vivo and release high amount of MMAE at the site of disease
  • OncoFAP-drug conjugates potently induce anti-tumor response at doses below tumor saturation both in monotherapy and in combination with immunotherapy
Nov 1015:00
Conference pass

A Platform Approach for Generation of BiSpecific Antibodies for Immunotherapy

Antibodies for Immunotherapy
  • Drug geometry mimicking target geometry
  • Choosing the best binding arm candidates through robust screening
  • Optimizing activity through platform selection
Nov 1015:00
Conference pass

A Symphony of Separation Techniques Hyphenated to MS for In-Depth Characterization - Applications and Case Studies from a Biopharmaceutical Development Lab

CMC & Developability
  • The strength of combining orthogonal separation techniques with mass spectrometry for biopharmaceutical characterization will be discussed
  • The importance of high quality characterization data in supporting process and formulation development will be highlighted
  • Multiple case studies from pre-clinical and clinical development will be presented
Dan Bach Kristensen, Principal Scientist, Symphogen
Nov 1015:00
Conference pass

Biosimilars in Non-Small Cell Oncology

Biosimilars in Oncology
Nov 1015:00
Conference pass

Biosimilars Uptake in LATAM

Biosimilars Emerging Regions
María Lucía Bettati, Business Unit Director Gen Med, Amgen
Nov 1015:00
Conference pass

Impact of human and non-human N-linked glycans on in vivo clearance of monoclonal antibody

mAbs
  • We hypothesized than immunogenic glycan structures can have immune-mediated clearance, resulting in faster clearance from in vivo circulation than non-immunogenic structures.
  • We developed a procedure to purify and analyze N-linked glycan profile of a therapeutic IgG1 from clinical serum samples.
  • The relative clearance of antibody containing human and non-human glycans are compared and discussed to assess the immunogenicity risk of non-human glycans.
Methal Albarghouthi, Senior Director, Analytical Sciences, AstraZeneca
Nov 1015:00
Conference pass

Targeting Tumor Neo-epitopes with Therapeutic Monoclonal Antibodies

Neoantigens & Therapeutic Vaccines
  • Platform using therapeutic cancer vaccine used to produce immunogenic monoclonal antibodies
  • Development and characterization of monoclonal antibodies
  • Clinical Trials utilizing Neo-epitope targeted therapy
Philip Arlen, President And Chief Executive Officer, Precision Biologics Inc
Nov 1015:00
Conference pass

TRuC T cells: Leveraging the potential of the entire TCR in solid tumors

Cell & Gene Therapy
  • Will describe the TRuC T cell platform
  • Will describe the advantages of TRuC T cells over CAR T cells in solid tumors
  • Will provide details around the ongoing clinical trials with TRuC T cells
Nov 1015:20
Conference pass

A tumour activated IL-15 immunocytokine

Antibodies for Immunotherapy
  • Evaluation of IL-15 as a tumour protease activated immunocytokine
  • Difficulties and solutions for the production and biodistribution of an IL-15 based immunocytokine
  • Potent dose dependent activity of protease activated IL-15 on the NK cell population in vivo
Nov 1015:20
Conference pass

CYAD-211, a Non-Gene-Edited Allogeneic anti-BCMA CAR T-cell product to treat Relapsed or Refractory Multiple Myeloma

Cell & Gene Therapy
Jennifer Bolsee, Research & Development Associate, Celyad Oncology
Nov 1015:20
Conference pass

Development of Antibody Fragment Drug Conjugates (FDCs), tailored for Solid Tumours

Armed Antibodies
  • Antikor’s FDC platform based on human single-chain Fvs, optimised for high-DAR bioconjugation
  • Preclinical data on ANT-043 (HER2-targeted FDC) and ANT-045 (target to be disclosed)
  • Development plan for ANT-045 and designing future FDC products.
Mahendra Deonarain, CEO, Antikor
Nov 1015:20
Conference pass

Problems with pharmacovigilance programs: an opportunity for improvement

Biosimilars in Oncology
Philip Schneider, Advisory Board Chair, Alliance for Safe Biologic Medicines
Nov 1015:20
Conference pass

Trends in Antibody Discovery and Development

mAbs
  • GenScript’s unique position to observe global trends in Antibody Discovery and Development.
  • Discussing the 5 main trends observed within the ADD industry.
  • GenScript's unique services and solutions to tackle these trends.
Libby Naylor, Sales, GenScript
Nov 1015:40
Conference pass

Artificial intelligence methods to detect dengue-specific antibody repertoire and sequence patterns

mAbs
  • Antibody Repertoire-Level Dengue Classification
  • Machine learning can classify dengue-Challenged antibody repertoire sequences
  • Comparison of the performance of different machine learning architectures
Nov 1015:40
Conference pass

Avoiding ADC Misdirection: Designing clinically effective agents from in vitro, in vivo, and in silico data

Armed Antibodies
  • The development of antibody drug conjugates (ADCs) is fundamentally different than both small molecule and macromolecular drug development and translation
  • Results from in vitro and preclinical animal studies often do not scale to the clinic due to delivery challenges and intrinsic sensitivity/tolerability differences
  • A combination of in silico and in vivo experiments can be designed to better represent the clinical scenario, using successful ADCs as an example, to aid in pipeline selection
Greg Thurber, Associate Professor in Chemical Engineering and Biomedical Engineering, University of Michigan
Nov 1015:40
Conference pass

Development challenges of monoclonal antibody formulations

mAbs
  • Formulation and manufacturing process
  • High concentration monoclonal antibody formulations
  • Analytical characterisation of monoclonal antibody drug products
Eva Kollar, Team Lead, Formulation Development, Biotechnology, Gedeon Richter PLC
Nov 1015:40
Conference pass

Harnessing innate immunity in cancer therapy

Antibodies for Immunotherapy
  • New therapies that promote antitumor immunity have focused on enhancing T-cell responses, either by targeting inhibitory pathways with immune checkpoint inhibitors, or by targeting activating pathways, as with chimeric antigen receptor T cells or bispecific antibodies
  • Only a minority of patients with cancer benefit from these treatments, highlighting the need to identify new cells and molecules that could be exploited in the next generation of immunotherapy
  • Given the crucial role of innate immune responses in immunity, harnessing these responses opens up new possibilities for long-lasting, multilayered tumor control. We will present innovative anti-tumor therapies based on the manipulation of the innate immune system
Nov 1016:30
Conference pass

Biosimilars clinical evidence and lessons learned

Biosimilars in Oncology
Mohamed Khater, samsung bioepis
Nov 1016:40
Conference pass

ADC Advances

Armed Antibodies
  • Stable bioconjugation to native antibodies with precise control of DAR
  • New mechanisms of rapid linker cleavage upon ADC internalisation
  • New cytotoxins for ADCs
David Spring, Professor, University of Cambridge
Nov 1016:40
Conference pass

Antibody-cytokine fusions for cancer therapy with “activity-on-demand”

Targeting the Tumour Microenvironment
  • Certain antibody-cytokine fusions are able to selectively localize on solid tumors and promote a potent anti-cancer activity
  • Products which gain activity upon antigen binding are particularly attractive
  • I will present a thorough in vitro and in vivo characterization of products with potent anti-cancer activity
Nov 1016:40
Conference pass

Improving cancer immunotherapy in a sweet way: How glycans can be used as targets for CAR T cell therapy

Cell & Gene Therapy
  • Cancer-associated changes of glycosylation
  • Enzymatic modulation of cancer-associated glycosylation
  • Glycan targets for CAR T cell therapy
Heinz Läubli, Attending Physician, Medical Oncology, University Hospital Basel
Nov 1016:40
Conference pass

Keeping pace with the increasing complexity of Multispecific Biotherapeutics: Bioanalysis of Mispairing & In-depth Peptide Mapping Analysis

Proteomics & Mass Spectrometry
  • Challenges of multispecific biotherapeutic analytics
  • Analytical strategies to characterize mispairing
  • Identification of labile hot spots to improve chemical stability
Soraya Hölper, Project Lead for Portfolio and Strategy, Sanofi - Biologics Research
Nov 1016:40
Conference pass

Lightning Fast Bispecifics - Rapid generation of modular bispecific antibodies with pyridazinediones

Research Hub
  • We have developed pyridazinediones (PDs) to rapidly generate bsAbs from Fabs of commercially available mAbs
  • Method relies on fast BCN-tetrazine click chemistry and allows subsequent dual modification of bsAb (e.g. to generate bsADC)
  • Applications of technology are currently being explored in collaborations
Peter Szijj, Phd Student, University College London
Nov 1016:40
Conference pass

The Biologic Revolution in Inflammatory Bowel Disease: Hits, Misses and What Comes Next

mAbs
  • Progress made in IBD medicine during the biologic era
  • Ongoing unmet needs despite the advent of biologics
  • Future directions for biologics in IBD
Mark Samaan, Consultant Gastroenterologist, Guy’s and St Thomas N.H.S Foundation Trust
Nov 1016:40
Conference pass

VHH as building blocks for immune and tumour cell-targeting

Antibodies for Immunotherapy
VHH are fast becoming accepted as alternatives to standard antibody-based biotherapeutics due to their improved stability, ability to address difficult-to-reach epitopes, and modularity - facilitating the combination of different specificities in a single product. This presentation will expand on the recent advances in the field of VHH-based therapeutics and highlight particular therapy applications where a naturally monovalent antibody domain structure can be combined to generate the next generation of biologics.
Nov 1016:50
Conference pass

A Clinician's Guide to Biosimilars in Oncology

Biosimilars in Oncology
  • Biosimilars in oncology:Key therapeutic options for cancer treatment
  • Extrapolation data to other Indications:Scientificrationale, Regulatory Guidelines, Case studies
  • Interchangeability, Switching, Substitution:Scientific rationale, Regulatory Guidelines
Hanmant Barkate, Senior Vice President, Global Medical Affairs, Glenmark Pharmaceuticals SA
Nov 1017:00
Conference pass

Baculovirus-free Insect Cell Expression System for expression of antibodies, antigens and VLPs

Research Hub
  • Valuable alternative expression system to mammalian expression
  • Especially suited for difficult to express antigens like the spike protein
  • VLP expression
Maren Schubert, Postdoc, Technical University of Braunschweig
Nov 1017:00
Conference pass

Cell Encapsulation for Cancer Immunotherapy: MVX2 a cell line for in-vivo sustained production of immunostimulatory Cytokines and therapeutic antibodies

Cell & Gene Therapy
Nicolas Mach, Head of Clinical Research Unit, MaxiVAX
Nov 1017:00
Conference pass

Exclusively local IL-12 immunotherapy of brain cancer with a compartment locked fusion cytokine

Antibodies for Immunotherapy
  • Rationale for local IL-12 immunotherapy of brain cancer
  • Our approach to abolish peripheral exposure upon local immunotherapy
  • Performance and mechanism of action in murine brain tumors and human explant cultures
Johannes Vom Berg, Groupleader, University of Zurich
Nov 1017:00
Conference pass

How innovations in antigen development for RabMab discovery has led to delivery of high quality recombinant protein reagents that can be used from research through to the clinic

mAbs
  • Development of a high-throughput platform for the optimization of protein expression
  • Stringent biophysical analysis leads to high quality proteins
  • Impact of Post-translational modifications on protein quality and disease state
  • Focus on cytokines
Gráinne Dunlevy, Head of Protein Science, Abcam
Nov 1017:00
Conference pass

Targeting the Receptor for Advanced Glycation Endproducts (RAGE): An ADC Perspective.

Armed Antibodies
  • Developed for ovarian and endometrial cancer treatment
  • Preclinical in vivo and 3D ex vivo characterisation
  • Discovery pipeline.
Nov 1017:00
Conference pass

TNFR2 - a pleiotropic target for cancer immunotherapy

Targeting the Tumour Microenvironment
Nov 1017:10
Conference pass

The importance of Biosimilars in Oncology

Biosimilars in Oncology
Andrew Spiegel, Executive Director, Globol Colon Cancer Association
Antonella Cardone, Director, European Cancer Patient Coalition
Nov 1017:20
Conference pass

A Novel Bispecific Antibody Platform that Elicits Efficient Tumor Lysis with Minimal Cytokine Release in Liquid and Solid Tumors

Antibodies for Immunotherapy
  • Using a unique sequence-based discovery approach, along with humanized transgenic rats, we have created a large collection of fully human antibodies targeting a variety of tumor antigens and activating receptors on immune cells.
  • Development of next generation Tcell engaging Bispecific Antibody
  • Teneobio’s CD3 X TAA bispecifics increase the therapeutic index by minimizing the toxicities associated with a systemic immune response couple with efficient tumor-targeted immune agonistic properties.
Harbani Malik, Senior Scientist, Teneobio
Nov 1017:20
Conference pass

Adoptive T Cell Therapy in Immuno-oncology

Cell & Gene Therapy
  • CAR-T cells
  • TCR-T cells
  • Tumor Infiltrating Lymphocytes (TILs)
Nov 1017:20
Conference pass

Glycoform-resolved pharmacokinetic studies by combining glycoengineering and bottom-up glycoprotein analysis

Proteomics & Mass Spectrometry
  • Glycoengineering and analytical approaches will be explained.
  • The strength of the approach will be demonstrated by clarifying the differential impact of exposed core- and outer-arm mannose to antibody PK.
  • Applications to different animal models, administration routes and therapeutic proteins will be discussed.
David Falck, Assistant Professor, Leiden University Medical Center (Netherlands)
Nov 1017:20
Conference pass

Next generation antibody drug conjugates and nanomedicine

Armed Antibodies
  • Novel conjugation chemises
  • Novel targeting approaches
  • Payload synergies - optimised therapies
Chris Scott, Acting Director of the Patrick Johnston Centre for Cancer Research, Queen's University Belfast
Nov 1017:20
Conference pass

Optimal use of mAbs (biotherapeutics); from pregnancy, via babies to long-term treatment

mAbs
  • Dose adjustment of biologics based on serum PK
  • Improvement of QoL
  • How to determine optimal dosing in juvenile patients?
  • Real-life data
  • What to advice pregnant women who are on biologics?
  • How much of the biologic is transferred to the foetus and/or baby?
  • Annick De Vries, Head Diagnostics, Biologics, Sanquin
    Nov 1017:20
    Conference pass

    Targeting proteins with biologicals inside cells

    Research Hub
    • Targeting proteins as an alternative to classic strategies
    • Aapproaches and applications of utilizing antibodies inside cells
    • Chemicals for delivering macromolecules into cells
    Andrea Marschall, Postdoctoral, Brandeis University
    Nov 1017:20
    Conference pass

    Tripokin: tumor targeted delivery of IL2 potentiated by TN

    Targeting the Tumour Microenvironment
    • Tripokinis an antibody fusion protein featuring both IL2 and TNF in one product
    • IL2 and TNF have a synergistic mechanism of action
    • Tripokinshows a strong anti-cancer activity in mouse models of cancer both as single agent andin combination with immune check-point inhibitors
    Nov 1017:40
    Conference pass

    Bispecific γδ-T cell engagers for cancer immunotherapy

    Antibodies for Immunotherapy
    • Vγ9Vδ2-T cells constitute the largest γδ-T cell subset in human peripheral blood and are powerful anti-tumor immune effector cells.
    • Bispecific antibodies designed to engage Vγ9Vδ2-T cells and their use for cancer immunotherapy will be discussed
    Hans Van Der Vliet, Chief Scientific Officer And Senior Vice President, Lava Therapeutics
    Nov 1017:40
    Conference pass

    High Throughput and Format-agnostic Mispairing Assay for Multispecific Antibodies using Intact Mass Spectrometry

    Proteomics & Mass Spectrometry
    We developed a high throughput mispairing assay using intact mass spectrometry. This assay can support screening campaigns and detect mispaired species of ~1000 molecules in three weeks by one person. As proof of concept the assay was used to detect and perform relative quantification of mispaired species in trispecific antibodies.”
    Jennifer Jung, Lab Head Mass Spectrometry, Sanofi
    Nov 1017:40
    Conference pass

    IgA tot target MDSC in the TME

    Targeting the Tumour Microenvironment
    • IgA is very potent in activating neutrophils to kill cancer cells
    • Can suppressive myeloid cells (MDSC) still killtumorcells?
    • Can IgA revert or prevent the suppressive phenotype of M+DSC?
    Nov 1017:40
    Conference pass

    SMAC™-Technology: a highly efficient method for the generation of homogeneous, site-specifically conjugated antibody drug conjugates

    Armed Antibodies
    • Site-specific conjugation using sortase enzyme consistently yields highly homogenous ADCs
    • Compatible with different payload classes, including NBE’s proprietary highly potent anthracycline-payload
    • NBE’s anthracycline payload provides access to difficult-to-address targets and has attractive IO properties
    • Pre-clinical data across different targets and indications will be presented
    Nov 1017:50
    Conference pass

    Clinical Data Requirements for Biosimilars: Have the regulators got it right?

    Biosimilars Real World Evidence and Pharmacovigilance
    • Why do biosimilars differ from generic drugs?
    • Drawing on totality.
    • What residual uncertainties need to be addressed by clinical data?
    • Challenges and value of therapeutic equivalence trials.
    Cecil Nick, Vice President - Technical, Parexel
    Nov 1017:50
    Conference pass

    Neoantigen cancer vaccines based on synthetic linear DNA with a pyroptotic adjuvant synergize with checkpoint inhibitors

    Innate & Adaptive Checkpoint Inhibition
    Sijme Zeilemaker, CEO, Immunetune

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    Nov 1109:05
    Conference pass

    Drug Company EU Trademark and Design Disputes

    Biosimilars Day 3 Opening Keynotes
    • With some 2 million EU trade marks on the register, it’s little wonder that conflicts abound. Earlier trade marks (international registrations designating the EU, EU trade marks and national registrations) sometimes collide with EU trade mark applications.
    • Drug companies are not immune to such conflicts and ensuing procedures can go through multiple appeal levels, causing delay and expense.
    • This presentation looks at examples of such cases and then goes on to consider how designs and alternative dispute resolution can offer interesting options to drug companies
    Nov 1109:05
    Conference pass

    Patient enrichment strategies to increase the success rate of Immuno-Oncology early clinical trials

    Immunotherapy Day 3 Keynotes
    Bruno Gomes, Global Head Of Biomarkers Oncology, Roche
    Nov 1109:05
    Conference pass

    The next steps in large molecule discovery and design

    Antibodies Day 3 Keynotes
    Andreas Plueckthun, Professor Of Biochemistry, Director, Department Of Biochemistry, University of Zurich
    Nov 1109:25
    Conference pass

    African Medicines Agency and Patient Engagement in Biosimilar Regulations

    Biosimilar Opening Keynotes
    • Improving Biosimilars Access, Safety, Quality and Equity in Africa
    Nov 1109:30
    Conference pass

    Antibody-cytokine fusions: from discovery to Phase III clinical trials

    Antibodies Day 3 Keynotes
    • Antibody-cytokine fusions for cancer therapy
    • Antibody-cytokine fusions for chronic inflammatory conditions
    • Antibody-cytokine fusions with “activity on demand”
    Nov 1109:30
    Conference pass

    Enabling Precision Medicine In Respiratory and Immunology

    Immunotherapy Day 3 Keynotes
    • New drug approvals for asthma, COPD and other common diseases remain low
    • Taking a Precision Medicine approach to find the Right Patient is part of the solution
    • By leveraging the worlds genomic data, exploiting large phenotyped cohorts and accessing target tissue non-invasively, we can change the target paradigm, linking the right target to right patient from the start
    Nov 1109:45
    Conference pass

    Building Resiliency in the Biosimilar Marketplace

    Biosimilars Day 3 Opening Keynotes
    Gregory Friberg, Vice President of Medical Affairs ELMAC, Amgen Inc
    Nov 1109:55
    Conference pass

    Humanizing Biosignatures and moving precision medicine from beyond Oncology

    Immunotherapy Day 3 Keynotes
    Nov 1109:55
    Conference pass

    Targeting FcRn for the generation of therapeutics

    Antibodies Day 3 Keynotes
    Sally Ward, Professor of Molecular Immunology and Director of Translational Immunology, University of Southampton
    Nov 1110:50
    Conference pass

    Interchangeability and extrapolation in biosimilars: lessons learnt from original biologics

    Biosimilars in the Clinical Setting: Education, Physician Engagement and Pricing Models
    Nov 1110:50
    Conference pass

    The Valore Project

    Biosimilars IP and Legal
    • The VALORE project multi-database network has access to data on more than 140,000 biological drug users with immune-mediated inflammatory diseases (with a cumulative exposure of 507,745 person-years during the entire follow-up) from 13 Italian regions.
    • Overall, the cumulated amount of person-time of exposure to biological drugs approved for immune-mediated inflammatory diseases provides enough statistical power to investigate weak, moderate, and strong associations of almost all individual biological drugs and the most clinically relevant safety outcomes.
    • This distributed database network captured data on a large number of etanercept, adalimumab, and infliximab users who switched between originator and biosimilar during the entire follow-up, thus offering the opportunity to investigate interchangeability in a real-world setting.
    Ylenia Ingrasciotta, Senior Pharmacoepidemiologist, University of Messina
    Nov 1111:10
    Conference pass

    De novo design of binding nanobodies

    Computational Approaches
    De novo design methods promise a cheaper and faster route to antibody discovery, while enabling the targeting of predetermined epitopes and the screening of multiple biophysical properties. I willpresent some recent advances, including a data-driven strategy to design nanobodies targeting structured epitopes. Our experimental validations demonstrate that in silico approaches are becomingincreasingly competitive, and can be applied in synergy with established laboratory-based procedures to streamline antibody development.
    Pietro Sormanni, Group Leader, University of Cambridge
    Nov 1111:10
    Conference pass

    Exploiting the unique epitope targeting ability of soloMERs to develop new therapeutic biologics

    Nanobodies, Peptides & Non-antibody Formats
    • Elasmogen has established robust, diverse platforms for the isolation of high affinity, highly selective soloMERs
    • Our lead domains demonstrate novel targeting via cryptic epitope binding across a number of target classes
    • Our lead soloMER-drug conjugate program demonstrates excellent efficacy in PDX models of TNBC
    Caroline Barelle, Chief Executive Officer, Elasmogen
    Nov 1111:10
    Conference pass

    Functional screening of B- and T-cell repertoires in a droplet microfluidic format

    Analytics, Screening & Immune Repertoire Technologies
    • Droplet microfluidic systems enable high throughput screening of antibodies for functional properties, including modulation of membrane receptors
    • Droplet microfluidics for the identification of matching TCR-antigen pairs in immune oncology
    • Introduction on how to get access to the technology
    Christoph Merten, Professor, Laboratory for Biomedical Microfluidics, EPFL
    Nov 1111:10
    Conference pass

    Learnings from 15 years of biosimilars: How to effectively educate HCPs and patients in new therapeutic areas

    Biosimilars in the Clinical Setting: Education, Physician Engagement and Pricing Models
  • Biosimilar misinformation and disparagement is a fact
  • The need for education about biologics including biosimilars is still significant, and will be critical for the uptake in new therapeutic areas
  • Effective education around biologics including biosimilars has to address all stakeholders in a tailored manner
  • Michael Wiechmann, Global Head Medical Affairs, Sandoz
    Nov 1111:10
    Conference pass

    Patenting Antibodies at the EPO – an update of the Examination Guidelines

    Investment & Patents
    The practice followed at the EPO to examine applications related to monoclonal antibodies has been incorporated into the new Examination Guidelines which were published in March 2021. The presentation will summarize the most relevant aspects incorporated into the guidelines and will also draw attention to other aspects that are becoming increasingly relevant are likely to be introduced into the guidelines in the near future.
    Helena Domingues, Patent Examiner, European Patent Office
    Nov 1111:10
    Conference pass

    Targeting bi-specific biologics to autoimmune disease tissues

    Antibodies for Immunotherapy
    • Bi-specific biologics such as immunocytokines and DVD-Ig permit the disease tissue specific targeting of active payloads
    • These formats maybe engineered as prodrugs with proteolytic linkers that minimize systemic payload activity without compromising activity
    Andrew Goodearl, Director, AbbVie
    Nov 1111:10
    Conference pass

    The Licensure of a Biosimilar or Biosimilar Interchangeable Product

    Biosimilars IP and Legal
    Nov 1111:10
    Conference pass

    Understanding mechanism of action in humans- the importance of translational studies in early phase IO clinical trials

    Precision Immunotherapy & Biomarkers
    • There is a growing appreciation of the limitations of preclinical cancer models in defining mechanisms and predicting response
    • Humans are the only truly applicable animal model
    • Maximising translational data from early clinical trials is key to unlocking mechanisms and rationalising combination therapy
    Philip Beer, Physician Scientist And Precision Oncology Specialist, Sanger Institute
    Nov 1111:30
    Conference pass

    Combining magnetic resonance imaging with systemic monocyte phenotype for GBM management

    Precision Immunotherapy & Biomarkers
    • Magnetic resonance imaging (MRI) is the gold standard for glioblastoma (GBM) patient evaluation. Additional non-invasive diagnostic modalities are needed
    • GBM is heavily infiltrated withtumorassociated macrophages that can be found in peripheral blood
    • FKBP51s supports alternative macrophage polarization
    • After surgery, MRI diagnosis of persistingtumorcoincides with an increase of FKBP51s+ monocytes in peripheral blood
    Nov 1111:30
    Conference pass

    Developments in screening technologies

    Analytics, Screening & Immune Repertoire Technologies
    Yariv Wine, Senior Lecturer And Assistant Professor, Tel Aviv University
    Nov 1111:30
    Conference pass

    New perspectives on novel biologic formats

    Nanobodies, Peptides & Non-antibody Formats
    Markus Seeger, Associate Professor, University of Zurich
    Nov 1111:30
    Conference pass

    NGS-powered antibody discovery: Implementing robust and scalable candidate selection

    Computational Approaches
    • Perform advanced clustering and phylogenetic analysis, independently and efficiently through an intuitive user interface
    • Scale up structural liability predictions to better rank and select candidates
    • Speed up the selection process by exploring multiple antibody characteristics from sequence and assay data in a single visualization
    Nov 1111:30
    Conference pass

    Patient and Physician uptake of biosimilars in Spain

    Biosimilars in the Clinical Setting: Education, Physician Engagement and Pricing Models
    Nov 1111:50
    Conference pass

    Accelerating the Next Generation of Immune Medicine with Automated and Highly Multiplexed Cellular Proteomics

    Precision Immunotherapy & Biomarkers
    Nov 1111:50
    Conference pass

    Benchmarking machine-learning-based prediction and generation of antibody specificity

    Computational Approaches
    • It is becoming increasingly clear that antibody-antigen binding is predictable
    • I will show experimental and synthetic data that indicate that combining sequence and structural data improves antibody specificity prediction
    • I will provide an in-silico proof-of-principle that generative machine learning can be used to generate unconstrained numbers of epitope-specific antibody binders
    Victor Greiff, Associate Professor, Department Of Immunology, The University of Oslo
    Nov 1111:50
    Conference pass

    Bispecific DART Molecules: From Bench to the Bedside

    Antibodies for Immunotherapy
    • Bispecific DART molecules for redirected T-cell killing
    • Combinatorial checkpoint inhibition via bispecific DART molecules
    • Current status and future opportunities
    Ezio Bonvini, Chief Scientific Officer, MacroGenics
    Nov 1111:50
    Conference pass

    Successful uptake of biosimilars in Kaiser Permanente

    Biosimilars in the Clinical Setting: Education, Physician Engagement and Pricing Models
    Sameer Awsare, Associate Executive Director, The Permanente Medical Group Inc
    Kathryn Brown, Intermin Vice President for pharmacy, Kaiser Permanente
    Nov 1112:10
    Conference pass

    Circulating tumor DNA as an early on-treatment predictive biomarker for patients with advanced non-small cell lung cancer receiving immune checkpoint inhibitors

    Precision Immunotherapy & Biomarkers
    • Circulating tumor DNA (ctDNA) is shed into the bloodstream and serves as potential predictive or prognostic biomarker
    • Changes in mutantctDNAlevels in plasmacfDNAdetected withddPCRorctNGSare associated with overall survival in NSCLC patients treated with immune checkpoint inhibitors
    • Interpretation ofctDNANGS results needs to account for clonal hematopoiesis of indeterminate potential (CHIP) representing variants incfDNAunrelated to the lung cancer
    Nov 1112:10
    Conference pass

    How to bypass legal challenges and bring a biosimilar to market

    Biosimilars IP and Legal
    Alix Dubes, Senior Director Patent Attorney, Biosimilars at Fresenius Kabi, Fresenius Kabi
    David Lancaster, Partner, Pinsent Masons LLP
    Nov 1112:10
    Conference pass

    Humanization of antibodies using a machine learning approach on large-scale repertoire data

    Analytics, Screening & Immune Repertoire Technologies
    • Monoclonal antibody therapeutics are often produced from non-human sources and can therefore generate immunogenic responses in humans.
    • I will describe our novel, computational humanization tool, Hu-mAb, that suggests mutations to an input sequence to reduce its immunogenicity.
    • Hu-mAb is an effective replacement for trial-and-error humanization experiments, producing similar results in a fraction of the time.
    Nov 1112:10
    Conference pass

    New tricks for old targets: Fc-enhanced CTLA-4 and TIGIT mAbs promote optimal T cell activation and improved anti-tumor immunity.

    Antibodies for Immunotherapy
    • Fc-FcgR co-engagement is critical for anti-CTLA-4 and anti-TIGIT function
    • Enhanced binding to FcgRIIIA improves T cell responsiveness, independent of Treg depletion
    • Novel Fc-mechanism enhances tumor control and broadens the therapeutic potential of CTLA-4 and TIGIT therapy
    Emmanuel Briend, Associate Antibody Discovery Director, Agenus
    Nov 1112:10
    Conference pass

    Pandemic changes in biosimilar use: where are we now?

    Biosimilars in the Clinical Setting: Education, Physician Engagement and Pricing Models
    Martin Perry, Consultant Physician And Rheumatologist, Honorary Senior Clinical Lecturer, NHS Greater Glasgow & Clyde
    Nov 1112:10
    Conference pass

    Panel discussion: computational approaches for antibody discovery & development

    Computational Approaches
    Pietro Sormanni, Group Leader, University of Cambridge
    Eliott Harfouche, Partner, Nodes Advisors
    Nov 1112:10
    Conference pass

    Structure guided design of peptides for VHH half-life extension

    Nanobodies, Peptides & Non-antibody Formats
    The presentation will demonstrate a structure guided approach to identify serum albumin binding peptides to improve the pharmacokinetic profile of Nanobody® VHHs. The concept was validated by in vivo PK studies in cynomolgus monkey.
    Carlo Boutton, Global Head Innovation, Large Molecule Research Platform, Sanofi
    Nov 1112:30
    Conference pass

    New immunotherapeutic antibodies for oncology and inflammation

    Antibodies for Immunotherapy
    Marjolein Van Egmond, Professor Of Oncology And Inflammation, VU University Medical Center Amsterdam
    Nov 1112:30
    Conference pass

    Pros and cons of several trial designs for immunotherapy and the choice of endpoints

    Precision Immunotherapy & Biomarkers
    • Clinical development of immune-oncology (IO) agents presents both opportunities and challenges and not all patients benefit to the same extent
    • Many factors influence trial designs and could potentially threat success of promising IO drugs:
  • Response evaluation criteria
  • Surrogate endpoints for efficacy still be in used and the need for validated  specifically for IO trials.
  • Biomarker-driven clinical studies in order to select appropriated patients.
  • Long-term toxicity monitoring and Optimizing the design of new IO agents
  • Nov 1112:30
    Conference pass

    Regeneron's perspective on novel antibody immunotherapeutics

    Antibodies for Immunotherapy
    David Di Lillo, Associate Director, Regeneron
    Nov 1112:30
    Conference pass

    Secretion-based live cell sorting using droplet microfluidic; application to hybridomas selection

    Analytics, Screening & Immune Repertoire Technologies
    • Single cell immunoassay
    • Single cell secretome
    • Droplet microfluidic
    • Live cell sub-population sorting
    • Secretion-based analysis of cell heterogeneity
    Alain Wagner, Research Director, Centre National De La Recherche Scientifique
    Nov 1112:30
    Conference pass

    Uplift Primary Care: Building a Path for Success: "The Grassroots Movement to Re-Design Healthcare"

    Biosimilars in the Clinical Setting: Education, Physician Engagement and Pricing Models
    In times of crisis, you learn a lot more about an organization than you otherwise would. At the same time, the pandemic has shown the many parts of fee-for-service health care that are broken. In this closing presentation, we will focus on group of 2,500 doctors organized together as an IPA under the leadership of Dr. Ramón Tallaj, called SOMOS, who has risen to meet the challenges of COVID-19, and serves as an example of what is possible through the value-based care model.
    • Why more healthcare and life science leaders should embrace the movement to transform medicine--a movement that can rebuild the public trust and save US from the crushing cost of healthcare.
    • What opportunities are available to integrate this VBC model in new marketplaces?
    • Maintaining quality while combatting health inequity
    • How non-medical factors can impact health and ways in which value-based healthcare can utilize these considerations to enable efficient care.
    • Using data-driven insights to identify care gaps, monitor impact of new workflows and care models, to aid this organizations in alleviating spending and utilization rates.
    Nov 1114:00
    Conference pass

    Antibodies to watch in 2022

    Antibodies Closing Keynotes
    This “Antibodies to watch” talk will summarize data for antibody therapeutics in regulatory review and recently approved in the US and EU, and project which may be approved in 2022. Trends in the development of antibody therapeutics for COVID-19 will also be discussed.
    Janice Reichert, Executive Director, The Antibody Society
    Nov 1114:20
    Conference pass
    Nov 1114:40
    Conference pass

    Keynote panel discussion: Exploring clinical needs and novel indications

    Antibodies Closing Keynotes
    last published: 28/Oct/21 16:16 GMT