Agenda 2024

 

 

Our agenda is expertly curated by an experienced team of producers with an expansive global network.

 

The Festival of Biologics is your opportunity to hear from industry leaders, global regulators and world-renowned academics at the forefront of innovation. Join us for 3 days of cutting-edge insights into the latest industry developments.   

Basel, 15 - 17 October 2024

Schedule

Create your personal agenda –check the favourite icon

Oct 159:05
Conference pass

Chair's opening remarks

Keynotes
antibodies
immunotherapy
biosimilars & late stage development
manufacturing & bioprocessing
clinical trials
Oct 159:35
Conference pass

Title TBA

Keynotes
antibodies
immunotherapy
biosimilars & late stage development
manufacturing & bioprocessing
clinical trials
Oct 1511:30
Conference pass

Antibody-based product successes and progresses in 2024

Keynotes
antibodies
Oct 1511:30
Conference pass

Biosimilar Development at Pfizer

Keynotes
biosimilars; late stage development
Roman Irsiegler, Global Biosimilars Team Lead, Pfizer
Oct 1511:30
Conference pass

Bringing medicine development to patients, The why and the how

Keynotes
clinical trials
  • Patients in Oncology can guide programs towards true unmet need
  • Regulators and Payers have started to acknowledge the value of PROs
  • Diversity in clinical trial is key to develop new medicines which meet real needs

Michael Zaiac, Head of Medical Affairs Oncology Europe and Canada, Daiichi Sankyo
Oct 1511:30
Conference pass

The present and future of bispecific antibodies

Keynotes
immunotherapy
Christian Klein, Dept Head, Roche Pharmaceutical Research and Early Development
Oct 1511:55
Conference pass

Gene Therapy: Bench to Bedside

Keynotes
immunotherapy
Joshi Venugopal, Head of Region Europe, Novartis Gene Therapy & Rare Diseases, Novartis
Oct 1511:55
Conference pass

Revolutionizing Clinical Trials through RWD and AI: Unleashing Innovation

Keynotes
clinical trials
Mats Sundgren, Senior Industry Scientific Director, i-hd (The European Institute for Innovation through Health Data)
Oct 1511:55
Conference pass

Title TBA

Keynotes
antibodies

Senior Representative, FUJIFILM Diosynth

Oct 1512:20
Conference pass

Innovative Biologics and Biosimilars: A regulatory panel

Keynotes
biosimilars; late stage development

·Streamlining regulatory guidelines

·Shifts in approval pathways

·Regulation in innovator biologics compared to biosimilars regulation.

Haoheng Yan, Head of US Regulatory Affairs, Shanghai Henlius Biotech Co., Ltd.
Oct 1512:20
Conference pass

Keynote panel discussion: Cutting-edge innovations in immunotherapies

Keynotes
immunotherapy

· Innovations in bi-specific antibodies, cellular therapies & checkpoint inhibitors

Stefanos Theoharis, Chief Executive Officer, OneChain Immunotherapeutics
Hans Keirstead, Chairman, Immunis Inc.
Angela Vollstedt, Global Director of Cell and Gene Therapies Portfolio Management, Novartis
Oct 1513:40
Conference pass

Silicone-oil-free syringe systems for deep cold storage of next generation drug products

Showcase
antibodies
immunotherapy
biosimilars & late stage development
manufacturing & bioprocessing
clinical trials

With the rise of new and sophisticated drug technologies such as RNAi and AAV-based gene therapies also the requirements for primary packaging containers change in regards to safe storage, improved handling during application and enhanced patient’s safety. Especially in areas for small injection volumes - such as Ophthalmics - prefillable syringes can be a valid option for gene therapies. To minimize risks related to interaction of vector molecules with silicone oil while maintaining container closure integrity at deep cold temperatures, Gerresheimer developed a silicone-oil-free syringe system configuration to support those new approaches along their journey to market approval. Join our session to learn more about our capabilities.

Oct 1514:20
Conference pass

Advances in pHLA directed T cell engager discovery and design

Antibodies for Immunotherapy
antibodies
immunotherapy
Oct 1514:20
Conference pass

Coping with Project Optimus in small biopharma

Precision Medicine & Biomarkers
immunotherapy
Oct 1514:20
Conference pass

De-centralized Manufacturing for Novel Modalities

Regulation
late-stage development
Oct 1514:20
Conference pass

Developability and risk-based control strategies of antibodies and ADCs

CMC, Developability & Analytics
antibodies
Oct 1514:20
Conference pass

Generative Models for Antibody variant generation: the good, the bad, and the ugly

AI and Computational Discovery & Development
antibodies
immunotherapy
Paolo Marcatili, Principal Scientist, Novo nordisk
Oct 1514:20
Conference pass

The Tubutecan Platform – Technology Enabled Payload Solutions Targeting Topoisomerase-I: Preclinical Data for Solid Tumor Targeting ADC Candidates TUB-030 and TUB-040

Armed Antibodies
antibodies
Oct 1514:20
Conference pass

Title TBA

Bispecifics & Multispecifics
antibodies
Tea Gunde, Chief Research Officer, Numab Therapeutics AG
Oct 1514:20
Conference pass

Title TBA

Trial Planning: Site Selection and Data Management
clinical trials
Martina Marauli, Director Clinical Supply Innovation, MSD Innovation & Development GmbH
Oct 1514:20
Conference pass

Tripokin: Best-in-Class potential for tumor targeted Interleukin-2 (IL2) potentiated by Tumor Necrosis Factor (TNF)

Targeting the Tumour Microenvironment
immunotherapy
Roberto De Luca, Head of Therapeutic Antibodies, Philochem
Oct 1514:20
Conference pass

Understanding and Mitigating Cytokine Cytokine Release Syndrome (CRS) mediated by T cell Bispecific antibody (TCB) treatment

Cell & Gene Therapy
immunotherapy

Cytokine Release Syndrome (CRS) is one of the main safety liabilities associated with T cell bispecific antibody (TCB) treatment. In this presentation, we will highlight the key cellular and molecular players involved in the early onset of CRS and highlight how glucocorticoids and Tyrosine Kinase Inhibitors (TKIs) can prevent CRS while retaining TCB activity.

Gabrielle Leclercq, Senior Scientist, Roche Glycart
Oct 1514:20
Conference pass

Using E. coli to map and understand protein aggregation landscapes

Protein Engineering
antibodies
Oct 1514:40
Conference pass

5 Elements for Successful Biologics/Biosimilars Development – The CDMO Perspective

CMC, Developability & Analytics
antibodies

Thebiologics CDMOMarket size is expected to grow from USD 13.58 billion in 2023 to USD 24.77 billion by 2028, at a CAGR of 12.78%. This growth is primarily driven by significant increase in outsourcing development and manufacturing activities by biotech as well as small and medium-sized pharmaceutical companies, to accelerate their biologic assets (e.g. bispecifics, mAbs and other recombinant proteins) into clinic and avoid the investment risk in capital-intensive manufacturing facilities. To stay competitive, biologics CDMO require not only high technical capability and globally compliant manufacturing facilities, but also unmatched agility and customer advocacy in their DNA to drive desired outcomes for their clients.

This talk will cover the 5 essential and fundamental elements (with examples), that are required for any CDMO to successfully deliver client programs and help them evolve from a mere service provider to a true value partner.

Oct 1514:40
Conference pass

BPT567, a first-in-class PD1-IL18 immunocytokine

Armed Antibodies
antibodies
JP Carralot, director of biology, Brightpeak
Oct 1514:40
Conference pass

Title TBA

Protein Engineering
antibodies

Senior Representative, Carterra

Oct 1514:40
Conference pass

Title TBA

Antibodies for Immunotherapy
antibodies
immunotherapy

Senior Representative, Genovac

Oct 1514:40
Conference pass

Title TBA

AI and Computational Discovery & Development
antibodies
immunotherapy
Oct 1514:40
Conference pass

Understanding the T cell adaptation to the tumour microenvironment to improve CAR-T therapy

Targeting the Tumour Microenvironment
immunotherapy
Carmen De Santo, Cruk New Investigator Fellow, University of Birmingham
Oct 1514:40
Conference pass

What next, clinical material from bulk selected CHO pools? Taking the Leap In Transposase platform to the next level.

Bispecifics & Multispecifics
antibodies

The Leap In Transposase platform for stable CHO cell line development attained rapid and robust market adoption. The platform continues to be optimized and has evolved to address various challenges of increasing complexity within the protein therapeutic space. This includes not only multi-specific antibodies and cytokines but, also dealing with the needs of a global pandemic. In this presentation, we'll highlight some recent case studies and elude to what the future might bring.

Oct 1515:00
Conference pass

A critical look at acid-catalyzed deamidation, peptide solubility and other challenges in conventional Multi-Attribute Method (MAM) workflows – potential pitfalls and solutions

CMC, Developability & Analytics
antibodies
Oct 1515:00
Conference pass

BiXAb MAIT engagers: redirecting an abundant cytotoxic T-cell subset to control solid tumors.

Bispecifics & Multispecifics
antibodies
Oct 1515:00
Conference pass

Engineering Complex Antigens for the Biopharma Industry: Major Histocompatibility Complexes (MHC) & Multipass Transmembrane Proteins (GPCR)

Cell & Gene Therapy
immunotherapy
  • We have developed versatile MHC molecules that enable rapid peptide loading in TCR-T cell therapy research, providing TCR-T cell therapy researchers with unparalleled ease of use.
  • We are now able to produce all GPCR targets, even those previously unattainable, in VLP or nanodisc formats, thereby expanding target options and speeding up antibody drug discovery.
  • Notably, our nanodisc extraction process uniquely eliminates the use of detergent, differentiating it from traditional methods
Man-Hee Suh, Founder & CTO, KACTUS
Oct 1515:00
Conference pass

Engineering Multispecifics Engagers

Antibodies for Immunotherapy
antibodies
immunotherapy
Oct 1515:00
Conference pass

Mammalian Antibody Display & Secretion for Microfluidic Hit Discovery

Protein Engineering
antibodies
Laura Unmuth, Merck Kgaa
Oct 1515:00
Conference pass

Revolutionizing in Development of Two Methodologies: Cell-Based Potency Bioassay and Mass Spectrometry-Based Host Cell Protein Analysis

Armed Antibodies
antibodies

In today's pharmaceutical landscape, developing highly effective analytical methods that consistently fulfill their intended purposes presents a significant hurdle for drug developers, testing laboratories, and regulatory agencies. Through the lens of two critical tests delineating the attributes of next-generation therapeutics, this presentation elucidates a contemporary methodology for crafting analytical methods tailored for employment within quality control (QC) laboratories.

In the first example, the bioassay, a technique aimed at gauging biotherapeutics' biological activity (potency) against a reference standard, reflects the drug’s mechanism of action (MoA). Positioned as the primary critical quality attribute (CQA), the bioassay represents a convergence of biology and statistics, providing a crucial means of determining a drug’s quality. The development and optimization of the bioassay necessitate meticulous verification and establishment of appropriate assay conditions to ensure accurate potency measurement.

In the second example, the mass spectrometry technique has expanded its applicability in analytical procedures over the past decade. This advancement allows for the concurrent identification and quantification of Host Cell Proteins (HCPs), which are notable process-related impurities derived from the host organism during the manufacturing of biotherapeutics. This discussion will encompass considerations of suitability, workflow, challenges, and the key advantages associated with monitoring residual HCPs by integrating liquid chromatography with mass spectrometry.

Oct 1515:00
Conference pass

Title TBA

Trial Planning: Site Selection and Data Management
clinical trials
Nadia Fernandez, Industry Clinical Collaboration Lead, F. Hoffmann-La Roche Ltd.
Oct 1515:00
Conference pass

Title TBA

Precision Medicine & Biomarkers
immunotherapy
Patrick Brossard, Director Clinical Pharmacology, Sobi (Swedish Orphan Biovitrum)
Oct 1515:00
Conference pass

Unraveling IGSF8 as an Innate Immune Checkpoint and Cancer Immunotherapy Target: Harnessing the Power of AI and Big Data

AI and Computational Discovery & Development

Caibin Sheng, Data scientist, machine learning, computational oncology, GV20 Therapeutics (RESERVED)

Oct 1515:20
Conference pass

Circulating macrophages provide valuable information about cutaneous squamous cell carcinoma response to cemiplimab

Targeting the Tumour Microenvironment
immunotherapy
Maria Fiammetta Romano, Prof, university of naples federico II
Oct 1515:20
Conference pass

Deep Screening in Harmony with AI for Bispecific Antibody Discovery

Antibodies for Immunotherapy
antibodies
immunotherapy
  • The integration of Biological Intelligence™(BI) and artificial intelligence (AI) has promise to streamline antibody discovery. Our OmniDeep™ AI-augmented workflow enables a deeper exploration of naturally optimized immune repertoires to discover additional non-obvious high-affinity and highly developable antibody candidates.
  • To address the challenge of expressing and testing large numbers of sequences and sequence combinations, we are incorporating mammalian secretion libraries and xPloration® for rapid and efficient evaluation of selected designs.
  • We will be showcasing the application of these tools in discovering common light chain antibodies for a potential bispecific NK cell engager.
Oct 1515:20
Conference pass

Generating potent CAR T-cells for targeting solid tumours

Cell & Gene Therapy
immunotherapy

The development of our ‘lateral CAR’ technology and how this achieves a step-change in the baseline function of the CAR T-cells. It will then go on to detail how combining these lateral CARs with the appropriate armouring technology results in transformative results against solid tumours.

Marc Davies, VP, R&D, Leucid Bio
Oct 1515:20
Conference pass

JJP Clinical Biomarker Development

Precision Medicine & Biomarkers
immunotherapy
Louis Boon, Chief Scientific Officer and Board member JJP Biologics, JJP Biologics
Oct 1515:20
Conference pass

Robust bispecific antibodies through fusion of single-domain antibodies on IgG scaffolds

Protein Engineering
antibodies
Oct 1515:20
Conference pass

Small Molecule Therapeutics targeting Fibroblast Activation Protein in the tumor microenvironment

Armed Antibodies
antibodies
Andrea Galbiati, Group Leader, Chemistry, Philochem
Oct 1515:20
Conference pass

Streamlining biosimilar development based on 20 years’ experience

Regulation
biosimilars;late stage development
Oct 1515:20
Conference pass

The Lab AI Revolution

AI and Computational Discovery & Development
antibodies
immunotherapy
    veraging the power of AI in a next generation biologics informatics platform
  • An AI digital assistant to create experiment content and perform advanced scientific search
  • Powering adoption and productivity with AI support assistants and code generation
  • Capturing biologic entities and end-to-end lineage
  • Unifying and contextualizing research data to build & apply AI/ML models

Oct 1515:20
Conference pass

The Leap-In Transposase Platform: Past, Present and Future

CMC, Developability & Analytics
antibodies

Launched only a few years ago, the Leap-In Transposase platform has rapidly become an industry standard technology for the generation of CHO cells for the manufacturing of antibodies and other biologics. This presentation will highlight achievements and case studies of the platform including high titer mAb manufacturing, rapid anti-COVID responses, and some novel, next generation, applications.

Oct 1515:20
Conference pass

Upstream process development strategies for challenging molecules

Bispecifics & Multispecifics
antibodies

Different from monoclonal antibodies, complicated molecules come in many formats, from relatively small proteins without FC region to large immunoglobulin G (IgG)-like molecules with additional domains attached. The complexity of the novel structure also posts challenges in CMC area such as expression, purification, and assay development.

In this talk, ProBio will present its optimized upstream strategies including cell line development, upstream process development which enable ProBio to break the bottlenecks in complicated molecule CMC area and provide its customer faster and better IND-enabling services.

1. Complicated molecules post challenges on process development

2. GenScript ProBio’s unique platform to address challenges for complicated molecules

3. Case studies for upstream process development for complicated molecule

Oct 1515:40
Conference pass

Advancing a novel linker technology

Armed Antibodies
antibodies
Oct 1515:40
Conference pass

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

AI and Computational Discovery & Development
antibodies
immunotherapy
Enkelejda Miho, Dean and Professor, University of Applied Sciences Northwestern Switzerland
Oct 1515:40
Conference pass

CB307: A novel T-cell costimulatory Humabody VH therapeutic for PSMA-positive tumors

Antibodies for Immunotherapy
antibodies
immunotherapy
Oct 1515:40
Conference pass

Development of remote-control CAR T cells for cancer immunotherapy

Cell & Gene Therapy
immunotherapy
Oct 1515:40
Conference pass

Single-domain antibodies targeting activating receptors on NK cells enable facile engineering of potent NKCE formats

Bispecifics & Multispecifics
antibodies
Oct 1515:40
Conference pass

Targeting the Warburg Effect with a Novel First-in-class Enolase-1 Blocking Antibody

Targeting the Tumour Microenvironment
immunotherapy

ENO1 (enolase-1 or alpha-enolase) is a cytosolic protein which normally involves in glycolysis pathway. In cancer cells, ENO1 overexpresses in cytosol to facilitate the Warburg effect and also moonlights on the cell surface as a plasminogen receptor to promote plasmin activation for invasion and metastasis. The specific surface expression makes ENO1 an accessible target for biologic therapies. Our proprietary ENO1 blocking antibody could reduce plasmin activation and surprisingly also aerobic glycolysis to modify the tumor microenvironment, such as angiogenesis and infiltration of monocytes.

Oct 1515:40
Conference pass

Title TBA

CMC, Developability & Analytics
antibodies
Oct 1515:40
Conference pass

Title TBA

Protein Engineering
antibodies
Vijaykumar Karuppiah, Associate Director, Immunocore Ltd
Oct 1516:00
Conference pass

Antibody Discovery Dead Ends and New Approaches

Showcase
showcase

Antibody discovery remains one of the most challenging aspects in antibody therapeutic development. Some of the biggest technology gaps reported in antibody discovery include diversity of antibody repertoires, functional screening, and lack of suitable in vitro models. A mass-spectrometry-based approach to antibody discovery offers a promising strategy to overcome the roadblocks associated with other discovery technologies. With REpAb polyclonal sequencing, antibody discovery with mass spectrometry enables the exploration of the natural immune repertoire with unparalleled antibody diversity - even directly in Humans

Oct 1516:50
Conference pass

A novel ADC therapy

Armed Antibodies
antibodies
Gundo Diedrich, Senior Director, MacroGenics
Oct 1516:50
Conference pass

ANV600 is a novel PD-1 targeted IL-2Rβ/γ agonist that is combinable with therapeutic PD-1 inhibitors

Targeting the Tumour Microenvironment
immunotherapy

Tumor-infiltrating lymphocytes (TILs) often become exhausted, limiting their effectiveness in cancer treatment. Targeted cytokine delivery to activatetumorantigen-specific TILs is a promising therapeutic approach.ANV600, a novel bispecific antibody IL-2 fusion, targets PD-1 and acts as an IL-2Rβ/γ agonist to re-activate pre-exhausted CD8+ T cells. ANV600's structure includes an αIL-2/IL-2 fusion protein to prevent IL-2Rα binding and selectively activate IL-2Rβ/γ expressing effector cells, and an αPD-1 antibody compatible with existing PD-1 inhibitors. Optimized for stability and low immunogenicity, ANV600 has demonstrated effective cis-signaling, increasing PD-1 expressing effector cell activation while reducing Tregsignaling. In transgenic human PD-1 mice, ANV600 significantly retardedtumorgrowth in B16F10 and MC38 models, with enhanced effects when combined with pembrolizumab or nivolumab. This was correlated with increased PD-1+ pre-exhausted and cytotoxic CD8 T cells intumors.ANV600 shows promise as an anti-tumortherapeutic for poorly immunogenictumorsand as a prototype for targeted cytokine delivery to TILs. Ongoing pharmaceutical development and clinical trials aim to further explore ANV600's therapeutic potential in cancer immunotherapy.

Alexander Rau, Scientist Protein Engineering, Anaveon
Oct 1516:50
Conference pass

Engineering human cytokines for therapy

Protein Engineering
antibodies
immunotherapy
Matthias Feige, Technical University Munich
Oct 1516:50
Conference pass

Generative AI for Protein Design

AI and Computational Discovery & Development
antibodies
immunotherapy

Generative AI is making huge impact across many domains including nature language, computer vision, and robotics. In this talk, I will introduce our recent progress on generative AI for protein design, including their applications in antibody design and enzyme design.

Jian Tang, Associate Professor, H.E.C. Montreal
Oct 1516:50
Conference pass

Immune-Modulating Secretome Benefits Muscle and Metabolism

Cell & Gene Therapy
immunotherapy
Hans Keirstead, Chairman, Immunis Inc.
Oct 1516:50
Conference pass

Integrating Patient Voice in Development

Patient Engagement and Study Activation
clinical trials
Julie Powell, Director, Patient Advocacy and Public Affairs, Pleco Therapeutics
Oct 1516:50
Conference pass

Recent Updates in Biosimilar Regulation

Regulation
biosimilars; late stage development
Meenu Wadhwa, Section Leader For Cyotkines And Growth Factors Section, MHRA
Oct 1516:50
Conference pass

Sane in the membrane - Discovery of antibodies against challenging membrane protein targets using Salipro nanoparticles

Antibodies for Immunotherapy
antibodies
immunotherapy
  • Many membrane proteins represent emerging drug targets known to be notoriously difficult to work with.
  • The Salipro DirectMX® technology incorporates membrane proteins directly from cell membranes into lipid Salipro® nanoparticles, presenting new opportunities for de novo development of biologics and small molecule drugs.
  • We will present our latest developments showcasing antibody discovery working with purified wildtype GPCRs and ion channels.
Oct 1516:50
Conference pass

Swissmedic Regulatory Landscape

Clinical Trials Regulation and Legal
clinical trials

-Clinical Trials

-Innovation

Mayra Latorre-Martinez, Clinical Study Assessor, Swissmedic
Oct 1516:50
Conference pass

Title TBA

CMC, Developability & Analytics
antibodies

Senior Representative, Lonza

Oct 1516:50
Conference pass

Title TBA

Bispecifics & Multispecifics
antibodies
Steve Quayle, VP Research Biology & Translational Medicine, CUE Biopharma
Oct 1517:10
Conference pass

Automated Bispecifics and Multispecifics Functional Screening via Miniaturized cFAE Workflows

Bispecifics & Multispecifics
antibodies
immunotherapy
Oct 1517:10
Conference pass

Bioassays informing quality control of multi-specific T cell engagers

CMC, Developability & Analytics
antibodies
  • T cell engagers (TCEs), multispecific antibody-like drug molecules that activate T cells in the presence of tumour associated antigen expressing cells, have recently shown impressive efficacy in clinical trials
  • One draw-back of TCEs has been the narrow therapeutic dose window between efficacy and toxicity as a result of unspecific T helper cell activation or cytokine release syndrome. Novel molecular design approaches are addressing this issue by carefully arranging and fine tuning the binding sites responsible for T cell activation
  • However, these designs rely on the integrity of the molecular structure involved in this fine tuning of T cell activation. This is challenging the validity of standard approaches for control of quality attributes. This presentation is going to outline how potency and other bioassays can inform on the nature and criticality of quality attributes to improve the control system for these novel and very promising molecules entering clinical development
Oct 1517:10
Conference pass

CAR-T Immunotherapies against hematological malignancies

Cell & Gene Therapy
immunotherapy
Stefanos Theoharis, Chief Executive Officer, OneChain Immunotherapeutics
Oct 1517:10
Conference pass

Patient Involvement in the Development of a Medicine

Patient Engagement and Study Activation
clinical trials
Oct 1517:10
Conference pass

Title TBA

Protein Engineering
antibodies
Oct 1517:10
Conference pass

Title TBA

Armed Antibodies
antibodies

Senior Representative, Veraxa

Oct 1517:10
Conference pass

Title TBA

Clinical Trials Regulation and Legal
clinical trials
Frederic Bouder, Professor Of Risk Management, University of Stavanger
Oct 1517:10
Conference pass

Title TBA

Regulation
biosimilars; late stage development
Joseph PARK, Senior Manager, Samsung Bioepis
Oct 1517:10
Conference pass

Title TBA

AI and Computational Discovery & Development
antibodies
immunotherapy

Senior Representative, Ardigen

Oct 1517:10
Conference pass

Using single-cell RNA at scale to dissect fibroblast biology identifies CTHRC1 as a novel highly selective antibody target in cancer and fibrosis

Targeting the Tumour Microenvironment
immunotherapy
Sam Cooper, Co-Founder, Phenomic AI
Oct 1517:30
Conference pass

Expanding the scope of conjugatable drugs for ADCs carrying payloads with novel modes of action

Armed Antibodies
antibodies

Payloads of current marketed ADC are limited to three Modes of Action (MoAs): DNA binders, Tubulin- and TOP-I-Inhibitors. With Alco5, we present a novel conjugation platform for stable conjugation and traceless release of hydroxy-containing payloads, broadly applicable to many existing drugs. We show how we built efficacious and stable ADCs carrying payloads with new MoAs.

Oct 1517:30
Conference pass

From Subjects to Partners: Transforming Research Through Patient Involvement

Patient Engagement and Study Activation
clinical trials
  • The roles of patient experts in research
  • How to integrate patient experts
  • Lessons learned at the Swiss Group for Clinical Cancer Research
Lorenz Tanner, Member of Patient Board, SAKK Swiss Group for Clinical Cancer Research
Oct 1517:30
Conference pass

Functional screening of a soluble TCR format library identifies novel molecular architectures for redirected T cell killing

AI and Computational Discovery & Development
antibodies
immunotherapy
Joseph Taft, Senior Scientist, Engimmune
Oct 1517:30
Conference pass

LAVA-1266, a CD123-Vd2 bispecific T cell engager

Antibodies for Immunotherapy
antibodies
immunotherapy
Lotte Mousset, Scientist, LAVA Therapeutics
Oct 1517:30
Conference pass

Title TBA

Protein Engineering

Senior Representative, Icosagen

Oct 1517:30
Conference pass

Title TBA

Bispecifics & Multispecifics
antibodies

Senior Representative, Lonza

Oct 1517:30
Conference pass

Title TBA

CMC, Developability & Analytics
antibodies

Senior Representative, Cygnus Technologies

Oct 1517:30
Conference pass

TME gene engineering to combat cancer

Targeting the Tumour Microenvironment
immunotherapy

Gene engineering of the tumor microenvironment (TME) with viral vectors is a promising way to induce stroma inflammation and stimulate anti-tumor immunity

CD40 stimulation of the TME such as stroma cells and endothelial cells reduce factors that promotes tumor cell growth and metastasis while inducing chemokines and receptors important for migration of immune cells into the TME

Clinical data using the TME gene engineering vector LOAd703 will be presented

Oct 1517:30
Conference pass

Towards Advancing the Biosimilars’ development pathway (The future of phase III)

Regulation
biosimilars; late stage development
Mourad Farouk Rezk, Global Head Of Medical And Regulatory, Biosimilars, Biogen
Oct 1517:50
Conference pass

ATACs as New Therapeutic Modality to Fight Cancer

Armed Antibodies
antibodies

Senior Representative, Heidelberg Pharma

Oct 1517:50
Conference pass

Discovery and optimisation of common light chain Fabs for the generation of multispecific antibody therapeutics based on the Ichnos BEAT® platform

Bispecifics & Multispecifics
antibodies
immunotherapy

The design of potent multispecific immune cell engager based on the Ichnos BEAT® platform relies on the identification of diverse and developable common light chain (cLC) Fabs. The Ichnos discovery engine will be presented: cLC Fab discovery by phage and mammalian display; screening for optimal affinity, specificity and developability and automated architecture exploration based on functional screening. The design, generation and validation of a state-of-the-art antibody phage display library as a source of diverse cLC Fab will be highlighted.

Oct 1517:50
Conference pass

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

Armed Antibodies
antibodies
Oct 1517:50
Conference pass

Next iteration in cytotherapy technologies

Cell & Gene Therapy
immunotherapy
Alain Vertes, Managing Director, NxR Biotechnologies GmbH
Oct 1517:50
Conference pass

Title TBA

Regulation
biosimilars; late stage development
Craig Burton, Executive Director, Biosimilars Council
Oct 1517:50
Conference pass

Title TBA

Patient Engagement and Study Activation
clinical trials
Oct 1517:50
Conference pass

Title TBA

Antibodies for Immunotherapy
antibodies
immunotherapy
Oct 1517:50
Conference pass

Unlocking the Discovery of Novel Therapeutics Against GPCRs, Ion Channels and Transporters

Protein Engineering
antibodies

Create your personal agenda –check the favourite icon

Oct 1610:00
Conference pass

Keynote Panel Discussion, sponsored by GeneData

Keynotes
antibodies
immunotherapy
biosimilars & late stage development
manufacturing & bioprocessing
clinical trials
Oct 1611:40
Conference pass

Roundtables

Keynotes
antibodies
immunotherapy
biosimilars & late stage development
manufacturing & bioprocessing
clinical trials
Bispecific antibody engineering: challenges strategies

Drugging the unreachable: strategies for tissue-specific intracellular delivery Antibody-drug conjugation strategies

Title TBA

Senior Representative, GeneData

Immunogenicity ConsiderationsImplementing AI into antibody discovery and engineering Collaboration between academia and industry

Title TBA

Senior Representative, Nanotemper

Intracellular delivery methods

Beyond mAbs: considerations for developing antibody-like biologics

Title TBA

Senior Representative, Seromyx

Title TBA

Senior Representative, GeneData

Current perspectives on agonists targeting theco-stimulatorymembers of the TNFRSF (CD27, 4-1BB, Ox40, GITR; LTBR)

Oliver Hill, Senior Director Protein Engineering,

YUMAB GmbH

Opportunities and challenges with multiplex immunofluorescence technologies for immunotherapy

A new era of autoimmune disease treatment using mRNA

Challenges in Immunotherapy Clinical Trial Design Advances in allogenic cell therapy

Biomarkers in Translational Medicine Sustainability of the industry

Pipeline development The impact of Interchangeability on biosimilar development

Embedding the patient voice in clinical trial design

Site Relationships

Formulation development strategies Drug Substance Development Strategies

Oct 1612:50
Conference pass

Building brands, optimising outcomes: Impact's biosimilar mission

Showcase
showcase

Accelerating biosimilar uptake and acceptance through specialist consultancy

Oct 1614:00
Conference pass

A next generation ADC for Nectin-4 expressing tumors: preclinical characterization of IPH45, a novel and differentiated exatecan-based ADC targeting Nectin-4

Antibodies for Immunotherapy
antibodies
immunotherapy

IPH45 is a novel exatecan-based anti-Nectin-4 ADC. Its hydrophilic profile, high DAR and strong bystander effect translate into better efficacy in low Nectin-4 expressing-tumor preclinical models and a longer half-life than enfortumab vedotin (EV), an approved anti-Nectin-4 MMAE-based ADC. IPH45 has the potential to have a broader therapeutic index than EV, improved safety and dosing regimen, and the ability to overcome resistance to EV or MMAE-based ADCs.

Oct 1614:00
Conference pass

Developing new gene therapy formulations & including patients in early stages

Cell & Gene Therapy
immunotherapy
Theodora Weisz, Head of Patient Advocacy and Public Affairs, Novartis Gene Therapies, Novartis Gene Therapies
Oct 1614:00
Conference pass

Driving molecular quality throughout Discovery

Protein Engineering
antibodies

Molecular quality attributes are assessed throughout the Discovery process, with 'developability' knowledge building though in silico prediction, engineering studies and biophysical screening. The resultant multi-faceted lead selection process also highlights risk areas for downstream CMC and in vivo groups, such that de-risking packages can be moved off critical path, accelerating the drug discovery process

Oct 1614:00
Conference pass

ImmunOs HLA-based Platform to Target Multiple Checkpoints for Treatment of Solid Cancer Indications

Targeting Checkpoint Pathways
immunotherapy

To develop novel anti-cancer therapeutics, we have used a reverse rational approach and searched for human HLA class I molecules known to induce autoimmunity and long-term lasting viral control as a surrogate marker for potential anti-cancer activity. HLA-B57 is one example of an HLA class I molecule described to target LILRB receptors in these studies. Here we demonstrate the proof of concept of a bispecific optimised HLA-Fc fusion conjugated to a SIRPa protein which shows potent in vitro and ex-vivo anti-tumor efficacy through its multimodal binding of LILRB1, LILRB2; KIR3DL1 and CD47 receptors. This novel modality of HLA/SIRPa Bispecifics has the unique characteristic of targeting myeloid cells (positive for LILRB1/2) and the ability to be directed to tumor sites by targeting the CD47 checkpoint receptor expressed on cancer cells.

Hilmar Ebersbach, Chief Scientific Officer, ImmunOs therapeutics
Oct 1614:00
Conference pass

Launching a Start Up as an academic spin out

Workshops
antibodies
immunotherapy
biosimilars & late stage development
manufacturing & bioprocessing
clinical trials

Reserved for University of Basel

Oct 1614:00
Conference pass

Market Access throughout the entire product lifecycle

Market Sustainability & Market Access
biosimilars;late-stage development
  • What is Market Access access, value outcomes and evidence?
  • When and why shall we start thinking about Market Access and involve the MAx team in the development discussions?
  • How to increase the chances of a timely and successful Market Access launch?
Oct 1614:00
Conference pass

Native Hydrophobic Interaction Chromatography Hyphenated to Mass Spectrometry for Characterization of Biotherapeutics

mAbs
antibodies

Therapeutics antibodies gain increased complexity in the last year requiring the development of new analytical methods. Hydrophobic interaction chromatography is one of them and the mass spectrometry coupling was a challenge due to the non-volatile salt. We developed here a simple, direct, and generic HIC-MS method to characterize side products or microheterogeneity of innovative drug candidates

Vincent Larraillet, Senior Scientist, Roche
Oct 1614:00
Conference pass

One-shot optimization of antibody/protein scaffolds by in-silico computational approaches

AI and Computational Discovery & Development
antibodies
Oct 1614:00
Conference pass

Reserved for Queen Mary's University of London

Translational Research
immunotherapy
Ahuva Nissim, Professor, Queen Mary University
Oct 1614:00
Conference pass

Title TBA

Bioprocessing: Upstream & Downstream
manufacturing & bioprocessing

Senior Representative, University of Sheffield

Oct 1614:00
Conference pass

Title TBA

Disease Areas: Autoimmune Disorders, Inflammation, and Neurodegenerative
antibodies
Steve Quayle, VP Research Biology & Translational Medicine, CUE Biopharma
Oct 1614:20
Conference pass

From DNA-encoded Chemical Libraries to radioligand diagnostics and therapeutics against cancer

Translational Research
immunotherapy
clinical trials
Oct 1614:20
Conference pass

IOMX-0675 - A LILRB1 and LILRB2 cross-specific antibody, effectively activating myeloid and lymphoid cells for potent tumor cell killing

Targeting Checkpoint Pathways
immunotherapy

IOMX-0675 is a fully human antibody, identified from iOmx's proprietary phage display library that antagonizes two immuno-suppressive receptors, LILRB1 and LILRB2, expressed on myeloid and lymphoid cells.

A highly differentiated binding profile and promising preclinical data support a best-in-class approach for IOMX-0675.

Oct 1614:20
Conference pass

Supporting Early-Stage Innovation at Johnson & Johnson Innovation

Workshops
antibodies
immunotherapy
biosimilars & late stage development
manufacturing & bioprocessing
clinical trials
Michael Huebner, Director, Country Lead, Johnson & Johnson Innovation
Oct 1614:20
Conference pass
Oct 1614:20
Conference pass

Title TBA

Bioprocessing: Upstream & Downstream
manufacturing & bioprocessing
Oct 1614:20
Conference pass

Title TBA

mAbs

Senior Representative, Bio-Techne

Oct 1614:20
Conference pass

Title TBA

Antibodies for Immunotherapy
antibodies
immunotherapy

Senior Representative, Twist Bioscience

Oct 1614:20
Conference pass

Title TBA

Disease Areas: Autoimmune Disorders, Inflammation, and Neurodegenerative
antibodies
Simone Bido, Researcher, IRCCS Ospedale San Raffaele
Oct 1614:20
Conference pass

Title TBA

Market Sustainability & Market Access
biosimilars;late-stage development

Reserved forOresta Piniazhko

Oct 1614:20
Conference pass

Towards more accessible AAV Gene Therapies by Capsid and Cell line Engineering

Cell & Gene Therapy
immunotherapy

Current limitations with AAV gene therapies include low manufacturing yields, poor quality of viral vectors and high required dosages to reach therapeutic effects. This results in low accessibility and sustainability of AAV gene therapies. In the GeneNova research milieu, we target several limitations in the AAV development pipeline, including manufacturing and quality control. By characterization and engineering of AAV capsids as well as the AAV manufacturing life cycle in HEK293 cells, we aim to generate more specific AAV vectors with increased producibility in cell lines adapted for viral vector manufacturing. In addition, we have developed a sample preparation and data analysis pipeline for quality control of encapsidated viral genomes by Oxford Nanopore sequencing.

Magdalena Malm, Lab Manager / Research Scientist, Royal Institute of Technology
Oct 1614:20
Conference pass

Utility of in silico tools in prediction of target engagement of antibody drugs in vivo

AI and Computational Discovery & Development
antibodies

Binding of antibody drugs to their targets is the first step towards the pharmacological effect. In silico PKPD models integrate binding parameters together with in vitro data to predict target engagement in vivo and support compound selection. We demonstrate how to use these models and their utility in antibody drug discovery.

Oct 1614:40
Conference pass

Biosimilar Market Sustainability | The edge (age) of reason?

Market Sustainability & Market Access
biosimilars;late-stage development
  • Major LoE events will occur in Europe in the next 10 years & evolving/ growing policy uncertainty for biosimilar developers
    • Overview of challenges, new and old
  • To deliver on the massive opportunity to 2032 and lower the risk and uncertainty, concerted actions across the policy landscape are needed
    • Horizon scanning to anticipate and prevent the biosimilar void
    • Streamlining clinical studies to accelerate biosimilar development and reduce costs
    • Convergence of biosimilar guidelines to expedite the entry of biosimilar medicines
    • Market conditions and procurement process improvements could facilitate greater availability, affordability, and plurality of supply
    • Clear regulatory pathways could incentivise development of next-generation biosimilar medicines
Oct 1614:40
Conference pass

BYON4228, a clinical stage potentially best-in class anti-SIRPα antibody for promoting antibody-mediated tumor elimination

Targeting Checkpoint Pathways
immunotherapy
Timo van den Berg, Senior Director Immuno-Oncology, Byondis
Oct 1614:40
Conference pass

Design of novel agents for solid tumours

Antibodies for Immunotherapy
antibodies
immunotherapy
Sophia Karagiannis, Professor Of Translational Cancer Immunology And Immunotherapy, King's College London
Oct 1614:40
Conference pass

Finance & Investment for Start Ups - Panel Discussion

Workshops
antibodies
immunotherapy
biosimilars & late stage development
manufacturing & bioprocessing
clinical trials
Dominik Escher, Managing Partner, Pureos Bioventures
Jae Sly, Chief Business Development Officer, Obatala Sciences
Gregory Fiore, Former CEO, Exacis Biotherapeutics
Sascha Oliver Buchner, Co-Founder and Partner, Forty51 Ventures AG
Oct 1614:40
Conference pass

Targeting the inside of cells with biologicals

mAbs
antibodies
Oct 1614:40
Conference pass

Title TBA

AI and Computational Discovery & Development
antibodies

Senior Representative, Schrödinger

Oct 1614:40
Conference pass

Translational development of a non-mAb protein

Protein Engineering
antibodies
Darko Skegro, Senior Investigator, Novartis Institutes for BioMedical Research
Oct 1615:00
Conference pass

Approaches to treating inflammation with monoclonal antibodies

Disease Areas: Autoimmune Disorders, Inflammation, and Neurodegenerative
antibodies
John Mccafferty, Founder and Chief Executive Officer, Maxion Therapeutics
Oct 1615:00
Conference pass

Combinatorial assembly of bispecific antibodies by modular, in vitro protein-protein-conjugation

Protein Engineering
antibodies
Andreas Stengl, Team Lead, Protein Engineering, Ludwig Maximilians University Munich
Oct 1615:00
Conference pass

Curative stem cell-based gene therapy for severe immune disorders

Cell & Gene Therapy
immunotherapy
Frank Staal, Professor of Molecular Stem Cell Biology, Leiden University Medical Center (Netherlands)
Oct 1615:00
Conference pass

In silico Formulation Development for Protein-Based Therapeutics

AI and Computational Discovery & Development
antibodies

Advances in molecular format complexity and the need for higher protein concentrations in biotherapeutics present significant formulation challenges. Ourin silicopipeline streamlines the development of stable liquid formulations, saving time and cost. By employing physics-based simulations, we predict protein behavior in diverse conditions, facilitating the pre-selection of optimal excipients and conditions for specific active pharmaceutical ingredients, thereby enhancing the success of formulation development

Oct 1615:00
Conference pass

Panel Discussion: Biosimilars and Market Sustainability

Market Sustainability & Market Access
biosimilars;late-stage development
Matthew Turner, Head government affairs Europe, ROW, Fresenius kabi
Michael Muenzberg, Business Development Officer, Rotterdam Biologics B.V.
Oct 1615:00
Conference pass

Reserved for University of Southampton

Targeting Checkpoint Pathways
immunotherapy
Stephen Beers, Professor of Immunology and Immunotherapy, University of Southampton
Oct 1615:00
Conference pass

Targeting Dendritic Cells to make Cancer Cell Death Immunogenic

Translational Research
immunotherapy

Adendra’s Cross Training Technology is aimed at enhancing cross presentation of antigens released by necrosis. This Ag-agnostic approach is designed to augment anti-cancer immunity, prevent acquired resistance and enhance epitope spreading.

Oct 1615:00
Conference pass

Title TBA

Bioprocessing: Upstream & Downstream
manufacturing & bioprocessing
Divor Kiseljak, Chief Operating Officer, ExcellGene
Oct 1615:00
Conference pass

Title TBA

mAbs
antibodies

Senior Representative, Refeyn

Oct 1615:20
Conference pass

Auditory Gene Therapy at Regeneron

Cell & Gene Therapy
immunotherapy
Meghan Drummond, Director, Regeneron Genetic Medicines, Head of Auditory Sciences, Regeneron
Oct 1615:20
Conference pass

Comprehensive Artificial Intelligence Solutions for Protein Engineering

AI and Computational Discovery & Development
antibodies

AlphaFold2 focuses on predicting the three-dimensional structures of proteins, yet knowing a protein’s structure doesn’t guarantee functional specificity. Over the past three years, our team has developed a universal artificial intelligence platform for protein engineering, known as the Pro series, built on a pre-trained, large-scale protein language model. Unlike AlphaFold2, the Pro series excels in designing proteins from sequences directly to functions. It learns from existing protein sequences and structural features, identifying the natural relationships between sequences and functions. This innovative approach enables the creation of diverse, high-quality protein products with improved stability, activity, and functionality.

Oct 1615:20
Conference pass

Finance & Investment Q+A - Ask the Investors

Workshops
antibodies
immunotherapy
biosimilars & late stage development
manufacturing & bioprocessing
clinical trials
Dominik Escher, Managing Partner, Pureos Bioventures
Gregory Fiore, Former CEO, Exacis Biotherapeutics
Sascha Oliver Buchner, Co-Founder and Partner, Forty51 Ventures AG
Jae Sly, Chief Business Development Officer, Obatala Sciences
Oct 1615:20
Conference pass

Improved cell line development techniques for recombinant protein production

Bioprocessing: Upstream & Downstream
manufacturing & bioprocessing
Oct 1615:20
Conference pass

Novel immunotherapies for treating solid tumours

Antibodies for Immunotherapy
antibodies
immunotherapy
Stefano Gullà, CSO, Kling Biotherapeutics
Oct 1615:20
Conference pass

Reserved for Pilatusbio

Translational Research
immunotherapy
Oct 1615:20
Conference pass

Reserved for University of Zurich

Targeting Checkpoint Pathways
immunotherapy
Ulisse Salazar, PhD Candidate, University of Zurich
Oct 1615:20
Conference pass

Revisiting Biomarkers in Lupus Nephritis

Disease Areas: Autoimmune Disorders, Inflammation, and Neurodegenerative
antibodies

In this presentation, we will revisit the spectrum of biomarkers for lupus nephritis (LN), evaluating traditional perceptions and exploring novel insights. Through a critical examination of both classical and emerging biomarkers we aim to enhance and refine accessible diagnostic strategies in LN management.

Oct 1615:20
Conference pass

Superior antiviral antibodies from cognate recombinant antibody repertoires of human donors

mAbs
antibodies
Oct 1615:20
Conference pass

The influence of DM1, MMAE, and MMAF on biodistribution and pre-clinical therapeutic efficacy of affibody-based drug conjugates

Protein Engineering
antibodies
Oct 1616:30
Conference pass

Anti-tau immunotherapy targeting the core demonstrates potential best-in-class potency for indication of Alzheimer’s disease

Antibodies for Immunotherapy
antibodies
immunotherapy
Lewis Penny, Senior Scientist and Fluid Biomarkers, Taurx Therapeutics Ltd
Oct 1616:30
Conference pass

Biosimilars in Denmark. The road to high market access

Market Sustainability & Market Access
biosimilars;late-stage development
  • A fundamental and thorough belief in science
  • A rational and efficient procurement system
  • An involvement of all relevant stakeholders
  • Available and reliable information to patients
  • Application of the lessons learned

Oct 1616:30
Conference pass

Developing peptide barcoded antibodies for precision medicine

Nanobodies, peptides, and non-classical antibody formats
antibodies
Oct 1616:30
Conference pass

Mammalian highthroughput expression platform (mHTX) for protein reagent generation and beyond

Protein Engineering
antibodies

This presentation will cover:

· Introduction to the mHTX process that allows for design, generation, and expression tests of hundreds of constructs in parallel, followed by purification screen for selected panel of up to 96 molecules.

· Challenges encountered while developing robust, high-throughput and automation friendly methodologies as well as data capture solutions enabling efficient data mining and reuse.

· Examples how mHTX was instrumental for delivering both secreted and membrane protein reagents as well as identifying optimal constructs for cellular reagents generation.

Oct 1616:30
Conference pass

New class of Antigen-specific Cancer Active Immunotherapies based on an off-the-shelf Antigen Presenting Cell line (PDC*line)

Therapeutic Vaccine Development
immunotherapy
eric Halioua, President & Chief Executive Officer, PDC*line pharma SA
Oct 1616:30
Conference pass

ON104: Pioneering Treatment for oxMIF-Driven Autoimmune Diseases

Disease Areas: Autoimmune Disorders, Inflammation, and Neurodegenerative
antibodies
immunotherapy
Michael Thiele, Founder and Chief Scientific Officer, OncoOne Research & Development GmbH
Oct 1616:30
Conference pass

Reserved for UDIBI

Antibody Library Development
antibodies
immunotherapy
Juan Carlos Amalgro, R&D Director, UDIBI-National Polytechnique Institute
Oct 1616:30
Conference pass

Systems biology approaches in improving quality and titer of biologics

Bioprocessing: Upstream & Downstream
manufacturing & bioprocessing
Oct 1616:30
Conference pass

Title TBA

Trial Planning: Site Selection and Data Management
clinical trials
Haneen Njoum, Senior Data Scientist, Sanofi
Oct 1616:50
Conference pass

A Phase 3 personalized vaccine platform technology for cancer and infectious disease

Therapeutic Vaccine Development
immunotherapy
Oct 1616:50
Conference pass

Development of NANOBODY® therapeutics for the treatment of hematological diseases

Nanobodies, peptides, and non-classical antibody formats
antibodies
Oct 1616:50
Conference pass

Early clinical results of an anti-CD89 antagonist for treating IgA-mediated autoimmune and fibrotic diseases

Disease Areas: Autoimmune Disorders, Inflammation, and Neurodegenerative
antibodies
immunotherapy
Louis Boon, Chief Scientific Officer and Board member JJP Biologics, JJP Biologics
Oct 1616:50
Conference pass

Optimised bioprocessing aids for manufacturing biotherapeutics

Bioprocessing: Upstream & Downstream
manufacturing & bioprocessing

Bioprocessing aids such as surfactants play a key role in maximising the output of production cell lines,alongside their importance in producing and maintaining a safe, efficacious, and high purity drug substancethroughout the downstream process. In this talk we shall discuss how Croda Pharma has developed andoptimised specific surfactants for upstream processing to insure consistency in performance and quality. Indownstream we will demonstrate how surfactants can be used for processes such as viral inactivation, cell lysis, antibody stability and purification. Learn more about the cutting-edge advancements that set CrodaPharma apart as an integral supplier to the biopharmaceutical industry, helping us to empower biologicsdelivery.

Oct 1616:50
Conference pass

Preparing for, and Running a Successful Launch

Market Sustainability & Market Access
biosimilars;late-stage development
Oct 1616:50
Conference pass

The Clinical Research Data Revolution: EHR-to-EDC Delivers Transformative Results

Trial Planning: Site Selection and Data Management
clinical trials;antibodies;immunotherapy

Electronic Health Records (EHR) to Electronic Data Capture systems (EDC) enables clinical research coordinators to transfer of regulatory-grade data from EHR to a sponsor’s study database in moments – without the need for time-consuming and error-prone data duplication. The technology dramatically reduces manual data entry, eliminates data queries, re removes site burden, and accelerates timelines, particularly in oncology trials where data requirements have tripled over the last 10 years. Conducted with patient consent and quality checks, EHR-to-EDC enhances data quality and patient safety while significantly cutting the costs associated with Source Data Verification (SDV). Featuring Archer, the system-agnostic and scalable solution used by a number of leading research sites, this presentation will demonstrate the substantial efficiency gains and transformative ability of EHR-to-EDC technology to accelerate the delivery of clinical trials, ultimately enabling new medicines to reach patients faster.

Key topics covered:

  • Setting the Scene
  • Overview of EHR-to-EDC technology
  • 5000 hours & revisit value propositions
  • Archer EHR-to-EDC platform
  • Results of eSource-enabled on-going trials
  • Outlook & Conclusions
  • Q&A
Mats Sundgren, Senior Industry Scientific Director, i-hd (The European Institute for Innovation through Health Data)
Dan Hydes, President, IgniteData
Oct 1616:50
Conference pass

Title TBA

Protein Engineering
antibodies

Senior Representative, Nanotemper

Oct 1616:50
Conference pass

Title TBA

mAbs
antibodies

Senior Representative, Alloy Therapeutics

Oct 1617:10
Conference pass

An automated transient transfection platform for the expression of complex, multispecific antibodies

Protein Engineering
antibodies

Production of candidates, control molecules and targets at a preclinical stage is a critical activity for the development of therapeutic antibodies. Automation of certain processes (e.g., transfection, purification) can help achieve high protein production reproducibility and throughput to facilitate the identification of lead candidates. The Tecan Fluent liquid handling system was customized to perform automated transient transfection in 50-mL TubeSpin and plate formats. This platform is adapted for the transfection of complex, multispecific antibodies in the same run and led to improved titers compared to manual transfection.

Andreas Reimann, Principal Scientist, Ichnos Glenmark Innovation
Oct 1617:10
Conference pass

Engineering novel monoclonal antibodies

mAbs
antibodies
Dimitri Bieli, EVP Molecular Biology, Mabylon AG
Oct 1617:10
Conference pass

Title TBA

Antibodies for Immunotherapy
antibodies
immunotherapy

Senior Representative, LightCast

Oct 1617:10
Conference pass

Title TBA

Antibody Library Development
antibodies
immunotherapy
Philipp Holliger, Program Leader, M.R.C. Laboratory of Molecular Biology
Oct 1617:30
Conference pass

An antibody-like format for TCR base bispecifics

Antibodies for Immunotherapy
antibodies
immunotherapy
Colette Johnston, VP - Head of Product Platform Research, Enara Bio
Oct 1617:30
Conference pass

Clinical update on the DC targeting melanoma vaccine, SCIB1 and the Modi-1 vaccine targeting citrullination

Therapeutic Vaccine Development
immunotherapy
Oct 1617:30
Conference pass

Considerations for biosafety testing of cell and gene therapies

Bioprocessing: Upstream & Downstream
manufacturing & bioprocessing

Regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) impose stringent limits on the amount of microbial contaminants and impurities present during the manufacturing of biological medicines and vaccines, and present in cell and gene therapy products. These regulations ensure sterile products and thus patient safety. To establish that the testing procedures are accurate, regulatory authorities require proof of testing before clinical trials can be approved. Consequently, all components of the manufacturing process must undergo extensive safety testing to demonstrate identity, stability, and purity. This talk will review general approaches to biosafety testing, with specific focus related to cell (for example CAR-T cell therapies) and gene therapies.

Key Discussion Points:

· Cell bank & Virus Seed Biosafety & Characterisation, including a brief overview of

o Identity Testing

o Genetic Stability

o Purity (freedom from bacteria, fungi and mycoplasma)

o Virus Safety will be the focus of the talk, considering

§ Broad specificity approaches in vitro, in vivo, NGS non-targeted

§ Retroviruses – infectivity /EM/RTase/PCR

§ Species specific - PCR / targeted NGS / 9CFR / MAP / HAP

· How are viruses detected?

· Considerations for viral vectors

Oct 1617:30
Conference pass

Exploring the potential of single domain antibodies for cancer immunotherapies and imaging

Nanobodies, peptides, and non-classical antibody formats
antibodies
Oct 1617:30
Conference pass

New opportunities to overcome the efficacy and toxicity problems of immunotherapies with affinity-switchable antibodies

Protein Engineering
antibodies
Oct 1617:30
Conference pass

Title TBA

Disease Areas: Autoimmune Disorders, Inflammation, and Neurodegenerative
antibodies
immunotherapy
Valentin Bruttel, CSO, Toleris
Oct 1617:30
Conference pass

Title TBA

Market Sustainability & Market Access
biosimilars;late-stage development
Bert Thomas, Senior Vice President Of Business Development, Bio-Thera Solutions
Oct 1617:50
Conference pass

ARM-X: An adaptable anti-cancer vaccination platform

Therapeutic Vaccine Development
immunotherapy

This presentation shows how AccuTOX, an Accum variant, can reprogram mesenchymal stromal cells to behave as antigen presenting cells in the context of cancer immunotherapy. As such, this vaccination platform can be adapted to any cancer patient or indication given that we have access to tumor lysate.

Moutih Rafei, Chief Scientific Officer, Defence Therapeutics
Oct 1617:50
Conference pass

Identification of novel target biology as well as antibodies from patients

mAbs
antibodies
Francesca Nice, Senior Scientist, Alchemab Therapeutics Ltd
Oct 1617:50
Conference pass

Predicting Intestinal Therapeutic Protein-Target Engagement in Inflammatory Bowel Disease with a Minimal Physiologically-based Pharmacokinetic (PBPK) Model

Disease Areas: Autoimmune Disorders, Inflammation, and Neurodegenerative
antibodies
Oct 1617:50
Conference pass

Screening flows for the identification of potent and developable multispecific antibodies

Protein Engineering
antibodies

Multispecific antibodies offer unique opportunities through the combination of binding arms to different epitopes or antigens. These engineered antibody formats can result in specificities or functions that are unattainable to classical monovalent antibodies. To generate successful drugs, multispecific antibodies need to be safe and active but also developable and manufacturable. This presentation explains how we screen through large panels of multispecifics that meet all these requirements.

Oct 1617:50
Conference pass

The Role of Inflammatory Redox Environment on The Efficacy and Safety of anti-TNF Therapies in Rheumatoid Arthritis

Antibodies for Immunotherapy
antibodies
immunotherapy

Monoclonal Antibodies (mAbs) have revolutionised the treatment of autoinflammatory diseases and cancers, but they are not 100% effective. I will discuss how thioredoxin, a redox enzyme, heavily secreted in the joints of Rheumatoid Arthritis patients can modify mAbs altering their structure and function thus reducing their clinical efficacy.

Oct 1617:50
Conference pass

Title TBA

Trial Planning: Site Selection and Data Management
clinical trials
Oct 1617:50
Conference pass

Title TBA

Market Sustainability & Market Access
biosimilars; late stage development
Andres Gassert, Director, Former Dicrector at STADA, Observa

Create your personal agenda –check the favourite icon

Oct 179:00
Conference pass

Value-based framework for prices that align with value and ability to pay

Evidence, Pricing, and Access
biosimilars;late-stage development
  • Patient access inequities, delays and the unavailability of medicines
  • Challenges for health system constraints and resources
  • Novel payment and pricing models
Oct 179:05
Conference pass

Title TBA

Keynotes
immunotherapy

Reserved for Senior Representative, Regeneron

Oct 179:20
Conference pass

Experiences with Launching a Gene Therapy

Evidence, Pricing, and Access
biosimilars;late-stage development;immunotherapy
Oct 179:30
Conference pass

Precision medicine – limitations and learnings in (ultra-)rare diseases

Keynotes
immunotherapy
Thomas Hach, ED, Novartis
Oct 179:30
Conference pass

Trends over time in the development of non-standard antibody formats

Keynotes
antibodies
Oct 179:40
Conference pass

What makes your antibodies happy if not (anti-)genius purification

Bioprocessing: Upstream & Downstream
manufacturing & bioprocessing
Oct 179:55
Conference pass

Keynote Panel Discussion: The accessibility of curative gene therapies

Keynotes
immunotherapy
Frank Staal, Professor of Molecular Stem Cell Biology, Leiden University Medical Center (Netherlands)
Oct 1710:20
Conference pass

MCC process implementation - from batch to continuous

Bioprocessing: Upstream & Downstream
manufacturing & bioprocessing

Moving forwards to continuous processes becomes nowadays a critical factor to ensure competitivity of the biopharma industry, especially to produce monoclonals antibodies and more recently biosimilars. One of the key bottlenecks in biopharmaceutical production could be attributed to the capture step using the protein A resin which has moderate binding capacities together with high a price. This can be tackled by switching from typical batch operation to continuous processing. To address upcoming biomanufacturing needs, the Mobius ® Multi Column Capture System was developed for large scale continuous capture operation. This study describes how to scale and mimic continuous capture starting with a standard bench-scale system (small scale) demonstrating benefits of continuous operations (buffer and resins saving together with enhanced productivity).

Oct 1711:20
Conference pass

Biosimilar Manufacturing

Manufacturing
biosimilars
Andreu Soldevila, Chief Executive Officer, SYNA therapeutics
Oct 1711:20
Conference pass

Challenges/Considerations for formulation development in case of different devices in QTPP

Formulation, Fill/Finish & Supply Chain
manufacturing & bioprocessing
Ilona Vollrath, Senior Scientist, Roche
Oct 1711:20
Conference pass

Current Landscape of Cell and Gene Therapy

Cell & Gene Therapy
immunotherapy
Oct 1711:20
Conference pass

Diligent design of antibody-antisense oligonucleotide conjugate architecture enables peripheral drug delivery to the brain

Therapeutic Vaccine Development
immunotherapy

The ability to delivery antisense oligonucleotides (ASOs) to the central nervous system after peripheral administration would greatly enhance the impact of this modality on the clinical landscape of neurological disorders as the currently established intrathecal route puts a heavy burden on patients and healthcare systems. As a potential solution, the principal feasibility of using an antibody (a so-called brain shuttle) to carry the ASO across the blood-brain barrier (BBB) has been shown in seminal work by various groups. In this talk, we will share a diligent approach to designing such antibody-ASO conjugates with drug-like properties, beyond the published proof-of-concept molecules. As a good PK profile has been established in the past as a main driver of successfully trans-BBB transport, this aspect was a first major focus when deciding on architectural aspects such as conjugation technology, conjugation site and linker selection. To account for the inherent complexity of antibody-ASO conjugates when it comes to manufacturing, design choices regarding chemistry, manufacturing and controls (CMC) were a second main topic and included conjugation sequence, linker chemistries and the optimization of reaction conditions. Building on this knowledge, we combined a disease relevant transcript-targeting ASO with a TfR-based brain shuttle and successfully tested the performance of such a conjugate in vitro and in vivo. We believe that our findings have the potential to serve as a basic blueprint for antibody-ASO conjugates in general and thus will greatly accelerate the research currently happening in the field.

Oct 1711:20
Conference pass

Engineering monoclonal antibodies against Tumor-associated carbohydrate antigens (TACAs) for cancer immunotherapy

Protein Engineering
antibodies
  • The mAb TCX-101 showed a full recovery of activity after humanization and engineering.
  • TCX-101 shows interesting preclinical efficacy profile in breast and lung cell line-derived xenografts.
  • A mAb against another target, TCX-201, shows attractive in vitro data and is going through similar process of engineering.
Oct 1711:20
Conference pass

Immunogenicity has a complicated relationship with Self

Immunogenicity
antibodies
Bernard Maillere, Head of laboratory, CEA
Oct 1711:20
Conference pass

Mass Spectrometry applications for Host Cell Protein Analysis in biopharmaceuticals

Proteomics & Mass Spectrometry
antibodies

· Host Cell Proteins (HCP) are process related impurities that can impact activity, safety, and stability of the drug.

· Mass Spectrometry is a useful tool that recently is gaining a lot of importance in HCP characterization

· Applications of LC-MS in HCP analysis during development stage can help the identification of the best downstream process parameters.

Oct 1711:20
Conference pass

OSE- Cytomask® Technology: Cis-Demasking Cytokine Technology for targeted Delivery

Antibodies for Immunotherapy
antibodies
immunotherapy

OSE-Cytomask technology allows a strict CIS-delivery of the cytokine by masking cytokine on peripheral cells while unmask the cytokine specifically on immune cells expressing the appropriate target

New linker technology allowing on demand cytokine signaling on the right cells and at the right site without use of cleavable linker

Improves therapeutics index of cytokine by reducing off-tumor peripheral toxicity while maintaining high activity on activated immune cells into TME and lymph noes

Oct 1711:20
Conference pass

Title TBA

CMC, Developability & Analytics
antibodies
Nicolas Lebesgue, Principal Scientist, Novartis Pharma AG
Oct 1711:40
Conference pass

Current Approach to Immunogenicity risk assessments for multi-specific and non-antibody scaffolds

Immunogenicity
antibodies
Oct 1711:40
Conference pass

Merus Class of Bispecific ADC (ADClonics) to Achieve Improved Binding Selectivity, Internalization, and Tumor-Cell Killing

Antibodies for Immunotherapy
antibodies
immunotherapy

Merus Biclonics fully human IgG1 large-scale screening bispecific antibody platform has given rise to multiple clinically active cancer drug candidates, and can also facilitate the discovery of optimal candidates for improved ADC performance and therapeutic index.

Here we demonstrate the compatibility and favorable pharmaceutical properties of Merus Biclonics conjugated with a range of linkers and payloads to generate ADClonics, with improved binding selectivity, internalization, and cancer-cell killing activity

Oct 1711:40
Conference pass

Title TBA

Proteomics & Mass Spectrometry
antibodies
Thierry Besson, Senior scientist, Novartis
Oct 1711:40
Conference pass

Two Targets, Two Signals: A Combinatorial Concept for Cancer Therapy with Bispecific Antibodies Directed to CD3 and CD28

Cell & Gene Therapy
immunotherapy

Success of bispecific antibodies (bsAbs) in solid tumors is still limited due to the lack of (i) accessibility of the tumor site for immune effector cells, (ii) sufficiently tumor-specific target antigens and (iii) missing costimulatory “signal 2” to enable long-lasting T cell activation. Our approach overcomes these limitations by a combination of functionally interrelated bsAbs that target two different antigens on the tumor and the tumor vasculature, and stimulate CD3 and CD28 on T cells.

Oct 1712:00
Conference pass

A Developability Screening Cascade to Advance Multi-specific Therapeutic Antibodies to the Clinic

CMC, Developability & Analytics
antibodies

The flexible BEAT® platform enables 5 or more functional modules to be combined into a single molecule. The biophysical properties of a complex multi-specific immune cell engager antibody can be quite different to the sum of its parts. Therefore, a developability screening cascade was developed starting from Fab or cytokine selection to multi-specific lead candidate selection. This was applied to identify ISB 2001, a first-in-class tri-specific BCMA and CD38 T cell engager now advancing in the clinic to treat Multiple Myeloma.

Amélie Laurendon, Principal Scientist, Ichnos Glenmark Innovation
Oct 1712:00
Conference pass

Clinical mass spectrometry

Proteomics & Mass Spectrometry
antibodies

Mass spectrometry (MS) encompasses a very important panel of tools to fulfill unmet needs in personalized medicine. At any stage of the life cycle of a pathology, from diagnosis to surgery and therapy, adapted combinations of analytical modalities such as sampling, sample processing and MS instrumental setups represent unique analytical options to influence clinical decisions. In this presentation, a snapshot of selected MS methods in personalized medicine will be described. The presented MS applications range from proteomic profiling of formalin-fixed and paraffin-embedded (FFPE) histological samples for diagnostic purposes, to on-surface analyses of tissue sections during surgery for extemporaneous surgical decisions and patient plasma for high-throughput therapeutic drug monitoring (TDM).

Oct 1712:00
Conference pass

HDPs ADC Payload Toolbox – Multiple Options to Fight Cancer

Antibodies for Immunotherapy
antibodies
immunotherapy
  • Introducing Amanitin as an ADC Payload: a novel MoA offering new options in cancer treatment
  • Clinical Update on HDP-101 targeting BCMA: the first ATAC now undergoing dose escalation in Myeloma patients
  • Multimeric Linker-Exatecan-based ADCs: A new therapeutic approach for treating solid tumors

Oct 1712:00
Conference pass

mRNA Delivery of Therapeutic Proteins—the FDA Perspective

Therapeutic Vaccine Development
immunotherapy
Sarfaraz Niazi, PROFESSOR, University of Illinois
Oct 1712:20
Conference pass

A FAP X LTBR bispecific molecule conditionally activating LTBR to elicit formation of Tertiary Lymphoid Structures and promote tumour immunity

Antibodies for Immunotherapy
antibodies
immunotherapy
Ann White, Senior Director of Translational Science, Mestag Therapeutics
Oct 1712:20
Conference pass

Immunotherapeutic targeting of Fibroblast Activation Protein (FAP) in treatment refractory Glioblastoma using novel CAR-T cell therapy

Cell & Gene Therapy
immunotherapy
Oct 1712:20
Conference pass

Panel Discussion: Optimising RNA-based Cancer Vaccine Design

Therapeutic Vaccine Development
immunotherapy

Speakers TBA

Oct 1712:20
Conference pass

Panel: Pricing Strategies and Affordability

Evidence, Pricing, and Access
biosimilars; late stage development
Oct 1712:40
Conference pass

Gas phase stability of glyco-engineered therapeutic pentraxins

Proteomics & Mass Spectrometry
antibodies
Felix Kuhne, Process Development Scientist, Roche
Oct 1712:40
Conference pass

Molecular prediction and monitoring of clinical response to anti-PD-1/anti-PD-L1 immune checkpoint inhibitors: new perspectives for precision medicine and mass spectrometry-based investigations.

Antibodies for Immunotherapy
antibodies
immunotherapy

Immune checkpoint inhibitors (ICIs), such as monoclonal antibodies targeting the program cell death 1 protein (PD-1) or its ligand (PD-L1), are among the most frequently used immunotherapies in oncology. In precision medicine, the current approaches to predict patient response to treatment appear limited by the existence of interfering events that influence ICI efficacy, such as off-site binding and in vivo chemical modifications, degradation, and aggregation of the ICI and its molecular target. There is thus a need for better predictive and monitoring markers of therapy efficacy or resistance. In this presentation, we will review the current knowledge of ICI disposition and present perspectives for mass spectrometric quantification of anti-PD-1 ICIs and their circulating molecular targets in plasma from patients with non-small cell lung cancer.

Oct 1712:40
Conference pass

Next-Generation Biologics Engineering Platform: From Conventional Screening to Early Multiparameter Deep Characterization and Machine Learning-Based Properties Prediction

Protein Engineering
antibodies

The presentation will focus on a new end-to-end high-throughput biologics engineering platform. It describes the generation and multiparameter characterization of large panels of biological molecules enabling short design and learning cycles. Here, we report on how we apply this new high-throughput engineering platform for parallel multiparametric optimization of protein therapeutics and how these high-quality datasets can be applied for machine learning applications.

Oct 1712:40
Conference pass

Title TBA

CMC, Developability & Analytics
antibodies
Tanima Bose, Senior Principal Scientist, Analytical lead, Novartis
Oct 1714:25
Conference pass

Panel Discussion: Biologics and the Patient: Delivering better access for oncology

Keynotes
biosimilars; late stage development
This panel will explore challenges around access and patient centric development across the value chain

  • Meeting patient needs in development: personalised and precision medicine
  • Access considerations in translational and clinical development
  • Delivering the therapy to patients: patient involvement in bringing a product to market

Cost-saving potential of biosimilars

last published: 21/Jun/24 15:45 GMT