2018 Agenda

 

Switzerland, 29 - 30 October 2018

Schedule

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Oct 2908:55
Conference pass
Oct 2908:55
Conference pass
Oct 2909:00
Conference pass

Novartis: CART Innovation Journey

Keynotes
  • From academic lab to FDA approval: a 5 yr journey
  • Tisagenleucleceul a transformative therapy in ALL and DLBCL
  • Key challenges for global access to patients
  • Future innovations in CART
Oct 2909:00
Conference pass

What’s the most effective model for an organisation; internal, external, or hybrid?

Clinical Trials - plenary
  • A case study of Merck’s shift from outsourcing to an internal focused model
  • Highlighting the pros and cons of different approaches
Oct 2909:00
Conference pass

The totality of evidence for the approval of biosimilar applied

Keynotes
  • The concept of totality of evidence applied
  • Case studies for the development and assessment of biosimilar etanercept and rituximab
  • Tailoring biosimilar development in the future
Oct 2909:10
Conference pass

Targeted drug delivery for cancer therapy

Keynotes
  • Overview of antibody drug conjugates
  • Challenges to the field
  • Recent advancements in delivery, specificity, and optimizing activity
Oct 2909:20
Conference pass

Precision medicine in the era of immunotherapy

Keynotes
  • Why do we need new biomarkers?
  • Is tumor mutation burden the better single marker?
  • Do we need a multiparameter biomarker analyses or composite biomarker?
  • What are some potential new biomarkers?
Oct 2909:20
Conference pass

What outsourcing model to choose when going external?

Clinical Trials - plenary
  • What are the different Outsourcing models to choose from; Insource - Functional Service Provider – Fully Outsourced – Advantages and Disadvantages
  • Why outsource – what is the objective?
  • What to consider – Size does matter – Regulatory Environment – Expectations from Regulators on Oversight after ICH E6 (R2)
Oct 2909:20
Conference pass

The evolving Biosimilars landscape – key biosimilar trends and dynamics across Europe

Keynotes
  • Biosimilars as a mean to increase patient access to treatment
  • The role of education and incentives in building demand-side policies
  • The Value Proposition from Biosimilars
Erin Federman, VP, Head of Biologics, Boehringer Ingelheim
Oct 2909:35
Conference pass

Advancements in antibody drug conjugates: therapeutic challenges of safety and efficacy

Keynotes
  • Next generation ADCs with improved antibodies, payload, linkers, conjugation technology
  • Lessons learned from the clinical development of ADCs
  • Maximizing efficacy while minimizing toxicities
  • ADC disposition, PK-PD challenges
  • Translational challenges to ADC development
  • Looking at the future of ADCs
Oct 2909:40
Conference pass

Senior-level panel: Immunotherapy strategies for oncology

Keynotes
  • Short 5 minute presentations outlining strategies developing immunotherapy for oncology, given by 6 high level representatives from differing company sizes
  • Panel discussion talking about how strategies for cancer immunotherapy differ between companies, and advantages and disadvantages for both
  • Top level speakers representing big pharma, large biotech and mid-sized biotech
Oct 2909:40
Conference pass

International stakeholders panel discussion: What lessons have we learnt in the last 12 months?

Keynotes
Consisting of industry panellists, physicians, pharmacists, patient advocacy groups, payers, regulators and health authorities, the 360° Perspective Panel allows the whole industry to come together to discuss and debate the sector’s most pertinent topics of the day.
  • Experiences with Rituximab: how far from the uptake in the oncology space was Rituximab and why?
  • What lessons have we learnt with the move of biosimilars into oncology?
  • How does this impact on current understanding and future predictions of biosimilars uptake?
  • What does this mean for the recent European patent expiry of adalimumab?
  • How this will impact for adalimumab launch and for expectations over the next 6-12 months?
  • We have evidence that biosimilars impact healthcare systems sustainability, how do we then prove that this can or will improve patient access to the biosimilar opportunity?
Oct 2910:00
Conference pass

Formulation development cornerstone: building a successful journey from expression to patient

Keynotes
  • Discuss the critical aspect of formulation development to ensure the successful manufacturing and delivery of protein therapeutics
  • Provide an overview of the workflows and philosophies that are being adopted to ensure efficient, yet scientifically sound formulation selection
  • Share some experimental examples of the importance of considering a protein’s unique characteristics when selecting a final formulation
Oct 2911:30
Conference pass

Improving engagement with investigators and patients

Clinical Trials - plenary
  • Improving the effectiveness of investigator meetings
  • Collaborating with investigators using digital technology
  • Engaging with patients in clinical trials
Oct 2911:35
Conference pass

Plenary round table session

Keynotes
Table 4: Precision medicine in the era of Immunotherapy
Table 5: Scale-up and commercialisation of cell therapy products
Marc Kamp, Director CAR T Product Distribution and Supplier Quality Management, Kite Pharma, a Gilead Company
Table 6: Targeted vs no targeted treatment in arthritis diseases
Oct 2911:35
Conference pass

Plenary roundtable session

Keynotes
Table 1: Analytical and structural characterization of mAbs, biosimilars, ADCs, BsAbs, pAbs
Table 2: Indication selection/expansion and early biomarker discovery for bispecifics
Table 4: Muilti-specific formatomics – how much format diversity is required to address biology and developability?
Table 5: Therapeutic challenges of safety and efficacy in ADCs
Table 6: The role of bioassays in assessment of critical quality attributes
Table 8: Antibody discovery platforms: current trends
Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme
Oct 2911:35
Conference pass

Breakout sessions

Keynotes
  • WORKSHOP 1
Understanding issues around physician education and uptakeHost: Jonathan Underhill, Medicines Clinical Adviser, Medicines and Technologies Programme (MTP), NICEJames Kent, Regional medicine procurement specialist East of England, NHS EnglandTim McCarthy, Deputy Chief Pharmacist., The Royal Marsden NHS Foundation Trust
  • WORKSHOP 2
WHO Guidelines on Global reference productSuzette Kox, Senior Director International - Biosimilar Medicines Group, Medicines for EuropeMareike Ostertag, Director Science & Regulatory policy, Novartis
  • ROUNDTABLE 1
Tackling IP and Legal challengesTed Mathias, Partner, Axinn, Veltrop & Harkrider LLP
  • ROUNDTABLE 2
Working with multi-cultural, global virtual teams to develop biosimilar products – Challenges and solutionsShantreddy Soogareddy, Associate Director External R&D, Dr. Reddy's Laboratories SA.
  • ROUNDTABLE 3
Characterisation and analytics of products on the marketTudor Arvinte, Owner, Therapeomic Inc.
  • ROUNDTABLE 4
Market accessAdam Levysohn, Sr Director Market Access Biosimilar, Biogen
  • ROUNDTABLE 5
How to deal with competition and set yourself apart from other biosimilar companiesIf you are interested in being involved, please contact Derek Cavanagh at derek.cavanagh@terrapinn.com or +44 207 092 1297
  • ROUNDTABLE 6
InterchangeabilityMathias Flume, Head of Drug Department, KVWL
  • ROUNDTABLE 7
Challenging current FDA guidelines for BiosimilarsSarfaraz Niazi, Chairman, Professor, Karyo Biologics/University of Illinois
Oct 2911:50
Conference pass

Personalisation of Research

Clinical Trials - plenary
  • Digital Platforms
  • Transparency and Openness
  • Adoption of new treatments
Oct 2912:10
Conference pass

Patient centricity and clinical innovation in oncology trials

Clinical Trials - plenary
  • What patients actually want to read about in the informed consent documents
  • The value of patient input at all stages of a clinical programme, including protocol development
  • Insights from completing patient surveys mid-study
  • Novel approaches to deliver early phase trials that maximise patient benefit
Oct 2912:30
Conference pass

Engaging patient by providing access to patient data access in clinical trials

Clinical Trials - plenary
  • What patients wants in a clinical trial
  • Providing access to patient data while in a study
  • Global implementation of data access through the Janssen Global Trial Community
  • How a consortium creates new opportunities and greater value by increasing speed of innovation, adoption and responsiveness to customers
Oct 2914:09
Conference pass

Chair: Ian Henshaw, Global Head of Biogen’s Biosimilars Unit, Biogen

Biosimilars - Sustainability/Development and manufacturing
Oct 2914:10
Conference pass

Protein engineering to increase the potential of a therapeutic antibody Fab for long-acting delivery to the eye

Antibodies - Protein Engineering
  • Formulation and stability pose challenges for ocular biotherapeutics
  • Selection or re-engineering of protein therapeutics may be required for ocular delivery
  • Antibody Fab formulation and/or conjugation can be used to alter dosing frequency
Oct 2914:10
Conference pass

Selective SIRP-alpha antibodies: next-generation checkpoint inhibitors of myeloid cells

Immunotherapy - Immune Checkpoint Inhibitors
  • SIRPα is known as a myeloid cells checkpoint controlling macrophage phagocytosis of CD47-expressing targets.
  • SIRPα also controls antigen uptake, processing and cross-presentation in dendritic cells, as well as chemokine secretion and motility of macrophages, thereby indirectly modulating intensity and location of T cell responses.
  • Selective SIRPα antagonist antibodies have been shown to increase anti-tumor T cell responses in orthotopic cancer models, to increase intratumor cell migration and to synergize with anti-PD1/PDL1 antibodies.
  • Boehringer Ingelheim and OSE Immunotherapeutics entered into a global license and collaboration agreement in immuno-oncology to develop OSE-172/BI765063, a novel selective SIRPα antagonist antibody.
Oct 2914:10
Conference pass

Case Study: Biosimilar development in Russia and EuroAsian Union

Biosimilars - Market Access and Commercialisation
Oct 2914:10
Conference pass

Gene-edited CAR T

Immunotherapy - Cell Therapy
  • Allogenic CAR T-cells have shown they can work in the clinic
  • We have pipeline covering various indications in the Hem oncology space
  • TALEN(r) mediated gene editing allows addressing CAR T-cell persistence and provides solutions for solid tumors
  • Acceleration of manufacturing production
Oct 2914:10
Conference pass

Immunoglobulin domain interface exchange as a platform technology to engineer bispecific antibodies

Antibodies - Bispecifics
  • Bispecific antibodies based on heavy chain hetero-dimerization
  • Common light chain format
  • Clinical stage antibodies
Oct 2914:10
Conference pass

Antibody-tubulysin conjugates display activity in MDR+ and bystander activity models

Antibodies - Armed Antibodies
  • Tubulysin M and stabilized analogues were compared as ADC payloads
  • Quaternary ammonium-linked tubulysin linkers were evaluated for activity in models of multidrug resistance and antigen-heterogeneity
  • Tubulysin linkers are a promising payload class, combining potency in MDR+ and antigen-heterogeneous tumor models in a structure-dependent manner
Oct 2914:10
Conference pass

Biosimilars uptake and market considerations in the EU

Biosimilars - Sustainability/Development and manufacturing
Oct 2914:10
Conference pass

Bioassays for therapeutic proteins: design, validation and beyond

Antibodies - Regulation and Investment
  • Bioassays are an integral component of quality control testing in the development of therapeutic proteins, including monoclonal antibodies.
  • Assay acceptability depends on product type, mechanism of action, associated risk, phases of development, and availability of other quality data
  • This presentation provides regulatory expectations on bioassays with case studies highlighting the relevant issues commonly seen in the regulatory submissions
Oct 2914:15
Conference pass

Phase III trial design - primary endpoint

Clinical Trials - plenary
  • Primary Endpoint
  • Lost to follow-up
  • Impact of GDPR
Oct 2914:30
Conference pass

Structural and functional role of antibody variable domain glycosylation

Antibodies - Protein Engineering
  • What is the impact of variable domain glycans on structural aspects of IgG?
  • How do variable domain glycans shape the repertoire of antibody responses?
  • How is the functionality and immunobiology of IgG modulated by variable domain glycans?
Oct 2914:30
Conference pass

Analytical characterisation of BEAT bispecific antibodies

Antibodies - Bispecifics
  • Glenmark’s BEAT technology features heterodimerisation of heavy chain by bio-mimicry
  • scFv x FAB format allows for versatile combinations without use of common light chain
  • BEAT molecules have unique features – beneficial for manufacturing process, and requiring appropriate application of analytical techniques
  • This presentation would provide an overview of analytical techniques used for BEAT molecules, compared to “classic” monoclonal antibodies
Oct 2914:30
Conference pass

Biosimilar or Biogeneric

Biosimilars - Market Access and Commercialisation
  • Current situation
  • Challengeable business in Emerging Market
  • New environment of China Market
Oct 2914:30
Conference pass

PRS-343 (4-1BB / HER2) is a first-in-class T-Cell agonist which drives tumor localized activation of the immune system

Immunotherapy - Cell Therapy
  • Rationale for targeting 4-1BB and other costimulatory receptors
  • Preclinical characterisation of PRS-343 as a differentiated 4-1BB agonist
Oct 2914:30
Conference pass

Three next generation immuno-oncology

Immunotherapy - Cell Therapy
  • 2 novel allogeneic Immuno-Oncology cell types
  • Allogenic NK and mesodermal cellular oncology platforms
  • siRNA platform targeting novel oncology targets and MDSC cells
  • Preliminary data and partnering opportunities
Oct 2914:30
Conference pass

New opportunity to target Insulin-like growth factor receptor using a unique specific anti-IGF-IR immune-conjugate

Antibodies - Armed Antibodies
  • IGF-I receptor
  • Immuno-conjugate
  • Cancer
Oct 2914:30
Conference pass

Sustaining the value proposition of biosimilars

Biosimilars - Sustainability/Development and manufacturing
Erin Federman, VP, Head of Biologics, Boehringer Ingelheim
Oct 2914:30
Conference pass

An FDA perspective on the implementation of state-of-the-art analytical methods and understanding structure-function relationships

Antibodies - Regulation and Investment
  • Evolution of the analytical tool box
  • Implementation of state of the art methods and FDA expectations
  • Evolution of understanding mAb structure-function relationships and FDA expectations
Oct 2914:40
Conference pass

Clinical protocol feasibility as key activity for success: experiences from different therapeutic areas

Clinical Trials - plenary
  • Medical feasibility
  • Regulatory challenges
  • Operational challenges and implementation
Oct 2914:50
Conference pass

Engineering of highly selective anti- Aβ42 antibody with picomolar affinity for the treatment of Alzheimer’s disease

Antibodies - Protein Engineering
  • MEDI1814 is a novel, high affinity, Abeta-42 antibody being developed for the treatment of Alzheimer’s Disease
  • The antibody selectively binds and sequesters the most neurotoxic forms of the amyloid beta peptide, Aβx-42, whilst avoiding the non-toxic forms of Aβ40
  • This presentation will cover the discovery, in vitro characteristics, pre-clinical evaluation and phase 1 clinical trial data with MEDI1814
Oct 2914:50
Conference pass

Targeting immune checkpoints with Humabody VH therapeutics

Immunotherapy - Immune Checkpoint Inhibitors
  • Outline approach to developing differentiated Immuno oncology therapeutics
  • BiParatopic PD-1 inhibitor which shows efficacy in an anti-PD-1 insensitive in vivo model
  • BiSpecific molecule inhibiting both PD-1 and LAG3 for overcoming resistance or insensitivity to PD-1 inhibition
  • Targeted IO approach in which T-cell co-stimulation is focused away from the periphery and into the tumour microenvironment in order to improve the narrow therapeutic index observed with standard T-cell agonist antibodies
Phil Bland-Ward, Chief Scientific Officer, Crescendo Biologics Ltd
Oct 2914:50
Conference pass

Bispecific antibodies against Infectious and neurodegenerative diseases

Antibodies - Bispecifics
  • A combination of computational and experimental data to modulate protein properties
  • Engineered human monoclonal antibodies in a Bispecific molecule against Zika Virus
  • Bispecific antibody against Prions with therapeutic potential
Oct 2914:50
Conference pass

Efficient Development of Biosimilars - The importance of making your biosimilar development as specific, consistent and sensitive as possible

Biosimilars - Market Access and Commercialisation
  • Case study of pegfilgrastim biosimilar
  • Understanding how we can build a bridge between the originator and biosimilar product using a specific, consistent and tailor-made approach
  • The importance of sensitivity to detect differences
  • Collaborating with regulatory affairs
Oct 2914:50
Conference pass

NKG2D based CAR T cell therapy for cancer

Immunotherapy - Cell Therapy
  • T cells engineered to express a NKG2D based chimeric antigen receptor (CYAD-01) are endowed with the potential to target a wide range of haematological and solid tumors
  • The observation of a complete response in a relapsed / refractory AML patient receiving CYAD-01 cells in the absence of pre-conditioning chemotherapy provides clinical support for the approach.
  • Our developments in the allogeneic space focus on exploring non-gene edited approaches to deal with the graft versus host response and this forms the basis of our first clinical testing of the NKG2D CAR in the allogeneic setting.
Dr David Gilham, Vice President of Research and Development, Celyad
Oct 2914:50
Conference pass

Achieving broad and sustainable access to biologic medicines through biosimilars

Biosimilars - Sustainability/Development and manufacturing
Oct 2914:50
Conference pass

Development of potent and efficacious ADCs with payloads that target tubulin

Antibodies - Armed Antibodies
  • Payload and linker development
  • In vitro screening
  • In vivo efficacy
Oct 2914:50
Conference pass

When the cake gets small: broad antibody claims in a crammed field

Antibodies - Regulation and Investment
  • The breadth of allowable claims depends on the available prior art
  • A well characterized epitope may form the basis of a broad claim
  • Broad antibody composition claims
  • Good fall back position needed in case of attack in Opposition proceedings
Dr Helena Domingues, Examiner, Joint Cluster Biotechnology, Immunology Directorate, European Patent Office
Oct 2915:05
Conference pass

EHR-driven clinical studies – experience so far

Clinical Trials - plenary
  • What is Real-world Data and is it the future for healthcare and pharma development?
  • What has worked well, so far?
  • What has been more challenging, so far?
Oct 2915:10
Conference pass

IgA antibodies for the recruitment of myeloid effector cells in tumour immunotherapy

Immunotherapy - Immune Checkpoint Inhibitors
  • Myeloid cells constitute a significant population of the tumour immune cell infiltrate
  • Antibodies of IgA isotype effectively activate tumour cell killing by myeloid cells
  • Tumour cell killing by myeloid cells is enhanced by blockade of CD47/SIRPa interactions
Oct 2915:10
Conference pass

Validation and applications of llamdA™, Isogenica’s synthetic VHH library

Antibodies - Protein Engineering
  • llamdA™ is Isogenica’s fully synthetic, developability optimized VHH library
  • We will present validation data on use of the library to generate binders to various target classes
  • Examples will be provided on the use of formatting into multivalent VHHs enables rapid development of high potency leads
  • Recent developments on the generation of VHH to membrane proteins will be included
Oct 2915:10
Conference pass

Assessing strategies to neutralize the pro-tumour microenvironment to increase GoCAR-T efficacy in solid tumours

Immunotherapy - Cell Therapy
  • The utility of using in-vitro spheroid assays to mimic the in vivo tumour microenvironment to assess strategies in overcoming the pro-tumour microenvironment
  • Assessing the translatability of in vitro models to in vivo rodent models of oncology to guide lead candidate advancement
  • Whether Bellicum’s molecular activation/kill switches engineered into CAR T-cells are resistant to immunosuppressive pathways and increase solid tumour efficacy
Oct 2915:10
Conference pass

Entry strategies for biosimilars in emerging market - cost vs quality

Biosimilars - Market Access and Commercialisation
Kaustubh Berde, Vice President for International Business : Emerging Markets, Wockhardt Limited
Oct 2915:10
Conference pass

The CTLA-4 x OX40 bispecific antibody ATOR-1015 induces anti-tumor effects trough tumor-directed immune activation

Antibodies - Bispecifics
  • ATOR-1015 is a CTLA-4 x OX40 bispecific immune activating antibody developed for tumor-directed immunotherapy
  • ATOR-1015 binds both targets simultaneously, promoting cell-cell interactions expected to enhance the immuno-stimulating effects
  • The mode of action of ATOR-1015 is a combination of regulatory T cell (Treg) depletion and effector T cell activation
Oct 2915:10
Conference pass

Extended Q&A

Antibodies - Armed Antibodies
Your opportunity to ask the speakers your questions.
Oct 2915:10
Conference pass

Panel discussion: How can we sustain the value proposition of biosimilars in the future as an industry?

Biosimilars - Sustainability/Development and manufacturing
Oct 2915:10
Conference pass

Extended regulatory Q&A

Antibodies - Regulation and Investment
  • The floor will be opened to an extended Q&A session for our regulatory speakers
  • The session will be moderated byMarjorie Shapiro, Supervisory BiologistOffice of Biotechnology Products, CDER, FDA
Dr Helena Domingues, Examiner, Joint Cluster Biotechnology, Immunology Directorate, European Patent Office
Oct 2916:29
Conference pass

Chair: Adam Levysohn, Sr Director Market Access Biosimilar, Biogen

Biosimilars - Market Access and Commercialisation
Oct 2916:29
Conference pass

Chair: Aidan Fry, Editor, Generics bulletin

Biosimilars - Sustainability/Development and manufacturing
Oct 2916:30
Conference pass

Adopting patient-facing technology in clinical trials: an industry perspective on opportunities and challenges

Clinical Trials - plenary
  • Hundreds of study sponsors, sites, and patients weighed in on the use of patient-facing technology
  • What opportunities, barriers, and burdens did they perceive?
  • How can we adjust our approach to technology to enable a more patient-centric paradigm?
Oct 2916:30
Conference pass

Antibody-cytokine fusions for cancer therapy

Immunotherapy - Immune Checkpoint Inhibitors
  • Antibody-cytokine fusions based on IL2, TNF or IL12: preclinical results
  • Results of on-going clinical trials
  • Rationale for combinations
Oct 2916:30
Conference pass

Efficient and safe antibody delivery across the blood brain barrier

Antibodies - Protein Engineering
  • The cerebrovascular network constitutes an efficient route for biologics to the brain
  • Engagement with the Blood Brain Barrier receptor crucial for efficient brain exposure
  • Antibodies with full effector function can be delivered in a stealth mode to the brain
Oct 2916:30
Conference pass

Application of T4 CAR T-cell Immunotherapy in solid tumours: pre-clinical development and phase I trial results against head and neck cancer

Immunotherapy - Cell Therapy
  • We have generated a CAR (T28z) that utilises the promiscuous ErbB receptor binding peptide, T1E, to target 8/9 of the dimeric combinations formed by this family of growth factor receptors. This is co-expressed with a novel cytokine receptor, which enables selective growth of transduced T-cells in response to the poor T-cell mitogen, IL-4. Together, this construct is referred to as ‘T4 Immunotherapy'
  • The talk will comprise details of the pre-clinical efficacy and safety testing of T4 Immunotherapy in various tumour models, including head and neck cancer, ovarian cancer and mesothelioma.
  • I will outline the scope and design of an ongoing Phase I clinical trial for patients with locally recurrent and refractory squamous cell carcinoma of the head and neck.
  • An update of safety and efficacy data for the 15 patients so far treated will also be presented.
Oct 2916:30
Conference pass

Development of highly potent Anti-P-cadherin/Anti-CD3 bispecific DART molecule with extended half-life for the treatment of cancer

Antibodies - Bispecifics
Oct 2916:30
Conference pass

How an Iranian biologic manufacturer managed to receive EU-GMP as the first company in the MENA; A success story

Biosimilars - Market Access and Commercialisation
  • Overview of biosimilar industry in MENA
  • Factors that are important on achieving GMP from stringent authorities
  • Best practices in strategic development
Haleh Hamedifar, CEO/Pharmacist, CinnaGen
Oct 2916:30
Conference pass

Case study: CMC and manufacturing biosimilars for checkpoints inhibitors

Biosimilars - Sustainability/Development and manufacturing
  • Modulating the upstream process to get biosimilarity without losing productivity
  • Achieving successful quality modulation
  • Novel SPOT technology to increase productivity
  • The dangers of higher cell densities, clarification and increasing specific productivity
Oct 2916:30
Conference pass

Targeted alpha therapy: hopes and challenges of a novel anti-cancer approach

Antibodies - Armed Antibodies
  • The alpha particle-emitter thorium-227 can be conjugated through a chelator to a wide range of targeting molecules (e.g. monoclonal antibodies)
  • High linear energy transfer of alpha particles results in clusterer double-strand DNA damage in targeted tumor
  • Limited range of alpha-irradiation (2-10 cell diameters) reduces damage to healthy tissues surrounding tumor cells
  • Preliminary evidence suggest that alpha-particles induce in vitro immunogenic cell death
  • Alpha therapy enables clinically feasible supply logistic with centralized manufacturing sites, 48h drug product delivery and out-patient treatment
Oct 2916:30
Conference pass

Panel: Investors in biologics

Antibodies - Regulation and Investment
  • What do investors look out for in start-ups?
  • What are the current trends for biologics?
  • Where do we see the industry moving to in the next 5-10 years?
  • How can you gain investment?
Oct 2916:50
Conference pass

Patient engagement to support recruitment and retention in clinical trials

Clinical Trials - plenary
  • Early involvement of patients drives efficient clinical operations
  • Patients insights included in the total trial burden assessment for participants
  • “Nice to have” vs “need to have” assessment: trade-offs and risks
Oct 2916:50
Conference pass

Managing unwanted immune responses to antibodies including utilisation of MHC-Associated Peptide Proteomics (MAPPs)

Antibodies - Protein Engineering
  • Present accurate and sensitive ways to assess the potential immunogenicity and development of anti-drug antibodies against proteins and antibodies ex vivo by measuring CD4+ T cell responses
  • Methods for managing and reducing potential immunogenicity, and introduce MHC-Associated Peptide Proteomics (MAPPs) to augment data sets to better inform immunogenicity risk
Oct 2916:50
Conference pass

Next generation cancer immunotherapy using IL-2/antibody complexes

Immunotherapy - Immune Checkpoint Inhibitors
  • Present our re-direct strategy to increase the efficacy of IL-2 therapy and decrease toxicity
  • Antibody development and in vitro data
  • In vivo data in mice (and possibly monkeys)
  • Late pre-clinical development activities
Oct 2916:50
Conference pass

Cell encapsulation technology for personalized Immunotherapy:MVX-ONCO-1 in Phase 2 efficacy study

Immunotherapy - Cell Therapy
  • Personalized immunotherapy
  • Optimal adjuvant delivery
  • Cell encapsulation Technology
  • Clinical Trial
Oct 2916:50
Conference pass

Hooking TRAIL-R2 to “educate” immune system to recognize cancer cells

Antibodies - Bispecifics
  • The construction of the Bispecific antibody (anti-TRAIL-R2/anti-CD3) with a focus on the importance of the choice of a format suitable to obtain a stable reagent
  • Different experimental approaches from which we observed that our Bispecific Antibody can induce T-cell activation without off-target toxicity
  • The demonstration that this reagent is potentially useful in many tumour types for which alternative therapies are needed including melanoma, breast cancer (the triple-negative subtype) and ovarian cancer
  • An ex vivo human ovarian cancer model, that may represent a realistic simulation beyond the animal model
Oct 2916:50
Conference pass

MENA market access: Mission possible

Biosimilars - Market Access and Commercialisation
  • Biosimilar introduction to MENA region timing wise could not have been worse than coinciding with the Arab spring.
  • The regulatory pathway for approval was not in place and political regime change swept the region.
  • Turnover of health authorities’ key officials was the norm
Oct 2916:50
Conference pass

Development of the filamentous fungus Myceliophthora thermophila C1 into a next-generation therapeutic protein production system

Biosimilars - Sustainability/Development and manufacturing
  • Myceliophthora thermophila (C1) is a low viscosity, high productive and well-described platform for industrial enzyme production
  • Very high productivity, purity and protein stability has been achieved by using several recent engineering steps
  • The expression of Certolizumab (Cimzia® Pegol) with C1 reached a level of 2.0 g/L/day in Stainless Still Bioreactor and 1.9 g/L/day in Single use Bioreactor and the current development work is aiming to reach higher expression level.
Oct 2916:50
Conference pass

Protein-polymer conjugation to increase residence time of a Fab therapeutic in the eye

Antibodies - Armed Antibodies
  • Understanding the role that hydrodynamic size plays in clearance from the vitreous
  • Polymer-Fab conjugation as a strategy for extending size
  • Development of a accompanying biophysical toolbox
Oct 2917:10
Conference pass

Patient recruitment strategy from a site’s point of view

Clinical Trials - plenary
  • Patient focus groups and early involvement in protocol design
  • Strategy planning
  • Social networking tools
  • Simplifying study language for readability
  • What can sponsors do to help?
Oct 2917:10
Conference pass

Antibody engineering to overcome antigen mediated clearance in vivo

Antibodies - Protein Engineering
  • Antibodies targeting membrane bound antigens with a high rate of synthesis are rapidly eliminated from plasma by antigen mediated clearance, thus compromising their therapeutic utility
  • We present a case study to describe a protein engineering approach to generate a pH dependent binding antibody directed to a receptor
  • The resulting antibody has an extended half-life in vivo and its efficacy is not limited by dose
Claire Dobson, Director, Antibody Discovery & Protein Engineering, MedImmune
Oct 2917:10
Conference pass

ImmTAC(TM) technology platform: novel strategies to increase immunotherapy efficacy

Immunotherapy - Immune Checkpoint Inhibitors
  • Generating high-affinity, bi-specific TCR-molecules for cancer therapy
  • Addressing intra-tumour heterogeneity
  • Strategies to enhance tumour immunogenicity
Oct 2917:10
Conference pass

Identification of a PD-L1 binding FCAB: A potent inhibitor of immunosuppressive signals

Antibodies - Bispecifics
  • F-star has produced an Fcab, an antibody Fc domain modified to bind to a target, specific to PD-L1 The Fcab exhibits high affinity to human PD-L1 that translates into strong potency in cell-based functional assays
  • An anti-murine surrogate molecule, with similar potency, also exhibits activity in an MC38 syngeneic tumour model. This activity is improved when the Fcab is paired with Fabs targeting other immune checkpoint regulators
Oct 2917:10
Conference pass

The biosimilar introduction in Denmark: How we have made the success in both infliximab and etarnacept

Biosimilars - Market Access and Commercialisation
  • Success with introduction of infliximab and Etanercept
  • Who have we done it?
  • Biosimilar task force
  • Tendering process
Dorthe Bartels, Strategic Adviser, Bispebjerg Hospital
Oct 2917:10
Conference pass

Case Study: CMC, development, differentiation and formulation for orphan biosimilars

Biosimilars - Sustainability/Development and manufacturing
  • Clinical studies to show biosimilarity of own formulations
  • Better compliance
  • Outsourcing manufacturing
Andreas Herrmann, Chief Executive Officer, Valerius Biopharma
Oct 2917:10
Conference pass

Differentiating DeBouganin’s MOA from small molecules as ADC payloads

Antibodies - Armed Antibodies
  • The In vitro potency of deBouganin versus that of traditional small molecule drugs as payloads for tumour-targeted therapeutics (ADCs) will be discussed
  • Data will be presented demonstrating that deBouganin induces biomarkers associated with immunogenic cell death and does not enrich the presence of immunosuppressive cell surface markers
  • The presented studies will support the use of DeBouganin-loaded ADCs to both directly kill tumour cells and spark host immune responses that could pair well with the use of checkpoint inhibitors
Oct 2917:10
Conference pass

Developability assessment of therapeutic proteins – a toolbox for tackling increasing complexity

Antibodies - CMC and Developability
  • The concept of developability assessment of therapeutic proteins
  • Analytical challenges upon the shifting of biologics portfolio
  • Strategies and tool-box addressing the new demand
  • Case studies highlighting the analytical method development
Oct 2917:30
Conference pass

Panel Discussion: what are the biggest hurdles in clinical trial recruitment and how can they be solved?

Clinical Trials - plenary
  • Which tools can be used to ease the enrolment process?
  • What are the biggest factors contributing to patients and investigator concerns?
  • Should social media be embraced more?
Oct 2917:30
Conference pass

Bi- and trifunctional antibody-fusion proteins for cancer therapy

Immunotherapy - Immune Checkpoint Inhibitors
  • Combination of IL-15 with costimulatory TNF-superfamily ligands
  • Mode of action
  • Format development
Oct 2917:30
Conference pass

Brain delivery and intracellular sorting of affinity variants of the anti-TfR antibody OX26

Antibodies - Protein Engineering
  • Antibody engineering has been used to create affinity variants of the mouse anti-rat transferrin receptor antibody OX26
  • We found an inverse correlation between antibody affinity and brain penetration, and efficacy in a model of inflammatory pain when coupled to the peptide galanin
  • Cell fractionation revealed the affinity variants had different intracellular fates, helping us understand how changes in affinity improve brain exposure
Oct 2917:30
Conference pass

Bispecific DART® Molecules in the age of cancer immunotherapy: redirected T cell killing and beyond

Antibodies - Bispecifics
  • Notwithstanding recent progress, unmet needs still exist in immunotherapy of cancer
  • Bispecific molecules may offer unique opportunities to address such needs
  • Application of the DART platform in redirected T‐cell killing, checkpoint blockade and co‐stimulation will be presented
Oct 2917:30
Conference pass

Panel discussion: How can we best converge strategies and regulatory environments to market a biosimilar in an emerging market country in the future?

Biosimilars - Market Access and Commercialisation
Houng Kim, head of the strategy and operations division, Celltrion Healthcare
Dorthe Bartels, Strategic Adviser, Bispebjerg Hospital
Kaustubh Berde, Vice President for International Business : Emerging Markets, Wockhardt Limited
Haleh Hamedifar, CEO/Pharmacist, CinnaGen
Oct 2917:30
Conference pass

Challenges in biosimilar bioanalytical assays and sample processing

Biosimilars - Sustainability/Development and manufacturing
  • Strategies for PK assay development and compound comparison to show bioanalytical similarity
  • Automated sample analysis on biosimilar samples
  • Strategies for immunogenicity assessment and ADA assay development
  • Case study: Bioanalytical similarity of a pegfilgrastim biosimilar
Oct 2917:30
Conference pass

Treating tissue factor-positive cancers with antibody drug conjugates that do not affect blood clotting

Antibodies - Armed Antibodies
  • Antibodies against Tissue Factor (TF) that do not interfere with the coagulation cascade were identified by using a yeast-based selection system and various cell-based assays
  • A selection of antibodies conjugated to the prototypic cytotoxic agent monomethyl auristatin E (MMAE) was tested in cell- and patient-derived xenograft models
  • The coagulation-inert ADCs were as efficacious as tisotumab vedotin, a clinical stage MMAE-based ADC against TF that affected blood clotting
Oct 2917:30
Conference pass

Modern analytical development of biologics

Antibodies - CMC and Developability
  • Feasibility of modern analytical tools for biologics development
  • Innovative approaches for process analytics
  • Trends and upcoming requirements for the analytical control of biopharmaceuticals
Oct 2917:50
Conference pass

Mechanistic insight into transferrin receptor-mediated BBB shuttling antibodies based on VNARs

Antibodies - Protein Engineering
  • Novel approach for discovery of BBB penetrating antibodies
  • Optimisation of efficacy of BBB transporters
  • Mechanistic requirements for VNAR-based BBB shuttling antibodies
Oct 2917:50
Conference pass

The role of Fc receptor-IgG interactions in the therapeutic activity of checkpoint antibodies

Immunotherapy - Immune Checkpoint Inhibitors
  • FcR pathways involved in the therapeutic mechanism of different checkpoint mAbs
  • Harnessing Fc Receptors for optimizing the anti-tumour activity of checkpoint mAbs
  • Mouse models to study efficacy and toxicity of human checkpoint mAbs and for screening Fc-engineered clinical candidates.
  • Strategies to widen the therapeutic window of immunomodulatory mAbs
Oct 2917:50
Conference pass

BiTE® antibody constructs in clinic and development

Antibodies - Bispecifics
  • Following the approval of blinatumomab in relapsed/refractory ALL multiple BiTE candidates have entered or are about to enter the clinic in various indications
  • Give an update on Amgen’s BiTE pipeline at the discovery, translational, and early clinical stage of development
Oct 2917:50
Conference pass

Turning native antibodies into homogeneous ADCs without antibody engineering

Antibodies - Armed Antibodies
  • A new site-specific method to generate homogeneous ADCs will be introduced that does not require antibody engineering
  • Versatility of method will be shown
  • Comprehensive characterization of generated ADCs will be presented
Oct 2917:50
Conference pass

Mammalian display: antibody discovery, affinity maturation and developability screening in IgG format

Antibodies - CMC and Developability
  • Integration of IgG libraries into mammalian cells by CRISPR/Cas9 and TALE nucleases
  • Multi-parametric FACS used to discover antibodies with desired specificity, binding affinity, species cross-reactivity and expression level
  • Mammalian display for ultra-high throughput developability screening
  • Utility of Intellicyte iQue for human antibody screening
Oct 2918:00
Conference pass
Oct 2918:10
Conference pass

Structure guided rational design of de novo antibody specificity

Antibodies - Protein Engineering
  • Engineered rat specificity de novo into Amgen’s lead anti-migraine molecule (AMG334
  • Fine tuning of specificity to gain Rat specificity without losing the human one
  • Structural computational approach, used in parallel with other engineering yielding the best results in terms of time vs effort vs cost
  • Investigated deep sequencing to enhance and de-risk the Ab engineering process
Oct 2918:10
Conference pass

Extended Q&A

Antibodies - Bispecifics
An opportunity to ask the speakers your questions!
Oct 2918:10
Conference pass

Case Study: Developing biosimilars with a tobacco plant expression system

Biosimilars - Sustainability/Development and manufacturing
  • Pros and cons of alternative expression systems for biosimilars
  • Expression and post-translational modification in plant systems
  • Approaches to large scale cGMP manufacturing with plant systems
Oct 2918:10
Conference pass

DARPin-photosensitizer conjugates for EpCAM-directed photodynamic therapy of ovarian cancer

Antibodies - Armed Antibodies
  • Designed ankyrin repeat proteins
  • Photodynamic therapy
  • Ovarian cancer
  • Epithelial cell adhesion molecule (EpCAM)
Oct 2918:10
Conference pass

Extended Q&A

Antibodies - CMC and Developability
Extended Q&A - your chance to ask our speakers questions!

Create your personal agenda –check the favourite icon

Oct 3008:55
Conference pass
Oct 3008:55
Conference pass

Chair: Martin Schiestl, Chief Science Officer, Sandoz Biopharmaceuticals

Keynotes
Oct 3009:00
Conference pass
Oct 3009:00
Conference pass
Oct 3009:00
Conference pass

The rise of the digital clinical trials and methods to support your transformation

Clinical Trials - plenary
  • Exemplifying of how an agile approach is being used in pharma to support digital transformation
  • Analysing this customer-centric approach, which can have real impact on the way we address clinical research
  • Presenting concrete examples on how we apply design thinking to (digital) innovation in pharma
  • How to set yourself up for innovation
Oct 3009:00
Conference pass

The New FDA Biosimilars Action Plan—What to Expect?

Keynotes
  • Time to revisit the scientific rationale for approving generics and biosimilars—breaking out from tradition and rote practice
  • Encouraging fast to market approaches—a challenge for both developers and FDA
  • Making “what is clinically meaningful” truly meaningful-- a new class of substitutable biosimilars and compliant generics
Oct 3009:10
Conference pass

Keynote panel: Combination therapy strategies

Keynotes
  • Combination therapies – what are the next steps?
  • Toxicity and efficacy
  • Latest research and news
Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme
Dr Maria Karasarides, Executive Director, ImmunoOncology, Regeneron Pharmaceuticals
Oct 3009:10
Conference pass

Keynote panel: Combination therapy strategies

Keynotes
  • Combination therapies – what are the next steps?
  • Toxicity and efficacy
  • Latest research and news
Dr Maria Karasarides, Executive Director, ImmunoOncology, Regeneron Pharmaceuticals
Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme
Oct 3009:20
Conference pass

Cross-Industry Collaboration evaluating how Blockchain can Transform the Pharmaceutical and Healthcare Industry, part of Emerging Trends & Technology PhUSE Workgroup

Clinical Trials - plenary
  • Understanding the landscape in the pharma and healthcare settings
  • Exploring the areas where Blockchain could be used
  • Presenting two detailed use cases (a. Drug Supply Chain using Smart Contracts; b. Patient Data Access/Transparency) to support future development and implementation for proof of concept
Oct 3009:20
Conference pass

An FDA Perspective on the Quality of Module 3 in 351k BLA Applications

Keynotes
  • Areas that have been problems in 351k applications
  • Update on guidance document commitments (including Interchangeability and Statistical Approaches to Evaluate Analytical Similarity)
  • BSUFA II
Oct 3009:40
Conference pass

Blockchain technology for improving clinical research quality

Clinical Trials - plenary
  • How can blockchain improve reproducibility, data sharing, personal data privacy concerns and patient enrolment?
  • Core functionalities of blockchain applied to clinical trials
  • Impacts and implications
Oct 3009:40
Conference pass

Biosimilars: the vastly evolving HTA landscape

Keynotes
  • Biosimilar national HTA archetypes
  • Integrating Biosimilars in the therapeutic strategy:
  • Reimbursement in extrapolated indications, reimbursement of a biosimilar when the originator was not cost-effective, pharmacy substitution
  • Hospital-Based HTA for Biosimilars: How do providers and hospitals decide which biosimilar to list on their formulary?
Oct 3010:00
Conference pass

Panel Discussion: The realities of virtual trials: how companies are migrating from site based to de-centralized research and what you can be doing to start

Clinical Trials - plenary
  • Discuss the driving force behind pharma’s interest in virtual clinical trials
  • What are the steps necessary to set started in conducting virtual trials
Oct 3010:00
Conference pass

Biosimilars: Current requirements and experience with EU and FDA approvals

Keynotes
Panel Discussion on regulation followed by questions from the audience
Oct 3011:25
Conference pass

Changes in complementarity-determining regions significantly alter IgG binding to the neonatal Fc receptor (FcRn) and pharmacokinetics

Antibodies - Protein Engineering
  • Examined the role of IgG domains distal from the Fc in altering the affinity between IgG and FcRn
  • Identified that variable domains, and in particular complementarity-determining regions (CDRs), significantly alter binding affinity to FcRn in vitro and determined that affinity values correlated with calculated isoelectric point values
  • Demonstrated that tighter affinity values of IgG molecules to FcRn trend with faster in vivo clearance of a set of IgG molecules differing only by 1-3 mutations in human FcRn transgenic mice
Oct 3011:25
Conference pass

Targeting the integrin αvβ6 with CAR T-cells to treat multiple solid malignancies

Immunotherapy - Immunotherapy for solid tumours
  • The integrin αvβ6 is overexpressed in multiple solid cancers and is associated with poor prognosis
  • Development of CAR T-cells targeting αvβ6
  • Pre-clinical in vivo models to test CAR T-cell therapeutic approach
Oct 3011:25
Conference pass

Antibody discovery considerations for ImmunoOncology bi-specific molecules

Antibodies - Bispecifics
  • Antibody Discovery
  • T-cell Engager modalities
  • Bi-Specific scaffolds
Oct 3011:25
Conference pass

Closed systems for CAR T-cell production

Immunotherapy - Manufacture, logistics and supply chain
  • Closed non-magnetic selection technology (automated T-CATCH)
  • Soluble reversible activation technology (Expamer)
  • Short production process (Nex-T)
Oct 3011:25
Conference pass

Roles of Biosimilars in Patients Access to Biologic Treatments

Biosimilars - Market Access and Commercialisation
  • Improving patient access
  • Biologics in earlier stage
  • Impact of biosimilars in oncology
Oct 3011:25
Conference pass

Global comparator product for biosimilar development and waiving of bridging studies

Biosimilars - Sustainability/Development and manufacturing
  • Definitions of reference, comparator and global comparator product
  • Criteria to qualify as comparator product
  • Rationale for the global comparator product approach
  • Circumstances where bridging studies between local and foreign reference can be waived
Oct 3011:25
Conference pass

Pre-clinical development of HuMax-AXL-ADC

Antibodies - Armed Antibodies
  • Axl as a therapeutic target in human cancers
  • HuMax-AXL-ADC antibody generation and mechanism of action
  • Efficacy data for HuMax-AXL-ADC in preclinical models
Oct 3011:25
Conference pass

Cutting edge analytical and multiple attributes methods for mAbs and ADCs

Antibodies - CMC and Developability
  • 2 to 4D - LC-MS profiling and structure assessment
  • Insights gained from native, Ion Mobility, HILIC and CE mass spectrometry
  • Forced degradation, developability and comparability workflows
Oct 3011:25
Conference pass

Further advancement for human antibody discovery

Technology Showcase
  • Technological developments for human antibody discovery and optimization platform
Oct 3011:45
Conference pass

Clinical Operations Strategic Partnerships with CROs

Clinical Trials - plenary
  • Obstacles implementing a Risk Based Plan
  • Risk mitigation plans, activities, and risk response
Oct 3011:45
Conference pass

The importance of antibody isotype and Fc receptor interactions in engineering cancer immunotherapies

Antibodies - Protein Engineering
  • Immunomodulatory mAb can employ multiple mechanisms in tumours
  • Potential mechanisms depend on mAb isotype and FcγR availability
  • mAb engineering can allow multiple mechanisms to be engaged to therapeutic effect
Oct 3011:45
Conference pass

T-SIGn viruses: systemic delivery of localised combination immuno-gene therapy within the tumour microenvironment

Immunotherapy - Immunotherapy for solid tumours
  • T-SIGn platform: transgene-bearing genetically modified variants of enadenotucirev, an oncolytic chimeric group B adenovirus with clinical data demonstrating virus delivery to tumours following systemic dosing
  • Up to 4 different transgenes have been encoded in a single virus, enabling the design of candidates expressing combinations of biological agents for targeted immunotherapy
  • Local production of therapeutic combinations by tumour cells infected with the T-SIGn virus enables high local production for increased activity while minimizing systemic exposure for improved safety
Oct 3011:45
Conference pass

Biosimilars from a regulator’s perspective: the current European situation

Biosimilars - Market Access and Commercialisation
  • Update of the EU biosimilar guidelines -Current EMA regulatory status in Europe (biosimilars approved / under evaluation, and trends for scientific advices)
  • Frequent concerns (extrapolation, traceability, SmPC labelling and interchangeability)
Ingrid Bourges, Clinical Assessor, Federal Agency for Medicines and Health Products
Oct 3011:45
Conference pass

Cell therapy supply chain management, logistics and scale out

Immunotherapy - Manufacture, logistics and supply chain
  • Shipper suitability, features and options
  • Maintaining chain of custody for starting material and product
  • Logistics reliability and options
  • Supply chain sustainability and scale-out
Oct 3011:45
Conference pass

Multispecific CODV-Ig derived protein therapeutics – examples and future perspective

Antibodies - Bispecifics
  • Overcome limitations of existing bispecific bio therapeutics we created the universally applicable CODV (Cross -Over Dual Variable)–Ig format
  • Serves as a versatile platform for the development of bi- and multi-specific protein therapeutics
  • Will highlight the flexibility and variability of the corresponding technology
  • Show how this can be applied to different biological questions in different case studies and outline how a new high throughput biologics system will be used to further improve the therapeutic properties
Oct 3011:45
Conference pass

Biosimilars in the NHS; where are we now?

Biosimilars - Sustainability/Development and manufacturing
  • Biosimilar market uptake in the NHS
  • Challenges and solutions to biosimilar clinical trials
  • The Clinical Research Network
  • Real world evidence
Oct 3011:45
Conference pass

Expanding the potential of ADCs: EpCAM-targeting Probody Drug Conjugates

Antibodies - Armed Antibodies
  • Creating ADCs that are selectively activated in the tumor microenvironment would allow the inclusion of targets that would otherwise be incompatible with traditional ADC development due to high normal tissue expression
  • By combining ImmunoGen’s linker-payload technologies with CytomX’s ProbodyTM technology, we have generated Probody drug conjugates designed to preferentially bind EpCAM expressed in tumors and not in healthy tissues.
  • We will describe the preclinical activity and safety of EpCAM-targeting Probody drug conjugates
Oct 3011:45
Conference pass

Accelerating the timeline to GMP

Antibodies - CMC and Developability
  • Accelerated FIH Development requires knowledge of mAbs, bispecifics, fc-fusion proteins, recombinant enzymes, and other glycoproteins, and a good understanding of process and analytical tools to drive development from cell line development through manufacturing is critical.
  • KBI will be providing a roadmap to accelerated FIH Development and also an overview of KBI’s vast capabilities to support development and manufacturing of biomolecules
Oct 3011:45
Conference pass

Development of highly potent T-cell receptor bispecifics with picomolar activity against tumor-specific HLA ligands

Technology Showcase
  • Soluble cancer therapeutics consisting of a T-cell recruiting antibody fused to affinity maturated and highly selective TCR domains capable of targeting tumor-specific peptides presented by HLA class I
  • TCR discovery and affinity maturation, which allow the generation of highly affine and specific TCRs against tumor-specific HLA-bound peptides as identified and validated by our target discovery engine XPRESIDENT®
  • Obtain highly potent TCR bispecifics with picomolar activity against different tumor cell lines showing endogenous expression of the target peptide while exhibiting no reactivity towards cells lacking target peptide expression
Oct 3012:05
Conference pass

Biophysical characterization of bispecific antibodies for enhancement of dual-targeting specificity

Antibodies - Protein Engineering
  • Immunomodulatory mAb can employ multiple mechanisms in tumours
  • Potential mechanisms depend on mAb isotype and FcγR availability
  • mAb engineering can allow multiple mechanisms to be engaged to therapeutic effect
Oct 3012:05
Conference pass

T cell redirecting antibodies based on Glenmark’s BEAT® platform

Immunotherapy - Immunotherapy for solid tumours
  • Presentation of GBR 1302 a CD3xHER2 T cell redirecting BEAT antibody currently in clinical development in metastatic breast and gastric cancers
  • Preclinical data highlighting the mechanism of action, and potency, in relation with standard of care
  • Translational data on primary cancer samples in relation with checkpoint combination and immune contexture
Oct 3012:05
Conference pass

Development of endogenous and engineered TCR-T cell therapies for solid cancers

Immunotherapy - Manufacture, logistics and supply chain
  • Immatics has a proprietary tumor antigen targets discovery platform, XPRESIDENT® which identifies tumor targets and screen TCRs against off-target toxicities
  • Endogenous and engineered TCRs against these tumor targets are used in Immatics’ Adoptive Cellular Therapy programs
  • IMA101 is a multi-product endogenous T cells against a warehouse of targets against various solid cancers currently in phase 1 clinical trial
  • IMA201, 202, and 203 are individual TCR engineered T cell products in various phase 1 trials for various solid cancers
  • Extensive process development was carried out using primary T cells derived from multiple healthy donors and cancer patients to optimize each step in the manufacturing of TCR T cells for 3 clinical trials (IMA101, IMA201, and IMA202)
  • Manufacturing for 3 trials in progress and a 4th is in progress
Oct 3012:05
Conference pass

How have incentives helped deliver on the Biologic Medicines’ promise in the EU?

Biosimilars - Market Access and Commercialisation
  • The evolving Biosimilars landscape – key biosimilar trends and dynamics across Europe
  • How to ensure a proper balance between price- and demand-side policies?
  • How to create a win-win for all stakeholders with biosimilars
Maarten Van Baelen, Market Access Director, Medicines for Europe
Oct 3012:05
Conference pass

Next generation bispecific antibodies

Antibodies - Bispecifics
  • Platform technology vs format zoo: how to keep the right balance
  • Format defines function: size, valency, geometry, flexibility
  • Format examples in clinical development
  • Novel formats with differentiated features
Oct 3012:05
Conference pass

Biosimilars in breast cancer – the next challenge

Biosimilars - Sustainability/Development and manufacturing
  • Case study: very high and quick uptake of biosimilars in Denmark
  • Next challenge breast cancer
  • Drug committee perspective
Oct 3012:05
Conference pass

Click chemistry-triggered drug release from tumor-bound ADCs

Antibodies - Armed Antibodies
  • Learn how non-internalizing receptors can become amendable to ADC therapy
  • Development of a diabody-based MMAE ADC against non-internalizing TAG72 with a high tumor uptake and low retention in healthy tissues
  • ADC tumor binding and blood clearance is followed by systemic administration of a chemical activator that cleaves the ADC linker, leading to potent antitumor activity in murine tumor models
  • In contrast, the analogous ADC comprising a protease-cleavable linker is not effective in these tumor models
Oct 3012:05
Conference pass

Establishing highly precise, low material consuming biophysical platform for biologics developability assessment

Antibodies - CMC and Developability
  • New biophysical applications for Biologics characterization using
    • Second Harmonic Generation (SHG)
    • Nano Digferential Scanning Fluorimetry (nano-DSF)
    • Microscale Thermophoresis (MST)
  • Kinetics for thermal stability and Activation energy barrier determination for Biologics stability assessment
  • Long-terms stability prediction by computational biophysical approaches
Oct 3012:05
Conference pass

Mapping antibody epitopes using constrained bicyclic peptides

Technology Showcase
  • Arrays of overlapping peptides
  • Mapping of conformational and discontinuous epitopes
  • Use of constrained mono- and bicyclic peptides
Oct 3012:10
Conference pass

Panel Discussion - Site selection challenges and solutions

Clinical Trials - plenary
  • How to improve communication between sites, sponsors and CROs
  • Identifying the site’s relevant infrastructure, patient population and qualifications- what data should be collected by the sponsor?
  • Evaluating real-time feasibility
Oct 3012:25
Conference pass

Creating multifunctional VH-based biologics using Humabodies from the Crescendo Mouse

Antibodies - Protein Engineering
  • Proprietary transgenic mouse generates highly diverse fully human VH domain (‘Humabody’) building blocks
  • Fully modular plug & play approach lacks the constraints of traditional mAbs and enables a radical rethink of how a multifunctional molecule can be designed and assembled to deliver enhanced therapeutic benefit.
  • Examples of differentiated biology will focus on applications in immuno-oncology and Humabody drug conjugates
Oct 3012:25
Conference pass

T3 Pharma’s versatile bacterial cancer therapy

Immunotherapy - Immunotherapy for solid tumours
  • How to target bacteria to solid tumours
  • How to enable bacteria to fight solid tumours
  • Use of such bacteria in immunotherapy
Oct 3012:25
Conference pass

Application of the novel heterodimerization plattform Fc1k in mono- and multispecific molecules

Antibodies - Bispecifics
  • Principles of the novel heterodimerization strategy
  • Generation of a lead candidate as platform module
  • Examples for bispecific applications
  • Future opportunities
Oct 3012:25
Conference pass

Panel discussion: Equity of access to biologic medicines across Europe

Biosimilars - Market Access and Commercialisation
  • Expanded access to biologic drugs; the last piece of the biosimilar puzzle.o How can health systems expand access to biologic medicines for patients?
  • Updating clinical / prescribing guidelines:o How to increase access for patients through the updates of prescribing guidelines with the introduction of more cost-effective biosimilars? Biosimilars as a mean to break prescribing restrictions.
  • Are health systems missing out on the biosimilar opportunity?o How does the cost effectiveness of biosimilars compare to an average new drug?
Oct 3012:25
Conference pass

WORKSHOP: Logistics and supply chain management for cell therapy

Immunotherapy - Manufacture, logistics and supply chain
  • Developing manufacturing that produces a high-quality product
  • Scalable to meet changing demands of cell therapies
  • Keeping reasonable cost of goods
  • Fully characterising cell therapy products
Oct 3012:25
Conference pass

Functional disulfide re-bridging enables native full antibody DAR 2, 4 & 8 formation, site-selective orthogonal dual modification and homogeneous fragment drug conjugates

Antibodies - Armed Antibodies
  • Site-selective modification of antibodies (including robust serum stability, in vitro selectivity, in vivo efficacy with options for DAR 2, 4 & 8, dual drug conjugates and fragment drug conjugates).
  • Use of chemical linkers to form bi- and tri-specific scaffolds 3. Application of technology to generate oriented antibody fragments on nanoparticle surfaces
Oct 3012:25
Conference pass

Panel discussion: Clinical trials – do we need them to get biosimilars approved?

Biosimilars - Sustainability/Development and manufacturing
  • Clinical trials vs pharmacology studies, what does the current FDA and EU guidance say?
  • Clinical pharmacology studies: efficacy & safety
  • Future possibilities
  • Q + A with the audience
Oct 3012:25
Conference pass

Globally-optimised clinical candidates for maximised development success

Antibodies - CMC and Developability
  • Many therapeutic antibody candidates carry unnecessary amino-acid content in their binding domains
  • This extraneous content leads to significant proven CMC and clinical development risks
  • This presentation will present novel data translating fundamental antibody biology insights into improved-quality product candidates
Oct 3012:25
Conference pass

Chacterization and monitorization of Critical Quality Attributes. From Early to late-stage development

Technology Showcase
  • Overcome unusual challenges in the characterization of a monoclonal antibodies by LC-MS from early to late stage of development
  • Process the characterization of unusual modifications (such as sulfation, additional glycosylation), and of structural heterogeneity with both traditional methods as well as native SEC-MS method at the first stages of antibody development
  • Implement a complete and easy-to-use MAM workflow for biotherapeutic PQA monitoring using accurate mass LC-MS
  • Use this new streamlined MAM workflow to track known impurities and identify new impurities using a single software processing system that is as powerful as it is intuitive
Oct 3012:45
Conference pass

Engineering aggregation resistant human domain antibodies

Antibodies - Protein Engineering
  • Two novel highly diverse synthetic human domain antibody libraries
  • Versatility in targeting difficult epitopes
  • Strategies to engineer aggregation resistance
Oct 3012:45
Conference pass

Extended Q&A

Immunotherapy - Immunotherapy for solid tumours
Your opportunity to ask the speakers questions!
Oct 3012:45
Conference pass

Extended Q&A

Antibodies - Armed Antibodies
Your chance to ask the speakers questions!
Oct 3012:45
Conference pass

Clinical development of patient-centric injectable biologics-device combination products

Antibodies - CMC and Developability
  • The development of drug-device combination (DDC) products is a strategic imperative across the biopharmaceutical industry for injectable biologics
  • A successful clinical strategy to address changes in manufacturing processes for drug substance as well as for DDC presentations needs to be risk-based and scientifically sound
  • An injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC
Oct 3012:45
Conference pass

HybriFree: a robust and rapid method for the development of therapeutic antibodies from rabbit and chicken

Technology Showcase
  • Immunization of wild type rabbits and chickens provides great diversity with broad epitope coverage, and picomolar affinities without affinity maturation
  • Good manufacturability of the antibodies is achieved by using CHO cells for the expression of IgG libraries that are developed directly from B-cells
  • Greater evolutionary distance of chicken yields greater immunogenicity against conserved targets
  • HybriFree antibody discovery platform is further powered by Icosagen’s patented QMCF expression technology that includes a proprietary VLP-Technology for the high level expression of membrane proteins incl. GPCRs
Oct 3014:34
Conference pass

Chair: Stacie Ropka, Partner, Axinn, Veltrop & Harkrider LLP

Biosimilars - Market Access and Commercialisation
Oct 3014:34
Conference pass

Chair: Andreas Herrmann, Chief Executive Officer, Valerius Biosciences

Biosimilars - Sustainability/Development and manufacturing
Andreas Herrmann, Chief Executive Officer, Valerius Biopharma
Oct 3014:35
Conference pass

Clinical Data & Analytics

Clinical Trials - plenary
  • Analytics is the discovery, interpretation, and communication of meaningful patterns in data
  • How can we apply this approach to how we operationalize clinical trials in a world of technology transformations and availability of big data?
Oct 3014:35
Conference pass

Expanding immunotherapy by changing the tumour microenvironment

Immunotherapy - Combination therapy
  • MedImmune has a portfolio of therapies aimed at expanding the patient population that will be responsive to immunotherapy Including:
  • Modulating adenosine by CD73 blockade
  • Cytokine expressing Oncolytic virus
Oct 3014:35
Conference pass

Genetic encoding of a cyclopropene for the rapid and efficient generation of stable antibody conjugates

Antibodies - Protein Engineering
  • Efficient transient and stable expression systems
  • Rapid conjugation of tetrazine-bearing molecules
  • Dihydropyridazine bond stability in serum
  • Generation of a potent and selective ADC
Oct 3014:35
Conference pass

A year to review: 2018, more decisions, more launches, more unanswered questions

Biosimilars - Market Access and Commercialisation
Oct 3014:35
Conference pass

Bi/Multi-specific antibodies- technologies development

Antibodies - Bispecifics
  • Generation of multi-specific antibodies will be discussed
  • A new solution to avoid HC/LC mispairing and a fast screening method to visualize and deselect mis-paired antibodies will be presented
Oct 3014:35
Conference pass

From seeding doubt, to an evidence-based assessment

Biosimilars - Sustainability/Development and manufacturing
  • From theory to practice
  • The evolving evidence base
  • Closing the gap
  • Incremental risk vs expected risk
Oct 3014:35
Conference pass

Novel immune-stimmulatory ADCs (iADCs) for effective targeting of solid tumors

Antibodies - Armed Antibodies
  • Site-specific conjugates with ultra-potent anthracycline toxins
  • Immune-oncology function of NBE’s iADCs
  • Preclinical validation of a ROR1 targeting iADC
Oct 3014:35
Conference pass

CMC aspects of highly concentrated protein formulations

Antibodies - CMC and Developability
  • Why do we need HCLF?
  • How high is high?
  • CMC challenges
  • Some related case studies
Oct 3014:35
Conference pass

Moving bioprocess data into the cloud and towards big data – the first steps

Technology Showcase
  • Digitalization in bioprocessing
  • Centralized and standardized data
  • Data sharing across users, teams and organisation units to speed up time to market
  • Open access system: one platform for all bioprocess / analytical devices, brand independent
Oct 3014:55
Conference pass

The impact of the EU general data protection regulation on clinical trials: the challenges to transparency in an age of privacy

Clinical Trials - plenary
Oct 3014:55
Conference pass

Antibody protein sequencing with mass spectrometry

Antibodies - Protein Engineering
  • Robust service to routinely sequence antibodies proteins directly
  • Accurate determination of Isoleucine and Leucine using mass spectrometry
  • Beyond 100% protein coverage by examine individual amino acid
Oct 3014:55
Conference pass

Two ACTive immunotherapies in melanoma (TACTI-mel): results of a phase I trial combining a soluble LAG-3 receptor (Eftilagimod Alpha) with Pembrolizumab

Immunotherapy - Combination therapy
  • Understand the rationale for combining an APC activator (LAG-3lg or “efti”) with an immune checkpoint inhibitor (anti-PD-1 pembrolizumab)
  • Pharmacodynamic effects of efti (6 or 30 mg s.c.) in patients
  • Highlighting in vitro and in vivo preclinical data along with emerging clinical data
Oct 3014:55
Conference pass

How to navigate the IP and legal landscape when launching a biosimilar outside the US

Biosimilars - Market Access and Commercialisation
Oct 3014:55
Conference pass

Mechanistic modelling and simulation for bispecific antibodies and beyond

Antibodies - Bispecifics
  • Bispecific target space: in solution vs cell membrane-bound
  • Bispecific cross-linking on cell membrane targets
  • Implications for biparatopics and cell-cell cross-linking antibodies
  • Pharmacokinetics of bispecific antibody constructs
Oct 3014:55
Conference pass

Improving single-cell delivery of antibody and protein-drug conjugates: Multiple strategies to increase drug distribution and efficacy

Antibodies - Armed Antibodies
  • The distribution of cytotoxic payloads from antibody drug conjugates within a tumor, not just the total amount of payload, has a significant impact on efficacy
  • Multiple strategies can improve tumoral distribution including target selection, protein structure, and dosing to increase efficacy
  • These approaches and relevant examples will be discussed in the context of when each strategy is appropriate
Oct 3014:55
Conference pass

WHO International Standards for Biosimilars

Biosimilars - Sustainability/Development and manufacturing
  • Infliximab study
  • Future plans for biosimilar standards from the WHO
  • Harmonizing immunogenicity testing
Oct 3014:55
Conference pass

Advantages of perfusion processes for the production of difficult to express proteins

Antibodies - CMC and Developability
  • What are the currently used perfusion systems?
  • Advantages and challenges of perfusion strategies
  • Case studies
Oct 3014:55
Conference pass

Continuous bioprocessing: how to prepare for process efficiency in early stage process development

Technology Showcase
  • Using Quality by Design (QbD) principles for process design in early stage (continuous) process development
  • Process Failure Mode and Effect Analysis to identify risks and define mitigation strategies
  • Scale-up/scale-down considerations for continuous downstream processing
  • Bioburden control and virus safety strategies in continuous downstream processing
Oct 3015:15
Conference pass

Fighting pathogens and toxins with human and human-like antibodies

Antibodies - Protein Engineering
  • Recombinant antibodies for biodefense
  • Neutralizing and protective antibodies against viruses (Marburg virus, VEEV and WEEV)
  • Neutralizing and protective antibodies against toxins (botulinum toxins, diphtheria toxin)
  • Germline humanization of macaque antibodies
Oct 3015:15
Conference pass

IgA as novel antibody format for lymphoma and neuroblastoma is enhanced by myeloid checkpoint inhibitors

Immunotherapy - Combination therapy
  • IgA recruits neutrophils as effector cells for treatment of cancer
  • Preclinical evidence for mode of action of IgA
  • Adverse effect for neuroblastoma treatment is eliminated with IgA
  • Myeloid checkpoint block strongly enhances IgA effects
Oct 3015:15
Conference pass

CD47 targeting bispecific antibodies

Antibodies - Bispecifics
  • Rationale for CD47 neutralization in cancer
  • Targeting CD47 with bispecific vs monoclonal antibodies – what’s the difference?
  • Blockade of CD47 with bispecific antibodies promotes tumour elimination in vivo and modifies the tumour microenvironment
Oct 3015:15
Conference pass

Panel: Legal and IP strategies to strengthen biosimilar medicine developers

Biosimilars - Market Access and Commercialisation
Oct 3015:15
Conference pass

Chemoselectively induced bioconjugation for stable and homogeneous ADCs

Antibodies - Armed Antibodies
  • Linkage technology for both: native (cysteine) and engineered antibodies (chemo-enzymatic) has been developed in our laboratory
  • Chemically induced phosphonamidate electrophiles for selective conjugation to Cys-residues
  • Conjugates are stable in human serum and efficient in vivo
  • Intracellular lability opens the way to a novel, inherent drug release technology
Oct 3015:15
Conference pass

Originator and biosimilar mAbs and Fc-fusion state-of-the art analytical methods

Biosimilars - Sustainability/Development and manufacturing
Oct 3015:15
Conference pass

Enabling drug development of therapeutic proteins at the interface of research to development

Antibodies - CMC and Developability
  • Developability assessment of therapeutic proteins
  • State-of-the art cell line and strain development
  • A toolbox concept enabling drug development of therapeutic proteins of a rich portfolio with increasingly complex molecule formats
Oct 3015:15
Conference pass

Re-writing the rules of drug discovery: harness the power of biology to hit specified epitopes

Technology Showcase
  • Comp bio-derived immunogens and capture reagents to focus biology on high-value, differentiated epitopes
  • Immunization strategy informed by real-time immune response monitoring
  • elimination of promiscuous and high-risk specific off-target binders
  • Functional epitope mapping
Oct 3015:20
Conference pass

Panel Discussion:The value of sharing clinical trial data and challenges

Clinical Trials - plenary
  • Maximising the value of clinical data through data sharing
  • The role of clinical trial registries for trial registration, results posting, and lay summaries
  • The EMA Policy 0043 and Policy 0070
  • Redaction, perturbation, anonymization, and data utility
  • Transparency, CCI, privacy, and risk
  • The responsibilities of regulators, sponsors, researchers, IECs/IRBs, authors, editors, and publishers
Oct 3015:35
Conference pass

Harnessing biotechnology against snakebite and other neglected tropical diseases

Antibodies - Protein Engineering
  • Snake venoms - a diverse arsenal of highly potent protein-based toxins
  • Cocktails of monoclonal human IgG antibodies with in vivo efficacy against snake venoms
  • Discovery of neurotoxin-targeting human IgGs using phage display technology
  • Using snake venom toxins to target parasitic diseases
Oct 3015:35
Conference pass

Hexavalent TNFR-SF agonists for cancer Immunotherapy: HERA-CD40L, HERA-CD27L and beyond

Immunotherapy - Combination therapy
  • Understand the structure function relation of the TNFR-SF/TNF-SF interaction and the subsequent design of the HERA-fusion proteins
  • In vitro and in vivo preclinical data illustrating the activity of HERA-based agonists to specifically activate distinct immune cell types involved in the anti-tumor immune reaction
  • Outlook on potential combinations with other IO-drugs
Oct 3015:35
Conference pass

Extended Q&A

Antibodies - Bispecifics
An opportunity to ask the speakers your questions!
Oct 3015:35
Conference pass

Case studies of issues that occurred during the development of biosimilar products

Biosimilars - Sustainability/Development and manufacturing
Oct 3015:35
Conference pass

Radionuclide therapy using peptide nucleic acid (PNA)-mediated pretargeting of HER2-expressing tumors

Antibodies - Armed Antibodies
  • We have developed a system for peptide nucleic acid (PNA)-based pretargeting of tumors, which can be used to overcome the problem with renal accumulation of HER2-binding affibody molecules
  • Experimental therapy with a HER2-binding affibody and 177Lu-labeled PNA probes show promising results in a mouse model: prolonged survival for treated mice and no observed toxicity
  • PNA-based pretargeting in combination with the HER2-targeting antibody trastuzumab resulted in clear visualization of HER2-expressing xenografts in mice
Oct 3015:35
Conference pass

Analytical methods used to monitor size variants in new biotherapeutic modalities

Antibodies - CMC and Developability
  • Applications of SEC for bispecific mAbs
  • Complimentary CE-SDS for bispecific mAbs and single chain variable fragments
Oct 3015:35
Conference pass

Soteria®: Revolutionising Oral Delivery of Antibodies

Technology Showcase
  • All antibody therapeutics are currently administered via injection
  • High systemic exposure and lack of targeted delivery to the disease site poses serious risks of adverse effects
  • Soteria® is a revolutionary platform technology that allows formulation of antibodies in a tablet or capsule
  • Relies on dual mechanism:
    • Targeted delivery of antibodies to the lower GI tract using proprietary Phloral® coating technology
    • Excipients in the core that stabilizes the biologic against proteolytic degradation and improves local/systemic bioavailability
Oct 3017:00
Conference pass

Advanced therapeutics inference by high-dimensional analytics

Clinical Trials - plenary
  • A novel approach: high-dimension model
  • Big data in clinical environment
  • Machine learning applied in clinical studies
  • Improving clinical trials
Oct 3017:00
Conference pass

CMC strategies to influence pharmacokinetics

Keynotes
  • Mechanisms influencing the pharmacokinetics of antibodies
  • API-related critical quality attributes influencing pharmacokinetics
  • Considerations for antibodies with and without effector function
Oct 3017:00
Conference pass

Driving high T-cell titers to neoantigens in tumours – harnessing immunogenic viral vectors with immune check point modulators

Immunotherapy - Neoantigens
  • DNA damage may cause mutations in tumours that can generate new antigens, known as tumour-specific neo-antigens (TSNAs)
  • Accurate prediction of TSNAs is key to generate potent TSNA specific vaccine approaches
  • Viral vector based vaccine platforms have shown to induce hi-titer, polyfunctional and durable CD4+ and CD8+ T-cell responses in humans
  • The personalized vaccine is delivered in combination with immune checkpoint blockade, to keep TSNA-induced T-cells active in the immunosuppressive tumour microenvironment
Oct 3017:00
Conference pass

Implementation and administration of biosimilars in the clinic

Keynotes
Kalveer Flora, Specialist Pharmacist Rheumatology & Biosimilars, London North West Healthcare Nhs Trust
Oct 3017:00
Conference pass

Targeting combined treatments to arthritic joints by antibody-specific to damaged cartilage: a safer therapy platform for rheumatoid arthritis

Immunotherapy - Immunotherapy for non-oncology
  • There are 40% of patients with rheumatoid arthritis that do not respond to treatments
  • A major issue with systemic treatment due to side effects
  • We developed a platform that can address these unmet needs by:
    • Targeting treatments to the disease tissue
    • Utilize the efficacy of combined biologics which could otherwise lead to major advert effects if administered systemically
Oct 3017:20
Conference pass

Safety testing of monoclonal antibodies: new targets, new molecules, new challenges

Keynotes
  • In silico review of target biology
  • Rationale mAb design/selection to avoid unwanted biological/immune effects
  • In vitro studies: pharmacology/immunosafety studies to characterise Fab and Fc effects, off-target binding and immunogenicity
  • In vivo studies: safety/efficacy/PD studies in normal/disease models
  • Using safety, PK/PD and M&S data to select safe human starting doses and escalation schemes
Oct 3017:20
Conference pass

Towards objective clinical trials: decentralizing cancer pathology

Clinical Trials - plenary
  • Building a global decentralised resource for efficient pathology analysis
  • Blockchain as the solution for the challenge of large-scale diagnostic consensus making
  • Building a portfolio of image-based data and machine-learning algorithms using decentralised experts
Niels Grabe, Director, Tissue Imaging and Analysis Center, University of Heidelberg Medical Center
Oct 3017:20
Conference pass

ACE ImmunoID platform for the next generation of cancer immunotherapies and combination clinical trials

Immunotherapy - Neoantigens
  • Current limitations with conventional next generation sequencing assays and Personalis’ solutions to overcome these challenges with its Accuracy and Content Enhanced technology
  • Key considerations for designing rapid, patient-centric processes for neoantigen-based cancer vaccine clinical trials and combination therapies
  • A case study demonstrating the platform’s applicability in identifying multidimensional biomarkers for cancer immunotherapy
Oct 3017:20
Conference pass

Biosimilars: Physician education and Market Uptake

Keynotes
  • Unmet need of understanding Biologics/Biosimilars among Physicians
  • Understanding of Chemical vs Biologics, Biosimilarity: Totality of Evidence, Rationality of extrapolation of data, Interchangeability, Regulatory approval process etc.
  • Market Uptake of Biosimilars: Regulatory approval process, Patent litigations, “Interchangeability” designation, low physician awareness , Pharmacoeconomics etc.
Oct 3017:20
Conference pass

The promises of low dose IL-2 in autoimmune diseases

Immunotherapy - Immunotherapy for non-oncology
  • There is a regulatory T cell (Treg) insufficiency in most autoimmune diseases
  • IL-2 is the main cytokine supporting survival and activation of Tregs, and also block the differentiation of IL-17 and Tfh cells
  • IL-2 has proved efficient in more than 30 experimental models of autoimmune or inflammatory diseases in mice
  • We report “universal” biological and clinical effects of IL-2 in patients with one of 14 different autoimmune diseases treated in the same clinical trial
Oct 3017:40
Conference pass

Direct quantitation of therapeutic sntibodies for pharmacokinetic studies using immuno-purification and intact mass analysis

Keynotes
  • PK of mAbs has traditionally been measured using ligand binding assays
  • The use of mass spectrometry can complement LBA results
  • Results comparing LC-MS with LBA will be presented from GLP studies
Oct 3017:40
Conference pass

From tendering to long term partnership in CTS

Clinical Trials - plenary
  • Using data to improve trial accuracy
  • Forecasting systems: react to fluctuations in the supply chain and enable you to act in real time
  • Considerations of whether to build an internal forecasting system or rely on third party software?
Oct 3017:40
Conference pass

Development of a cost-effective personalized cancer neoantigen vaccines inducing a unique CD8-dominated T cell response

Immunotherapy - Neoantigens
  • Potentiating vaccines by attracting, activating and delivering antigens to antigen presenting cells
  • Targeting results in a unique CD8-dominated T cell response.
  • DNA vaccine format allows a rapid, cost-effective and robust manufacturing process viable for manufacturing patient-specific vaccines on demand
  • A clinical study using targeted Vaccibody neoepitope DNA vaccines in multiple advanced cancer indications is ongoing
Oct 3017:40
Conference pass

Proteomics crashes at the intersection of autoimmunity and cell biology

Immunotherapy - Immunotherapy for non-oncology
  • Review novel protein modifications that trigger autoimmune responses and pathology
  • Discuss proteins modifications that also alter cell biology and metabolism
  • Protein biomarkers as indicators of disease progression and therapeutic strategies
Oct 3018:00
Conference pass

Chair's final remarks

Clinical Trials - plenary
Oct 3018:00
Conference pass

Validation of a LC-MS/MS assay for the quantitation of a new trispecific antibody against AIDS virus HIV-1

Keynotes
  • A new trispecific antibody exhibits higher potency and confers complete immunity against a mixture of SHIVs in non-human primates
  • Toxicokinetic assessments required a GLP validate assay
  • Ligand-binding assays have been standard methods for measuring therapeutic antibodies, however not always suitable. In alternative, we developed and validated a fast and accurate LC-MS/MS assay for quantitation of the trivalent antibody in the toxicological studies
Oct 3018:00
Conference pass

Individualized therapeutic cancer vaccines – How to select for immunogenic neoantigens?

Immunotherapy - Neoantigens
  • Selecting the right tumour specific antigens - the key for successful therapeutic T cell cancer vaccines
  • Bypassing prediction - identification of tumour specific T cell antigens by a functional readout
  • Vaccination with common tumour antigens - decoding the “Mutanome” presented on HLAs
Oct 3018:00
Conference pass

Combinatorial therapeutic HIV-1 vaccines: Time for immune checkpoint inhibitors

Immunotherapy - Immunotherapy for non-oncology
  • Talk will focus on HIV-1 infected and treated patients who received therapeutic vaccination
  • Discuss the current work on how to improve therapeutic vaccination using immune checkpoint inhibitors

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Oct 3108:50
Conference pass
Oct 3109:00
Conference pass
Oct 3109:00
Conference pass

Toxic/Sterile Containment system with integrated process equipment

Keynotes
  • Gain an overview of novel facility and how it works to process high potency compounds
  • How has this novel approach differed from a containment perspective?
  • In addition to cost effectiveness, what else has this approach enabled for Merck within high potency compounds?
Oct 3109:05
Conference pass

An alternative strategy to generate binding proteins

Keynotes
    New concept for generating binding proteinsExploiting progress in protein design and crystallographyExploiting the modularity of targets
Oct 3109:05
Conference pass

Hiding in plain sight: Fc-receptor variation and comparison of human and animal models

Keynotes
  • Human Fc-receptor variation can affect response to vaccines and passive immunotherapy
  • Animal model testing of therapeutics that require Fc-receptor dependent interactions could give different results than human studies
  • Fc-receptor diversity in humans appears to be low but significant, while in non-human primates, diversity appears to be high and of unclear significance
Oct 3109:30
Conference pass

Antibodies against GOLPH2 for cancer therapy

Keynotes
  • GOLPH2 (GP73/GOLM1), a pro-oncogenic protein in a variety of cancers has hitherto been regarded to be undruggable
  • Novel antibodies with a unique mode of action target GOLPH2 positive tumors are to be presented
  • Preclinical data of these antibodies show high efficacy in vitro in EGFR- and KRAS-mutated cell lines
  • In vivo data of patient-derived xenografts confirm efficacy and indicate the way of further clinical development
Oct 3109:30
Conference pass

Targeting of the sialoglycan-SAMP/Siglec pathway in vitro and in vivo resulted in increased anti-cancer immunity

Keynotes
  • Changes of glycans in the tumor microenvironment
  • Upregulation of sialoglycans increase density of ligands for Siglec receptor
  • Siglec receptors are new immune checkpoints upregulated on tumor-infiltrating T cells
  • Siglec-sialoglycan interactions can be targeted to improve anti-cancer immunity
Oct 3109:55
Conference pass

Bispecific and bifunctional fusion proteins

Keynotes
  • Concept of bispecific and bifunctional fusion proteins
  • Bispecific antibodies for dual targeting
  • Dual-acting costimulatory fusion proteins
  • Hexavalent death ligand fusion proteins
Oct 3109:55
Conference pass

Strong anti-tumor immunity synergistically activated by an oncolytic virus VG161 armed with multiple immune stimulating genes

Keynotes
  • VG161: An Investigational New Drug (IND) enabled oncolytic virus (OV) armed with multiple anti-tumor regulatory factors
  • Strong anti-tumor effect demonstrated in multiple animal tumor models
  • Lasting anti-tumor immunity by VG161 in comparison with non-armed OV
Oct 3111:20
Conference pass

Syngeneic system for a cell-based vaccination in rabbit

Antibodies - Novel targets and biomarker discovery
  • Antibody discovery in rabbit using a syngeneic cell-based vaccination
  • Large and diverse set of immortalized rabbit cells available with broad antigen expression capability
  • System well-suited to generate antibodies against complex membrane-bound antigens (transporter, GPCR)
  • Promising alternative to genetic or cross-species cell-based vaccination
Oct 3111:20
Conference pass

Universal allosteric switch modules to regulate antibody affinities

Antibodies - Antibody screening and immune repertoire sequencing
  • Antibody affinities in FACS were regulated by a linker-based allosteric effector domain
  • Validated with 5 different svFv so far
  • Works both in VH-VL / VL-VH orientation
  • Regulation under physiological conditions (no ion concentration change)
Oct 3111:20
Conference pass

Experimental and computational profiling of Biologics: a powerful duo for next generation developability

Antibodies - Computational discovery and development
  • Early lead selection of biotherapeutics during preclinical development requires careful characterization of a variety of molecule properties to reduce the risk for encountering unexpected obstacles during technical development
  • Developability assessment at Novartis combines information about expression, aggregation propensity, process fit, stability, solubility, physicochemical properties, in vivo fitness and immunogenicity of potential candidates
  • This integrated approach prior to lead selection provides a thorough, yet resource efficient approach
Oct 3111:20
Conference pass

Antibody discovery and engineering in mammalian cells by homology-directed mutagenesis

Antibodies - Research hub
  • Optimizing conditions for homology-directed mutagenesis in mammalian cells
  • Designing, generating, and analyzing synthetic antibody libraries
  • Full-length antibody screening and affinity maturation in mammalian cells
  • Deep mutational scanning in mammalian cells by combining homology-directed mutagenesis and deep sequencing
Oct 3111:20
Conference pass

Anthracycline-based antibody drug conjugates with potent immune-stimulatory functions

HPAPI - ADCs and New Molecules
Roger Beerli, CSO, NBE Therapeutics
Oct 3111:20
Conference pass

Facility case study 1

HPAPI - Controls and Containment
Oct 3111:40
Conference pass

Advanced antibody and assay capabilities to support target and biomarker validation and implementation

Antibodies - Novel targets and biomarker discovery
  • Robust antibody development, IP and regulatory management to deliver best-in-class antibodies, from research grade to IVD.
  • Abcam delivers true end-to-end solutions: from antibody discovery to assay development and commercialisation.
  • New FirePlex® platform for biomarker validation and implementation; robust detection from low sample input with exceptional performance and reproducibility.
Oct 3111:40
Conference pass

PDC*line Pharma semi-allogeneic cancer vaccine: how abortive allogeneic immune response can prime and boost the induction of specific anti-tumor T cells

Immunotherapy - Cancer vaccines
  • PDC*line is a new potent and scalable therapeutic cancer vaccines based on a proprietary allogeneic cell 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 type of cancer
Oct 3111:40
Conference pass

Deep sequencing analysis of phage selection outputs: Leaving conventional screening behind

Antibodies - Antibody screening and immune repertoire sequencing
  • We will show adaptations to library design and panning strategies exploiting the full potential of deep sequencing analysis of phage selection output pools to identify high affine antibodies without conventional screening
Oct 3111:40
Conference pass

Tolerogenic nanoparticles to mitigate immunogenicity and improve the efficacy of immunotoxins for cancer therapy

Immunotherapy - Safety and efficacy
  • The development of anti-drug antibodies (ADAs) can compromise the efficacy and safety of biologic therapies
  • Recombinant immunotoxins are potent but highly immunogenic anti-cancer agents
  • We have partnered with the National Cancer Institute to demonstrate that synthetic vaccine particles nanoparticles containing rapamycin (SVP-Rapamycin) effectively mitigate ADAs against LMB-100, a mesothelin-targeted immunotoxin, and enables robust anti-tumor responses in preclinical models
  • The combination of LMB-100 and SVP-Rapamycin is currently in clinical trials for the treatment of patients with mesothelioma
Oct 3111:40
Conference pass

A computational framework for predicting protein liabilities & improvement of antibody developability

Antibodies - Computational discovery and development
  • AggScore: a new method to identify aggregation hotspots on the interaction surface of proteins by evaluating hydrophobic, but also charged surface patches
  • BioQSPR: a machine-learning suite to generate prediction models to address issues like aggregation, solubility, stability and viscosity
Oct 3111:40
Conference pass

Targeting the inside of the cell with antibodies

Antibodies - Research hub
  • Approaches to target the inside of the cell
  • Knockdown of various membrane receptors with intrabodies
  • Intrabody mediated knockdown in mice
Oct 3111:40
Conference pass

Kinesin Spindle Protein Inhibitors (KSPi): A Novel Payload Class for ADCs

HPAPI - ADCs and New Molecules
Oct 3111:40
Conference pass

Drug safety- challenges in launching new biologics

HPAPI - Controls and Containment
Michael Von Forstner, Co-chair, Pharmacovigilance Working Group, Medicines for Europe
Oct 3112:00
Conference pass

Preclinical Development of ADCs against NSCLC

Antibodies - Novel targets and biomarker discovery
  • Antibody discovery via cell-based immunization
  • Phenotype-based drug screening approach to identify lead candidate
  • Characterisation and validation of antigen targets
  • Pre-clinical development of ADC in vitro and in vivo
Oct 3112:00
Conference pass

Overcoming tolerance by deep mining of natural immune repertoires

Antibodies - Antibody screening and immune repertoire sequencing
  • Antibodies from natural immune responses are widely regarded as superior to those generated by display technologies
  • Immune tolerance poses a serious challenge for targets with high inter-species homology and Insoluble and poorly immunogenic targets such as membrane proteins exacerbate this challenge.
  • AbCellera’s ultra-deep screening technology overcomes these challenges, producing hundreds of diverse rodent antibodies against targets with 100% rodent-human homology, including G protein-coupled receptors
Oct 3112:00
Conference pass

Physical stability – structural homogeneity of biotherapeutic antibodies: property prediction by in silico methods

Antibodies - Computational discovery and development
  • Discovery and development of biotherapeutic mAbs is a multiparametric optimization to balance biological and pharmaceutical properties such as stability
  • Stability refers to intricate structural, chemical, and physical processes. Methods for theoretical prediction of these processes generally focus on particular aspects, not on the global outcome of such modifications
  • We will report on a knowledge-based approach to predict aspects of stability by combining homology modelling, structural descriptor calculations, and classification algorithms
Oct 3112:00
Conference pass

Moving forward with adoptive transfer of expanded tumour-infiltrating lymphocytes (TIL) scientifically and in clinical practice

Antibodies - Research hub
  • Determination of TIL quality and potential after initial harvesting
  • Effector phenotype of lymphocytes after excision and before infusion
  • Effect of serum and serum free medium on T lymphocytes
  • Timing and quantity of addition of antibodies to the TIL production
Julia Manzetti, PostDoc, Head of production of TILs, University Hospital Basel
Oct 3112:00
Conference pass

Health effects and legal actions

HPAPI - ADCs and New Molecules
Reinhold Maeck, Head of Corporation EH&S Regulatory Intelligence, Boehringer Ingelheim
Oct 3112:00
Conference pass

Facility case study 2

HPAPI - Controls and Containment
Karoline Bechtold Peters, Senior Strategy & Technology Leader - Pharmaceutical Development, Novartis
Oct 3112:05
Conference pass

Cell penetrating peptides and TLR peptide agonist: the swiss army knife of cancer vaccines

Immunotherapy - Cancer vaccines
  • Therapeutics cancer vaccines
  • Chimeric proteins
  • Multi-antigenic T cells immunity responsive
Oct 3112:05
Conference pass

Toxicities after CART cell therapy: New insights in pathophysiology and management

Immunotherapy - Safety and efficacy
  • Recognize toxicities after CART cell therapy
  • New insights in the pathophysiology of neurotoxicity after CART cell therapy
  • Discuss novel strategies to prevent and treat cytokine release syndrome and neurotoxicity after CART cell therapy
Saad Kenderian, Assistant Professor of Medicine, Oncology, and Immunology Director, T Cell Engineering Program, Mayo Clinic
Oct 3112:20
Conference pass

Thinking beyond antigen expression: SLC46A3 as a potential predictive biomarker for specific non-cleavable ADCs

Antibodies - Novel targets and biomarker discovery
  • While antibody-drug conjugates (ADCs) utilizing non-cleavable payloads have been approved for clinical use, and several are in development, predictive biomarkers beyond antigen expression are unknown.
  • We examined in vitro and patient-derived models of ADC resistance and found that loss of SLC46A3 expression is a mechanism of acquired and innate resistance to ADCs bearing the non-cleavable payloads DM1 and the pyrrolobenzodiazepine SG3376.
  • Expression of SLC46A3 may be more predictive of activity than target antigen levels alone
  • Our findings support SLC46A3 as a potential patient selection biomarker with immediate relevance to clinical trials involving these ADCs
Oct 3112:20
Conference pass

Droplet-microfluidics in antibody discovery and immunoncology

Antibodies - Antibody screening and immune repertoire sequencing
  • New 2-cell platform enabling the screening of antibodies for their effect on target cells
  • Compatible with difficult targets such as GPCRs
  • Complementary platform for the stratification of cancer patients for personalized treatments
  • Results are available within 24h after surgery/biopsy at very competitive screening costs
Oct 3112:20
Conference pass

Computational and knowledge-based learning to optimise antibody design and engineering

Antibodies - Computational discovery and development
  • Understanding the relationship between antibody structure and function
  • Engineering aspects in therapeutic antibody discovery and development
  • Computer-aided fully automated antibody humanization design
Oct 3112:20
Conference pass

Cytosolic delivery of DARPins by retargeted bacterial protein toxins

Antibodies - Research hub
  • Crossing the cytoplasmic membrane remains the major hurdle in protein delivery
  • Cell-specific cytosolic delivery via toxin-inspired mechanism
  • Distinguishing intracellular from cytosolic localisation of delivered proteins
Oct 3112:30
Conference pass

Accelerate your immunotherapy target discovery using immune repertoire sequencing

Immunotherapy - Cancer vaccines
  • Key challenges in characterizing the immune repertoire
  • Using the ImmunoGenomiX (IGX) platform to accurately analyze the immune repertoire
  • Sequencing the immune repertoire to develop new biomarkers
  • Use cases in oncology and beyond
Oct 3112:30
Conference pass

Risk profiling of peptide targets for immunotherapeutic discovery

Immunotherapy - Safety and efficacy
  • Integrating multi-omics data and predictive algorithms.
  • Assessing off-target effects for immunotherapies provides clearer picture of risk landscape.
  • Direct and optimise screening to ensure risks are covered.
  • Systematic Identification of high priority targets using advanced predictive modelling.
Oct 3112:40
Conference pass

Towards a therapy of neurodegenerative diseases - a lesson learned from prion diseases

Antibodies - Novel targets and biomarker discovery
  • Neurodegenerative diseases
  • Prion diseases
  • Alzheimer's disease
  • Shed PrP, PrP226
  • Monoclonal antibody, scFv
  • BBB
  • Cell-penetrating peptide
Oct 3112:40
Conference pass

MemoMAB: Antibody repertoires

Antibodies - Antibody screening and immune repertoire sequencing
  • Immune repertoire analysis and antibody discovery from human donors and animals
  • Repertoire biobanking in a screenable format using mammalian cell display
  • High fidelity and rapid turn-over times
Oct 3112:40
Conference pass

The sequence space of antibody repertoires

Antibodies - Computational discovery and development
  • The sequence space that entire antibody repertoires cover is best investigated with large-scale networks
  • The sequence space architecture of antibody repertoires is reproducible, robust and redundant
  • Prospective on the predictability of evolutionary pathways in sequence space
Oct 3112:40
Conference pass

Highly homogeneous antibody modification through optimisation of the synthesis and conjugation of functionalised dibromopyridazinediones

Antibodies - Research hub
  • Introduction to disulfide rebridging as a strategy for the synthesis of homogenous bioconjugates
  • Introduction to dibromopyridazinediones as a conjugation reagent for disulfide rebridging
  • Exploring optimal conjugation conditions for achieving maximum homogeniety across multi-disulfide systems (especially IgG1 Abs)
  • Exploring the effect of disulfide rebridging on antibody activity, with focus towards Fc interactions
Oct 3114:00
Conference pass

Antibodies as drugs: Pursuit of the ‘high hanging fruit’

Keynotes
  • Opportunities and challenges with antibody drugs
  • Applications of bispecific antibodies
  • Efficient production of bispecific IgG in single host cells
Oct 3114:00
Conference pass

The future of precision medicine

Keynotes
  • Oncology and genomics: halfway there
  • Immunology and more Omics: we’re just starting
  • The future: complexity simplified, research put into practice, digital put into action
Oct 3114:00
Conference pass

Lifecycle Management of Analytical methods for Cleaning Verification Support

HPAPI - Workshops
  • Equipment Cleaning is a critical GMP element of the Manufacturing Process. It ensures quality and safety of future batch. Cleaning Validation/verification is a measurement of the effectiveness of the cleaning process
  • In this presentation we will go over advantages and challenges of specific and non-specific analytical methods based on risk assessment of the residual product.
  • Case studies, training and qualification programs will also be discussed.
Oct 3114:00
Conference pass

Demonstrating that Exposure Controls are Effective

HPAPI - Controls and Containment
  • Assessing containment performance
  • Data interpretation
  • Challenges when measuring very low concentrations
Martin Axon, Principal, Occupational Hygienist of Operations for Europe, Safebridge
Oct 3114:20
Conference pass

The HLA peptidome as a novel biomarker to predict response to immunotherapy

Keynotes
  • Antigen-specific T cells can mediate significant tumour cell killing
  • Immunotherapy can increase the number and activity of TILs
  • Increasing our knowledge of tumour-specific (neo-) antigens may facilitate therapeutic strategies
  • Peptides presented on HLA complexes predict response to therapy
Oct 3114:25
Conference pass

Evolution and advancements in cancer immunotherapy

Keynotes
  • An accidental beginning and the lag phase
  • Checkpoint modulators and establishment of a new treatment paradigm: the growth phase
  • Understanding the pitfalls and road blocks: future efforts to escape the lag phase
Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme
Oct 3114:40
Conference pass

The promise of artificial intelligence: a case for precision immunology

Keynotes
  • Personal immune repertoires
  • Network analysis deconvolutes immune repertoires
  • The potential of artificial intelligence for biomarker and innovative antibody discovery
Oct 3114:40
Conference pass

Turning native antibodies into homogeneous ADCs without antibody engineering

HPAPI - Workshops
Oct 3114:40
Conference pass

Panel discussion: containment comparisons

HPAPI - Controls and Containment
  • Questions about the ISPE Risk MAPP
  • Updates from ICH guidelines
  • Requirements for manufacturing in shared facilities
Martin Axon, Principal, Occupational Hygienist of Operations for Europe, Safebridge
Ulrich Scholz, Head of Scale Up and Processing, Bayer
Oct 3114:50
Conference pass

Antibodies to watch in 2019

Keynotes
  • Brief Overview mAb therapeutics 1997-2017
  • Approvals in 2018
  • Antibodies to watch in 2019
Oct 3115:00
Conference pass

The changing face of clinical cancer research in an era of personalized cancer care

Keynotes
  • Outline how advanced diagnostics has sharpened our understanding of cancer cancer complexity and heterogeneity
  • Outline how cancer complexity and heterogeneity drives the evolution of clinical study designs, in particular to address the high unmet need in an ever-growing number of rare or molecularly-defined cancers
  • Discuss concepts how to move from "one biomarker - one therapy" to a "many biomarkers - optimal therapeutic approach" mindset
Oct 3115:40
Conference pass

Risk-based handling of highly potent APIs: cross-contamination and transportation parameters

HPAPI - Management Systems and EH&S
  • Guidelines regarding Quality Risk Management
  • Case study 1: technical aspects and complexity in cross contamination risk analysis
  • Case study 2: temperature deviation during transportation
Oct 3115:40
Conference pass

Improving processes; batch vs continuous

HPAPI - Manufacturing
Jack Brown, Senior Principal Scientist, Boehringer Ingelheim Pharmaceuticals Inc
Oct 3116:00
Conference pass

Compliance, audit, training and worker risk perception

HPAPI - Management Systems and EH&S
Oct 3116:00
Conference pass

Moving away from traditional validation techniques Implementing a risk-based Commissioning & Verification approach in a new biotech greenfield site

HPAPI - Manufacturing
for more information please contact Alistair Wilmot:E: alistair.wilmot@terrapinn.comT: +44 (0) 207 092 1174
Thomas Cragnolini, Senior Manager C&Q, Recombinant Facility, CSL Behring
last published: 26/Oct/18 09:55 GMT

 

 

There are two parts to the Festival of Biologics: the five world-class international conferences covering Antibodies, Immunotherapy, BioSimilars, Clinical Trials, and High Potency APIs; and an exhibition featuring the most exciting technology and solutions for pharma and biotech. There is a registration fee to attend the conferences. To visit the exhibition is free.


Conference 29 - 31 October • Exhibition & Seminars 29 - 31 October 

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