2019 Archived Content

Breakout Discussions

Tuesday 19 November | 09:35 – 10:30

TABLE: Emerging Technologies for High Throughput Antibody Discovery
Thomas Bouquin, PhD, Head, Biologics Research France, Centre de Recherche de Vitry/Alfortville, Sanofi

Microfluidics
Engineering of antibody using eukaryotic display technologies

TABLE: Synthetic vs. Natural Diversity in Antibody Libraries
Pierre Martineau, PhD, Deputy Director, Functional Screening and Targeting in Cancer, Institut de Recherche en Cancérologie de Montpellier, Inserm, Université de Montpellier – ICM

Repertoire diversity
Affinity of clones
Epitope coverage
Developpability of obtained mAbs
Immunogenicity
Currently registered mAbs origin

TABLE: Is the QbD Toolbox Ready for Cell & Gene Therapies?
Moderator:Jose C. Menezes, PhD, CEO, 4Tune Engineering

How can Patient Outcomes be Integrated into Manufacturing of C&GT Bioproducts?
Can we deliver tailored products to terminally-ill patients and do so effectively right-first-time?
What will be the right risk-benefit balance that can justify speeding up through development to deliver just in time a-lot-for-a-patient?
Even if a solution for C&GT products might be far away, why can’t some streamlining of the current model be done?

TABLE: How to Attach Oligonucleotides
Moderator:Philipp Spycher, PhD, PSI Founder Fellow, Center for Radiopharmaceutical Sciences (CRS), Paul Scherrer Institute

Which sizes can be conjugated and their in-vivo effects
How to release the oligonucleotide and release from lysosome
Is a cleavage sequence needed?

TABLE: Developability of Biologic Drugs: Current Trends, Challenges and Opportunities
Moderator: Jonathan Kingsbury, PhD, Head, Developability and Preformulation, Biologics Development, Sanofi

What presentations in the conference so far have sparked your interest?
Are there any methods that you're interested in incorporating into your workflows?
What are the biggest unmet needs in the field of developability?
How successful have in silico approaches been in predicting liabilities?

TABLE: Topic TBD
Moderator: Anup Arumughan, PhD, Principal Scientist, Antibody Analytics, Roche

TABLE: Challenges and Immunosuppressive Mechanisms that Restrict Anti-Tumour Functions of Monoclonal Antibodies in the Tumour Microenvironment 19
Moderator: Stephen A Beers, PhD, Professor of Immunology and Immunotherapy, Centre for Cancer Immunology, University of Southampton

Selection of target antigens for antibody immunotherapy of solid tumours
Target antigen heterogeneity and its influence on anti-tumour functions of antibodies; escape mechanisms.
Importance of affinity to the target antigen and to Fc receptors for:

tissue penetration
anti-tumour functions

Interrogating the cytokine environment and the immunosuppresive cell populations infiltrating tumours

TABLE: Management of Checkpoint Refractory Patients
Moderator: David Mills, PhD, Director, Oncology, Therapeutics Research, Zymeworks

How to manage CPI resistant patients
Predicting, preventing and monitoring CPI resistance
New targets beyond PD-1/PD-L1 and CTLA-4
Assays to assess multiple mechanism-of-action: in vitro, mouse, and monkey
Hitting multiple targets: combinations vs. multi-specific antibodies

TABLE: Evaluating Protein Quality During Production in Real-time
Marco G. Casteleijn, PhD, Senior Researcher, Industrial Biotechnology, VTT Technical Research Institute of Finland

Reporter genes - good feed-back or just rumors?
Raman Spectroscopy - quality confirmed or just exited molecules?
Terahertz spectroscopy - protein quantification or too complex?
Optical sensors - nice close-up or a murky view?
Functionality assays - in vivo or sampling takes time?

TABLE: What Are the Promises of Synthetic Biology for Bioproduction?
Philippe H. Jais, MD, PhD, President and CSO, Eukarÿs SAS

Which product has benefited the most from synthetic biology? And in the future?
What can genome editing do for bioproduction?
Is bioproduction in mammalian cells the new frontier?
What can non-natural nucleotide and non-natural amino-acids bring to bioproduction?

TABLE: Cell-Free Protein Expression (CFPS) as a Useful Tool for Protein-Protein Interaction Analysis
Shayli Varasteh Moradi, PhD, Research Associate, Science and Engineering School, Queensland University of Technology

Advantages of CFPS system in synthetic biology
Using CFPS to study protein-protein interaction
The application of CFPS in antibody and drug screening

Wednesday 20 November | 18:45 – 19:45

TABLE: Challenges in Developing Antibodies against GPCRs and Ion Channels
Moderators:
Catherine Hutchings, PhD, Consultant
Trevor Wilkinson, PhD, Assoc Director, Antibody Discovery & Protein Engineering, AstraZeneca Biopharmaceuticals Unit

What has been an enablement for use as an antigen format?
What screening processes and assays have increased success?
Are there emerging trends for how to address specific target classes?
What else should we be integrating into the discovery flow?

TABLE: New Explorations in Antibody Engineering and Design
Moderator: Guy Georges, PhD, Expert Scientist, Large Molecule Research, Roche Innoavtion Center Munich

Engineer the perfect antibody suited for becoming a therapeutic?
Discover the ideal format?
Design the adequate bi- multi- specific antibody?

TABLE: Next Generation Bispecific T Cell Engagers
Moderators: Paul W.H.I. Parren, PhD, Executive Vice President, Head, R&D Lava Therapeutics B.V.
Adam Root, MSc, Senior Principal Scientist, BioMedicine Design, Pfizer Inc

Limitations and opportunities
Increasing the therapeutic window

Format optimization and Fc engineering
Preclinical models to use

TABLE: Development of Effective Combination Therapies for Immuno-Oncology
Moderators: Marina Bacac, PhD, Head, Cancer Immunotherapy Department 2 (CIT-2), Roche Innovation Center Zurich
Christian Klein, PhD, Head, Oncology Programs, Head, Cancer Immunotherapy Discovery, Roche Pharmaceutical Research and Early Development (pRED)Roche Innovation Center Zurich

Which are the most promising combination partners for CD3 bispecific antibodies beyond a-PD(L)1 antibodies?
Which could be the best combination strategies for inflamed/immunogenic and non inflamed/non immunogenic tumors?
What makes a good combination therapy and how to translate the results to humans?
What do we know about the optimal dosing regimens and schedules for combination therapies?
How do we assess the safety of combination therapies in pre-clinical models? Can this be accurately assessed at all?

TABLE: Native MS in biopharmaceutical development
Moderator: Dan Bach Kristensen, PhD, Principal Scientist, Symphogen

How is native MS applied during biopharmaceutical development?
What are the advantages/disadvantages relative to conventional intact MS?
How robust is the native MS platform?
What kind of non-covalent interactions are people studying with native MS?
Is native MS currently applied in QC (release testing according to specifications)?

TABLE: MAM – A Moving Target
Moderator: Matthias Berg, PhD, Group Head, Analytical Development and Characterisation (ADC) – Mass Spectrometry, Novartis Pharma AG

Peptide mapping versus subunit analysis
Define the limits of relevance
High resolution versus low resolution MS instrumentation for MAM

TABLE: In-use Stability for Biologics
Moderator: Sachin Dubey, PhD, Deputy Director/Head, Formulation, Analytical and Drug Product Development, Glenmark Pharmaceuticals

Generally acceptable approaches and good practices
What need to be tested and what shall be the quality requirements for the tests
Gearing up for upcoming USP<800>

TABLE: Challenge of Combination Drugs with Check Point Inhibitors
Moderator: Prof. Dr. René Hoet, CSO, Imcheck Therapeutics

Currently there are over 1700 clinical trials with combination therapies with approved check point inhibitors (anti-PD-1, anti-PDL1, anti-CTLA4) with far with limited success
What can we learn from this?
How can we improve?

TABLE: Cellular vs. Non-Cellular Antibody Therapies
Moderator: John Anderson, PhD, GOSHCC Professor of Experimental Paediatric Oncology, Honorary Consultant Oncologist, UCL Great Ormond Street Institute of Child Health

Cell therapies versus antibodies
Towards universal cell therapies

TABLE: Moving T-Cell Therapies
Moderator: Ricardo Baptista, PhD, Director, Process and Analytical Development, Cellectis

How gene editing is transformative in CAR T-cell therapies?
What are the main challenges to broaden the scope of T-cell therapies?
Industrializing cell therapy: Are T-cells a case that can be expanded to other cell therapies?

TABLE: Common Issues with Transient Protein Production
Moderators: Richard Altman, MS, Field Application Scientist, Protein Expression, Biosciences Division, Life Sciences Solutions Group, Thermo Fisher Scientific
Henry C. Chiou, PhD, Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
Dominic Esposito, PhD, Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research
Scalable and rapid transient protein production in mammalian cells continues its evolution as an integral part of the biotherapeutic drug discovery process as well as an important tool to generate recombinant proteins for a variety of other applications. We discuss the common issues facing researchers as they try to meet an expanding demand for transiently produced recombinant protein.

What are the current challenges to transient protein production?
What are the keys to optimizing expression?
How do we optimize the whole protein expression process?
How can we maintain volumetric yields while scaling transient expression up or down?
What cell line(s) should we use and when?
What parameters can impact the quality or physical attributes of transiently produced proteins?

TABLE: High-Throughput Purification, Stability Screening
Moderator: Peter Schmidt, PhD, Director, Recombinant Technologies, CSL Behring

High-throughput purification approaches
Conformational stability screening methods
Colloidal stability screening methods
Early research formulation strategies

TABLE: Cell-Free Protein Synthesis: Pros and Cons
Moderator: Takanori Kigawa, DSci, Team Leader, Center for Biosystems Dynamics Research, RIKEN

Cell-free expression vs. cellular expression
Prokaryotic system vs. Eukaryotic system
Good practices

Friday 22 November | 12:05 – 13:00

TABLE: Current and Upcoming Strategies to Screen Pharmacokinetic Parameters of Bispecifics
Moderator: Pascal Egloff, PhD, Platform Leader, Medical Microbiology, University of Zurich

Conventional PK determination approaches and their limitations
Technical requirements for different scaffolds
HTP-PK determination technologies: How big is the need?
Benefits of engineered peptide barcodes for HTP-PK determination via LC-MS/MS

TABLE: Agonist Antibody Approaches
Moderator: Bruce Keyt, PhD, CSO, Research & Development, IGM Biosciences

TNFrSF targeted therapies
Multivalent constructs for active oligomerization
Alternative strategies for trimerization

TABLE: Particle Analytics – Advanced Instrumentation and Data Modeling
Moderators:
Jonas Hoeg Thygesen, PhD, Area Specialist, R&D Microanalysis Centre, Novo Nordisk Pharmatech A/S, and
Anacelia Rios Quiroz, PhD, Scientist, Group Leader, Particle Lab, Pharma Technical Development Biologics Europe, Hoffmann-La Roche

What are the current analytical methods available for identification and characterization of particles in biopharmaceuticals?
What are the advantages and challenges with the methods? Possibilities for automation/high-throughput?
What are the challenges with analysis of sub-visual vs. visual particles
May deep learning and machine learning be used for particle identification? If so what are the challenges and advantages by these methods?

TABLE: The New Challenges of Developing Formulations for Advanced Therapy Medicinal Products (ATMPs)
Moderator: Danny K Chou, PharmD, PhD, President, Compassion BioSolution, LLC

What are some of the new types of therapeutic modalities that just arrived on the market or are on the horizon that are different from monoclonal antibodies?
What types of challenges will we face when developing stable/efficacious dosage forms for these new types of therapy?
What types of analytical challenges will ATMPs bring to the industry?
What are some of the known critical quality attributes associated with each class of APMTs (i.e., Gene therapy, MRNA, etc).

TABLE: Polysorbate in Bipharmaceutical Products – Current Concerns and Future State
Moderator: Klaus Wuchner, PhD, Scientific Director, DPDS/BioTD-Analytical Development, Janssen R&D, Cilag AG

Experience with different grades/purities of polysorbate (Do you set specific requirements for PS as raw material for biothech products)?
Chinese pharmacopoeia (ChP) requires an oleic acid content of ≥98.0% in PS80; do you consider switching to this grade or to other higher purity PS?
Do you consider alternatives to PS?
Did you develop/implement successful mitigation strategies for PS degradation?

TABLE: Clinical Relevance of in vitro Mouse Data to in vivo Results for Single and Combination Studies
Moderator: Erminia Massarelli, MD, PhD, Assoc Clinical Prof, Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center?

TABLE: Combining Virotherapy with Immunotherapy – Challenges and Opportunities
Moderator:Christope Queva, PhD, CSO, Oncorus, Inc.

Opportunity?
Rationale for the combination of virotherapy and immunotherapy?
Beside the combination with checkpoint inhibitors, is there anything else that make sense?
Challenge?

Do IO drugs accelerate the clearance or limit the replication of Interferon sensitive virus, thus limiting the efficacy of virotherapy?

In or out?

Is it best to combine virotherapy with systemic administration of checkpoint inhibitors or to encode those checkpoints inhibitors in the virus?

TABLE: Inclusion Bodies – Curse or Blessing?
Moderator:Oliver Spadiut, PhD, Associate Professor, Chemical, Environmental and Bioscience Engineering, Integrated Bioprocess Development, Vienna University of Technology (TU Wien)

Can IB processes oucompete mammalian production processes?
What do we miss to make IBs competitive?
How can we use IBs directly?
Shedding light onto the black box refolding.