Biotherapeutics Agenda

Registration

Importance of Formulation for the Success of Biotherapeutics
Tudor Arvinte, Chairman and CEO, Therapeomics Inc/University of Geneva, Switzerland

The talk will present case studies documenting the importance of formulation for the proof-of-concept of new biopharmaceutics as well as for the success of clinical trials and market launch. 

Bicyclic Peptides with Antibody-Like Binding Affinity and Specificity
Vanessa Baeriswyl, Postdoc Researcher, EPFL, Switzerland

We are generating bicyclic peptide ligands for disease targets using an approach based on phage display technology. The bicyclic peptides combine key qualities of antibody therapeutics (high affinity and specificity) and advantages of small molecule drugs.

Coffee Break and Networking in Exhibition Hall

Immunogenicity Assessment for the Successful Development of Biosimilars
Michael Tovey, Director, Institut Andre Lwoff/INSERM, France

Successful development of biosimilars requires the establishment of a validated and standardized assay that allows direct comparisons of the relative potency and immunogenicity of innovator molecules and biosimilars as illustrated by case studies for interferon beta products and TNF-alpha antagonists.

Regulation of antibody immunotherapy by fine-tuning FcR interactions
Mark Cragg, Professor, University of Southampton, United Kingdom

Monoclonal antibodies (mAb) represent a growing class of ‘block-buster’ cancer drugs and so understanding of their modes of action is critical. Here, we present evidence that different mAb interact with Fc receptors differently in order to achieve their therapeutic activities.

Lunch and Networking in Exhibition Hall

Poster Session

Sabin-IPV Development for Clinical Studies and Technology Transfer to Local Manufacturers – Opportunities for Process Optimization and Cost-price Reduction
Wilfried Bakker, Senior Research Scientist, Netherlands Vaccine Institute, Netherlands

A production process for Sabin-IPV was developed, using a lab-scale model based on historical Salk-IPV manufacturing data. This process was used to generate clinical lots. Currently, technology transfer to local manufacturers has started. In parallel, successful cost-price reduction studies are ongoing.

The Global Market Opportunity for Biologics and Biosimilars
Enal Razvi, Managing Director, Select Biosciences Inc, United States of America

Select Biosciences has been tracking the market landscape for biologics and biosimilars and in this presentation describes the current market size, growth rates, as well as industry segmentation and opportunities worldwide.  Furthermore, we characterize the new entrants into this marketplace and outline the challenges and emerging themes that are influencing this exciting space.

Coffee Break and Networking in Exhibition Hall

Biologicals, Biosimilars, and Bio-others
Paul Declerck, Professor, Katholieke Universiteit Leuven, Belgium

Since the recent introduction of the concept of biosimilars, new terminology in the area of biotherapeutics has been introduced. Often these “bio-“terms are ill-defined and scientifically not well-founded. This leads to confusion among scientists, healthcare professionals, patients, regulatory bodies.

Biologicals, Biosimilars, and Bio-others
Paul Declerck, Professor, Katholieke Universiteit Leuven, Belgium

Since the recent introduction of the concept of biosimilars, new terminology in the area of biotherapeutics has been introduced. Often these “bio-“terms are ill-defined and scientifically not well-founded. This leads to confusion among scientists, healthcare professionals, patients, regulatory bodies.

Are Biosimilar Cell Therapy Products Possible?
Christopher Bravery, Director, Consulting on Advanced Biologicals Ltd, United Kingdom

This presentation will explore the eligibility criteria for the EU biosimilar paradigm and consider whether some or all cell therapy products could meet these.

Autologous Dendritic Cells Loaded with Antigens from Autologous Proliferating, Self-renewing Tumor Cells, as Active Specific Immunotherapy in Metastatic Melanoma
Robert Dillman, Executive Medical Director, Hoag Institute for Research and Education, United States of America

Active specific immunotherapy using autologous dendritic cells loaded with antigens from proliferating autologous tumor cells was associated with a high long-term survival rate, and was superior to immunotherapy utilizing tumor cells alone as the source of antigen.

Drinks Reception

Exploring the Potential of Antibody-Targeted Nanoparticles for Cancer Treatment
Kerry Chester, Professor, University College London, United Kingdom

Antibody-targeted superparamagnetic iron oxide nanoparticles (SPION) have potential to provide selective tumour imaging followed by potent localized hyperthermic therapy upon application of an alternating magnetic field. The feasibility and translational challenges of these new nanomedicines will be discussed.

Coffee Break and Networking in Exhibition Hall

Glycooptimized Biotherapeutics by Production in GlycoExpress™
Steffen Goletz, Chief Executive & Scientific Officer, Glycotope GmbH, Germany

GlycoExpressTM is a toolbox of glycoengineered human cell lines for high yield production of fully human glycosylated biotherapeutics. These are glycooptimized in respect to bioactivity, bioavailability, immunogenicity and patient coverage obtaining manifold improved Biobetters.

Biosimilars, Bio-betters, Comparability and Adverse Reactions
Roy Jefferis, Professor Emeritus, University Of Birmingham, United Kingdom

The glycoform profile of antibodies determines biologic efficacy and is a Critical Quality Attribute (CQA). Ideally, antibody therapeutics should express a pre-selected and homogeneous glycoform profile. Progress towards realising this goal will be presented.

Lunch and Networking in Exhibition Hall

Poster Session

Development of a Bioluminescent Cell-based Bioassay to Measure Fc Effector Functionality in Antibody-dependent Cellular Cytotoxicity
John Watson, Director, Promega Corporation, United States of America

We have developed an alternative cell-based bioassay that can be used to quantify potency of Fc effector function of monoclonal antibodies bound to target cells.  The assay is a thaw-and-use bioluminescent NFAT-RE-luciferase reporter bioassay.which differentiates between antibodies with small differences in glycosylation that affects Fc effector activity in ADCC.

Coffee Break and Networking in Exhibition Hall

Careful Selection of the Proper Tools to Increase Productivity and Quality of Products Supporting Pharmaceutical Research
Tim Sheehy, Director, Promega Corporation, United States of America

To illustrate the selection of tools in building a bioprocessing workflow to supply quality samples for discovery. These turn-key systems coupled to chemistries for selection and purification allow for increases in throughput, decreased costs per samples and an increase in the consistency and quality of the materials produced.

Adoptive T Cells Therapy with Engineered T Cells: Pre-Clinical and Clinical Assessment
Robert Hawkins, Professor, University of Manchester, United Kingdom

Engineering T cells with antibody based chimeric receptors to target tumour associated antigens is a potentially general approach to treating malignant disease – these have been extensively optimised to produce efficient expression of functional, folded protein as an active receptor. Pre-clinical models suggest that the adoptive transfer of such engineered T cells is most effective when it follows chemotherapy as this greatly facilitates expansion and survival of the gene-modified cells. Based on pre-clinical models, trials targeting CD19 (in B-cell malignancies) and CEA (in gastrointestinal cancer) have been undertaken. Early clinical results will be presented and outcomes in other trials using engineered T cells will also be reviewed.

Close of Conference