Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 10th International Conference and Exhibition on Biologics and Biosimilars San Francisco, California, USA.

Day 1 :

Conference Series Biosimilars 2017 International Conference Keynote Speaker Peter Bernhardt photo
Biography:

Peter Bernhard is a Biotechnology professional with significant technical leadership experience and a proven track record in Analytical and CMC Development. He quickly and fearlessly gets to the heart of situations, identify areas for improvement, and then seek to implement creative and efficient solutions that generate value. His continuous improvement mindset and drive towards future possibilities, combined with his action-oriented nature and ability to navigate around obstacles, allowed him to excel at initiating and executing new projects or developing and refining business processes. He is a quick thinker and learner who can assimilate information from multiple sources and then communicate this information effectively and clearly to the target audience.

Abstract:

Analytical similarity assessments typically focus on comparing the physical, chemical and functional properties of a biosimilars product to the reference product, to understand where the two products are similar and where they are not similar. An attempt is then made to justify why observed differences will or will not impact the clinical outcomes (e.g. safety, including immunogenicity, efficacy, PD or PK). The justification typically requires making a bridge between an observed difference and a clinical outcome via some type of a functional assay. This type of assessment is only as good as the assays being used (e.g. what level of difference would have to be present in order to observe a difference in the functional response). When differences are observed, new or more sensitive assays may be developed, independent of a relationship between the observed
difference and a clinical outcome. We argue that if one starts from a detail understanding of the product, clinical indications,
and safety profile of the reference product and other similar products, then one can a priori determine which physical, chemical
and functional attributes are either known to impact or likely to impact the clinical outcomes. Using this knowledge, attributes
can be identified that may require a detailed understanding of the relationship and interrelationship(s) between the attribute
and the clinical outcomes as well as between attributes and the clinical outcomes (e.g. is there a relationship between high
mannose and sialic acid levels on PK?). With this knowledge first, methods are developed, along with the appropriate controls,
that have the sensitivity required to detect meaningful differences. The assessment of fingerprint like similarity can then be
based on (1) both the full physical and chemical comparison of the product to the RPP and (2) the detailed analysis of the key
properties, with sensitive assays, that allow linkage between key product attributes and clinical outcomes. We will provide an
overview of our view on fingerprint-like similarity and how it can be applied to biosimilars development.

Keynote Forum

Laszlo Endrenyi

University of Toronto, Canada

Keynote: Interchangeability, switch ability and substitution of biosimilars drug products

Time : 11:10-12:00

Conference Series Biosimilars 2017 International Conference Keynote Speaker Laszlo Endrenyi photo
Biography:

Laszlo Endrenyi is a Professor Emeritus of Pharmacology and Biostatistics in the University of Toronto. He has served the university in various positions including
on its Governing Council and as Associate Dean of Graduate Studies. He sat on the Board of Directors of the American Statistical Association and the Canadian
Society for Pharmaceutical Scientists. He served as President of the latter and received its Lifetime Achievement Award. Externally, he has served on grant review
committees and editorial boards of research journals. He has received several recognitions, including an honorary doctorate from the Semmelweis University of
Medicine. He is a Fellow of the Canadian Society for Pharmaceutical Sciences and of the American Association of Pharmaceutical Scientists. He has published
books on Kinetic Data Analysis and Biosimilar Drug Product Development, and over 200 research papers. He has advised and widely consulted with industry and
regulatory agencies.

Abstract:

The assessment of and conditions for the interchangeability of biological and small-molecule drug products are very
different. Small-molecule drugs are well defined and can be exactly reproduced. If their products, brand-name and
generic, are declared to be bioequivalent then they are (most frequently but not always) therapeutically equivalent and can
be substituted and interchanged. In contrast, biological drugs are structurally and functionally complicated, can be only
imitated but not identically reproduced, are sensitive to various environmental and manufacturing conditions, are subject
to biological and immunological influences. Consequently, only high similarity but not equivalence can be demonstrated, in
various respects, between the marketed and new products. However, even the stated bio similarity of two products does not
enable their interchangeability in terms of switching and alternating. For this, additional conditions must be satisfied. There
has been no agreement on these conditions among the various jurisdictions. Legislation in the United States, and also FDA,
has set general principles. The European EMA has issued biosimilarity guidelines for several drug products. The latter permit
in some cases possible interchangeability even though the issue is under the judgment of the member states. It is desirable to
develop a general, scientific basis for the evaluation of interchangeability of biological drug products. Suitable study designs are
considered, an approach for the assessment of switching and alternating across multiple domains is presented, and a possible
criterion for the interchangeability of biological products is described.