Programme

Programme Day One Wednesday 18 February 2009

Registration

Opening remarks from the Chair

Key-note session: assessing global biosimilars market

• Why generic companies are pursuing biosimilars
• What is needed to be successful?
• Who are potential players?
• What are the challenges that they face?
• How do regulations impact portfolio development and market approval

Dr. Rashbehari Tunga
Senior Scientist
INTAS BIOPHARMACEUTICALS

Developing a biosimilar product in a regulated market

• Factors driving the biosimilars market
• Establishing product development strategies
• Considering quality and cost when developing biosimilars

Dr. Gary Walsh
Senior Lecturer, Industrial Biochemistry, Chemical & Environmental Sciences
Department
UNIVERSITY OF LIMERICK

Post translational modifications (PTMs): importance in the context of therapeutic proteins

• Range of PTMs, their structure, function and importance in the context of therapeutic proteins
• Discussing the potential of PTMs to affect product functional equivalence and immunogenicity
• Reviews of PTMs associated with actual/likely biosimilar products

Morning refreshments

Philippe Stas
CEO
ALGONOMICS

Strategies for immunogenicity assessment

• An update on regulatory guidance
• Preclinical and clinical strategies for immunogenicity risk assessment
• An overview of selected case-studies

Keith Powell
CEO
POLYTHERICS

Half-life modification and superior biosimilars

• Unmodified biosimilars and how the market moved on: e.g. Interferon alpha vs. PEGylated molecules
• Outlining the need for site-specific modification of the protein
• Assessing the potential for an improved molecule with improved properties
• Examples of generic proteins with half-life modification

Lunch

Simon Sturge
CEO
OCTOPLUS

Differentiating follow-on biologicals using controlled release drug delivery

• What kind of added value can drug delivery technologies offer follow-on biologicals?
• What are the success factors for effective long-acting drug delivery?
• PolyActive(R) case study: phase II clinical proof of concept with a controlled release formulation of interferon alfa

Prof. Dr. Georg-Burkhard Kresse
VP Biologics Research Strategy and Communication
ROCHE DIAGNOSTICS

Assessing biosimilar antibodies as the 2nd generation of follow-on protein products

• Identifying new opportunities as therapeutic antibodies come off patents
• Outlining the process of developing antibody biosimilars
• Specific technical issues concerning monoclonal antibodies
• Clarifying issues with clinical proof of similarity
• Discussing strategic issues and understanding feasibility

Afternoon refreshments

Prof. Dr. Ulrich Kalinke
Director and Head of Division,
Centre for Experimental and Clinical Infection Research
TWINCORE

Is the existing framework for biosimilars in Europe applicable to monoclonal antibodies?

• Current experience with biosimilars
• Challenges for biosimilar antibodies
• Future perspectives in the EU

Marc Martens
Senior Associate
BIRD & BIRD

Frank Landolt
IP and Legal Counsel
ABLYNX

Patents, patent term extensions and data exclusivity: opportunities for biosimilars?

• How to make optimal use of “composition of matter” patents and “life cycle” patents
• Clarifying the IP implications of launching a biosimilar
• Data exclusivity, patent term extensions and new EU legislation on biosimilars
• Impact of the stringent regulatory regime involved in bringing biosimilars to market on your patent strategy

Programme Day Two Thursday 19 February 2009

08:30

Registration

09:00

Milena Izmirlieva
Senior Analyst/Project Manager
IHS GLOBAL INSIGHT

Opening remarks from the Chair

09:15

Roundtable morning sessions

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of biosimilars.

Roundtable summary session

Roundtable leaders will discuss the key findings and highlight future challenges that were uncovered during the morning session

Entering the market: highlighting a US biosimilar case study

Dr. Geoffrey Allan
President and Chief Executive Officer
INSMED

Insmed’s approach to entering the U.S. Follow-On Biologics (FOB)
market

• Pursuing a dual path strategy involving entry into the FOB arena
• Advancing Insmed’s proprietary protein platform into niche markets with unmet needs in the U.S.
• Taking a leadership role in promoting an FOB approval pathway
• Outlining the replication of Neupogen and the pursuit of a follow-on version of Neulasta

Ensuring successful product design throughout the process

Anjan Selz
CEO
FINOX

Similarity vs. differentiation – a look at product design

• The similarity requirement within the EU
• The prescription logic and its inherent need for product differentiation
• Possibilities of positive product differentiation by product design

Dr. Gita Sharma
CSO
CLARIS LIFE SCIENCES

Discussing Quality by Design (QbD) in developing a follow-on biological product

• Explaining the principle of QbD and the benefits for the development of a biosimilar
• Identifying the critical quality elements and quality targets
• Outlining practical approaches to ensure assurance of suitable product performance

16:30