Day 1 Congress

• Current Environment is constantly changing
• Health systems are seeing the benefits
• Patient impact should be a major consideration
• How do we keep competition in the market

Kavya Gopal, Head, Specialty, Sandoz Limited

• Latest strategies in overcoming obstacles in Biosimilar development
• Effective strategies for product design
• Essential requirements for product development program
• What biosimilars do we expect to see in the next 2 years

Prof. Sarfaraz Niazi, Founding Chairman, Karyo Biologics

• What impression does recent changes in regulation, science & production technologies on future patterns of production
• Issues to overcome to increase uptake of biosimilars
• How to generate enough interest and enthusiasm for biosimilars
• Sensitive clinical trial models for Biosimilar development
• Use of Biomarkers in clinical trials
• Balancing patient - vs healthy volunteer studies for Biosimilar developments

Dr. Karsten Roth, Director Clinical Operations and Pharmacovigilance, Cinfa Biotech GmbH

• Perception of Biosimilars: Awareness and Communication Gaps
• A Common Phenomenon Known as the Nocebo Effect Can Impact Outcomes
• Strategies to Minimize the Possibility of a Nocebo Effect with Biosimilar Agents

Dr. Mourad Farouk Rezk, Senior Director, Global Head of Medical and Scientific Affairs, Biosimilars, Biogen

• Nature and extent of clinical studies
• State-of-the-art technologies to demonstrate a high degree of structural and functional similarity
• Clinical pharmacokinetic and pharmacodynamics studies and data
• Identifying specific product associated with adverse events
• Importance of product naming for biosimilars traceability
• Establishing full characterization of immunogenicity profile
• Continues post-post marketing surveillance is critical for effective risk management
• Considerations for quality attributes selection for comparability study and similarity assessment
• Drug substance versus drug product testing in biosimilarity assessment
• Development of biosimilar products as combination products
• CMC challenges in developing biosimilar products
• Challenges and obstacles faced by manufacturers in developing biosimilars
• How to overcome challenges, increase development success and optimize result
• Techniques in bringing the next generation of Biosimilars to the market
• Reducing capital investment and creating cost effective and scalable manufacturing operations

Moderator: Richard Dicicco, Co-founder, Harvest Moon Pharmaceuticals

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