Agenda

19-21 November 2018

• National and International developments in biosimilar medicines
• Challenges of Physicians education: Understanding the differences between biosimilars and generics
• Importance of Physician and Patients input in shaping international standards for biosimilars
• Policies in place to encourage physicians / pharmacist collaboration
• Harmonizing global standards to ensure safety and efficacy of biosimilars
• Commercial potential and best ways on how to gauge such an opportunity in biosimilar.
• What are the latest trends in biosimilar development
• Risk management approaches and innovative entry strategies
• Effective time and cost management to increase sales and profitability
• Leading strategies in launching new biosimilar product
• 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

• Attitudes and acceptance in clinical practice
• Uptake in clinical practice
• Nor-switch Study and other clinical trials
• Switching and interchangeability

Dr Steinar Madsen, Medical Director, Norwegian Medicines Agency

• Updates on the latest EU regulatory guidelines
• In what capacity should EMA act on switching and interchangeability?
• Close collaboration with HTA’s for patients benefit
• Current challenges to make sure the development pathways are ready for the latest scientific development

Cecil Nick, Vice President, Technical, PAREXEL International

• Dealing with current issues on interchangeability and extrapolation
• Different approaches for interchangeability based on individual product characterization
• What are the challenges and latest guidelines
• Challenges encountered and opportunities in global Biosimilars market
• Current trends in global industry of Biosimilars
• Priorities of investments and opportunity for market growth
• Marketing strategies to guarantee market success

Paul Harmon, Senior Director, European Oncology Biologics Lead, Mylan

• Share experiences of creating an educational resource for the research workforce
• Hear case studies of biosimilar clinical research trials being delivered within the NHS
• Understand how a network approach can be deployed to overcome unexpected challenges

Divya Chadha Manek, Head of Business Development, NIHR Clinical Research Network

• Regulatory and clinical considerations in emerging markets
• Operational issues in emerging markets
• Challenges and opportunities in emerging market countries

Dr. Haleh Hamedifar, CEO, CinnaGen Co.

• Key success principles for biosimilar utilization have been identified
• The focus in now shifting towards sustainable market environments
• Key factor for sustainability are responsible procurement practices

Prof. Dr. Florian Turk, Head Global Payor Marketing, Sales and Relations, Sandoz Biopharmaceuticals

• Special trends impacting market access in Europe and globally
• Evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access
• Ways of balancing rewards of access and inherent risk between manufacturers and insurers
• Challenges in ensuring market access and reimbursement

Adam Levysohn, Head of Global Market Access, Biosimilars Business Unit, Biogen

• Impact of pharma pricing on pharmaceutical innovations
• Biosimilars influence on pricing and reimbursement
• How to ensure market access success
• Patient centric approach in driving market access growth
• Is there an alternative payment model?

Moderator: Ian Henshaw, VP, Global Head, Biosimilar’s Business Unit, Biogen