- 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
Led by Stephen Murby, International Advisory Board Member, Alliance for Safe Biologic Medicines
• What role does the pharmacy plays in the adoption of biosimilars?
• Identify the key parameters associated with biosimilars market dynamics
• What biosimilars do we expect to see in the next 2 years
Panelist: Divya Chadha Manek, Head, Business Development, NIHR
Panelist: Duncan Emerton, Senior Director, FirstWord
• Comparing progress to Europe
• A future look on the market.
Warwick Smith, Director General, British Biosimilars Association
• The successful network approach - a UK strategy to drive delivery of biosimilar clinical trials
• Forward thinking approach - attitudes, appetite and acceptance in the NHS
Divya Chadha Manek, Head, Business Development, NIHR
• Impact of cultivation media
• Impact of process conditions
Dr. Lars Kober, UGA Biopharma
• Uptake in clinical practice – the Scandinavian experience
• Nor-Switch study and other clinical trials
• Switching and effective competition
Dr. Steinar Madsen, Medical Director, Norwegian Medicines Agency
Ronen Tchelet, VP Research & Business Development, Dyadic International Inc.
Dr. SungHwan Kim, Biological Assay Team Leader, Celltrion
• Clinical switching studies
• Different approaches for interchangeability based on individual product characterization
Mourad Farouk Rezk, MD MSc MBA, Global Head of Medical and Scientific Affairs - Biosimilars, Biogen
• 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
Panelist: Mourad Farouk Rezk, MD MSc MBA, Global Head of Medical and Scientific Affairs - Biosimilars, Biogen
Panelist: Divya Chadha Manek, Head, Business Development, NIHR
Panelist: Ronen Tchelet, VP Research & Business Development, Dyadic International Inc.
Panelist: Duncan Emerton, Senior Director, FirstWord
• 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
- Pharmacovigilance related guidelines: EU and US
- Hot topics: Immunogenicity, Interchangeability, Traceability
- Risk management approach for biosimilars
Dr. Niraj Chhaya, Risk Management, Biosimilars, Boehringer Ingelheim
- Demonstrating Interchangeability
- How to design switching studies
- How to carefully consider product presentation
Rodeina Challand, Biosimilars Expert, Challand Consulting
- One in ten clinical trials don’t generate a single patient volunteer..the other nine experience low retention rates.
- Patients input is critical to develop successful Clinical Development Plans, Patients support and educational programs
- as stated by Janet Woodcock (FDA) “it is critical for the clinical research community to recognize the shift from “patients as consumers” to patients as partners
François-Xavier Frapaise, Vice President, Clinical Development, Drug Safety & Medical Affairs, Merck Biosimilars
- Key commercial events in the biosimilars market, and what they could mean
- What do payers think about biosimilars in the US and Europe
- Biologics lifecycle management in the biosimilars age
- Key commercial tactics for biosimilar companies
- Future perspectives and key themes to watch
Duncan Emerton, Senior Director, FirstWord
• Regulatory - differences between Canada and abroad
• Pricing – The top, the bottom and everything in between
• Reimbursement – How the process works and result to date
• Biosimilars track record
• How brand names are responding
George Wyatt, Executive Senior Consultant, Innomar Strategies
• 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?
Panelist: Duncan Emerton, Senior Director, FirstWord
Panelist: George Wyatt, Executive Senior Consultant, Innomar Strategies
Panelist: Cecil Nick, Vice President (Technical), PAREXEL