Agenda

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

• How biosimilars will finally impact the healthcare market
• 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

• Challenges and opportunities in the UK market
• Comparing progress to Europe
• A future look on the market.

Warwick Smith, Director General, British Biosimilars Association

• Facilitating success - case study examples of working with the biosimilars industry
• 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 host cell line
• Impact of cultivation media
• Impact of process conditions

Dr. Lars Kober, UGA Biopharma

• Attitudes and acceptance
• 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

Progress reached to date with C1 as a production platform for producing therapeutic proteins such as mAbs. The benefits of C1 technology over other production hosts will also be presented.
Ronen Tchelet, VP Research & Business Development, Dyadic International Inc.

CT-P13 showed similar biological activities to infliximab as gauged by neutralisation of soluble TNFα, as well as blockade of apoptosis and suppression of pro-inflammatory cytokines in intestinal Caco-2 cells. Infliximab and CT-P13 equally induced apoptosis and outside-to-inside signals through transmembrane TNFα `{`tmTNFα`}`. Moreover, regulatory macrophage induction and ensuing wound healing were similarly exerted by CT-P13 and infliximab. However, neither CT-P13 nor infliximab exerted any significant ADCC of ex vivo-stimulated peripheral blood monocytes or lamina propria mononuclear cells from IBD patients. These findings indicate that CT-P13 and infliximab exert highly similar biological activities in intestinal cells, and further support a mechanistic comparability of these two drugs in the treatment of IBD.

Dr. SungHwan Kim, Biological Assay Team Leader, Celltrion

• Assessing biosimilarity with the reference product
• 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

• 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

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

• Updates on the latest EMA 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

• 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

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

• Canadian Market
• 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

• 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?

Panelist: Duncan Emerton, Senior Director, FirstWord
Panelist: George Wyatt, Executive Senior Consultant, Innomar Strategies
Panelist: Cecil Nick, Vice President (Technical), PAREXEL