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Conference Documentation: Biosimilars and Biobetters

Conference Documentation: Biosimilars and Biobetters

The development of the Biosimilars market is growing exponentially with the industry forecast to be worth $25 billion by 2020. With the regulatory landscape evolving rapidly, it is important to understand the developments in the biosimilar guideline framework and the cohesion in legislation between Europe and the US.

With Europe leading the way in the field of Biosimilar development, it is important to get to grips with all areas in the product lifecycle from early stage developments, protein characterisation and analytical comparability to patent litigation, market access, pricing and reimbursement through to emerging markets and global developments. Every angle should be considered and taken account for through the development process and with the EU the most advanced market for biosimilars, accounting for 80% of global spending on these molecules, the learning curve for biosimilars is essentially still building and there are hurdles to overcome.

Unlocking the potential of biosimilars will require a focused strategy along the whole value chain, from optimizing the clinical development program through developing the most suitable strategy for commercialisation.


Day 1
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
9:10
Biosimilars’ Long Term Potential to Wipe Out Innovation Budgets
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
9:50
Blockades to U.S. Biosimilar Entry and What to do About Them
Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner & Kluth
10:10
Non-BPCIA Resolution of IP litigation Issues Concerning Biosimilars in the U.S.
Albin James Nelson, Senior Principal & Owner, Adversarial Proceedings/ Pharma & Biotech, Schwegman Lundberg Woessner & Kluth
10:30
Morning Coffee
11:00
Patent litigation of biologics - past, present and future
Christopher Stothers, Intellectual Property Litigation, Arnold and Porter
11:00
Patent litigation of biologics - past, present and future
Kathy Osgerby, Associate, Intellectual Property, Arnold & Porter
11:40
Biosimilars and the use of medical devices
Dirk Kreder, Founder and CEO, Anteris Medical GmbH
12:20
Networking Lunch
13:30
Session Reserved
Bracha Timan, Director, Israel Site Head, Global Bioassays and Technology, Global R&D, TEVA
14:10
Case Study: Emerging Markets for biosimilars
Michel Mikhail, Expert in Biosimilars, Consultant, Germany
14:50
Case Study: Creating Biobetters with Improved Efficacy and Safety by Addressing Product Immunogenicity With Tolerogenic Nanoparticles
Kei Kishimoto , Chief Scientific Officer, Selecta Biosciences
15:30
Afternoon Tea
16:00
Market outlook – What’s the future of biosimilars?
Alan Sheppard, Principal, Global Generics and Biosimilars, Thought Leadership, IMS Health UK
16:40
ROUND TABLE DISCUSSION - Reviewing the sustainability of the biosimilars market – “Where stakeholders align and policies collide”
Chris Teale, Vice President Europe, GfK NOP Ltd
17:20
Chairman’s Closing Remarks and Close of Day One
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
9:10
OPENING ADDRESS- Safety First! “Totality of Evidence” and residual risk
Uwe Gudat, Head of Safety Biosimilars, Merck Serono
9:50
KEYNOTE ADDRESS – UK regulator’s experience of PV and RMP for biosimilars
Shahin Kauser, Senior Scientific Assessor, MHRA
10:30
Morning Coffee
11:00
Clinical Update- The latest in biosimilar development
11:40
Meeting the challenges of the market for biosimilars
12:20
Networking Lunch
13:30
Switching patients to biosimilars: Interchangeability/Substitution
Steinar Madsen, Medical Director, Norwegian Medicines Agency
14:10
Case Study: Clinical Development Strategies
Karsten Roth, Director Clinical Operations, Cinfa Biotech
14:50
Afternoon Tea
15:20
An automated high throughput platform for the assessment of potency of biosimilars
Michael Tovey, INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan
16:00
How do you collect data efficiently and effectively?
Julian Morris, Technical Director Centre for Process Analytics and Control , Centre for Process Analytics & Control Technology
16:40
Chairman’s Closing Remarks and Close of Day Two
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
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