Day One
Alan Sheppard
CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:
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- Analytics
- Business Development
- Business Strategy
- Corporate Development Strategy
- Commercial Affairs
- Intellectual Property
- Marketing & Sales
- Medical Affairs
- New Product Development
- Legal Affairs
- CMC
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- Preclinical and Clinical Development
- Product Development
- Regulatory Affairs
- Pricing and Reimbursement
- Research and Development
- Biologic Production
- Quality Assurance
- Scientific Affairs
- Strategic Planning
- Strategic Sourcing
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Conference programme
8:30 Registration & Coffee9:00 Chairman's Opening RemarksAlan Sheppard, Global Head Generics, Thought Leadership, IMS Health 9:10 The market for biosimilars: unravelling the mysteryAlan Sheppard, Global Head Generics, Thought Leadership, IMS Health
Although the biosimilars launched to date have started to gain market share this is variable by molecule and country.
Is it the molecule or the country which will decide success?
Will it be payer or prescriber who has the final say?
9:40 The EMA scientific advice compared with EMA guidelines
Conclusions from the EMA biosimilars mAb guideline text
How the guidelines can differ from scientific advice
Possible future mAb guidelines
How to achieve the best dossier from scientific advice
Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting Ltd (Previously Chief Medical Officer, Teva Pharmaceuticals Europe from March 2006 to March 2011) 10:30 Morning Coffee11:00 Industry interpretation the new guideline on biosimilar mAbs
Overview of the new mAb biosimilar guideline
What scientific advice can we expect from the EMA following the guideline release?
Clinical requirements with examples for some well known mAbs
What to expect in term of Statistical requirements?
Size of patients population to be recruited
A look into clinical and non-clinical concerns surrounding the guideline
Cost of development and timelines
What this regulation will mean for industry, and more specially, for the European Biosimilar market
Louis-Christian Clauss , Senior Consultant Health Care, Atheln Biomed 11:40 Next generation monoclonal antibody development and clinical challenges with biosimilar drug developmentFrank Scappaticci, Associate Group Medical Director, Genentech
The advancement of Monoclonal antibody technology and the enhancement of oncologic disease therapy by next generation antibody drugs
Promising early clinical studies and growing interest
The clinical challenges in the biosimilar drug development: manufacturing, preclinical testing, and clinical trial implementation
12:20 Networking Lunch13:30 EU litigation considerations and update
Litigation strategy in the EU including an update on the proposed European Patents Court
Settlements and overview of the impact of the Pharmaceutical Sector Inquiry
Need for regulatory and patent coordination and an update on SPC issues
Recent case law relating to biotech products
Christopher Stothers, Counsel, Arnold and Porter (UK) LLP Camilla Balleny, Partner, Pinsent Masons 14:10 The Ins And Outs Of The Biosimilar Regulatory Pathway Anita Varma, Partner, Ropes & Gray
An overview of the statutory framework
An overview of the FDA hearings to implement the Abbreviated Biologics Pathway
Some considerations:
Prosecution strategy in view of the legislation
Licensing considerations in view of the legislation
Diligencing your portfolio to get ready for a biosimilars challenge
14:50 The developing biosimilars regulatory framework in the U.S.Ross Lobell, Vice President, Regulatory Affairs, Medimmune
Current status – Developments since March 2010
The exclusivity debate
FDA guidance
Data requirements & exclusivity periods
15:30 Afternoon Tea15:50 US patent issues in biosimilarsAnne Dollard, Chief Patent Counsel, Deputy General Counsel, Takeda Pharmaceuticals
What strategies are innovator companies using to extend exclusivity and fend off competition?
Revaluating technology in-licensed from universities and Strategic alliances with companies
Considering where to file suit and conduct a jurisdictional analysis
The FDA’s guidelines for biosimilars
Anti-competitive and unfair methods of competition, including patent settlements, and patent pools
16:10 Biosimilars: patent protection issues
Why biotech patents are difficult to enforce?
Could biotech patents be easier circumvented compared to chemical product patents?
Biotech product and SPC : how to define a “biotech product" and how to apply the “one SPC per product” rule?
What about the USA legislation on follow-on biologics (“FOBs”)?
Elisabeth Berthet-Maillols, Lawyer at the Paris Bar, Armengaud-Guerlain 16:50 Chairman’s Closing Remarks and Close of Day One8:30 Registration & Coffee9:00 Chairman's Opening RemarksRichard Dicicco, Chairman, Harvest Moon Pharmaceuticals 9:10 Maintaining a consistent quality standard of BiosimilarsJean-Yves le Cotonnec, Managing Director, TRISKEL Integrated Services S.A
Detection and data analysis for immunogenicity of biopharmaceutical products
Strategy and development
Demonstrating comparability to regulators
Future considerations
9:50 From Imitation to Innovation – Biosimilars are not GenericsCarsten Brockmeyer, Founder, Brockmeyer Biopharma GmbH
The future of the global biosimilar market
From differentiated Biosimilars to Biobetters
Successful development plans for Biosimilars, enhanced Biosimilars, and Biobetters
What are the must consider elements to any biosimilar development plan
Critical difference in the development for a Biosimilar, enhanced Biosimilar, and Biobetter
Manufacturing and Capacity Considerations for Biosimilars
Will there be enough capacity?
Can there be a global supply for a global market?
How much can modern biomanufacturing contribute to reduced costs?
10:30 Morning Coffee11:00 Making things last longer for less
What makes a biobetter?
Classical biologics versus antibody molecules
How can biobetters be really better?
Use of modern biotech versus classical products
Making things better for the patient
Jeff Edwards, Director of Alliance Management, PolyTherics Ltd. 11:40 Pharmacovigilance & biosimilar monoclonal antibodies: practical considerationsPeter De Veene, EU Qualified Person for Pharmacovigilance, Roche
Why are monoclonal antibodies different?
Substitution and interchangeability: potential effects on PV
Extrapolation and labelling: how to ensure that patients and prescribers get the right information?
12:20 Networking Lunch13:30 Factors to be considered for Biosimilar CMC development Hans-Martin Mueller, Associate Director, Biotech Development, Merck
Reference characterisation
Importance of comparability - how similar is similar?
Factors introducing unpredictability
14:10 Biosimilar sales forecast in seven unregulated markets in 2016: How large is the opportunity?Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
Current biosimilar sales in the emerging markets of Brazil, Russia, India, China, South Korea, Turkey and Mexico (BRICKTM)
Issues for growth: regulatory requirements; protectionism; MNC competition
Future emerging markets (BRICKTM): dominant players, biosimilars in rural areas, and how the market size will change in 2016
14:50 Chairman’s Closing Remarks and Close of Day Two15:00 Afternoon Tea
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