Conference: 3rd Biosimilars Summit & Trade Exhibition - 2013 Innovations & Developments : A Decade at a Glance
Appel Consulting Ltd, June 2013, Days: 2
25 Jun - 26 Jun 2013
VENUE:
37th floor One Canada Square Canary Wharf, London UK
Join your peers and colleagues at our Biosimilars event.
The objective of this conference is to provide communication, education and networking opportunities for scientists engaged in Biosimilars whether in academia, biotech or industry.
Our Biosimilars Conference will encompass six scientific areas:Attendees will hear world-class speakers discussing the challenges and opportunities facing the Biosimilars field.
- Scientific advancement in Biosimilars: a decade at a glance
- Emerging business models and strategies
- Patent issues in the development of Biosimilars
- Evaluate the major risks and challenges for manufacturing of Biosimilars
- Asses the future of Monoclonal Antibodies in the Biosimilar Market
- Business development and financial analysis for Biosimilars
Who should attend?
Branded Biotechnology, Pharmaceuticals & Generic Pharmaceutical Companies, Drug Regulators, Healthcare Agencies, Government Departments, Contract Research/Bio manufacturing, Organisations, Regulatory Affairs, Pharmacovigilance VPs, Directors, Heads and
Managers of:
- Follow on Biologics/Follow on Proteins/Biosimilars
- Biologics/Biotechnology/ Biogenerics
- Legal Affairs
- Intellectual Property
- Health Economics
- Pricing and Reimbursement
- Biopharmaceuticals/ Biotherapeutics
- Clinical Immunology
- Chief Scientific Officer
- Process Control and Analytical Technologies
- Analytical Characterisation
- Regulatory Compliance
- Pharmacovigilance
- Drug Safety & Risk Management
- Quality Affairs/ Quality Control
- New Product Development
- Process Science
- Portfolio Management
- Research & Development
- Business Development
- Business Operations
- Scientific Affairs
- Commercial Affairs
- Marketing
VENUE:
37th floor One Canada Square Canary Wharf, London UK
DAY 1
09:30 Registration and refreshments
10:00 Opening address from the chair
Dr Virginia Acha
Director of International Affairs Strategy & Analysis
Pfizer
10:10 Biosimilars a new era for biopharmaceutical companies?
- Overview of the Biosimilar market.
- Main issues raised by Biosimilar arrival
- What business model for Biosimilars
Dr Pierre Emmanuel Gerard
Partner
AEC Partners
10:50 Building confidence through scientific rigor and engagement
- Europe's successful pathway continues to evolve
- Uptake and understanding still lagging
- Science led engagement drives confidence
Dr Virginia Acha
Director of International Affrairs Strategy & Analysis
Pfizer
11:30 Morning refreshments
11:50 How “similar” is a Biosimilar a case study for Rituxan
- High-Density Peptide Array Platform
- Proteome wide binding assay
- Biosimilar vs MabThera Comparison
Dr Klaus-Peter Stengele
Head of NimbleGen
Roche
12:30 Exhibition & Networking Lunch
Opportunities for business Development
Open Buffet Lunch & Drinks
14:10 European issues in Patenting Biologics
- Obtaining antibody patents
- The position on stem cells
- Patent term extensions for biologics
Mr Andrew Sharples
Partner
EIP
14:50 Analytical Structural Chracterisation for Biosimilar Comparability Purposes
- Physicochemical comparability methods
- Strategies for primary and higher order structure
- Regulatory expectations
Dr Fiona M Greer
Global Director,
SGS M-Scan Ltd
15.30 Networking Drinks
Take your discussions further and build new relationships.
16:30 End of Networking drinks
DAY 2
09:30 Registration and refreshments
10:00 Opening address from the Chair
Dr Fiona M Greer
Global Director
SGS M Scan
10:10 Scientific challenges for development for Monoclonal Antibodies
- Understanding the challenges associated with mAbs
- Regulatory framework ready for mAbs biosimilar
- Bioanalytical assay development considerations
- PK and immunogenicity assays
Rafiqual Islam
Director-Bioanalytical Services
Celerion
10:50 Comparability Exercise for Biosimilars
- Quality strategy in developing Biosimilars
- State-of –the-art analytics
- Case studies with regulatory acceptance
Dr Martin Bluggel
COO, Exec VP & Co founder
Protagen
11:30 Morning refreshments
11:50 Biosimilar Clinical Development Plan Considerations
- Study design challenges
- Statistical consideration
- Operational considerations
Rodeina Challand
Exec Director, Biosimilar Drug Development
PRA International
12:30 Exhibition & Networking Lunch
Opportunities for business Development
Open Buffet Lunch & Drinks
14:10 Biosimilars: Regulatory Status & Trends
- Current status & future plans for Biosimilars guidance in Europe
- New FDA guidance for Biosimilars
- Regulatory trends outside Europe & US
Mr Tilo Netzer
Partner
PharmaLex
14:50 Designer cell lines in Biosimilar testing
- Regulatory expectations
-Assays for functional mAb testings
- Case study on ADCC effector cell line
Mr Volker Jenzelewski
Managing Director
Eufets
15:30 Chair's closing remarks
15:10 End of conference
According to industry analysts the Global Biosimilar market is projected to increase from $243 million in 2010 to 3.7billion in 2015.
With more than 30 branded biologics with sales of $51billion set to lose patent exclusivity.
Between 2011 and 2015, it is forecast that “biosimilar monoclonal antibodies” and “second-generation” biosimilars represent “high –value” proposition for biosimilar manufacturers and key drivers for future growth.
Join us at Appel Consulting's Biosimilars Conference, where our expert panel of speakers, will share insights on ‘commercial development & management strategies' pivotal to achieve success in the global Biosimilars market. We have a special spotlight on “biosimilar monoclonal antibodies “and “second-generation biosimilars” . This conference is a key opportunity to maximise your knowledge and network with senior level industry leaders from the Biosimilars sector.
Our Biosimilar Global Summit will encompass six areas:
- Scientific advancement in Biosimilars: a decade at a glance
- Emerging business models and strategies
- Patent issues in the development of Biosimilars
- Evaluate the major risks and challenges for manufacturing of Biosimilars
- Asses the future of monoclonal antibodies in the Biosimilar market
- Business development and financial analysis for Biosimilars
Our Advisory Board have identified these strategic areas to be addressed:
- Biopharmaceutical and clinical development of biosimilars
- The commercial landscape and patent issues in relation to biosimilars
- Advances in the development of monoclonal antibodies
- Dr Virginia Acha, Director of International Affairs Strategy & Analysis, Amgen
- Dr Klein Thomas, Head of Oncology Patents, Roche
- Dr Robert E Zoubek, Director of Scientific Affairs , Formycon
- Dr Fiona M Greer, Global Director, SGS M-Scan Ltd
- Dr Vid Stanulovic, COO, Medical Safety Officer, ADDS
- Dr Duncan Emerton, Biosimilars Practice Lead, Datamonitor
- Dr Andrea Laslop, Austrian Head of Scientific Office, Austrian Agency Health & FoodSafety
- Dr Roman Ivanov, Vice President R&D, CJSC BIOCAD
- Dr Pierre-Emmanuel Gerard, Partner, AEC Partners
- Dr Parastoo Azadi, Technical Director, Complex Carbohydrate Research Center
- Dr William Simmons, Attorney, Sughrue Moon PPLC Partners
- Dr Harshal Kubavat, Consultant, Deallus Group
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