Conference: 6th Biosimilars Congregation 2015

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Bharat Book Bureau

12 Feb, 2015, 21:00 IST

MUMBAI, February 12, 2015 /PRNewswire/ --

Date Info: 10 Mar 2015 to 11 Mar 2015

Venue Info: The Kensington Close Hotel, Wrights Lane, London, UK

Studies after research predicts the world market for biosimilars and related follow-on biologics will reach $9.2bn in 2018, and multiply in size to 2024. By 2020, some $55 Billion worth of biologic patents are due to expire. Key factors driving market growth include patent expiries of key biological drugs, cost containment measures from governments, aging population, and supporting legislations. The recent establishment of regulatory guidelines for biosimilars in the US is expected to add further momentum to the growth of the global biosimilars market. Increasing pressure from governments and insurers for greater biologic competition, there exists an incredible opportunity for biosimilar producers to capitalise on what is set to become the fastest growing sector of the pharmaceutical industry. Advice from experts was clear; biosimilar companies need to focus on products that see IP [intellectual property] begin to expire beyond 2020, the so-called third wave of biosimilar opportunity

It is also predicted that the world biosimilar monoclonal antibody (mAbs) market will generate $3,229m in 2018. That drug industry earned $61.88m in 2012

This conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. Hence, this 4th Biosimilars Congregation 2014 will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects. This Biosimilars conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, biosimilar products to the market place. By attending this conference you will gain a comprehensive outlook on the key issues surrounding biosimilars. This event will provide an important platform for Biosimilars stakeholders to discuss and share best practices in expediting Biosimilars development.

For more information: 

https://www.bharatbook.com/seminars-conferences-517088/biosimilars-congregation-517088.html

Key speakers:- 

  • Chetak Buaria, Director - Alliance Management (Biosimilars), Merck Serono
  • Ira Jacobs, Oncology Portfolio Global Medical Lead-Biosimilars, Pfizer (USA)
  • Malcolm I Mitchell, Director - BioPharmaceuticals, Eli Lilly
  • Patrick Liu, Senior Director and Global Head of Bioassays, Teva Pharmaceutical
  • Sumit Munjal, Medical Director, Takeda Pharmaceuticals
  • Juan Vergez, Global Brand Manager & Global Biosimilars Business Intelligence, Merck Serono
  • Cecil Nick, Vice President, Biotechnology, Parexel
  • Steinar Madsen, Medical Director, Norwegian Medicines Agency
  • Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord
  • Peter Wittner, Senior Consultant, Interpharm Consultancy (Former Managing Director Ranbaxy UK)
  • Kristie C. Kuhl, Senior Vice President, Makovsky & Co (USA)
  • Michael Tovey, Director of Research, Laboratory of Biotechnology and Applied Pharmacology, INSERM
  • Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting
  • Lincoln Tsang, Partner, Arnold & Porter LLP
  • Gopalan Narayanan, Managing Director, Biologicals Advice Limited
  • Anna Harrington-Morozova, Scientific & Regulatory Director, Regem Consulting
  • Ash Patel, Director of Regulatory Affairs (Biologics), ERA Consulting
  • Marie Manley, Partner & Head of the Regulatory Practice, Bristows
  • Liz Fuller, Partner, Bird & Bird

Plus Many More... 

Key themes:- 

  • Gain access to the latest developments and expert views on future trends across a range of topics, from competitive strategy, clinical development, IP, policy and pricing
  • How to approach the rapidly emerging and developing biosimilar market?
  • Next generation monoclonal antibody development and clinical challenges with biosimilar drug development
  • Understand the key issues, such as country-level policy changes in relation to biosimilar naming, interchangeability and automatic substitution
  • Biosimilars Infliximab - Experiences and Expectations
  • Upcoming EU Clinical Trials regulation (2016); where are we heading in terms of biosimilars development?
  • Scientific and clinical considerations for biologics and biosimilars
  • Biosimilars development and impact on clinical practice
  • Research-based industry biosimilar strategies
  • Technical case studies for analytical and clinical comparability strategies
  • Role of technology transfer - How does this effect market access?
  • Challenges and opportunities - strategies to develop Biosimilars
  • Leading Biosimilars companies share their views and strategies on successful market penetration and learn to implement best practices through recent successful strategies and business models - real time case studies
  • Biosimilarity concept: a paradigm shift for many key stakeholders
  • Manufacturing changes for the upcoming biosimilars era
  • Determining the right investments & potential returns from Biosimilars
  • Biobetters & biosimilars
  • Safeness - Patients and their data
  • Regulations - EU, US, ROW and WHO guidelines
  • Be part of a major networking opportunity

Who should attend:- 

CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:

  • Biopharmaceuticals/ Biotherapeutics
  • Follow on Biologics/Follow on Proteins/Biosimilars
  • Biologics/Biotechnology/ Biogenerics
  • Legal Affairs
  • Intellectual Property
  • Health Economics
  • Pricing and Reimbursement
  • Clinical Immunology
  • Principal Scientist
  • Chief Scientific Officer
  • Process Control and Analytical Technologies
  • Analytical Characterization
  • 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

Why should you attend? 

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins.

Agenda 

Day One 

08:30 - Coffee and registration - An opportunity to meet and to network with your conference colleagues.

09:30 - Chairperson opening remark

09:40 - Morning Keynote Address 1: Emerging markets - Focus update

10:20 - Morning Keynote Address 2: Biosimilars in USA

11:00 - Morning Coffee/Tea & Discussion

11:20 - Keynote Panel Discussion: Challenges and Opportunities

12:00- Initiative and Commercialization of biosimilars and biobetter and access to emerging markets

12:40 - Networking luncheon

13:50 - Creating a successful global biosimilars strategy

14:30 - Capturing the mAb biosimilar opportunity

15:10 - Afternoon Tea/Coffee

15:30 - Afternoon Keynote Panel Discussion: Biosimilars: Global commercial potential in the upcoming markets

16:10 - Manufacturing changes for the upcoming biosimilars era

16:50 - Chairperson's closing remarks and end of conference

17:00 - 18:00 - Networking Drinks Session

Day Two 

08:30 - Coffee and registration - An opportunity to meet and to network with your conference colleagues

09:30 - Chairperson opening remarks

09:40 - Morning Keynote Address 1: Biosimilars: Providing on global commercial potential in the upcoming markets

10:20 - Morning Keynote Address 2: How to create a global development plan to increase your ROI

11:00 - Morning Coffee/Tea & Discussion

11:20 - Achieving regulatory approval of monoclonal biosimilars in the EU and US

12:00 - Afternoon Keynote Address: Scientific and clinical considerations for biologics and biosimilars

12:40 - Networking luncheon

13:50 - Non - Clinical development of biosimilars and innovator products: status and perspective

14:30 - Biosimilar infliximab - Norwegian experiences and European expectations

15:10 - Afternoon Tea/Coffee

15:30 - Biosimilars perpective: Maximization of IP regulatory rights

16:10 - Panel Discussion: The developing regulatory framework in advanced and developing markets - for Today & Tomorrow

16:50 - Chairperson's closing remarks and end of conference

17:00 - End of the 6th Biosimilars Congregation 2015

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