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Conference Booking Details: Standard Price after 20th December 2011 - Conference Delegate Pass (£ 500 + VAT per delegate) - You can simply email or call and book your conference delegate seats on TEL: + 44 20 3302 4659. Email – delegate.uk@virtueinsight.com Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to –TEL: + 44 20 3302 4659. Email - sponsor.uk@virtueinsight.com Conference Introduction: According to Global Industry Analysts Inc.. the global market for biosimilars is forecast to reach US$4.8 billion by the year 2015. 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. The pharmaceutical industry is facing a tough road ahead in the future marketplace. Though pharmaceuticals remain the most cost-effective healthcare intervention, everyone should bring about a significant transformation in their organizations to realize a glorious future. Biosimilars remains to be a provocative subject in the global pharmaceutical industry. However, with the sector promising significant cost savings to the industry, several major markets are welcoming biosimilar legislations for the development of biosimilars. Consequently, biosimilars are expected to grow into a multi-billion dollar market in future The absence of widespread legislations for biosimilars is primarily due to the complexity of biological drugs, as compared to the small molecule drugs. Production of biosimilars is also marred with huge technological investments and other clinical entry barriers, which is not the case with generic copies of small molecule drugs. The high-cost and complex technology involved in the production of biosimilars also restricts biosimilar companies from offering huge price discounts. As a result, a well-established regulatory framework, as seen in most countries for the approval of small molecule generics, is conspicuously absent in case of biosimilars, except in Europe and Japan, and recently in the US. The regulatory agencies, across the rest of world, have been adopting a rather slow approach to frame a clear set of guidelines for the approval of biosimilar products, precisely in view of the enormous safety and efficacy risks involved with biosimilars. The Conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. Hence, this Biosimilars Congregation 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. 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. It gives me great pleasure in welcoming all of you to the Virtue Insight’s Biosimilars Congregation 2012. I wish and pray that all our efforts will be beneficial to our industries folks at large. Key Themes Discussed at this Conference:
Key Speakers Include:
Who Should Attend: CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:
Why Should Attend: Biosimilars Congregation 2012 – “Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars” 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 vendorsExpand your knowledge of the latest business models and strategies in the high-level conference. showcasing the products of tomorrow in the co-located exhibition. |
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:30 – Chairperson opening remarks
Duncan Emerton, Principal Consultant, Datamonitor Healthcare Consulting
Market Overview & Analisys
09:40 – Morning Keynote Address 1 – Commercializing biosimilars and increasing access to medicine in the uk
Paul Tredwell, Head of Biopharmaceuticals - UK, Sandoz
10:20 – Morning Keynote Address 2 – Analysing the next generation monoclonal antibody development & the clinical challenges with biosimilar drug development
- What are the special requirements for demonstrating biosimilarity of monoclonal antibodies?
- 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
Sandy Eisen, CMO, Frontline Pharma Consulting
11:00 – Morning Coffee/Tea & Discussion
CHALLENGES & OPPORTUNITIES
11:20 – Keynote Panel Discussion: Challenges and Opportunities
- Biosimilars versus biobetters – positioning for a new market with lucrative prospects
- Biosimilar sales forecast - How large is the opportunity?
- Issues for growth: regulatory requirements; protectionism; MNC competition
- Opportunities to drive your longer term biosimilars strategy – Possible strategies to enter in emerging markets
- Identifying a roadmap for success for the EU biosimilars market to minimise costs and maximise return on investment
- How to meet payers & customer needs to ensure a successful market share
Moderator:
Duncan Emerton, Principal Consultant, Datamonitor Healthcare Consulting
Panellists:
Paul Greenland, Biosimilars and Proprietary Marketing Director – EMEA, Hospira, UK
Keith Powell, Chairman, Domainex (Former CEO, Polytherics)
Lincoln Tsang, Partner, Arnold & Porter LLP
Lee Coney, Chief Scientific Officer – Biologics, Huntingdon Life Sciences
12:00– Update on biosimilars in Europe
- Current trends for EU biosimilar approvals, and new and future guidelines.
- Scientific advice and how to achieve the best dossier
- Discussion of some of the additional hurdles for biosimilars to access European markets.
- Evolving biosimilar guidelines in the EU and how these have, or could, influence other worldwide biosimilar regulations
Richard Dennett, Director, Voisin Consulting Life Sciences
12:30 - Status and challenges of regulatory development and biosimilar registrations outside ICH regions.
Anna Harrington Morozova, Scientific & Regulatory Director, REGEM Consulting
13:00 - Networking luncheon
14:10 – Afternoon Keynote Address -Biosimilars: learning from successes and failures from Recombinant proteins to monoclonal antibodies
- What make successful EMA submissions for biosimilars
- Review causes of failures
- Major misunderstandings about biosimilars
- Review on-going evolution of the legislation and
- Review likely issues with biosimilar monoclonal antibodies.
Jean-Yves le Cotonnec, CEO, Triskel Integrated Services
CLINICAL STUDIES FOR BIOSIMILARS
14:50 – Panel Discussion: Clinical evaluation of biosimilars: challenges and potential pitfalls
- Reviewing the challenges in clinical study design for biosimilar development arising from endpoint variability
- Changes in clinical practice, and evolution in understanding of the biology of the disease under study
- What are there specific issues for use of biologicals, including biosimilars in clinical practice
- Assessing clinical consequences in safety & efficacy when comparing originator with Biosimilar/Copies
Moderator:
Duncan Emerton, Principal Consultant, Datamonitor Healthcare Consulting
Panellists:
Cecil Nick, Vice President - Biotechnology, Parexel
Sandy Eisen, CMO, Frontline Pharma Consulting
Violeta Stanimirovic, Expert of medicines and medical devices agency, Serbia-Alims & expert of Montenegrian National Drug Agency – CALIMS
Anthony Grosso, Associate Professor in Clinical Pharmacy Practice (Honorary), UCL Hospitals NHS Trust, University of London
15:20 – Afternoon Tea/Coffee
15:40 - Biosimilar market in China: overview of trends and growth.
Alex Kudrin, Medical Director, Takeda Pharmaceuticals
REGULATION OVERVIEW & UPDATE
16:20 – Panel Discussion: The developing regulatory framework in advanced and developing markets – for Today & Tomorrow
- EMA Regulatory Opinions on Treatment of mAbs
- Current Biosimilars practices in UK and examining various methods for improvement
- An overview of the FDA hearings to implement the Abbreviated Biologics Pathway
- Licensing considerations in view of the legislation
- Assessing the government incentives and initiatives currently in place and planned, around EU biosimilars
- Analysing the developing biosimilars regulatory framework in the U.S.
Moderator:
Christopher Holloway, Group Director of Regulatory Affairs, ERA Consulting
Panellists:
Kristie C. Kuhl, Senior Vice President, Makovsky + Company (USA)
Francis P. Crawley, Executive Director, Good Clinical Practice Alliance – Europe (GCPA)
Steinar Madsen, Medical Director, Norwegian Medicines Agency
Jan Petracek, MD MSc DIC CEO, Pharminvent
Anna Harrington Morozova, Scientific & Regulatory Director, REGEM Consulting
17:00 - Chairperson’s closing remarks and end of conference
Duncan Emerton, Principal Consultant, Datamonitor Healthcare Consulting
17:10 – 18:10 Networking Drinks Session
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Virtue Insight
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Keeping in mind actuality of the biotech drug discovery and development, the Biosimilars Congregation 2012 defined topics can be for congratulations only.
Key items as pharma and generics industries approach relative to emerging and developing biosimilar market, clinical trials changes in clinical practice and evolution in understanding of the biology of the disease, challenges in clinical study design for biosimilar development arising from endpoint variability, identifying issues and solutions surrounding biosimilars etc., that have been discussed at the conference, gave the course for predicting future trends inside the pharmaceutical industry worldwide.
Choice of the lecturers as well as panelists with so divergent, but so complementary professional background, gave the Meeting special seriousness.Owing to this heterogeneity, the success of the after-lecture discussion as well as the panel ones, was even more productive and promotional for next similar meetings. Moderators were professional and prepared for all the Keynote Addresses. They successfully managed to bridge the gaps arisen from divergent attitudes occurred during the discussions. It contributed to the air of specificity and uniqueness of that very Meeting. Summaries done from this Meeting shall remembered and incorporated in my professional work.
I do hope that I could be able to participate your next Meeting /2013./
The programme and the format were very good and the atmosphere provided great encouragement for the networking. It was timely organised allowing the participants to exchange opinions on very recent regulatory changes in the US and the EU.
All in all, Biosimilars Congregation 2012 was a very worthwhile and informative conference.
The Biosimilars Congregation proved to be an insightful range of presentations which covered the most important aspects of the biosimilars field. I’d recommend it to all stakeholders, manufacturers and regulators alike, who wants to network and gain more up-to-date knowledge in this exciting business area of biologics.
The presentations were informative and the panel discussions engaging, covering key and important topics of debate. The food and wine reception were excellent and allowed for relaxed networking opportunities.
Biosimilar Congregation was a really good conference, well organized and of good quality.
Biosimilars Congregation 2012 organised by Virtue Insight was a professionally managed event that was able to pull together a broad and relevant agenda presented by a well informed and insightful faculty. It was also very timely with the recent release of the US Biosimilar guidance which added a lot of new information that has not been previously discussed. I would certainly be interested in attending future events organized by Virtue Insight.
The Biosimilars Congregation has been a very informative gathering especially with respect to the future landscape and opportunities in Biosimilars.
Dr. Sandy Eisen, Frontline Pharma Consulting Ltd Dr. Duncan Emerton, Datamonitor Healthcare Consulting Anna Harrington - Morozova, REGEM Consulting Ltd Sponsorship or exhibition is the best way to speed network with decision makers. The world leader speakers in our conferences attract niche delegates from all over the world. This would be a wonderful opportunity to reach the right audience and save money and time on all your other advertising gimmicks.
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