rd e Bi t.. or ly un bef 1 Biosimilars r Ea sco ay 01 Di & P ec 2 .c om ok h D - ight o sBo 20t l t in ai irtue el e ga Em @v te .u k ll Ca 33 0 s u 2 - 0 46 59 Congregation 2012 d 2 44 + 24th February 2012, Hilton London Euston Hotel, London, UK “Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”Key Speakers Include: To be updated shortly.... Organised By
Biosimilars Congregation 2012 February 24th 2012, Hilton London Euston Hotel, London UKConference Intro: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 growthinclude patent expiries of key biological drugs, cost containment measures from governments, aging population, and supporting legislations. The recent establishmentof 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 theglobal pharmaceutical industry. However, with the sector promising significant cost savings to the industry, several major markets are welcoming biosimilarlegislations for the development of biosimilars. Consequently, biosimilars are expected to grow into a multi-billion dollar market in futureThe absence of widespread legislations for biosimilars is primarily due to the complexity of biological drugs, as compared to the small molecule drugs. Production ofbiosimilars is also marred with huge technological investments and other clinical entry barriers, which is not the case with generic copies of small molecule drugs. Thehigh-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 inEurope 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 ofguidelines 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 clinicaldevelopment, to the legal and economic aspects. By attending this conference you will gain a comprehensive outlook on the key issues surrounding biosimilars. Thisevent 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 Insights Biosimilars Congregation 2012. I wish and pray that all our efforts will be beneficial to ourindustries folks at large.Key themes discussed at this Summit:· Reviewing some of 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· How should the pharma and generics industries approach the rapidly emerging and developing biosimilar market? The future of next generation Biosimilars· How are policy makers shaping the contours of this new generic frontier, and what implications they have for current biologic drug development and patent protection?· Identifying issues and solutions surrounding biosimiliars and clinical trials.· Next generation monoclonal antibody development and clinical challenges with biosimilar drug development· Overcoming pricing and reimbursement challenges to maximise the ROI· Determining the right investments & potential returns from Biosimilars· Commercial challenges and opportunities - strategies to develop Biosimilars· Biosimilars Vs Bio-betters – positioning for a new market with lucrative prospects· Learn to implement best practices through recent successful strategies and business models – real time case studies· Analyze the FDAs current view of biosimilars· The developing regulatory framework in advanced and developing markets· EMA Regulatory Opinions on Treatment of mAbs· Critical issues in demonstrating biosimilarity and maintaining diligent quality control· 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: Analytics, Business Development, Business Strateg, Corporate Development Strategy, Commercial Affairs, Intellectual Property, Marketing & Sales, Medical Affairs, NewProduct Development, Legal Affairs, CMC, Preclinical and Clinical Development, Product Development, Regulatory Affairs, Pricing and Reimbursement, Research and Development, Biologic Production, Quality Assurance, Scientific Affairs, Strategic Planning, Strategic Sourcing. Sponsorship & Exhibition Opportunities: Why should you attend:If you would like to benefit by promoting your organization at one of Biosimilars Congregation 2012 – “Uniting industry leaders toour events then exhibit is perfect for you. analyse advanced commercial developments & to identify successful management strategies of Biosimilars”· Hosting a networking drinks reception· Increase and maintain brand awareness Get more from the event, with a broader scope bringing the whole· Taking an exhibition space at the conference communications value chain together. Enjoy and make the best out of our· Target your marketing campaign dedicated networking drinks time, meet the leading international· Advertising in the delegate documentation pack vendors showcasing the products of tomorrow in the co-located exhibition.· Providing branded bags, pens, gifts, etc. Expand your knowledge of the latest business models and strategies in· Network with industry decision-makers the high-level conference.· Meet potential clients & Present your products and ideasAny questions on Sponsorships or Exhibition – Email your queries firstname.lastname@example.org Delegate Registration: To register and to book your seats at the conference - please email your interest to email@example.com
Biosimilars Congregation 2012 February 24th 2012, Hilton London Euston Hotel, London UK 12:00– Update on biosimilars in Europe·08:30 – Coffee and registration- An opportunity to meet and to · Current trends for EU biosimilar approvals, and new and futurenetwork with your conference colleagues. guidelines.09:30 – Chairperson opening remarks · Scientific advice and how to achieve the best dossier · Discussion of some of the additional hurdles for biosimilars toDuncan Emerton, Prinicpal Consultant, access European markets.Datamonitor(http://uk.linkedin.com/in/duncanemerton) · Evolving biosimilar guidelines in the EU and how these have, or could, influence other worldwide biosimilar regulations MARKET OVERVIEW & ANALISYS Richard Dennett, Director,Voisin Consulting Life Sciences(http://fr.linkedin.com/pub/richard-dennett/7/837/739)09:40 – Morning Keynote Address 1 – Analysing the currentmarket for Biosimilars & where is it heading? 12:40 - Networking luncheon - Take your discussions· Identifying the key drivers for the development of biosimilars and further & build new relationships in a relaxed establishing EU share of the market & informal setting...· What are the key opportunities in the emerging markets?· Determining EUs core strengths in biosimilars to underpin the growth strategy· Moving from generics to biosimilars, what are the factors to consider?· Overcoming the impediments and obstacles hampering the growth of Afternoon Chairperson biosimilars· Analysing the key action plan necessary to fast-track the development of current biosimilars market 14:00 – Afternoon Keynote Address - Overcoming pricing and10:20 – Morning Keynote Address 2 – Analysing the next reimbursement challenges to maximise the ROIgeneration monoclonal antibody development & the clinicalchallenges with biosimilar drug development · What are the key drivers for a successful pricing and reimbursement strategies· What are the special requirements for demonstrating biosimilarity of · Evaluating value perception of stakeholders and its impact on monoclonal antibodies? pricing and reimbursement strategies· The advancement of Monoclonal antibody technology and the · Understanding market access hurdles and how to overcome enhancement of oncologic disease therapy by next generation antibody them drugs · Forecasting market dynamics and their impact on pricing and· Promising early clinical studies and growing interest reimbursement strategies· The clinical challenges in the biosimilar drug development: manufacturing, preclinical testing, and clinical trial implementation11:00 – Morning Coffee/Tea & Discussion CLINICAL STUDIES FOR BIOSIMILARS CHALLENGES & OPPORTUNITIES 14:40 – Panel Discussion: Clinical evaluation of biosimilars: challenges and potential pitfalls 11:20 – Keynote Panel Discussion: Challenges and Opportunities · Reviewing the challenges in clinical study design for biosimilar development arising from endpoint variability · Biosimilars versus biobetters – positioning for a new market with · Changes in clinical practice, and evolution in understanding of lucrative prospects the biology of the disease under study · Biosimilar sales forecast - How large is the opportunity? · What are there specific issues for use of biologicals, including · Issues for growth: regulatory requirements; protectionism; MNC biosimilars in clinical practice competition · Assessing clinical consequences in safety & efficacy when · Opportunities to drive your longer term biosimilars strategy – comparing originator with Biosimilar/Copies Possible strategies to enter in emerging markets · Identifying a roadmap for success for the EU biosimilars market Moderator: to minimise costs and maximise return on investment · How to meet payers & customer needs to ensure a successful Panellists: market share Violeta Stanimirovic, Expert of medicines and medical Moderator: devices agency, Serbia-Alims & expert of Montenegrian National Drug Agency – Claims Duncan Emerton, Prinicpal Consultant, Datamonitor Panellists:· Paul Greenland, Biosimilars and Proprietary Marketing Director – EMEA, Hospira, UK Keith Powell, Chairman, Domainex (Former CEO, Polytherics)
Biosimilars Congregation 2012 February 24th 2012, Hilton London Euston Hotel, London UK15:20 – Afternoon Tea/Coffee15:40 - Sponsored SessionGrab this exclusive opportunity to be a part of the BiosimilarsCongregation to network, share ideas and provide an overview of your product/services to the audience.To avail this sessions speaking opportunity, please contact – SarikaSareen at firstname.lastname@example.org REGULATION OVERVIEW & UPDATE16:20 – Panel Discussion: The developing regulatoryframework 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:Panellists:Francis P. Crawley, Executive Director, Good Clinical PracticeAlliance – Europe (GCPA)(http://be.linkedin.com/pub/francis-p-crawley/9/357/22b)Steinar Madsen, Medical Director, Norwegian MedicinesAgency17:00 - Chairpersons closing remarks and end of conference 17:10 -18:10 Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting...
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