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4th Biosimilars Congregation 2014
 

4th Biosimilars Congregation 2014

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4th Biosimilars Congregation 2014 ...

4th Biosimilars Congregation 2014
“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”
26th & 27th February 2014, Thistle Marble Arch Hotel, London, UK

info.uk@virtueinsight.com

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    4th Biosimilars Congregation 2014 4th Biosimilars Congregation 2014 Document Transcript

    • Conference Hashtag - #VI_Pharma Key Speakers Include:Chetak Buaria, Director - Alliance Management (Biosimilars), Merck Serono Mohamed Oubihi, Associate Director JAPAC, EU and Emerging Market Regulatory Affairs, Abbott Malcolm I Mitchell, Director, BioPharmaceuticals, Eli Lilly Cecil Nick, Vice President, Parexel Jean-Yves le Cotonnec, CEO, Triskel Integrated Services Bruno Flamion, Advisory Board Member, NDA Regulatory Martin Bluggel, CEO, Protagen Protein Services Kristie C. Kuhl, Executive Vice President, Makovsky (New York) Steinar Madsen, Medical Director, Department of Drug Information, Norwegian Medicines Agency Catherine Akers, Regulatory Affairs Manager - EU Policy, Amgen Tony Williams, CEO, TWC Pharma Consulting Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord François Lawny, Director of Biotechnology, Triskel Integrated Services Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting (Former CMO, Teva Pharmaceuticals) Lincoln Tsang, Partner, Arnold & Porter Peter Wittner, Senior Consultant, Interpharm Consultancy (Former Managing Director Ranbaxy UK) Sahar Shepperd, Commercial and IP Associate - Life Sciences Sector, Bristows Brij Patel, CEO, RegExcelconsulting (Former Biological Assessor, MHRA) Marie Manley, Partner & Head of the Regulatory Practice, Bristows Plus Many More...
    • 4th Biosimilars Congregation 2014 26th & 27th February 2014, Thistle Marble Arch Hotel, London, UK ASSOCIATE SPONSOR BRONZE SPONSOR EXHIBITOR SUPPORTED BY ORGANIZED BY
    • 4th Biosimilars Congregation 2014 26th & 27th February 2014, Thistle Marble Arch Hotel, London, UK 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. 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. The barriers to entry for this lucrative market however require that companies establish and harmonise carefully planned regulatory, clinical and marketing strategies. Innovators and biosimilar applicants need to find answers to the current myriad of commercialisation questions that face the market. Those to establish their market presence first will dictate the success of companies in the biosimilar space.Europe holds the highest number of biosimilar approvals, and this number will continue to increase in the near future. Further biologic patent expiries will boost the number of biosimilars to be approved, thereby bringing in an increased number of products that will help increase market size and competition among market participants. The biosimilars market is in the nascent stage of the industry life cycle with limited market and product development experience. However, there is a significant market opportunity from patent expiries. High initial investments are still a major barrier for new entrants. Collaborations among large pharmaceutical companies with financial capabilities and specialty biotech companies with technical expertise are expected. The strong integration of marketing and research and development skills is the key to success in the biosimilars market. 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, according to Biosimilar Monoclonal Antibodies: World Market Prospects 2013-2023, published in July 2013 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. It gives me great pleasure in welcoming all of you to the Virtue Insight’s 4th Biosimilars Congregation 2014. KEY THEMES DISCUSSED AT THIS SUMMIT:• • • • • • • • • • • • • • • • How should the pharma and generics industries approach the rapidly emerging and developing biosimilar market? The future of next generation Biosimilars Getting to the market faster with critical updates on partnering and global developments 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? What is the authorised Biosimilar and how will this affect your market share? Next generation monoclonal antibody development and clinical challenges with biosimilar drug development Research-based industry biosimilar strategies Technical case studies for analytical and clinical comparability strategies Gain in-depth knowledge on role of technology transfer - How does this effect market access? Commercial 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 Considerations for the analytical similarity assessments when designing a biosimilar development program Determining the right investments & potential returns from Biosimilars Considering the growing importance of biobetters over biosimilars Ascertaining the volume and level of safety data that will be required to prove patient safety and efficacy to facilitate approval Understanding the current regulatory approval standards for Biosimilars in Europe, US and ROI including for monoclonal antibodies 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 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 WHY SHOULD YOU ATTEND:4th Biosimilars Congregation 2014 – “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 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.
    • 4th Biosimilars Congregation 2014 26th & 27th February 2014, Thistle Marble Arch Hotel, London, UK DAY ONE - 26TH FEBRUARY 2014 08:30 – Coffee and registration - An opportunity to meet and to network with your conference colleagues. 12:10 – Biosimilars: How is this risk worth the recompense? Situation in EU 09:30 – Chairperson opening remarks • Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord (http://www.linkedin.com/in/duncanemerton) • • • • MARKET OVERVIEW & ANALYSIS • 09:40 – Morning Keynote Address 1 – Biosimilars: The EU Regulatory Commitment • • • • • Latest progress in biosimilars development and assessing the promise and potential of biosimilars Perspectives and acceptance of biosimilars Biosimilar ROI considerations Biosimilar development as a seamless process Why biologics are of increasing interest to emerging markets? Defining the market factors which have influenced the growth or posed hindrance to the pharmaceutical industry 12:50 - Networking luncheon - Take your discussions further & build new relationships in a relaxed & informal setting... Evolving regulatory landscape in the EU First biosimilar monoclonal antibody approved The weight of nonclinical data Extrapolation of indications: regulators vs clinicians Substitution and pharmacovigilance BUSINESS MODELS Bruno Flamion, Advisory Board Member, NDA Regulatory (http://www.linkedin.com/pub/bruno-flamion/1/93b/784) 10:20 – Morning Keynote Address 2 – Update on Biosimilars in USA • • • • Evolving regulatory landscape for biosimilars in USA USA guidelines for biosimilar products What are the current trends for USA biosimilar approvals Critical steps in the development of Biosimilars Kristie C. Kuhl, Executive Vice President, Makovsky (New York) 11:00 – Morning Coffee/Tea & Discussion 14:00 – Capturing the mAb biosimilar opportunity • • • • • Analysing the Monoclonal Antibody Guidelines: How to get regulatory approval of your mAb Historic uptake of generics and biosimilars -key learnings Drivers and bariers form mAb uptake: aligning the players mAb opportunity in autoimmune disease: stakeholders and entry strategy Ensuring Quality CMC in place before embarking on mAb production Peter Wittner, Senior Consultant, Interpharm Consultancy (Former Managing Director Ranbaxy UK) (http://www.linkedin.com/in/interpharmconsultancy) CHALLENGES & OPPORTUNITIES 11:20 – Keynote Panel Discussion: Challenges and Opportunities • • • • Opportunities to drive your longer term biosimilars strategy – Possible strategies to enter in emerging markets Challenges in selecting the most appropriate cell line for producing biosimilar products Strategies for change: how can we ensure that biosimilars are still safe and efficacious, but also affordable and globally accessible for patients? What characteristics of biosimilar partnerships are critical in developing commercially successful biosimilars? Moderator: Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord (http://www.linkedin.com/in/duncanemerton) Panellists: Chetak Buaria, Director - Alliance Management (Biosimilars), Merck Serono Malcolm I Mitchell, Director, BioPharmaceuticals, Eli Lilly 14:40 – Afternoon Keynote Panel Discussion: Biosimilars: Driving on Global Commercial Potential through the Emerging Markets • • • • • Find out on which of the biologic therapies that carry the greatest competitive pressures and why? How are some of these competitive pressures relieved by environmental opportunities unique to the emerging markets? Which are the emerging markets that represent the greatest commercial opportunity for biosimilars and why? What are the funding opportunities for biosimilars within the emerging markets? What are the pricing and market access challenges associated with biosimilars within these markets? Moderator: Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord (http://www.linkedin.com/in/duncanemerton) Panellists: Steinar Madsen, Medical Director, Department of Drug Information, Norwegian Medicines Agency Peter Wittner, Senior Consultant, Interpharm Consultancy (Former Managing Director Ranbaxy UK) (http://www.linkedin.com/in/interpharmconsultancy) Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting (Former CMO, Teva Pharmaceuticals) (http://www.linkedin.com/in/sandyeisen)
    • 4th Biosimilars Congregation 2014 26th & 27th February 2014, Thistle Marble Arch Hotel, London, UK 15:20 – Afternoon Tea/Coffee BIOMANUFACTURING & PRODUCTION 15:40 – Reaching and demonstrating Biosimilarity by state of the art analytics • • • • Regulatory demand for demonstrating biosimilarity Monitoring reference molecule Matching critical quality attributes during development Comparability exercise Martin Bluggel, CEO, Protagen Protein Services DAY TWO - 27TH FEBRUARY 2014 08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues. 09:30 – Chairperson opening remarks Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord (http://www.linkedin.com/in/duncanemerton) COMMERCIALISATION & MARKET ACCESS (http://www.linkedin.com/pub/martin-bl%C3%BCggel/2/891/89a) 09:40 – Morning Keynote Address 1 – Commercial Challenges Facing Monoclonal Biosimilar Firms 16:10 - Importance of Downstream Processing in the development of Biosimilars (http://www.linkedin.com/in/tonywilliams1) • • • • Need of good understanding the concept of a biosimilar Reasons for registration failure (historical review) Usual traps and pitfalls in biosimilar development Examples of DSP fine tuning to meet biosimilarity requirements François Lawny, Director of Biotechnology, Triskel Integrated Services (http://www.linkedin.com/pub/fran%C3%A7ois-lawny/6/573/837) Tony Williams, CEO, TWC Pharma Consulting 10:20 – Morning Keynote Address 2 – How to create a global development plan to increase your ROI • • • 16:50 - Chairperson’s closing remarks and end of conference Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord (http://www.linkedin.com/in/duncanemerton) • • 17:00 - 18:00 Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting... • • To what extent do the costs of biosimilar production necessitate a global development plan to access non - European markets? What are the challenges presented by the requirement for different reference products in different regulatory regimes worldwide? What are the differing reference standards, and where can you use clinical trial data for products that are registered in different regions? To what extent can biosimilar producers harmonize their global operations? What bridging studies are required to create a global development plan? How to overcome challenges relating to current good manufacturing practice (GMP) requirements. What are the current commercial opportunities exist for biosimilar producers in emerging markets? What are the difficulties for market entry here? Jean-Yves le Cotonnec, CEO, Triskel Integrated Services (http://www.linkedin.com/pub/jean-yves-le-cotonnec/10/55/902) 11:00 – Morning Coffee/Tea & Discussion 11:20 – The Dilemma of B-Sim Technologies - Commercial Contracts update This presentation would be an update of recent cases that may affect or influence the way we draft our contracts particularly in the Biosimilar space Sahar Shepperd, Commercial and IP Associate - Life Sciences Sector, Bristows (http://www.linkedin.com/pub/sahar-shepperd/1/b2a/203)
    • 4th Biosimilars Congregation 2014 26th & 27th February 2014, Thistle Marble Arch Hotel, London, UK CLINICAL STUDIES FOR BIOSIMILARS 12:00 – Afternoon Keynote Address – Determining the type & volume of clinical data that is essential for establishing biosimilarity - An EU, FDA, and RoW perspective • • • • • Regulatory & clinical development considerations for biosimilars Striking a balance between requiring larger and more sophisticated trials and facilitating market entry for biogenerics Understanding the patient perspective in the biosimilar conversation o Biologic and biosimilar safety and efficacy o Pharmacovigilance: collecting, monitoring, researching, assessing and evaluating adverse events o Cost to the patient o Therapeutic substitution issues o Barriers to care Clinical and commercial advantages through the application of manufacturing technologies Extrapolating data obtained in clinical trials for a reference product to support biosimilar applications PRICING & REIMBURSEMENT 15:40 – Pricing and Reimbursement of Biosimilars – Identifying successful access & pricing strategies • • • • • • • Exploring reimbursement and coverage decisions What is required for local authorities to reimburse your product? The race to market and cost mitigation Determining the right investments & potential returns from Biosimilars Lessons from the EU pricing challenges for biosimilars entrants Coping with cuts in government expenditure Ensuring long-term sustainability in Global healthcare, by reducing the cost of biologics REGULATION OVERVIEW & UPDATE 16:10 – Panel Discussion: The developing regulatory framework in advanced and developing markets – for Today & Tomorrow Cecil Nick, Vice President, Parexel (http://www.linkedin.com/pub/cecil-nick/10/984/573) 12:40 - Networking luncheon - Take your discussions further & build new relationships in a relaxed & informal setting... 14:00 – Biosimilars development & impact on clinical practice • • • • • From approval to clinical use – obstacles and opportunities How should Biosimilars be developed to get over current market hurdles? What impacts will we see in prescribers, payers and patients and what does this mean for drug developers? Analysis on the current situation in terms of biosimilar infliximab Managing clinical needs rather than cost in areas of terminal care where advances arises from biologicals offering improved life expectancy Steinar Madsen, Medical Director, Department of Drug Information, Norwegian Medicines Agency • • • • • • The latest in regulatory thinking - Update on biosimilars in Europe - Current trends for EU biosimilar approvals, and new and future guidelines – Get yourself updated. Non-clinical studies in the development of biosimilars – regulatory requirements in EU Assessing the government incentives and initiatives currently in place and planned, around EU biosimilars Analysing the developing biosimilars regulatory framework in the U.S. Reviewing and applying comparability studies by the FDA Legal for Biosimilars - Turning antitrust laws to your advantage in the generics and biosimilars Moderator: Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord (http://www.linkedin.com/in/duncanemerton) Panellists: Mohamed Oubihi, Associate Director JAPAC, EU and Emerging Market Regulatory Affairs, Abbott (http://www.linkedin.com/in/mohamedoubihi) 14:40 – How important is the traceability of biologics? Lincoln Tsang, Partner, Arnold & Porter • • • • Key safety difference between biologics and small molecules PV and Safety Reporting after authorisation Implementation status of the new EU PV legislation specifically article 102 (e) – what has been done at a Member State level? Further research into PV for biologics Catherine Akers, Regulatory Affairs Manager - EU Policy, Amgen (http://www.linkedin.com/pub/lincoln-tsang/0/74b/aaa) Brij Patel, CEO, RegExcelconsulting (Former Biological Assessor, MHRA) Marie Manley, Partner & Head of the Regulatory Practice, Bristows (http://www.linkedin.com/pub/marie-manley/12/41/834) 15:20 – Afternoon Tea/Coffee 16:50 – Chairperson's closing remarks and end of conference Duncan Emerton, Senior Director, Syndicated Insights & Analysis, FirstWord (http://www.linkedin.com/in/duncanemerton) 17:00 – End of the 4th Biosimilars Congregation 2014.
    • 4th Biosimilars Congregation 2014 FLOOR PLAN - Book your stalls now before they run out !!! 3x2m 3x2m 3x2m S6 S5 3x2m Door S4 S1 S2 Door S3 REGISTRATION DESK 3x2m 3x2m CONFERENCE HALL 1 3 5 2 4 6
    • 4th Biosimilars Congregation 2014 26th & 27th February 2014, Thistle Marble Arch Hotel, London, UK REGISTRATION:For Multiple Bookings - Photocopy this form... DELEGATE DETAILS: Title Mr Mrs Ms Miss Dr First Name Surname Position Company Address Postcode Fax Telephone Email RESERVATION PRICING: Super Early Discount (Till 08th November 2013) - £500 + VAT (Per Delegate) Early Discount (09th November 2013 - 23rd December 2013) - £700 + VAT (Per Delegate) Standard Pricing (24th December 2013) - £1000 + VAT (Per Delegate) PAYMENT: Please send me a VAT invoice Our purchase order no.is I enclose a cheque for £ Payable to Virtue Insight Ltd Please charge my card £ Card type: Visa Mastercard Maestro Card Number Security No Issue Date / Expiry Date / Cardholder’s Name Cardholder’s Registered Address Postcode Date Signature FOR BANK TRANSFER: Account Name - Virtue Insight LTD Account Number - 62318474 Bank Name - HSBC Sort Code - 40-25-27 TERMS AND CONDITIONS: Payment terms: Virtue Insight requires the full amount to be paid before the conference. Virtue Insight may refuse entry to delegates who have not paid their invoice in full. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, or email. There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences and executive briefings. However, if you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or organization and are not transferable between countries. Indemnity: Virtue Insight reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of Virtue Insight. If such a situation arises, we will refund your registration fee and we will try to reschedule the event. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel or hotel accommodation. How we will contact you: Virtue Insight's preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you.