6th Annual
  Biosimilars Conference
  Revolutionizing biosimilars market - debates, challenges and innovations

Conference Introduction
Pre-Conference Interactive Workshop
Day 1
                                                                                   6th Annual Biosimilars Conference...
Day 2
                                                                                       6th Annual Biosimilars Confer...
Registration Form
Upcoming SlideShare
Loading in …5

6th Annual Biosimilars 2010 (Usa)


Published on

I\'ll be a panelist for a workshop on biosimilars.

1 Comment
  • My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public.
    Various issues have been dealt with, such as:
    - Patent expirations
    - Regulatory frameworks
    - Infrastructure Requirements
    - Etc.
    If anyone is interested in this report, please contact me at (infoalcpl AT gmail DOT com), and I would send you the brochure and other details.
    Are you sure you want to  Yes  No
    Your message goes here
  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

6th Annual Biosimilars 2010 (Usa)

  1. 1. 6th Annual Biosimilars Conference Revolutionizing biosimilars market - debates, challenges and innovations 2nd - 4th March 2010, Boston, USA BOOK NOW! Key Speakers Tina S. Morris, Vice President, Biologics and Biotechnology, United States Pharmacopeial Convention Yining Zhao, Associate Research Fellow, Strategy Management Group, Pfizer Dr. David L. Gollaher, President and Chief Executive Officer, California Healthcare Institute Les Jordan, CTO, Life Sciences Industry Unit, Microsoft Terry Hisey, Vice Chairman, U.S. Life Sciences Leader, Deloitte LLP James Harris, CEO, Healthcare Economics LLC Clifford S. Mintz, Founder, BioInsights Mateja Urlep, Director, TikhePharma Dr Duu-Gong Wu, Executive Director, Pharmanet Brian J. Del Buono, Director, Sterne, Kessler, Goldstein & Fox Dr. Fethi Trabelsi, Director, Scientific & Regulatory Affairs, Anapharm Roger Lias, President, Eden Biodesign Senior Representative, Paraxel Consulting Pre conference Workshop, Tuesday 2nd March 2010 Creating confidence in a new wave of biologics therapy - Overcoming barriers to entry led by: Gil Bashe, Executive Vice President, Health Practice, Makovsky + Company Media Partners Driving the Industry Forward | www.futurepharmaus.com Organised By To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilarsusa
  2. 2. Conference Introduction 6th Annual Biosimilars Conference 2nd – 4th March 2010, Boston, USA “The US biosimilar market, generating $0.06bn sales in 2008, will Media Partners: achieve significant revenues only after expected implementation of PharmiWeb.com is the leading industry-sponsored portal for a biosimilar regulatory pathway in 2013, visiongain predicts. If this occurs, the US biosimilar market will increase to annual revenues of the pharmaceutical sector. Supported by most of the leading $1.95bn in 2014” (Source: Visiongain Report ‘Biosimilars and Follow-on pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, Biologics 2009-2024’ Published: April 2009) events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com Dear Colleague, BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. Biologics constitutes a major share of expenditure in the USA and globally. It is one of the It is based and located in Warsaw, Poland. Biotechnology World was fastest growing sectors of the pharmaceutical industry which corresponds to over 15% founded in 2007 to provide the world’s biotech and pharma information and market to of the total pharmaceutical market. make it universally accessible and useful for scientific and business processes. Its first step There is a large and potentially lucrative demand for lower cost biological drugs to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will worldwide. With favourable regulatory developments, the biosimilar sector should pick allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers up significantly, however, forming an important developing pharma market. companies completed internet public relations, publication and marketing solutions. One of Visiongain’s 6th Annual Biosimilars Conference will feature keynote addresses, the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector presentations, case studies and interactive discussions from regulatory issues to in Europe to global biotechnology, pharmaceutical and life science activities. manufacturing process, clinical assessment, commercialization and pricing. For further information please visit www.biotechnology-europe.com Future Pharmaceuticals has forged powerful relationships with Driving the Industry Forward | www.futurepharmaus.com This three day event is an ideal forum for experts from the industry and academic sector together to discuss and share their experience and best practices. key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan Why Attend? implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future • Discover the key strategies for process development/manufacturing of biosimilars Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted • Discuss the key regulatory and scientific issues of biosimilars and follow-on biologics and responsive audience, bridging the gap between the industries’ top issues and the • Examine commercialisation of biosimilars solutions top-tier vendors can provide. • Understand the development and marketing of biosimilars For further information please visit: www.futurepharmaus.com • Assessing impact of IT driven patient adherence methodologies on biologics and InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to biosimilars InPharmjobs.com, Pharmafile and Pharmafocus. • Learn how to develop and create strategic outsourcing strategies for biosimilars For further information please visit: www.In-Pharm.com • Network and discuss ideas with the leaders in the field ‘Pharma Connections Worldwide® is the leading professional I look forward to meeting you at the conference business networking website focused in the Pharmaceutical, Best regards Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. ‘ For further information please visit: www.pharmaconnections.com Pranita Nangia Conference Producer Biosimilars and Follow-On Biologics Report: The Global Outlook 2009-2024 A visiongain report Who should attend? Branded Biotechnology, Pharmaceuticals & Generic Pharmaceutical Companies, Drug Regulators, Healthcare Agencies, Government About visiongain: Departments, Contract Research/Bio manufacturing, Organisations, Visiongain is a specialist business information company focused on providing cutting Regulatory Affairs, Pharmacovigilance edge products and services across the Pharmaceutical/Biotech, Telecommunications, VPs, Directors, Heads, Managers of: Defence and Finance sectors, which include reports, conferences, online daily news and • Follow on Biologics/Follow on Proteins/Biosimilars offline news analysis and bespoke consultancy. With a commitment to innovation and • Biologics/Biotechnology/ Biogenerics excellence, visiongain offers flexible solutions to meet our clients’ business intelligence needs, providing the right information at the right time to facilitate the commercial • Legal Affairs decision-making process. Our pharmaceutical products include Pharma Business Daily, • Intellectual Property the leading daily email newsletter for the pharmaceutical, biotech and healthcare • Health Economics industries, and a range of independent, high-quality, in-depth reports covering focused • Pricing and Reimbursement and topical areas of concern. Our pharmaceutical conferences address the hottest • Biopharmaceuticals/ Biotherapeutics commercial, regulatory and technical topics and provide an ideal forum for debate and • Clinical Immunology networking for pharmaceutical professionals from around the world. • Principal Scientist For further information, please visit: www.visiongain.com • Payers • Chief Scientific Officer • Process Control and Analytical Technologies • Analytical Characterisation Sponsorship and exhibition opportunities: • Regulatory Compliance This event offers a unique opportunity to meet and do business with some of the key • Pharmacovigilance players in the pharmaceutical and biotech industries. If you have a service or product to • Drug Safety & Risk Management promote, you can do so at this event by: • Quality Affairs/ Quality Control • Hosting a networking drinks reception • New Product Development • Process Science • Taking an exhibition space at the conference • Portfolio Management • Advertising in the delegate documentation pack • Research & Development • Providing branded bags, pens, gifts, etc. • Business Development If you would like more information on the range of sponsorship or exhibition possibilities for • Business Operations visiongain's 6th Annual Biosimilars Conference, please contact us: • Scientific Affairs • Commercial Affairs Sandra Clout +44 (0)20 7549 9969 • Marketing sandra.clout@visiongainglobal.com
  3. 3. Pre-Conference Interactive Workshop 6th Annual Biosimilars Conference Tuesday 2nd March 2010, Boston, USA Creating confidence in a new wave of biologics therapy - Overcoming barriers to entry Led by: Gil Bashe, Executive Vice President, Makovsky + Co Timings: 09:30 - 10:00 Coffee & Registration 10:00 - 15:00 Workshop Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy, Sanofi-Aventis Kristie Kuhl, JD, Senior Vice President, Makovsky + Company Timing includes lunch and refreshment breaks Francis B. Palumbo, PhD, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy Agenda: About your workshop leaders: Legislative pathways for biosimilar regulatory approval Gil Bashe, Executive Vice President, Makovsky + Co may provide significant implementation confusion. The Workshop Leader wrong path to biosimilar approval may jeopardize ability to develop future advancements and place obstacles in the Mr. Bashe is counselor to pharmaceutical, biotechnology, medical-device path to reducing healthcare costs. The debate on whether manufacturers and patient advocacy groups. He has advised clients on follow- legislation is pro-innovator or biogenerics entrepreneur on-biologic (FOB) policies and reimbursement, first in Europe and now in the may overshadow addressing key concerns for future United States. Mr. Bashe is a limited partner with GTCR Golder Rauner, one of success. This workshop will summarize the key concerns the nation’s leading private-equity firms and was CEO of CommonHealth, a and enable participants to tackle these issues. Discussions WPP Group company, having served as at sister-company Hill and Knowlton include: as Worldwide Health Practice director overseeing policy, provider and product communications. • How much authority will FDA have to make case-by-case approval decisions? Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy, • What should the clinical data requirements be Sanofi-Aventis for approval, immunogenicity and subsequent Dr. Harvey leads the sanofi-aventis Corporate Regulatory Affairs (CRA) office interchangeability? in Bethesda, Maryland and interacts with the Food and Drug Administration • Class and product-specific naming (FDA), C-Path Institute and key industry representatives on behalf of sanofi- aventis. He represents sanofi on PhRMA, Regulatory Affairs Coordination • How should market exclusivity address ever greening? Committee, and BIO’s Regulatory Affairs Committee. Prior to joining sanofi, Dr. • How does patent law affect FOBs entry into the market? Harvey worked at the FDA in CDRH, CBER and CDER centers for more than 11 years and worked on health issues in the U.S. Senate. Dr. Harvey completed • What should the nomenclature system be to reduce his Ph.D. in biochemistry and his M.D. degree at the University of Connecticut. confusion and promote patient safety? Kristie Kuhl, JD, Senior Vice President, Makovsky + Company Kristie Kuhl provides counsel on issues that impact biotechnology, specialty pharma, dietary supplements and medical devices. Her legal and communication skills provide keen insight in bringing together communities About: Makovsky + Co with diverse interests especially important in the FOB arena. She has provided counsel on the issues surrounding biosimilar approvals in Europe including communicating the differences between biosimilars and generic drugs. Francis B. Palumbo, PhD, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy Founded in 1979, Makovsky + Company is today one of the nation’s leading independent global public relations consultancies. The firm attributes its Dr. Francis Palumbo is both a lawyer and registered pharmacist and success to its original vision: that the Power of Specialized ThinkingTM is the approaches biosimilars with a unique perspective. He has a strong best way to build reputation, sales and fair valuation for a client. Celebrating interest in pharmacy and food and drug law, pharmacoeconomics, its 30th year in 2009, Makovsky has received numerous industry accolades pharmacoepidemiology and health services research. As an adjunct professor including; the American Business Awards 2009 PR Agency of the Year and at the Maryland School of Law, he teaches a course in food and drug law, Holmes Report 2009 Multispecialist Agency of the Year. Based in New York including content on foods, dietary supplements, drugs and other products City, the firm has agency partners in more than 26 countries and in 35 U.S. regulated by the FDA and its sister agencies. Dr. Palumbo received his B.S. in cities through IPREX, the third largest worldwide public relations agency Pharmacy from the Medical University of South Carolina, M.S. and Ph.D. in partnership, of which Makovsky is a founder. Health Care Administration from the University of Mississippi and J.D. from For further information, please visit: www.makovsky.com the University of Baltimore Law Center.
  4. 4. Day 1 6th Annual Biosimilars Conference Wednesday 3rd March 2010, Boston, USA 09:30 Registration and refreshments 13:10 Networking lunch 10:00 Opening address from the chair 14:30 The impact of a patient centric viewpoint on James Harris biosimilars CEO • Review of emerging PHR and patient centric healthcare information Healthcare Economics LLC technology (HIT) and how it applies to biosimilars • Includes a discussion of the effect of IT driven patient adherence 10:10 Opportunities and challenges for biosimilars in the methodologies on biologics and biosimilars global market Les Jordan • Assessing the promise and potential for biosimilars CTO, Life Sciences Industry Unit Microsoft • Latest progress in biosimilars development • Regulatory update on bioequivalence, interchangeability and substitution for biosimilars 15:10 Strategies for process development/manufacturing • Provider perspectives and acceptance of biosimilars of biosimilars (for global markets) • The biosimilar CMC section - what does it look like? • Payer perspectives and formulary acceptance • Where (if anywhere) can time be saved when developing a biosimilar • Examining the viability of biosimilars & ROI considerations production process? James Harris • Derivation of cell lines and materials CEO Healthcare Economics LLC • The importance of analytics and comparability protocols • Early mistakes can be expensive - what to be aware of 10:50 Commercializing biosimilars: Will they really be able Dr. Roger Lias to compete? President • Size and location of markets Eden Biodesign • Manufacturing and distribution challenges • Interchangability and substitution issues 15:50 Afternoon refreshments • Branding and pricing concerns • Market penetration and physician uptake 16:10 Presentation to be announced Clifford S. Mintz Senior Representative Founder Parexel BioInsights 16:50 Acceptance criteria for immunogenicity of 11:30 Morning refreshments Biosimilars • Assessing the risk of strategies of immunogenicity 11:50 Demystifying the market aspects/implications of • Evaluating the potential of immunogenetic response follow on biologics • Market positioning and attractiveness 17:30 Closing remarks from the chair • Strategies • Commercial operations R.T. (Terry) Hisey Vice Chairman and U.S. Life Sciences Leader Deloitte LLP 17:35 Networking drinks Take your discussions further and build new relationships in a relaxed and informal setting. 12:30 Presentation to be announced Dr. David L. Gollaher President and Chief Executive Officer California Healthcare Institute (CHI) Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2009
  5. 5. Day 2 6th Annual Biosimilars Conference Thursday 4th March 2010, Boston, USA 09:30 Registration and refreshments 12:30 Trends and technical challenges for the development of biosimilars in China • Understanding the current competitive landscaping of China’s biosimilars market 10:00 Opening address from the chair • Addressing the critical issues and gaps of China’s biologics R&D and manufacturing capabilities 10:10 Role of USP standards in the quality assessment of • Discussing the trends and opportunities of the biosimilars/biobetters in China biological medicines Yining Zhao • Role of the official compendial and standard-setting process Associate Research Fellow, Strategy Management Group Pfizer • Value of public standards and monographs James Leung • Quality assessment of biological medicines Founder • Analytical challenges and future developments James Leung Consulting Tina S. Morris Vice President, Biologics and Biotechnology 13:10 Networking lunch United States Pharmacopeial Convention 14:30 Pharmacovigilance and risk management plans • Evaluating key challenges 10:50 An overview on regulatory and scientific issues of biosimiars and follow-on biologics • Thorough risk-benefit analysis • Updates on regulatory and, scientific issues related to biosimilars and • Need for a robust pharmacovigilance plan follow-on biologics • Discussions on technical challenges for the approval of biosimilars/follow- 15:10 Biosimilars - Succeeding in the market of the future on biologics • From dream to reality • Requirements of CMC, pre-clinical and clinical studies using examples of • The global biosimilars market today approved products in both US and Europe • Lessons learned so far Dr. Duu-Gong Wu Executive Director, Consulting Division • Evolving business models PharmaNet • Delivering against the promise? Mateja Urlep 11:30 Morning refreshments Founder, Tikhe Pharma Former Global Head of Marketing and Medical, Sandoz 11:50 Legislative and regulatory developments impacting 15:50 Afternoon refreshments the biologics and biosimilars marketplace • Update on progress of biosimilars legislation through the U.S. House 16:10 Clinical Phase 1 PK/PD trials for and Senate biosimilar/follow-on products • Analysis of the provisions of the competing U.S. bills • The clinical comparability exercise • Comparison of the proposed biosimilars legislation to small molecule • PK/PD studies for early efficacy and safety assessment regulation under Hatch-Waxman • Study design challenges with some particular specific biosimilars • Views of affected constituencies (biopharma companies, generics companies, health care providers, patients) Dr. Fethi Trabelsi Director, Scientific & Regulatory Affairs • Comparison of the proposed US regulatory scheme to those in other Anapharm parts of the world (especially Europe and Japan) Brian J. Del Buono 16:50 Chair’s closing remarks Director Sterne, Kessler, Goldstein & Fox 17:00 End of Conference * Invited
  6. 6. Registration Form 6th Annual Biosimilars Conference 2nd – 4th March 2010, Boston, USA For multiple bookings Photocopy this form Conf. code VG Standard Prices 6th Annual Biosimilars Conference Conference and workshop Fee: £1699 Conference only Fee: £1299 2nd - 4th March 2010 Workshop only Fee: £599 Boston, USA Promotional Literature Distribution Distribution of your company’s promotional literature to all conference attendees Fee: £999 Details How to book Forename: Surname: Email: conferences@visiongainglobal.com Web: http://www.visiongain.com/biosimilarsusa Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100 Main Switchboard Number: Fax: +44(0) 20 7549 9932 Visiongain Ltd Address: BSG House 226-236 City Road London EC1V 2QY UK Country: Postcode: General information Venue: TBA Phone: Fax: Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may Email: be requested if payment has not been received in full before the event. Visiongain Ltd reserves the right to charge interest on unpaid invoices. Signature: Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, email or web. There is a no refund policy for cancellations received on I confirm that I have read and agree to the terms and conditions of booking 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 Methods of payment 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 Payment must be made in sterling organisation and are not transferable between countries. By Mail: Complete and return your signed registration form together with your cheque payable Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK excluding substitutions/name changes, requested by the customer. This will be charged to the customer by credit card prior to the changes being made. By Fax: Complete and fax your signed registration form with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive to +44 (0) 20 7549 9932 briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or expenses, which may be incurred by the customer as a consequence of the event being postponed or By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses. By Bank Transfer: Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Visiongain Ltd A/C: visiongain Ltd Protection Act 1988. Your personal information contained in this form may be used to update you on Barclays Bank Sort Code: 20-71-64 visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We may also share your data with external companies offering complementary products or services. If you Piccadilly Branch Account No: 6038 7118 wish for your details to be amended, suppressed or not passed on to any external third party, please 48 Regent Street Swift Code: BARC GB22 send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. London, W1B 5RA IBAN: GB80 BARC 20716460387118 Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from Please debit my credit card: visiongain Ltd during the transitional period, whilst the changes are coming into effect. Access MasterCard Visa American Express Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain). Card number: VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. Expiry Date: How we will contact you: Visiongain Ltd’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. Security number (last 3 digits on back of credit card): Unable to attend Obviously nothing compares to being there but you need not miss out. Simply tick the box and send Signature: with your payment. You will receive your copy of the event CD Rom two weeks after the event. Yes, please send me a copy of the CD for Price£550 VAT:£82.50 Total:£632.50 Cardholder’s name: Office use only News updates Please tick if you do not want to receive email news updates in the future www.visiongain.com/biosimilarsusa