CBI's 3rd Biosimilars and FOB Summit

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CBI's 3rd Biosimilars and FOB Summit

  1. 1. Register by July 17, 2009 and Receive $400 Off of Your Registration Fee! C B I ’ s 3 r d S u m m i t o n Biosimilars and CLE Credits Available Pending Approval Follow-On Biologics Providing Timely and Relevant Insight on Political, Safety, Regulatory and Strategic Implications of Pending Legislation September 14-15, 2009 • Gaylord National • National Harbor, MD Conference Legisl ative and R egul atory Addresses Co-Chairs: The Pathway for the Biosimilars Act Juliana Reed, Kay Holcombe, Senior Health Policy Advisor, Genzyme Corporation Vice President Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc. Government Affairs, Hospira, Inc. Promoting Innovation and Access to Life-Saving Medicines Act Gil Bashe, Ann M. Witt, Health Counsel, Office of Henry Waxman, U.S. House of Representatives Executive Vice President, Makovsky + Company Analyze Patient Safety Concerns and Biologic/Biosimilar Comparability Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Additional Office of Biotechnology Products, CDER, U.S. Food and Drug Administration Faculty from: Assess Antitrust Concerns and the Competitive Impact of Biosimilars BIO Suzanne Drennon, Counsel for Intellectual Property, Bureau of Competition, GlaxoSmithKline Federal Trade Commission Glenmark Generics Hogan & Hartson LLP Featur ed Sessions Hospira, Inc. HPS Group LLC Healthcare Policy and Payment Perspective — MedImmune Reimbursement Payment System and Benefit Design Implications NORD James Langley, Vice President Reimbursement, Accredo Health Group NPS Pharmaceuticals Analyze the Commercial and Pfizer Inc Economic Implications of Biosimilars Legislation Sandoz sanofi-aventis Biotech Market Analysis – Vinson & Elkins LLP Mark Schoenebaum, M.D., Biotechnology Analyst, Deutsche Bank Wyeth Biosimilars Market Analysis – R.T. (Terry) Hisey, Vice Chairman and U.S. Life Sciences Leader, Deloitte LLP Organized By: Visit Us Outstanding on the Web at Support www.cbinet.com Provided by:
  2. 2. Dear Colleague, For the last three years it has been said that this is the year that an approval pathway for biosimilars will be created. With two competing bills in the House and one before the Senate, combined with the Obama administration allocating budget funding, this year that prediction might actually be right. What great news this is for the slowing pharma industry as biologics continue to outperform the global pharma market with premium prices and specialty therapies that cannot be treated with conventional drugs. Biosimilar market entry carries high hopes for those willing to take the risk, and it is becoming clear that many are. For several years now, the bio/pharmaceutical industries have been debating the policy of this pathway, along with many other political and government organizations. For much of this time, the data on which these arguments were founded was dubious at best, but since the U.S. has found itself trailing other countries in creating this pathway, more data is becoming available in terms of costs, pricing and market effects. So although the actual market effects of an approval pathway for biosimilars in the U.S. will never truly be known until they’ve happened, as an industry, we have enough collective information now on which to base our individual company decisions and start taking our next steps – no matter if a company’s steps are to enter the biosimilars market or to protect their innovative biologic from a lower priced alternative. Because the fact is, an approval pathway is going to be created. And whether it occurs sooner or later, don’t you think you should be ready? All of these considerations were in play in developing CBI’s 3rd Summit on Biosimilars and Follow-On Biologics, taking place September 14-15, 2009 at the Gaylord National, National Harbor, MD. Through our esteemed and diverse faculty, this meeting gathers the collective information from many facets of industry to share with the delegates over two days of keynote presentations, panel discussions and case studies. Key policy makers, regulators, analysts, healthcare organizations and bio/pharma companies are on hand to share their timely, relevant and practical insights so that delegates can best advise their companies on next steps – and more importantly, start taking them. As conference Co-Chairperson, I invite you to join us in September for this critical juncture in the evolution of healthcare and the bio/pharma industry. I will be sharing the stage with an impressive group of representatives from the Office of Henry Waxman, FDA, FTC, BIO, MedImmune, Pfizer, Sandoz, GSK, NORD, Deloitte, Deutsche Bank, Genzyme, Genentech, Accredo Health and many more. I look forward to meeting you this September! Sincerely, Juliana Reed Juliana Reed Vice President, Government Affairs Hospira, Inc. P.S. Don’t miss Accredo Health’s presentation on understanding the reimbursement and benefit implications for biosimilars – it provides perspective from PBMs, CMS and Commercial Insurers!
  3. 3. • Understand how and why this bill differs from the MaIN CONFereNCe 2007 Waxman bill (H.R. 1038) • Discuss key components to the legislation and their Day One — Monday, September 14, 2009 intended outcomes 8:00 Main Conference Registration and Ann M. Witt, Health Counsel, Office of Henry Waxman, Continental Breakfast U.S. House of Representatives 9:00 Co-Chairs’ Opening Remarks 10:45 Networking and Juliana Reed, Vice President Government Affairs, Hospira, Inc. Refreshment Break Hosted by: Ms. Reed has overall responsibility for the Government Relations function which includes the oversight of global government relations and public policy initiatives for the corporation. As the first U.S. based company to launch a biosimilar product in Europe, Retacrit® (epoetin zeta), Hospira — the world POLIC Y Pa NeL leader in generic injectables — has the scientific expertise and manufacturing 11:15 Explore the Political Principles, Expectations and capabilities to bring biogenerics to market in the United States. Ms. Reed Implications of Pending Biosimilars Legislation has also held positions in health policy and reimbursement, both at Hospira and Baxter Healthcare. In addition, Ms. Reed has extensive experience The 2009 versions of biosimilars legislation are currently in U.S. healthcare, where she has worked as a hospital administrator and being debated among many parties with vested interests. clinician. Ms. Reed holds a BS degree from Marquette University and While almost everyone can agree that it is time for a a Master’s Degree from DePaul University. She is a licensed Physical regulatory pathway to approve biosimilars or biogenerics, Therapist and Nursing Home Administrator in the State of Illinois. there is not yet a consensus of how to achieve this. Gil Bashe, Executive Vice President, Makovsky + Company This, coupled with the enormity of potential implications As executive vice president at Makovsky + Co., Mr. Bashe is counselor to resulting from this pathway, has industry keeping a close pharmaceutical, biotechnology, medical-device manufacturers and patient- eye on biosimilars policy. This panel discusses the pending advocacy groups. He has advised clients on follow-on-biologic (FOB) policies legislation, the principles in which they are based, the and reimbursement, first in Europe and now in the United States. Through force behind enactment on the Hill and expectations for the years, Mr. Bashe has left his mark on health-product access. At the implementation. The potential implications of pending onset of the CMS Part D program, he helped change a Medicare drug benefit – ensuring continued reimbursement for a leading heart-disease medication. legislation are also explored. Mr. Bashe was CEO of CommonHealth, a WPP Group company, having • What is the public positioning of pending legislation? served as vice-chairman for strategic planning. At sister-company Hill and • What timelines for enactment and implementation Knowlton, he was worldwide Health Practice director overseeing policy, are most likely? provider and product communications. In the frontlines of ensuring patients retain access to care; Mr. Bashe served as paratrooper commander and • What are the potential implications for industry? combat medic. He is an American Heart Association (AHA) New York * patient safety past chair, and AHA regional affiliate board member. Mr. Bashe is co- * FDA’s resources editor of Branding Health Services: Defining Yourself in the Marketplace * healthcare and a member of the American Pharmacists Association, National Lipid Association and the Society for Nuclear Medicine. * ability to manufacture biotech drugs * ability to manufacture biosimilars Policy Update and analysis Moderator: Steven Grossman, President, HPS Group LLC Panelists: Ann M. Witt, Health Counsel, Office of Henry Waxman, U.S. House of Representatives L eGISL at I v e a DDr eSSeS Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc. 9:15 Pathway for the Biosimilars Act Elizabeth Seifert, Director Public Policy, GlaxoSmithKline On March 17, 2009, Representatives Anna G. Eshoo, Inslee and Barton introduced a bill that would create an Kent Jancarik, Director Federal Policy, Pfizer Inc abbreviated pathway for the FDA to approve biosimilars. Diane Edquist Dorman, Vice President, Public Policy, Eshoo’s bill differs significantly than the Waxman bill on National Organization for Rare Disorders (NORD) several issues such as naming, clinical trials and exclusivity. This address discusses Eshoo’s proposed legislation and the 12:15 Luncheon intended outcomes of its provisions. • Compare the 2009 bill to the 2008 version evaluate the regulatory Challenges • Discuss key provisions of the bill, what they are and and expectations for Biosimilars what they mean for industry Kay Holcombe, Senior Health Policy Advisor, Genzyme Corporation Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc. 1:30 Analyze Patient Safety Concerns and Biologic/Biosimilar Comparability 10:00 Promoting Innovation and Access to Life-Saving Medicines Act The foundation of the biosimilars debate is focused on patient safety — whether biosimilars can achieve acceptable On March 11, 2009, House Energy and Commerce levels of safety, including immunogenicity, and what level Chairman Henry Waxman and Representatives Pallone, Deal and Emerson introduced their version of bill that would of clinical data is needed to ensure an acceptable risk. give the FDA the authority to approve generic versions of This address evaluates the factors of biologic comparability FDa and provides an assessment of available data in relation to biotech drugs. This address discusses this bill and how it address differs from Waxman’s bill that was introduced to the 2007 patient safety. Congress, as well as key points that set it apart from other • Explore the criteria used to evaluate comparability pending legislation. of biologics
  4. 4. “the conference gave me a good view of what important issues should be investigated for impact on my company.” — Previous Attendee, Eric A. Utt, Ph.D., Specialty Market Access, Pfizer Inc • Assess available data supporting and opposing review antitrust Provisions predictions on safety and immunogenicity and Lessons Learned from Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, Hatch-Waxman U.S. Food and Drug Administration Dr. Shacter received her Ph.D. in Biochemistry from Johns Hopkins University in 1982, carried out basic research on cell regulation and cancer 4:00 Assess Antitrust Concerns and the Competitive at the National Institutes of Health for twelve years, and then joined the Impact of Biosimilars FDA in 1994. Dr. Shacter oversees the review of INDs and BLAs for The unintended competition and antitrust issues that novel therapeutic proteins covering a wide range of clinical indications, stemmed from Hatch-Waxman are a source of concern including cancer, hematopoiesis, tissue repair, hemostasis, inflammatory diseases and bioterrorism. Dr. Shacter is engaged in establishing CDER among industry and government when considering the policy regarding product manufacture and characterization and performs structure of an abbreviated approval pathway for biosimilars. inspections of biotechnology manufacturing facilities. Dr. Shacter speaks The desire to avoid pharma Hatch-Waxman-like issues in frequently at national and international meetings on a wide range of the biotech market prompted the FTC to take a proactive topics related to the development and licensure of therapeutic proteins. role in evaluating and shaping this impact by encouraging She is an Agency expert on scientific issues associated with evaluation of stakeholders to consider unintended consequences before follow-on biologics. Dr. Shacter also runs an active laboratory research hand. This address discusses these potential unintended FtC program to support the scientific review of therapeutic proteins. Her address anticompetitive consequences and how they are addresses laboratory research focuses on studying the cytotoxic mechanisms of cancer chemotherapy drugs and understanding how elements of the immune in pending legislation, as well as the antitrust provisions and system, such as oxidants and activated phagocytes, influence killing and what they could mean for industry. clearance of dying cells. Her research expertise in the area of protein • Methods of patent disputes and resolution oxidation is applied regularly to the review of protein therapeutics. • Settlements and reverse payments • Authorized generics r eGUL atOrY Pa NeL • Exclusivity 2:15 Regulatory Mechanisms, Considerations and • Forfeiture and other “parking” mechanisms Implications of Biosimilar Policy Suzanne Drennon, Counsel for Intellectual Property, The proposed regulatory pathways for the approval of Bureau of Competition, Federal Trade Commission biosimilars greatly vary on the mechanisms by which Ms. Drennon focuses on antitrust and intellectual property policy and approval takes place. The mechanisms, in addition to being enforcement. Prior to joining the FTC, Ms. Drennon was an antitrust and heavily debated, also bring up many questions and concerns about our regulatory system in general, like whether or not intellectual property litigator in Los Angeles. She received her A.B. in we are equipped to handle this change in our current state mathematics from Bryn Mawr College and her J.D. from the University of and what is the potential fall out of legislation. This panel Minnesota Law School where she was Managing Editor of the Minnesota discusses these issues in-depth from multiple perspectives. Law Review. • What should the clinical data requirements be for immunogenicity? 4:45 Close of Day One • What should the clinical data requirements be for interchangeability? • How descriptive or flexible will the legislation be? • How much authority will the FDA have to make decisions? 4:45-5:45 Networking, • How would the regulatory mechanisms for a pathway be established? Wine & Cheese Reception * universal model or class systems? Join colleagues and friends in a relaxed setting. • What should the naming requirements be for biosimilars? photo by: Photolink / Getty Images • What are the potential regulatory implications for biologics currently on the market? Day Two — Tuesday, September 15, 2009 Moderator: Steven Grossman, President, HPS Group LLC Panelists: Ross Lobell, Senior Director — Regulatory Affairs, MedImmune 7:30 Continental Breakfast Brian E. Harvey, M.D., Ph.D., Vice President, Regulatory Policy, sanofi-aventis 8:00 Co-Chairs’ Review of Day One Philip Katz, Partner, Hogan & Hartson LLP Juliana Reed, Vice President Government Affairs, Hospira, Inc. 3:30 Networking and Refreshment Break Gil Bashe, Executive Vice President, Makovsky + Company
  5. 5. to register Call toll Free 800-817-8601 (339-298-2100 outside the U.S.) or Fax 781-939-2490. register on our website at www.cbinet.com Identify the Commercial, economic and 10:30 Networking and Str ategic Implications of Biosimilars Refreshment Break Hosted by: Analyze the Biotech and Biosimilars Markets Understand the reimbursement and The commercial and economic implications of biosimilars Benefit Implications for Biosimilars legislation are largely debated by industry, but remain fundamental to the business decisions of both biotech and biosimilar 11:00 Healthcare Policy and Payment Perspective — manufacturers and their key stakeholders. The following sessions Reimbursement Payment System and provide an in-depth analysis of biotech and biosimilars markets Benefit Design Implications with top economic, commercial, risk and strategic considerations. This session evaluates likely government and commercial insurer payment/reimbursement policy strategies for 8:15 Biotech Market Analysis biosimilars. The discussion focuses on three key areas • Understand the top biotech therapeutic areas and including, 1) The PBM perspective — How will PBM’s view patient population demographics biosimilars and what drug utilization management models • Evaluate the EU system and experience to date might they consider? What are the major concerns/issues • Analyze biotech pricing performance and impacting these models? 2) The Government Payor Policy market share — Key issues around CMS payment policy, both based on • Assess the commercial impact of biosimilars legislation current systems/tools and potential emerging legislative • Forecast the long term effects of an abbreviated implications; and 3) Commercial Insurers — Potential pathway on the risk-sensitive biotech industry strategies to be utilized by commercial insurers including benefit category and payment systems considerations. Mark Schoenebaum, M.D., Biotechnology Analyst, Deutsche Bank • Review/discuss the major Reimbursement System categories impacting biosimilar adoption 9:00 Biosimilars Market Analysis • Evaluate the conflicting perspectives driving the • Review key factors affecting biosimilar market different major reimbursing entities — PBM’s, creation and entry Government Payors and Commercial Insurers and • Examine lessons learned from the EU discuss current and likely tools they may use • Discuss key considerations that will impact • Linking likely Payment System strategies with key biosimilar adoption clinical/patient safety considerations • Identify the commercial opportunities for biosimilars James Langley, Vice President, Reimbursement, Accredo Health Group R.T. (Terry) Hisey, Vice Chairman and U.S. Life Sciences Leader, Deloitte LLP examine Patent Dispute Mechanisms, 9:45 Biosimilars versus Biobetters — IP Issues and Litigation Concerns A Side-By-Side Strategic Analysis Since the actual cost savings for biosimilars is still unknown, 11:45 Analyze the Methods of Patent Dispute and some of industry has been looking at a different “follow-on” Resolution in Pending Legislation biologic opportunity in biobetters. Biobetters are considered The methods of patent dispute and resolution in pending biologics that are similar to the original product but better biosimilars legislation differ substantially from those in some way i.e. less side effects, reduced dosing schedule, set forth in Hatch-Waxman and are a key component better delivery system, higher absorption rate, multiple of the biosimilars debate. This session analyzes the Case indications, etc. Biobetters may be considered traditional methods outlined in pending legislation to provide a better analyses “Fast Follower” therapeutics where the strategy is to launch understanding of what the mechanisms are and how they into established categories with a “best-in-class” brand impact patent dispute strategies, while incorporating lessons profile. The evolving regulatory landscape will determine learned from Hatch-Waxman and what they tell us for if Biobetters will face greater scrutiny or benefit from a biologic patent disputes. streamlined development program. This session compares the opportunities and challenges to consider when deciding • Methods for filing disputes biosimilars or biobetters. • Timelines for notification and response — • Traditional Biobetters — Recent case studies Potential areas to delay or speed up litigation • Capture market share through price or • Which comes first — Approval or litigation? therapeutic benefits? • Are there penalties involved? • Are improvements in delivery sufficient to • Will settlements and authorized generics be allowed accelerate adoption ? or encouraged? • Is a novel indication a requirement for regulatory Sean Ryder, Director of Intellectual Property, Glenmark Generics and commercial success? David Fox, Partner, Hogan & Hartson LLP Robert Ward, Vice President, Corporate Development, NPS Pharmaceuticals 12:30 Luncheon
  6. 6. 1:45 Current and Future IP Challenges for Biogenerics Players — A Global Perspective Here are Just a Few of the Organizations As the U.S. finds itself trailing other countries in creating a that have Benefitted from pathway to approve biogenerics, a global (and strategic) approach to patent issues is warranted. In this session, we knock down attending CBI’s Previous Summits the domestic “silo” approach to biogenerics patent issues as we on Biosimilars and Follow-On Biologics: consider the following issues from a global perspective: • The differences between pharma and biopharma AARP * Abbott Diabetes Care Inc * Abbott Laboratories * Accredo Health Group patent landscapes Inc * Allergan * American Ent Institute for Public Policy Research * American • Strategic implications of the patent landscape differences Pharmacists Association * AmerisourceBergen Specialty Group * Amgen • Current and future patent challenges for global Amylin Pharmaceuticals Inc * ASCP * Axinn Veltrop & Harkrider LLP * Ballard biogenerics players Spahr Andrews & Ingersoll LLP * Barr Pharmaceuticals Inc * Baxter Health • “Patently obvious” lessons learned from biogeneric Care * Bayer Healthcare LLC * Bexton Dickinson * Bi Pharma GmbH & Co KG launches to date BIO * Biogen Idec * Biolex Therapeutics Inc * BioMarin Pharmaceuticals Naomi Pearce, IP Director & Counsel Lawyer & Patent Attorney, Hospira, Inc. Biotechnology Industry Organization * Biotechnology Information Institute Boehringer Ingelheim GmbH * Brigham & Woman Hospital * Brinks Hofer Gilson 2:30 A Change in the Patent Litigation Dynamic — & Lione * Bristol-Myers Squibb Co * Centocor * Congressman Waymans Office Will “Big Pharma” Become “Big Generic?” DataMonitor * DDN * DDN Obergfel LLC * Department of Business & Econ De Traditionally (with some exceptions), patent litigation under Duane Morris LLP * Eisai * Eli Lilly & Co * EMD Serono Inc * Engel & Hatch-Waxman has been thought of as a dispute between P a “big pharma” and “small generic” company, but early Novitt LLP * Enzon * Express Scripts Inc * Federal Trade Commission Finston Consulting * Foley Hoag LLP * Food & Drug Administration a observations of the biosimilars big pharma companies have different picture. A number of market is painting a much Forest Laboratories * Genentech Inc * Genzyme * Gibraltar Associates llc GlaxoSmithKline * Glycofi Inc * GlycoFi Merck and Co Inc * Health Results N already shown interest in entering the follow-on market and Group * Healthpoint * Hoffmann-La Roche Inc * HPS Group LLC * Hyman more are popping up all the time. So what does “big generic” Phelps & McNamara PC * ImClone Systems Inc * Insmed Corp * Johnson & e pharma mean to “small biotech” companies in the court room? How will this change in dynamic affect the biologics industry? Johnson * Kardiatech Inc * Loyola University Medical Center * Makovsky & Co L The pharma industry? Only time will tell, but this panel of McDermott Will & Emery LLP * MedImmune Inc * Merck & Co Inc * Momenta experts attempts to shed light on the future of patent litigation. Mylan Pharmaceuticals Inc * National Economic Research Associates Inc • Analyze the Hatch-Waxman IP and patent landscape NERA Economic Consulting * Novartis * Novo Nordisk Pharmaceuticals • Evaluate how the size of a company and litigation Nucleonics Inc * Pfizer * Pharmaceutical Executive Magazine * Pharmaceutical resources impacts litigation Strategic Initiatives * Pink Sheet * Plasma Protein Therapeutics • Understand the role of risk assessment in patent Association Procer & Gamble * Questcor Pharmaceuticals * sanofi -aventis disputes and how this may differ from a change in Shire Human Genetic Therapies Inc * Taro Pharmaceuticals USA Inc the dynamic Technology Catalysts International * Teva Neuroscience * Teva Pharma AG • Consider how biosimilars legislation could change the Teva Pharmaceuticals Europe BV * The Henry L Stimson Center patent litigation dynamic across industry Thomas Jefferson University * Thomson Reuters * Vinson & Elkins LLP Moderator: Constance S. Huttner, Partner, Vinson & Elkins LLP VirSci Corp * Watson Pharmaceuticals Inc * West Pharmaceutical Services Panelists: Naomi Pearce, IP Director & Counsel Lawyer & Patent Attorney, Widener University * Zuckerman Spaeder LLP * Zymo Genetics Corp Hospira, Inc. Hans Sauer, Ph.D., Associate General Counsel, BIO Mark Bowditch, Patent Attorney, Sandoz Geoffrey Levitt, Vice President, Chief Regulatory Counsel, Wyeth 3:30 Close of Conference Previous attendee representation In recognition of Our Sponsors: CBI Research, Inc’s corporate sponsors represent select companies that share a common mission: business advancement through thought leadership, strategic interaction and innovation. The companies represented below are proud contributors on this program and have carefully selected messaging, branding or positioning statements to encourage the evaluation and investigation of quality products and/or 33% 22% Regulatory services available. We applaud these companies as well as others that wish to join the Attorney/Counsel conference, as important members of this event’s delegation. 12 % 22% Policy 11 Government Affairs % Patents If you are interested in sponsorship or exhibit opportunities, please call Alexa Moore at 339-298-2107, fax 781-939-2694 or email alexa.moore@cbinet.com
  7. 7. Register by July 17, 2009 and Receive $400 Off of Your Registration Fee! C B I ’ s 3 r d S u m m i t o n — Top Reasons to Attend — Biosimilars and • Key policy updates from the Office of Henry Waxman, U.S. House of Representatives, Genzyme, NORD, Follow-On Biologics Genentech, GlaxoSmithKline and Pfizer • Biotech and biosimilar market analyses by Deutsche Bank and Deloitte LLP Providing Timely and Relevant Insight on Political, Safety, • Healthcare policy and payment perspective by Accredo Health Group Regulatory and Strategic Implications of Pending Legislation • Patient safety concerns addressed by the U.S. Food and Drug Administration September 14-15, 2009 • Antitrust and competition insights by the Gaylord National • National Harbor, MD Federal Trade Commission CD-rom Compendiums CBI Research, Inc. PRSRT STD 600 Unicorn Park Drive • Woburn, MA 01801 U.S. Postage If you are unable to attend the conference or you would like extra copies for your colleagues, PAID you can order your conference CD-Rom today. Gallery Don’t miss out on the valuable information presented by industry leaders exclusively at this event. The CD-Rom is available for only $198 and includes the conference agenda, presentations and speaker biographies. Simply fill out the order form 853209 and the CD-Rom will be shipped to you photo by: Keith Brofsky / Getty Images 2 weeks after the conference occurs. • Registration Fee: Standard Advantage Pricing 2-Day Conference $2095 $1,695 Advantage Pricing — Register by July 17, 2009 and SAVE $400. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and CD-Rom Compendium. Please make checks (in U.S. funds drawn on a U.S. bank) registration Card DO NOT REMOVE MAILING LABEL. PLEASE RETURN ENTIRE FORM. PC09070 payable to CBI Research, Inc. (No personal checks accepted.) Advantage Pricing may not be combined with other discount offers, special category rates or promotions. Yes! Please register me for CBI’s 3rd Summit on Biosimilars and Follow-On Biologics Discounts only apply to standard rates. • Team Discount: I am registering for ADVANTAGE PRICING Your organization may send 1 executive free for every 3 delegates registered. All registrations must be made at the same time to qualify. We would like to take advantage of the TEAM DISCOUNT (see left for details). • Discount Accommodations & Travel: I cannot attend. Please send me a Conference CD-Rom Compendium. Contact CBI’s official travel service Travel Concepts for all of your travel needs. Register 3 In order to receive CBI’s special discounted hotel rate, you must call Do you have any special needs? ________________________________________________ Get 1 FREE Travel Concepts at 800-640-8082 (508-879-8600 outside the U.S.) or email reservations@travelconcept.com by September 1, 2009. Travel Concepts KEY CODE (appears above mailing address): ___________________________________ can also negotiate low group airfares and car rentals. Mention that you are attending CBI’s 3rd Summit on Biosimilars and Follow-On Biologics to qualify for hotel and 1. NAME POSITION travel discounts. All travel arrangements subject to availability. 2. NAME POSITION • Venue: Gaylord National CAll TRAVEl COnCEPTS 3. NAME POSITION 201 Waterfront Street TOdAy AT 800-640-8082 National Harbor, MD 20745 4. NAME POSITION Negotiated rates only available through Travel Concepts free COMPANY DIVISION • Substitution & Cancellation: Your registration may be transferred to a member of your organization up to ADDRESS 24 hours in advance of the conference. Cancellations received in writing on or before September 1, 2009 will be refunded, less a $195 administrative charge. No refunds CITY STATE/COUNTRY ZIP/POSTAL CODE will be made after this date; however, the registration fee less the $195 administrative TELEPHONE FAx E-MAIL charge can be credited to another CBI conference if you register within 30 days from the date of this conference. In case of conference cancellation, AUTHORIZED SIGNATURE CBI’s liability is limited to refund of the conference registration fee only. CBI reserves the right to alter this program without prior notice. Please Note: Speakers and agenda are subject to change without notice. Payment Options: Payment in full is required to process registration. Please call with any payment questions. In the event of a speaker cancellation, every effort to find a suitable replacement will Enclosed is a check for payment in full (No personal checks accepted) Please be made. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or The Center for Business Intelligence. MC/Visa: photocopy this form for additional • Satisfaction Guaranteed: Amex: delegates. CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable NAME (AS APPEARS ON CARD) ExP. DATE CBI conference of your choice. Please contact 800-817-8601 for further information. CARDHOLDER SIGNATURE Advanced preparation for CBI conferences is not required. WeBSiTe Phone fAX e-MAil MAil 5 Easy Ways www.cbinet.com 800-817-8601 781-939-2490 cbireg@cbinet.com Registration Dept. 339-298-2100 Please include all information CBI Research, Inc. to REgistER outside the U.S. requested on registration card. 600 Unicorn Park Drive Woburn, MA 01801

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