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Product Launch Market Access July 19-20, 2012 • Loews Hotel • Philadelphia, PA

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Product Launch Market Access July 19-20, 2012 • Loews Hotel • Philadelphia, PA R e g i s t e r b y m a y 1 1 , 2 0 1 2 a n d R e c e i v e $ 3 0 0 o f f o f Y o u r Registration F e e ! CBI’s 3rd annual bio/Pharmaceutical and medical Device Product Launch Graphic by Getty Images Market access July 19-20, 2012 • loews Hotel • PHiladelphia, Pa Conference Co-Chairs: Ahead-of-the-Curve Strategies to Successfully Launch Ryan Saadi, M.D., World Wide New Products or Indications: Vice President, Health Economics, • understand how a Special Protocol assessment (SPa) may lower the Reimbursement, Strategic Pricing & risk of regulatory rejection Market Access, Cordis Corporation, a Johnson & Johnson Company • hear how AstraZeneca approaches lifecycle management for mid- to late-stage assets Sam Rasty, Vice President, • Discuss top influencers on payer decision making and specialty New Products, pharmacy management with Excellus Blue Cross Blue Shield, Shire HGT Community Specialty Pharmacy Network and MedImpact • integrate launch planning across global affiliates 15+ Industry Experts Share Best Practices • analyze key inputs to determine price and the impact on a product’s commercial success and Case Studies from Companies Including: • hear how Novartis weighs different types of data when determining the product development path astraZeneca novartis Pharmaceuticals corporation • understand how ViroPharma integrated commercial analytics to right-size their sales force and ensure a successful ultra-orphan product launch iSTA Pharmaceuticals ethicon endo-Surgery, inc. PLUS! Genzyme choose between Two Interactive Workshops: onconova therapeutics A: Product Commercialization Simulation eisai ViroPharma B: Effective Reimbursement Planning and Integration into Product Pricing and Launch Design endo Pharmaceuticals medimmune Content. Community. Connections. noven Pharmaceuticals 3 Industry-Leading Events. baxter bioscience One Powerful Experience. Supernus Pharmaceuticals Lead Media Partner: Additional Media Partners: Supporting Sponsor: www.cbinet.com/launch Meet Your CONference Leaders Choose from Two IN-Conference Workshops — Thursday, July 19, 2012 Ryan Saadi, M.D., M.P.H., World Wide Vice President, 7:30 Conference Registration and Continental Breakfast • 8:30 Workshop Leaders’ Welcome and Opening Remarks Health Economics, Reimbursement, Strategic Pricing & Market Access, Cordis Corporation, a Johnson & Johnson Company A: Product Commercialization Simulation — Optimize Strategies from Candidate Selection through Launch Dr. Saadi’s role reflects over seventeen years spent in leadership positions in hospital administration, managed care Workshop Objective: and the pharmaceutical, biotechnology and medical device industries. At Cordis Corporation, his responsibilities include Engage in a simulated commercialization environment and establishing pricing to reflect product value, assessing business compete in teams to develop a hypothetical asset and move it opportunities and, above all, developing reimbursement through various stages of clinical and commercial development. strategies and programs to ensure successful market access. He is also currently a voting member of Medicare Evidence Test your decision-making throughout product development Development & Coverage Advisory Committee (MEDCAC), and understand how it impacts a brand’s success long-term. which reports to the Secretary of the Department of Explore best practices for commercial planning, gain a realistic Health and Human Services and provides technical advice view of the requirements at each stage of product development and to assist the Centers for Medicare & Medicaid Services recognize how decisions affect long-term brand performance. in determining reasonable and necessary uses of medical services and technologies. Previously, he was Vice President of Global Health Outcomes and Strategic Pricing at Genzyme Key Questions to Be Addressed: Corporation. As part of his position at Genzyme, as well as previous pharmaceutical companies, e.g. Sanofi-Aventis and • How do decisions made early in a product’s development impact Knoll Pharmaceuticals, Dr. Saadi was closely involved in commercialization efforts and the overall success of a product global research-based activities, including study design. Prior to joining the pharmaceutical industry, Dr. Saadi worked throughout its lifecycle? for managed care organizations including Aetna, Prudential • What should your scope of investment in market development Healthcare, Americhoice and Multiplan Inc. He was involved look like? in the process of formulary decision-making, development of • What resources are required at various milestones? disease management programs and the supervision of plan accreditation. His vision regarding how the industry needs to adapt to the current evidence-based, value-focused market is articulated in his upcoming book, The Science of Commerce: Succeeding in the Changed Healthcare Market. B: Effective Global Reimbursement Planning and Integration into Product Pricing and Launch Design Sam Rasty, Workshop Objective: Vice President, New Products, Reimbursement is a critical factor to drive product access and Shire HGT uptake. This workshop, led from bio/pharmaceutical and medical device viewpoints, explores approaches to assessing the reimbursement environment in different geographies of Mr. Rasty leads a team that drives new product planning and strategy, while working closely with R&D and Business interest prior to product launch. Understand key players and Development to champion new product investment trends influencing coverage decisions globally and how to utilize recommendations to management. His prior experiences reimbursement data to inform early launch planning and decisions have encompassed a range of commercial, licensing and R&D around pricing strategy. leadership roles in multiple therapeutic areas and technology platforms, spanning from start-up biotech to global large- Key Questions to Be Addressed: pharma. Prior to joining Shire HGT, Mr. Rasty was Director of Corporate Development at Endo Pharmaceuticals where • At what point in the commercialization process should you invest his responsibilities included strategic identification of product/ franchise growth strategies across multiple therapeutic areas resources to determine the likely rate of reimbursement across all and sourcing, evaluation and due-diligence of several in- geographies of interest? license and M&A opportunities, leading both scientific and • How is information utilized to shape pricing and launch strategy commercial assessments in the process. Previously, he was for different markets? Director of Portfolio Management, Global Commercial • What is the impact of this information on global rollout? Strategy, at GlaxoSmithKline. In this highly matrixed global role, he led the effort to collaborate with heads of R&D • How detailed do you need to be and how early? and the commercial organization on product development strategies, commercial analysis, in-licensing and portfolio Workshop Outline: management, covering GSK’s diverse portfolio of Discovery and Development assets in multiple therapeutic areas including I. Understand the Global Reimbursement Environment oncology, cardiovascular/metabolic, infectious diseases, • Key players at home and abroad musculoskeletal, inflammation, gastrointestinal and urology. • What may the ex-U.S. environment look like in three years? His experiences prior to GSK have included strategy consulting and venture capital work in healthcare, business development/ licensing roles in biotech and management of R&D teams. VISIT WWW.CBINET.COM/launch TO REGISTER OR CALL TOLL fREE 800-817-8601 (339-298-2100 OUTSIDE ThE U.S.) Choose from Two IN-Conference Workshops — Thursday, July 19, 2012 7:30 Conference Registration and Continental Breakfast • 8:30 Workshop Leaders’ Welcome and Opening Remarks A: Product Commercialization Simulation — Optimize Strategies from Candidate Selection through Launch Workshop Outline: III. Understand Downstream Commercial Implications of Early Decisions I. Team Role Play — Commercialize a Development Asset from Candidate Selection through Launch in a • Identify common pitfalls encountered Simulated Environment • Recognize long-term impacts on • Choose the asset that fits best with your brand performance defined organization (e.g., small biotech, mid-size or large pharma) • Summarize best practices • Target the asset’s patient population(s) 12:00 Close of Workshop A and Luncheon • Select your clinical development path • Determine the right scope and deployment of market There will be a 30-minute networking and refreshment break at 10:00 a.m. development spending II. Assess Requirements for Commercial Workshop Leaders: Success at Important Milestones • Identify what key cross-functional Tom Luginbill, Regional General Manager, deliverables must be completed Campbell Alliance • Define roles and responsibilities Yesim Ilkin, Service Line Manager, • Characterize resource requirements Campbell Alliance B: Effective Global Reimbursement Planning and Integration into Product Pricing and Launch Design • Navigating single-payer reimbursement systems versus IV. Determine the Right Time in the Commercialization the U.S. multi-payer system Process to Dedicate Resources to Country-Specific * understand current trends impacting coverage Reimbursement Planning decisions in the EU • How do you account for the rapid pace of change? • Project planning — What to do and when to do it? II. Evaluate Appropriate Price Points Globally • Resource planning — Lining up field-based resources
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