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 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 , 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 • Reference pricing considerations to support success • Potential parallel trade implications • Value-based pricing V. Apply Learning to Launch Design and Strategy • When is premium pricing justified? • Examine implications for product pricing • Case study examples case III. Value-Based Contracting studies • Identifying outcomes-based contract measures * population-based vs. individual-based 12:00 Close of Workshop B and Luncheon * chronic disease management There will be a 30-minute networking and refreshment break at 10:00 a.m. * produce the evidence necessary • Payer provider incentives and their effect on Workshop Leaders: value-based contract performance Heath A. Nivens, MBA, Associate Director, Market Access & * impact across stakeholders Reimbursement Services, Eisai • Variation in health system environment and David E. Banko, CPA, Director, Health Economics, value-based contracting Reimbursement and Strategic Pricing, * utilizing PCMH and ACO incentives as drivers Cordis Corporation, a Johnson & Johnson Company • Avoiding unintended consequences Todd Berner, Health Outcomes and Pharmacoeconomics * aligning incentives Research & Development, Endo Pharmaceuticals

visit www.cbinet.com/launch To Register or Call Toll Free 800-817-8601 (339-298-2100 outside the U.S.) M ain con f erence Day One — Thursday, July 19, 2012 * niche indications * pricing and reimbursement challenges 1:00 Co-Chairs’ Welcome and Opening Remarks • Explore different enterprise strategies and commercial Ryan Saadi, M.D., M.P.H., World Wide Vice President, Health models that can affect product launch success and ROI Economics, Reimbursement, Strategic Pricing & Market Access, * lessons from recent global launches Cordis Corporation, a Johnson & Johnson Company * creative solutions to common problems Sam Rasty, Vice President, New Products, Shire HGT * the new marketing mix to reach patients, physicians and payers 1:10 Balance Strategy and Risk — Achieving Approval * GM mentality — balancing focus on revenues and Optimizing Access in the Current Regulatory with cost efficiency and flexibility and Reimbursement Environment Rick Modi, Senior Director of Marketing, MedImmune In this panel discussion, leaders discuss what proactive 3:10 Networking and Refreshment Break p steps a company can take to lower the risk of not gaining regulatory approval and raise the likelihood that a 3:40 Product Lifecycle Management — a product will be reimbursed. Topics discussed include: Marketing and Sales Approaches for • How are changes in healthcare delivery integrated into Mid- to Late-Stage Assets your business plan? • Explore strategies to maintain share and market in n * how are companies engaging with payers in the U.S.? generics-dominated markets • What regulatory changes are impacting approval for • Understand considerations for sales and marketing e devices, biologics and drugs today? of established brands * how should these impact product-level strategy? l * new formulations and indications * how do you make good assessments of how robust * strategic brand management your filing is? * messaging to consumers, HCPs and • How might a Special Protocol Assessment (SPA) case managed markets lower the risk of regulatory rejection? study • Examine line extensions that meet patient and • How does a Corporate Integrity Agreement (CIA) physician needs impact decisions and strategy? Evan Lippman, Executive Director and Commercial Brand Lead — • What are best practices for approaching compliance CRESTOR, AstraZeneca with the Sunshine Act? Moderator: Sam Rasty, Vice President, New Products, Shire HGT 4:15 Explore the Payer Landscape and Factors Panelists: Scott Megaffin, Senior Vice President, Commercial Development, Impacting Reimbursement and Patient Access Onconova Therapeutics • Discuss top influencers on payer decision-making and Gary Ellexson, Vice President Corporate Accounts, how companies reach patient populations Supernus Pharmaceuticals * hear perspective on what product data is truly of Jacob Drapkin, Vice President, Reimbursement and Healthcare value to payer organizations Economics, Ethicon Endo-Surgery, Inc. * examine how payers prefer to receive communications from industry 2:00 Understand Global Trends Impacting • Explore views on management of specialty pharmacy Commercialization Strategy and * what’s driving decisions around specialty? Their Influence on Tactical Business Planning * what may the specialty reimbursement environment • Macro-view of global shifts in economics and look like in 3-5 years? emerging markets Mona M. Chitre, Pharm.D., CGP, Director, Clinical Services, * explore new markets and sub-markets Strategy and Policy, FLRx Pharmacy Management, * corporate pressures resulting from these shifts Excellus BlueCross BlueShield • Key takeaways to inform your tactical Nick Calla, Vice President Industry Relations, business planning Community Specialty Pharmacy Network Bill Barre, Vice President, Business Development, MedImpact * uncover data to support rationale and tactics for entering new markets 5:05 Innovative Approaches to Channel Management Sanjeev Ganatra, Product Marketing Director, and Reimbursement as an Integrated Solution ISTA Pharmaceuticals • Understand how program consolidation may improve messaging and result in cost consolidation 2:35 Enterprise Strategies and Commercial Models to • Explore drivers that influence patients to get on Maximize Product Launches in the New Era medicines and stay on medicines • Recognize the increasing complexity of the * hear examples of successful tactics environment in which manufacturers are (e.g., use of well-designed patient enrollment forms) launching new products • Understand how different channel management * small molecules and biologics by the options can be beneficial for unique brands same organization David Hileman, R.Ph., Senior Vice President — Specialty Care Group, * biomarkers and personalized healthcare Omnicare * digital technology advances (e.g., social media, electronic medical records) 5:40 Close of Day One 5:40-6:40 Networking, Wine and Cheese 9:55 Launch and Growth of an Orphan Product — Reception Hosted by: Finding Needles in a Haystack to Avoid “Maturity” and Ensure Commercial Success and Access • Hear about the staggered global product launch for a rare genetic disorder Day Two — Friday, July 20, 2012 * European introduction and subsequent U.S. launch 7:30 Continental Breakfast * challenges to finding patients and access to care in orphan drug markets 8:00 Co-Chairs’ Review of Day One case • Understand changes in strategy that kept the patient Ryan Saadi, M.D., M.P.H., World Wide Vice President, Health study Economics, Reimbursement, Strategic Pricing & Market Access, pool expanding well into traditional product “maturity” Cordis Corporation, a Johnson & Johnson Company * key lessons and unique resources developed to Sam Rasty, Vice President, New Products, Shire HGT support product growth

8:10 Succeeding in a Changed Medical Device World — * physician and patient education Addressing New Customers, Processes and John King, Senior Product Director, Fabrazyme, Genzyme Evidence Needs • Explore the emergence of a re-aligned customer base 10:30 Networking and Refreshment Break (i.e., payers, hospital decision-makers and physicians) and the role of payers as primary gatekeepers of market access • Understand new decision-making (e.g., hospital access world shared content committees) and reimbursement processes • Examine clinical and economic value metrics Access World brings together content, community and connections from being used for decision-making by payers and three industry-leading events for one powerful experience. For the next two hospital committees sessions, delegates from the 5th Annual Congress on Access Programs for * generate data to meet value metrics Investigational and Pre-Launch Drugs come together with the delegation • Hear about a proposed framework for addressing new of CBI’s 3rd Annual Product Launch and Market Access Congress. customer needs and establishing the full product value The content presented has been carefully designed to benefit both groups. proposition from early pre-launch to post-launch • Analyze the role of health economic teams in market access success of medical devices 11:00 Identify Clinical, Medical and Commercial Ryan Saadi, M.D., M.P.H., World Wide Vice President, Health Opportunities in the Early Stages of Economics, Reimbursement, Strategic Pricing & Market Access, Product Development Cordis Corporation, a Johnson & Johnson Company • Understand how one company approaches challenges 8:45 New Product Planning — Preparations for in early commercialization of a novel product Bringing a Product or Indication to Market * defining the target patient population, indications • Establish market development and preparation plans and commercial forecasts * consider product type and community in * managing global requests for access prior to decision-making approval and launch • Strategies for introducing and launching a new formulation of a known compound or new indications * balancing launch resources of a current product • Hear approaches on how to suitably weight Jorge Lorenzo, Senior Director New Product Commercialization, different types of data (e.g., preclinical, safety) Noven Pharmaceuticals when determining the product path for development 9:20 Achieving Launch Excellence through Superior • Turn challenges into opportunities to build in Cross-Functional Collaboration product differentiation In this case study, discover how a world-class Jose Ricardo Perez, Oncology Senior Director, Clinical Research pharmaceutical company used an innovative web-based Physician, Novartis Pharmaceuticals Corporation platform to share information, stay connected and synchronize their work to produce the breakthrough 11:35 Optimize Resource Allocation — Effectively results necessary for a successful launch across multiple Balance Product Launch Preparation with countries. The challenges addressed were: • Visibility of project status — How does the team Pre-Approval Access Program Management gain clear insight into the status of issues, risks, • Consider launch priorities and determine milestones and key decision documents for important the appropriate resources for access launch activities? program management • Cross-functional collaboration — How to enable • Explore the costs and benefits associated with an access case global and distributed cross-function teams to work program when evaluating commercial expectations study together and have real-time visibility of information • Execution efficiency — How does the launch team • Determine a plan to transition participants to a ultimately transform the launch strategy into commercially-available product tangible outcomes? Jeff Oliva, Senior Vice President, Global Business Development, Idis Janaki J. Joshi, CEO, Iris Interactive 12:10 Luncheon who should attend 1:20 Pricing Strategy — Understand Key Inputs to Determine Price and the Impact on a You will benefit from attending this event if you are a senior-level Product’s Commercial Success executive at a bio/pharmaceutical or medical device company with • Understand the value of your product or technology responsibilities or involvement in the following areas: from your customers’ perspective * what does “value” mean? • Commercialization/Commercial Operations • Examine key information inputs including • Brand Management payer feedback • Product Management • Develop a value proposition to support your pricing • Reimbursement * why does it matter? • New Product Planning Jacob Drapkin, Vice President, Reimbursement and Healthcare Economics, • Managed Markets Ethicon Endo-Surgery, Inc. • Market Access Ryan Saadi, M.D., M.P.H., World Wide Vice President, • Strategic Accounts Health Economics, Reimbursement, Strategic Pricing & Market Access, • National Accounts Cordis Corporation, a Johnson & Johnson Company • Medical Affairs 1:55 Launch Execution — Integrated Launch Planning • Strategic Pricing Across Global Affiliates • Sales • Standardize processes to ensure critical tasks are • HEOR identified and completed to support launch • Optimize your global team This conference will also benefit consultants, technology vendors * define clear roles and responsibilities for and companies providing services to the above audience. multiple functions around the globe • Establish efficient communication and problem-solving processes * identify clear communication triggers • Explore practical applications and how to overcome hurdles to integration Marisa Fienup, Program Director, Baxter Bioscience

2:30 Leverage Integrated Commercial Analytics to Ensure a Successful Ultra Orphan Product Launch • Develop a systematic approach to assess market awareness changes Access World convenes attendees * evaluate pre-launch baseline and from CBI’s annual Congresses on launch effectiveness Product Launch and Market Access, • Right-size the sales force Rare Disease and Access Programs * utilize primary market research and for Investigational and Pre-Launch secondary data to target desired physicians Drugs. This unique format provides case * develop disease and market appropriate metrics an opportunity for cross-functional study • Plan early-on lifecycle management collaboration and networking * find the winning indication(s) surrounding market and patient access. * assess development efforts and commercial value of indication(s) Participants of each Congress benefit Jian Xi, Director Commercial Analytics and Decision Support, from shared networking breaks, ViroPharma luncheons and cocktail receptions, as well as tailored content. 3:05 Close of Conference

w w w . c b i n e t . c o m / l a u n c h Last Year’s Congress United Senior-Level why this conference Executives Responsible for All Facets of is important to you Product Launch and Market Access Healthcare reform, increased 4% pressure to align product price with 11% value and the abundance of generic and biosimilar competition are % 39 driving shifts in market access and 14% commercialization strategies by bio/pharmaceutical and medical 32% device companies. Successful executives are determining the best ways to bring a new product or a marketing/Branding/Commercialization — 39% new indication for an existing product Reimbursement/Managed Markets/HEOR — 32% to market, ensuring both product business Development — 14% viability and uptake during every step Product Development/Operations — 11% of development through launch in light of overarching trends. legal/Compliance — 4%

conference sponsors

CBI Inc.’s corporate supporters represent select companies that share a common mission: business advancement through thought leadership, strategic interaction and innovation. The companies 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 services available. We applaud these companies, as well as others that wish to join the conference, as important members of this event’s delegation.

about our lead sponsor

Campbell Alliance is the Consulting business segment of inVentiv Health, a leading global provider of best-in-class clinical, commercial and consulting services to companies seeking to accelerate performance. Campbell Alliance is the leading management consulting firm specializing in the pharmaceutical and biotechnology industry. The firm’s clients include all of the world’s top-20 pharmaceutical companies, as well as numerous emerging and midsize firms. Campbell Alliance is organized into practice areas, each specializing in a critical industry function: Brand Management, Business Development, Clinical Development, Pricing and Market Access, Medical Affairs and Sales. From its locations in Raleigh, NC, Parsippany, NJ, , San Francisco, Chicago, , Philadelphia, , and Zug, Switzerland, the firm serves clients throughout North America, Europe and Japan. For more information on Campbell Alliance, please visit http://www.campbellalliance.com.

a great place to meet your market

Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact Taylor Biggers at 339-298-2108 or email [email protected]. 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 Market Access July 19-20, 2012 • Loews Hotel • Philadelphia, PA

CBI 600 Unicorn Park Drive Woburn, MA 01801 3 Ways to Register SCAN HERE WEBSITE www.cbinet.com/launch

E-Mail [email protected]

Phone 800-817-8601 339-298-2100 outside the U.S.

CBI’s 3rd Annual Product Launch and Market Access Congress PC12121

Registration Fee: venue: Advantage Pricing (2-Day Congress) by 5/11/12: ...... $1,895 Loews Hotel Standard Pricing (2-Day Congress): ...... $2,295 1200 Market Street • Philadelphia, PA 19107 Phone reservations: (888) 575-6397 Advantage Package Pricing (3-Day Access World) by 5/11/12: ...... $2,395 Hotel direct line: (215) 627-1200 Package Pricing (3-Day Access World): ...... $2,795

Register by May 11, 2012 and SAVE $300. Fee includes continental breakfast, lunch, accommodations: wine and cheese reception, refreshments and conference documentation. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) To receive CBI’s special discounted hotel rate online or by phone, please go to: PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate. • Online: www.cbinet.com/launch • Phone reservations: (888) 575-6397 and mention CBI’s Product Launch Team discount: Cut-off date is July 6, 2012. Reservations made after the cut-off date or after group room block has been filled (whichever comes first) will be accepted on a space and rate availability basis. Your organization may send 1 executive free for every 3 delegates registered. All registrations must be Rooms are limited so please book early. All travel arrangements are subject to availability. made at the same time to qualify. satisfaction guaranteed: The Next Best Thing to Being There: CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, Order the Online Compendium if you would like to capture what you’ve missed at the conference. It couldn’t a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-8601 be easier. The link to the online compendium is available for only $298 and includes the conference agenda, presentations and speakers biographies. Next day access is delivered through email on past conferences or for further information. Advanced preparation for CBI conferences is not required. two weeks post-conference on future events. Call 800-817-8601 to order a compendium now. substitution and cancellation: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $295 administrative charge. No refunds will be made after this date; however, the registration fee less the $295 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, 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. In the event of a speaker cancellation, every effort to find a suitable replacement will be made without notice. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI. Graphic by Getty Images www . cbinet . com / launc h