Researched & Organized by eyeforpharma9 Big Pharma speakers reveal their strategies and top tips Pharma Market Access Canada Two Day Conference November 10–11, 2009 Radisson Admiral, Toronto, Ontario SPEAKER FACULTY: Brian O’Rourke Vice President CDR Barbara Ouellet Executive Director PMPRB SAVE CDN $300 book before 18th September Add Value for Stakeholders to Achieve Effective Drug Approval // // // Better CDR Engagement Best Practice Pricing & Reimbursement Case Studies Federal & Provincial Government Communication Daaron Dohler President and General Manager Takeda Canada, Inc Doug Grant Vice President Corporate Affairs Bayer Experts Will Discuss: // // The Impact Of PMPRB On Pharma In 2010 Effective Internal Market Access Management Krista Scaldwell Vice President Market Access BMS Lesia Babiak Director, Federal Policy Janssen-Ortho Real Case Studies from 6 VPs eyeforpharma always deliver cutting-edge, concise conferences on a global scale, I am proud to be associated with them and see them as a key player in delivering up-to-date intelligence to the industry. Len Starnes, Head Of Digital Marketing & Sales, Bayer Schering For the latest information visit www.eyeforpharma.com/MACanada Global Sponsor Gold Sponsor Supporting Sponsor Dear Colleague... After many months speaking to senior-level pharma industry executives in Canada, the biggest challenge we’re facing right now is how to bring a drug to market effectively and efficiently in this challenging environment. This is your invitation to attend an innovative summit that will address the most pressing issues unique to the Canadian pharma industry. This meeting will address the key challenges you face including payor, patient and KOL engagement, relationship building, pricing & reimbursement strategy, CDR plans, pricing & drug safety and internal access management. Hear from experts on the changing governmental and provincial landscape and learn how to get the most out of your relationship on a federal level. We will bring together pharma industry thoughtleaders from Bayer, Abbott, BMS, Takeda, J&J and teamed them up with CDR, PMPRB and Cancer Care Ontario as well as many other key stakeholders to provide you with a platform for learning, debate and networking. You will leave the summit with a case-study driven road map for success in Canadian market access landscape – guaranteed. I look forward to meeting you and your colleagues in Toronto. Best regards, World Class Speakers at a Glance Brian O’Rourke Vice President, CDR Normand Laberge Barbara Ouellet Daaron Dohler Doug Grant Vice President, Rx&D Executive Director, PMPRB President & General Manager, Takeda Canada, Inc Vice President, Bayer Anna Braeken Lesia Babiak Head General Medicine, Bayer Director Federal Affairs & Health Policy, Johnson & Johnson Krista Scaldwell Martin Mason David Shum Vice President, BMS Partner, Gowlings Legal Director Reimbursement & Health Economics, Roche Scott Gavura Director Provincial Drug Reimbursement Programs, Cancer Care Ontario Claudia Neuber Gerogre Wyatt Senior Pricing Manager, AstraZeneca Managing Director, Wyatt Health Jon Gwillim VP North America eyeforpharma PS. Sign up early and save CDN $300! Ed Schoonveld Neelima Firth Principal, Market Access & Pricing Practice Lead, ZS Associates Director, The Aequitas Group Supported by Follow me on LinkedIn www.linkedin.com/in/JonathanGwillim Group Search: Market Access for Canadian Pharma PM THE FULL SPECTRUM OF PRODUCT MANAGEMENT 36O Day 1 / Conference Agenda November 10, 2009 Session A: Federal Government Access Dynamics Where do we stand? The Canadian Healthcare market in a global context // Hear a descriptive and comparative analysis of the Canadian market from an IP, Pricing and reimbursement aspect and how this impacts on your geographic strategy. // Establish where the future funding and control lies, with the PMPRB or Provincial authorities? // Develop best-practice in listing negotiations and understand how transparency and value can lead to greater success in pricing. Normand Laberge Vice-President, Rx&D Explore novel approaches in a new marketplace Session B: Provincial Government Approval & Relationships A Policy Update from the Common Drug Review (CDR) Strategies you need to implement to get the best probability of national coverage for your drug // Establish where the future funding and control will lie: PMPRB or Provincial authority and what this will mean for the price of your drug. // Discover strategies which dictate the provincial thinking when discussing your reimbursement. // Develop best-practice methods in listing negotiations and how value can lead to success in pricing. // Learn how a flexible global culture can be applied and implemented for local success. // Hear an expert view of how a new start up in Canada can maximize success in a rapidly changing environment. // Best practice examples of how to adapt in today’s marketplace. Daaron Dohler President, Takeda Inc // An update on the CDR process, timelines and activity you need to know for effective drug approval. // New initiatives introduced by the CDR. // Understand how you can solidify your submission to the CDR. // Future trends in the reimbursement environment you need to be aware of. Doug Grant, Vice President, Corporate Affairs, Bayer // How to work effectively with your biggest customers: governments. // Stakeholder and government advocacy to support your regulatory, reimbursement and policy objectives. // Examples of how to implement an effective product life-cycle strategy in the evolving regulatory environment. Government Relations Strategies: critical success factors for resolving regulatory, reimbursement and health policy challenges Brian O’Rourke Vice President, Common Drug Review (CDR) CDR: What you need to know to succeed in the Canadian Healthcare Technology environment. // Submissions to the CDR: What they need to see to give you the ‘Yes’. // How you can effectively manage your mainstream and biologics submissions to develop a consistent and credible plan which will enhance long-term relationships with the CDR. // How you can overcome the challenges and meet the gold standard. New ways in creating value through the measurement of real world drug safety and effectiveness (RWDSE) Bill Dempster Director, Health & Pharma, Global Public Affairs WORKSHOP Lesia Babiak Vice-Chair, Federal Policy, Johnson & Johnson Preparing for a negotiated agreement: ensuring a profitable outcome Adam Siskind Associate Principal. ZS Associates // Payers have always said that they will pay for drugs that are effective in the real world, but how do you prove effectiveness in the real world? // What perspectives and elements do you need to consider when measuring real world drug safety and effectiveness? // Learn a practical approach to measuring effectiveness that will validate desired outcomes and give payers the confidence they need to reimburse your drug. George Wyatt Managing Director, Wyatt Health. PA N E L D I S C U SS I O N TO REGISTER 4 EASY WAYS CALL FAX EMAIL +1 866 996 1235 +1 800 814 3460
[email protected] Strategies to succeed in a competitive market for public reimbursement ONLINE www.eyeforpharma.com/MACanada Day 2 / Conference Agenda November 11, 2009 Session C: Public Drug Plan Approval & Government Relationships Use systemic treatment data to improve outcomes for patients Session D: Market Access with Commercial Divisions Strategies you need to know in the product launch phase Session E: Pricing & Reimbursement - Key Strategies For Effective P&R Negotiations The Changing PMPRB landscape and the impact of the new Excessive Pricing Guidelines // What are the main changes to the PMPRB’s 1994 Excessive Pricing Guidelines? // What are the implications of the new Guidelines? // What can be expected in the future and what measures should be taken. // An update on the New Drug Funding Program, with highlights of treatment patterns and program forecasts. // A description of CCO’s data analysis and reporting framework for systemic treatment data. // Why you should incorporate this framework to help you align best practice with public reimbursement. Scott Gavura Director, Provincial Drug Reimbursement Programs // When should you start and who should you speak to? How to ensure your marketing is aligning the messages agreed upon in Market Access negotiations. // One goal - one strategy - one message: Best practice in setting up your launch team to effectively optimize market access knowledge. // Learn the importance of how feedback from the field force can produce an effective internal cycle of information to further improve approval processes. Barbara Ouellet Executive Director, Patented Medicine Prices Review Board The Provincial Challenge: Examine real challenges and opportunities when getting your drug approved in the provinces and learn the crucial do’s and don’ts when in negotiations // The methods you need to know when presenting drug safety, costeffectiveness and pricing agreements between each province and what the major barriers are that you will face. // Discover what priority the provinces give for approval and what added value you need to show to win them over. // Establish a clear plan that ensures you continue to improve on dialogue and relationships to develop a win-win situation in the provinces. Anna Braeken Head of General Medicine, Bayer Measuring the long-term impact of pricing regulations What should marketers know about payers, market access and risk sharing? // Overview of global payer environment and latest trends. // How should market access impact the marketing process and clinical research? // How do you craft a value story that is compelling to payers? // What exactly is risk sharing and who is actually sharing? // Discover how to manage PMPRB scrutiny whilst developing competitive prices in the market. // Identify what market forces are proving major barriers in sustaining long-term pricing i.e Generics, Public Opinion, how you can manage these to lower the impact on your drug. // Understand what the new excessive price guidelines released this summer will mean for your products. Martin Mason Partner, Gowlings Legal Ed Schoonveld Principal, Market Access & Pricing Practice Lead, ZS Associates Krista Scaldwell VP Market Access, Bristol Myers Squibb Canadian pharmaceutical pricing – where do we go from here? How you should plan and implement negotiated agreements for drugs in today’s market // Analyze the current negotiated agreement environment and impacts on stakeholders. // Are negotiated agreements a fad or trend? // Looking forward: is the future for negotiated agreements sustainable? Expanded access using Named Patient Programs: Named Patient Programs to speed pre-launch market access David Shum Director Reimbursement, Health Economics Roche PA N E L D I S C U SS I O N Private payers in the Canadian Market. What are the future challenges and opportunities. // Learn the role of Named Patient Programs and expanded access programs, what they are and why they exist. // Understand the Special Access Program of Health Canada from a pharma perspective including legal, regulatory and compliance requirements. // Review best in class recommendations and internal resource requirements to effectively manage and execute named patient programs. // New PMPRB Guidelines – examine the day to day impact on Canadian pricing practice. // How does Canada fare in the global context of competitive pricing? // Looking ahead – is there a formula for success? Claudia Neuber Senior Pricing Manager, AstraZeneca PA N E L D I S C U SS I O N Reality in 2010 and beyond Neelima Firth Director, The Aequitas Group // Understand the emerging role of the pharmacists as KOLs in the Market Access environments. // How can innovatives move away from ‘me-too’ drugs to show incremental value from the current formulary drug. // Establish new ways in creating clear and transparent safety of your drug. Senior Level Pharma Speakers TBC Visit www.eyeforpharma.com/macanada for more information Three Simple Steps to Register Now! Or visit www.eyeforpharma.com/macanada to register instantly FOR PHARMA & BIOTECH COMPANIES EARLY BIRD PRICE STANDARD PRICE (Save CDN $300 - Register by September 18th, 2009) Gold Pass 2 Day Conference Pass, Full event recording, Workshops, Roundtables, Lunch, Access to pre-event and post event networking. CDN $1699 CDN $1999 Silver Pass 2 Day Conference Pass, Workshops, Roundtables, Lunch, Access to pre-event and post event networking. CDN $1499 EARLY BIRD PRICE CDN $1799 FOR SOLUTION PROVIDERS & CONSULTANTS (Save CDN $300 - Register by September 18th, 2009) STANDARD PRICE Gold Pass 2 Day Conference Pass, Full event recording, Workshops, Roundtables, Lunch, Access to pre-event and post event networking. CDN $1799 CDN $2099 Silver Pass 2 Day Conference Pass, Workshops, Roundtables, Lunch, Access to pre-event and post event networking. CDN $1599 CDN $1899 NGOs And Regulatory Bodies Pass 2 Day Conference Pass, Full event recording, Access to all workshops, Access to all roundtables, Lunch, Access to pre-event and post event networking. CDN $699 Full event recording Mr/Mrs/Ms/Dr: Company: Telephone: Email: Address: I enclose a check/draft for: (Payable to First Conferences Ltd) CDN $400 Last name: Position/Title: Fax: First name: Postcode: Credit card number: Expiry date: Name on card: Country: Security number: Please invoice my company: Purchase Order Number: Please charge my credit card: Amex Visa Mastercard Signature: FAX THIS FORM BACK TO +1 800 814 3460 TERMS & CONDITIONS Places are transferable without any charge. Cancellations before October 9, 2009 incur an administrative charge of 25%. If you cancel your registration after October 9, 2009 we will be obliged to charge the full fee. Please note – you must notify eyeforpharma in writing of a cancellation, or we will be obliged to charge the full fee. The organisers reserve the right to make changes to the programme without notice. All prices displayed are exclusive of VAT unless otherwise stated but, VAT will be charged, where applicable, at the prevailing rate on the invoice date and the relevant details will appear on the invoice. NB: FULL PAYMENT MUST BE RECEIVED BEFORE THE EVENT Researched & Organized by eyeforpharma 9 Big Pharma speakers reveal their strategies and top tips Pharma Market Access Canada Add Value for Stakeholders to Achieve Effective Drug Approval Two Day Conference November 10–11, 2009 Radisson Admiral, Toronto, Ontario Who Should Attend? The event will attract VPs, heads, directors and managers of: // Market Access // Pricing & Reimbursement // Health Economics // Federal Policy // CDR Policy // Provincial Policy // Regulatory Affairs // Commercial Management eyeforpharma events never fail to deliver. Ian Talmage, VP Global Marketing, Bayer Healthcare 4 EASY WAYS TO REGISTER CALL FAX EMAIL +1 866 996 1235 +1 800 814 3460
[email protected] ONLINE www.eyeforpharma.com/MACanada Visit www.eyeforpharma.com/MACanada Reasons to Attend // // // // 8 Presentations From VPs 18 Senior Level Speakers 12+ Hours Worth of Networking The Premier Meeting Place for Pharma & Regulators in Canada Join eyefoprharma’s Market Access Canada LinkedIn group to be kept updated and to open up your network to the key players in the space. Search for ‘Market Access Canada’ in the Group directory.