6th RISK EVALUATION AND MITIGATION STRATEGIES SUMMIT

6th RISK EVALUATION AND MITIGATION STRATEGIES SUMMIT Best Practices for Working Successfully with all Key Stakeholders to Assess Effectiveness and Modify REMS to Reduce the Burden JANUARY 28 29, 2014 WESTIN ALEXANDRIA ALEXANDRIA, VA Key Areas to be Addressed: STANDARDIZATION Lindsey R. Kelley Assistant Director of Pharmacy, Ambulatory Care Services University of Michigan EVALUATION Emily Freeman Director, Epidemiology, Health Behavior & Program Evaluation Pfizer Event Sponsor: BURDEN Gary Appio, PharmD, MBA, Head, US Safety Risk Management, Novartis MODIFICATION Michael Cheung Project Manager in Medical Affairs/ Risk Management Vivus Hot Topics Include: Get an update on the FDA s report regarding evaluation and standardization Address challenges and benefits in a single shared REMS and REMS that include CME Analyze methods to assess the effectiveness of risk mitigation tools Evaluate differences and similarities of RMP vs. REMS Learn about innovative tools and strategies in ehealth to improve REMS effectiveness Discuss meaningful metrics to measure the burden Understand what we can learn from other industries regarding risk minimization Balance REMS rules with CME Rules Hear how pharmacy organizations and hospitals are managing the risk Participate in roundtables to discuss your REMS challenges with peers Join Our Leading Industry Experts: Hisham Abu-Naba, Director of Healthcare Systems Engineering Program, LEHIGH UNIVERSITY Molly Billstein Leber PharmD, BCPS, Clinical Pharmacy Coordinator, YALE- NEW HAVEN HOSPITAL, INC. Madalina Chirieac, Medical Director, Safety and Benefit-Risk Management, BIOGEN IDEC Paul Coplan, Executive Director, Risk Management and Epidemiology, PURDUE PHARMA Milbhor D Silva, VP Product Safety and Pharmacovigilance, ASTELLAS Brian Malkin, Partner, FROMMER LAWRENCE & HAUG LLP Yola Moride PhD, FISPE, Professor, UNIVERSITÉ DE MONTRÉAL Pre-Conference Workshop: Best Practices for Regulatory Negotiation and Internal and External Audits Anthony Faragasso, Independent Consultant Andrea Stark, Manager QA, GlaxoSmithKline Enhance your skill set by registering for an All-Access Pass Rachel Sobel, Senior Director, Epidemiology, PFIZER Katie Stabi, Drug Information Pharmacist (REMS), CLEVELAND CLINIC Stephen Sun, MD, MP, Chief Medical Officer, PARAGONRX Barbara Troupin, Antitrust Partner, VIVUS Darren Tucker, Senior Director, Risk Management Center of Excellence, BINGHAM MCCUTCHEN LLP Mostafa Walli, Senior Director, Risk Management Center of Excellence, SANOFI Michael Wolf, Professor of Medicine and Learning Sciences, Associate Division Chief, NORTHWESTERN UNIVERSITY, FEINBERG SCHOOL OF MEDICINE To Register Call 866 207 6528 or visit www.exlpharma.com/rems This was an excellent meeting bridging academia, industry and government for seeking practical and effective solutions for improving timely risk communication. Michael Wolf, Professor of Medicine and Learning Sciences, Associate Division Chief, Northwestern University, Feinberg School of Medicine page 1

Dear Colleague, While significant advances have been made in developing and implementing appropriate REMS elements for specific drug products, much work needs to be done in furthering the state of science in two areas: 1. Designing REMS programs on the basis of objective data-led design decisions 2. Evaluating REMS programs in today s emerging US Healthcare setting The recent HHS OIG Evaluation Report, coupled with the OIG Semi-annual Report to Congress (March 2013), anchored the opportunity for open discussion, debate, and innovative ideas in this specialized field. Together, these reports indicate that FDA lacks comprehensive data to determine whether REMS improve drug safety. Consequently, this provides the basis for focused work in refining and enhancing the design of REMS programs, the adequacy and validity of conventional RM tools, the methodology in selecting fit-for-purpose REMS evaluation criteria a priori, and the rigor and robustness of REMS Program Evaluation. As a result of recent developments, we are faced with an opportunity and a choice to either: more proactively engage and partner with FDA in designing and evaluating such programs, or accept the status quo. At the 6th Risk Evaluation and Mitigation Strategies Summit the most experienced professionals from a cross section of small to large companies, pharmacy organizations, hospitals, academia and government agencies share their perspectives, experiences, and leverage the discussions from the FDA public meeting in July 2013. The conference provides a platform to take a proactive approach and discuss: Recent developments and initiatives Possible frameworks for standardization Tools for evaluation Best practices for modification Methods to measure the burden Lessons learned from various REMS programs Innovative approaches to improve REMS effectiveness What can be learned from other industries Challenges working in single shared REMS This summit presents a well-rounded perspective on the OIG s findings, global developments and the impact on the industry. In interactive workshops, panel discussions, case studies and presentations, our expert speaker faculty addresses major issues and provides methods to work more effectively with all key stakeholders. No matter if REMS veteran or absolute newbie, this conference offers valuable insights on recent developments, paired with the opportunity to network and share with peers what has worked and what has not. We look forward to seeing you in January at the 6th Risk Evaluation and Mitigation Strategies Summit! Kai Hahn Senior Conference Director ExL Pharma Milbhor D'Silva Chairman/VP Product Safety & Pharmacovigilance Astellas Who Should Attend This boot camp is designed for VP s, Department Heads, Directors and Managers of Medical Device, Pharma and Biotech companies whose responsibilities include: REMS Risk Management Pharmacovigilance/ Surveillance Epidemiology/ Pharmacoepidemiology Pharmacoeconomics Quality Assurance Drug/Product Safety Clinical Risk Management Lifecycle Management This conference is also of interest to: REMS/Drug Safety Service Providers Contract Research Organizations Data Management Services Technology Vendors Pharmaceutical Consultants Drug Safety & Risk Management Services Regulatory Affairs Clinical Affairs Clinical Data Management Clinical Operations Clinical Risk Management Compliance Medical Writers/ Communications Marketing Branding Health Care Regulators and Policy Makers Health Services Research and Academics Lifecycle Management Services Speaker Bureaus Venue The Westin Alexandria 400 Courthouse Square Alexandria, VA 22314 Direct Line: 703 253 8600 Reservations: 1 866 837 4210 If you require overnight accommodations, please contact The Westin Alexandria at 1 866 837 4210 to book your room. ExL Pharma has reserved a block of rooms at a discounted rate for conference participants. Please mention ExL s January Meetings to take advantage of the discount. You must book your room by January 6, 2014 to be eligible for the discounted rate. Please book your room early, as the rooms available at this rate are limited. ExL Events, Inc. is not affiliated with any third-party booking agencies, housing bureaus or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly e-mail us at info@exlevents.com Sponsorship & Exhibiting Opportunities Do you want to spread the word about your organization s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event, or distribute promotional items to attendees. ExL Pharma will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact: Jeffrey Friedman, Business Development Manager (917) 258 5140 jfriedman@exlpharma.com page 2

Day One Tuesday January 28, 2014 Pre-Conference Workshop 8:00 Registration Opens & Continental Breakfast for Workshop Participants 9:00 Pre-Conference Workshop Begins 12:00 Lunch for Workshop Participants *There will be a 30 minute networking break during this workshop Best Practices for Regulatory Negotiation and Internal and External Audits FDA Advisory Committee meeting preparation Understand the factors that might trigger an audit Outlining necessary steps to prepare for an audit The do s and don ts when going through an audit Lessons learned from recent audits Anthony Faragasso, Independent Consultant Andrea Stark, Manager QA, GLAXOSMITHKLINE Day One Tuesday January 28, 2014 Main Conference 12:30 Registration 1:00 Welcome and Opening Remarks by Chairperson Milbhor D'Silva, VP Product Safety and Pharmacovigilance, ASTELLAS 1:15 Understand the FDA Report and the Impact on the Industry Outlining of the FDA s findings since the public meeting in July 2013 Explore the implications and impact on the industry Outlook on developments in 2014 Assess changes to the existing regulations Understand the real lifecycle of a REMS and the different decision points for modification Trends in the conversation of the different regulatory bodies Brian Malkin, Partner, FROMMER LAWRENCE & HAUG LLP Yola Moride PhD FISP, Professor, UNIVERSITÉ DE MONTRÉAL 2:00 PANEL DISCUSSION Leverage the Possibilities of Standardization Understand the different aspects of standardization: Minimizing variance, improving quality and standardized approaches and tools Identify which aspects can be standardized Discuss ideas for a framework such as the implementation of tiers Develop a common language for tools and effectiveness evaluation (Pregnancy rules enrollment, certification) Developing a standard repository, where all REMS programs list their submission documents, as a type of clearing house Molly Billstein Leber PharmD, BCPS, Clinical Pharmacy Coordinator, YALE- NEW HAVEN HOSPITAL INC. Lindsey R. Kelley, Assistant Director of Pharmacy, Ambulatory Care Services, UNIVERSITY OF MICHIGAN HEALTH SYSTEM Mostafa Wali, Senior Director, Risk Management Center of Excellence, SANOFI 2:45 Making Sense of Risk Minimization Evaluation in the US and EU: Pfizer s Experience with REMS and RMMs Compare the US FDA and EMA perspectives on risk minimization evaluation Describing a large pharmaceutical company s experience Outlining challenges in designing, executing, and interpreting the results of REMS and RMM Evaluation programs Rachel Sobel, Senior Director, Epidemiology, PFIZER 3:30 Afternoon Networking and Refreshment Break 4:00 Outlining Risk Evaluation and Mitigation Strategies in a Health System Describe inpatient and outpatient challenges of REMS Give examples of how a health system manages REMS requirements Provide possible solutions to help health systems manage REMS requirements Katie Stabi, Drug Information Pharmacist (REMS), CLEVELAND CLINIC 4:45 PANEL DISCUSSION Address the Elephant in the Room: Developing Meaningful Metrics to Measure the Burden Identify what to measure and how to measure directly and indirectly Assessing burden in relation to effectiveness Defining a burden in different organizations How to set thresholds in accordance with the FDA Understand the responsibilities of all stakeholders Leverage shared decision making Katie Stabi, Drug Information Pharmacist (REMS), CLEVELAND CLINIC Gary Appio, PharmD, MBA, Head, US Safety Risk Management, NOVARTIS Barbara Troupin, VP Scientific Communication & Risk Management, VIVUS 5:30 End of Day One For More Information Call 866 207 6528 www.exlpharma.com/rems page 3

Day Two Wednesday January 29, 2014 Main Conference 8:00 Continental Breakfast 8:45 Chairperson's Recap of Day One Milbhor D'Silva, VP Product Safety and Pharmacovigilance, ASTELLAS 9:00 Antitrust Issues Raised by REMS Programs The elements of REMS programs raising antitrust concerns The FTC and FDA s positions on alleged REMS abuses The duty of branded pharmaceutical companies to assist generic Darren S. Tucker, Partner, BINGHAM MCCUTCHEN LLP Former advisor to FTC Commissioners J. Thomas Rosch and Joshua D. Wright 9:30 Address Challenges and Opportunities in a Single Shared REMS and REMS that Involve CME Review approaches for collaborative participation agreements Balance CME Rules with REMS rules Develop evaluation metrics for shared REMS and REMS involving CME Paul Coplan, Executive Director, Risk Management and Epidemiology, PURDUE PHARMA 10:15 The Evolution of Risk Management Implementation: Science, Systems, and Simplicity Assessing science-based methods for the design and evaluation of risk minimizations, including FMEA (Failure Mode and Effects Analysis), longterm outcome measurements and modeling Incorporating systems thinking in risk management by including public stakeholder input, discovery-to disposal responsibility, and corporate swimlane planning Analyzing the next phase of risk management and the art of simplistic design and implementation for better public health Highlighting observations from other industries and its potential applications to the pharmaceutical industry Stephen Sun, MD, MPH, Chief Medical Officer, PARAGON RX 10:45 Morning Networking and Refreshment Break 11:15 PANEL DISCUSSION Methods to Assess the Effectiveness of Risk Mitigation Tools Dealing with a lack of guidance Identify and evaluate the risks involved How to identify which tools to use Target tools toward the most severe risks Track identified risks Milbhor D Silva, VP Product Safety and Pharmacovigilance, ASTELLAS Yola Moride PhD FISP, Professor, UNIVERSITÉ DE MONTRÉAL 12:00 The Out of Industry Perspective: What Can Be Learned from other Industries with Regards to Risk Evaluation and Minimization Explore how successful risk management principles in other industries can be applied to the Life Science industry Outlining the benefits of checklists and hazard analysis critical control points Reinforcing the roles of stakeholders Defining industry-wide principles 1:45 Lessons learned from Biogen Idec Tysabri REMS Stakeholders Project The project was designed to collect TOUCH stakeholder data to aid in future modification/improvement of TOUCH and REMS Research objectives focused on: Gaining better understanding of the level of burden associated with REMS Assessing effectiveness of tools and various elements of REMS programs Assessing effectiveness of communication aspects of REMS programs Biogen s recommendations for REMS modifications triggered by the results of this project Madalina Chirieac, Medical Director, Safety and Benefit-Risk Management, BIOGEN IDEC 2:30 PANEL DISCUSSION Discussing Methods to Evaluate if the REMS is Achieving its Goals Innovative strategies to evaluate a REMS program Understand the evidence Identify what has worked and what didn t Lindsey R. Kelley, Assistant Director of Pharmacy, Ambulatory Care Services, UNIVERSITY OF MICHIGAN HEALTH SYSTEM Emily Freeman, Director Epidemiology, Health Behavior & Program Evaluation, PFIZER Paul Coplan, Executive Director, Risk Management and Epidemiology, PURDUE PHARMA 3:15 Afternoon Networking and Refreshment Break 3:45 Highlighting Innovative Tools and Strategies in ehealth to Improve REMS Effectiveness Evaluate the efficiency of Med guides, CMI, DHCP letters and emails as prime information source and educational tools Leverage gamification and elearning to ensure better results The shift towards digital: an outlook what the future will bring Michael Wolf, Professor of Medicine and Learning Sciences, Associate Division Chief, NORTHWESTERN UNIVERSITY, FEINBERG SCHOOL OF MEDICINE 4:30 Modifying a REMS to Expand Patient Access: The Qsymia Case Study Strategies used to build the REMS modification proposal Strategies used to optimize the REMS modification proposal presentation to FDA Meetings and negotiations with FDA Implementing the approved REMS modification Michael Cheung, Project Manager in Medical Affairs/Risk Management, VIVUS 5:15 ROUNDTABLE DISCUSSION Lessons Learned from Various REMS Programs In this interactive session you will get a chance to discuss your REMS program with peers and exchange views, find out what worked and what didn t work for others and learn how they have tackled various challenges. Please come prepared with one challenge you d like to discuss. 5:45 End of Summit and Closing Remarks Hisham Abu-Naba, Director of Healthcare Systems Engineering Program, LEHIGH UNIVERSITY 12:45 Networking Luncheon For More Information Call 866 207 6528 www.exlpharma.com/rems page 4

Registration Information 5 WAYS TO REGISTER Group Discount Programs Offers cannot be combined, early bird rates do not apply. To find out more on how you can take advantage of these group discounts, call 866 207 6528. Save 25% Per Person When Registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at one time). Save 15% Per Person When Registering Three Can only send three? You can still save 15% off of each registration. ExL Events, Inc. 494 8th Ave, Fourth Floor New York, NY 10001 www.exlpharma.com/rems MEDIA PARTNERS registration@exlpharma.com 866 207 6528 888 221 6750 I enjoyed meeting with the other speakers and exchanging ideas regarding REMS and drug safety. Sitting in on the workshops and presentations gave me a wonderful overview of new regulations in the US and the EU. This meeting allowed me to upgrade my knowledge for world wide regs. Anthony Faragasso, Independent Conusltant Registration Fees Early Bird Pricing Register by Friday, December 13, 2013 Conference & Workshop: $2095 Conference Only: $1795 Standard Pricing Register after Friday, December 13, 2013 Conference & Workshop: $2295 Conference Only: $1995 Onsite Pricing Conference & Workshop: $2395 Conference Only: $2095 Includes Sales Taxes and Service Fees Questions? Comments? Do you have any questions, comments on the program, or specific topics you would like addressed? Would you like to get involved as a speaker, moderator, or discussion leader? Please email the Program Director, Kai Hahn at khahn@exlpharma.com Tri-located Event This event will be tri-located with ExL Pharma s 4th Annual Developing CAPAs in the GCP Environment and 3rd Trial Master File Summit, increasing the networking capabilities and creating a terrific onsite atmosphere for industry representatives. PAYMENT Make checks payable to ExL Events, Inc. and write code C453 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. Please note, there will be an administrative charge of $300 to substitute, exchange and / or replace attendance badges with a colleague occurring within five business days of any ExL conference. CANCELLATION POLICY If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date of the event: Four weeks or more: A full refund (minus a $295 processing fee), or a voucher to another ExL event valid for 18 months from the voucher issue date. Four weeks or less: A voucher to another ExL event valid for 18 months from the voucher issue date. If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less. To receive a refund or voucher, please fax your request to 888 221 6750 or call 212 400 6240. ExL Pharma reserves the right to cancel any conference it deems necessary and will not be responsible for airfare hotel or any other costs incurred by registrants. ExL Pharma s liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date content speakers or venue. TERMS AND CONDITIONS By registering for an ExL Events, Inc. ( ExL Pharma ) event, you agree to the following set of terms and conditions listed below: Registration Fee: The fee includes the conference all program materials and designated continental breakfasts lunches and refreshments. The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc. 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Register Today ExL Events, Inc. 494 8th Ave, Fourth Floor New York, NY 10001 www.exlpharma.com/rems registration@exlpharma.com 866 207 6528 888 221 6750 Method of Payment: p Check p Credit Card Make checks payable to ExL Events, Inc. Card Type: p MasterCard p Visa p Discover p AMEX p Yes! Register me for the Conference and Workshop p Yes! Register me for the Conference Only Card Number: Name on Card: Exp. Date: Name: Company: Dept: Job Title: Signature: Address: City: State: Zip: Email: Conference Code: C453 Please Mention Priority Code Phone: Fax: p I wish to receive email updates on ExL Pharma's upcoming events SUMMIT Best Practices for Working Successfully with all Key Stakeholders to Assess Effectiveness and Modify REMS to Reduce the Burden JANUARY 28 29, 2014 WESTIN ALEXANDRIA ALEXANDRIA, VA Key Areas to be Addressed: 6th RISK EVALUATION AND MITIGATION STRATEGIES STANDARDIZATION Lindsey R. Kelley Assistant Director of Pharmacy, Ambulatory Care Services University of Michigan EVALUATION Emily Freeman Director, Epidemiology, Health Behavior & Program Evaluation Pfizer Event Sponsors: BURDEN Gary Appio, PharmD, MBA, Head, US Safety Risk Management, Novartis MODIFICATION Michael Cheung Project Manager in Medical Affairs/ Risk Management Vivus page 6