Risk Evaluation & Mitigation Strategies

Risk Evaluation & Mitigation Strategies Elevate Risk Management Operations to Ensure Patient-Centricity, Open communication Channels, and Advanced Efficacy SUMMIT January 29-30, 2018 Hilton Crystal City Arlington, VA Conference Chair Jamie Parker Wilkins, Deputy Director, Division of Risk Management, FDA Emily Freeman, Ph.D., Director, Risk Management Sciences, Paul Sheehan, Executive Director, Head of U.S. REMS, CELGENE CORPORATION Top Reasons to Attend Kim H. Bullano, B.S., Pharm.D., Senior Director, Risk Management Team Lead, SHIRE Linda Scarazzini, M.D., Vice President Pharmacovigilance and Patient Safety (PPS), May Chan-Liston, Director, REMS Strategy, CELGENE Deb Tiffany, Director, Global Risk Management Product Lead, Process Analyst, Worldwide Safety and Regulatory, Michael von Forstner, Co-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE Rachel Sobel, Senior Director, Epidemiology - Group Lead Global Innovative Pharma, Cheryl Renz, M.D., Head, Benefit-Risk Management Pharmacovigilance and Patient Safety (PPS), Sponsors Michael S. Wolf, Ph.D., MPH, Professor, Medicine and Learning Sciences, Associate Chair, Department of Medicine, Associate Division Chief, Research, General Internal Medicine and Geriatrics, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY Disrupt the Patient Care Model to Ensure Risk Management Strategies Effect Educated Patients I ncorporate Novel Approaches in RealWorld Data (RWD) to Evaluate Risk Minimization (RM) Interventions Examine Best Practices in Developing and Operationalizing Shared REMS Ensure How to Discuss Risk and Benefits in a Fair and Balanced Manner From a Professional and Patient Perspective nce Complia n Educatio igation Risk Mit es Outcom Patient Safety Patient OUTPUT RE MS EFFORT ed g Shanr-Makin sio Deci ation r Integ tion a ardiz Stand logy no Tech nt ssme Asse

Dear Colleague, Bringing together professionals involved in REMS programs to propagate the core principles of risk management and to help ensure patient safety has been the founding mission of ExL Events Risk Evaluation and Mitigation Strategies Summit for a decade. The immediate success of risk management and mitigation strategies rests on the ability to address and communicate digestible information to HCPs and patients that profoundly outlines risks and benefits. The long-term success of risk management and mitigation strategies relies on the manufacturer s ability to design and redesign REMS programs that reflect changing FDA regulations and evolving population health crises, while accounting for healthcare providers input on patient feedback. This ability is only supported through the consistent evaluation and assessment of risk management strategies. Developing and assessing a basic REMS programs is a thing of the past; it is now time to elevate your risk management operations to ensure patient safety and population health. Now celebrating its tenth anniversary, the REMS Summit convenes pharma, regulatory agencies, healthcare providers, and patient advocates to elevate and advance the operations of REMS programs. Our adept speaking faculty will arm you with proven strategies to facilitate benefitrisk counseling, optimize REMS operations through streamlined health system integration, leverage interoperable technologies for consistent communication, and increase patient safety through cross-functional collaboration. I look forward to welcoming you to Arlington this winter! Sincerely, Mercy Lister Mercy Lister Conference Production Director ExL Events, a division of Questex, LLC WHO SHOULD ATTEND This event is ideal for professionals from pharmaceutical, patient advocacy, and academic organizations with responsibilities in the following areas: REMS Risk Management Pharmacovigilance/Surveillance Quality Assurance Drug/Product Safety Clinical Risk Management Lifecycle Management Regulatory Affairs/Legal/Compliance Clinical Affairs Clinical Data Management Clinical Operations Clinical Risk Management Compliance Epidemiology/ Pharmacoepidemiology Marketing This conference is also of interest to: Risk Safety and REMS Service Providers Data Management Service Providers Healthcare Information Marketing and Technology Providers Dashboard and Metrics Service Providers Law Firms Consultancies PV Software Professionals VENUE Hilton Crystal City at Reagan National Airport 2399 Jefferson Davis Hwy Arlington, VA 22202 To make reservations, please call 1-800-695-7551 and request the negotiated rate for ExL s January Meetings. You may also make reservations online using the following weblink: http://bit.ly/2uvozxg. The group rate is available until January 9, 2018. Please book your room early, as rooms available at this rate are limited. *ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL s reserved guest room block using the details provided. SPONSORSHIP AND EXHIBITION OPPORTUNITIES Do you want to spread the word about your organization s solutions and services to potential clients attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees.

Monday, January 29, 2018 8:00 Registration and Continental Breakfast 9:00 Chairperson s Opening Remarks Emily Freeman, Ph.D., Director, Risk Management Sciences, 9:15 REMS Carousel Discussion Exercise This conversational forum is ideal for sharing and exploring best practices. Each group is assigned a different operational challenge that professionals face. After 20-minutes, they begin a rotation in which they spend 10 minutes reading the recorded solutions of other groups, then add their own. The end product of this activity is a comprehensive digest of participants best practices in relation to the following operational themes: Governance models Financing IT infrastructure Cross-functional management Emily Freeman, Ph.D., Director, Risk Management Sciences, CHERYL RENZ, M.D., Head, Benefit-Risk Management Pharmacovigilance and Patient Safety (PPS), 10:15 Reduce the Burden on Pharmacists and HCPs Through Interoperable Technologies Standardize the REMS implementation process that relieves the burden from HCPs and pharmacists Open communication channels amongst all relevant entities to streamline risk management discussion Create a transparent environment to advance REMS programs John Klimek, R.Ph., Senior Vice President, Standard and IT, NCPDP 10:45 Networking Break 11:15 Integrate Consumer and Health Information Technologies Within the Primary Care Practice to Promote Safe Medication Use Understand the current state of patient-provider risk communication and monitoring of patients prescription medication use Learn about recent and ongoing research and practice initiatives to promote medication adherence and safety Stacy Cooper Bailey, Ph.D., MPH, Assistant Professor, Division of Pharmaceutical Outcomes and Policy, UNC ESHELMAN SCHOOL OF PHARMACY 12:00 Enhance Patient Understanding and Engagement by Knocking Down Barriers to Proper Medication Use Identify three common, patient-reported unintentional barriers to proper medication use, and three health system root causes to patients being under-informed about medication risks (and benefits) State how patients who are either at risk for medication errors or adverse events, or poorly adherent to their treatment could be readily identified in clinical practice Provide three examples of possible health system-based interventions that could be deployed to readily monitor, prevent, or mitigate medication safety and adherence concerns Michael S. Wolf, Ph.D., MPH, Professor, Medicine and Learning Sciences, Associate Chair, Department of Medicine, Associate Division Chief, Research, General Internal Medicine and Geriatrics, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY 12:45 Luncheon 1:45 Evaluate Patient Understanding of Risks: The Value of Cognitive Vs. Metacognitive Methods Distinguish cognition (what people know) vs. metacognition (what they think they know) Compare results from the same patients using cognitive vs. metacognitive methods Consider what can and cannot be learned from each approach Ruth S. Day, Ph.D., Director, Medical Cognition Lab, Senior Fellow, Center for Aging and Human Development, DUKE UNIVERSITY 2:30 Benefit, Risk, Removals, and Corrections: Putting the Pieces Together Understand how and when a formal benefit-risk evaluation can help decision-making regarding correction and removal actions Examine the role that risk mitigation can play in determining recall strategy, communication, and follow-up Consider how a firm s regulatory and quality behavior can influence compliance and enforcement determinations Adam E. Saltman, M.D., Ph.D., FACS, FACC, FACP, FAHA, Medical Officer, CDRH Office of Compliance, FOOD AND DRUG ADMINISTRATION 3:15 Networking Break 3:45 Examine a Real-World Pharmaceutical Benefit-Risk Management Review how the analysis varies by stakeholder Discuss use of analytical tools such as Decision Tree Analysis and Failure Modes and Effects Analysis (FMEA) Outline application in patient-centered care models Expose fundamental issues with utilization by the medical community Larry Risen, MBA, President and CEO, BIOTRAK RESEARCH CASE STUDY Day One 4:30 Develop and Deliver Effective Evaluation of Risk Minimization Measures Select process and outcome parameters for your risk minimization program Discuss the merits and drawbacks of various data collection methodologies Fine tune your data analysis and risk minimization program Michael von Forstner, Co-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE 5:15 CO*RE and the Opioid REMS: Significant Learnings From an Eight-Year CE/CME Collaboration Understand benefits and challenges of association collaboration as one response to a shared REMS Recognize the metric results, outcomes and best practices of CO*RE Appreciate the complexities and hurdles implicit in a shared REMS Cynthia Kear, Lead, Collaboration Management, CO*RE Absolutely brilliant. Stunning insights! Senior Director, Drug Regulatory Affairs, ACTELION

Monday, January 29, 2018 Day One 6:00 Integrate REMS Requirements with the EHR and Provider Workflows Understand the potential use of EHR Decision support tools to meet REMS requirements Discuss the benefits and pitfalls of EHR integration of REMS requirements Identify the key benefits of REMS integration in the EHR and discuss workflow and patient safety benefits Dean T. Parry, RPH, Assistant Vice President, Clinical Informatics, Care Support Services, GEISINGER HEALTH SYSTEM 6:45 Day One Concludes Tuesday, January 30, 2018 8:00 Continental Breakfast 9:00 Chairperson s Recap of Day One Emily Freeman, Ph.D., Director, Risk Management Sciences, 9:15 Integrating an Existing REMS Program Into Your Organization Following an Acquisition Discuss possible challenges an organization faces when acquiring an existing REMS program Examine the critical roles of cross-functional stakeholders Transform lessons learned into best practices for a seamless integration Kim H. Bullano, B.S., Pharm.D., Risk Management Team Lead, SHIRE 10:00 Incorporating HIT Within REMS Programs to Address REMS Stakeholder Burden Understand how REMS programs can be integrated into Health Information Technology (HIT) Examine what is required to implement the FDA s REMS Common Platform Assess alternative ready-now REMS technology models Review Celgene s progress implementing a REMS HIT interoperability strategy Paul Sheehan, Executive Director, Head of U.S. REMS, CELGENE CORPORATION 10:45 Networking Break 11:15 Compare and Contrast REMS Program Models and Assessment Reporting Aspects Evaluate similarities and differences between REMS Program product dispensing models Increase program efficiency and compliance by integrating REMS within provider workflow Assess program burden and effectiveness promptly and accurately through pharmacy data Nathan Kopper, Pharm.D., Director, REMS Consulting and Strategy, MCKESSON Pat dacosta, Pharm.D., REMS Sr. Product Manager, RELAYHEALTH Valuable presentations with great insights into each stakeholder s challenges. Executive Director, Pharmacovigilance, RETROPHIN 12:00 Applying the RE-AIM Framework for REMS Assessments Discuss current approaches to REMS Assessments Evaluate the RE-AIM framework and examine how it could be applied to REMS program assessments Review use case: The RE-AIM Framework and REVLIMID REMS Program methodology for REMS Assessment May Chan-Liston, Director, REMS Strategy and Policy, CELGENE CORPORATION 12:45 Luncheon 1:45 Incorporate Novel Approaches Into Real-World Data (RWD) to Evaluate Risk Minimization (RM) Interventions Understand how RWD/longitudinal healthcare databases can be used to evaluate risk minimization interventions in the EU and the U.S. Describe the advantages and disadvantages among other commonly used approaches to fulfill EU GVP Module XVI and U.S. FDA requirements Analyze and discuss Pfizer case studies of novel EU and U.S. evaluations using RWD to judge RM interventions Rachel Sobel, Senior Director, Epidemiology - Group Lead Global Innovative Pharma, 2:30 FDA Presentation Led By Cynthia LaCivita, Director, Division of Risk Management, FDA Jamie Parker Wilkins, Deputy Director, Division of Risk Management, FDA 3:15 REMS Restrictions and Generic Entry: Trends and Developments in Legislative and Regulatory Activity Learn what to expect from Congress and the FDA Understand the implications of possible or pending legislative actions directed at curing potential REMS abuse Andrew Wasson, Partner, HAUG 4:00 Examine Best Practices in Developing and Operationalizing Shared REMS Discuss the balance between competition and innovation Examine the competing priorities for generic and branded companies involved in shared REMS development Discuss operational challenges in the shared REMS development process Kevin Holman, Senior Director, Drug Regulatory Affairs, ACTELION Deb Tiffany, Director, Global Risk Management Product Lead, Process Analyst, Worldwide Safety and Regulatory, PANEL 4:45 Conference Concludes Day Two

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Ways to Register q YES! Register me for this conference! Name: Title: Company: Dept.: Address: City: State: Zip: Email: Phone: Fax: Method of Payment: q Check q Credit Card Make checks payable to ExL Events. Card Type: q MasterCard q Visa q Discover q AMEX Card Number: Exp. Date: CVV: Name on Card: Signature: Please contact me: q I m interested in marketing opportunities at this event. q I wish to receive email updates on ExL Events upcoming events. CONFERENCE CODE: C988 Risk Evaluation & Mitigation Strategies Elevate Risk Management Operations to Ensure Patient-Centricity, Open communication Channels, and Advanced Efficacy SUMMIT January 29-30, 2018 Hilton Crystal City Arlington, VA Jamie Parker Wilkins, FDA Kim H. Bullano, B.S., Pharm.D., SHIRE May Chan- Liston, CELGENE Michael von Forstner, MEDICINES FOR EUROPE Cheryl Renz, M.D., Paul Sheehan, CELGENE CORPORATION Linda Scarazzini, M.D., Deb Tiffany, Rachel Sobel, Michael S. Wolf, Ph.D., MPH, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY