THE SECOND ANNUAL FULL LIFE CYCLE SWITCH EVENT. Assessing the Safety, Profitability and Marketability of an OTC Switch

Transcription

1 THE SECOND ANNUAL FULL LIFE CYCLE SWITCH EVENT RX - TO - OTC SWITCH SUMMIT Assessing the Safety, Profitability and Marketability of an OTC Switch DECEMBER 3-4, 2015 THE INN AT PENN, A HILTON HOTEL PHILADELPHIA, PA FEATURED SPEAKERS: Chairperson BERNIE SIMONE Vice President, Rx-to-OTC Switches and Business Development, CHATTEM JOHN WHYTE, M.D., MPH Director, Professional Affairs and Stakeholder Engagement, FOOD AND DRUG ADMINISTRATION, CENTER FOR DRUG EVALUATION AND RESEARCH MARIO CRUZ-RIVERA Senior Director of Global Clinical Research and Rx-to-OTC Switch, PFIZER TERRI GOLDSTEIN Chief Executive Officer, THE GOLDSTEIN GROUP CATHERINE SEGAL Global Marketing Director, GLAXOSMITHKLINE FOCUS AREAS FOR 2015: Hear directly from the FDA regarding efforts to reduce preventable harm through the Safe Use Initiative Receive guidance on label writing to ensure appropriate selfselection Understand digital technology s role in bridging the gaps between pharmaceutical companies, providers and consumers Learn marketing and branding techniques to solidify consumer loyalty to a product Network with seasoned professionals who have worked on a number of successful switches Explore case studies of successful switches Analyze the potential for a global switch standard Discuss the challenges of Rx-to-OTC switches involving chronic diseases REGULATORY GUIDANCE DIRECTLY FROM THE FDA Meet Dr. John Whyte, Director of Professional Affairs and Stakeholder Engagement, who will give the Keynote address on the FDA s Safe Use Regulatory Initiative DECIDING TO MAKE THE SWITCH? ATTEND OUR WORKSHOP ON POST-LAUNCH FACTORS FOR PRELAUNCH CONSIDERATION Examine the top 10 post-launch factors for commercial success and maximize marketplace performance and profitability! Susan B. Levy, Founder and Principal, SUSAN B. LEVY CONSULTING Sponsor:

2 THE SECOND ANNUAL FULL LIFE CYCLE SWITCH EVENT RX -TO- OTC SWITCH SUMMIT DEAR COLLEAGUE, The process of an Rx-to-OTC switch involves stringent testing, regulatory and safety concerns, and a complicated marketing process. A primary concern in OTC availability is patients self-medicating and self-regulating drugs that were formally prescribed. Improper doses, frequency and combinations could have lethal affects. On the opposite end of the spectrum are the benefits switches create opportunities for a variety of savings. Lives are saved by the use of nicotine replacement therapies, money is saved when patients on heartburn medication do not have to go to the doctor, and even time is saved when individuals purchase OTC yeast infection treatments. Drug manufacturers looking to make an Rx-to-OTC switch with a specific medication need to submit an NDA (new drug application) to the appropriate FDA department, where its safety and efficacy are highly scrutinized before a determination is made regarding whether it can be used responsibly by consumers. ExL s 2nd Rx-to-OTC Switch Summit is designed for industry professionals who are looking to enter the OTC market to gain a better understanding of quality, testing and marketing in the switch process. The summit also focuses on sharing best practices and exploring case studies on how organizations are successfully overcoming switch challenges. This program features: An update from the FDA on the Safe Use Initiative Detailed case studies of successful OTC switches A collaborative, intensive workshop where attendees will learn strategies for a profitable OTC switch An expert speaking faculty delivering presentations on relevant, topical issues in the Rxto-OTC market, such as branding, labeling, future switches and much more WHO SHOULD ATTEND? This conference is designed for representatives from pharmaceutical and biotechnology companies with responsibilities in the following areas: Rx-to-OTC Switches Drug Safety Research/Drug Development Regulatory/ Compliance Marketing/Branding/ Commercialization Statistics/ Biostatistics Medical/Scientific Affairs This conference is also of interest to: Drug Developers/ Pharmaceutical Companies Clinical Research Labs CROs/CMOs Drug After-Market Manufacturers/ Suppliers VENUE Clinical Development Clinical Trials Research and Development Life Cycle Management Labeling/Packaging Product Development Global Business Consumer Insight Regulatory Consultants Statistical Service Providers Marketing/Media Organizations I look forward to welcoming you to Philadelphia this December! Sincerely, Derek O C onnor Derek O Connor Conference Producer, ExL Events doconnor@exlevents.com SPONSORSHIP AND EXHIBITION OPPORTUNITIES Do you want to spread the word about your organization s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact David Borrok, Senior Business Development Manager, at or dborrok@exlevents.com. The Inn at Penn, A Hilton Hotel 3600 Sansom St, Philadelphia, PA, To make reservations please call HILTONS and request the negotiated rate for EXLP. You may also make reservations online using the following link: The group rate is available until November 19, Please book your room early as rooms available at this rate are limited. ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or 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 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.

3 THURSDAY, DECEMBER 3, 2015 PRE-CONFERENCE WORKSHOP 8:15 Registration and Continental Breakfast for Workshop Participants PRE-CONFERENCE WORKSHOP 9:00 POST-LAUNCH FACTORS FOR RX-TO-OTC SWITCH SUCCESS AND THEIR PRELAUNCH PREPARATION IMPLICATIONS Would you be surprised to learn that only half of the last 10 Rx-to-OTC switches that have launched in the United States have sales in excess of $100 million today? In this advanced workshop, we ll examine the top 10 post-launch factors for commercial success based on actual case studies and explore what switch teams should be doing from project onset to maximize marketplace performance. In this workshop, participants will: Explore ways that Rx-to-OTC switches can be successful when launched Review the factors that determine whether a drug will be commercially successful when switched Create a checklist that covers what switch teams can do from the onset of a project to maximize commercial value while minimizing project time Benchmark lessons learned from prior switches Learn what technologies are available to facilitate the switch process, particularly for potentially new categories Susan B. Levy, Founder and Principal, SUSAN B. LEVY CONSULTING *There will be a half-hour networking break at 10:30. 12:15 Luncheon for Workshop Participants THURSDAY, DECEMBER 3, 2015 MAIN CONFERENCE DAY ONE 12:30 Main Conference Registration 3:00 Networking Break 1:15 CHAIRPERSON S WELCOME AND OPENING REMARKS 1:30 REDUCTION OF PREVENTABLE HARM THROUGH THE FDA S SAFE USE REGULATORY INITIATIVE Hear about the FDA s collaboration with external organizations in an effort to encourage and facilitate proper OTC drug use Learn funding opportunities from the Safe Use Initiative Analyze proposed regulatory and legal solutions to combat OTC abuse John Whyte, M.D., MPH, Director, Professional Affairs and Stakeholder Engagement, FOOD AND DRUG ADMINISTRATION, CENTER FOR DRUG EVALUATION AND RESEARCH KEYNOTE 2:15 COGNITIVE STRATEGIES FOR SUCCESSFUL BRAND ESTABLISHMENT Create a shelf strategy that utilizes colors, shapes and unexpected symbols to connect with consumers brand recall and impulsive purchase behavioral patterns Identify other brands that have accomplished secure levels of protection and establish a road map to do the same Target consumer emotions with visuals that capture their wants, needs, aspirations and rituals to turn them into an intuitive, yet powerfully emotive visual vocabulary for brand packaging Terri Goldstein, Chief Executive Officer, THE GOLDSTEIN GROUP 3:30 BEST PRACTICES TO ENSURE LABEL COMPREHENSION AND APPROPRIATE SELF-SELECTION FOR A SWITCH Study label comprehension and self-selection studies and their key objectives Analyze consumer behavior studies and how they translate to label optimization Use detailed success stories to craft compliant and appropriate labels 4:30 LESSONS LEARNED FOR AN OTC SWITCH FROM AN RX PROFESSIONAL Hear evolving perspectives from an Rx professional with 25+ years of experience who recently transitioned to OTC switches Decipher if there are any differences between Rx and OTC programs and submissions Learn Rx best practices that can be applied to the OTC switch space Discover how OTC switches can influence early life cycle management (LCM) strategies at the Rx level Mario Cruz-Rivera, Senior Director of Global Clinical Research and Rx-to-OTC Switch, PFIZER 5:15 Day One Concludes To Register Call or Visit

4 FRIDAY, DECEMBER 4, 2015 MAIN CONFERENCE DAY TWO 8:15 Registration and Continental Breakfast 9:00 CHAIRPERSON S RECAP OF DAY ONE 9:15 CASE STUDY: FLONASE RX-TO-OTC SWITCH Review the marketing approach used to bring Flonase to the OTC market Recognize Flonase s effect on future OTC switches Pinpoint branding techniques to ensure Flonase s success Catherine Segal, Global Marketing Director, GLAXOSMITHKLINE 10:00 DIGITAL TECHNOLOGY S ROLE IN BRIDGING THE GAPS BETWEEN PHARMACEUTICAL COMPANIES, PROVIDERS AND CONSUMERS Understand how mobile technology tools can meet regulatory requirements for an Rx-to-OTC switch Learn how KOLs can help a pharmaceutical company s digital strategy Discover why digital tools are critical to consumer and patient engagement David Lee Scher, M.D., FACP, FACC, FHRS, Director, DLS HEALTHCARE CONSULTING 10:45 Networking Break 11:15 RX-TO-OTC SWITCH AFTER THE DISCONTINUED LIPITOR SWITCH SUBMISSION Hear what really happened from a business and regulatory perspective Discuss the statins and their Rx-to-OTC switch historical relevance Assess how healthy the Rx-to-OTC switch industry is now Steve Francesco, President, FRANCESCO INTERNATIONAL 1:45 THE ROLE OF PHARMACOVIGILANCE AS IT RELATES TO OTC SWITCHES Learn what is needed from a PV perspective for an Rx-to-OTC switch Hear PV SOPs and techniques used in an OTC switch Detect common adverse events Ariel Abreu-Pena, M.D., MBA, Associate Director, Product Vigilance Physician, Consumer Medicinal Products OTC, JOHNSON & JOHNSON PHARMACEUTICALS 2:30 Networking Break 3:00 THE GLOBAL REGULATORY ENVIRONMENT FOR OTC SWITCHES Analyze Europe s DCP versus CP and how one size does not fit all Discuss Brazil s proposed new regulations that could expand access to self-care Discover how New Zealand and the UK are leading the international market 3:45 THE VALUE OF SELF CARE AND THE IMPORTANCE OF ACCESS Observe a physician s perspective on OTC drugs in comparison to Rx drugs Understand the role of patient education and shared responsibility among consumers, doctors and pharmacists Learn how patients are conducting more research Juby Jacob-Nara, M.D., MPH, MBA, CMO and Vice Presdident, Global Medical Affairs, PFIZER 4:30 CHAIRPERSON S CLOSING REMARKS 4:45 Summit Concludes 12:00 Luncheon 1:00 POTENTIAL FUTURE OTC SWITCHES FROM A PHARMACIST S PERSPECTIVE Profile current Rx medications that could become OTC switch candidates Identify opportunities to maximize exposure and profitability by making the switch Debate the expanding role of the pharmacist as a stakeholder in patient engagement Daniel Hussar, Ph.D., Remington Professor of Pharmacy, PHILADELPHIA COLLEGE OF PHARMACY, UNIVERSITY OF THE SCIENCES IN PHILADELPHIA Excellent insight! Director, R&D, BAYER CONSUMER CARE A great presentation looking at the hurdles that exist for OTC switches. Regulatory Associate, TEVA

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