RX - TO - OTC SWITCH SUMMIT EVENT HIGHLIGHTS. Hear from an expert speaking faculty, including: THE THIRD ANNUAL FULL LIFE CYCLE SWITCH EVENT

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1 THE THIRD ANNUAL FULL LIFE CYCLE SWITCH EVENT RX - TO - OTC SWITCH SUMMIT Profiling the next wave of over-the-counter availability through an assessment of the safety, marketability and profitability of in-demand drugs DECEMBER 1-2, 2016 SONESTA PHILADELPHIA RITTENHOUSE SQUARE PHILADELPHIA, PA FEATURED SPEAKERS: CHAIRPERSON BERNIE SIMONE Vice President, Rx-to-OTC Switches and Business Development, CHATTEM PHILIP KANTOR Global Marketing Director, GLAXOSMITHKLINE JUDITH PLON Associate Vice President, Global Regulatory Affairs, SANOFI JAMES KENNEY Global Brand Marketing Director, GALDERMA MARIO CRUZ-RIVERA, PH.D., MPH Senior Director of Global Clinical Research and Rx-to- OTC Switch, PFIZER GUIDO SCHMITZ Head of Packaging and Technology Innovation, BAYER EVENT HIGHLIGHTS Analyze current trends and business models, and identify how to lead your Rx drug through the OTC switch journey Benchmark case studies of successful and failed switches and recognize the best practices for ensuring profitability following an Rx-to-OTC switch Hear from an expert speaking faculty, including: Ozgun Demir, Associate Director, e-marketing, BAYER Alankar Gupta, Associate Vice President and Head of Medical Affairs, CHC North America, SANOFI Discuss the latest regulatory challenges and initiatives, including NSURE, and learn how to effectively communicate with the FDA Assess the current switch market and explore the potential for the next wave of switches Establish packaging and labeling best practices to ensure patient safety Learn digital media, advertising, marketing and branding strategies to maximize your switching success Discover anti-counterfeit strategies to fully own your OTC product Network with industry professionals to exchange best practices for ensuring profitability following an Rx-to-OTC switch Gerard McNally, Vice President, R&D, JOHNSON & JOHNSON Terri Goldstein, Chief Executive Officer, TERRI GOLDSTEIN GROUP Stephane Bissonnette, DPH, Pharm.D., Director, Global Rx-to-OTC Switch, BAYER Susan B. Levy, Founder and Principal, SUSAN B. LEVY CONSULTING Joseph C. Gioconda, Founder, GIOCONDA LAW

2 THE THIRD ANNUAL FULL LIFE CYCLE SWITCH EVENT RX -TO- OTC SWITCH SUMMIT Dear Colleague, WHO SHOULD ATTEND? This conference is designed for professionals from pharmaceutical companies with responsibilities in the following areas: Since 2013, there have been six successful Rx-to-OTC switches and a plethora of highprofile switch failures and disappointing results. Successful switches are as much an art as a Rx-to-OTC Switches science, and it has become increasingly apparent that switch teams must revise their best Regulatory Affairs/Regulatory Processes practices if they are to effectively lead an Rx product through the switch to OTC. Brand Management/Product Management/ Brand Marketing Legal Affairs/Counsel/Regulatory Counsel Now in its third consecutive year, ExL s Rx-to-OTC Switch Summit will bring industry leaders Medical/Scientific Affairs together to provide a complete understanding of the switch landscape from quality, testing, Consumer Healthcare Products regulatory strategy and marketing standpoints. The 3rd Rx-to-OTC Switch Summit is the Clinical Development most advanced thought leadership event experts can attend to discuss all aspects of a Clinical Trials switch, from the NDA process to the final over-the-counter product. Our speaking faculty, Research and Development representing Bayer, Pfizer, Chattem, GlaxoSmithKline, Sanofi, Galderma and many other Business Strategy organizations, will help you to: Labeling/Packaging Drug Delivery Technology Grasp the fundamentals of the switch process Product Development Review successful case studies and strategies Corporate Development Innovate with OTC packaging and label writing Stay up to date with regulatory challenges and initiatives This conference is also of interest to: Brainstorm new marketing and branding strategies Strategy and Marketing Consultants Clinical Research Labs CROs/CMOs Drug After-Market Manufacturers/Suppliers Legal/Regulatory Advisors Statistical Service Providers Marketing/Media Organizations VENUE SONESTA PHILADELPHIA RITTENHOUSE SQUARE 1800 Market Street, Philadelphia, PA To make reservations please call SONESTA ( ) and request the negotiated rate for ExL s December Meetings. You may also make reservations online at The group rate is available until November 10, 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 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 1, 2016 Pre-Conference Workshop 8:15 REGISTRATION AND CONTINENTAL BREAKFAST FOR WORKSHOP PARTICIPANTS 9:00 HOW SWITCH PROGRAMS GET BUILT: AN INTRODUCTION TO THE RX-TO-OTC SWITCH PROCESS Switching a drug from prescription to OTC status is an NDA-driven process. The FDA considers the safety and efficacy of the drug, in addition to how consumers will behave in the absence of a learned intermediary. With rarely more than one switch approved a year in the United States, each switch program is unique. Firm up the basics of the switch process Update best practices for building an Rx-to-OTC switch program Select the ideal Rx-to-OTC switch candidates Susan B. Levy, Founder and Principal, SUSAN B. LEVY CONSULTING There will be a half-hour networking break at 10:30. 12:00 LUNCHEON FOR WORKSHOP PARTICIPANTS Thursday, December 1, 2016 Day One 12:00 CONFERENCE REGISTRATION 1:00 CHAIRPERSON S WELCOME AND OPENING REMARKS Bernie Simone, Vice President, Rx-to-OTC Switches and Business Development, CHATTEM 1:15 UNDERSTAND THE DYNAMICS AND UPCOMING DEVELOPMENTS IN RX-TO-OTC SWITCHES Analyze the current Rx-to-OTC switch market environment Profile current Rx categories that could become OTC switch areas Discuss the broad scope of issues organizations currently face during an OTC switch Learn how to enable new switch opportunities Compare global Rx-to-OTC switch best practices Stephane Bissonnette, DPH, Pharm.D., Director, Global Rx-to-OTC Switch, BAYER 2:00 PRIORITIZE THE KEY FEATURES THAT INCREASE THE LIKELIHOOD OF A SUCCESSFUL SWITCH Explore how to increase your commercial switch success Recognize how to balance Rx heritage with OTC needs and usage Hear case studies on establishing a consumer-recognized brand name to initiate an effective revenue and profit stream Understand the strengths of your OTC product to maximize the probability of success Uncover methods to leverage consumer insights and build a winning position for your brand Philip Kantor, Global Marketing Director, GLAXOSMITHKLINE 2:45 NETWORKING BREAK 3:15 HOW TO FULLY OWN YOUR BRAND: ANTI-COUNTERFEIT PRODUCT STRATEGIES FOR YOUR RX-TO-OTC SWITCH Hear legal and branding experts discuss how to secure intellectual property rights for the name and visual appearance of your product and packaging Delve into the nuances of anti-counterfeiting measures via specific OTC product case studies Gain real-world techniques to combat brand counterfeiting and infringement Examine the sequence of cognition at retail and the manner in which consumers see and recall brands Identify other brands that have accomplished secure levels of protection and examine their road map to doing so Meet the brand impostors/counterfeit brands and their fraudulent activities Learn valuable information for your next branding project and trailblaze your brand to a highly memorable and protectable stance Terri Goldstein, Chief Executive Officer, TERRI GOLDSTEIN GROUP Joseph C. Gioconda, Founder, GIOCONDA LAW 4:00 PANEL DISCUSSION: DRIVE INNOVATIVE REGULATORY STRATEGIES AND INTERACT EFFECTIVELY WITH THE FDA Establish do s and don ts for FDA advisory meeting preparation Assess the current regulatory switch landscape Outline ongoing regulatory work Discuss the lessons learned from recent applications Judith Plon, Associate Vice President, Global Regulatory Affairs, SANOFI Alankar Gupta, Associate Vice President and Head of Medical Affairs, CHC North America, SANOFI 5:00 DAY ONE CLOSING REMARKS 5:15 DAY ONE CONCLUDES

4 Friday, December 2, 2016 Day Two 8:15 REGISTRATION AND CONTINENTAL BREAKFAST 9:00 CHAIRPERSON S RECAP OF DAY ONE Bernie Simone, Vice President, Rx-to-OTC Switches and Business Development, CHATTEM 9:15 REVIEW LESSONS LEARNED FOR AN OTC SWITCH FROM AN RX PROFESSIONAL Hear an Rx professional with 25+ years of experience discuss his evolving perspective after transitioning to OTC switches Decipher whether 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, Ph.D., MPH, Senior Director of Global Clinical Research and Rx-to-OTC Switch, PFIZER 10:00 A MEDICAL ROAD MAP TO SWITCHING AN RX MOLECULE TO OTC Check the list of critical actions for switching your Rx molecule to OTC Enhance your switch strategy road map Examine switch planning strategies employed by a professional who has led multiple Rx-to-OTC switch activities related to dermatology, respiratory, urology, cardio-vascular and GI categories Alankar Gupta, Associate Vice President and Head of Medical Affairs, CHC North America, SANOFI 10:45 NETWORKING BREAK 11:15 PANEL DISCUSSION: BEST-IN-CLASS MARKETING AND BRANDING STRATEGIES TO COMMERCIALIZE YOUR BRAND Hear from marketing thought leaders about how to successfully lead an Rx product through the switch to OTC for commercial success Discuss the key marketing tools and strategies that require flawless execution in addressing the unique characteristics of a switch Walk through communication strategies that better position you for a successful product launch Understand the fundamentals of digital/mobile marketing and discover its effects on consumer and patient engagement Analyze shelf strategies and identify consumers behavioral patterns Learn how patients are conducting more research Philip Kantor, Global Marketing Director, GLAXOSMITHKLINE Ozgun Demir, Associate Director, e-marketing, BAYER James Kenney, Global Brand Marketing Director, GALDERMA 1:15 USE A HOLISTIC DESIGN APPROACH TO OVER-THE- COUNTER PACKAGING Explore beyond regulatory guidelines to assess the marketing potential of your labeling and packaging, and the product as a whole Identify packaging and labeling best practices to ensure patient safety Incorporate an effective branding strategy into your business model through innovative packaging Guido Schmitz, Head of Packaging and Technology Innovation, BAYER 2:00 THE IMPORTANCE OF DRUG DELIVERY TECHNOLOGY IN THE SUCCESS OF RX-TO-OTC SWITCHES Discover how new drug delivery technologies can help increasing compliance in switches from prescription to OTC Recognize drug delivery best practices for the successful commercialization of Rx-to-OTC switches Analyze the impact of drug delivery as an essential component of switch strategies for the safe delivery of OTC pharmaceuticals Gain a competitive advantage by understanding consumer preferences and perceptions Gerard McNally, Vice President, R&D, JOHNSON & JOHNSON 2:45 STRENGTHEN LABEL COMPREHENSION AND APPROPRIATE SELF-SELECTION FOR A SWITCH Delve into label comprehension and self-selection studies and their key objectives Examine consumer behavior studies and how they translate to label optimization Use detailed success stories to craft compliant and appropriate labels Bernie Simone, Vice President, Rx-to-OTC Switches and Business Development, CHATTEM 3:30 CONFERENCE CONCLUDES Excellent insight! Director, R&D, BAYER CONSUMER CARE A great presentation looking at the hurdles that exist for OTC switches. Regulatory Associate, TEVA Brought up some new points that I did not think of previously. Senior Director of Regulatory Affairs, PERRIGO 12:15 LUNCHEON This event covered all areas of the switch process. Associate Director, Clinical Operations, NOVEN PHARMACEUTICALS Very interactive! Associate Director, CHC, SANOFI

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