RX - TO - OTC SWITCH SUMMIT EVENT HIGHLIGHTS THE THIRD ANNUAL FULL LIFE CYCLE SWITCH EVENT FEATURED SPEAKERS: JOIN OUR PRE-CONFERENCE WORKSHOP

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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: CO-CHAIR STEPHANE BISSONNETTE, DPH, PHARM.D., Director, Global Rx to OTC Switch, CO-CHAIR MARIO CRUZ-RIVERA, PH.D., MPH Senior Director of Global Clinical Research and Rx-to- OTC Switch, PFIZER TERRI GOLDSTEIN CEO, THE GOLDSTEIN GROUP JAMES KENNEY Global Brand Marketing Director, GALDERMA PHILIP KANTOR Former Global Marketing Director, GLAXOSMITHKLINE GUIDO SCHMITZ Head of Packaging and Technology Innovation, 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 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 JOIN OUR PRE-CONFERENCE WORKSHOP HOW SWITCH PROGRAMS GET BUILT: AN INTRODUCTION TO THE RX-TO-OTC SWITCH PROCESS In this workshop, participants will: 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 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 SPONSORED BY:

2 THE THIRD ANNUAL FULL LIFE CYCLE SWITCH EVENT RX -TO- OTC SWITCH SUMMIT Dear Colleague, 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 science, and it has become increasingly apparent that switch teams must revise their best practices if they are to effectively lead an Rx product through the switch to OTC. Now in its third consecutive year, ExL s Rx-to-OTC Switch Summit will bring industry leaders together to provide a complete understanding of the switch landscape from quality, testing, regulatory strategy and marketing standpoints. The 3rd Rx-to-OTC Switch Summit is the most advanced thought leadership event experts can attend to discuss all aspects of a switch, from the NDA process to the final over-the-counter product. Our speaking faculty, representing Bayer, Pfizer, Johnson & Johnson, Sanofi, Galderma and many other organizations, will help you to: VENUE Grasp the fundamentals of the switch process Review successful case studies and strategies Innovate with OTC packaging and label writing Stay up to date with regulatory challenges and initiatives Brainstorm new marketing and branding strategies I look forward to welcoming you to Philadelphia this December! Sincerely, Koray Ozkal Koray Ozkal Conference Production Director ExL Events SONESTA PHILADELPHIA RITTENHOUSE SQUARE 1800 Market Street, Philadelphia, PA WHO SHOULD ATTEND? This conference is designed for professionals from pharmaceutical companies with responsibilities in the following areas: Rx-to-OTC Switches Regulatory Affairs/Regulatory Processes Brand Management/Product Management/ Brand Marketing Legal Affairs/Counsel/Regulatory Counsel Medical/Scientific Affairs Consumer Healthcare Products Clinical Development Clinical Trials Research and Development Business Strategy Labeling/Packaging Drug Delivery Technology Product Development Corporate Development This conference is also of interest to: Strategy and Marketing Consultants Clinical Research Labs CROs/CMOs Drug After-Market Manufacturers/Suppliers Legal/Regulatory Advisors Statistical Service Providers Marketing/Media Organizations SPONSORSHIP AND EXHIBITION 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 Events will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact Justin Kreamer, at or jkreamer@exlevents.com. 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 12:15 CONFERENCE REGISTRATION 1:15 CO-CHAIRS WELCOME AND OPENING REMARKS Stephane Bissonnette, DPH, Pharm.D., Director, Global Rx to OTC Switch, 1:30 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, Former Global Marketing Director, GLAXOSMITHKLINE 2:15 NETWORKING BREAK 2:45 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 3:30 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 Eric Pierre Guenin, Director of Medical Affairs, RB Mridul Shah, Associate Director, Global Regulatory Affairs, SANOFI Nancy Pierro, Director, Regulatory Affairs, Global Rx-to-OTC Switch, 4:15 DAY ONE CLOSING REMARKS 4:45 DAY ONE CONCLUDES

4 Friday, December 2, 2016 Day Two 8:15 REGISTRATION AND CONTINENTAL BREAKFAST 9:00 CO-CHAIRS RECAP OF DAY ONE Stephane Bissonnette, DPH, Pharm.D., Director, Global Rx to OTC Switch, 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 10:00 HOW TO BUILD COMPETITIVE STRATEGIES THAT MAXIMIZE SWITCH SUCCESS Explore the range of competitive strategies available to switch brands Review regulatory approaches to strengthen differentiation and thwart competition Examine the unique range of claims available to switch brands Learn how to succeed in categories when multiple brands switch OTC Susan Lavine Coleman, President, NCI CONSULTING 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 James Kenney, Global Brand Marketing Director, GALDERMA 12:15 LUNCHEON 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, 2:00 KEY CONSIDERATIONS FOR PACKAGE DESIGN AND SHELH STRATEGY TO EFFECTIVELY ENGAGE CONSUMERS Highlight key learnings and best practices in package design and consumer engagement Ensure a strong shelf presence, effective consumer engagement, complemented by a robust and responsive supply chain to address dynamic market conditions Embrace a thorough approach for maximum market success Justin Schroeder, Executive Director, Marketing, Business Development & Design, PACKAGING COORDINATORS INC. (PCI) 2:45 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 3:30 CONFERENCE CONCLUDES Excellent insight! Director, R&D, 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 This event covered all areas of the switch process. Associate Director, Clinical Operations, NOVEN PHARMACEUTICALS Very interactive! Associate Director, CHC, SANOFI

5 REGISTRATION INFORMATION Pricing Early Bird Pricing Register By Friday, October 21, 2016 MEDIA PARTNERS Conference and Workshop $2,095 Conference $1,795 Standard Pricing Register After Friday, October 21, 2016 Conference and Workshop $2,295 Conference $1,995 Onsite Pricing Conference and Workshop $2,395 Conference $2,095 Includes Sales Tax and Service Fees - QUESTIONS? COMMENTS? Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please contact Koray Ozkal, Conference Production Director, at kozkal@exlevents.com. GROUP DISCOUNT PROGRAM Offers may not be combined. Early bird rates do not apply. To find out more on how you can take advantage of these group discounts, please call 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). 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