THE ONLY EVENT COVERING A SWITCH FROM END-TO-END. Assessing the Future of Switches in the US and Beyond

Transcription

1 THE ONLY EVENT COVERING A SWITCH FROM END-TO-END RX TO OTC SWITCH SUMMIT Assessing the Future of Switches in the US and Beyond DECEMBER 4-5, 2014 HYATT AT THE BELLEVUE PHILADELPHIA, PA FEATURED SPEAKERS: SANOFI JUDITH R. PLON Associate Vice President Regulatory Affairs Consumer Healthcare US/Chattem JAMES WALKER Global Leader of Strategic & Clinical Marketing BD MEDICAL - DIABETES CARE BRIAN SWANKOSKI Senior Director, Business Technology R&D and Rx to OTC Switch PFIZER CONSUMER HEALTHCARE ROSANNE ROTONDO Vice President New Growth Switch R&D Franchise Head NOVARTIS CONSUMER HEALTH JOSEPH REO R&D Lifecycle Management Lead BAYER CONSUMER CARE FOCUS AREAS: Predict the Future of Switches and New Categories Understand the FDA NSURE Initiative and the Implications of the Affordable Care Act for OTC Drugs Learn Best Practices to Interact Effectively with the FDA when Applying for a Switch Collaborate with Retailers and Pharmacists to Ensure Safe Use Hear Examples of Successful Life-Cycle Management Strategies Leverage Technology to Enable Complicated Switches Use Marketing Intelligence and Leverage Data to Develop a Successful Global Marketing Switch Strategy Assess the Architecture of a High Performance Switch Team Apply a Patient-Centric Approach in Drug Development Leverage Social Media for Patient Adherence NEW TO THE SWITCH ARENA? ATTEND OUR INTENSIVE MASTERCLASS: Explore Switch Strategy and Develop a Road- Map for a Successful Switch Susan B. Levy, Founder & CEO, SUSAN B. LEVY CONSULTING ADVANCED IN THE SWITCH ARENA? Participate IN OUR INTERACTIVE ROUNDTABLES: Lessons Learned from Various Switches Bernie Simone, Vice President, Corporate Development and Rx-to-OTC Switches, SANOFI CHATTEM Alankar Gupta, Executive Director & Franchise Head (CCR) Clinical, Medical, Safety, NOVARTIS CONSUMER HEALTH Eric Guenin, Director of Medical Affairs, RECKITT BENCKISER Steve Francesco, President, FRANCESCO INTERNATIONAL Sponsor:

2 RX TO OTC SWITCH SUMMIT Dear Colleague, The market potential for switches is huge and the FDA is actively working with industry stakeholders to look into new classes and accelerate switches. Most easy switches have been done, so the next hurdles can only be tackled if the industry successfully collaborates with pharmacists, retailers, physicians, patients, ACOs, payers, government and technology experts. As the premier event for Rx-to-OTC professionals, we provide the only forum where the future of Rx-to-OTC switches can be discussed, strategized and leveraged. No matter if you re only playing with the idea of tapping into the very lucrative OTC marketplace or if you are an expert in the area, this one-of-a-kind conference assesses the current switch landscape in the US and beyond, providing a comprehensive overview of marketing trends, cutting-edge technology and regulatory developments, while discussing lessons learned from past switches. The Rx to OTC Switch Summit brings together switch experts from Pfizer, Bayer Health Care Consumer Care, Sanofi- Chattem, Novartis, Johnson & Johnson, Reckitt Benckiser, BD Medical, the American Pharmacist Association, Penn State University College of Medicine, the American Academy of Nurse Practitioners and many more. The event features: Panel Discussions on Best Practices to Interact Effectively with the FDA when Applying for a Switch, Innovative Ideas to Leverage Collaboration with Retailers, Pharmacists and other Stakeholders and the Possibilities of Technology to Ensure Safe Use Interactive Workshop to Enhance your Switch Strategy and Provide you with a Road Map to Success Roundtables to Discuss Lessons Learned from Various Switches Presentations on the Regulatory Switch Landscape in the US and around the Globe, Successful Life Cycle Management Strategies, a Patient Centric Approach in Drug Development, Global Commercialization, Best Practices for Consumer Marketing, the Role of Medical Information, the Architecture of a High-Performance Switch Team and the Possibilities of Social Media for Safe Use Networking and Benchmarking sessions Be sure to register yourself and colleagues for this important event today We look forward to seeing you in Philadelphia come December! Sincerely, Kai Hahn Kai Hahn Senior Conference Director WHO SHOULD ATTEND: This event is designed for pharmaceutical, biotechnology, medical device and healthcare professionals, who have already switched products, those who are currently undergoing a switch and those who potentially forecast a switch down the road with responsibilities in the following areas: Brand Marketing Clinical/Medical Affairs Consumer Communication/Marketing Product Launch Commercialization Drug Safety DTC Marketing IT/Business Technology Packaging & Labeling Legal Lifecycle Management Managed Care MSL/Medical Information Product Development/Strategy Promotion Regulatory R & D SPONSORSHIP AND EXHIBIT 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, Sean Blank T: sblank@exlpharma.com MEET THE ADVISORY BOARD Ed Hemwall, Vice President, BAYER HEALTH CARE CONSUMER CARE Judith R. Plon, Associate Vice President Regulatory Affairs Consumer Healthcare US/Chattem, SANOFI Suzanne Brabant, Director, Global Regulatory Affairs, NOVARTIS CONSUMER HEALTH

3 DAY ONE PRE-CONFERENCE WORKSHOP Thursday, December 4, :00 Registration and Continental Breakfast for Workshop Participants 9:00 WORKSHOP: Explore Switch Strategy and Develop a Road-Map for a Successful Switch This master class offers valuable insights for senior managers contemplating switching a product from Rx to OTC and will help you determine next steps to create a road map. Understand the current switch landscape and regulatory requirements Outline the approach of an end-to-end switch Highlight post-switch considerations to keep new new and reach your customers Outline vital steps to create a road map for a successful Marketing Strategy Susan B. Levy, Founder & CEO, SUSAN B. LEVY CONSULTING 12:00 Lunch for Workshop Participants DAY ONE MAIN SUMMIT Thursday, December 4, :30 Registration 1:00 Welcome and Opening Remarks by Chairperson 1:15 Understand Recent Regulatory Developments in the US and Beyond Assess the current regulatory switch landscape in the US, China, Latin America, Australia, Japan and Europe Understand the FDA NSURE Initiative and outline how NSURE s goals coincide with the greater goals of the health care reform Examine FDA s authority, goal, objectives and strategy to approve and monitor OTC drugs with conditions of safe use David Hilfiker, Sr. Director, Global Regulatory Affairs, JOHNSON & JOHNSON FAMILY OF CONSUMER COMPANIES 2:00 PANEL DISCUSSION: Highlight Best Practices to Interact Effectively with the FDA when Applying for a Switch FDA Advisory Committee meeting preparation Understand the factors that might trier denial The do s and don ts when going through the application process Lessons learned from recent applications Judith R. Plon, Associate Vice President Regulatory Affairs, Consumer Healthcare US/Chattem, SANOFI Rosanne Rotondo, Vice President, New Growth Switch R&D Franchise Head, NOVARTIS CONSUMER HEALTH David Hilfiker, Sr. Director, Global Regulatory Affairs, JOHNSON & JOHNSON FAMILY OF CONSUMER COMPANIES Stephane Bissonnette, Director, Global Rx to OTC Switch Franchise; R&D Program Leader, BAYER HEALTH CARE CONSUMER CARE 2:45 Predict the Future of Switches and New Categories in the US and Beyond Discuss recent trends and developments around the globe and what the future of switches could look like Identify opportunities in the marketplace Predict which compounds could be switched in the near future and what categories are on the horizon Steve Francesco, President, FRANCESCO INTERNATIONAL 3:30 Afternoon Networking and Refreshment Break 4:00 PANEL DISCUSSION: Collaborate with Retailers, Pharmacists and other Stakeholders to Ensure Safe Use Discuss innovative ideas to ensure patient safety and comprehension Work towards shared accountability Highlight which role physicians and pharmacists can play in the furtherance of NSURE s goals Assess how pharmacists could be incentivized Understand the retailer perspective and what support they are willing to provide Outline ongoing work with all stake holders including government officials, policy-making bodies, patient advocacy organizations, pharmacy associations etc to improve adherence and safe use Jan Towers, Director of Health Policy/Federal Government & Professional Affairs, AMERICAN ACADEMY OF NURSE PRACTITIONERS Tom Menighan, Executive Vice President and CEO, AMERICAN PHARMACIST ASSOCIATION 4:45 Roundtables: Lessons Learned from Various RX to OTC Switches In this interactive session you will get a chance to discuss successful and unsuccessful switches with peers and exchange views, find out what worked and what didn t work for others and learn how they have tackled various challenges. Bernie Simone, Vice President, Corporate Development and Rxto-OTC Switches, CHATTEM -SANOFI Alankar Gupta, Executive Director & Franchise Head (CCR) Clinical, Medical, Safety, NOVARTIS CONSUMER HEALTH Eric Guenin, Director of Medical Affairs, RECKITT BENCKISER Steve Francesco, President, FRANCESCO INTERNATIONAL 5:45 End of Day One

4 DAY TWO MAIN SUMMIT Friday, December 5, :00 Registration & Continental Breakfast 8:55 Chairperson s Recap of Day One 9:00 Best Practices for Post-Switch Lifecycle Management (LCM): Products, Claims, Packaging and More Growing, Sustaining and Defending the new Switch Brand Venue: Why start LCM early in the Switch process Staging the investment for post-switch offerings Financial incentives Consumer-centricity Case studies Joseph Reo, R&D Lifecycle Management Lead, BAYER HEALTH CARE CONSUMER CARE 9:45 Applying a Patient-Centric Approach in Drug Development Identify what patients want and include real-life considerations into product development to maximize your reach and lay foundations for a switch early on Identify patient-centered outcomes (symptom, functional, and other outcomes affected by a disease or product and important to patients) through direct patient feedback Take a patient-centered approach and a holistic view of the patient Use patient-centered measures in pivotal trials Integrate patient, HCPs and pharmacists early on Shape the patient-provider conversation and provide the most relevant information targeted towards specific patient cases Include a representative sample of the target population throughout the drug-development life cycle Use real-time claims data to identify windows of opportunity Rosanne Rotondo, Vice President, New Growth Switch R&D Franchise Head, NOVARTIS CONSUMER HEALTH 10:30 Morning Networking and Refreshment Break 11:00 Assess the Architecture of a High Performance Switch Team Outline best practices in building a switch team Overcome common pitfalls in the collaboration between the Rx brand and the switch team Highlight the importance of a thorough competitive assessment Develop a vision and a claims and communication strategy (including label; behavioral support development; professional; consumer & managed care); packaging and trade / sales strategy; commercialization research plan Identify, develop and adjust global launch best practices Bernie Simone, Vice President, Corporate Development and Rx-to-OTC Switches, CHATTEM -SANOFI Hyatt at the Bellevue 200 South Broad Street Philadelphia, PA To make reservations guests can call and request the negotiated rate for ExL December Meetings. The group rate is available until November 12, Please book your room early as rooms available at this rate are limited. 11:45 PANEL DISCUSSION: Leverage Technology to Ensure Safe Use Highlight cutting-edge technologies that could become a game changer in the near future Combine technology with analysis, education and measurement Create monitoring mechanisms through technology Assess the possibilities and barriers of mobile apps to ensure safe use Discuss interactive labeling Overcome literacy and comprehension issues through technology Assessing the possibilities of cutting-edge labels and packaging Brian Swankoski, Senior Director, Business Technology R&D and Rx to OTC Switch, PFIZER CONSUMER HEALTHCARE David Lee Scher, Clinical Associate Professor of Medicine, Heart and Vascular Institute, PENN STATE UNIVERSITY COLLEGE OF MEDICINE 12:30 Networking Luncheon 1:30 Outline the Role of Medical for a Successful Switch Understand what medical activities need to be completed Highlight collaboration with Marketing and required materials Outline best practices for training other departments Overcome common challenges Tamar Yarkoni, Pharm D., Senior Manager, Medical Information, SANOFI 2:15 Use Marketing Intelligence and Leverage Data to Develop a Successful Global Marketing Switch Strategy Understand how purchase history can be connected to the journey of a consumer Highlight opportunities to leverage this data Build meaningful reports and understand how to max out on your data through predictive analytics Develop a category/brand strategy and execute detailed plans for implementation in line with the divisional short term and long term objectives Forecast brand performance based on investment assumptions and market dynamics Focus on keeping existing customers Speaker To Be Determined If you are interested in speaking, please contact Sean Blank at sblank@exlpharma.com 3:00 Afternoon Networking and Refreshment Break 3:30 Leverage Social Media for Patient Adherence Harness Social Media as an information source for patient needs and patient-reported outcomes Understand the fundamental personal media choices of mobile, app, social media, , and SMS, and how they relate to the support needs and lifestyle requirements of different patient groups Use social media as a effective method for monitoring adherence James Walker, Global Leader of Strategic & Clinical Marketing, BD MEDICAL - DIABETES CARE 4:15 End of Summit and Closing Remarks

5 REGISTRATION INFORMATION Media Partners To Register Contact: Marcie Cruz or Registration Fees for attending ExL s RX TO OTC SWITCH SUMMIT EARLY BIRD PRICING* Register by October 24, 2014 Conference & Workshop: $2,095 Conference Only: $1,795 STANDARD PRICING* Register after October 24, 2014 Conference & Workshop: $2,295 Conference Only: $1,995 GROUP DISCOUNT PROGRAMS: *Offers may not be combined. Early Bird rates do not apply* 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 4 at one time) this is a savings of 25% per person. Save 15% per person when registering three Can only send three? You can still save 15% off of every registration. ONSITE PRICING* Conference & Workshop: $2,395 Conference Only: $2,095 *Includes Sales Taxes and Service Fees Questions? Comments? Do you have a question or comments that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please Program Director, Kai Hahn, at khahn@exlpharma.com TERMS & 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. Payment: Make checks payable to ExL Events, Inc. and write code C582 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full prior to the commencement of the conference. 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. Group discounts available to individuals must be registered simultaneously and employed by the same organization. CANCELLATION AND REFUND POLICY If you need to cancel your registration for an upcoming ExL event, please note the following policies derived from the Start Date of the event: n Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date. n Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date If you cancel within five business days or at any time after receiving the conference documentation, the voucher issued will be $395 less. SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference. 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. * The opinions of ExL speakers do not necessarily reflect those of the companies they represent, nor ExL Events, Inc. Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL Events, Inc. s ( ExL s ) designated speakers and is designed for informational purposes for its attendees, and is NOT INTENDED for purposes of copywriting, nor redistribution to other outlets without the express written permission of ExL s designated speaking parties. Neither ExL, nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY THE CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of or endorse the views or opinions given by any third party content provider. ExL presentations may point to other Internet sites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites

6 To Register Contact: Marcie Cruz or Method of Payment: Check Credit Card Make checks payable to ExL Events, Inc. Card Type: MasterCard Visa Discover AMEX Card Number: Exp. Date: Name on Card: Yes! Register me for the Conference + Workshop Yes! Register me for the Conference Please contact me: I wish to receive updates on ExL Pharma's upcoming events Signature: Conference Code: C582 Name: Title: Company: Dept: Address: City: State: Zip: Phone: Fax: THE ONLY EVENT COVERING A SWITCH FROM END-TO-END RX TO OTC SWITCH SUMMIT Assessing the Future of Switches in the US and Beyond DECEMBER 4-5, 2014 HYATT AT THE BELLEVUE PHILADELPHIA, PA