November 11-12, 2021
Online Livestream
2nd Rx to OTCSymposium
Leverage Novel Digital Tools, Telemedicine and eCommerce Breakthroughs to Maximize Success at Launch
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Rx to OTC switches become even more important in the current era where responsibility for healthcare is being assigned to consumers. In new scenarios where consumers are making important decisions about their care, we must first improve the problems of access to and costs of medicines. Increasing the availability of appropriate over the counter medicines helps ease the burdens of cost and access.
The strategy and execution of a successful Rx to OTC switch requires assurance that consumers can self-diagnose, self-treat and self-manage on their own and that the drug has low potential for misuse and abuse. Demonstrating that a medicine should switch from prescription to over the counter requires the help of a cross functional team including regulatory, clinical, and marketing. DGE’s Rx to OTC Switch Symposium provides an excellent opportunity to bring your team together to talk about the latest challenges and opportunities in switches including human factor studies to help prevent misuse of products, digital tools to enable switching in more difficult categories, and the impact of increasing use of telemedicine on the potential for a switch.
Top Reasons to Attend
  • Gain an update on DTC companies causing a barrier to traditional switch and the current consumer landscape
  • Take a deep dive into strategies for commercializing switches and retail execution
  • Identify the pathway moving forward from the FDA and regulatory approaches
  • Obtain an update on digital initiatives to aid more complex switches
  • Determine how to manage COVID related regulatory and clinical delays
Agenda at a Glance

Topics covered will include:

  • Conduct human factors studies to help prevent misuse of a product and improve packaging
  • Use digital tools including medical devices and apps to accompany more complex products
  • Determine whether telemedicine will slow or quicken future switches
  • Highlight the current landscape and areas most currently active for switch candidates
  • Work cross functionally to develop claims and bring science to life
Who Should Attend

This conference is designed for pharmaceutical, biotech, and medical device professionals responsible for:

  • Rx-to-OTC Switch/Rx Access
  • Regulatory Affairs
  • Brand Management
  • Product Management
  • Brand Marketing
  • Legal Affairs
  • Digital
  • Medical/Scientific Affairs
  • Consumer Healthcare Products
  • Consumer Marketing
  • Clinical Development
  • Clinical Trial
  • Drug Safety
  • Research and Development
  • Business Strategy
  • Packaging & Labeling
  • Drug Delivery Technology
  • Product Development
  • Portfolio Strategy
  • Project Management
Event Sponsors
Conference
New Topics
Featured Speakers
Alankar Gupta
Associate Vice President, Global Head Medical Rx to OTC Switch
SANOFI
Anna Maxwell
CEO
Maxwellia
David Grob
Director of Regulatory Affairs
AVRIO HEALTH L.P.
Erin Oliver
Head, US Regulatory Affairs
GSK Consumer Healthcare
Frank M. McCabe
Pharmacy Operations Manager
Allegheny Health Network
Heidi Gertner
Partner
Hogan Lovells US LLP
Izabela Sadej
Policy Analyst
PEPReC VA Boston, Boston University
Jeffery Reichard
Jeffrey Reichard
Director of Pharmacy
UNC HEALTH
Jerry Valentine
Senior Director, Business Development, New Technology
AstraZeneca
Joshua Cohen
Independent Healthcare Analyst
Joshua P. Cohen Healthcare Analytics, LLC
Kate Stockman
Pain Category Lead, Senior Director, Global Regulatory Affairs
GSK Consumer Healthcare
Kevin Homler
Senior Director and Commercial Lead, Rx to OTC Switch
GSK Consumer Healthcare
Matt Poli
President and Founding Partner
Conduit Brands
Mike Power
former Vice President Marketing
Pfizer Consumer Health
Russell Bradford
Senior Vice President, Medical Affairs
PEGUS Research
Stephen Mann
Stephen Mann Associates
Susan B. Levy
Founder & Principal
SUSAN B. LEVY CONSULTING, LLC
Terri Goldstein
Founder and CEO
Goldstein Group Branding
Vidhu Bansal Dev
Vidhu Bansal Dev
Vice President, Rx to OTC Switch and Digital Transformation, R&D
GSK Consumer Healthcare
Event Schedule
ALL TIMES ARE IN EST
There were five switched products in 2020 and one in 2021, after a fairly long period of few switches. Get an inside look at successful case studies and winning teams.
  • What were the recent Rx-to-OTC switches?
  • What lessons can we learn from a regulatory or commercial perspective from these switches?
  • What is the ideal way to structure an Rx-to-OTC switch team to drive regulatory and commercial success?

This session will focus on how the environment both from a regulatory, technology, and consumer perspective is rapidly evolving and considerations sponsors will need to take into account early on in order to create winning switches for the U.S. market.

More complex switches can be accompanied by digital tools that aid the consumer with self-diagnosing and managing treatment. Hear about innovative tools and how to use them.
  • Review how smartphones support consumers in managing care through apps and even closed loop technology
  • Consider how an increase in remote health monitoring could aid patient use of OTC products
  • Learn about advances in supporting health literacy with technology
  • Regulatory exclusivities
  • Use of technology
  • FDA priorities/switch drivers
  • Expanded labeling/conditions of use
Review the items critical for a successful regulatory strategy.
  • Gain an understanding of what is required for regulatory approval to switch and how best to demonstrate safety
  • Prepare the risk/benefit proposition
  • Understand data requirements that may be needed depending on the nature of the switch

Find out more about overcoming challenges involved in a successful switch for non-traditional products, including:

  • Addressing and overcoming key selection problems
  • Innovative labeling changes
  • NSURE conditions
  • Creating the right consumer research program to address regulators' issues
  • Remote/decentralized research methods
  • Overcoming obstacles with recruitment and enrollment
  • Assessing literacy
  • Human factors
ALL TIMES ARE IN EST
The panel discusses the status of current healthcare initiatives for giving consumers/patients more responsibility for managing and paying for their care. This puts access and affordability in the spotlight.
  • Discuss varying pros and cons of the impact of switches on consumers
  • Share perspectives on future of switches
  • Hear about other relevant healthcare policy initiatives and trends impacting switch
Rx to OTC Switch is handled differently around the world. Gain perspective on new developments and how switches are managed internationally.
  • Discover the specifics of a second or third class of drugs used in countries around the word
  • Explore where the most recent switch activity has occurred and for what therapeutic areas
  • Recognize similarities and differences and what that means for a global launch
Are you overlooking a good potential candidate for a switch? Gaining deeper understanding of the therapeutic area landscape can help boost your chances of finding the right prospective molecule.
  • Analyze therapeutics areas and product types to evaluate switch potential
  • Investigate which product areas are most active for switch products
  • Benefit from key takeaways from case studies of switched products
Telemedicine is upending the healthcare industry and COVID-19 has only accelerated its adoption. Despite being heavily regulated, a new generation of Pharma brands are leading the charge through uncharted territory with direct-to-consumer strategies—this includes prescription brands like Roman, Hims and
Nurx and OTC brands like Care/Of. Digital platforms represent a massive frontier for healthcare companies but as competition increases brands need thoughtful visual, marketing and business strategies. This talk will reveal the fundamentals of DTCs:
  • How to use the E-Sight Sequence ™, a proprietary understanding of a consumer’s sequence of cognition online, to maximize a brand impact and conversion.
  • Using color and the science of brand design to build memorability and presence online.
  • How to use online media to increase sales.
  • How to set up a successful DTC supply chain including shipping partners.
  • How virtual prescribing works.
Switch success depends on pharmacy engagement. Your plans must ensure that pharmacists stay equipped to help consumers find and choose your product.
  • Enhance tools for educating pharmacists on available switches
  • Discuss the evolving role of the pharmacist in healthcare today
  • Consider ways to gain best placement on pharmacy shelves for your switched products
Register Now

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Event Partners
15
Speakers
21
Days
251
Participants
125
Workshops
90
Venue
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