Conference Schedule
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

Benefit from an examination of FDA’s 2018 draft guidance about innovative approaches for OTC drugs, as well as:

  • Understand the market for switches
  • Hear about FDA laws governing switches and FDA processes involved with switching
  • Consider the market exclusivities associated with switching
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
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