Featured Speakers
Alankar Gupta
SANOFI
Associate Vice President, Global Head and Clinical, Rx to OTC Switch
Ameet Suratkar
AbbVie
Head of Marketing
Andrea Leonard-Segal
ANDREA LEONARD-SEGAL M.D. CONSULTING, LLC.
President and Chief Executive Officer
Anna Strzelecka
GALDERMA
Head of UK Marketing, Aesthetics
Bruce Lifka
WELMEDIX CONSUMER HEALTHCARE
President, Americans Region, Consume Healthcare
Dahai Guo
ZENNOVA PHARMACEUTICALS
Chairman and CEO
David Grob
AVRIO HEALTH L.P.
Director of Regulatory Affairs
Erin J. Leslie
SANOFI
Assistant General Counsel, Consumer Healthcare
Frank M. McCabe
ST. JOSEPH’S HEALTH
Pharmacy Manager, Pharmacist in Charge
Jeffrey Reichard
UNC HEALTH
Director of Pharmacy, Home Delivery and Specialty Pharmacy
Kate Stockman
GLAXOSMITHKLINE CONSUMER HEALTHCARE
Pain Category Lead, Global Regulatory Affairs
Kristie Licata
BAYER CONSUMER HEALTH
Vice President, Rx to OTC Switch
Mayank Bansal
AbbVie
Director of Product Development
Paul Wardle
BEACON ASSOCIATES, LLC
Founder and Principal
Philip Kantor
KANTOR STRATEGIC MARKETING, LLC
Principal, Consumer Health Consulting
Randall Thornton
EMORY HEALTHCARE
Clinical Pharmacist
Spiros Verginis
BAUSCH HEALTH
Head of Business Unit, Rx and OTC
Sriman Banerjee
TAKEDA
Head of Packaging Development
Susan B. Levy
SUSAN B. LEVY CONSULTING, LLC
Founder & Principal
Vidhu Bansal Dev
GLAXOSMITHKLINE
Vice President, Rx to OTC Switch and Digital Transformation, R&D
Event Schedule
Switches are often considered in a company when a patent is near its expiration date because the price drastically decreases. Another crucial consideration is whether the drug’s safety profile is clean and safe for consumers to use.
• Determine when the patent on a drug expires and whether it will benefit the company to make the switch
• Assess consumer needs to determine if there is a market need for it
• Evaluate scale and volume and how the business model will change and determine if the company is prepared to handle these changes
Rx-to-OTC Switch can be a high-risk/high-reward proposition. In order to maximize the potential of an Rx to OTC switch, it is critical to ensure that the proposed switch is addressing an unmet consumer need. In addition to this, a switch must make strong financial sense for your company.
• Evaluate unmet consumer needs
• Build a dynamic forecast model
• External considerations that could impact the financial viability of your switch
A submission process can be lengthy and expensive. Save time and money by
creating an organized plan and understanding of what is required for approval.
• Hold preliminary meetings with the FDA before submission to determine the potential for a switch
• Conduct consumer behavior studies that demonstrate the medication can be taken without HCP supervision
• Create arguments that show the benefits outweigh the risks
• Provide sufficient data demonstrating the safety profile of the drug
It is important to determine how to address labeling and packaging needs while staying in compliance. Proper consideration for key safety features is a must.
• Understand key packaging considerations in Rx to OTC switches
• Discuss the challenges on Rx package insert and adaptation for OTC
• Evaluate key aspects for on shelf presence
• Examine supply chain and scale up challenges
In order to have a drug approved for OTC use, sufficient data has to be submitted to the FDA demonstrating that consumers will understand how to use the product safely. This data is collected though consumer behavior studies.
• Establish communication objectives for your drug facts language and provide an assessment of the consumer’s ability to understand the OTC labeling through label comprehension studies
• Test if consumers will be able to determine whether they should or should not use the product through self-selection studies
• Analyze how consumers will behave in a real world setting and whether they can use the product correctly through actual use studies
Breaking into an OTC market can be challenging and requires creative and innovative marketing strategies.
• Conduct consumer research to determine what consumers are looking for and how they behave when finding products
• Compete for positions on the shelf in retail stores and obtain the best displays
• Demonstrate value by pricing competitively
• Create eye-catching designs
A switch is a complex process and may seem like daunting task to smaller
companies that lack the resources. How can smaller companies align their
strategy to become a player in this field?
• Obtain an understanding of what is required
• Fully understand your drug proposition and unmet consumer needs
• Stay focused and ensure your plan aligns with FDA requirements to give you commercial success
• Rely in bulk and less advertisement until you build a larger base
• Partner with someone who has a large space in OTC
Marketing to doctors and other HCPs is drastically different from marketing to
consumers. HCPs are more concerned with scientific data behind a product.,
whereas consumers are interested in how a product can help them.
• Discuss new marketing and branding strategies for selling power
• Understand the OTC landscape
• Discuss how to make a difference and be at the forefront of consumer minds
Consumers can take advantage of utilizing pharmacists, as they are extremely
knowledgeable about medications and are easily accessible. How should drug
companies bear this in mind when planning upcoming switches?
• Educate consumers on medications
• Transfer responsibility from HCPs and allow pharmacists to play an active role in consumer health
• Bridge the gap for consumers who may not have access to healthcare
Providing access to more OTC medications empowers consumers to take control
of their health. With that accomplished, they can achieve better health
outcomes while avoiding market cost increases.
• Discuss the benefits of consumers taking more control of their health and allowing them to feel empowered to make their own health decisions
• Prevent consumers from neglecting their own treatment due to lack of access to HCPs
• Drive affordability without relying on insurance and copays
Digital platforms are a necessary tool in consumer engagement. They can help
pharmacies understand consumer needs and behavior patterns. Digital
platforms can also be a great tool to collect data from consumers.
• Share the role of digital platforms for consumer engagement at a leading health-system outpatient pharmacy
• Explain lessons learned in creating a digital presence that is consumer-centric and allows consumers virtual engagement with care providers
• Propose future directions in digital platforms for outpatient pharmacy
The evolving consumer behavior and new era of switches will benefit from a new
focus on digital engagement. This session covers the value of incorporating
technology for Rx to OTC switches.
• Promote safety usage
• Embrace wearables and digital technology
• Utilize AI
• Take advantage of future packaging
Every organization grows its business by introducing new products (or services) to the market. An effective approach for development and launch of new products ensures success by minimizing the chance of failure. This presentation will focus on the following:
• Process of taking the product from a concept to commercialization that provides rapid R&D time and cost efficiency
• Strategic Project Management for flawless execution
• Managing R&D and scale up to prepare to larger markets
• Artificial Intelligence in Process Validation
Gain an understanding of how other markets handle switches while exchanging
best practices and novel strategies. Each company’s advances earn credibility for
switches as a whole across the industry, setting everyone up for success.
• Highlight each market
• Discuss how other countries are handling switches
• Unify regulations and systems
Innovative strategies and leadership practices spell success or failure for
switches. By reviewing what has worked in the past, you can improve the
likelihood of securing approval and commercial success moving forward.
• Discuss recent legislative changes
• Outline the FDA’s authority, goals, and objectives
• Create a guide and pathway for future switches
Rx companies with switchable prescription assets can achieve long-term life cycle value by pursuing an Rx to OTC switch. Driving success with OTC drugs requires different capabilities than driving success with Rx drugs, however, and therefore a strategic assessment of whether to build, borrow, or buy those capabilities is a critical part of the Rx to OTC switch process.
• Discuss how Rx and OTC capabilities differ
• Analyze the options that should be considered to ensure that OTC capabilities are established for the switch
• Consider partner selection if you choose to partner with an OTC company
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