Iqvia Holdings, Inc. · NYSE:IQV
Iqvia — Technical Presentation (October 2021)
21 slides from Iqvia's technical presentation, Oct 28, 2021
Slide 1: New Paths to Applying RWE to OTC Medicines
New Paths to Applying RWE to OTC Medicines 28 October 2021 © 2021. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Slide 2: Speakers
Speakers Christelle Anquez-Traxler Emese Csőke Dr. Sabine Landes Denise Pohlhaus Regulatory and Scientific Global Regulatory Medical Safety Medical Head CHC Germany Director Digital Solutions Affairs Manager and Compliance (RMSC) Strategy Sanofi Consumer Healthcare GSK Consumer Healthcare AESGP Dire
Slide 3: RWE and OTC today
TLL PANANANRANAART RWE and OTC today
Slide 4: Evidence for OTC drugs primarily generated through classic clinical research
In the past, evidence to support decision making during the life cycle of OTC drugs was primarily generated through «classic» clinical research methods Randomized-controlled clinical trials as «gold standard» come with certain limitations Evidence gap between RCT and the real world RCTs Real-World N
Slide 5: RWD and RWE playing an increasing role in health care decisions
In Pharma, Real-World Data (RWD) and Real-World Evidence (RWE) are playing an increasing role in health care decisions According to US FDA's definition, RWE RWE is the information derived is the clinical evidence regarding the from analysis of RWD. usage and potential benefits, or risks of a medical
Slide 6: How can real-world evidence aid decision making for non-prescription medicines?
How can real-world evidence aid decision making during the life cycle of non-prescription medicines? New Paths to Applying RWE to OTC Medicines - IQVIA Consumer Health - October 2021 6
Slide 7: How can RWE be applied to decision making for medicines?
How can RWE be applied to decision making for medicines? RCT RWE • High internal validity • Higher external validity Current limitations • Remain necessary to demonstrate • Can complement evidence derived efficacy and safety for new drug from RCTs of RWD: approvals • incomplete and non- • Understand
Slide 8: The non-prescription medicine life cycle
The non-prescription medicine life cycle Life cycle of medicines Launch STAGES Clinical Post approval life Late life cycle Prescription Research Non-clinical Development Regulatory Market access/ cycle management (Generics entry & Discovery Development Review Reimbursement Medicines (Phase I, II, II
Slide 9: Real-world evidence – where is the data sourced?
Real-world evidence – where is the data sourced? 01 02 Prescription- only medicines Non-prescription medicines Spontaneous adverse event reporting Real-world studies Population health surveys Social media Patient/consumer surveys Health apps Electronic health records Non-prescription Medicines Presc
Slide 10: Defining real-world data to enable use with OTC medicines
Defining real-world data to enable use with OTC medicines RWD is a broad term which lacks a single internationally agreed definition EMA FDA Different approach (Cave at al) (FDA RWE Framework) needed for OTC Data relating Routinely collected data relating to a patient’s to patient health RWD should
Slide 11: Panel Discussion
Panel Discussion 11
Slide 12: Q – Data Gaps
Q – Data Gaps 1. How can we foster routinely collected data for OTC as well as encourage the consideration of observational data around non-prescription medicines? 2. Is patient generated health data a real opportunity for OTC RWE? 12
Slide 13: Where might RWE aid decision making for OTC medicines?
Q- Where might RWE aid decision making when it comes to OTC medicines? 13
Slide 14: Aiding decision making – RWE/OTC examples
Aiding decision making – RWE/OTC examples Rx-to-OTC Switch Real Life Effectiveness Post-Marketing Safety Orlistat | Flurbiprofen Nicotine Replacement Therapy Ibuprofen 14
Slide 15: Biggest hurdles for utilizing RWE in the OTC space
Q- What are the biggest hurdles at the moment for utilizing RWE in the OTC space? 15
Slide 16: What needs to happen next to harness the power of RWE
Q- What is the one thing that needs to happen next to ensure the power of RWE can be harnessed to help drive the future of OTC medicines? 16
Slide 17: Q&A
Q&A 17
Slide 18: Conclusion
Conclusion 18
Slide 19: What is needed to make RWE and digital research successful now?
What is needed to make RWE and digital research successful now? Start to engage and create high-quality outcomes to convince regulators Advantages Get ready Success • Opportunities for new claims and for RWE • Be open to innovate how to approach indications evidence generation despite uncertainties
Slide 20: Your IQVIA Consumer Health contact
Your IQVIA Consumer Health contact Volker Spitzer Senior Director, Global Consumer Health R&D Services, IQVIA Consumer Health Please submit your questions and enquiries to: consumer.health@iqvia.com Or visit iqviaconsumerhealth.com for more information Virtual Real-World Research: The new normal in
Slide 21: Thank You
SIQVIA CONSUMER HEALTH Thank You