Circles For OTC and Nutraceutical Firms
April 11, 2023
Circles For OTC and Nutraceutical Firms
TABLE OF CONTENTS
Improve Distributor Relations and Effectiveness
Engage With and Attract Clinical Influencers
Summary
Two major trends in healthcare have important regulatory and marketing significance for the OTC drug and nutraceutical markets. These are registries and real-world evidence.
Real world evidence is not only an adjunct to traditional clinical trials; it is often of primary importance in supporting safety and efficacy. Registries, properly constructed, provide large databases of real-world data from which statistically and clinically significant correlations can be derived.
RegenMed’s Circles provide a turnkey registries solution allowing industry participants to drive sustained return on investment in the context of their research operations, regulatory affairs and provider/consumer engagement.
Market Challenges
The OTC drug and nutraceutical markets share several characteristics, including:
- High growth rate; dynamically evolving markets.
- Strong competition, placing a premium on branding and marketing.
- Increased regulatory oversight and scrutiny of marketing claims.
- High research costs, and lengthy time to market.
- Criticality of distribution systems.
- Increasingly discerning consumers.
Illustrative Use Cases
The establishment of registries by companies in the OTC drug and nutraceutical spaces can support the following:
Regulatory
New Drug Applications
Randomized, controlled clinical trials will always have their place in NDAs. However, regulators, payers and providers also recognize the value of verifiable real-world evidence. Such RWE derives from, for example, pragmatic trials, observational studies, case series and quality improvement studies.
Registries can apply a common study design to a large number such studies. This in turn generates statistically and clinically significant correlations faster, and at a lower cost, than traditional approaches. In some instances, such registries may be sufficient to meet regulatory needs; in others, they are important adjuncts.
This approach is effective for traditional as well as Abbreviated NDA’s.
Consumer Studies
OTC drug companies may be required to conduct label comprehension, self-selection, actual use and/or human factor studies. These provide assurance to the regulatory body that the consumer is able properly to assess and use the product in the absence of healthcare provider guidance. Registries are an economical way to do so.
Post-Market Surveillance
The U.S. post-market surveillance programs may apply to OTC drugs. Properly structured registries are an efficient approach to conducting such surveillance.
Research
An important characteristic of real-world data is its large n-value. In principle, this allows for not only the conformation of pre-supposed clinical/scientific hypotheses, but also the identification of “serendipitous” correlations. Moreover, real-world evidence registries can substantially reduce the cost of patient and investigator enrollment and follow-up.
Improve Distributor Relations and Effectiveness
Distributors are typically the critical connectors between manufacturers and providers and/or consumers. In the competitive environment of OTC drugs and nutraceuticals, distributors seek manufacturers with the most compelling products, marketing strengths and brand stories. The registry use cases described in this article give distributors substantive, fresh and evidence-based talking points for their interactions with providers, pharmacies, and consumers.
Engage With and Attract Clinical Influencers
Healthcare professionals increasingly recommend OTC drugs and nutraceuticals alongside ethical drug prescriptions and other treatment protocols. Demonstrating safety and efficacy is therefore not merely important in obtaining market authorization. It is critical in developing positive relationships with key clinical opinion leaders.
Registries are ideal platforms through which physician or scientific influencers can be involved as study investigators, medical experts, conference speakers and other capacities.
Branding, Marketing
Correlations from registries – and indeed the fact of the registries themselves – provide ongoing data-driven substance for marketing materials. Such materials can be used not only at medical conferences and articles, but in social media channels directed to providers and clinicians alike.
Consumer motivation usually derives from perceived efficacy in achieving general well-being, improved aesthetics, prevention or management of chronic disease, longevity, fitness, and/or sport performance. There is indeed already a trend towards evidence-based marketing. Well designed and executed registries can capitalize on this trend.
New Indications
Registries represent a substantial number of trial sites collaborating on a common study design in the context of the investigators’ specific clinical environments. The better the registry platform capitalizes on that collaboration, the more likely clinicians are likely to discover and develop new evidence-based indications.
Sustained Consumer Engagement
Leading manufacturers develop communities among their users which foster mutual support, stories, and discussion. These communities can contain their own two-way registries comprising consumer-reported outcomes, improvement against personal and group goals, physician thought-leader commentary, educational programs, etc.
Reimbursement
Registries can provide payers – including employer groups and other sponsors of narrow networks – with the data they need to justify reimbursement of OTC drugs and nutraceuticals.
Circles-Based Registries
General
Circles represent a turnkey, integrated approach to outcome capture, studies, registries, publication, and other solutions. A successful Circle comprises two closely integrated components:
- inCytes™ , the Company’s proprietary technical platform.
- Circle Academies, which enable the collaboration, education, discussion, publication, and the “network effect” needed to realize the full potential of correlations developed through inCytes™.
Circles provide excellent user experiences – and motivation -- for clinicians, patients, and other users. More information can be found on its website, rgnmed.com.
Circles For Registries
As mentioned, registries are increasingly common in the healthcare world. Circles-based registries are clinical-grade, turnkey and designed and executed with sustained return on investment for the Client in mind. They represent a powerful approach for OTC drug and nutraceutical manufacturers to meet a variety of clinical, regulatory and marketing challenges.
Please contact us to find out more.
Copyright © 2023 Regenerative Medicine LLC
Circles For OTC and Nutraceutical Firms
April 11, 2023
TABLE OF CONTENTS
Improve Distributor Relations and Effectiveness
Engage With and Attract Clinical Influencers
Summary
Two major trends in healthcare have important regulatory and marketing significance for the OTC drug and nutraceutical markets. These are registries and real-world evidence.
Real world evidence is not only an adjunct to traditional clinical trials; it is often of primary importance in supporting safety and efficacy. Registries, properly constructed, provide large databases of real-world data from which statistically and clinically significant correlations can be derived.
RegenMed’s Circles provide a turnkey registries solution allowing industry participants to drive sustained return on investment in the context of their research operations, regulatory affairs and provider/consumer engagement.
Market Challenges
The OTC drug and nutraceutical markets share several characteristics, including:
- High growth rate; dynamically evolving markets.
- Strong competition, placing a premium on branding and marketing.
- Increased regulatory oversight and scrutiny of marketing claims.
- High research costs, and lengthy time to market.
- Criticality of distribution systems.
- Increasingly discerning consumers.
Illustrative Use Cases
The establishment of registries by companies in the OTC drug and nutraceutical spaces can support the following:
Regulatory
New Drug Applications
Randomized, controlled clinical trials will always have their place in NDAs. However, regulators, payers and providers also recognize the value of verifiable real-world evidence. Such RWE derives from, for example, pragmatic trials, observational studies, case series and quality improvement studies.
Registries can apply a common study design to a large number such studies. This in turn generates statistically and clinically significant correlations faster, and at a lower cost, than traditional approaches. In some instances, such registries may be sufficient to meet regulatory needs; in others, they are important adjuncts.
This approach is effective for traditional as well as Abbreviated NDA’s.
Consumer Studies
OTC drug companies may be required to conduct label comprehension, self-selection, actual use and/or human factor studies. These provide assurance to the regulatory body that the consumer is able properly to assess and use the product in the absence of healthcare provider guidance. Registries are an economical way to do so.
Post-Market Surveillance
The U.S. post-market surveillance programs may apply to OTC drugs. Properly structured registries are an efficient approach to conducting such surveillance.
Research
An important characteristic of real-world data is its large n-value. In principle, this allows for not only the conformation of pre-supposed clinical/scientific hypotheses, but also the identification of “serendipitous” correlations. Moreover, real-world evidence registries can substantially reduce the cost of patient and investigator enrollment and follow-up.
Improve Distributor Relations and Effectiveness
Distributors are typically the critical connectors between manufacturers and providers and/or consumers. In the competitive environment of OTC drugs and nutraceuticals, distributors seek manufacturers with the most compelling products, marketing strengths and brand stories. The registry use cases described in this article give distributors substantive, fresh and evidence-based talking points for their interactions with providers, pharmacies, and consumers.
Engage With and Attract Clinical Influencers
Healthcare professionals increasingly recommend OTC drugs and nutraceuticals alongside ethical drug prescriptions and other treatment protocols. Demonstrating safety and efficacy is therefore not merely important in obtaining market authorization. It is critical in developing positive relationships with key clinical opinion leaders.
Registries are ideal platforms through which physician or scientific influencers can be involved as study investigators, medical experts, conference speakers and other capacities.
Branding, Marketing
Correlations from registries – and indeed the fact of the registries themselves – provide ongoing data-driven substance for marketing materials. Such materials can be used not only at medical conferences and articles, but in social media channels directed to providers and clinicians alike.
Consumer motivation usually derives from perceived efficacy in achieving general well-being, improved aesthetics, prevention or management of chronic disease, longevity, fitness, and/or sport performance. There is indeed already a trend towards evidence-based marketing. Well designed and executed registries can capitalize on this trend.
New Indications
Registries represent a substantial number of trial sites collaborating on a common study design in the context of the investigators’ specific clinical environments. The better the registry platform capitalizes on that collaboration, the more likely clinicians are likely to discover and develop new evidence-based indications.
Sustained Consumer Engagement
Leading manufacturers develop communities among their users which foster mutual support, stories, and discussion. These communities can contain their own two-way registries comprising consumer-reported outcomes, improvement against personal and group goals, physician thought-leader commentary, educational programs, etc.
Reimbursement
Registries can provide payers – including employer groups and other sponsors of narrow networks – with the data they need to justify reimbursement of OTC drugs and nutraceuticals.
Circles-Based Registries
General
Circles represent a turnkey, integrated approach to outcome capture, studies, registries, publication, and other solutions. A successful Circle comprises two closely integrated components:
- inCytes™ , the Company’s proprietary technical platform.
- Circle Academies, which enable the collaboration, education, discussion, publication, and the “network effect” needed to realize the full potential of correlations developed through inCytes™.
Circles provide excellent user experiences – and motivation -- for clinicians, patients, and other users. More information can be found on its website, rgnmed.com.
Circles For Registries
As mentioned, registries are increasingly common in the healthcare world. Circles-based registries are clinical-grade, turnkey and designed and executed with sustained return on investment for the Client in mind. They represent a powerful approach for OTC drug and nutraceutical manufacturers to meet a variety of clinical, regulatory and marketing challenges.
Please contact us to find out more.
Copyright © 2023 Regenerative Medicine LLC