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TABLE OF CONTENTS‍ABSTRACTTHE IMPORTANCE OF REAL-WORLD EVIDENCEELEMENTS OF A REAL-WORLD EVIDENCE PROGRAMSTRATEGIC BENEFITS OF A CIRCLE PROGRAM Provider Engagement More Efficient Trials and Studies Product Improvement/Development Consumer/Patient Branding Cost ReductionLEARN MOREENDNOTESAbstractA Real-World Evidence Program based on Circles can represent a strategic pillar of the business plan for any medical product company. It can generate sustained return on investment in the context of provider engagement, research initiatives, product development, company branding, and regulatory submissions/compliance.RWE is fast becoming an essential component of value-based care, health equity, and controlling costs. RWE, in turn, is derived from the large amounts of real-world data (RWD) generated daily in busy clinical practices. Circles integrate the technology and processes required to capture RWD, generate RWE, and convert it into value. Importantly, Circles do so with minimal administrative burden, excellent clinical and patient user experience, and at a low cost.RegenMed works as a long-term partner with product manufacturers to help them achieve multiple strategic objectives through a Circles-based Real-World Evidence Program.The Importance Of Real-World EvidenceProduct manufacturers must rely heavily on research and trials for INDs, IDEs, PMAs, 510Ks, post-market surveillance and other regulatory approvals. However, the cost, delay, and exclusionary criteria of traditional clinical trials have become serious obstacles to genuine clinical translation for most indications and patient populations. [1] As a result, pragmatic, “n of 1”, properly curated registries [2], and other modern study designs based on RWE are seen as providing critical support for, and often alternatives to, traditional RCTs. Recent FDA draft guidance, for example, states that RWE “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”. [3]RWE is fast becoming an essential element of most of the major trends in healthcare – value-based care, health equity/SDOH, controlling costs, regenerative medicine, and precision care and “bending the cost curve”. [4]Elements Of A Real-World Evidence ProgramA Circles-based Real-World Evidence Program (RWP) can be modest or comprehensive. It is modular, flexible, and scalable. A typical RWP comprises the following sequence and elements: Development of two to three Circles targeting clinical/scientific endpoints with particular relevance to the manufacturer’s targeted provider segment. Principal investigators are identified from current product users, or other thought leaders recruited by RegenMed.Recruitment of five or more current users as Circle co-investigators.Link to a Join-A-Circle page to enhance recruitment of additional existing and prospective users as co-investigators. This is actively promoted by RegenMed.Establishment of dedicated research pages on the principal investigators’ websites, which are also actively promoted by the investigators. This page describes Circles protocols, endpoints, principal, and co-investigators, and developing real-world data.Communications through posts from principal investigators, RegenMed newsletters and other suitable communication channels of preliminary aggregated data and related observations. Use of Circle Academies to host periodic “Circle Hours” among investigators and other Circle members. If desired, these discussions can be open to prospective Circle members/product users as well. These private discussions are moderated by principal investigators, and cover learnings from ongoing Circle activities to date.Circle Academies also support secure 24/7 interaction among Circle members and, if desired, other current and prospective product users. Industry space.Establish corollary initiatives with relevant medical societies and/or their research arms. Society sponsored investigator-initiated trials, training and education sessions, society meeting break-out sessions, newsletter posts, dedicated research page.Scaling of the program to include additional provider groups, international regions, research topics.Strategic Benefits Of A Circle ProgramProvider EngagementA Circles-based Real-World Evidence Program allows manufacturers and their representatives to provide ethical, demonstrable, and sustained clinical and educational value to clinicians. It enables meaningful communications with product users regarding product expectations and leading to product improvements. Medical society conference presentations, break-out sessions, and dedicated research pages greatly amplify that value.More Efficient Trials and StudiesAn RWP establishes and executes comprehensive research protocols which are “fit-for-purpose” [5], and can accommodate any level of complexity. An RWP nurtures a growing and committed base of influential principal investigators and co-investigators.It encompasses investigator training, and administration.An RWP also handles study-specific patient consents, enrollment, long-term outcomes capture and compliance. It includes data validity confirmation, 24/7 real-time data access, sophisticated report generation and raw data export consistent with pre-established roles and permissions.Product Improvement/DevelopmentBusy clinicians, especially when collaborating with medical scientists, are the most valuable source of product development and improvement. RWPs deliver value and excellent user experience to those clinicians and scientists, enabling them to discover and refine their inventions, as well as establish corresponding safety/efficacy databases.Consumer/Patient BrandingCompelling communication of the evidence-based safety and efficacy of a product is of course an essential part of the brand of any successful manufacturer. Incorporating into that brand the real-world evidence which is directly relevant to patients in the context of their specific indications, outcomes objectives and providers’ treatment protocols is far more impactful. An RWP provides that RWE, developed by therapeutic influencers, on a sustained basis.Cost ReductionCost control and improving operational efficiencies are basic strategic goals for any successful product manufacturers. A Circles-based Real-World Evidence Program is highly cost-effective and flexible. [6] RegenMed works as a long-term partner to ensure that each RWP delivers substantial and transparent return on investment to a product manufacturer in the context of its specific research, commercial and valuation objectives.Learn MoreLeadership History and Principles How Circles Work Circles Value PropositionsProcesses For PhysiciansProcesses For Industry Circle Academies Latest LinkedIn Pricing and Terms Contact UsENDNOTES1 These challenges have long been recognized. See for example Examination of ClinicalTrial Costs and Barriers For Drug Development, US Department of Health and Human Services, 2014; Lack of Diversity in Clinical Trials Costs Billions of Dollars, Goldman et al, 2023; Why 90% of Clinical Drug Development Fails And How To Improve It, Sun et al, 2022.2 See AHRQ Registries Users Guide, cited above in footnote 1.3 Use of Real-World Evidence to Support Regulatory Decision-Making For Medical Devices, FDA, December 2023. 4 World Evidence in Regulatory Decision-Making, (EMA). Creating Value From Next-Generation Real-World Evidence, (McKinsey). Real World Evidence, FDA, February 2023. Registries for Evaluating Patient Outcomes: A User’s Guide, HHS/AHRQ, September 2020.5 As required by the FDA in its recently released draft guidance onthe use of real-world evidence for regulatory decision-making. See footnote 3.6 Further information on pricing can be found here.Copyright 2024 © Regenerative Medicine LLC

Relevance Of OrthobiologicsOrthobiologics are increasingly used as alternatives to, or to defer, surgical interventions. Regenerative rehabilitation and “prehabilitation” underscore the importance of orthobiologics as adjunct therapies.The fast-growing orthobiologics market is valued in excess of $8 billion. Leading orthopedic medical centers such as Hospital For Special Surgery, Northwell, and Mayo Clinic operate dedicated orthobiologics centers of excellence.ClinicalTrials.gov lists hundreds of studies focusing on biologics and other regenerative medicine approaches for musculoskeletal indications. Smith & Nephew, Stryker, Arthrex and other orthopedic product manufacturers actively develop and market orthobiologics products. Journals and other medical literature focusing on orthobiologics are common. [1]The AAOS Biologics Initiative, AO Foundation Osteobiologics, and the Biologic Association represent but a few orthopedic society activities focusing on orthobiologics.The Relevance Of Real-World EvidenceSupporting research is a major objective of most medical societies. However, the cost, delay, and exclusionary criteria of traditional clinical trials have become serious obstacles to genuine clinical translation for most indications and patient populations. Pragmatic, “n of 1”, properly curated registries [2], and other modern study designs based on RWE provide critical support for, and often alternatives to, traditional RCTs. Recent FDA draft guidance states that RWE “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”. [3]Three of the most important trends in healthcare are value-based care, health equity/SDOH, and controlling costs. RWE is an essential element of each of these. [4]RWE study designs are particularly important in the field of orthobiologics, which often involve autologous and/or systemic datapoints.Program ElementsA society can design a COP to be modest or comprehensive. It is modular, flexible, and scalable. A typical COP comprises the following sequence and elements: Development of two to three Circles targeting clinical/scientific endpoints with particular relevance to society members. Principal investigators are identified from among society leadership or member thought leaders.Recruitment of five or more society members as Circle co-investigators. Link to an actively promoted Join-A-Circle page to enhance recruitment of additional society members as co-investigators.Establishment of a dedicated society website research page, which is also actively promoted. This page describes Circles protocols, endpoints, principal and co-investigators, and developing real-world data.Communications through the society newsletter and other suitable communication channels of preliminary aggregated data and related observations. Use of Circle Academies to host periodic “Circle Hours” among society members. These private discussions among society members, moderated by principal investigators, cover learnings from ongoing Circle activities to date.Circle Academies also support secure 24/7 interaction among Circle members and, if desired, other society members.Engagement with industry and donor organizations to support investigator-initiated trials, training and education sessions, society meeting break-out sessions, and other society initiatives derived from the COP.Publication of select COP activities or results by the society and/or principal investigators through internal and external conferences, articles, and social media.Scaling of Circles to include provider groups and/or other societies outside of society membership. Design and implementation of additional Circles addressing specific member research or clinical interests.Development of COP monetization opportunities resulting from product development, conference sponsorship, data licensing and other pathways.Execution And PricingThe inCytes™ and Benchmarc™ platforms, and accompanying physician processes, ensure that RegenMed can handle all COP elements on a turnkey basis on behalf of a society.A COP can begin modestly, allowing members to join one or more of the dozens of orthobiologics Circles already available. The corresponding cost is only $5 per Case, and $35 per month per subscriber.As a society wishes to scale its COP, pricing remains low and flexible. Any COP program can be terminated at any time. [5]RegenMed engages with industry and donors to develop financial support for the COP. Properly designed and executed, a society COP can represent a significant source of revenues to support its mission.RegenMed works as a long-term partner to ensure that each COP is tailored to a society’s objectives, mission, and membership.Learn MoreLeadership History and Principles How Circles Work Circles Value Propositions Circle Academies Latest LinkedInPricing and Terms Contact UsEndnotes1 See for example, Biologic Orthopedics; MDPI Biologics (Open Access); Biologics In Orthopaedic Surgery; Science Direct, 2019; Orthobiologics A Comprehensive Review of the Current Evidence and Use in Orthopedic Subspecialties, ResearchGate, 2018; Orthobiologics: A Review, ResearchGate, 2023. 2 See AHRQ Registries Users Guide, cited above in footnote 1. 3 Use of Real-World Evidence to Support Regulatory Decision-Making For Medical Devices, FDA, December 2023, https://www.fda.gov/media/174819/download. 4 Real World Evidence, FDA, February 2023. Registries for Evaluating Patient Outcomes: A User’s Guide, HHS/AHRQ, September 2020. Creating Value From Next-Generation Real-World Evidence, McKinsey July 2020. 5 Further information on pricing can be found here.‍Copyright © 2024 Regenerative Medicine LLC

Type image caption here (optional)The FDA has released draft guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”. The principles underlying this guidance have important – and advantageous – implications not only for device manufacturers but also for clinicians.The FDA states that real-world evidence (RWE) “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”. However, the guidance also emphasizes that data quality, good clinical practice, proper study design, longitudinal outcomes data and other traditional methodological considerations remain critical.The FDA enumerates many potential sources of RWE. Nevertheless, it is clear from the guidance that only specific types of real-world data (RWD) surrounding a discrete category of clinical interventions, and causally correlated to longitudinal outcomes, will generate acceptable “study-specific derived dataset(s).”This means that busy clinicians and their patients are essential to developing the RWD which can be converted into RWE. It is those already over-worked clinicians who are best positioned to design, capture and analyze study-specific RWD. It is their patients who must report long-term outcomes against standardized assessment measures. The overriding question is: where is the time or incentive to do so?The technology and processes underlying each Circle is “fit-for-purpose”in the context of any RWE objective to comply with the FDA’s guidance. (Indeed, the U.S. patent underlying Circles is titled “Method and System For Processing Large Amounts of Real-World Evidence”.) Moreover, Circles eliminate administrative burden for clinicians in generating RWE, while developing accompanying ethical professional and financial incentives.Please contact us to find out more.

RegenMed’s December 2023 Newsletter may be found here. It summarizes many of the ways our clients around the world are generating clinical, scientific, and financial value through Circles. The Newsletter also covers select company developments.Value-based care, real-world evidence and health equity will remain forceful healthcare trends in 2024. Addressing and benefiting from these trends is the essence of our client partnerships. All of us at RegenMed wish a restful and joyful holiday season to the exemplary healthcare professionals with whom we have the pleasure of working. We look forward to expanding and deepening those partnerships in the New Year.

Type image caption here (optional)Institutional constraints can limit the ability of physicians and researchers to collect long-term outcomes, design and execute studies, develop value-based care models best suited to their patient panels, or publish. Obstacles include time and RVU pressures, funding, complex IRB processes, and access to laboratory time and scientific experts. ‍Circles address these challenges. They inherently support collaboration across institutional and national borders. Their patented functionality is clinical grade, but imposes virtually no administrative burden. Cost is minimal; indeed, RegenMed often sources investigator-initiated study funding for Circle Members.Circles thus represent a powerful yet efficient solution for observing, participating in, or even designing “external” real-world evidence initiatives.Moreover, simple “internal” Circles implementations – such as long-term capture of standardized outcomes measures – can provide substantial clinical value to employed physicians. At only $5 per Case, and with easy data import capability for institutional EMRs, the cost-benefit analysis is straightforward.