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It’s been two years since Health Canada released a position paper clarifying their regulations on autologous cell therapy products. Among their key requirements were redefining that “the process is the product” and that “products with proper process controls” could increase the probability that “products would be consistent in strength, quality and purity”. Thus, autologous cell therapies are “drugs” and are subject to the specific provisions for drugs under the Act. Platelet Rich Plasma, or PRP, falls within the exception zone of “lymphohematopoietic cells which are minimally manipulated and are intended for homologous use”. However, the fact that PRP is not currently regulated as a drug doesn’t mean the product yet delivers consistent strength, quality, or purity, nor does it consistently yield standardized outcomes for all patients.Martin Lamontagne, M.D. of La Clinique de Physiatrie et de Médecine du Sport Rockland is out to answer these pervasive questions around PRP variability, dosing, and patient outcomes. With the support of MDBiologix, and RegenMed’s inCytes™ platform, Dr. Lamontagne will begin capturing the long-term outcomes of his everyday PRP patients, including their pain and WOMAC outcomes measures up to one year post-injection. Furthermore, he will be performing benchside characterization on his PRP products, yielding useful correlations between PRP dosage and his patient’s self-reported outcomes. This information will help Dr. Lamontagne and his Canadian colleagues better predict and deliver optimal PRP outcomes, while also exploring possible procedural standards for other autologous cell therapies.To learn more about Dr. Lamontagne’s study, and please contact info@physiatrie.ca

Ardent Animal Health (Lexington, KY) and researchers from the University of Kentucky Markey Cancer Center have developed a customized cancer treatment for dogs, known as K9-ACV1. The aim of this vaccine is to trigger the canine patients’ immune system to identify the cancer as a foreign invader. The safety and efficacy of this vaccine are not yet formally established, and these treatments are delivered under 9 CFR 103.3 via USDA Center for Veterinary Biologics oversight, and through supervision/prescription of a licensed veterinarian. A formal clinical trial featuring blinded randomization of patients’ responses associated to the standard of care has been submitted for formal licensure.Ardent has begun capturing the real-world outcomes associated with administration of their K9-ACV vaccine, and subsequent survivability of their canine patients. In this example of real-world evidence, patients were subdivided by breed, and their survival post diagnosis was plotted. The resulting graph shows a growing divergence in postdiagnosis lifespan of different canine breeds. For example, Rottweilers (n=5) experienced a median of 336 days of survival after their cancer diagnosis, while Labrador Retrievers (n=16) had a median survival of only 148.5 days, or roughly half as long. Overall, the data suggests that as genetic variation exists across canine breeds, it may impact the outcomes of cancer treatments. In addition to breed specific survival, Ardent is tracking long-term survival of approximately 1,000 dogs median survival times across a variety of cancer types.As a greater quantity of data is collected, and further correlations are made, Ardent Animal Health hopes that these data will help veterinarians and their patient’s families make more informed choices about cancer treatment. Additionally, real world cancer disease progression in dogs can also inform future human studies. Ardent and its fund Breakthru Strategies (Milwaukee, WI) are committed to bridging the gap between human and animal health. Its partnered mission is to strengthen the human-animal bond, while positively impacting innovation in human and animal health.Find out more about Ardent or its K9-ACV Therapy here: https://ardentanimalhealth.com/canine-cancer/[1] Yannelli JR, Wouda R, Masterson TJ, et al. Development of an autologous canine cancer vaccine system for resectable malignant tumors in dogs. Vet Immunol Immunopathol. 2016;182:95-100. doi:10.1016/j.vetimm.2016.10.011

TABLE OF CONTENTS‍INTRODUCTIONVALUE-ADDED PATIENT ENGAGEMENT The Importance Of First Impressions Creating a Powerful First Impression Sustaining Patient Engagement Delivering On The PromisesSOLUTIONS The Key: Developing and Publishing “Real-World Evidence” Turnkey, Burden Free and Low CostIntroductionThe modern patient, in her everyday life, has become accustomed to high-quality user-experiences in all her dealings as a consumer. These experiences influence her healthcare delivery expectations, leading her to look for and evaluate:Multiple providers.Professional credentials, reviews and other forms of patient testimonials.Value for price.Access to reliable and useful information.Interactions personalized to her patient history, perceived condition and ultimate clinical intervention, continuing post-clinically.An efficient, predictable and welcoming clinical experience.Many clinical settings – even large hospital groups – fail to meet these expectations due to various financial, technological and personnel issues. These are no longer acceptable excuses, however, since comparable consumer expectations are regularly met by other heavily regulated and operationally-complex verticals – for example financial services. Value-Added Patient EngagementThe Importance Of First ImpressionsIt is the rare provider who does not have its own website. It is the rare patient who does visit that site to evaluate practitioner credentials, testimonials, procedure descriptions, pricing, and other elements. The patient is also evaluating alternative providers and procedures not only through competing providers’ sites, but through the myriad other sources easily accessible to him.A provider’s website is therefore its all-important “first impression”. Frequently, however, those online experiences are deficient, especially when compared with the those in other aspects of a potential patient’s life.Creating A Powerful First ImpressionAt the minimum, a provider’s website should clearly convey at least five fundamental elements:Professional credentials of the treating clinician specifically relevant to a potential patient’s indication or complaint.A description of the proposed clinical intervention for that indicationAn overview of the evidence supporting positive long-term outcomes for that intervention.Testimonials from other patients with similar indications.A description of the approach to monitoring of patient progress.These five elements give the practitioner the best chance of a consultation or at least inquiry from an educated and qualified patient.Ideally, the provider’s site goes well beyond the foregoing five elements – for example, providing efficient initial patient history entry, well-produced educational materials, multi-media assets featuring specific clinicians, etc. Best practices for early prospective patient engagement also include professional use of social media platforms.Sustaining Patient EngagementFor the patient, there is always a “patient journey”. That journey begins with symptoms, and continues through discussions with friends and families, Internet research, consultations with one or more clinicians, one or more procedures, and ideally recovery. (For many patients, unfortunately, the journey continues with revisions and other subsequent procedures.)Best clinical practice is of course to take the time to understand the patient’s history, in her own words, monitor long-term outcomes and continually improve evidence-based standards of care. However, workload, financial and other realities of contemporary medical practice usually prevent even the best-intentioned clinicians from doing so.Given the realities of today’s healthcare delivery, the treating physician typically accompanies her patients on only a small part of their journeys. This fundamental “disconnect” not only leads to deep dissatisfaction by both the patient and the clinician, but it is also often a cause of sub-optimal care.Delivering On The PromisesIt is one thing to “talk the talk”; the practitioner must also be able to “walk the walk”. From his everyday experience as a skeptical consumer, a prospectivepatient has become used to well-designed websites, followed by poor execution. Healthcare regulators are also highly attuned to misleading claims fromproviders. The website design and content should represent a road-map of the actuallongitudinal clinical experience – a roadmap not only for the prospectivepatient, but for the practitioner himself.‍SolutionsThe Key: Developing and Publishing “Real-World Evidence”Within the busy clinical practice of every provider lies the foundation of value-added patient recruitment and long-term engagement – real-world evidence. Such RWE is not only the language which regulators and payers speak, but also the language patients speak. By using modern and clinically-efficient platforms to harness this real-world evidence, a provider is able to:educate, recruit and retain patients;collect from, and report back to, patients germane pre-, peri- and post-clinical information;establish clinically-useful correlations from aggregated real-world datasets;support reimbursement, as well as legal/regulatory compliance;develop and publish compelling, fresh and evidence-based multi-media materials for website, conference, social media or other publication;enhance its professional reputation with patients, as well as among healthcare peers.Turnkey, Burden Free and Low CostThrough its clinical-grade inCytes™ and Benchmarc™ platforms, RegenMed helps large and smaller provider around the world develop and generate value from real-world evidence.In the context of patient recruitment and long-term engagement, RegenMed also works with providers to:Include “digital front doors” within their websites for secure patient enrollment, comprising not only demographic data, but also clinical benchmark information tailored to the selected indication and proposed intervention.Integrate as needed with calendaring or other practice management software.Provide the patient with high quality and evidence-based digital and in-office education materials customized for specific indications and procedures.Ensure long-term compliance with clinical recommendations, as well as outcomes reporting.Monitor post-clinical adverse events.Create videos and other multimedia presentations featuring the practitioner and/or her patients in the context of evidence-based outcomes and other best clinical practices.Publish that content on the provider’s website, social media channels and other platforms.RegenMed recognizes the financial and practice realities of today’s busy clinician. It provides its products and services in a turnkey, efficient and burden-free manner. Contact us today to find out more.Copyright © 2022 Regenerative Medicine LLC

Bioxcellerator, located in Medellin, Colombia, treats patients from around the world with its unique, expanded MSC therapy from Wharton’s Jelly. They have been tracking their patients’ outcomes for over a year, and have granted us permission to share the following early and RWE derived insights:This ongoing study focuses on every knee osteoarthritis case treated at Bioxcellerator (they have similar ongoing studies for other indications).The primary endpoint is the WOMAC scale, which is answered easily by patients from their own mobile devices.The study currently has 120 patients, 25 of whom have reached the 6-month time point.Out of those 25, WOMAC scores were reduced by an average of ~55%, indicating substantially reduced pain (+ is the plotted mean).Diving deeper, 6 of the 25 patients were non-responders, reporting very little change from their baseline measurement. Of the remaining 19, the average WOMAC score reduction was ~75%, demonstrating an even greater diminishment of pain.These follow up data are crucial to helping Bioxcellerator better understand their patients’ outcomes, communicate those expected outcomes to new patients, and achieve more predictable outcomes for all. Upcoming insights will include identifying the patient criteria more commonly associated with non-responders, as well as obtaining statistically significant 12 month follow-ups.To learn more about Bioxcellerator, click here.

TABLE OF CONTENTS‍EXECUTIVE SUMMARYKEY ELEMENTS OF A REAL WORLD STUDYKEY ELEMENTS OF REAL-WORLD STUDY PUBLICATIONINDUSTRY SUPPORTDEVELOPING A SUCCESSFUL REAL-WORLD PROGRAMABOUT REGENMEDExecutive Summary“It is the rare Society which does not wish to grow its membership, to add more value to those members, and to make a bigger impact in its chosen mission. A properly executed real-world study program can achieve each of these objectives in a substantial, sustained and self-supporting manner.”GeneralMedical societies, patient advocacy groups and other not-for-profits [1] can greatly enhance their impact and value to members by sponsoring “real- world” studies, and developing a related publication program. This white paper reviews how Societies can get started with a low-cost pilot project, achieve some “early wins”, and then build upon that pilot to exploit many significant adjacent opportunities.Real-World StudiesThe criticality of real-world evidence and data in modern healthcare is broadly recognized by regulators and in the literature. See here, here and here. Legislation such as the 21st Century Cures Act, and “Right-To-Try” laws have put a premium on the prompter release of real-world data. There are many forms of studies based on real-world data; pragmatic and n of 1 trials are but two examples. Societies in principle are in a strong position to harness the power of real-world data. Their practitioner members, and their members’ patients, represent the most important sources of such data. Many Societies also include researchers who can help establish the scientific mechanism of action underlying treatment protocols and clinical outcomes.Impact and PublicationEvery Society wishes to increase its impact. It does so – or should do so – by disseminating the meaningful results of its activities to the right audiences, at the right time, and in a professional, compelling and sustained manner. Unfortunately, it is often difficult for all but the largest Societies to achieve even a fraction of their potential due to time, budget and personnel constraints, as well as inexperience with modern communications platforms.Financial SupportLike for-profit organizations, Societies depend on funding to support their mission and everyday operations. However, their funding typically relies on membership dues, donations and, often, industry support. (This last source of funding can be an important but sensitive one, and is discussed further in this paper.) A well-designed and executed program of real-world studies sponsorship and publication can substantially increase funding opportunities for a Society, as well as for its members.Key Elements Of A Real World StudySociety executives and members can be forgiven for worrying about the cost, complexity and length of clinical trials and studies. A double-blinded, randomized controlled trial (“RCT”) intended for Premarket Approval caneasily exceed $20 million and require five or more years before regulatoryapproval. As a result, only the most well-capitalized pharmaceutical and medical device companies can afford RCT’s. However, as mentioned above, all major healthcare constituencies have recognized the importance of more efficient and less costly study formats which advance medicine in a safe and efficacious manner. To achieve that efficiency without sacrificing their value, real-world studies will greatly benefit from the following components.Electronic Data CaptureA robust turnkey and flexible EDC platform will include capabilities such as:Compliance with HIPAA, GDPR and other legal and institutional patient privacy and personal data requirements.Compatibility with 21 CFR Part 11, CDISC, FHIR HL7 and other requirements for electronic data submissions, audit trails, consent signatures, etc.Ability to use standard outcomes measures, or to design and implement custom ones.Equally efficient performance with small as well as large “n” study sizes. Flexibility in study design, report generation, investigator customization. 24/7/365 availability of aggregated datasets on any device. Ability to assign various “roles and permissions” sets to specific personnel categories involved in the study.Raw data export. Experienced technical team available for ongoing support, including EMR and other integrations.Multi-center support, including multi-lingual implementations, efficient collaboration among investigators wherever located.Seamless input and integration of third-party data sources (laboratories, call centers, team members). Ability easily to generate a variety of reports and correlations, including from various studies sharing common questions.Investigator User ExperienceThe most powerful real-world data is found in the busy clinic. Thus, each Society member is a potential study Investigator. (And each Investigator conducting a study in the Society’s field is a potential Society member.)However, today’s busy clinicians have little time or incentive to collect real-world data in a structured and sustained manner. In addition to an EDC for the capabilities listed above, practitioners conducting a real-world study require the following.Minimum BurdenThe average practitioner wants to be evidence-based, to conduct studies relevant to her specific practice. However, the realities of modern healthcare delivery are such that she has little time to do so.ValueIn addition to the daily time demands of EMR, insurance and other administrative data entry, practitioners are deluged with surveys, registry participation and similar requests. They are constantly asked to collect and provide data for others, but understandably fail to see the value it provides to them.SupportExecuting a meaningful study requires support with design, patientenrollment, collaboration with co-investigators and team members, patientfollow-up, development of correlations, dealing with IRB’s or medical ethicscommittees, publication, obtaining industry honoraria or investigator fees, andother matters.Patient User ExperienceMuch of the expense, duration and premature terminations of traditional RCT’s can be ascribed to poor patient experience. A proper real-world study will educate, follow up with and otherwise engage with each patient in a personalized manner for the full duration of the study.Key Elements Of Real-World Study PublicationGeneralTraditionally, study methodology and results have been reported at conferences, in medical journals or included as part of regulatory submissions. Often, the study design, results and other elements are “embargoed“ for many months if not years prior to such publication. The 21st century publication environment has changed dramatically. There is a proliferation of medical societies, advocacy groups, foundations, digital journals, online medical education, journal clubs, clinical trial registries – all seeking and disseminating clinical/scientific content on a much more frequent basis than in the past.Social MediaThe majority of a Society’s members have social media accounts. Many of them use social media for medical education, and otherwise to keep current in their clinical/scientific field. Many also would like to position themselves as social media “influencers”. A well-designed, modern and sustained publication program enables Societies and their members to benefit in multiple ways from their real-world studies.Bespoke Academies and Journal ClubsDespite the power of social media channels – or indeed because of that power – many practitioners and healthcare institutions are wary of them. Much of the content posted by clinicians is often more “social” than medical. That content which purports to be medical or scientific is highly variable in its quality, relevance and verifiability. Confidentiality is always a concern. The sheer volume of postings makes it difficult to find clinically relevant information. It is possible, however, to have the best of both worlds. Modern technology allows Societies to host proprietary digital properties with the utility of social media channels, but with highly curated content and membership. Such “academies” or digital journal clubs ideally offer the following features:The clinical/scientific theme of each academy can be as broad or narrow as desired by the Society or its members. (Many societies have memberships with different clinical interests. The end-points of real-world studies being carried out by members will vary.)The Society establishes the academy membership criteria. It could be only those involved in a particular real-world study or type of study. It could be all members. It could be by invitation only.The Society or its delegates could curate and add to all content posted within the academy. It could offer CME or other educational content.The academy could offer product manufacturers a digital space to communicate study sponsorship opportunities, product discounts and other item of potential interest to members.The academy can provide all of the typical utility of large social media channels – multimedia presentations, private and public chats, threaded comments, etc.Industry SupportEthical collaboration between practitioners and industry is essential to advance in medicine. However, laws and ethical policies sharply circum-scribe the ways in which these two groups can interact.Real-world studies represent an important medium through which such interaction can properly and effectively occur. As is the case with traditional RCT’s, industry is able to support investigators who are conducting independent and properly designed studies through study fees, honoraria and product discounts. Societies can serve as natural intermediators of these industry-practitioner interactions, for the benefit of both groups and medicine at large.‍Developing A Successful Real-World ProgramA Society can cost-effectively and conservatively develop a successful program of real-world studies and corresponding publication through sequencing three stages: discovery, a pilot project and scaling.Discovery and DesignThis stage involves the Executive Director and board agreeing on which of the Society’s strategic objectives will most benefit from such a program. They will also establish the program’s key performance metrics (“KPI’s”). Finally, they will assess the budgetary and operational resources available to the Society to implement a program over time. It will often be useful to involve experienced vendors or other third parties in this discovery phase.A Pilot Project With “Early Wins”The discovery phase will identify a narrowly defined “pilot project”. This will reveal the operational capabilities of the Society, generate some early wins as defined by the chosen KPI’s, and set the stage for a broader implementation of the program. A sensible pilot project will comprise one or two relatively straightforwardstudy designs, a principal and one or two co-investigators, and a modest but curated publication program. Depending on the Society’s current website and other modalities used to communicate with members, these might also be improved in the context of the pilot project.ScalingIt is the rare Society which does not wish to grow its membership, to add more value to those members, and to make a bigger impact in its chosen mission. A properly executed real-world study program can achieve each of these objectives in a substantial, sustained and self-supporting manner. Each Society represents in theory a large amount of valuable real-world data generated daily among its members – if those data can be properly structured to support statistically-significant correlations. Building upon and then scaling a well-designed pilot project is the key to unlocking that value.The nature and timing of such scaling will vary according to a Society’s objectives and resources. However, several avenues can be pursued, whether singly or in parallel:Offer members a library of study designs and procedure protocols, and/or the support to develop new ones.Establish an IRB and/or medical ethics committee within the Society.Create and curate indication- and/or procedure-specific journal clubs.Establish a Society-branded platform for demonstrable, sustained and value-added collaboration among its members.Explore data-licensing, product incubation and similar Society revenue opportunities.Establish a specific program to develop the Society as an “influencer”, and/or to develop Society members as influencers.Establish a program of ethical intermediation between industry and the Society to support the improvement and development of devices, diagnostics, biologics and protocols.Develop and standardize real-world outcomes scoring systems in theSociety’s field(s).Create and curate various indication- or procedure-specific registries in the Society’s field.Utilize results from Society-sponsored real-world studies to develop productive engagement with relevant regulatory bodies.Support members in the context of legal/regulatory compliance, reimbursement, patient education and other barriers to the adoption of evidence-based procedures.Develop and disseminate educational and training modules.Expand the Society’s impact and affiliations by collaborating with other clinicians and organizations.Expand the Society’s geographic footprint.Support members in obtaining third-party research grants and/or industry study support.Exploit social media channels in a deeper manner to promote the work and brand of the Society and its members.About RegenMedRegenMed is a product agnostic firm partnering with healthcare constituencies around the world to develop financial, professional and communications value inherent in everyday clinical cases. The Company enables ethical intermediation between clinicians and industry, preserving the independence, while recognizing the business and professional realities, of each group. The Company’s platforms and processes are clinical grade, turnkey, scalable and highly cost-effective. They provide excellent user experiences for practitioners, scientists, study sponsors and patients.‍1 We refer to all such organizations as “Societies” in this paper.Copyright © 2022 Regenerative Medicine LLC