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TABLE OF CONTENTS‍INTRODUCTION General Investigator Initiated Trials The Sponsor-InvestigatorKEY ELEMENTS OF AN IIT Application/Study Design Research Protocol Study Management PublicationREFERENCE MATERIALSIntroductionGeneralEthical collaboration between practitioners and industry is essential to advances in medicine. However, laws and institutional policies sharply circumscribe 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 can support investigators who are conducting independent and properly designed studies through study fees, honoraria and product discounts.RegenMed provides the clinical grade yet cost-effective tools and processes intermediating the funding and execution of real-world studies.Investigator Initiated TrialsAn Investigator Initiated Trial (“IIT”) is a common example of real-world study ethically accommodating the objectives of the independent provider, as well as a third party with related objectives which can provide financial support.An IIT is a study where the study investigator is also the study sponsor. In other words, the Investigator is not only responsible for execution of the study, but also for its design and oversight. In an IIT, the investigator is therefore called the Sponsor-Investigator.Many medical product manufacturers, foundations, governmental and non-governmental organizations have programs to help fund IIT’s. The Sponsor-InvestigatorThe Sponsor-Investigator may be an individual clinician, small clinic, medical society, or a hospital department.Although each category differs markedly in its capacity to design and manage an ITT, it is unlikely any will be able properly to do so without third-party support. (The only exception is a large academic/medical center, which has in place a Clinical Trial Unit or similar infrastructure.)Although real-world studies can be executed efficiently even by individual clinicians, the expectations of IIT funding sources usually demand a more robust study design and management infrastructure. Typical elements are described in the following section.Key Elements of an IITAn IIT usually involves the following important elements:Application/Study DesignAn IIT Sponsor-Investigator will apply to a suitable funding source. This process typically begins with a “concept note” which, if approved, will be fleshed out into a more thorough study design. Many IIT funding sources articulate their IIT criteria and evaluation processes on their websites. The concept note of course should be drafted in accordance with these guidelines.It is important to distinguish between two types of “audiences”: clinical/ scientific and business. Usually, both groups will be involved in evaluating an IIT application. Sometimes, however, the evaluation may be made solely by the clinical/scientific group. This factor obviously dictates the emphasis of certain elements of the application.Important components of an IIT application include:Study Rationale/Unmet Need. Why might the results of the study make a difference? For which patient population? Study rationale criteria will often include relevance to the funder’s products or therapeutic area of interest.Purpose of the Study. Examples include (i) test the safety/efficacy of two or more products; (ii) test a product in different population subsets; (iii) test a non-approved use for the product; (iv) combine the product with other technologies to improve its safety and/or efficacy; (v) develop a new product.Type of study. (Prospective randomized double blind controlled, in vitro, animal, observational, surveys, clinical, pragmatic, “n of 1”, other.)Summary of relevant prior literature.Identity and credentials of team members. (Principal and sub-investigators. Researchers. Laboratories. Statisticians. Medical writers. Support staff.)Experience of Team Members, especially with similar studies.Ability of Team Members to adhere to Good Clinical Practice. Research Protocol. (See below.)Approach to assessing clinical and statistical significance.Software and other technical support.Legal/Regulatory Compliance. (Including IRB/Medical Ethics Committee processes.)EndpointsData ownership and rights.Budget and Financial Resources.Research ProtocolThese are the parameters pursuant to which the study will be carried out. Key components include:Population size.Inclusionary and exclusionary criteria.Blinding or other approaches to remove bias.Specific comparators. (Dosages, products, patient cohorts, etc.)Outcomes measures, and timing of measurement reports.Type(s) of statistical analysis, including methods for determining statistical significance as well as clinical significance.)Reports (type, illustrative, frequency).Adverse Events Reporting.Planned regulatory submissions, and coordination with regulators.Study ManagementImportant items here include:Legal/Regulatory (Consent forms, data privacy, allocation of liability, data ownership and rights, anti-corruption, anti-bribery and anti-kickback laws.)Institutional Review Board/Medical Ethics Committee identification and processes.Quality control and assurance. (More complex in context of multi-center studies.)Allocation of financial/legal liabilities. (An IIT funding source will not accept legal liability arising from the study.)(E.g., Part 11 compliance if in the U.S., database management, source data review/verification, HIPAA/GDPR compliance, electronic Case Report Forms.)PublicationThis element includes medical writing, diagrams and tables, citations, journal selection. Some funding sources may look for publication in peer-reviewed print journals; others may be satisfied with publication through on-line journals or presentations of abstracts at conferences Reference materialsF.D.A.Important F.D.A. links relating to ITT’s include:Good Clinical Practice.Good Laboratory Practice. IIT IND’s.ICHThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)World Health OrganizationWHO Consent Form TemplatesCopyright © 2022 Regenerative Medicine LLC

RegenMed and MDBiologix have partnered to deploy inCytes™ data-capture technology suite alongside innovative medical technology to advance patient care and clinical collaboration in Canada. This partnership will work closely with Canadian clinicians, scientists and governmental authorities in the development of evidence-based standards of care in the highly promising field of regenerative medicine.Utilizing the body’s innate reparative, immunomodulatory and regenerative capabilities, regenerative medicine is relevant to orthopedics, oncology, peripheral vascular diseases, wound care, cardiology, plastic/reconstructive surgery and most other medical specialties.Led by nationally renowned clinical leaders such as Dr. Grant Pagdin of Pagdin Health, Kelowna, BC; Dr. Robert Burnham of Vivo Cura Health Calgary, AB; and Dr. Nathan Thakur of Regenerative MD, Calgary, AB; this mission will offer Canadian clinicians the platforms, tools and support allowing them to:Comply with applicable Canadian regulations and best practices in delivery of autologous cell therapies and associated regenerative medicine technologies.Identify, aggregate and share the substantial real-world evidence arising from their everyday clinical practices using an anonymized, secure platformImprove the patient experience and communication channels through engagement with Benchmarc™ patient portal.Establish relevant outcomes measures for specific indications and treatments, and capture those measures from patients on a long-term basis.Improve intra-clinical quality assurance and continuous improvement through data-driven initiatives.Regularly and securely collaborate with each other to discuss protocols, developing clinical evidence, best practices, evolving medical science and other matters of common interest.Access evidence-based approaches in the U.S., Europe and other regions.Maintain an open dialogue with Health Canada, with a goal of supporting appropriate legislation and/or biologics licenses.If you are interested in learning more about this mission, membership requirements or benefits, please contactConnor Downs | MDBiologix | cdowns@mdbiologix.com‍About MDBiologixMDBiologix has for twenty-plus years brought point-of-care autologous cell therapies to Canadian practitioners and their patients. It is a privately held, family-run business that is committed to improving patient care with innovative medical technologies, clinical expertise, and education. Its products are developed and manufactured by some of the world’s most advanced medical device companies, and together with its complete clinical support allow physicians to offer new treatment options to patients that can improve their quality of life and help them live pain free.For more information, please see https://www.mdbiologix.com/.‍About RegenMedRegenMed platforms, processes and support allow hospitals, clinicians, industry and other healthcare constituencies around the world to generate real-world evidence. That RWE adds substantial value in a wide variety of use cases, including regulatory submissions, standards of care, legal/regulatory compliance, value-added medicine, reimbursement, research, HCP communications and patient engagement.For more information, please see www.rgnmed.com.

INTRODUCTIONHealthcare data is all the rage. Big data, artificial intelligence, value-based care, metadata, real-world data, clinical trials, registries, genomic data — they are all part of a market with an estimated value in 2028 of $130 billion. But who really owns this data? Who controls it? Who benefits from it, and who is left out?Ownership is often not the same as control. Neither does it guarantee value. Clarifying one’s objectives in the context of healthcare data, generating inherently valuable datasets, and specifying one’s rights with other stakeholders are all important steps for any clinician in today’s modern healthcare world.OWNERSHIPIn the healthcare sector, data ownership is generally governed by national laws and institutional policies. Typically, but not always, these relate to personal data and protected health information. HIPAA in the U.S. and GDPR in the European Union are important examples. GDPR’s provisions are widely recognized as the strictest regarding personal data and special categories thereof, including personal health information (сollectively referred to as Personal Data in this article).The spirit and letter underlying Personal Data laws are patient ownership of such data. Patients may consent to share or otherwise convey some of their ownership rights, but that consent must be highly explicit. Civil and criminal penalties for wrongfully and even accidentally appropriating personal data are severe.Healthcare data which has been suitably anonymized or pseudonymized is not considered Personal Data. The laws governing adequate anonymization or pseudonymization are complex and highly fact specific. They involve aggregation, security, encryption, consent form, control, data-processing and other elements, looked at as a whole. Failure to comply with any of these elements can render non-Personal Data into Personal Data, with resultant liability.Some organizations, including RegenMed, refer to properly anonymized or pseudonymized Personal Data as Aggregated Non-Personal Data. Such data may be owned wholly or in part by entities or individuals other than the individuals from whom such data originally derived. However, absent clear contractual specification of Aggregated Non-Personal Data ownership rights, disputes can arise, especially once it is clear that such data can generate value.CONTROLIn the healthcare world, it is not unusual for control of data — whether Personal Data or Aggregated Non-Personal Data — to be separate from ownership. The GDPR, for example, has detailed provisions covering data controllers, data processors, sub-processors, joint controllers and similar designations covering control of data which may be wholly or partially owned by others.Similarly, physician employment agreements, hospital data policies, registry participation, grant terms and conditions, clinical trial consent forms and many other arrangements restrict and grant various degrees of control over healthcare data. Such transfers of control can of course substantially vitiate the value otherwise obtainable from ownership of Aggregated Non-Personal Data.Control over Aggregated Non-Personal Data thus takes many forms and has many serious implications — not all of them initially evident. Physicians and other healthcare providers (HCPs) frequently sign away any control over or interest in discoveries, inventions and datasets deriving from their everyday clinical practices. Healthcare professionals and their patients are the principal contributors to registries and other aggregated healthcare datasets, but often transfer substantial control over the use and value of such contributions. Clinical trial, journal article and medical research data are often maintained in secrecy for many years, and even then, released only partially.GENERATING VALUEAs mentioned, healthcare data generates well over $100 billion in value each. Major areas of value generation include product development, regulatory compliance, marketing, government- and foundation-funded research, payer reimbursement, value-based care and the large infrastructure of vendors servicing such segments. Thus, most monetary value generated through healthcare data accrues to medical product manufacturers and distributors, payers, hospital systems, EMR companies and various data vendors.Very little of that monetary value flows to the healthcare professionals. This is paradoxical since the most important — and therefore the most valuable — healthcare data emanates directly from the everyday clinician-patient interaction.This inability of HCPs to develop value from healthcare data can be attributed to several factors, including everyday clinical burdens, challenges in collaborating in data aggregation with peers, inadequate tools and processes, expense and limited business/legal expertise.CONCLUSIONAs mentioned, the most potentially valuable healthcare datasets are those which are based on the clinician-patient interaction. To achieve that value, those datasets must include long-term follow-up tied to specific clinical hypotheses. The datasets should also be verifiable, integrated and statistically significant in the context of those hypotheses.Circles, powered by inCytes™, support HCPs around the world in developing and generating value from such datasets. Circles can be implemented to address any clinical or medical-scientific question and are supported by an enterprise-grade yet low-priced SaaS platform equipped with international collaboration with like-minded peers and experts.

In these final days of 2021, RegenMed pays tribute to the world’s healthcare professionals. We see first-hand the burdens, stresses and challenges of everyday clinical life — all of course exacerbated by COVID-19. In the U.S., a full one-third of clinicians now report burnout. For many, this stems from an increasing sense of isolation — from peers, patients, mentors and even purpose. These are alarming trends for the future of healthcare.We all do our best work, and feel most fulfilled, by interacting with colleagues, and collaborating in a deep and sustained manner. It has been our privilege this past year to support such deep collaboration among clinicians in Europe, North America, South America and Asia. Their evidence-based Circles are fostering new relationships, and helping to advance tomorrow’s clinical standards across a multitude of specialties and topics of interest.Meet some of our Circle Founders from around the world.To learn more about any of the above Circles or explore how a Circle can advance your evidence-based initiative, contact us today.

Regenerative medicine and precision cancer care may be the future of healthcare for humans, but it is yesterday’s news for forward-thinking company Ardent Animal Health, LLC. Ardent and its affiliated veterinary clinics have treated more than 20,000 horses, dogs and cats with their innovative regenerative and oncology armamentarium. These therapies have shown promising results with degenerative joint and oncological indications — even in instances where traditional therapies have failed — creating a growing list of “petsimonials”.Working with RegenMed, Ardent plans on launching a leading clinical data registry in early 2022 to aggregate and assess those animal outcomes. Bolstered by participation from more than 1,000 affiliated clinics, Ardent anticipates that their data will play a pivotal role in helping to standardize regenerative treatments and precision cancer care for animals, and perhaps one day, their owners, too.Thomas Masterson, President of Ardent Animal Health, states, “Aggregating data and sharing patient outcomes is integral to the sustainability of innovative technology. Our veterinarian customers are outstanding clinicians and scientists. RegenMed will unlock collaboration and allow for a registry that is aimed to raise the standard of care for veterinary patients.”Ardent Animal Health will launch its first two Circles for Osteoarthritis and Oncology in early 2022.To learn more about Ardent Animal Health or its Circle, contact us today.