TABLE OF CONTENTS
Provider-Scientific-Industry Partnership
Creating Value: Clinical, Financial, Reputational
Introduction
Since its founding in 2014, RegenMed’s solutions have been driven by two powerful and closely related healthcare trends – regenerative medicine and real-world evidence. Today, RegenMed partners with providers, product manufacturers and other healthcare stakeholders around the world, across a variety of medical disciplines.
Driven by Client demand, all Company solutions share the following elements: clinical/scientific/business expertise, professionalism, demonstrable value, world-class platforms and processes, cost-effectiveness, turnkey execution, and long-term partnership.
How we got here, and where we are going, are summarized below.
Regenerative Medicine
In 2014, businessmen and physicians from leading academic medical institutions co-founded RegenMed. Their objective was to support clinicians in the delivery of evidence-based regenerative medicine procedures. The regenerative medicine market today is valued at $20 billion, with a 16% annual growth rate forecast through 2030.
In 2015 and 2016, the Company hosted two well-received international CELLS™ conferences in Europe. (VUMC, one of the largest hospital groups in Europe, co-hosted the second conference.) The CELLS™ conferences underscored the strong interest among providers and industry in regenerative medicine. However, they also revealed the limited evidence and lack of standardization for products and protocols.
Also, during this time, the FDA, European Medicines Agency and other regulators began developing frameworks to encourage the development of legitimate regenerative medicine products and procedures, while discouraging “bad actors”.
The Company built its initial value propositions on the basis of these factors – the need for evidence and regulatory compliance in the growing field of regenerative medicine.
Real-World Evidence
Another critical trend in healthcare soon emerged -- real-world evidence. Real-world outcomes data are now at the heart of value-based medicine, narrow networks, accountable care organizations and other reimbursement schema. In addition, various forms of real-world evidence are now mandated by regulatory agencies.
Those agencies and other healthcare stakeholders began to recognize that reliance on the “gold-standard” of randomized controlled trials had led to several negative unintended consequences: The vast majority of RCT’s are sponsored by industry, with narrow commercially driven endpoints. Most “standards of care” in fact have poor levels of evidentiary support. There is limited safety and efficacy evidence in the context of post-market usage, co-morbidities or broader patient populations.
RegenMed recognized that while real-world evidence holds great promise in principle, it faced many challenges in execution. It is not easy for busy clinicians to identify, collect, aggregate and analyze foundational real-world data. Moreover, they have little training or incentive to do so. It is difficult to extract clinically useful real-world evidence from EMR, claims and other forms of “big-data”. Real-world evidence requires large, coherent datasets, requiring efficient collaboration among clinicians; there are many obstacles to such collaboration.
To address these multiple challenges, the Company has invested heavily over the past several years in “Circles”, including the patent-pending inCytes™ and Benchmarc™ platforms.
Provider-Scientific-Industry Partnership
Most advances in medicine depend on sustained collaboration among researchers, industry and clinicians. Each plays a critical role in discovery, funding, patient education, product development, regulatory approvals, standards of care, new indications, and public policy – to name a few.
However, effective collaboration is rare. Barriers include the pace of scientific advances, hyper-specialization, literature overload, competing incentives, budget limitations, inaccessible data, time constraints, and legal/ethical concerns.
Facilitating science-based collaboration among industry and providers through Circles has become a major focus of the Company. Investigator-initiated studies, sponsored trials, publication and educational events are but a few of the ways in which real-world evidence can drive value from such collaboration for all parties.
User Experience
In the non-healthcare world, the most successful companies focus relentlessly on providing the customer with an excellent user experience. In the context of real-world evidence, the busy clinician and patient are the customers. Their frustration with everyday healthcare interactions is well reported. RegenMed soon recognized that a major barrier to the adoption of real-world evidence was the expense, inflexibility and limitations of most software platforms.
The Company believes that its Clients – whether provider, product manufacturer or other healthcare stakeholder – should be able to recognize value with a minimum investment of time and money. Moreover, it should be free easily to terminate its relationship with RegenMed if they so desire. (As it turns out, very few Clients do so; to the contrary, they increase Circles usage over time.)
RegenMed therefore continues to invest substantially in user experience. Key components include SaaS pricing, in-person support, multimedia materials customized to individual clinicians and specific patient panels, 24/7/365 access, minimization of clinical burden, longitudinal patient engagement tools, flexibility, scalability, and the regular addition of new features.
Creating Value: Clinical, Financial, Reputational
The Company’s growing Client base reflects a variety of objectives. Circle use cases include clinical decision support, practice growth, research, branding, education, product sales, reimbursement, HCP engagement, practice growth, standards of care development, patient engagement, product development and regulatory compliance. (Often, a single Circle will address many of these goals for a Client.)
As RegenMed grows, it has recognized the importance of becoming a profit center, and not a cost center, for its Clients. The Company’s business roots allow it deliver near-term return on investment for any specific healthcare goal, and then scale that ROI in the context of a long-term partnership.
The Future
Looking ahead to its next eight years, RegenMed is preparing for a global healthcare market which will become increasingly reliant on real-world evidence. The strategic focus of the Company will be building upon the Client-validated foundation it has now established. Specific directions will include:
- Geographic expansion into Middle East, Southeast Asia, China, Korea and Japan.
- Continued releases of new inCytes™ and Benchmarc™ feature sets.
- Development of additional patient enrollment, outcomes follow-up and similar services to reduce burden for clinician burden.
- Development of “Open” Outcomes and Registry Circles across dozens of therapeutic categories and protocols.
- Expansion of Circle Academies, as well as other publication initiatives on behalf of Clients, and of RegenMed itself.
- Expansion of Circle use cases for the health/wellness industry, hospitals, ambulatory surgery centers, self-insured employer groups, medical societies, healthcare foundations, patient advocacy groups.