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Medical Societies Adding Value To Their Members, and Advancing Their Mission

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September 14, 2019
Professional medical societies are committed to providing value to their members, and advancing science and ...
Professional medical societies are committed to providing value to their members, and advancing science and clinical excellence. They do so through education, fostering collaboration and often engagement with regulators. However, the plethora of conferences, the dynamic nature of medicine, members’ busy clinical schedules, funding limitations and lack of engagement between meetings all challenge societies’ desire to maintain their relevance and impact. While most societies have third parties to assist with conference logistics, few have the outside support needed to achieve even a fraction of the potential of their mission.inCytes™ — developed by clinicians for clinicians – allows societies to add real value to members’ everyday practices at nominal cost. A society-designed study enhances education, evidence-based clinical procedures and continuous, real-time collaboration in a manner highly attractive to physicians. The society will justify membership dues, attract more members, establish new revenue opportunities and increase its scientific and clinical relevance.Illustrative uses of inCytes™ by a medical society include:Development of society-branded and product-agnostic Observational Protocols and Reports specific to the society and its clinical/scientific focus.Invitation to existing and prospective members to participate in a corresponding study, based on members’ current clinical practices and utilizing inCytes™.Collection of real-world data through the society, which then converts it into real-world evidence as increasingly demanded by regulators, providers, payers and patients.Reports on results throughout year, or at next annual meeting. Society-specific registry.
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FDA HCT/P Guidelines: Understanding and Adherence

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June 27, 2019
The FDA HCT/P regulations in this broad field involve three foundational concepts: autologous source, minimal manipulation and homologous use.
SummaryGovernment regulators, providers, payers and patients increasingly recognize the potential benefits of human cell and tissue products (“HCT/P”). At the same time, they are differentiating between “good actors” and “bad actors” in the clinical delivery of those HCT/P’s. The recent U.S. federal court injunction against US Stem Cell Centers confirms the FDA’s commitment to enforcing its HCT/P regulations against clinicians it places in the latter category. That case makes clear, for example, that enzymatic digestion of adipose – commonly used to produce stromal vascular fraction – is considered more than minimal manipulation and thus subject to regulation as a drug.The FDA HCT/P regulations in this broad field involve three foundational concepts: autologous source, minimal manipulation and homologous use. To help clinicians understand and document compliance with them, inCytes™ now includes a short survey/report addressing key elements surrounding harvest, processing and delivery of a large number of applicable cell/tissue types. The survey and report – easily modifiable for specific practice considerations – will inform regulatorily-compliant clinical protocols, support patient engagement, establish correlations with outcomes, and document protocol and regulatory compliance.Surveys and reports, all easily customized, are available on inCytes™ for many indications, procedures and patient cohorts. New ones are created regularly, often for the specific needs of Users. Sign up for a free, custom trial today of the platform designed by clinicians for clinicians to capture and exploit true clinical evidence.
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