Scottsdale Healthcare Corp.

[Editor's Note: This is part 2 of 2. To read part 1, click here .] Change management is a very important subject today in health IT as more and more new and amazing technologies make their way into the delivery of healthcare. (Hello, artificial intelligence.) Robert Slepin knows quite a bit about change management. He is an emeritus CIO advisor at EHR kingpin Epic. There, he constantly is helping CIOs across the country change their health IT setups. There are only a dozen or so of these contractors, who are available on demand to Epic provider clients that need strategic advice or interim executive assistance from someone who's deeply experienced with planning, implementing and maintaining Epic EHR systems. Slepin – who has served as chief information officer or in other top IT roles at many top health systems nationwide – enjoys helping other healthcare leaders manage the challenges of EHR operation and optimization. And how to manage change – which he is there to do. Yesterday we offered part one of his comprehensive exploration of change management . Here's some more of what he had to say on that critical topic. Q. What would you say are the important components of a change management initiative? What must CIOs be doing? A. There are several key areas to consider, starting with: Socio-technical alignment. There is a mantra of "people-process-technology" aligning together, which CIOs have long talked about. Any major IT-enabled business transformation needs to bring these pieces together to be effective. Talking the talk is one thing; walking the talk is another. To align the human and technical elements in a way that achieves the best possible outcomes, CIOs should be knowledgeable not only in information and technology but also in complex, adaptive systems, program/project management, risk management and change management theories, frameworks and practices, and approach change projects accordingly. By understanding and applying an evidence-informed approach, CIOs will be more capable of managing change. Adopting or adapting established frameworks to directing complex, large-scale change programs helps mitigate risk and improve engagement and adoption. Change framework. An extremely important component is the change management framework. No need to reinvent the wheel; there are many "best practice" frameworks to choose from, and arguably any one of them could do the job. If the healthcare organization already has a standard framework used across the enterprise and/or for the IT department's purposes, it might make sense to adopt or adapt it to all major change initiatives. If an approach doesn't exist internally, pick one with guidance from peers or advisors. In my experience, a proven framework and toolset contributes significantly to more efficient and effective change management process. Vendor alignment. CIOs must take care to align their preferred change management framework with the standard approach of their software and systems integration vendors. In my experience, it is unwise to blindly adopt a vendor's approach or rely solely upon a vendor's change management team; nor is it smart to reject a vendor's methods or dismiss a vendor's change team out of hand. "Seek to align and adapt the frameworks, processes and tools, and change team members, in a way that is culturally compatible and puts the organization in the driver's seat of leading the change, while respecting and incorporating the essential elements of the vendor's methodology." Robert Slepin, Epic emeritus CIO advisor Rather, seek to align and adapt the frameworks, processes and tools, and change team members, in a way that is culturally compatible and puts the organization in the driver's seat of leading the change, while respecting and incorporating the essential elements of the vendor's methodology. Being rigid and insisting on only using the vendor's "best practice" methodology or only following the organization's internal "this is how we have always done it" practices is a risk to the implementation, engagement and adoption process and ultimately to project and business outcomes. For example, if a hospital has widely adopted SBAR as a standard template for key decision briefing notes, repurpose or adapt the hospital's template for the change project; don't force a different tool on people that takes more effort and time – which they likely have none to spare – to consume. Change team. CIOs should appoint a dedicated change management lead (and additional team members depending on project size), as well as communications and training leads and team members. Change, communications and training/education are critical functions, and they need to work very well together – and they need to work well with everyone else associated with a project. Form follows function and ideally, in my experience, the change team should be organizationally aligned with the technical and project management functions in a single, cohesive socio-technical change project/program organization reporting to the CIO. It is possible to organize the team differently, but this consolidated organization is the best structure for a complex IT-enabled healthcare change initiative , from what I have observed in the industry and based on my own experience at numerous hospitals and healthcare organizations. Other approaches to organizing change management are recommended by some consultancies and vendors, in particular firms serving other industries. For example, separating the program management office, a technical project management function, from the change transformation management office, a people/organization change management function. While a separation of these structures is possible and has been successfully used in healthcare and other industries, most large hospitals and health systems in my experience have chosen to seamlessly integrate the people-process-technology functional areas. The advantage of structural integration is its ability to simplify, clarify and streamline coordination, accountability and execution. Working together as a unified team is easier in a project when these functions are organized as one large team, while there is a necessity to divide further into logical sub-team parts necessary for span of control and specialization, for example, into technical, application, training, integration and other functional areas. Q. What is an example of a successful change management initiative from your extensive experience? What did you do and how did it go? A. One example of a successful change management initiative was JCL Connect, a complex business, clinical, electronic health record and technology infrastructure transformation program at John C. Lincoln Health Network, during 2011-2012. Before its merger into a larger health system, JCL was an independent local integrated delivery system consisting of two community hospitals, level 1 trauma center and medical group in Phoenix, Arizona. Despite its fair share of the usual bumps and bruises incurred during such an ambitious endeavor, JCL Connect was deemed a success. Happily, the hospital network achieved all, and exceeded some, of its business objectives for the program. This program integrated and delivered several related major projects: activation and migration to a new corporate data center; modernization of enterprise network, server and storage; standardization of outpatient clinics' practices; start-up of one of the first 100 Medicare Shared Savings Plan accountable care organizations; and last, but not least in complexity and effort, an enterprise Epic implementation including most clinical and revenue cycle modules. My role as CIO was serving as technical sponsor of the program, partnering with the SVP for the hospitals, SVP for ambulatory and SVP/CFO who collectively served as business co-sponsors. Each sponsor, along with other senior leaders, played a pivotal role in the transformation. "The quality and safety team closely followed post-live performance and collaborated with clinical teams to effect significant improvement across numerous key performance areas, improving the environment of care and patient safety." Robert Slepin, Epic emeritus CIO advisor A key part of my job was fielding the right team to get this ambitious job done, on time, within budget and with quality and safety of patients as the top priority. My job was made easier as I was lucky to inherit an exceptional IT team, including a project director with prior experience working on an EHR implementation at a university health system, as well as highly talented and capable applications, infrastructure, integrations and operations directors, managers, leads, and staff. The outcomes were excellent. Within the first two years following the final go-live in the program, JCL had earned a place for the first time as a Top 100 hospital for excellence in cardiology and was recognized as one of seven U.S. health systems to receive the "MAP Award for High Performance" from the Healthcare Financial Management Association for excellence in revenue cycle. The IT and EHR foundation supported 2X growth in the physician network and addition of a freestanding emergency department. JCL's IT department improved in numerous performance metrics, including an increase in employee engagement from 64% to 85%. Most important, the quality and safety team closely followed post-live performance and collaborated with clinical teams to effect significant improvement across numerous key performance areas, improving the environment of care and patient safety. The JCL Connect program, as it was called, had a lot of moving parts, making the program very high in complexity and risk, and the timeframe was compressed to achieve the meaningful use requirements of the Center for Medicaid and Medicare Services on a timely basis. A critical success factor in managing complexity and mitigating risk was the extremely strong commitment from the hospital network's executive sponsors, and really the entire C-suite, was among the critical factors to our success. Sponsorship was another critical success factor. The SVP for ambulatory operations oversaw and championed outpatient clinical practice standardization. The CFO and VP revenue cycle did the same for finance and revenue. The SVP for facilities partnered with IT for the data center build-out and migration and hardware refresh. The SVP for public relations provided communications resources and strategic guidance. The VP quality was a close partner for leading clinical change management, while the CMO/CMIO held the torch for leading physician change management. The 100% commitment, passion, dedication and hands-on role from every senior executive in the organization was crucial in leading the change. While the importance of top executive sponsorship cannot be understated, leadership at all levels across the organization was another key ingredient to our success. JCL had an exceptional EHR project director with prior experience at another institution; her contribution was immense, as was the strong support and leadership of the other talented IT directors, managers and team leads. Leadership also came from the numerous champions and subject matter experts that volunteered to join the project on a part-time basis from start to end. They led and participated in dozens of work groups and hundreds of design sessions and readiness activities, pouring countless hours, abundant energy, bringing great enthusiasm and making thousands of decisions along the way. To read an in-depth interview with Epic Emeritus CIO Advisor Robert Slepin about EHR optimization, click here . Follow Bill's HIT coverage on LinkedIn: Bill Siwicki Email him: bsiwicki@himss.org Healthcare IT News is a HIMSS Media publication.

STC-15 was well tolerated and clinical activity was observed across the pharmacologically active dose range in advanced cancer patients Primary objectives were achieved to progress STC-15 into combination with checkpoint inhibitor combination studies CAMBRIDGE, England, June 3, 2024 /PRNewswire/ -- STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, today announces that interim Phase 1 clinical data from its first-in-class lead product, STC-15, was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago, US. The presented poster, entitled, 'Phase 1 Dose Escalation and Cohort Expansion Study Evaluating Safety, PK, PD and Clinical Activity of STC-15, a METTL3 Inhibitor in Patients with Advanced Malignancies', highlighted recent findings on STORM's lead product, STC-15, a potent and selective METTL3 inhibitor and the first molecule specifically targeting an RNA methyltransferase enzyme to enter clinical development. The study was conducted to evaluate the safety, pharmacokinetics, target modulation and clinical activity of STC-15 in patients with advanced malignancies, with the aim of establishing a recommended Phase 2 dose escalation to support future clinical development. The study enrolled 33 patients across five dose escalation cohorts ranging from 60mg to 200mg and explored daily and thrice weekly oral dosing regimens. Data presented at ASCO from 33 patients is outlined below: STC-15 is well tolerated across the pharmacologically active dose range Treatment emergent adverse events (TEAEs) were manageable: common related adverse events were thrombocytopenia, rash, and pruritus As of April 15, 2024, 27 patients were evaluable for response assessment with at least 1 on-treatment scan. Clinical activity was observed, comprising of; - 11% Overall Response Rate (3 partial responses) - 63% Disease Control Rate (14 stable disease, 3 partial responses) PK simulations and safety data support oral administration of STC-15 three times a week (TIW) Significant reductions in methylated polyA-RNA in blood samples from all cohorts demonstrated METTL3 target engagement and rapid PD effect Additional PD biomarker analysis indicated activation of interferon signaling and innate immune responses, as measured by RNA transcript analysis in blood cells from treated patients Recommended Phase 2 doses were identified as between 60mg and 200mg TIW Advancement of STC-15 into combination studies with checkpoint inhibitors is expected to commence in 2024 Jerry McMahon, Chief Executive Officer of Storm Therapeutics, said: "This Phase 1 data, to date, demonstrates the encouraging potential of STC-15 and its ability to impact a wide range of cancers. STC-15 is showing excellent safety and pharmacologic properties as it advances further into clinical development. As part of STORM's evolving strategy, we are expanding our studies and structuring clinical trial designs to include patients with cancers such as lung, melanoma, head and neck, and endometrial cancer in the future, and we look forward to providing further updates in due course." Josi Holz , Chief Medical Officer of STORM Therapeutics, commented: "These data signify great progress for STORM as we continue to develop our pipeline of RNA modifying enzyme inhibitors. We are pleased to be presenting data that demonstrates the potential of STC-15 and its promising signs of tolerability and clinical activity. We look forward to completing the current Phase 1 study and including the addition of checkpoint inhibitors." Justin Moser, Principal Investigator at HonorHealth Research Institute and First Author, remarked: "These new data presented at ASCO on STC-15 are promising and support future clinical studies with this novel agent and new mechanism. METTL3 inhibition has demonstrated early clinical activity and represents a new way to activate the innate immune system with the potential to treat cancer in patients across a range of tumor types." Abstracts are available on the ASCO program guide here, and on the STORM website here. STC-15 is currently under evaluation for the treatment of patients with advanced solid tumors in a first-in-human, Phase 1 clinical study with ongoing with cohorts being expanded to further evaluate safety, food effect, PK/PD, clinical activity, with the goal of determining optimized active doses. Details of the study can be found on clinicaltrials.gov under the identifier NCT05584111. About STORM Therapeutics STORM Therapeutics is a clinical-stage biotechnology company pioneering cellular reprogramming through RNA modifications to treat disease. Its world leading understanding of RNA modifying enzymes (RME) has led to the discovery of breakthrough small molecule drugs that precisely reprogram cells through RNA biology for the treatment of cancer, inflammation, viruses and CNS diseases. STORM's lead product, STC-15, is the first RNA modifying enzyme inhibitor to enter human clinical development. STC-15 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors, establishing a data set allowing development in future clinical studies. Preclinical data have revealed that METTL3 inhibition stimulates immune cells and activates interferon pathways, leading to the destruction of tumor cells. Additional preclinical studies have demonstrated enhanced anti-tumor properties in combination with checkpoint inhibitors, supporting clinical development in tumor types where an augmented immune response may result in anti-cancer activity. STORM is building on its first-mover advantage by positioning additional RME inhibitor programs to advance into IND-track activities in 2024. STORM is seeking partners to collaborate and accelerate development of these novel drugs for disease applications outside of oncology. STORM's specialist healthcare investors include M Ventures, Pfizer Ventures, Taiho Ventures LLC, Seroba Life Sciences, Cambridge Innovation Capital Limited, IP Group plc, UTokyo Innovation Platform Co., Ltd. and the Fast Track Initiative (FTI). For more information, please visit About STC-15 STORM's lead product, STC-15, is the first RME inhibitor to enter human clinical evaluation. This agent is an oral small molecule that inhibits METTL3, an RNA methyltransferase implicated in oncology and other diseases. Certain RNA methyltransferases are important regulators of RNA sensing and innate immune activation and, as such, represent novel immune-regulatory targets. STC-15 has also been shown preclinically to inhibit tumor growth through mechanisms involving anti-cancer immune responses, such as changes in interferon signalling and synergy with T cell checkpoint blockade. STORM is studying the safety and pharmacology of STC-15 in a Phase 1 clinical study in patients with solid tumors. Details of the study can be found on clinicaltrials.gov under the identifier NCT05584111. About ASCO Founded in 1964, the American Society of Clinical Oncology is the world's leading professional organization for physicians and oncology professionals caring for people with cancer. SOURCE STORM Therapeutics

STC-15 is the first METTL3 inhibitor to enter clinical development Clinical data will include safety, pharmacology, target modulation, and clinical activity CAMBRIDGE, England, May 24, 2024 /PRNewswire/ -- STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, today announces that it will be presenting interim clinical data on its first-in-class lead product, STC-15 at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, US from May 31 to June 4, 2024. The poster presentation, entitled 'Phase 1 Dose Escalation and Cohort Expansion Study Evaluating Safety, PK, PD and Clinical Activity of STC-15, a METTL3 Inhibitor, in Patients with Advanced Malignancies', describes findings from STORM's ongoing dose escalation and expansion Phase 1 clinical study to evaluate STC-15, an oral and highly selective small molecule inhibitor of METTL3, in advanced cancer patients. These interim results will focus on safety, pharmacokinetics, target modulation and tumor assessments to support future clinical studies. STC-15 is the first molecule specifically targeting an RNA methyltransferase enzyme to enter clinical development. Preclinical data has demonstrated that METTL3 inhibition stimulates immune cells and activates interferon pathways, leading to the destruction of tumor cells. The poster presentation will detail the study design, patient demographics, safety data, pharmacokinetics, METTL3 target engagement, mechanistic biomarker data, and assessments of clinical activity. Details of the poster presentation are as follow: Poster Title: Phase 1 dose escalation and cohort expansion study evaluating safety, PK, PD and clinical activity of STC-15, a METTL3 inhibitor, in patients with advanced malignancies Presenter: Justin Moser at HonorHealth Research Institute Authors: Justin Moser[1], Kyriakos Papadopoulos[2], Jordi Rodon Ahnert[3], Yaara Ofir-Rosenfeld[4], Josefin-Beate Holz[4] Organizations: [1]HonorHealth Research Institute, [2]START San Antonio, [3]The University of Texas MD Anderson Cancer Center, [4]Storm Therapeutics Ltd Poster Session: Developmental Therapeutics—Immunotherapy Session Date and Time: Saturday June 1, 2024, 9:00 AM - 12:00 PM CDT Poster Board Number: 65 Abstract Presentation Number: 2586 The Abstract is available on the ASCO online itinerary planner here, and on the STORM website here. NOTES TO EDITORS About STORM Therapeutics STORM Therapeutics is a clinical-stage biotechnology company pioneering cellular reprogramming through RNA modifications to treat disease. Its world leading understanding of RNA modifying enzymes (RME) has led to the discovery of breakthrough small molecule drugs that precisely reprogram cells through RNA biology for the treatment of cancer, inflammation, viruses and CNS diseases. STORM's lead product, STC-15, is the first RNA modifying enzyme inhibitor to enter human clinical development. STC-15 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors, establishing a data set allowing development in future clinical studies. Preclinical data have revealed that METTL3 inhibition stimulates immune cells and activates interferon pathways, leading to the destruction of tumor cells. Additional preclinical studies have demonstrated enhanced anti-tumor properties in combination with checkpoint inhibitors, supporting clinical development in tumor types where an augmented immune response may result in anti-cancer activity. STORM is building on its first-mover advantage by positioning additional RME inhibitor programs to advance into IND-track activities in 2024. STORM is seeking partners to collaborate and accelerate development of these novel drugs for disease applications outside of oncology. STORM's specialist healthcare investors include M Ventures, Pfizer Ventures, Taiho Ventures LLC, Seroba Life Sciences, Cambridge Innovation Capital Limited, IP Group plc, UTokyo Innovation Platform Co., Ltd. and the Fast Track Initiative (FTI). For more information, please visit About STC-15 STORM's lead product, STC-15, is the first RME inhibitor to enter human clinical evaluation. This agent is an oral small molecule that inhibits METTL3, an RNA methyltransferase implicated in oncology and other diseases. Certain RNA methyltransferases are important regulators of RNA sensing and innate immune activation and, as such, represent novel immune-regulatory targets. STC-15 has also been shown preclinically to inhibit tumor growth through mechanisms involving anti-cancer immune responses, such as changes in interferon signalling and synergy with T cell checkpoint blockade. STORM is studying the safety and pharmacology of STC-15 in a Phase 1 clinical study in patients with solid tumors. Details of the study can be found on clinicaltrials.gov under the identifier NCT05584111. About ASCO Founded in 1964, the American Society of Clinical Oncology is the world's leading professional organization for physicians and oncology professionals caring for people with cancer. SOURCE STORM Therapeutics