The Rare Therapies Launchpad: a pilot program for individualized medicines in the UK.

Key TakeawaysFour pilot teams shared experiences with piloting during the COVID‐19 pandemic, emphasizing that thoughtful planning streamlines the piloting process while mitigating the risk of transmitting illness.Remote access to and control of pilot equipment, along with the use of virtual communication platforms, enabled teams to successfully perform pilot‐scale studies.Operating pilot systems through the pandemic allowed teams to respond to drastic changes on a small scale to mitigate risks around full‐scale processes at the treatment plant.

OBJECTIVES/GOALS: Pilot grants are small financial investments given out by CTSA hubs to facilitate new clinical and translational research projects. The New Jersey Alliance of Clinical and Translational Science (NJ ACTS) is one of 65 CTSA hubs. The goal of this project was to evaluate and improve the NJ ACTS program by learning from pilot programs across the consortium. METHODS/STUDY POPULATION: The initial research on pilot programs was conducted using the CTSA Search Solutions tool, a tool developed at NJ ACTS which provides links to individual pages by topic in all the hub websites. Using the tool, public information was accessed, including common award amounts, significant dates, and preferred categories of research. Then, a survey created in REDCap was distributed to colleagues at all CTSA hubs to gather additional information and thoughts on pilot programs. The data were compiled in an excel database to observe and analyze trends. These trends were graphically presented in figures developed from the data to see how NJ ACTS compares to other CTSA hubs in how they focus and operate their pilot programs. RESULTS/ANTICIPATED RESULTS: There are both similarities and differences between NJ ACTS and other hubs. NJ ACTS utilizes a REDCap form for its application, as do 14 other CTSA hubs. Surveys also show that NJ ACTS follows similar processes for: letter of intent and application due dates; having a standing review committee; and the categories of awards. Award categories for Clinical/Translational Innovation, Methodology/Infrastructure, and Partnership/Collaboration are shared with 47, 25, and 41 institutions, respectively. NJ ACTS requires collaboration between its multiple institutions, as do 28 other hubs. It does not, however, have a public notification of award date, and notifications tend to go out relatively late. NJ ACTS funded multiple proposals pertaining to COVID-19, something 11 other CTSA hubs did as well. DISCUSSION/SIGNIFICANCE: Although a new CTSA hub, NJ ACTSs Pilot Program operates comparably to more mature CTSA hubs. Using the survey data, NJ ACTS can implement modest changes, better serving its scientific community. CTSA Search Solutions has proven an excellent tool and can be used by any hub to understand how they compare and implement changes to improve their programs.

The longitudinal integrated clerkship is an innovative approach in medical education that emphasizes continuity as a key principle to provide student-centered experiences and learning. Seoul National University College of Medicine decided to adapt longitudinal integrated clerkships to the new curriculum beginning in 2018, and therefore conducted pilot studies in 2016 and 2017. This study aimed to analyze the program evaluation results of the two pilot programs and discuss issues related to the successful implementation of longitudinal integrated clerkships in Korea. We conducted a focus group interview with nine students who participated in the 2016 pilot program and 13 students who participated in the 2017 pilot program. We also conducted a focus group interview with 11 faculty members who either participated in the pilot program or will participate in the main program. From the 2016 experience, we found that it is not appropriate to assign each patient to a single student and let the students contact their patients personally for feasibility and safety reasons. In the 2017 pilot program, we assigned each patient to a group of students, which made it more feasible for the students to follow-up with their patients. The students were satisfied with their new experience of longitudinal patient follow-up and regular meetings in the pilot program. Faculty emphasized the importance of establishing the course objectives and holding an orientation for the students and the faculty. Further study is planned to evaluate the early outcomes of the main longitudinalintegrated clerkship.

Regional Pilot Programs: The New Lab for Innovation and Research Pilot program has become a recent buzz term in the media and in business circles, especially in China where Taiwan is forging increasingly closer ties. Armed with massive regional markets, the pilot programs in China have attracted the earnest attention of multinational companies and government agencies hoping to expand their markets and improve industry development by participating in the early-stages of development. A pilot program usually refers to the development of a new product or application for a technical concept, or to the experimental operations of new business models, service models, policies, or systems in a specific region. The programs usually range in size from family or hospital use, to that of a community or city, with user feedback serving as a basis for subsequent improvement. This concept is similar in spirit and function to Living Labs, which were proposed by Massachusetts Institute of Technology Professor William Mitchell and have sparked a wave of innovative R&D and applications in Europe, the U.S., Japan, Korea, as well as in other countries. Both concepts emphasize employing a user-centered research method in various experience tests by observing users in live scenarios and using feedback from users as they interact with stakeholders including governments, private enterprises, research organizations, and communities to co-create value in the early-stages of innovation and creation, ultimately resulting in market-ready products or services. In recent years, Taiwanese organizations, such as the National Science Council, Institute for Information Industry, National Taiwan University, National Chiao Tung University, and National Cheng Kung University, have invested in and promoted user-centered smart living labs. The Ministry of Economic Affairs’ Smart Living Technology & Service Program (i236) is aimed at developing Smart Towns and Intelligent Parks in the pilot areas (test-beds) of Songshan, Nantou Puli, Yilan, Taichung, and Kaohsiung. If proven successful, they can serve as regional models for industrialization, where the results will multiply and bring Taiwan closer to the long-term goals of raising industrial value and expanding into global markets............................................................

Veterinary RecordVolume 175, Issue 14 p. 337-337 News and Report 100,000 adverts removed in ‘hugely successful’ pilot scheme First published: 11 October 2014 https://doi.org/10.1136/vr.g6077Read the full textAboutPDF ToolsRequest permissionExport citationAdd...

Food retailers are key stakeholders in the development, implementation, and effectiveness of Supplemental Nutrition Assistance Program (SNAP) nutrition pilot programs. Qualitative interviews were conducted to gather insight from food retailers regarding the feasibility of proposed strategies to improve food choices among SNAP participants. Two corporate and six local-level food retailer managers were identified for interviews based on SNAP participation, rural- urban code, and type of food retail settings in the selected counties. Qualitative thematic analysis was performed by four research team members, and themes were identified via consensus. Marketing, incentive, and disincentive program models were well-received, while restriction and stocking standards models were less well-received. Food retailers viewed simple programs with easy implementation and educational components positively. Driving sales and programs that align with corporate and social responsibility goals were important factors related to willingness to participate in pilot programs. Insights from this present study can inform future pilot programs and promote food retailer buy-in.

The Ministry of Health and Welfare's "Pilot Program of Home Care for Acute Symptoms", launched in 2024, and complementary measures for long-term care services are introduced in this article. The goal of the pilot program is to provide appropriate home medical care to specific emergency patients as an alternative to hospitalization, allowing the extension of emergency care from hospitals to home and residential institutions and connecting long-term care resources during and after acute care. Given that many of those targeted by the pilot program are individuals with mobility issues or who require long-term care, and thus subject to higher levels of treatment difficulty and care service demand, the Ministry has relaxed the rules initially set for this program. Now, cases that meet the conditions for long-term care benefits under the "Regulations on Application and Payment for Long-Term Care Services" are eligible to access long-term care services during the home care period within the scope of care provided by the home care team without adjusting payment limits or co-payment terms. For institutional residents, additional incentive indicators for the pilot program have been incorporated into the "Plan for Minimizing Outpatient Visits by Institutional Residents". In summary, these measures are designed to improve the efficiency and quality of home care provided to address acute symptoms while optimizing the use of long-term care resources to address future medical and caregiving challenges in Taiwan's future super-aged society.

Introduction: This manuscript reports on a pilot program focused on implementing pharmacogenetic testing within the framework of an employer-sponsored medical plan at University of Florida (UF) Health. The aim was to understand the challenges associated with program implementation and to gather insights into patient attitudes towards PGx testing.Methods: The pilot program adopted a partially preemptive approach, targeting patients on current prescriptions for medications with relevant gene-drug associations. Patients were contacted via phone or through the MyChart system and offered pharmacogenetic testing with no additional direct costs.Results: Of 244 eligible patients, 110 agreed to participate. However, only 61 returned the mailed DNA collection kits. Among these, 89% had at least one potentially actionable genotype-based phenotype. Post-test follow-up revealed that while the majority viewed the process positively, 71% preferred a consultation with a pharmacogenetic specialist for better understanding of their results. Barriers to implementation ranged from fatigue with the healthcare system to a lack of understanding of the pharmacogenetic testing and concerns about privacy and potential misuse of genetic data.Conclusion: The findings underscore the need for clearer patient education on pharmacogenetic results and suggest the importance of the role of pharmacogenetic-trained pharmacists in delivering this education. They also highlight issues with relying on incomplete or inaccurate medication lists in patients’ electronic health record. The implementation revealed less obvious challenges, the understanding of which could be beneficial for the success of future preemptive pharmacogenetic implementation programs. The insights from the pilot program served to bridge the information gap between patients, providers, and pharmacogenetic -specialists, with the ultimate goal of improving patient care.

As an emerging short-distance mobility mode, the shared e-scooter system has been studied extensively; however, an unexplored question going forward is how equitably this system is accessible among different population groups. In this study, we utilize spatial analyses to identify disparities in accessing e-scooters during the Chicago 2019 pilot program. Moreover, previous studies assessing spatial accessibility of micromobility mainly use highly aggregated data overlooking the heterogeneity within spatial units. To address this issue, we employ a block group-level data set comprising location records of the e-scooters in the pilot program, socio-demographics, and built environment factors. Further, our approach constitutes both horizontal and vertical equity perspectives. To assess horizontal equity, we apply Lorenz curve analysis to characterize the spatial distribution of e-scooters. Subsequently, from a vertical equity perspective, we employ ordinary least square and geographically weighted regression models to investigate the underlying factors associated with e-scooter accessibility within the pilot area. The findings show a wide racial gap in e-scooter accessibility, where Asian areas have better accessibility than Hispanic areas with associated Gini indices of 0.467, and 0.752, respectively. Further, the GWR results revealed disparities in e-scooter accessibility for females, the elderly, and the Hispanic race. The findings of this study provide valuable lessons from Chicago's 2019 e-scooter pilot program and can contribute to improving equity in e-scooter accessibility for future pilot programs.

This pilot study is an innovative approach to addressing the issue of childhood obesity that starts with the primary care physician and involves group education with peers. The primary care physician assesses the child's well-being at each interaction, whether for a scheduled well-child visit or for an acute illness. At each office visit the vital signs are taken, including the height, weight, and the calculated body mass index (BMI). The BMI is a tool that helps the provider identify children who are overweight or obese. Using the patient empowerment readiness model, the provider addresses obesity with the patient and the parent to determine if they are ready to implement behavioral changes. During a 10-month period, 68 patients were enrolled in the pilot program. The initial results after the 10 months showed that when the provider identified the issue of obesity and the child was assessed for readiness and integrated in the behavioral modification program the outcome was 63% of the group reduced their BMI. It was also noted that asthma was the most frequent comorbidity in the overweight/obese children. Whereas BMI increased in a matched control group, participants in the pilot program succeeded in reducing BMI.

An in situ chemical oxidation (ISCO) pilot program, using Fenton’s Reagent (hydrogen peroxide and a ferrous sulfate catalyst), was performed to assess its effectiveness in destroying chlorinated volatile organic compounds (CVOCs) in a fractured-bedrock aquifer. This case study is unique because it was one of the first applications of ISCO in fractured bedrock. In addition, the targeted CVOC reduction from 1,500 to 100 micrograms per liter (μg/L) was relatively aggressive compared to most ISCO applications. This pilot program also provided the opportunity for an independent, third party evaluation of ISCO in a fractured-bedrock environment. The site geology consists of approximately 6 meters (m) of unconsolidated glacial deposits overlying fractured bedrock, with a groundwater depth of approximately 2 m. Initial characterization activities, including injection testing and multi-level packer sampling, identified a pre-ISCO CVOC plume extending approximately 90 m long by 45 m wide and spanning a vertical depth between 3 and 35 m. Packer sampling results indicated the pre-ISCO plume had an asymmetric configuration that was consistent with the injection-test results. The ISCO pilot program involved the injection of 14,237 liters of 50% hydrogen peroxide, combined with a ferrous sulfate and pH-buffering catalyst. Two injection events were performed, with overlapping performance sampling. Samples collected 30 to 45 days after each injection event showed CVOC concentrations below the treatment objective in many areas of the plume. However, samples collected 60 to 100 days after each event revealed significant rebound in most areas, at concentrations that approached initial pre-ISCO aquifer conditions. An assessment of the results suggests that the injected oxidants primarily influenced the more transmissive fractures in the treatment zone, whereas the less transmissive fractures were less influenced. Geochemical data and calculations indicate that the peroxide and catalyst may persist in the subsurface for prolonged periods (>200 days), thus complicating the assessment of rebound and the actual effectiveness of the technology. Although the success of treatment was limited, it proved to be successful in enhancing the conceptual site model of the subsurface, better defining the applications and limitations of ISCO treatment in fractured bedrock, and most importantly, clearly identifying the source of residual CVOCs at the site.

Virden and Daly are giant fields with mature waterfloods that have received minimal development attention since the waterfloods were initiated more than 30 years ago. An evaluation of the wells' production symptoms suggested that many areas within the fields were not optimized. Some areas display long, harmonic production declines with large remaining reserves. Other areas display injected water cycling through layers of high permeability while still other areas display a strong bottom-water drive that resulted in water coning. This paper describes a low-cost. short cycle-time method in which these fields were modeled and tested. A development pilot project was initiated to determine the economic viability of optimizing these fields. A conscious decision was made to accept a higher risk, but save time and money by designing a development pilot program directly from a conceptual. Streamtube displacement reservoir simulation. The 1996 pilot program consisted of 6 horizontal wells and 3 producer to injector conversions in areas of slow waterflood response, and in areas of water-cycling 3 polymer workovers on injectors were done to redirect water. Results suggested that the pilot program was an economic success. resulting in an expanded program for 1997 (9 horizontal wells, 5 conversions, and 1 polymer workover). P. 177

How to Predict the Consequences of a Tick Value Change? Evidence from the Tokyo Stock Exchange Pilot Program

Michigan Gov. Gretchen Whitmer on Oct. 21 ended pilot programs to test whether health plans should manage the care of the state's nearly $3 billion system, the Michigan health department announced, Crain's Detroit Business reported. Part of the reason for the pilots' end was Whitmer's veto of funding that encompassed the controversial program, which faced skepticism and opposition from many mental health providers, administrative organizations and families of the 300,000 patients in the Medicaid behavioral health system in Michigan. Managed care health plans have argued that they can successfully integrate management of behavioral health services with Medicaid physical health coverage, which they already administer. Three pilot programs in Genesee, Saginaw, Muskegon, Lake, Mason and Oceana counties that were supposed to test the ability to integrate physical health and mental health under Medicaid were instead terminated. After two delays on the pilots going back to 2018, the health plans and mental health providers had not been able to reach agreement on how to do it. “After years of work to reach consensus, it has become clear that agreement will not be reached,” Michigan Department of Health and Human Services Director Robert Gordon said in a statement. “We remain committed to making our behavioral health system work better for all Michiganders, and it is time to look for new ways to achieve this goal.”

e14125 Background: Cancer therapeutics often receive FDA approval months to years before regulatory submission to other countries. [i] Registrational trials in oncology are increasingly international, with many patients enrolled outside of the United States. Harmonizing access to new global standards of treatment may facilitate optimal design and conduct of global clinical trials. Methods: In May 2019, the Oncology Center for Excellence launched Project Orbis in collaboration with the Australian Therapeutic Good Administration (TGA) and Health Canada. The aim of this initiative is to provide a framework for concurrent submission and review of oncology products among international partners to facilitate global access. Results: The first Project Orbis was a collaborative review of a supplemental application for lenvatinib and pembrolizumab for patients with advanced endometrial cancer. This review also deployed other OCE regulatory review tools including the Real-Time Oncology Review (RTOR) pilot program, which can streamline the submission of data prior to the completion and submission of the entire application, and its accompanying Assessment Aid, to facilitate discussions among regulatory agencies. Lenvatinib and pembrolizumab was approved on September 17, 2019, in conjunction with the TGA and Health Canada, three months prior to the FDA goal date. FDA, TGA, and Health Canada issued a second action under Project Orbis on November 21, 2019, with the approval of acalabrutinib for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Several other products are under international review as part of this pilot program and a summary of timelines and outcomes will be described. Conclusions: Project Orbis is an innovative OCE initiative that leverages the Center’s longstanding communication and collaboration with international regulators. This pilot program facilitates concurrent submission and review of oncology products among global regulatory health agencies. Continued efforts under Project Orbis will build on the initial success to incorporate additional global partners including Swissmedic and Singapore’s Health Science Authority. [i] The Centre for Innovation in Regulatory Science (CIRS). R&D Briefing 70 New drug approvals in six major authorities 2009-2018: Focus on Facilitated Regulatory Pathways and Orphan Status