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Mar 13, 2025·Frontiers in Systems Biology
0 cites
Scientia machina: a proposed conceptual framework for a technology-accelerated system of biomedical science

Sean T. Manion

What is the brain that it can understand science?What is science that it can understand the brain?These two basic questions (with homage to Warren McCulloch in the framing) have guided my career, aiming to understand the brain and an effort to understand science. This journey has taken me from academic lab work to clinical research oversight and government policy to the emerging health & science technology industry and back to academia. It has now led me to co-lead, along with Dr. Jennifer Lovejoy of the Institute of Systems Biology, this section of Frontiers in Systems Biology -Systems Concepts, Theory and Policy in Biology and Medicine. Our journal Chief Editor, Dr. Yoram Vodovotz, has laid out the overarching vision for this and the other sections (Vodovotz, 2021). This Grand Challenge is an effort to add another layer of detail to the portions of that broad scope contained in our Systems Concepts section (Lovejoy, 2024).Systems biology and systems medicine have roots going back to at least World War II, when biologists and physiologists were recruited into the war effort in the United States and Britain, trained in computational approaches, and joined with engineers and mathematicians to solve complex problems with communications, radar, anti-aircraft guns and more (Churchill, 1949). This alignment led to the foundation of the field of cybernetics and the related Macy Conferences in the U.S. postwar, while in Britain, "This coalescing of biological, engineering, and mathematics frameworks would continue to great effect a few years later as the Ratio Club," (Husbands, 2008). In the decades that followed, this robust milieu of ideas would foster the development of everything from general systems theory and information theory to artificial intelligence (AI) and cognitive science (Pickering, 2010). Despite this early alignment, it would be decades before systems biology and systems medicine arose as formal fields of inquiry (Green, 2017).Science has arguably been the most effective way of generating and validating new knowledge for the past few centuries. New technologies and computing approaches now provide us with novel tools to accelerate this process. While early work is being done to explore the use of these new tools for science, these have been limited in success to real-world application to detailed aspects of biology and medicine (McCoy, 2024). A comprehensive conceptual framework may be a more effective way to realize the value of technology in accelerating science. Modern science is not a simple holistic process, but an amalgam of processes and interests that have accumulated over centuries.By analyzing this system of science, we can better synthesize a new approach to using the array of emerging technologies now available. This will require us to revisit the current human and institutional processes that govern the creation of new scientific knowledge. A human and machine hybrid approach, aligned with a governance in the classic cybernetic style (i.e. control and communication in humans and machines), may allow us to optimize our scientific efforts and advance knowledge for the betterment of all of humanity.There has been much excitement about the potential of emerging technologies applied to science in recent yearsfrom AI to applications of blockchain technologies and web3 applied as decentralized science (DeSci) (Weidener, 2024). In these nascent efforts there has often been an oversimplification of science in order to capture technical requirements to automate or simulate biomedical research.Science is not done by a single person or organization. Science embodies the contribution of multiple individualswhose brains are themselves collections of dozens of subsystems (Kirby, 2024)processed through a series of refinement and testing. The results of these are moved through a longitudinal process of validation, contextual framing against prior accumulated knowledge, and consensus determination of evidence level and confidence in the results. Only then does this new knowledge contribute to the body of generalized knowledge we applied to the real world.Creating a new technology-accelerated knowledge system for biomedical science -what I'm calling here Scientia Machinamay be best approached through first articulating the conceptual and epistemological framework of the current system of biomedical science as it moves from data to information to evidence to knowledge and its application. Along the way it passes through layers of trust and is eventually captured in the artifacts of biomedical science we have come to rely on and expect. For applications of emerging technologysuch as the automated complex information processing of AI and the automated trust and governance of blockchainto be most beneficial to science, we should use them to systematically augment and accelerate these processes and creation of the artifacts of science while maintaining or improving the basic conceptual framework of biomedical knowledge discovery and implementation. Eventually parts of the current system may be sundowned leading to an even greater acceleration of science.This Scientia Machina framework starts with identifying key layers of trust in the biomedical bench to bedside process of evidence based medicine. Here I have proposed five layers of trust along with examples of their current artifacts and processes, plus potential approaches to augmenting these with technology and related adjustment to the current workflow (Figure 1).Data Layer -Data are collected in experimental and/or clinical context, often based on specific methodology. The principal investigator (PI) and team, along with the equipment and techniques used, are trusted to produce and capture explainable and reproducible data. This layer is only sometimes made transparent and rarely validated.Future of Data -Data are verifiable through trackable provenance and alignment with related metadata (e.g. demographics, treatment delivery details, device and equipment specifications, etc.). Data can be accessed for querying and algorithm training without moving, copying or exposing the data.Information Layer -Data are combined in datasets with contextual meta-data (e.g. demographics of research participants). The PI and team are trusted to compile, store and manage this data. It is increasingly becoming requested by funders and publishers to be made available. Some programs promote dataset sharing through centralized repositories or direct PI to PI contact.Future of Information -Data confidence fabrics allow sorting combined datasets based on confidence levels for each data point related to their associated metadata, with deployable programming to temporarily convert non-standard data into a calculable or trainable standard.Evidence Layer -Analysis of the datasets and testing hypotheses produces results that interpreted as findings. These are presented as novel assertion, backed by the data and methods, and put into the context of previously identified findings in the field in the form of a manuscript submitted for peerreview. The journal editors and peer-reviewers are trusted to confirm the assertions are supported by the evidence, fit (or convincingly contradict) previously established knowledge in the field.Future of Evidence -Swarm approach, i.e. networked, auditable crowd-sourcing, to peer review with a wider array of contributors with inputs weighted based on preset governance and continuous crowd feedback for nearer to real-time review with broader, multi-discipline input.Knowledge Layer -Combined sets of published articles are reviewed by a group of experts against certain criteria to answer specific questions about the state of evidence in the field as systematic reviews and meta-analyses to provide the most up-to-date knowledge in the specific area of focus.The groups of authors along with editors and peer-reviewers of those systematic reviews and metaanalyses are trusted to have executed and validated, respectively, a thorough and sound assessment of the evidence for the area in question to provide new knowledge.Future of Knowledge -Swarm approach (see above) to systematic review with network on demand request for new or updated reviews of existing evidence along with evidence threshold signals (i.e. sufficient new evidence in a particular areas prompts new or updated systematic review).Applied Knowledge Layer -Applications of knowledge can come in various forms, including pharmaceuticals, devices and procedures. The application of knowledge is periodically assessed for incorporation into clinical practice guidelines (CPG) and similar clinical guidance documents. The CPG group is trusted to have found and appropriately graded all of the available evidence and refined knowledge on a topic area to best inform clinicians how to address the area optimally.Future of Knowledge Application -Networked clinical practice guideline wiki (collaboratively edited living document) allowing for continuous, network refereed input and update of new knowledge.Each of these layers and their future states can be augmented, enhanced, accelerated and potentially replaced with appropriate applications of an array of automated processing and trust technologies. Additional administrative areas of biomedical research such as gap analysis, funding, regulatory review and more can be similarly improved.The call to action for this Grand Challenge is to: a) Consider the core elements of what we need to maintain and continue to elevate from our past and current successful biomedical research and knowledge translation effort, along with areas where those efforts have been flawed, corrupt or unsuccessful. b) Critique (and adjust or replace as needed) the Scientia Machina framework proposed here as the backbone for the layers of trust that are the core elements to be maintained as we continue to bring new technologies into biomedical research to accelerate and improve science. c) Capture and assess those current pilots to apply emerging technology -especially within AI (complex information processing) and DeSci (automated governance, auditing and/or incentivization) as umbrella categories for these effortsand place them in the context of a broader framework of what we are trying to achieve with biomedical research. d) Conceptualize gaps in our current efforts along with bridges from the current status quo to the desired future that may give us a better chance of success at transformational change to the systems of biomedical research and knowledge translation. e) Communicate all aspects of the above areas in appropriate venues of biology, medicine, technology and policy. This includes formal submissions of manuscript on any related topics to this journal section and its partnered sections as appropriate.This proposed conceptual framework is merely a jumping off point for broader consideration of how to maintain the core elements of the trust we have imbued in biomedical research as we continue to explore applications of emerging technology to improve its quality, manage its costs, and accelerate its contribution to the health and well-being of everyone. In the not so distant future, it is conceivable that we may be able to make all available relevant data on a topic or a patient accessible to any researcher to make AI-augmented and blockchain-audited hypothesis testing to provide near realtime, peer-validated contributions to evidence-based medicine. This could allow clinicians to query and access this near real-time evidence as part of compressing the 17 years it takes to go from bench to bedside by a factor of 10,000xgiving us new, actionable evidence-based precision medicine for patients in under a day. This future is within reach. Aligning behind a shared framework like Scientia Machina can bring it into our reality even faster. Better science. Cheaper research. Faster Miracles.STM is the sole author, having conceived, written, and edited this manuscript.

Open access
Biomedical and Engineering Education
Interdisciplinary Research and Collaboration
Genetics, Bioinformatics, and Biomedical Research
Original source
Dec 17, 2024·International Journal For Innovative Engineering and Management Research
0 cites
International Journal For Innovative Engineering and Management Research

Authors unavailable

In recent years, the integration of blockchain technology into Corporate Social Responsibility (CSR) practices has gained significant attention due to its potential to address transparency, accountability, and sustainability challenges in business operations.Blockchain, with its decentralized nature, offers a secure and immutable platform that allows organizations to track, verify, and share data related to their CSR initiatives in real time.This level of transparency enhances trust among stakeholders and provides a reliable way to demonstrate a commitment to ethical and sustainable business practices.Blockchain technology is emerging as a transformative tool for enhancing Corporate Social Responsibility (CSR) practices, offering innovative solutions to foster transparency, accountability, and sustainability.By providing a decentralized, immutable ledger, blockchain ensures that CSR-related activities are traceable, verifiable, and free from manipulation, thereby building trust among stakeholders and mitigating issues such as fraud and resource misallocation.This study explores the potential of blockchain technology to transform Corporate Social Responsibility (CSR) practices, focusing on its role in promoting transparency, accountability, and sustainability.Blockchain's decentralized and immutable ledger enables organizations to track and verify transactions, enhancing trust among stakeholders and ensuring ethical business practices.The study identifies key blockchain innovations such as smart contracts, decentralized finance (DeFi), and energy-efficient consensus mechanisms that contribute to achieving the United Nations Sustainable Development Goals (SDGs).However, the adoption of blockchain in CSR initiatives faces challenges including regulatory uncertainty, integration complexities, scalability issues, and privacy concerns.To overcome these barriers, the research offers strategic recommendations, such as the adoption of energy-efficient blockchain solutions, the integration of smart contracts, and enhanced stakeholder education.This paper contributes to understanding how blockchain can be leveraged to create a sustainable and efficient CSR ecosystem, aligning business operations with global sustainability objectives.

Open access
2 source records
Collaboration in agile enterprises
Biomedical and Engineering Education
Technology Assessment and Management
Original source
Nov 26, 2024·2024 6th International Conference on Blockchain Computing and Applications (BCCA)
1 cites
Advancing Medical Device Management Systems through Ethereum Blockchain

Ahmed Shuhaiber, Nishara Nizamuddin

The management of medical devices throughout their lifecycle is a complex and critical process in healthcare, traditionally handled through centralized systems that often suffer from significant challenges such as data security vulnerabilities, inefficiency, and lack of transparency. This research paper introduces a novel approach to Medical Device Lifecycle Management (MDLCM) by leveraging blockchain technology to decentralize the process, aiming to enhance security, efficiency, and stakeholder trust. We identify the inherent problems in current centralized systems, including data tampering risks and operational inefficiencies, which can compromise patient safety and impede the seamless management of medical devices. To address these issues, our study proposes a blockchain-based decentralized system, utilizing Ethereum smart contracts to automate and secure the MDLCM process. The methodology encompasses the design and implementation of a smart contract framework to facilitate transparent and secure interactions among all stakeholders involved in the lifecycle of medical devices, from manufacturing to post-market surveillance. Our results demonstrate the potential of blockchain technology to provide a robust solution for the challenges faced by traditional MDLCM systems, offering improved data integrity, traceability, and automation of compliance checks. The implications of this research are significant, suggesting a transformative shift towards more secure, efficient, and transparent management of medical devices within the healthcare sector. However, limitations such as blockchain scalability and the need for a supportive regulatory framework are acknowledged. Future work will focus on enhancing the scalability of the blockchain solution, exploring integration with other technologies like IoT and AI, and fostering collaboration among stakeholders to facilitate widespread adoption.

Biomedical and Engineering Education
Quality and Safety in Healthcare
Original source
Jun 11, 2024·Frontiers in Digital Health
12 cites
Non-fungible tokens (NFTs) in healthcare: a thematic analysis and research agenda

Khulekani Sibanda, Patrick Ndayizigamiye, Hossana Twinomurinzi

Introduction: In the big data era, where corporations commodify health data, non-fungible tokens (NFTs) present a transformative avenue for patient empowerment and control. NFTs are unique digital assets on the blockchain, representing ownership of digital objects, including health data. By minting their data as NFTs, patients can track access, monetize its use, and build secure, private health information systems. However, research on NFTs in healthcare is in its infancy, warranting a comprehensive review. Methods: This study conducted a systematic literature review and thematic analysis of NFTs in healthcare to identify use cases, design models, and key challenges. Five multidisciplinary research databases (Scopus, Web of Science, Google Scholar, IEEE Explore, Elsevier Science Direct) were searched. The approach involved four stages: paper collection, inclusion/exclusion criteria application, screening, full-text reading, and quality assessment. A classification and coding framework was employed. Thematic analysis followed six steps: data familiarization, initial code generation, theme searching, theme review, theme definition/naming, and report production. Results: Analysis of 19 selected papers revealed three primary use cases: patient-centric data management, supply chain management for data provenance, and digital twin development. Notably, most solutions were prototypes or frameworks without real-world implementations. Four overarching themes emerged: data governance (ownership, tracking, privacy), data monetization (commercialization, incentivization, sharing), data protection, and data storage. The focus lies on user-controlled, private, and secure health data solutions. Additionally, data commodification is explored, with mechanisms proposed to incentivize data maintenance and sharing. NFTs are also suggested for tracking medical products in supply chains, ensuring data integrity and provenance. Ethereum and similar platforms dominate NFT minting, while compact NFT storage options are being explored for faster data access. Conclusion: NFTs offer significant potential for secure, traceable, decentralized healthcare data exchange systems. However, challenges exist, including dependence on blockchain, interoperability issues, and associated costs. The review identified research gaps, such as developing dual ownership models and data pricing strategies. Building an open standard for interoperability and adoption is crucial. The scalability, security, and privacy of NFT-backed healthcare applications require further investigation. Thus, this study proposes a research agenda for adopting NFTs in healthcare, focusing on governance, storage models, and perceptions.

Open access
2 source records
Blockchain Technology Applications and Security
Biomedical and Engineering Education
Artificial Intelligence in Healthcare and Education
Original source
May 28, 2024·Journal of Innovation & Knowledge
22 cites
Academic performance indicators for the hackathon learning approach – The case of the blockchain hackathon

Ana Miličević, Marijana Despotović‐Zrakić, Danijela Stojanović, Marko SuvajĆŸić · 5 authors

The subject of this article is an analysis of the hackathon concept as an educational approach and its role in the development of students' knowledge and skills. The goal is to conduct an in-depth examination of the effectiveness and achievements of the hackathon, with special reference to the attitudes of students and teachers involved in this educational methodology. The key emphasis is placed on participants' perception of the possibilities of hackathons providing long-term results and hackathons' impact as an educational format. Through a specific blockchain hackathon jointly organized by the University of Belgrade, Serbia, and the University of Florida, USA, the research examines participants' perspectives and their expectations, experiences, and overall impressions. The research focuses on the readiness of hackathon participants to incorporate new technical skills through this form of learning, knowledge acquisition, attitudes, and motivational drivers. Furthermore, the research examines how participants' views change before and after the event. The paper contains the insights of educators who, relying on their experiences at the hackathon, emphasize the importance of measuring and monitoring the outcome of the hackathon. Their perspectives highlight the motivation for promoting experimental learning methods in academic settings. This comprehensive research sheds light on multiple impacts of hackathon participation, which extend beyond knowledge acquisition to include changes in technological interests, success in specific domains, and the broader implications of hackathons as a transformative learning experience. The research contributes to the ongoing discussion about innovative approaches to learning. It provides a foundation for a better understanding of how hackathons shape attitudes and contribute to long-term outcomes for both students and teachers, establishing a conceptual framework for hackathon-based learning approaches and opportunities to monitor the effects of hackathons.

Open access
Biomedical and Engineering Education
Original source
Jan 1, 2024·Procedia CIRP
1 cites
Conceptional Thoughts on a Holistic Support Tool for Biointelligence-Related Strategic Decisions in Enterprises

Ronny Hauf, Robert Miehe, Oliver Schöllhammer, Thomas Bauernhansl

Biological transformation represents one of the most promising optimization strategies for a sustainable economy. The rapid convergence of biotechnology, information technology and production technology provides a vast area of innovation. From an economic and innovation policy perspective, cooperation structures and value creation systems will change significantly in a biointelligent transformation process. In the future, many industries will produce personalized products in a much more decentralized manner based on locally provided, renewable resources using autonomous non-expert systems. Such a profound change affects not only products and processes but also the organization of companies and how innovations are evaluated and implemented. In this paper, we thus discuss the need for a reorientation of innovation management in companies in the context of biological transformation. This article focused the central question of how the innovation management can change in the context of biointelligence so that companies can be helped to invest strategically in biointelligent innovations. We then outline the basic elements of a framework and discuss key challenges for future research and development. In this paper, we present initial thoughts on a framework for the management of biointelligent innovation that aims to solve the complex requirements of BioIntelligence. Our approach is based on a holistic view of different methods and techniques to provide a comprehensive solution to the challenges. We discuss the basic concepts and goals of this framework as well as potential application areas and challenges. Furthermore, we present first approaches for implementation and evaluation.

Open access
2 source records
Biotechnology and Related Fields
Supply Chain Resilience and Risk Management
Biomedical and Engineering Education
Original source
Nov 8, 2023·Blockchain in Healthcare Today
19 cites
Impact of Blockchain-Digital Twin Technology on Precision Health, Pharmaceutical Industry, and Life Sciences Conv2X 2023 Report

Ingrid Vasiliu-Feltes, Michael Mylrea, PhD, Christina Yan Zhang, Tyler Cohen Wood · 5 authors

The convergence of Digital Twin technologies with precision health, the pharmaceutical industry, and life sciences has garnered substantial recent attention. As we advance toward personalized medicine and precision health, the fusion of Digital Twin and blockchain technologies is poised to enhance healthcare outcomes fundamentally. This conference discussion highlighted pivotal drivers accelerating the adoption of Digital Twin-enabled blockchain solutions, encompassing the shift to a decentralized World Wide Web (Web 3.0), the establishment of a global interconnected health ecosystem, and the distinct advantages offered by converging frontier technologies in optimizing healthcare, pharmaceutical industry, and life sciences. Yet, the effective deployment of blockchain-powered Digital Twins in precision health necessitates robust cyber safety measures, proactive ethical frameworks, data validation, provenance assurance, streamlined supply chain management, and heightened interoperability. These proceedings underscored blockchain-powered Digital Twins' pivotal role in reshaping health data management, security, sharing, ownership, and monetization and in revolutionizing pharmaceutical supply chain management and novel drugs and therapeutics development within the precision health domain.

Open access
Biomedical and Engineering Education
Law, AI, and Intellectual Property
Biosimilars and Bioanalytical Methods
Original source
Jan 1, 2022·Apress eBooks
5 cites
Getting Started

Davi Pedro Bauer

In this chapter, I’ll explain what Ethereum is and take you through the installations you’ll need to perform before you can start using it.

Biomedical and Engineering Education
Original source
Aug 21, 2020·Academic Medicine
4 cites
University of California, San Francisco School of Medicine

Catherine R. Lucey, Karen E. Hauer, Patricia O’Sullivan, Ann Poncelet · 6 authors

Medical Education Program Highlights In 2016, the University of California, San Francisco (UCSF) School of Medicine launched the Bridges Curriculum, developed to ensure that graduates are prepared to tackle the most complex problems of 21st-century patients and communities. The curriculum has an enduring focus on providing evidence-based, compassionate care while leveraging emerging skills in systems science and new methods of discovery. The Bridges Curriculum seeks to instill the 4 UCSF physician habits of mind: inquiry, continuous improvement, adaptive leadership, and social justice. To teach these habits of mind, the curriculum has an inquiry thread focusing on deep exploration into a scholarly area. Each step advances the learner, first to a sophisticated consumer of biomedical science, then to a producer of new knowledge. Continuous improvement skills are instilled through the clinical microsystem clerkship (CMC), a longitudinal clinical skills curriculum integrating skills in direct patient care, health systems improvement, and interprofessional collaboration. The CMC engages students in systems improvement work directly affecting the quality and safety of care. During the core clerkship phase, we offer a series of clinical immersion experiences (CIExes) electives, which provide opportunities for deeper exploration of a specialty or subspecialty. Trained and dedicated faculty “coaches” support students’ progression. The coaching program is designed to provide academic guidance for students and support professional/personal development throughout the curriculum. Curriculum Curriculum description The Bridges Curriculum is a 4-year, 3-phase curriculum: Foundations 1 (F1) is the preclerkship phase, including foundational sciences coursework and early, robust instruction and practice of health systems sciences (CMC). Foundations 2 (F2) starts in December, year 2, with six 8-week blocks for 8 core clerkships and 8 weeks of CIExes. Career launch starts in March of year 3, including a longitudinal ambulatory subinternship, dedicated time for completing scholarly projects, and advanced clinical training preparing students for their chosen career paths. Other curricular characteristics: Early, robust instruction and practice of health systems science (CMC) Incorporation of a dedicated coaching program, integrated with the CMC during the preclerkship phase, embedded in a longitudinal curriculum in assessment, reflection, coaching, and health (ARCH) across all 3 phases Deliberate instruction with dedicated time in concepts and application of inquiry in scientific domains Intentional incorporation of elements of social justice into all curricular aspects, including a planned required rotation demonstrating these principles in the community-engaged context Collaborative integration of foundational science content into clerkships Curriculum changes since 2010 The rollout of the Bridges Curriculum will be complete in May 2020, a significant evolution of our curricular content and pedagogy. Structural changes within the 4-year timeline include: A shortened preclerkship phase (ends December, year 2) Earlier start of clerkship phase (January, year 2) Longitudinal structure of the family and community medicine clerkship Shift in placement of USMLE Step 1 examination to after core clerkships (January, year 3) Earlier start of postclerkship phase (March, year 4) Over the coming year, we will also adjust delivery of foundational science content. Class size changes since 2010 In AY 2019–2020, UCSF became the sponsoring institution for the San Joaquin Valley Program in Medical Education (SJV PRIME), serving central California communities. The class size increased by 6 students for the first academic year’s entering class and will subsequently rise to 12. These students have been incorporated into class structures with minimal change required in structure or function, primarily because their clerkship and postclerkship phases take place at UCSF Fresno, where they had been placed previously for clerkships while managed by a different institution. Assessment Medical education program objectives are based on ACGME domains of competence, with the addition of interprofessional collaboration as a separate domain. See Supplemental Digital Appendix 1—Program Objectives and Assessment Methods——at https://links.lww.com/ACADMED/A959. Assessment changes since 2010 UCSF has implemented programmatic assessment in the F1 phase of the curriculum and is in the process of implementing programmatic assessment in core clerkships, F2. Implementation of programmatic assessment aims to support students’ learning across the curriculum and ensure achievement of expected competence. The assessment system emphasizes students’ development of reflection, learning, and planning skills in close coordination with their coaches throughout the 4-year curriculum. Students and coaches have ready access to performance data in an individual electronic student dashboard containing visual displays of student progress compared with expected benchmarks and class averages. The dashboard includes score reports from summative assessments and students’ reflections and learning goals. In the core clerkships, the school eliminated tiered (honors) grades in January 2019. This decision was made after a multiyear effort to explore and address concerns about accuracy, fairness, and equity of clerkship grades and the impact of grading on students’ learning and well-being. Clerkships are now graded Pass/Fail, with a new requirement for 2 weekly work-based assessments for formative feedback, completed collaboratively by a faculty/resident supervisor working with the student. Parallel curriculum or tracks UCSF has 5 parallel tracks: Joint Medical Program is a 5-year integrated MS–MD program for 16 students who begin their education at UC Berkeley and transfer to the UCSF campus for clerkships and senior year. Program in Medical Education for the Urban Underserved is a 5-year track accepting 12 students annually. Students take a year off to pursue a master’s degree in a field enhancing their leadership ability in the care of vulnerable populations. SJV PRIME is a 4-year track recruiting 12 students from the Central Valley of California committed to addressing health care disparities in this underserved area. Students participate in their preclerkship years at UCSF in San Francisco, then relocate to Fresno to complete clinical studies. The Medical Scientist Training Program is the UCSF MD–PhD program, accepting 12 students yearly into a T32 and institutionally supported combined program. The Oral Maxillofacial Surgery (OMFS) program accepts 4 students with DDS degrees into an integrated MD–OMFS residency program. Pedagogy The core curriculum and 5 parallel tracks use these pedagogical approaches: Case-based learning Clinical experience: ambulatory Clinical experience: inpatient Discussion: large group (> 12) Discussion: small group (≀ 12) Laboratory Lecture Peer teaching Preceptorship Problem-based learning Changes in pedagogy since 2010 Our work since 2010 has been in identifying the balance between instructional strategies and content to best help learners with cognitive integration, particularly in the content-dense, preclerkship phase. Clinical experiences Clinical sites represent the spectrum of communities for which we provide care, including urban and rural, primary and tertiary/quaternary, ambulatory, and inpatient sites. Required longitudinal experiences The Bridges Curriculum has numerous longitudinal experiences: Longitudinal small groups to support learning for each key element in the preclerkship phase Longitudinal delivery of the family and community medicine core clerkship 3 longitudinal integrated clerkships Longitudinal, ambulatory experience during the postclerkship phase (specialty practice ambulatory subinternship) A longitudinal curriculum (ARCH) delivered at key touchpoints across all 3 phases Clinical experience first encounter Students first enter the clinical environment in the third week of the preclerkship phase, during the CMC. This experience starts with a focus on health systems and systems improvement, gradually introducing patient care skills. Required and elective community-based rotations All core clerkship rotations have community-based sites; many clinical electives are also offered at community-based sites. The San Francisco Veterans Affairs Health System is a key affiliate, and over 75% of students rotate there at some point during medical school. Challenges in designing and implementing clinical experiences for medical students The primary limitation on students’ clinical experiences comes from increased demands placed on limited clinical sites by learners from other domestic and international institutions, and across the health care training spectrum. Curricular Governance The faculty committee with primary curricular responsibility is the Committee on Curriculum and Educational Policy (CCEP), a standing committee of, and deriving its authority from, the Council of the Faculty. The CCEP accomplishes its work through a group of subcommittees: an executive committee, subcommittees focused on operations during the 3 phases, Mapping and Integration Committee, and Student Governance Committee. Each committee has LCME standards of primary responsibility and meets monthly. The executive committee is responsible for operational management of and reporting on CQI through reviewing operations reports and program evaluation data. Decentralized curricular governance None of our governance is managed at the department level. Clerkship directors and staff are funded through a centrally managed budget for curriculum leadership. Education Staff The Medical Education Unit oversees the continuum of medical education, under the vice dean for education and associate dean for medical education (ADME). The ADME oversees all staff, including the medical student programs. The structure includes a central office under the chief of staff, which oversees accreditation, financing, staff engagement, affiliations, communications, and overall strategic support. The ADME oversees educational technology, data and analytics services, and simulation and anatomy centers. Medical student programs are organized under the associate deans for admissions, students, curriculum, and assessment. Student services provides daily support for students and career advising. The Assessment, Curriculum, and Evaluation Unit oversees curriculum support and clinical phase coordination. It also supports required scholarly activities (inquiry curriculum), student coaching program, and CQI of the curriculum under the director of program evaluation. Medical education leadership The dean provides overall leadership for the School of Medicine. Reporting to the dean is the executive vice dean and vice dean for education, responsible for the medical education continuum. There are 6 associate deans reporting to the vice dean for education: Associate dean for medical education: Responsible for staff, program development and support, communications, physical space, technology, finance Associate dean for admissions: Responsible for admissions process, student scholarships, financial aid Associate dean for students: Responsible for the medical student experience and assisting students and faculty with issues with student activities, supports, career planning, professional development Associate dean for curriculum: Responsible for the medical student curriculum, including foundational sciences, clinical and systems sciences, the inquiry curriculum, and curriculum governance and CQI Associate dean for competency assessment and professional standards: Responsible for student assessment, including competencies and milestones, and the MSPE; also oversees the coaching program, which provides nonevaluative longitudinal student support Department of Medical Education Medical education staff support the medical education continuum: outreach and postbaccalaureate preparation for medical school, admissions, medical student curriculum, GME, continuous professional development, educational technology, and simulation and anatomy-based instruction. Central staff also support multiple student support services. The Office of Medical Education includes the Center for Faculty Educators (CFE), which houses our Academy of Medical Education (AME), faculty develop programs, and educational research. The center includes faculty directors of the academy and of faculty development and educational research. Faculty Development and Support in Education Professional development for faculty as educators The CFE hosts the AME and an award-winning faculty development program, recipient of an ASPIRE to Excellence Award. Faculty can view online orientation resources for the Bridges Curriculum and coaches receive tailored faculty development. We are initiating workplace-based faculty development through the Learning and Caring Ecosystem program. Faculty can participate in “Teach for UCSF” certificates in general, clinical, simulation, interprofessional, quality improvement and patient safety, and equity and inclusion teaching as well as educational leadership. Education-focused faculty can apply to the longitudinal Teaching Scholars Program and advance to master’s and doctoral degrees in health professions education through external partners. Role of teaching in promotion and tenure Faculty must demonstrate quality teaching. Peer observation of teaching can be submitted as data for promotion and tenure application. Clinical educators must show engagement in creative activity and/or dissemination of educational scholarship and/or substantial educational leadership and can be promoted through the University of California “clinical X” series. Educators can embed a teaching portfolio into their CV. Academy for Medical Educators Since 2000, the AME has supported the educators who carryout and advance UCSF’s education mission through community, diversity, advocacy, service, and innovation. The AME currently has 163 members from medicine, dentistry, nursing, and pharmacy, selected by a rigorous application process. Programs include education grants, endowed chairs (24), teaching awards, quarterly meetings/workshops, an education showcase, teacher observation program, and UCSF-wide initiatives to address diversity/equity/inclusion, wellness, learning climate, and education finance. Regional Medical Campuses Directors of both campuses are ex officio members of the CCEP, which oversees educational programming. See Table 1—Regional Medical Campuses.Table 1: Regional Medical CampusesEducational experiences across sites Directors of each program meet quarterly with main campus associate education deans to review curriculum, assessment, student experience, and progress. Each regional campus submits an annual report to the CCEP demonstrating equivalency in student satisfaction, outcomes, and competency. Memorandums of understanding between main and regional campuses are reevaluated and renewed every 5 years.

Open access
Health and Medical Research Impacts
Biomedical and Engineering Education
Original source
Nov 11, 2019·JMIR Publications Inc.
0 cites
Developing a Blockchain-Based Supply Chain System for Advanced Therapies: Protocol for a Feasibility Study (Preprint)

Ching Lam, Michelle Helena van Velthoven, Edward Meinert

BACKGROUND Advanced therapies, including cell and gene therapies, have shown therapeutic promise in curing life-threatening diseases, such as leukemia and lymphoma. However, these therapies can be complicated and expensive to deliver due to their sensitivity to environment; troublesome tissue, cell, or genetic material sourcing; and complicated regulatory requirements. OBJECTIVE This study aims to create a novel connected supply chain logistics and manufacturing management platform based on blockchain, with cell and gene therapy as a use case. Objectives are to define the requirements and perform feasibility evaluations on the use of blockchain for standardized manufacturing and establishment of a chain of custody for the needle-to-needle delivery of autologous cell and gene therapies. A way of lowering overall regulatory compliance costs for running a network of facilities operating similar or parallel processes will be evaluated by lowering the monitoring costs through publishing zero-knowledge proofs and product release by exception. METHODS The study will use blockchain technologies to digitally connect and integrate supply chain with manufacturing to address the security, scheduling, and communication issues between advanced therapy treatment centers and manufacturing facilities in order to realize a transparent, secure, automated, and cost-effective solution to the delivery of these life-saving therapies. An agile software development methodology will be used to develop, implement, and evaluate the system. The system will adhere to the EU and US good manufacturing practices and regulatory requirements. RESULTS This is a proposed study protocol, and upon acceptance, grant funding will be pursued for its execution in 2021. CONCLUSIONS The successful implementation of the integrated blockchain solution to supply chain and manufacturing of advanced therapies can push the industry standards toward a safer and more secure therapy delivery process. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/17005

CAR-T cell therapy research
Biomedical Ethics and Regulation
Biomedical and Engineering Education
Original source
Jun 25, 2019·Digital Education Review
33 cites
Blockchain in the university: a digital technology to design, implement and manage global learning itineraries

Pablo Rivera-Vargas, Carles Lindí­n

Making universal access to education compatible with different paths of learning is one of the great challenges of the last century. Technology has provided solutions to access information, for communication and collaborative work. Blockchain emerges as a technology that can be useful for the development of an evaluation model of individualized learning itineraries in mass university subjects. In this line, the Edublocs project has been designed and executed, an initiative where these itineraries have been designed, incorporating elements of peer learning, team-teaching, PLEs, microlearning, technology-enhanced assessment... The objective of the Edublocs project is to design and implement a system of recording the results of activities through Blockchain that allow the student to follow a personal itinerary, and the teacher-tutor of the subject to carry out a formative evaluation and an accrediting appraisal of their work. The project is well underway in the evaluation of the implementation process. The experience with some elements of the design and the experimental execution in a formal university context during the present academic course, has allowed us to obtain important indications on the viability and relevance of the use of Blockchain in education. These, together with the explanation and justification of explaining the context of its applicability, will be laid out in the broad development of the article.

Open access
E-Learning and Knowledge Management
Educational Leadership and Innovation
Biomedical and Engineering Education
Original source
May 27, 2017·Nursing Management
0 cites
Research for academic credit in the healthcare workplace

Sean P. Clarke

FigureEmployees in hospitals and other healthcare settings are increasingly returning to school to obtain advanced degrees. In addition to course papers, graduate programs often require a thesis or major paper; not surprisingly, students often look for projects where they can collect needed data quickly and easily. They may even desire to have a project address a job requirement and an academic requirement at the same time. This article reviews the potential advantages and pitfalls of conducting a school project in one's own workplace and offers suggestions for students, faculty, and managers when this occurs (see Suggestions for students, faculty, and managers). When a student is also an employee Students taking advanced courses may be assigned to a specific project on a unit or in a practice setting other than where they normally work. The matchmaking of students with settings can happen in two ways: Healthcare managers may reach out to professors with a project for which they need assistance or managers may be approached by professors or students asking about potential projects. The student who's either not employed or employed at another institution gets to try out the role of consultant, and there's “free labor” on both sides. The setting receives hours of student time, and the students and their programs receive free supervision—the trade-off is often well worth it on both sides. Managers don't have to pay for a staff member's time or an external consultant to work on a project; however, they'll often spend extra time explaining exactly what's expected and may need to follow the work closely. Students can try out new skills under supervision where stakes are relatively low and without needing to spend a lot of time establishing their credibility. But there are drawbacks, such as when the student's time in a course or on a placement runs out before a project is finished. Situations get more complicated when the student is also an employee on the unit or within the setting that he or she is writing about. The convenience of not having to find (or travel to) another site beyond school and work to complete a project can be appealing. From the manager's perspective, a student who's also an employee may have insider knowledge, connections, or permissions that may make a project run more smoothly and it may be easier to hold him or her accountable for project outcomes. But there can be complications. The student wants to be a good employee, but also needs to be a successful student. If the employer evaluates or is in some way a grader of the project, there's a dual role that can create problems for everyone. And if the project somehow doesn't live up to the manager's expectations, the student may feel special pressures and worry that both a grade and his or her standing in the organization are at stake. There are four basic scenarios for students in an advanced course or graduate program completing projects in their work settings for academic credit. The first, and simplest, is when the student writes a course paper to describe and analyze a clinical case or ongoing situation from his or her workplace. The primary concern here is making sure that the student doesn't openly name the institution and/or specific unit, or specific patients and staff members. Usually using pseudonyms and changing identifying details are sufficient. In most cases, the manager's interest in the paper is typically minimal and he or she may not even know about it. Things get blurrier when students are involved in a quality improvement (QI) project within their normal work setting that they write up for academic credit; for instance, for a course on healthcare quality. Almost by definition, a QI project is one where there's some level of manager or leader agreement. QI projects mostly involve analyzing data that are normally gathered in the course of delivering care and managing operations and service quality. If any new or additional data gathering, interviews, or questionnaires are involved, they need to fall within the scope of what the manager can reasonably ask of others. On the other hand, a research project aims at original knowledge discovery for potential applications beyond the management of a particular setting and often does ask more of patients and staff. Students, faculty, and managers need a sense of QI project boundaries, which normally don't require research ethics clearance; exceeding these limits and purposes can cause problems for everyone involved. (On a side note, it's sometimes recommended that Institutional Review Board [IRB] clearance be sought for QI projects that a student or team hopes to publish.) Action research—a specific kind of scholarship in graduate programs emphasizing leadership—is the third type of academic project that can be done in one's own workplace. In some fields, a dissertation or thesis can take the form of a detailed review of a work situation and efforts to change it. The scholar-leader analyzes a situation, but also usually intervenes and evaluates the workplace's responses to interventions or programs. Action researchers understand that complete objectivity as a participant and leader in a change project is impossible; coming to terms with this is a key part of the method. As appealing as action research may sound, not all academic programs allow this type of thesis or dissertation. There are many layers of planning and a whole vocabulary and toolkit of data gathering and analysis skills that must be mastered. Action research also demands political skills, including securing the permission of one's superior to engage in the project (and to use it as the basis for an academic paper), obtaining agreement of major workplace stakeholders affected by the project, and working closely with university faculty to ensure that the project and its write-up meet program requirements. Depending on the nature of interviews and other forms of information gathering, research ethics clearance can be necessary for some or all of the data collection. Such projects can be, and often are, very rewarding, but they must be a good fit for the overall program of study and approached with recognition that they involve considerable effort beyond just doing one's job within the work setting. The fourth, and most complicated, situation occurs when the student embarks on original data collection for a research project in a clinical setting. Normally, confidential information is sought or the needed time and effort of patients and/or staff is above and beyond what's typically required for clinical care, monitoring, or QI. This is often considerably beyond the information use in the student's role as an employee. In many clinical settings, staff members are encouraged to get involved in research and even run small team projects as part of their roles. Sometimes these projects involve replicating earlier clinical findings or testing an instrument to see if it applies or how a local setting compares with a sample in the literature. The motivations for doing local clinical research include a general desire for on-site research activity or unit staff members' particular interest in a specific clinical topic. Unit-based research is above and beyond the scope of this article; however, in most cases, it's done out of intellectual curiosity and for professional development rather than academic reasons or advancement as researchers. Just as in the case of QI projects, there can be a special appeal to employees and managers for running a local research project as an academic study. The ideas for the study can come from the student/employee or the organization. Prominent among the advantages of students collecting data in their work settings is time saved in finding an appropriate site and obtaining an entrĂ©e into a setting. Employers may find it attractive to have a degree-seeking employee working on a project that's an organizational priority because it's assumed that he or she will want to follow through in a timely manner and at a high level of performance. However, there are some potential complications. Research is nearly always examined and approved by some kind of ethics or IRB before data collection. For students in degree programs, this often occurs at both the educational institution and clinical facility. Whereas being known as a staff member may help obtain permissions to perform a study in a clinical facility (and some agencies actually require that at least one staff member be an investigator on any project taking place in the organization), being on staff at an institution can also add wrinkles to a project being cleared. Today, most clinical agencies and ethics review boards see a clinician or manager approaching his or her own patients or coworkers directly to ask them to participate in a research project as a conflict of interest. Subjects are likely to feel pressure to sign up for a study out of duty or obligation, or even a concern that they'll somehow disadvantage themselves if they opt out. Even when there are no special surveys, interviews, blood draws, or instrument readings involved, as in the case of secondary analysis (a form of research reusing data originally collected for other purposes), researchers typically need to have arms-length contact with any identifiable data they don't have a job-related reason to access (as in the case of patients for whom they aren't personally caring or data they don't need to carry out their jobs). Dealing with these ethics issues in a manner acceptable to all parties can lead to projects needing extra personnel or other costs. Challenges of note One of the main challenges of embarking on a research project as a student is that studies for academic credit are often extensively planned, involve careful literature reviews, and require regular consultation with a committee of research faculty advisors. Because the thesis or dissertation is the proof that the student has mastered research skills in the relevant discipline at the level required for the degree, the professor(s) involved usually pays very close attention to detail in relation to how research principles are reflected in the project and how it's written up. To the student and/or manager, having the student graduate and fulfilling a functional purpose for the organization are likely to be much more important. Between ethics issues and disagreements about project direction from academic versus practical standpoints, without careful planning, the supposed time savings of “easy access” to a setting and its patients or staff can quickly be erased and the student-employee may find him- or herself in conflicts between academic and work supervisors. It's also important to remember that actually carrying out research projects can be very unpredictable. The ethics clearance process alone can take months (being known to the institution or the IRB as an institutional employee may or may not accelerate getting approval) and subject recruitment and having subjects complete all necessary data collection tends to have a number of twists and turns. Coming to work in a clinical setting where one's managers and colleagues are well aware of slow or no progress on a study can be challenging, and may be doubly challenging when managers have a special stake in seeing the project finished. Some final cautionary notes about doing research in the workplace for degree credit relate to publishing and dissemination. Reporting results when findings aren't flattering to patients, clinicians, or care quality can be challenging under any circumstances; this is even truer when researching in one's own work setting. Keep in mind that even if the workplace's identity can be camouflaged in a written report, it often doesn't take much sleuthing to figure out identities of institutions, units, and even managers, staff members, or patients, especially because institutional affiliations are often part of the author's byline or acknowledgments. Also, depending on the student's career goals and the needs and preferences of colleagues, managers, and professors, authorship considerations, such as who becomes a named author on any publications resulting from a dissertation or thesis, may become complicated if not worked out up front. Careful consideration needed It's indeed possible for nurses to do academic research that counts for credit toward an advanced degree in the clinical settings where they work. However, this kind of involvement has to be thought through carefully on all sides. Understanding common pitfalls can be helpful in starting productive dialogues between students, faculty members, and managers. Suggestions for students, faculty, and managers Tips for students Recognize the trade-offs involved in doing research for academic credit on the job and be cautious about accepting compromises that may jeopardize your future at the organization or your ability to complete projects or courses and earn your degree. Understand the difference between QI and research in terms of the types of clearance required. Be extremely careful about naming patients, staff, or practice settings in any notes or drafts of papers and assignments, and about making unflattering comments/analyses about any setting (whether you work in it or not), particularly if you present or publish your work. Tips for educators Make sure that confidentiality issues are addressed if students are asked to write about or discuss clinical or management situations from their own workplaces. These include not only the obvious need to protect information that may lead to patients being identified, but also the privacy of care settings and those who work in and manage them. Think carefully before asking or encouraging students to do a large-scale project in their workplace and be ready to steer them to other settings. Tips for managers Recognize the risks of double roles (being both a researcher trainee or student and employee in a setting or being both a work supervisor and a preceptor/project advisor/evaluator). Pressures, stresses, and possible ethical conflicts can result. Staff members must be careful about mingling their schoolwork and paid work too closely and neglecting their job duties. Be understanding if employees and their professors decide that projects are best done in settings other than the student's own workplace. Help students from local colleges and universities, your own employees, and students employed by other local organizations network to find appropriate clinical settings for their academic work when necessary.

2 source records
Innovations in Medical Education
Health and Medical Research Impacts
Biomedical and Engineering Education
Original source
Sep 26, 2014·Technology Transfer and Entrepreneurship
1 cites
Community Based Biomedical and Health Innovation and Entrepreneurship and the Emerging Paradigm of Engaging Crowds

Arlen D. Meyers

Physician entrepreneurs, technologists, investors, service providers, patients and other innovation stakeholders have embraced biomedical and health innovation and entrepreneurship in an effort to provide higher value care and lower the discovery and development costs of drugs, devices and digital health products and services. To that end, traditional brick and mortar cluster innovation models are being supplemented with virtual networks that are online, decentralized and community based. This paper reviews the evolution of these models and their future development and presents examples of virtual organizations that support biomedical and health innovation and entrepreneurship, fundraising, and new product development and clinical trial recruitment using crowd sourcing. Community based innovation and biomedical and health online innovation networks have the potential to speed new product development, offer alternative financing platforms for early stage ventures, provide education, information and support to those with particular diseases and help to lower the costs and speed of clinical trials. However, questions remain about their effectiveness in creating value, security, commercial and clinical validity, legal status and sustainability. Keywords: Bioentrepreneurship, collaborative online networks, crowd funding, crowd sourcing, health innovation, physician entrepreneurs.

Biomedical and Engineering Education
Biotechnology and Related Fields
Original source