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29:55

The Patient-Centered Outcomes Data Repository: Preparing and Depositing Your Dataset

ICPSR

/@icpsr

Dec 10, 2021

This video provides an in-depth exploration of the Patient-Centered Outcomes Data Repository (PCODR), a specialized archive for clinical research data funded by the Patient-Centered Outcomes Research Institute (PCORI). The presentation, delivered by representatives from PCORI and ICPSR (Inter-university Consortium for Political and Social Research), outlines PCORI's comprehensive policy on data management and data sharing. The primary goal is to maximize the utility of PCORI-funded data as a scientific asset, encouraging rigorous secondary use to ultimately improve patient and population health. The speakers detail the policy's core features, the practicalities of depositing data, and the secure mechanisms for accessing it. The policy emphasizes systematic creation and preservation of research data and documentation, which resides at the ICPSR-hosted PCODR. Key features include clear expectations for awardees, funding support for data preparation, specified data availability timelines, and a robust data request review process. A central tenet is the deposition of de-identified data in accordance with the HIPAA Privacy Rule, forming a "full data package" that encompasses not just the analyzable dataset but also the full protocol, metadata, data dictionary, analytic plan, and analytic code. The importance of informed consent, ensuring it permits secondary research purposes, is also highlighted, with PCORI working closely with awardees to align consent processes with the policy. The video further elaborates on the governance and access mechanisms. Data generators (awardees) enter into a Data Contributor Agreement (DCA) with ICPSR, establishing their rights and obligations. For data requestors, an independent committee reviews applications based on scientific purpose, contribution to generalizable knowledge, feasibility, and requestor expertise, with strict prohibitions against re-identification and redistribution. Approved requestors sign a Data Use Agreement (DUA) and gain secure access to the microdata via a Virtual Data Enclave at the University of Michigan. This enclave provides analytic software but restricts printing and copying, with all output undergoing a disclosure review to prevent sensitive information release. The process from pre-deposit kickoff meetings to data curation, long-term preservation (in formats like ASCII, XML, PDF), and eventual release in statistical software formats (SAS, SPSS, Stata) is meticulously described, along with resources like checklists and tutorials to aid depositors. Key Takeaways: * **Core Policy Objective:** PCORI's data management and sharing policy aims to maximize the scientific utility of funded clinical research data, treating it as a valuable asset for improving patient and population health through rigorous secondary analysis. * **Comprehensive Data Package:** Depositors are required to submit a "full data package" which includes de-identified data (compliant with HIPAA Privacy Rule), the full study protocol, metadata, data dictionary, analytic plan, and analytic code, ensuring comprehensive documentation for secondary users. * **Informed Consent and De-identification:** Adherence to the HIPAA Privacy Rule for data de-identification is paramount. PCORI actively collaborates with awardees to ensure informed consent processes are developed to explicitly allow for secondary research purposes, facilitating broader data utility. * **Structured Data Governance:** Data deposition is governed by a Data Contributor Agreement (DCA) between the awardee and ICPSR, while data access for secondary users is managed through a Data Use Agreement (DUA) with ICPSR, outlining specific terms, conditions, and obligations. * **Timely Data Availability:** Data is made available to the public upon the earlier of two triggers: the final research report being posted on PCORI's website, or the primary research results being published in a peer-reviewed journal, balancing dissemination with researchers' publication needs. * **Rigorous Data Request Review:** An independent committee, including data scientists, clinical researchers, PCORI staff, and patient representatives, evaluates data requests based on criteria such as scientific purpose, contribution to generalizable knowledge, feasibility, and the requestor's expertise. * **Secure Data Access Model:** Approved data users do not receive direct copies of the microdata. Instead, they gain credentials to a secure Virtual Data Enclave hosted at the University of Michigan, which provides analytic software but restricts printing, copying, and pasting, with all analytical outputs subject to a disclosure review. * **Exemption Process for Unique Cases:** The policy includes provisions for exemptions in situations where full compliance is not feasible, such as with proprietary data or specific informed consent limitations. Awardees must provide a written explanation for a case-by-case review by an internal PCORI team. * **Financial Support for Data Preparation:** PCORI provides specific funding, typically not exceeding $75,000, and incorporates milestones into existing awards to support the personnel costs associated with preparing and depositing the full data package. * **Professional Data Curation and Preservation:** After submission, data undergoes a multi-stage process including completeness review, professional curation (organization, quality checks), and long-term preservation in standard formats like ASCII for quantitative data and XML/PDF for documentation. * **Transparency in Data Utilization:** The PCODR promotes transparency by publicly listing the names of approved data users and publishing summaries of findings derived from the accessed data, fostering accountability and showcasing research impact. * **Comprehensive Depositor Resources:** ICPSR offers a suite of resources to assist awardees, including checklists for data preparation and HIPAA Privacy Rule compliance, a comprehensive roadmap of the deposit process, and tutorial videos for using the online data submission tool. Tools/Resources Mentioned: * Patient-Centered Outcomes Data Repository (PCODR) * ICPSR (Inter-university Consortium for Political and Social Research) * MyData account (for online data deposit) * Checklist for preparing your data for deposit * HIPAA Privacy Rule Checklist (for de-identifying data) * Roadmap (overview of the deposit process) * Online tutorial video (for depositing data) * Virtual Data Enclave (for secure data access) Key Concepts: * **Patient-Centered Outcomes Research Institute (PCORI):** A non-profit organization that funds comparative clinical effectiveness research and mandates data sharing. * **Patient-Centered Outcomes Data Repository (PCODR):** The specific data repository established by PCORI and hosted by ICPSR for archiving and sharing PCORI-funded clinical research data. * **Full Data Package:** A comprehensive collection of research materials required for deposit, including the de-identified dataset, study protocol, metadata, data dictionary, analytic plan, and analytic code, ensuring reproducibility and usability. * **De-identified Data:** Health information from which specific identifiers have been removed, in accordance with the HIPAA Privacy Rule, to protect individual privacy while allowing for research use. * **Data Contributor Agreement (DCA):** A legal contract between the data generator (PCORI awardee) and ICPSR that outlines the terms and conditions for depositing data into the PCODR. * **Data Use Agreement (DUA):** A legal contract between an approved data requestor and ICPSR that specifies the terms, conditions, and responsibilities for accessing and using restricted data from the PCODR. * **Virtual Data Enclave:** A secure, remote computing environment that allows approved researchers to analyze sensitive microdata without physically downloading or removing it from the host institution, thereby enhancing data security and preventing unauthorized re-identification. * **Disclosure Review:** A process applied to all outputs generated within the Virtual Data Enclave to ensure that no potentially re-identifiable or sensitive information is inadvertently released.

287 views

42.2

Top 10 TMF Specialist Interview Questions||Trial Master File||TMF||Clinical Research

9:24

RegTalks about Regulatory Information Management Systems (RIMS)

Asphalion

/@Asphalion.

Nov 29, 2021

This RegTalks episode, featuring Lidia Canovas of Asphalion and Udo Griem of Körber Pharma Software, provides an in-depth discussion on Regulatory Information Management Systems (RIMS) within the pharmaceutical and biotech industries. The speakers emphasize the critical role of RIMS in managing medicinal product data, particularly in anticipation of the complex transition to ISO IDMP standards. Griem defines RIMS through three core pillars: a solid, data-oriented database serving as a single source of truth for product master data, a robust workflow engine to manage submissions and approval processes, and capabilities for structured data submissions to authorities. He advocates for a data-oriented approach over traditional document-driven methods to ensure data quality and consistency. Key drivers for RIMS implementation include the impending IDMP mandate, the industry's shift towards structured data, competitive pressures for faster time-to-market, and the need for organizational process optimization. RIMS are shown to be beneficial for companies of all sizes and product portfolios, fostering a culture of quality and improving cross-departmental collaboration. While regulatory affairs is the primary user, RIMS serve as a central hub, supporting cross-functional processes across clinical, ERP, safety/pharmacovigilance, MES, and label artwork management. A significant emerging trend highlighted is the connection of RIMS data to data lakes for future evaluation with artificial intelligence. The discussion also underscores the importance of experienced implementation partners who can bridge the gap between software solutions and organizational needs, ensuring successful deployment and continuous improvement. Körber's AI Manager RIMS aims to minimize compliance risks, enhance efficiency, enable teamwork, and reduce costs, with IDMP compliance being a high priority in its development roadmap. **Key Takeaways:** * **RIMS are Foundational for Regulatory Compliance and Efficiency:** RIMS are critical for managing complex regulatory data, streamlining submissions, and ensuring compliance with evolving standards like IDMP, which is rapidly approaching and will significantly increase data complexity. * **Data-Oriented Approach is Paramount for RIMS:** A consistent, data-oriented design with a well-organized database is considered superior to document-driven approaches, ensuring high data quality, consistency, and adaptability for future regulatory requirements. * **RIMS Drive Cross-Functional Integration and Quality Culture:** Beyond regulatory affairs, RIMS act as a central hub, connecting and supporting various departments (e.g., clinical, ERP, safety, MES, QA) to improve collaboration, reduce error rates, and shorten response times across the pharmaceutical value chain. * **AI Integration is an Emerging Trend for RIMS Data:** There is a growing focus on connecting RIMS data to data lakes, specifically for evaluation with artificial intelligence, indicating a future direction for leveraging regulatory information for advanced insights and automation. * **Implementation Partners are Crucial for Successful RIMS Adoption:** Experienced partners with deep regulatory and product knowledge are vital for guiding companies through organizational and process changes, customizing solutions, and ensuring successful integration and continuous improvement. * **RIMS Benefits Extend to All Company Sizes and Diverse Portfolios:** While historically adopted by large multinationals, RIMS are now essential for small and mid-tier firms, including startups, to effectively build and scale regulatory organizations and manage diverse product portfolios beyond human medicine.

396 views

46.5

1:11:56

Meet with Veeva!

Black Women In Clinical Research

/@BlackWomenInClinicalResearch

Nov 24, 2021

This video provides an in-depth exploration of Veeva Systems' vision for transforming clinical trials through digital innovation, focusing on speed, efficiency, and compliance. Bree Burks, a representative from Veeva, outlines the company's commitment to creating an end-to-end operating system for new product development in human health. The presentation, delivered to "Black Women In Clinical Research," details how Veeva is bridging content gaps and fostering global harmonization while supporting local autonomy in clinical research. Burks emphasizes Veeva's transition to a Public Benefit Corporation, signaling a long-term commitment beyond just profits, focusing on societal benefit, employees, customers, and human health. The core of Veeva's strategy revolves around "digital trials," which go beyond mere decentralization to encompass paperless, electronic, and truly synchronized processes. This approach aims to reduce trial costs and timelines by 25% by 2025, addressing the industry's current challenges of disconnected technologies, manual administrative tasks, and site burnout. Veeva's unified Vault platform serves as the foundation, integrating data, documents, and workflows across various applications, including quality, regulatory, clinical operations, safety, and commercial cloud. A significant portion of the discussion is dedicated to patient-centricity, exemplified by the MyVeeva for Patients application, which aims to provide a seamless, single-login experience for participants, contrasting with the current fragmented app landscape. A key differentiator highlighted is Veeva's "Site Connect" initiative, designed to automate the exchange of documents and information between sponsor/CRO systems (like Veeva TMF) and site systems (Veeva SiteVault). This direct, middleware-free connection addresses the massive administrative burden of document exchange, particularly for the 60% of TMF documents originating from sites. The e-consent process is presented as a concrete example of digital transformation, where consent templates are electronically sent, reviewed, approved by IRBs within the system, and then securely delivered to patients via MyVeeva, with automatic filing and version control. Furthermore, Veeva SiteVault is offered free to sites, providing a structured investigator site file and robust remote monitoring capabilities, allowing CRAs to access certified copies of source documents and engage in real-time document review and communication within the platform. Key Takeaways: * **Veeva's Public Benefit Corporation Status:** Veeva transitioned to a Public Benefit Corporation in 2023, legally committing to a vision beyond profits, focusing on society, employees, customers, and human health, signaling a long-term dedication to industry transformation. * **End-to-End Operating System Vision:** Veeva aims to provide a comprehensive operating system for the entire R&D process, from clinical operations to commercialization, connecting all stakeholders and applications to bring new products to market efficiently. * **Digital Trials vs. Decentralized Trials:** Veeva's "digital trials" vision emphasizes paperless, electronic, and synchronized processes across all trial types, not just decentralized ones, with a goal of reducing trial costs and timelines by 25% by 2025. * **Patient-Centric Technology (MyVeeva for Patients):** MyVeeva for Patients is an application designed for patients to provide a single, seamless, and synchronized experience for all trial-related interactions, contrasting with the current disconnected app landscape for participants. * **Transformative E-Consent Process:** Veeva's e-consent system enables electronic template exchange between sponsors/CROs and sites, in-system IRB approval, and direct, secure delivery to patients via MyVeeva, ensuring version control, automatic filing, and the ability to embed rich media and capture structured data. * **Site Connect for Automated Document Exchange:** Site Connect facilitates automated, direct document exchange between Veeva TMF (used by 60% of industry-sponsored studies) and Veeva SiteVault, eliminating manual email attachments and reconciliation for regulatory and source documents. * **Benefits of Connected Studies:** This connectivity reduces manual administrative burden, improves compliance by ensuring correct document versions are used and filed, enhances sponsor-site relationships, and provides cross-coverage for site staff. * **Veeva Vault's Unified Architecture:** All Veeva applications are built on a unified Vault platform, integrating data, documents, and workflows, ensuring seamless information exchange and improved functionality as more applications are adopted. * **Free SiteVault for Sites:** Veeva SiteVault is provided free of charge to sites, offering a comprehensive electronic investigator site file (eISF), e-consent, patient status tracking, and digital delegation logs, with documents hosted for 25 years. * **Enhanced Remote Monitoring Capabilities:** SiteVault supports advanced remote monitoring by allowing CRAs to access certified copies of site source documents, annotate, stage reviews, and track monitoring activities within the same Vault environment. * **Challenges in Digital Adoption:** A significant hurdle remains the transition of paper documents into electronic systems, although Veeva is developing tools like the TMF bot (using AI for auto-classification) and streamlined upload processes to ease this burden. * **Industry Mindset Shift:** The speaker advocates for the industry to value "connection over customization" to achieve true optimization and standardization, as excessive customization can hinder seamless integration and automation. * **Future Developments:** Veeva is continuously building, with plans to expand MyVeeva for Patients beyond e-consent to include all patient-related documents and communications, and to integrate granular patient visit data from SiteVault with payment systems. * **Career Opportunities at Veeva:** Veeva actively recruits individuals with clinical operations experience, particularly those interested in consulting roles for technology implementation, with a strong commitment to diversity and inclusion. **Tools/Resources Mentioned:** * **Veeva Vault:** The foundational platform for all Veeva applications. * **Veeva SiteVault:** A free eISF and site operations system for clinical research sites. * **MyVeeva for Patients:** A patient-facing application for engaging with clinical trials. * **Veeva TMF (Trial Master File):** A flagship product for managing sponsor/CRO trial documents. * **Veeva CDMS (Clinical Data Management System):** An EDC-plus system for modern data management, including IRT/IWR capabilities. * **Veeva CTMS (Clinical Trial Management System):** For managing clinical trial milestones and operations. * **Veeva Study Startup:** An application for tracking and managing study startup processes. * **Veeva Payments:** A system for managing site payments, linked to CTMS. * **Site Connect:** A feature enabling automated document exchange between Veeva TMF and SiteVault. * **TMF Bot:** An AI-powered tool for scraping and auto-classifying documents in the TMF. * **clinicaltrials.viva:** An upcoming application described as a "LinkedIn for clinical trials." **Key Concepts:** * **Digital Trials:** A comprehensive approach to clinical trials that are paperless, electronic, and synchronized, aiming for process transformation rather than just decentralization. * **Patient-Centricity:** Designing clinical trial processes and technologies with the patient experience at the forefront, ensuring ease of participation and engagement. * **Connected Studies:** The concept of seamlessly linking sponsor/CRO systems with site systems to automate document and information exchange, reducing manual effort and improving data flow. * **Unified Vault Platform:** Veeva's proprietary architecture where all applications are built on a single, integrated platform, allowing for shared data, documents, and workflows. * **Public Benefit Corporation (PBC):** A legal structure for a for-profit corporation that is committed to operating in a way that benefits society, employees, customers, and shareholders. * **E-consent:** The electronic process of obtaining informed consent from trial participants, often incorporating interactive elements and digital signatures. * **Remote Monitoring:** The practice of monitoring clinical trial data and documents remotely, often leveraging electronic systems to access site files and conduct source data verification (SDV). * **Source Data Verification (SDV):** The process of ensuring that data recorded in the case report forms (CRFs) matches the original source documents at the clinical site. **Examples/Case Studies:** * **Pfizer Vaccine Study:** Mentioned as an example of patients experiencing a fragmented and disconnected technology experience with multiple apps for a single trial. * **Bayer:** Identified as the first early adopter of Veeva's Site Connect technology for automated document exchange. * **IRB Approvals:** Veeva worked closely with major IRBs like WCG and Advarra, as well as academic medical centers such as Hopkins, Vanderbilt, and Penn, to get their e-consent technology approved and gather feedback.

163 views

39.3

Clinical ResearchBlack WomenClinical Trials

12:00

Iatrogenesis: Harm from Healthcare - Mortality and Economic Impact

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Nov 14, 2021

This video provides an in-depth exploration of iatrogenesis, defined as harm caused by healthcare itself. Dr. Eric Bricker begins by establishing the term's Greek roots ("physician" and "origin") and immediately highlights its severe impact, citing a controversial but widely referenced study by Dr. Marty Makary from Johns Hopkins. This study suggests that iatrogenesis is responsible for 250,000 deaths per year in the United States, positioning it as the third leading cause of death, surpassing many well-known diseases. The speaker emphasizes that this harm extends beyond mortality to significant patient suffering, including side effects from medications and complications from surgical procedures. The presentation delves into specific examples to illustrate the nature of iatrogenesis. One common example is antibiotic-associated diarrhea, where antibiotics, while treating an infection, inadvertently kill beneficial gut bacteria, leading to severe gastrointestinal distress, dehydration, and even repeated hospitalizations. Another surgical example is dysphagia (difficulty swallowing) following a Nissen fundoplication, a procedure for severe heartburn. Dr. Bricker explains how improper tension during the surgical wrap of the stomach around the esophagus can lead to long-term swallowing problems for a significant percentage of patients. These examples underscore the unintended but serious consequences that can arise directly from medical interventions. A crucial aspect discussed is "informed consent," the process by which physicians are ethically and legally obligated to discuss the condition, treatment nature, anticipated results, alternatives (including non-treatment), and the risks, complications, and benefits of a proposed medical intervention with a patient. However, Dr. Bricker critically examines the practical shortcomings of informed consent, noting that it is often delegated to junior staff, performed with doctor bias, or even manipulated to ensure patient compliance. This gap between the ideal and the reality of informed consent means patients may not fully grasp the potential iatrogenic risks. The video then transitions to the significant economic burden of iatrogenesis, detailing how hospital inpatient complications lead to substantial costs, much of which is passed on to third-party payers and ultimately to employers through commercial insurance premiums. The economic analysis is particularly detailed, tracing the cost from a 2007 study on hospital inpatient iatrogenesis. The study found that while hospitals bore a direct cost of $238 per patient, they passed on an additional $1,775 per patient to third-party payers, totaling $2,013 per patient. Adjusting for healthcare inflation to 2021, this cost rises to $3,180 per patient. Factoring in the 88% passed to payers and the 40% typically covered by commercial insurance, Dr. Bricker calculates that iatrogenesis costs employers approximately $40.5 billion annually. This translates to a hidden cost of $522 per employee per year, or $44.50 per employee per month (PEPM), which is often more than the administrative service organization (ASO) fee for managing an entire employee health plan. This hidden financial impact, combined with the human suffering and mortality, underscores iatrogenesis as a critical and often overlooked issue in healthcare. Key Takeaways: * **Definition and Scale of Iatrogenesis:** Iatrogenesis refers to harm, suffering, side effects, or even death caused by medical care itself. It is a significant public health issue, with one study estimating 250,000 deaths per year in the US, making it the third leading cause of death. * **Diverse Manifestations of Harm:** Iatrogenesis can manifest in various ways, from medication side effects like antibiotic-associated diarrhea (affecting 5-35% of antibiotic users) to surgical complications such as dysphagia after a Nissen fundoplication (occurring in 3-24% of patients). * **Informed Consent: Ideal vs. Reality:** The concept of informed consent requires physicians to comprehensively discuss a condition, treatment, anticipated results, alternatives, and risks/benefits. However, in practice, this process is often flawed due to delegation to junior staff, physician bias, or even manipulation, leading to patients not being truly "informed." * **Significant Economic Burden:** Iatrogenesis imposes a substantial financial cost on the healthcare system. A 2007 study, adjusted for inflation to 2021, estimated the total cost of hospital inpatient iatrogenesis at $3,180 per patient. * **Hidden Costs for Employers:** A large portion of iatrogenesis costs (88%) is passed on to third-party payers, with commercial insurance bearing a significant share. This translates to an estimated $40.5 billion annually charged to commercial insurance plans, ultimately paid by employers. * **High Per-Employee Cost:** For employers, the cost of inpatient hospital iatrogenesis alone amounts to approximately $522 per employee per year, or $44.50 per employee per month (PEPM). This hidden cost often exceeds the administrative fees employers pay for their entire health plans. * **Lack of Transparency in Reporting:** These substantial iatrogenesis costs are typically hidden within general claims data and are not itemized in employer reporting, making it difficult for organizations to identify and address this specific financial drain. * **Impact on Pharmaceutical and Medical Device Industries:** The examples of harm from medications and surgical procedures directly relate to the products and services provided by the pharmaceutical and medical device sectors, highlighting the critical need for safety, efficacy, and robust post-market surveillance. * **Need for Improved Systems and Compliance:** The prevalence of iatrogenesis and the shortcomings of informed consent underscore the necessity for better systems, processes, and regulatory compliance to prevent medical errors and ensure patient safety. * **Relevance to Data Analysis and AI:** The hidden nature of iatrogenesis costs in claims data suggests a strong need for advanced data engineering and business intelligence to identify patterns, quantify impact, and inform strategies for mitigation. AI and LLM solutions could potentially assist in analyzing vast amounts of clinical data to predict risks, improve diagnostic accuracy, and enhance patient safety protocols. Key Concepts: * **Iatrogenesis:** Harm, suffering, side effects, or death caused by medical care itself. * **Informed Consent:** The process by which a patient gives permission for a medical procedure or treatment after understanding all the relevant facts, including risks and alternatives. * **Antibiotic-Associated Diarrhea (AAD):** Diarrhea caused by the disruption of beneficial gut bacteria due to antibiotic use. * **Nissen Fundoplication:** A surgical procedure to treat severe heartburn (GERD) by wrapping the upper part of the stomach around the lower esophagus. * **Dysphagia:** Difficulty swallowing, often a complication of surgical procedures affecting the esophagus. * **Per Employee Per Month (PEPM):** A common metric in employee benefits to express costs on a monthly basis per employee. Examples/Case Studies: * **Antibiotic-Associated Diarrhea:** Illustrated by a case of a 23-year-old woman hospitalized multiple times for severe diarrhea after taking antibiotics for a sinus infection. * **Nissen Fundoplication Complications:** Discussed in the context of food getting stuck in the esophagus (dysphagia) if the surgical wrap is too tight, affecting 3-24% of patients.

2.6K views

42.9

13:51

RegTalks about Regulatory Information Management Systems (RIMS)

Asphalion

/@Asphalion.

Nov 5, 2021

This video explores the critical role of Regulatory Information Management Systems (RIMS) within the pharmaceutical industry, particularly in light of the upcoming transition from XEVMPD to the more complex ISO IDMP standard. Featuring insights from Veeva's Director of Strategy for Vault RIM, Katrin Spaepen, the discussion highlights the drivers for RIMS adoption, essential capabilities of future systems, and the multi-departmental nature of their use. The speakers emphasize that RIMS are key to managing vast amounts of regulatory data, ensuring compliance, and optimizing operations for medicinal products. Key Takeaways: * **Strategic Importance of RIMS:** RIMS are fundamental for data management, operational efficiency, and maintaining regulatory compliance in the pharmaceutical industry, especially with the impending, more complex ISO IDMP standard. * **Drivers for RIMS Adoption:** Companies adopt RIMS for three primary reasons: driving enterprise-wide digital transformation, achieving process efficiencies and cost optimizations in regulatory domains, or ensuring compliance (often driven by mandates like IDMP). These drivers influence the scope and approach to implementation. * **Core Capabilities of Future RIMS:** Effective RIMS must offer native support for both data and documents, ensure synchronization between them, feature an open architecture for data exchange with non-RIM systems, provide a complete view of license data across the enterprise, and embed real-time reporting and business intelligence dashboards. * **Multi-Departmental Utility:** RIMS are not solely for regulatory affairs; they serve as an enterprise-wide solution involving various departments such as regulatory operations, CMC writers, medical writers, manufacturing, quality control, and safety, particularly in processes like post-approval variation management. * **Crucial Role of Implementation Partners:** Successful RIMS implementation necessitates strong partnerships for process re-engineering, organizational impact assessment, change management, gap analysis, and defining key performance indicators (KPIs) and user requirements (URS). * **Veeva's Market Presence:** Veeva's Vault RIM suite (encompassing submissions, archive, publishing, and registration) is positioned as a leading end-to-end solution supporting the full regulatory process, indicating its significance in the industry.

1.2K views

44.1

23:18

VISEVEN | Webinar | 2021| How to make the most of your Veeva content

Viseven

/@VisevenMarTech

Nov 2, 2021

This video provides an in-depth exploration of optimizing content management within the Veeva ecosystem for pharmaceutical and life sciences companies. The presenters, Maria and Nina from Viseven, begin by outlining common challenges faced by pharma marketers, such as the use of multiple content management systems, fragmented content storage, slow content lifecycles, high production costs, lack of content visibility, and the prevalence of irrelevant or outdated materials. They emphasize that in today's environment, success hinges on proper data management and the timely delivery of fresh, consistent information to healthcare professionals (HCPs). The core problem identified is the inefficiency and risk associated with managing digital assets across disparate systems, hindering effective customer-centric engagement. The webinar then introduces Viseven's eWizard platform as a comprehensive solution designed to address these issues. eWizard is presented as a content production platform driven by cost-effectiveness, a modular approach for efficient content reuse, and alignment with pharma's digital content production principles across multiple channels. Key capabilities highlighted include a modular content framework that enables the creation, update, and reuse of cross-channel modules, facilitated by eWizard's multi-channel content builder, localizer, and converter. This allows for easy assembly of channel-specific content (emails, e-detailers, websites) within global templates, effortless localization, and automatic publishing to various corporate ecosystems like Salesforce Marketing Cloud and Adobe Experience Manager, in addition to Veeva products. A significant portion of the presentation details the deep integration of eWizard with a suite of Veeva products, including Veeva CRM, Veeva Vault PromoMats, Veeva Approved Email, Veeva CLM, Veeva MyInsights, and Veeva Engage. These integrations are positioned as unlocking "unlimited opportunities" for content management, accelerating time to market, and enhancing compliance. Specific benefits include direct access to global content from Veeva Vault PromoMats, enabling users to add approved digital assets to presentations and control expiration dates. The integration also streamlines the approval process, allowing content to be approved within eWizard or automatically published to Veeva Vault for review with a single click. Furthermore, it automates the setup of required fields (country, therapeutic area, product) when uploading to Veeva Vault and facilitates multi-channel distribution to CRM systems, mobile apps, or web browsers. The video also covers how eWizard enables fast localization (up to four times faster) using global master templates and pre-designed components, adapting content for local cultural differences and ensuring compliance with CLM/CRM requirements for face-to-face and remote communication. The latter part of the webinar focuses on optimizing remote communication with HCPs and leveraging data for insights. eWizard, in combination with Veeva, provides tools to quickly adapt existing materials for online interactions, allowing users to customize presentation structures, rearrange slides, modify content, and create dynamic call flows. It also supports planning and conducting remote calls directly from eWizard or Veeva, sending personalized invitations, presenting interactive visual aids in real-time, and sending follow-up emails with surveys. Crucially, all data collected during remote calls is automatically synchronized and stored in Veeva, providing valuable customer insights for understanding needs, defining market share, and predicting sales potential. The integration with Veeva MyInsights is showcased for advanced monitoring, enabling users to create custom dashboards, visualize KPIs (basic monitoring like slide usage and advanced insights like doctor loyalty or prescription potential), and gain a 360-degree view of field activities to achieve commercial excellence. The presentation concludes by reiterating Viseven's status as a certified Veeva partner and the combined power of eWizard and Veeva for efficient, compliant, and accelerated content delivery. Key Takeaways: * **Challenges of Fragmented Content Management:** Many pharmaceutical companies struggle with multiple content management systems, leading to fragmented content, slow content lifecycles, high production costs, lack of visibility, and outdated materials, which ultimately hinders effective engagement with HCPs. * **Unified Content Management Solution:** An ideal content management system should provide a single solution for creating a holistic, customer-centric experience, coordinating all digital assets in one place to maintain effective customer relationships and ensure content is fresh and consistent. * **Modular Content Framework for Efficiency:** Viseven's eWizard platform utilizes a modular content framework, enabling the creation, update, and reuse of cross-channel modules. This approach significantly simplifies content production, remixing, and reuse for non-IT specialists, making it faster and more cost-effective. * **Deep Integration with Veeva Ecosystem:** eWizard offers extensive integrations with key Veeva products, including Veeva CRM, Veeva Vault PromoMats, Veeva Approved Email, Veeva CLM, Veeva MyInsights, and Veeva Engage, to streamline content flow and maximize the value of existing Veeva investments. * **Accelerated Content Approval and Distribution:** The eWizard-Veeva integration facilitates quick publishing for medical, legal, and regulatory (MLR) approval, reducing manual operations and developer involvement. It automates field population for Veeva Vault uploads and enables instant distribution across multiple channels like CRM systems, mobile apps, and web browsers. * **Global-to-Local Content Adaptation:** The platform supports a "global to local content hub," allowing brand managers and agencies to access approved global assets (templates, images, PDFs) and localize them effortlessly, ensuring consistency with global branding while adapting to local market needs and cultural differences. * **Optimizing Remote HCP Engagement:** The solution provides tools to quickly adapt existing materials for remote calls, allowing for customization of presentation structures, dynamic call flows, and distribution to field forces. This is crucial for maintaining HCP access and engagement, especially when face-to-face interactions are limited. * **Automated Data Synchronization for Insights:** Data collected during remote calls, email interactions, and other field activities is automatically synchronized and stored in Veeva. This enables companies to gain deep customer insights, understand HCP needs, define market share, and predict sales potential. * **Advanced KPI Monitoring with Veeva MyInsights:** The integration with Veeva MyInsights allows for dynamic KPI monitoring on two levels: basic (e.g., slides used, time spent) and advanced (e.g., doctor loyalty, prescription potential, competitor comparison). Users can create custom dashboards and visualize reports for improved decision-making. * **Cost and Time Savings:** By enabling in-house content editing and localization, the solution reduces reliance on external agencies, significantly cutting down on waiting times and additional budget expenditures for content updates and adaptations. * **Ensuring Regulatory Compliance and Brand Consistency:** The system helps maintain consistency and compliance with global branding and messaging, while also streamlining the approval process for medical and legal teams, ensuring all distributed content adheres to regulatory standards. * **360-Degree View of Field Activities:** The integrated system provides a comprehensive 360-degree view of all field activities, including completed and planned calls, orders, emails, and reaching frequency, allowing for better tracking of sales, marketing activities, and overall commercial excellence. * **Enhanced Email Marketing Flexibility:** Users can leverage pre-approved email templates from Veeva Vault, personalize them for target contacts, and send them directly from CLM presentations before, during, or after calls. The system also tracks email performance (opens, click-through rates) in real-time within the CRM. * **Viseven as a Certified Veeva Partner:** Viseven's status as a certified Veeva partner (Level 4 in multi-channel content creation and certified Veeva CRM administrator) underscores their expertise and the reliability of their integrations within the Veeva ecosystem. **Tools/Resources Mentioned:** * Viseven eWizard Platform * Veeva CRM * Veeva Vault PromoMats * Veeva Approved Email * Veeva CLM (Closed Loop Marketing) * Veeva MyInsights * Veeva Engage * Veeva CRM iPad * Salesforce Marketing Cloud * Adobe Experience Manager **Key Concepts:** * **Modular Content:** A content strategy where content is broken down into small, reusable components (modules) that can be easily assembled, updated, and localized across various channels and presentations, enhancing efficiency and consistency. * **Global-to-Local Content Hub:** A centralized repository and workflow that facilitates the adaptation and localization of global content assets (e.g., master templates, images, PDFs) for specific local markets, ensuring brand consistency while meeting local regulatory and cultural requirements. * **MLR Approval (Medical, Legal, Regulatory Approval):** The critical process in the pharmaceutical industry where all promotional and medical content must be reviewed and approved by medical, legal, and regulatory teams to ensure accuracy, compliance with regulations (e.g., FDA, EMA), and adherence to company policies before dissemination. * **Multi-channel Content Strategy:** An approach to content delivery that involves distributing content across various communication channels (e.g., e-detailers, emails, websites, mobile apps, remote calls) to reach target audiences effectively, ensuring a consistent message and optimized experience across all touchpoints. * **Dynamic KPIs (Key Performance Indicators):** Performance metrics that are automatically tracked, aggregated, and visualized on dashboards, often in real-time, to provide actionable insights into content effectiveness, sales performance, customer engagement, and other business objectives.

198 views

43.4

visevenewizardpharma marketing

4:11

CTMS & eTMF implementation – Flex Databases & FGK CRO case study

Flex Databases

/@Flexdatabases

Nov 1, 2021

This video presents a case study on the successful implementation of Flex Databases' Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) for FGK CRO, a full-service contract research organization. The discussion highlights FGK CRO's objectives to standardize and simplify clinical trial management across various phases and sponsors, aiming for increased cost-effectiveness and quality. The video details the project scope, a rapid implementation timeline (5.5 weeks vs. 8 weeks estimated), and emphasizes the critical role of client involvement in achieving a smooth and accelerated deployment. Key decision factors for FGK CRO included the system's clear structure, intuitive handling, flexible modules (e.g., investigator payments), offline capabilities for CRAs, and the competence of the Flex Databases team. Key Takeaways: * **Active Market for eClinical Solutions:** CROs and pharmaceutical companies are actively investing in and implementing eClinical platforms like CTMS and eTMF to enhance the efficiency, standardization, and quality of clinical trial operations. * **Importance of Implementation Expertise:** Successful and expedited software implementation is a critical value proposition, with client-vendor collaboration and high client involvement being crucial for achieving faster-than-expected deployment times. * **Client-Centric System Selection:** Key criteria for selecting eClinical systems include intuitive user interfaces, clear structure, specific functional advantages (e.g., offline access for CRAs, flexible payment modules), and the vendor's team competence. * **Foundation for Advanced Data Solutions:** The successful deployment of core eClinical systems like CTMS and eTMF creates a structured data environment, which serves as an ideal foundation for integrating advanced data engineering, business intelligence, and AI/LLM solutions to further optimize clinical operations and regulatory compliance. * **Focus on Regulated Environments:** The context of clinical trials and eClinical systems inherently involves strict regulatory compliance

477 views

44.9

31:28

Webinar: Webinars in Pharma. Are you ready to integrate Veeva and Salesforce Marketing journeys?

showerthinking

/@showerthinking

Oct 27, 2021

This video explores the strategic integration of webinar platforms with Veeva and Salesforce Marketing Cloud to create comprehensive, automated marketing journeys within the pharmaceutical and healthcare industries. The speakers advocate for a shift from viewing webinars as isolated tactics to leveraging them as integral touchpoints within a broader cross-channel customer experience, aimed at enriching HCP knowledge, generating leads, and optimizing digital marketing strategies. The discussion covers best practices for platform selection, data synchronization, consent management, HCP identification, and empowering sales representatives with real-time visibility and actionable insights. A detailed case study highlights a multinational pharma company's successful implementation, showcasing one-click registration, LinkedIn ad integration, and robust analytics using Google Tag Manager and DataRama to measure engagement via Key Educational Messages (KEMs). Key Takeaways: * **Strategic Shift for Webinars in Pharma:** Webinars should evolve from isolated events to integrated components of a larger, automated marketing journey, focusing on improving the HCP customer experience and enriching customer data. * **Seamless Cross-Channel Integration is Crucial:** Effective digital marketing in pharma requires a seamless integration between webinar platforms, Salesforce Marketing Cloud, and Veeva CRM, enabling journeys that can be triggered by reps (Veeva Approved Email) and digital channels (Marketing Cloud emails, social media, advertising). * **Data Synchronization and HCP Identification:** A core challenge and opportunity is to accurately identify HCPs across platforms, synchronize data (especially Veeva identifiers), and manage multi-channel consents within Veeva to personalize interactions and avoid redundant data requests (e.g., one-click registration). * **Empowering Sales Reps with Visibility and Actionable Insights:** Integrated solutions should provide reps with real-time visibility into HCP engagement on their Veeva timeline and suggest "next best actions" based on journey interactions, enhancing rep-HCP interactions. * **Comprehensive Analytics for Campaign Performance:** Beyond basic platform analytics, a robust solution integrates data from Veeva, Salesforce Marketing Cloud, webinar platforms, and advertising channels (like LinkedIn) into a business intelligence tool (e.g., DataRama) to measure campaign performance, track engagement (e.g., KEMs), and inform future strategies. * **Regulatory Compliance and Content Access:** Solutions must ensure that content access is restricted to verified HCPs, often through approval processes based on Veeva identifiers, and that all consent management adheres to industry regulations. * **Optimizing User Experience and Conversion:** Leveraging features like one-click registration, deep linking for content access, and native social media forms (e.g., LinkedIn forms) significantly improves the user experience and conversion rates for HCPs.

1.0K views

45.7

salesforcepharmasalesforce marketing cloud

11:42

Virtual Primary Care Article by Dr. Marshall Chin in New England Journal of Medicine

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Oct 24, 2021

This video provides an in-depth exploration of virtual primary care (VPC), drawing insights from a New England Journal of Medicine article by Dr. Marshall Chin, an expert in chronic care. Dr. Eric Bricker, the presenter, begins by establishing the critical context that the COVID-19 pandemic starkly exposed the profound inadequacies and exclusionary nature of traditional, in-person-only primary care, particularly for chronic disease management. He highlights how this model disproportionately disadvantages vulnerable populations, including low-income individuals, hourly wage earners without paid time off, and those residing in rural or underserved areas, due to significant barriers such as transportation costs, childcare needs, and the sheer time commitment required for appointments. The core argument, championed by Dr. Chin and echoed by Dr. Bricker, is that telemedicine, specifically in the form of virtual primary care, offers a vastly superior alternative when combined with a per-member-per-month (PMPM) reimbursement model, as opposed to the traditional fee-for-service approach. This hybrid model, incorporating both virtual and necessary in-person care, promises increased access to high-quality medical expertise, enhanced convenience for patients who can manage appointments without significant disruption to work or family life, faster and timelier care delivery, and substantial cost-effectiveness by reducing the need for extensive physical infrastructure associated with conventional clinics and hospitals. However, the video pivots to a critical analysis of the major insurance carriers' recent initiatives to launch their own virtual primary care offerings. Dr. Bricker contends that despite the inherent benefits of VPC, these insurance-led models are fundamentally flawed and destined to fail due to five significant conflicts of interest and systemic issues. These include a pervasive lack of trust in insurance companies among both patients and doctors, the inherent conflict arising from insurance carriers owning Pharmacy Benefit Managers (PBMs) whose growth is tied to "script count" (potentially incentivizing over-prescription), the ethical dilemma of a doctor employed by an insurer having to fight their employer for prior authorizations, contractual restrictions preventing insurance carriers from "steering" patients to the highest quality providers within their networks, and the negative impact on employer flexibility when employees' primary care physicians are directly tied to a specific insurance plan. Key Takeaways: * **Inadequacies of Traditional Chronic Care:** The COVID-19 pandemic illuminated how the historical model of in-person-only primary care for chronic conditions (e.g., diabetes, hypertension) is inherently exclusionary, creating significant barriers for low-income individuals, hourly workers, and those in rural areas due to transportation, time off, and location challenges. * **Benefits of Virtual Primary Care (VPC):** VPC, especially when coupled with a per-member-per-month (PMPM) payment structure, offers superior primary care by providing increased access to quality doctors, enhanced convenience for patients, faster appointment scheduling, and greater cost-effectiveness through reduced infrastructure needs. * **Critical Role of Payment Model:** The video emphasizes that combining virtual care with a PMPM reimbursement model (rather than fee-for-service) is crucial for its success, aligning incentives towards proactive, holistic patient management rather than volume of services. * **Low Trust in Insurance Carriers:** A significant impediment to the success of insurance-led VPC is the pervasive lack of trust: only 33% of patients and a mere 19% of doctors trust health insurance companies, which will severely limit patient engagement and adherence to medical advice. * **PBM Conflict of Interest:** Insurance carriers' ownership of Pharmacy Benefit Managers (PBMs) creates a direct conflict, as PBM growth is often tied to "script count." This incentivizes insurance-employed doctors to potentially over-prescribe medications to maximize PBM revenue, undermining patient best interests. * **Prior Authorization Dilemma:** The process of prior authorization presents an ethical and practical conflict for primary care physicians employed by insurance companies, as they would be forced to advocate for their patients' diagnostic tests (e.g., MRIs, CT scans) against the financial interests of their own employer. * **Network Steerage Restrictions:** Many PPO contracts between major hospital systems and insurance carriers contain clauses that prohibit the insurance carrier from "steering" patients to specific providers within their network. This prevents insurance-employed PCPs from referring patients to the highest quality specialists, compromising patient care. * **Impact on Employer Flexibility:** Tying primary care doctors directly to an insurance carrier reduces employer flexibility. If an employer wishes to change insurance providers, it would necessitate forcing all employees to switch their primary care doctors, creating significant disruption and resistance. * **Shift Towards Virtual Care:** The broader healthcare industry is undeniably moving towards virtual care models, but the success hinges on addressing systemic issues and conflicts of interest rather than simply adopting the technology. * **Understanding Financial Incentives:** The focus on "script count" in PBM earnings calls highlights a key financial incentive within the pharmaceutical supply chain that can influence prescribing patterns and patient care. * **Relevance of Corporate Practice of Medicine:** The conflicts discussed, particularly around prior authorization and PBM incentives, underscore the importance and relevance of corporate practice of medicine laws designed to prevent undue influence on medical decisions. Key Concepts: * **Virtual Primary Care (VPC):** A healthcare delivery model that leverages telemedicine to provide primary care services, often combining virtual consultations with necessary in-person visits. * **Per Member Per Month (PMPM) Payment:** A capitated payment model where healthcare providers receive a fixed amount per patient per month, regardless of how many services are utilized, incentivizing preventive care and cost efficiency. * **Fee-for-Service:** A traditional payment model where providers are paid for each service they provide, potentially incentivizing a higher volume of services. * **Pharmacy Benefit Manager (PBM):** A third-party administrator of prescription drug programs for health insurance companies, often responsible for negotiating drug prices, processing claims, and managing formularies. * **Prior Authorization:** A requirement from health insurance companies that a healthcare provider obtain approval before prescribing a specific medication, performing a procedure, or ordering certain tests. * **Network Steerage:** The practice of an insurance carrier directing patients to specific providers or facilities within their network, often based on cost or quality metrics. * **PPO Contract:** A contract between an insurance carrier and a Preferred Provider Organization (PPO) network, outlining terms for patient access to providers and reimbursement rates. * **Corporate Practice of Medicine:** Laws that prohibit corporations from practicing medicine or employing physicians, designed to prevent non-physician entities from interfering with medical judgment. Tools/Resources Mentioned: * **New England Journal of Medicine (NEJM):** A prestigious medical journal, where Dr. Marshall Chin's article on virtual primary care was published (October 23, 2021 issue). * **UnitedHealth Group, Aetna, Anthem:** Major health insurance carriers cited as examples of companies announcing virtual primary care offerings. * **Sutter Health:** Mentioned as an example of a hospital system that faced issues related to network steerage in California.

2.6K views

41.0

9:46

Quality and Quality Systems (QMS and TQM) | Operations Management | Quality Control

Data Driven Management

/@datadrivenmanagement6230

Oct 20, 2021

This video provides a foundational understanding of quality and quality management systems, specifically discussing Total Quality Management (TQM) and Quality Management Systems (QMS). It begins by defining quality through various perspectives, such as fitness for use, conformance to specifications, and customer satisfaction, and then elaborates on key dimensions of quality including performance, reliability, durability, and serviceability. The discussion further breaks down quality into three aspects: quality of design, quality of conformance (manufacturing), and quality of performance (in use), highlighting their interconnectedness. The video then differentiates and relates TQM and QMS, presenting TQM as a company-wide philosophy focused on continuous improvement and customer satisfaction, while QMS is described as a system of standards, like ISO 9000, designed to help organizations meet customer and regulatory requirements. It outlines the principles of QMS, such as customer focus, leadership, and a process approach, and details the elements and outcomes of TQM, including waste elimination, defect reduction, and innovation. Key Takeaways: * **Foundational Quality Definitions:** Quality is multifaceted, defined by fitness for use, conformance to specifications, and customer requirements, with dimensions spanning performance, reliability, and serviceability, which are critical considerations for any product or service in regulated industries. * **QMS for Regulatory Adherence:** Quality Management Systems (QMS), particularly those based on ISO standards (e.g., ISO 9000, ISO 15189), provide structured frameworks for organizations to consistently meet both customer expectations and stringent regulatory requirements, which is essential for compliance in pharmaceutical and life sciences. * **TQM for Continuous Operational Excellence:** Total Quality Management (TQM) promotes a holistic, company-wide commitment to continuous improvement, employee involvement, and customer focus, aligning with the goal of optimizing operations and fostering long-term efficiency within complex enterprise environments. * **Integrated Quality Lifecycle:** Quality encompasses the entire lifecycle from design (quality of design) through implementation and manufacturing (quality of conformance) to actual use (quality of performance), emphasizing the need for quality considerations at every stage of solution development and deployment. * **Tangible Benefits of Quality Systems:** Implementing effective QMS and TQM leads to significant outcomes such as waste elimination, reduction of defects and variations, and fostering innovation, all of which directly contribute to improved efficiency and compliance in highly regulated sectors.

424 views

43.7

QualityQuality SystemsQuality management system

38:45

RegTalks about Regulatory Information Management Systems (RIMS)

Asphalion

/@Asphalion.

Oct 15, 2021

This video provides an in-depth exploration of Regulatory Information Management Systems (RIMS), their evolving definition, key drivers for implementation, and their strategic importance beyond mere compliance within the pharmaceutical and life sciences industries. Featuring insights from Lidia Canovas of Asphalion and Esteve Clark of Ennov, a RIMS vendor, the discussion highlights how RIMS are becoming increasingly critical due to the approaching implementation of ISO IDMP and other structured content submission initiatives. The conversation establishes RIMS as a foundational element for managing the complexities of global regulatory affairs, emphasizing their role in consolidating information, tracking registrations, and influencing business strategy. The discussion traces the evolution of RIMS from simple tools designed to replace spreadsheets and bespoke databases to sophisticated platforms that emulate the entire regulatory business process. It positions RIMS as the third pillar alongside document management and publishing tools, forming a cohesive regulatory ecosystem essential for handling the unified submission of structured data and documents to health authorities. A significant portion of the talk focuses on the primary motivators for companies to adopt or refresh RIMS, including the mandate for structured content submissions like IDMP and UPD, the need to modernize outdated regulatory infrastructures, and the growing recognition of RIMS as a valuable source of intellectual property and business intelligence. Furthermore, the video delves into the practical benefits of RIMS, particularly in improving impact assessment. It illustrates how RIMS can provide internal regulatory intelligence, aid in strategic decision-making regarding product portfolios, and, most notably, offer a comprehensive view of the end-to-end costs and timelines associated with organizational changes, such as manufacturing improvements. A compelling case study reveals how one company leveraged RIMS data to determine that nearly 60% of manufacturing changes had a negative financial impact after considering all factors, including regulatory timelines. The speakers also broaden the scope of RIMS applicability, asserting their utility across human medicine, veterinary products, medical devices, and API manufacturing, and stress the importance of seamless integration with other enterprise systems like Quality Management Systems (QMS) for optimal efficiency and data consistency. Key Takeaways: * **Core Function of RIMS:** Regulatory Information Management Systems are designed to consolidate all regulatory information into a single source, enabling comprehensive tracking and management of global product registrations. This replaces fragmented data stored in spreadsheets or bespoke departmental databases. * **IDMP and Structured Content as Key Drivers:** The impending implementation of ISO IDMP (Identification of Medicinal Products) and other structured content submission initiatives like UPD (Union Product Database) are the most significant catalysts for companies to adopt or upgrade their RIMS, necessitating a unified approach to data and document submission. * **RIMS as a Regulatory Ecosystem Component:** RIMS are intrinsically linked with document management and publishing tools, forming a unified "regulatory ecosystem" where structured data and documents are managed in unison to ensure consistency and compliance with evolving regulations. * **Strategic Value Beyond Compliance:** While RIMS serve as essential compliance tools, their value extends significantly to operational efficiency, strategic planning, and providing critical business intelligence. They help influence future business and regulatory strategies by offering insights into past precedents and current statuses. * **Enhanced Impact Assessment Capabilities:** RIMS significantly improve impact assessment by providing a clear view of regulatory process mechanics, allowing companies to assess internal regulatory intelligence, evaluate product performance (e.g., sunset clauses), and contribute to activities like product transfers or mergers and acquisitions. * **Data-Driven Decision Making:** A powerful application of RIMS is the ability to integrate its data with other organizational data sources (e.g., manufacturing, quality) to perform comprehensive cost and timeline analyses for changes. One example cited a company using RIMS data to discover that 60% of manufacturing improvements had a negative financial impact when all end-to-end costs and approval timelines were considered. * **Importance of System Integration:** Direct integration between RIMS and other enterprise systems, particularly Quality Management Systems (QMS), is highly advantageous. This seamless communication streamlines information flow, reduces manual effort, and ensures consistency across critical organizational functions. * **Broad Applicability Across Sectors:** RIMS are not exclusive to human medicines but are equally crucial for veterinary products, consumer health, medical devices, and even API manufacturers. The complexity of global registrations necessitates these tools regardless of the product type. * **Company Size is No Longer a Barrier:** The need for a RIMS is driven by the inherent complexity of global registrations, not company size or revenue. Small, innovative companies preparing for their first registration can benefit as much as large multinationals, and the competitive RIMS marketplace offers solutions for all scales. * **Diverse Stakeholders and Data Consumption:** While regulatory departments typically own RIMS, the data collected within them is valuable to a wide array of internal stakeholders, including clinical management, artwork and labeling, pharmacovigilance, quality management, portfolio management, intellectual property, sales, and marketing. * **Criticality of Data Exchange Capabilities:** Modern RIMS must offer robust capabilities for exposing and exchanging data with other systems, often through data marts. This ensures that valuable regulatory information is accessible and consumable by various groups across the organization, provided the context of the data is understood. * **Role of Implementation Partners:** Engaging world-class implementation partners is crucial for a successful RIMS deployment. These partners bring specialized expertise, save time and money, help navigate the RIMS landscape, and ensure the chosen solution aligns with specific company needs and integrates smoothly with existing systems. * **Proactive Adaptation to Evolving Regulations:** Adapting to new standards like ISO IDMP requires early involvement, a clear understanding of overall objectives, and proactive development. Strategic partnerships with software providers and implementation vendors are essential to ensure the RIMS continuously evolves with regulatory changes. **Examples/Case Studies:** * **Manufacturing Change Assessment:** A high-tech company utilized its existing RIMS data to analyze the economic and practical sense of manufacturing changes. This analysis revealed that almost 60% of manufacturing improvements, despite being beneficial to the manufacturing process, had a negative financial impact overall due to end-to-end costs (including regulatory affairs) and lengthy approval timelines. This led to a significant shift in how manufacturing changes were evaluated.

665 views

41.8

18:19

RegTalks about Regulatory Information Management Systems (RIMS)

Asphalion

/@Asphalion.

Oct 1, 2021

This video directly addresses Regulatory Information Management Systems (RIMS) within the pharmaceutical and life sciences industries, a core area for companies seeking to optimize operations and maintain regulatory compliance. **Summary:** The "RegTalks" video, featuring Lidia Canovas from Asphalion and Frank Dickert from EXTEDO, provides an in-depth exploration of Regulatory Information Management Systems (RIMS) and their increasing importance in the pharmaceutical and life sciences sectors. The speakers define RIMS as comprehensive solutions for master product data management, regulatory activity tracking, and integrated document management, serving as a crucial "single source of truth." A central theme is the significant industry transition from xEVMPD to the complex ISO IDMP standard, which necessitates robust RIMS to handle increased data transmission and regulatory compliance. The discussion highlights how RIMS enhance operational efficiency by replacing fragmented manual systems, improve impact assessment capabilities, and are applicable across various regulated fields beyond human medicines, including animal health and medical devices. Furthermore, the video emphasizes that RIMS benefit a wide array of departments beyond regulatory affairs, such as quality, clinical, manufacturing, and supply chain, and stresses the indispensable role of experienced implementation partners in successfully deploying these complex systems. **Key Takeaways:** * **RIMS as a Foundational Compliance System:** Regulatory Information Management Systems (RIMS) are critical enterprise solutions for the life sciences, providing a "single source of truth" for master product data, regulatory activities, and integrated document management, essential for ensuring regulatory compliance and operational efficiency. * **IDMP Transition Drives RIMS Adoption:** The impending transition to the ISO IDMP standard is a major catalyst for RIMS implementation, as it significantly increases data complexity and submission requirements, necessitating sophisticated systems to manage and submit data effectively, often integrated with eCTD submissions. * **Broad Organizational Impact:** RIMS are not exclusive to regulatory affairs but serve a wide range of departments across a life sciences company, including quality, clinical, manufacturing, marketing, and supply chain, by providing centralized access to regulatory information, thereby improving cross-functional decision-making and impact assessment. * **Beyond Human Medicines:** The utility of RIMS extends beyond human pharmaceuticals to other regulated sectors such as animal health, consumer health, and medical devices (e.g., for IVDR/MDR compliance), indicating a broader market need for robust regulatory data management solutions. * **Criticality of Implementation Expertise:** Successful RIMS deployment, especially in the context of IDMP compliance, requires knowledgeable external implementation partners who can provide technical support, guide necessary process changes, and leverage deep industry experience to ensure optimal system configuration and user adoption.

964 views

49.1

7:49

FDA Pharmaceutical Industry Ties

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Sep 6, 2021

This video, presented by Dr. Eric Bricker of AHealthcareZ, delves into the intricate and often problematic financial and personnel ties between the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry it is tasked with regulating. Drawing insights from a 2021 New York Times opinion piece by Farhad Manjoo, Dr. Bricker explores two primary areas of potential conflict of interest: the FDA's funding model and the "revolving door" phenomenon where regulators transition to industry roles. The overarching purpose is to highlight systemic issues that may compromise the FDA's impartiality and, consequently, drug safety for patients, prompting a discussion on how physicians should approach prescribing newly approved medications. The speaker details a significant shift in FDA funding that occurred in 1992, where the agency began collecting fees directly from pharmaceutical companies to cover the salaries of FDA employees. This arrangement, which includes "performance guarantees" from the FDA related to the speed of drug reviews, creates a direct financial link between the regulator and the regulated, raising concerns about "regulatory capture." Dr. Bricker emphasizes that this model means the industry itself funds the very body designed to oversee it, inherently creating grounds for a conflict of interest that could prioritize speed of approval over thoroughness or safety. Further exacerbating these concerns is the "revolving door" phenomenon, where FDA personnel, particularly those involved in drug approval, leave their government positions to take up more lucrative roles within the pharmaceutical industry. The video cites an example of over 13 cancer drug reviewers making this transition. A particularly egregious case highlighted is that of Curtis Wright, the FDA regulator specifically responsible for Oxycontin, who subsequently left the FDA to work for Purdue Pharma, the manufacturer of Oxycontin and a central figure in the opioid epidemic. These instances suggest a potential for regulators to be overly lenient in the approval process, possibly with an eye toward future employment opportunities within the industry. The consequences of these ties are illustrated by a troubling statistic: one-third of drugs approved by the FDA between 2000 and 2010 were later found to have safety problems during Phase 4 post-market surveillance. In response to these systemic issues, Dr. Bricker shares a practical recommendation from his residency training at Johns Hopkins: physicians might consider waiting five years after a new drug's approval before prescribing it, especially if other proven and safe alternatives exist. This allows for more extensive real-world data collection and identification of issues missed in initial clinical trials, as seen with drugs like Vioxx, Avandia, and Zelnorm. While acknowledging exceptions for critical medications with no alternatives, such as the COVID vaccine, the video concludes with a strong call for fundamental changes to the FDA's funding and operational structure to restore public trust and ensure unbiased regulation. Key Takeaways: * **FDA Funding Model Conflict:** Since 1992, the FDA has received funding directly from pharmaceutical companies to pay employee salaries, creating a direct financial tie and potential conflict of interest, as the regulated industry funds its regulator. * **Performance Guarantees:** In exchange for industry funding, the FDA reportedly offered "performance guarantees" related to the speed of drug reviews, suggesting a prioritization of efficiency that could compromise thoroughness. * **High Incidence of Post-Approval Safety Issues:** A significant concern is that one-third of drugs approved by the FDA between 2000 and 2010 were later found to have safety problems during Phase 4 post-market surveillance, indicating potential gaps in the initial approval process. * **The "Revolving Door" Phenomenon:** Many FDA regulators transition to high-paying jobs within the pharmaceutical industry after their tenure, raising ethical questions about potential leniency during their regulatory roles. * **Egregious Example of Conflict:** The case of Curtis Wright, the FDA regulator for Oxycontin, who later worked for Purdue Pharma, serves as a stark illustration of how the "revolving door" can lead to severe conflicts of interest with public health consequences. * **Physician's Prudent Prescribing Strategy:** A recommendation from Johns Hopkins suggests physicians consider waiting five years after a new drug's approval before prescribing it, allowing for more robust post-market safety data to emerge. * **Importance of Phase 4 Surveillance:** This waiting period emphasizes the critical role of Phase 4 post-market surveillance in identifying adverse effects or safety issues that may not be apparent during pre-market clinical trials. * **Historical Precedents for Caution:** Past examples like Vioxx (increased cardiovascular risk), Avandia (poor cardiovascular outcomes), and Zelnorm (liver function problems) underscore the historical basis for exercising caution with newly approved medications. * **Exceptions for Unmet Needs:** The strategy of waiting five years is not absolute; in situations where no other effective treatment options exist (e.g., the COVID vaccine), the immediate use of new drugs may be justified, balancing risks and benefits. * **Broader Regulatory Context:** When evaluating critical new drugs, especially in global health crises, considering approvals by multiple international regulatory agencies can provide an additional layer of validation beyond the FDA's assessment. * **Call for Systemic Reform:** The video advocates for fundamental changes to the FDA's funding and operational structure to eliminate conflicts of interest, enhance regulatory independence, and rebuild public trust in drug approval processes. Tools/Resources Mentioned: * New York Times article by Farhad Manjoo (September 2, 2021) * AHealthcareZ video on Regulatory Capture * AHealthcareZ video on Stages of Drug Approval Key Concepts: * **Regulatory Capture:** A form of political corruption that occurs when a regulatory agency, created to act in the public interest, instead advances the commercial or political concerns of special interest groups that dominate the industry or sector it is charged with regulating. * **Post-Market Surveillance (Phase 4):** The ongoing monitoring of a drug's safety and effectiveness after it has been released to the market and is being used by the general public. This phase is crucial for detecting rare or long-term side effects that may not have been observed during clinical trials. * **Conflict of Interest:** A situation in which a person or organization has a vested interest—financial, personal, or otherwise—that could potentially bias their judgment or actions in a professional or official capacity. * **Quid Pro Quo:** A favor or advantage granted or expected in return for something. In this context, it refers to the implied exchange of industry funding for faster drug review times or future job opportunities. Examples/Case Studies: * **Curtis Wright and Oxycontin:** The FDA regulator responsible for Oxycontin who later took a job with Purdue Pharma, the drug's manufacturer, illustrating a direct "revolving door" conflict. * **Vioxx:** A pain medication found to increase cardiovascular and stroke risk after its approval. * **Avandia:** A diabetes medication found to increase poor cardiovascular outcomes post-approval. * **Zelnorm:** An IBS medication taken off the market due to problems with liver function. * **COVID Vaccine:** Cited as an example of a critical new drug where immediate use was justified due to the lack of alternatives and global pandemic circumstances, despite broader concerns about FDA processes.

4.4K views

45.6

8:39

QMS Software Overview of The Lean Machine - Quality, Risk, and Material Management

Total Lean Management Software

/@totalleanmanagementsoftwar8554

Aug 21, 2021

This video provides an in-depth overview of "The Lean Machine," an all-in-one Quality Management Software (QMS) solution designed to help businesses optimize resource utilization, manage risks, and ensure continuous improvement. The presenter, David, highlights how the software addresses the critical need for organizations to get and stay organized, orchestrating resources effectively to satisfy customers and drive sales, while simultaneously identifying and mitigating risks that could otherwise squander efforts. The core message emphasizes that an effective QMS is vital for business success, and The Lean Machine is engineered to enhance this system through user-friendly, comprehensive, and integrated functionalities. The presentation systematically walks through the software's key attributes, starting with its ease of implementation and intuitive user interface. It then delves into the comprehensive nature of the system, which comprises 26 modules covering quality, risk, and material management workflows. A significant focus is placed on the system's integration capabilities, demonstrating how various modules interlink to provide a holistic view of operations, from inventory management integrated with approved parts and suppliers to document control linked with ISO standards for auditor review. The speaker underscores the importance of visible accountability, achieved through user-specific dashboards that consolidate assignments and prioritize tasks with color-coded alerts. Further, the video details the robust support structure, including direct technical assistance from the development team, and advanced communication features like integrated email alerts and server-side escalation systems. The Lean Machine's ability to integrate with existing ERP systems is presented as a major advantage, allowing quality-related data to be leveraged from enterprise-wide systems. Custom development is offered as a flexible solution for unique business requirements, ensuring the software can adapt to specific organizational needs. Finally, the presentation addresses affordability through flexible pricing and a companion web app, and critically, highlights the software's strong validation support for medical device customers, boasting a 100% success rate in first-time registration audits and a commitment to evolving with regulatory standards like ISO 9001:2015. Key Takeaways: * **Strategic Resource Management:** The Lean Machine helps businesses intelligently use limited resources (time, money, knowledge, employee motivation) by getting organized, staying organized, and orchestrating tasks towards customer satisfaction and sales, while proactively managing risks. * **User-Friendly Design:** The software is designed for ease of use and rapid implementation, featuring a consistent interface across its 26 modules, with simple navigation, filtering capabilities, and tabbed record views. * **Comprehensive Modular System:** It offers a wide array of modules covering quality, risk, and material management, allowing companies to incorporate necessary quality principles, eliminate waste, and drive continuous improvement. * **Integrated Workflows:** The system provides deep integration between modules, such as linking inventory with approved parts/suppliers and inspection plans, or connecting document control to specific ISO sections for streamlined auditing and compliance. * **Visible Accountability:** User dashboards centralize assignments, linking users directly to their tasks. Priority information is color-coded based on age and system configuration, ensuring nothing falls through the cracks and critical tasks are addressed promptly. * **Robust Communication and Escalation:** An integrated email system automates communication points, such as alerting reviewers for document approvals. A server-based alerts and escalation system sends targeted emails to users based on dashboard categories, enhancing inter-user communication for quality system tasks. * **ERP System Integration:** The Lean Machine can integrate with existing ERP systems, allowing for the import of data (e.g., PO numbers) to enrich quality processes, providing robust solutions for quality-side data management that many ERPs lack. * **Custom Development Flexibility:** The vendor offers custom development projects to add unique functionalities requested by customers, often implementing minor changes free of charge and significant efforts for a modest project fee, ensuring the software evolves with user needs. * **Affordable and Scalable Pricing:** Pricing is structured to be affordable, including all modules with permission settings to control user access. Volume discounts are available, and a companion web app offers access to released documents and training sign-offs for a larger user base, reducing the need for full desktop licenses. * **Critical Validation Support for Regulated Industries:** For medical device customers, the software provides comprehensive validation documentation sets, including pre-written test protocols and online tutorials, which are robust enough to satisfy auditors and can be executed with risk-appropriate effort. * **High Audit Success Rate:** The Lean Machine boasts a 100% success rate at first-time registration audits and has successfully navigated countless customer installations, often receiving compliments from auditors who appreciate its effectiveness. * **Commitment to Evolving Standards:** The software is continuously updated to address new regulatory requirements, such as the dedicated module for risk and opportunity requirements introduced in ISO 9001:2015, ensuring ongoing compliance. * **Direct Technical Support:** Technical support is provided directly by the development team, which serves as a strong motivator for getting features right before release and ensures faster resolution of technical issues by actual experts. Tools/Resources Mentioned: * The Lean Machine QMS * ERP Systems * Active Directory Key Concepts: * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **Risk Management:** The process of identifying, assessing, and controlling risks to an organization's capital and earnings. * **Material Management:** The process of planning, organizing, and controlling the flow of materials from their initial purchase through internal operations to the final product. * **Continuous Improvement:** An ongoing effort to improve products, services, or processes. * **ISO 9001:2015:** An international standard for quality management systems, which includes requirements for risk and opportunity management. * **Software Validation:** The process of ensuring that software meets its intended use and user requirements, particularly critical in regulated industries like medical devices and pharmaceuticals.

38 views

41.8

8:21

Doctor Specialties That Have Power at Hospital Systems

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Aug 1, 2021

This video provides an in-depth exploration of the financial power dynamics within major hospital systems, identifying specific physician specialties that drive the majority of hospital revenue and influence. Dr. Eric Bricker, Chief Medical Officer of a Value-Based Care Company, frames the discussion by recounting an offer to become a Chief Medical Officer of Value-Based Care at a top hospital system, immediately questioning the actual influence such a role could wield given the established financial incentives. He posits that the administration of hospital systems maintains a highly symbiotic relationship with particular physician groups, not based on medical necessity alone, but primarily on their ability to generate high-margin services. The core of the video details how Orthopedics, Neurosurgery (specifically spine), Cardiology, and Oncology are the "royalty" within hospital systems. These specialties are highlighted for performing complex, high-cost procedures on commercially insured patients, such as knee and hip surgeries, spine surgeries, cardiac cath lab procedures, nuclear stress tests, and inpatient chemotherapy. These services are presented as the primary drivers of hospital growth and profitability. Hospitals, therefore, go to great lengths to attract and retain these specialists, offering incentives like co-owned ambulatory surgery centers and facility fee sharing to ensure their continued presence and productivity. In contrast, other specialties like ENT, Urology, Vascular Surgery, Ophthalmology, and OB/GYN are categorized as mid-tier, often dealing with lower-paying Medicare or Medicaid populations, or performing procedures that yield less significant margins. Specialties such as Psychiatry, Primary Care Physicians, ER physicians, and Radiologists are deemed to hold minimal power, often seen as cost centers or easily replaceable. A significant portion of the video is dedicated to explaining why value-based care (VBC) models inherently conflict with this established fee-for-service financial structure. Dr. Bricker argues that VBC, by design, "betrays" the high-margin specialties by reducing patient volume and procedure counts. This reduction occurs through mechanisms like increased referrals to physical therapy by primary care physicians, decreased complex imaging, fewer emergency room visits, and more effective cancer screening leading to earlier-stage diagnoses that require less intensive (and less profitable) treatments like chemotherapy. The speaker concludes that the vast majority of hospital systems are unwilling to adopt VBC widely because it directly undermines the financial stability provided by these high-margin specialties. A rare successful example of VBC implementation involved hospitals paying these specialists *more* to perform *fewer* procedures, essentially buying them out of the fee-for-service model to align incentives. Key Takeaways: * **Financial Drivers of Hospital Power:** The true power dynamics within hospital systems are dictated by physician specialties that generate high-margin revenue, primarily Orthopedics, Neurosurgery (spine), Cardiology, and Oncology. * **High-Margin Procedures:** These dominant specialties drive profitability through expensive procedures like knee/hip surgeries, spine surgeries, cardiac cath lab interventions, nuclear stress tests, and inpatient chemotherapy, especially when performed on commercially insured patients. * **Hospital Incentives for Specialists:** Hospitals actively court and retain high-margin specialists by offering significant incentives, including co-ownership opportunities in ambulatory surgery centers and sharing facility fees to ensure their continued loyalty and productivity. * **Hierarchy of Influence:** A clear hierarchy exists where high-margin specialists are treated as "royalty," while specialties like Psychiatry, Primary Care, and Emergency Room physicians hold minimal sway, often viewed as cost centers or easily replaceable. * **Value-Based Care Conflict:** Value-Based Care (VBC) models fundamentally conflict with the fee-for-service incentives of high-margin specialties by aiming to reduce patient volume and procedure counts through preventative care and conservative treatments. * **Impact of VBC on Procedure Volume:** VBC initiatives lead to decreased complex imaging, increased utilization of physical therapy, and fewer ER visits, directly impacting the revenue streams of orthopedic, neurosurgery, and cardiology departments. * **Oncology Revenue Implications:** In oncology, VBC's emphasis on early cancer screening results in detecting earlier-stage cancers (e.g., DCIS, pre-cancerous polyps) that often do not require chemotherapy, thereby reducing high-margin treatment volumes for oncologists. * **Hospital Resistance to VBC:** Most hospital systems are reluctant to fully embrace VBC because it directly threatens the financial viability and profitability derived from their high-margin, fee-for-service specialties. * **Cost of VBC Transition:** A rare successful strategy for transitioning high-margin specialists to VBC involves paying them *more* to perform *fewer* procedures, effectively compensating them for lost fee-for-service revenue to align with value-based goals. * **Intermountain Health Case Study:** The experience at Intermountain Health with its patient-centered medical home demonstrated a tangible reduction in imaging, orthopedic/neurosurgery procedures, and ER visits, validating the volume-reduction effect of VBC. * **Strategic Implications for Life Sciences:** Pharmaceutical and medical device companies must understand these hospital financial dynamics and physician power structures to effectively tailor their commercial strategies, market access approaches, and product messaging when engaging with high-value specialties and hospital systems. * **Commercial Operations Insight:** For commercial operations, recognizing which specialties are critical revenue drivers for hospitals can inform sales targeting, resource allocation, and partnership strategies, especially when considering the potential shifts introduced by value-based care. * **Regulatory and Operational Challenges:** The inherent conflict between fee-for-service profitability and value-based care goals presents significant operational and potentially regulatory challenges for hospitals, impacting how new technologies and treatments are adopted. **Key Concepts:** * **High-Margin Specialties:** Physician groups (Orthopedics, Neurosurgery Spine, Cardiology, Oncology) that generate substantial profit for hospitals due to expensive procedures performed on commercially insured patients. * **Fee-for-Service (FFS):** A traditional payment model in healthcare where providers are reimbursed for each service they perform, incentivizing higher volumes of care. * **Value-Based Care (VBC):** A healthcare delivery model where providers are paid based on patient health outcomes, quality of care, and cost-efficiency, rather than the volume of services. * **Commercially Insured Patients:** Patients covered by private health insurance plans, which typically offer higher reimbursement rates to hospitals and providers compared to government programs like Medicare or Medicaid. * **Ambulatory Surgery Centers (ASCs):** Outpatient facilities where surgical procedures are performed, often co-owned by hospitals and physicians to share facility fees and increase profitability. **Examples/Case Studies:** * **Intermountain Health:** The video references Intermountain Health's "third-generation patient-centered medical home" as a real-world example where the implementation of value-based care principles led to a measurable decrease in imaging, orthopedic/neurosurgery procedures, and ER visits, illustrating the direct impact of VBC on procedure volume.

9.8K views

42.0

12:04

Machine Learning for Population Health

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Jul 19, 2021

This video provides an in-depth exploration of machine learning (ML) applications in population health, demystifying the concept for a general audience. Dr. Eric Bricker begins by establishing a clear distinction between traditional, human-programmed "if-then" algorithms and true machine learning, where software autonomously learns and generates its own rules. He emphasizes that "real AI" lies in this self-learning capability. The presentation then pivots to a practical application, showcasing ClosedLoop.ai, an Austin-based startup that won the prestigious CMS AI Challenge, beating out 300 other organizations including IBM and the Mayo Clinic, for its prowess in applying ML to population health data. The core purpose of applying machine learning in population health, as highlighted in the video, is to significantly improve the identification of high-risk individuals who are most likely to benefit from targeted interventions. This contrasts sharply with historical "predictive analytics" methods, which have proven largely ineffective in accurately pinpointing the small percentage of people (e.g., 5%) who drive a disproportionate amount of healthcare costs or adverse outcomes. ClosedLoop.ai's approach leverages ML to overcome these limitations, enabling health plans and systems to proactively intervene with individuals at high risk of complications, ER visits, or hospitalizations, thereby improving health outcomes and optimizing resource allocation. The video further delves into three crucial aspects that make machine learning effective and trustworthy in a healthcare context. First, **explainability** is paramount; ML models cannot be black boxes, as healthcare professionals need to understand *why* a particular individual is flagged for intervention to build trust and ensure effective action. Second, **addressing bias** is critical, as historical health data often contains inherent biases related to demographics, income, or race, which ML models must be explicitly programmed to counteract. Third, ML's ability to handle **messy data** is a significant advantage, as it can infer insights (e.g., a diabetes diagnosis from insulin prescriptions, even without an ICD-10 code) in a way that traditional algorithms or human analysis often struggle with. A compelling case study of ClosedLoop.ai's COVID-19 Vulnerability Index demonstrates these principles in action, showing how ML can rapidly identify individuals at high risk of severe COVID-19 complications, leading to practical interventions like home delivery of groceries and prescriptions. Finally, the discussion touches upon the transformative impact of the COVID-19 pandemic on ML in population health, particularly in two areas: speed and implementation. The pandemic underscored the need for rapid model development, with ClosedLoop.ai creating their COVID-19 index in a single weekend due to an existing platform. More profoundly, the video identifies the "limiting reagent" for wider ML adoption not as the software or data, but as the **ability to persuade and consult** with organizations to effectively integrate and apply these solutions. This highlights a critical gap in translation and implementation, emphasizing the need for strong consulting and sales capabilities to bridge the divide between advanced ML technology and its practical application in healthcare settings. Key Takeaways: * **Machine Learning vs. Traditional Algorithms:** Machine learning distinguishes itself by enabling software to autonomously learn and create its own "if-then" rules, unlike traditional algorithms that rely on human-programmed instructions. This self-learning capability is considered the hallmark of "real AI." * **Purpose of ML in Population Health:** The primary goal is to accurately predict individuals who are at high risk of adverse health outcomes (e.g., hospitalizations, ER visits, complications) so that targeted, proactive interventions can be implemented. * **Ineffectiveness of Historical Predictive Analytics:** Traditional methods of identifying high-risk populations have proven largely ineffective, often failing to accurately pinpoint the small percentage of individuals responsible for a majority of healthcare costs or negative outcomes. * **Importance of Explainability:** For machine learning models to be trusted and utilized by healthcare professionals (nurses, physicians), their predictions cannot be black boxes. The rationale behind identifying a high-risk individual must be explainable and transparent. * **Explicitly Addressing Bias:** Healthcare data inherently contains biases related to demographics, socioeconomic status, and other factors. ML models must be designed and programmed to explicitly identify and mitigate these biases to ensure equitable and accurate predictions across all populations. * **Handling Messy Data:** Machine learning excels at making sense of imperfect or "messy" healthcare data. It can infer conditions or risks even when complete or perfectly coded data is absent, such as identifying diabetes from insulin prescriptions without an official ICD-10 code. * **Case Study: COVID-19 Vulnerability Index:** ClosedLoop.ai developed an index using 21 measures (demographics, chronic conditions, utilization data) to predict with 80% sensitivity who would be at high risk of severe COVID-19 complications if infected. * **Practical Interventions:** Based on the COVID-19 Vulnerability Index, health plans implemented real-world interventions for high-risk individuals, including arranging grocery deliveries and ensuring home delivery of prescription medications to minimize exposure risks. * **Speed of ML Development:** With an established platform and framework, machine learning projects can be developed rapidly, as demonstrated by the COVID-19 index being created in a single weekend, enabling quick responses to emerging health challenges. * **The Limiting Factor is Consulting and Persuasion:** The primary barrier to wider adoption and implementation of machine learning in population health is not the software, the data, or even the programming skill. Instead, it's the ability to effectively persuade and consult with organizations (health plans, hospitals, employers) on how, when, and why to apply these solutions. * **Opportunity for Consulting Firms:** The identified "limiting reagent" highlights a significant opportunity for consulting and sales professionals to bridge the gap between advanced ML capabilities and organizational implementation, translating technical solutions into practical value. Key Concepts: * **Machine Learning (ML):** A subsegment of AI where computer software can create and improve algorithms on its own, learning from data without explicit programming of "if-then" statements. * **Population Health:** An approach to health that aims to improve the health outcomes of a group of individuals, including the distribution of such outcomes within the group. * **Predictive Analytics:** The use of data, statistical algorithms, and machine learning techniques to identify the likelihood of future outcomes based on historical data. * **Explainability (in ML):** The ability to understand and interpret how a machine learning model arrives at its predictions or decisions, crucial for trust and adoption in critical fields like healthcare. * **Bias (in ML):** Systematic and repeatable errors in a computer system that create unfair outcomes, such as favoring or disfavoring certain groups of people. * **Messy Data:** Imperfect, incomplete, or inconsistently formatted data that often requires significant effort to clean and prepare for analysis. Examples/Case Studies: * **ClosedLoop.ai:** A company based in Austin, Texas, specializing in applying machine learning to population health data. They won the CMS AI Challenge, beating out 300 other organizations including IBM, the Mayo Clinic, and Deloitte. * **COVID-19 Vulnerability Index:** A machine learning model created by ClosedLoop.ai to identify individuals at high risk of severe complications if they contracted COVID-19. This index was used by institutions like Johns Hopkins, the University of Texas Medical Branch, and Einstein. * **Interventions for High-Risk Individuals:** A New York City health insurance plan used the COVID-19 Vulnerability Index to identify high-risk members and arranged for groceries and prescription medications to be delivered to their homes, helping them avoid exposure to the virus.

4.2K views

43.8

12:07

Traditional Medicare vs Medicare Advantage vs Medicare Part D vs Medicare Supplement Explained

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Jul 18, 2021

This video provides a high-level overview and comparison of the four main components of Medicare: Traditional Medicare (Parts A and B), Medicare Advantage (Part C), Medicare Part D, and Medicare Supplement (Medigap) plans. Dr. Eric Bricker, the presenter, aims to clarify the often-complicated distinctions between these options, responding to viewer requests for this topic. He uses a structured approach, breaking down each plan by its coverage, costs, and implications for both beneficiaries and healthcare providers, highlighting the significant differences in flexibility, benefits, and financial structures. The discussion begins with Traditional Medicare, explaining Part A for hospital coverage and Part B for physician and outpatient services. Dr. Bricker details the associated costs, such as the low or zero premium for Part A (for those who've worked enough), the proactive sign-up and premium for Part B, and the critical point of a 20% co-insurance for Part B services with no out-of-pocket maximum. He also notes that under Traditional Medicare, prices for providers are set by CMS (Centers for Medicare & Medicaid Services), it operates on a straight fee-for-service model with no prior authorizations or referrals, and offers broad access to doctors and hospitals. The video then shifts to Medicare Advantage, often called Part C, which bundles hospital, doctor, outpatient, and typically prescription drug coverage, along with additional benefits like dental, vision, and hearing. A key insight is that Medicare Advantage plans often have low or even zero premiums for beneficiaries, contributing to their rapid growth, now covering 40% of Medicare enrollees. Dr. Bricker explains the financial mechanics, where the government pays a fixed amount (around $1,000 per beneficiary per month) to commercial insurance companies (e.g., UnitedHealthcare, Humana), which then manage care. These plans achieve lower costs and offer extra benefits by implementing tighter care restrictions, such as HMO models with PCP gatekeepers, narrow provider networks, and extensive prior authorization requirements for tests, procedures, and surgeries. The video also touches on the rise of capitated and value-based payments to physician groups (like ChenMed, Oak Street) within the Medicare Advantage framework, where providers take on financial risk for keeping patients healthy. Finally, Dr. Bricker covers Medicare Part D, which provides prescription drug coverage for those on Traditional Medicare, noting its low or zero premium, tiered formularies, co-pays, co-insurance, and the concept of a "donut hole." He emphasizes that Part D plans, administered by private insurers, also involve prior authorizations and formulary controls for medications. The video concludes with Medicare Supplement (Medigap) plans, optional commercial insurance policies that beneficiaries can purchase to cover the out-of-pocket costs not covered by Traditional Medicare, particularly the 20% Part B co-insurance, without altering the provider's interaction with Medicare. Key Takeaways: * **Traditional Medicare Structure:** Consists of Part A (hospital coverage, often zero premium for eligible individuals) and Part B (physician and outpatient services, requires a premium). Part B has a 20% co-insurance with no out-of-pocket maximum, posing significant financial risk. * **Provider Reimbursement in Traditional Medicare:** Prices are set by CMS on a fee-for-service basis, with no prior authorizations or referrals required, offering beneficiaries broad access to providers. * **Medicare Advantage (Part C) as an All-in-One Solution:** These plans bundle hospital, physician, outpatient, and prescription drug coverage, often including additional benefits like dental, vision, and hearing, which are not covered by Traditional Medicare. * **Growth and Financial Incentives of Medicare Advantage:** Medicare Advantage is rapidly growing, now covering 40% of beneficiaries, partly due to low or zero premiums and added benefits. Insurance companies receive a fixed payment from the government per beneficiary (e.g., $1,000/month) and can achieve significant profit margins (e.g., $1,600/year per beneficiary). * **Care Restrictions in Medicare Advantage:** To manage costs and offer additional benefits, most Medicare Advantage plans utilize HMO models with primary care physician (PCP) gatekeepers, narrow provider networks, and frequent prior authorization requirements for tests, procedures, and specialist visits. * **Value-Based and Capitated Payments:** Medicare Advantage plans are a hotbed for innovation in payment models, frequently employing capitated and value-based payments to physician groups (e.g., ChenMed, Oak Street), where providers take on financial risk for patient health outcomes. * **Medicare Part D for Prescription Coverage:** This separate plan provides prescription drug coverage for those on Traditional Medicare. It features tiered formularies, co-pays, co-insurance, and a "donut hole" phase where beneficiaries pay a higher percentage of drug costs. * **Prior Authorizations for Medications:** Regardless of whether coverage is through Medicare Advantage or Part D, prescription drugs are subject to formularies and prior authorization controls by private health insurance companies. * **Medicare Supplement (Medigap) Plans:** These optional commercial insurance policies cover the out-of-pocket costs associated with Traditional Medicare, such as the 20% Part B co-insurance, providing financial protection without altering access to providers. * **Beneficiary Choice vs. Restriction:** Traditional Medicare offers broad choice and no referrals/prior authorizations but higher potential out-of-pocket costs. Medicare Advantage offers lower premiums and more benefits but comes with significant restrictions on provider choice and care access. * **Market Dynamics:** The shift from Traditional Medicare to Medicare Advantage is a significant trend, driven by both beneficiary demand for lower premiums and added benefits, and insurer profitability. * **Impact on Pharmaceutical and Medical Device Companies:** Understanding these different Medicare structures, especially the growth of Medicare Advantage, its prior authorization requirements, formularies, and value-based payment models, is crucial for market access, commercial strategy, and sales operations within the pharmaceutical and medical device sectors. **Key Concepts:** * **Traditional Medicare (Part A & B):** Government-run health insurance for people 65 or older, and some younger people with disabilities. Part A covers hospital stays, Part B covers doctor visits and outpatient care. * **Medicare Advantage (Part C):** Private insurance plans that contract with Medicare to provide all Part A and Part B benefits, often including Part D and additional benefits. * **Medicare Part D:** Prescription drug coverage, typically offered by private insurance companies. * **Medicare Supplement (Medigap):** Private insurance policies that cover costs not covered by Original Medicare, such as co-payments, co-insurance, and deductibles. * **Fee-for-Service:** A payment model where services are unbundled and paid for separately. * **HMO (Health Maintenance Organization):** A type of health insurance plan that usually limits coverage to care from doctors who work for or contract with the HMO. It generally won't cover out-of-network care except in an emergency. Often requires a PCP gatekeeper. * **PPO (Preferred Provider Organization):** A type of health insurance plan that has a network of providers but allows members to see out-of-network providers for a higher cost. * **Capitated Payments:** A payment arrangement where a fixed amount is paid per patient per unit of time, regardless of the services rendered. * **Value-Based Payments:** Payment models that incentivize healthcare providers to improve the quality and efficiency of care. * **Formulary:** A list of prescription drugs covered by a health insurance plan. * **Donut Hole (Coverage Gap):** A temporary limit on what the drug plan will cover for drugs. * **Prior Authorization:** A requirement that a healthcare provider obtain approval from a health plan before providing a service or prescribing a medication. * **Co-insurance:** The percentage of costs of a covered health care service you pay after you've paid your deductible. * **Deductible:** The amount you must pay out-of-pocket for covered healthcare services before your insurance plan starts to pay. * **Out-of-Pocket Maximum:** The most you have to pay for covered services in a plan year. **Examples/Case Studies:** * **Medicare Advantage Insurers:** UnitedHealthcare, Humana, Blue Cross plans (e.g., Anthem), Aetna, Cigna. * **Capitated Physician Groups:** ChenMed, Oak Street, Devoted. **Tools/Resources Mentioned:** * medicare.gov/your-medicare-costs/medicare-costs-at-a-glance * healthaffairs.org/doi/10.1377/hblog20210304.136304

24.7K views

43.4

7:26

IQVIA Technologies eTMF demo

IQVIA

/@IQVIA

Jul 14, 2021

This video provides an in-depth demonstration of the IQVIA Technologies eTMF (electronic Trial Master File) system, presented by Charles Patrell, a Solutions Engineer at IQVIA. The primary purpose of the demo is to showcase how the eTMF facilitates inspection readiness, drives quality and completeness, and ensures timeliness in managing Trial Master Files for clinical studies. The system is presented as a rule-based platform, granting specific rights and permissions to users, and its structure is based on the industry-standard TMF Reference Model, which is fully configurable to meet individual customer needs. The demonstration begins with an overview of the user's personalized homepage, which serves as a central hub for managing eTMF activities. This dashboard displays announcements, personal notes for follow-up, and an inbox for assigned tasks such as document rework or approval requests. A "work area" highlights documents in draft or unfinished states, emphasizing the system's "eTMF as a factory" concept, where continuous movement of documents is crucial to prevent backlogs. The homepage also features a study grid dashboard, allowing users to monitor the TMF health of their favorite studies and those recently accessed, with information integrated from CTMS (Clinical Trial Management System) and supported by study setup wizards. A significant portion of the demo focuses on the system's ability to track and analyze TMF health through key performance indicators (KPIs): completeness, quality, and timeliness. Completeness measures the percentage of finalized documents against those due by a specific date, quality assesses rework rates during the QC process, and timeliness tracks prompt document finalization. Users can drill down into a completeness dashboard for a specific study, comparing its performance against others in their portfolio and analyzing missing document statuses by country, site, organization, or risk level. The video also illustrates a streamlined document submission process, utilizing planned placeholders that automatically apply metadata, reducing manual data entry. Documents can be reviewed, assigned dates, and finalized, with the option for a risk-based specialist review before finalization. The system offers various views, including a folder tree structure for navigating by Zone, Section, and Artifact, alongside robust search and filtering capabilities, and the ability to export study items to Excel for authorized users. Finally, a study timeline feature allows users to visualize events and associated documents, enhancing oversight of trial progression. Key Takeaways: * **Centralized TMF Management for Inspection Readiness:** The IQVIA eTMF functions as a comprehensive system designed to maintain Trial Master Files in an "inspection ready" state at all times, ensuring compliance with regulatory authorities. * **Rule-Based System with Configurable Structure:** The eTMF employs a rule-based permission system and its structure is built upon the industry-standard TMF Reference Model, offering extensive configurability to adapt to specific customer requirements. * **User-Centric Homepage and Workflow Management:** The system provides a personalized user homepage displaying critical information such as announcements, personal notes, and an inbox for assigned tasks, streamlining individual workflow and task prioritization. * **"eTMF as a Factory" Concept:** The platform promotes a continuous workflow, conceptualizing the eTMF as a "factory" where documents must consistently move forward to prevent backlogs and ensure efficient trial conduct. * **KPI-Driven TMF Health Monitoring:** The eTMF utilizes a "Quality by Design" approach to define and track key performance indicators (KPIs) for TMF health, specifically completeness (finalized documents vs. due), quality (rework rates), and timeliness (prompt finalization). * **Granular Completeness Analysis:** Users can access detailed completeness dashboards to compare study performance, identify missing documents, and analyze status breakdowns by country, site, organization, or risk level, enabling targeted intervention. * **Streamlined Document Submission:** The system facilitates efficient document submission through pre-planned placeholders, which automatically apply relevant metadata (e.g., study, country, site, document type), significantly reducing manual data entry and potential errors. * **Risk-Based Document Review and Finalization:** The eTMF supports a structured document review and finalization process, including the option to implement a risk-based approach requiring specialist review for critical documents before finalization. * **Multiple Viewing and Navigation Options:** Users can view TMF items in various formats, including a detailed item list and a hierarchical folder tree structure (Zone, Section, Artifact), catering to different navigation preferences. * **Advanced Search and Filtering Capabilities:** The system offers robust search functionality, allowing users to search by keyword across metadata, content, or both, complemented by extensive filters (facets) to refine results, similar to e-commerce platforms. * **Study Timeline for Event Tracking:** A dedicated study timeline feature provides a chronological view of events that have occurred during a study, enabling users to quickly identify and review documents associated with specific milestones or changes. * **Integration with CTMS:** The eTMF integrates with Clinical Trial Management Systems (CTMS) to import study information and leverage industry-leading study setup wizards, simplifying the process of determining required documents for regulatory compliance. Tools/Resources Mentioned: * **IQVIA eTMF:** The core electronic Trial Master File system demonstrated. * **CTMS (Clinical Trial Management System):** Mentioned as a source for integrating study information into the eTMF. * **Excel:** Authorized users can export all study items to Excel for further analysis. Key Concepts: * **eTMF (electronic Trial Master File):** A digital system for managing all essential documents of a clinical trial, crucial for regulatory compliance and audit readiness. * **TMF Reference Model:** An industry standard for structuring the content of a Trial Master File, ensuring consistency and completeness. * **Inspection Readiness:** The state of having all necessary documentation organized, complete, and readily accessible to satisfy regulatory authority inspections. * **Quality by Design (QbD):** An approach to defining and monitoring KPIs within the eTMF, ensuring that the system is designed to achieve desired quality outcomes from the outset. * **KPIs (Key Performance Indicators):** Specific metrics used to evaluate the health and efficiency of the TMF, including Completeness, Quality (rework rates), and Timeliness. * **Placeholders:** Empty document slots created during the TMF planning process, which, when populated, automatically apply associated metadata, streamlining document submission.

7.0K views

40.6

8:23

What is TMF Reference model||DIA||Trial master file||Clinical Research

Vikas Singh

/@VikasSinghPharmalive

Jul 4, 2021

This video explores the Trial Master File (TMF) Reference Model, detailing its historical context, purpose, and structure. The speaker explains the evolution from paper-based clinical trial documentation, which was time-consuming for audits, to electronic Trial Master Files (eTMFs). The video highlights the challenge of inconsistencies arising from different companies and countries using varied eTMF systems, which the TMF Reference Model was created to address. As a supported initiative of the DIA, the model provides a unified interpretation of regulations and best practices for TMFs, serving as a reference tool for document location, keywords, and quality checks. It outlines the model's four main areas (Content, Location, Keywords, Quality Check) and various sections (e.g., Trial Management, Regulatory, Site Management), emphasizing its role in ensuring proper filing and management of essential clinical trial documents for regulatory compliance and operational efficiency. Key Takeaways: * **Standardization for Compliance:** The TMF Reference Model is crucial for standardizing clinical trial documentation, providing a unified interpretation of regulations and best practices to ensure consistency and facilitate regulatory audits, which is vital for FDA and EMA compliance. * **Evolution to eTMF:** The industry's transition from inefficient paper-based TMFs to electronic TMFs (eTMFs) was driven by the need for more efficient auditing, with the TMF Reference Model addressing initial inconsistencies in eTMF implementations. * **Structured Document Management:** The model defines specific sections and provides detailed information (e.g., Artifact ID, purpose, retention, language) for categorizing and managing essential documents, enabling precise location and quality control within clinical operations. * **Operational Efficiency:** By standardizing document filing and naming conventions, the TMF Reference Model significantly enhances the efficiency of clinical operations, data management, and compliance tracking

3.9K views

47.4

7:05

Veeva Systems Interview Process | Tips on How to Be Successful

Generation Veeva

/@GenerationVeeva

Jun 28, 2021

This video provides an in-depth guide to the Veeva Systems Associate Consultant interview process, as experienced and presented by Tyler Binion, a current Associate Consultant in Veeva's Consultant Development Program (CDP). The primary purpose of the video is to equip prospective and current candidates with a clear understanding of what to expect during the five-step interview journey and to offer actionable tips for success. The speaker systematically breaks down each stage, sharing her personal preparation strategies, what she found effective, and common pitfalls to avoid, all aimed at helping candidates navigate the process confidently. The interview process is structured into five distinct phases, beginning with the University Recruiter step, followed by the Candidate Exercise, the Hiring Manager interview, a session for Role Specific Questions, and culminating in the Veeva Leadership interview. A recurring theme emphasized throughout the video is the critical importance of thorough research—not just into Veeva as a company and its clients, but also into the specific role, the interviewer, and, most importantly, understanding one's personal "why" for pursuing the position. This foundational understanding is presented as crucial for articulating genuine interest and aligning personal goals with Veeva's mission. A significant portion of the advice focuses on the Candidate Exercise, which is highlighted as potentially the most intimidating part due to its technical nature. This stage requires candidates to demonstrate problem-solving abilities and a rapid learning curve, often involving business cases where they must propose and configure a solution using specific software. The speaker details a structured approach to preparing for this exercise, including allotting dedicated time for studying the software, building the solution, and practicing the presentation, especially given the customer-facing nature of the consultant role. The video underscores that success hinges on strategic planning, diligent preparation, and effective communication of solutions. Key Takeaways: * **Understand Your "Why":** Before and throughout the interview process, candidates must clearly articulate their motivations for applying to Veeva and how the Associate Consultant role aligns with their personal and career goals. This "why" should be consistently communicated to recruiters, hiring managers, and leadership. * **Thorough Company and Client Research:** Dedicate significant time to researching Veeva Systems, its client base, and how the company delivers value. This knowledge is essential for demonstrating genuine interest and understanding the context of the role. * **Strategic Preparation for the Candidate Exercise:** This technical assessment requires candidates to solve a business problem and configure a solution using software. It's crucial to research business cases, understand problem-solving methodologies, and frame the task as providing a solution. * **Structured Planning for Technical Tasks:** For the Candidate Exercise, create a detailed plan that allocates specific time for learning the software, building/configuring the solution, and practicing the presentation. Avoid last-minute preparation. * **Develop Strong Presentation Skills:** Given that the Associate Consultant role is customer-facing, practicing the demonstration and presentation of solutions is vital. The goal is to explain complex technical solutions clearly to an audience that may lack technical understanding. * **Research Your Interviewers:** Before meeting with a hiring manager or other team members, research their background, team, and role. This helps in stimulating small talk, finding common ground, and asking more informed, relevant questions. * **Ask Role-Specific Questions:** In later stages, especially during the session for role-specific questions, inquire about work-life balance, typical challenges, and how successful consultants overcome obstacles. This demonstrates foresight and a desire to understand the day-to-day realities of the job. * **Engage with Leadership Thoughtfully:** During the Veeva Leadership interview, focus on asking questions that reveal more about Veeva's broader vision, company culture, and the qualities leadership values in successful employees. This shows a deeper interest beyond the immediate role. * **Demonstrate Learning Agility:** The Candidate Exercise specifically tests the ability to learn new software and apply it quickly to solve problems, highlighting the importance of a fast learning curve in a consulting role. * **Confidence Through Preparation:** The speaker repeatedly advises believing in oneself, which stems from thorough preparation. Confidence in one's efforts and abilities is a key factor in navigating the challenging interview stages successfully. **Key Concepts:** * **Consultant Development Program (CDP):** A new graduate development program at Veeva Systems designed to train Associate Consultants. * **Candidate Exercise:** A critical interview stage that assesses technical skills, problem-solving ability, and quick learning through a business case scenario involving software configuration and presentation. * **Business Cases:** Real-world scenarios presented to candidates to evaluate their analytical, problem-solving, and solution-designing capabilities. * **"Your Why":** The personal motivation and rationale behind pursuing a specific role or company, which candidates are encouraged to articulate clearly and consistently.

34.4K views

43.5

8:57

Robert Lustig's "Hacking of the American Mind" Summarized

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Jun 27, 2021

This video provides an in-depth summary of Dr. Robert Lustig's book, "The Hacking of the American Mind," presented by Dr. Eric Bricker of AHealthcareZ. The core premise is that corporate entities strategically exploit human brain chemistry, specifically the reward pathways involving dopamine, to increase profits at the expense of public health. Dr. Lustig, a pediatric neuroendocrinologist, argues that this intentional manipulation contributes significantly to the burden of chronic diseases and the escalating costs within the U.S. healthcare system. The presentation delves into the fundamental differences between two key neurotransmitters: dopamine and serotonin. Dopamine is characterized as the "pleasure" or "euphoria" chemical, associated with rewards. Its release provides a brief mood elevation, but this is quickly followed by a drop to a mood level lower than the original baseline, leading to a craving for more dopamine and the development of tolerance. In contrast, serotonin is presented as the "contentment," "peace," or "calm" chemical, fostering a stable and steady mood. The video highlights that dopamine-stimulating substances and behaviors include sugar, caffeine, alcohol, nicotine, illicit drugs, prescription narcotics, social media usage, gambling, and sex, while serotonin is stimulated by tryptophan (an amino acid in protein), positive relationships, service to others, prayer, and meditation. A central theme is how various industries—including the food and beverage, alcohol, tobacco, illicit drug, pharmaceutical, social media, gambling, and sex industries—have engineered their products and services to trigger dopamine release, creating addictive feedback loops. Specific examples include the increased use of high fructose corn syrup in processed foods since the 1970s and Facebook's admitted design to stimulate dopamine through "likes" to encourage continued app usage. The video also introduces cortisol, the stress hormone, explaining how elevated stress levels lower baseline mood, intensifying the craving for dopamine and further inhibiting serotonin, thus creating a vicious cycle that undermines overall well-being. The profound consequences of this "hacking" are then detailed, linking constant dopamine stimulation to a rise in obesity, metabolic syndrome, cancer, cardiovascular disease, diabetes, decreased cognitive ability, memory impairment, addiction, and depression. Dr. Lustig estimates that a staggering 75% of the $4 trillion spent annually on the U.S. healthcare system is attributable to diseases stemming from these "hacked minds." The video concludes by positing that corporate practices, driven by profit motives, represent a significant and often unrecognized public health threat, urging a deeper understanding of these biological and commercial dynamics within the healthcare finance community. Key Takeaways: * **Dopamine vs. Serotonin:** Dopamine provides short-lived pleasure and euphoria, leading to cravings and tolerance, while serotonin fosters sustained contentment and peace. Understanding this biochemical distinction is crucial for comprehending human behavior and well-being. * **Corporate Exploitation of Brain Chemistry:** Various industries intentionally design products and services to stimulate dopamine pathways, creating addictive cycles that drive consumption and profit. This includes the food, beverage, pharmaceutical, social media, and gambling sectors. * **Pharmaceutical Industry's Role:** The video specifically identifies "big pharma prescription narcotics" as a category of substances that stimulate dopamine, highlighting the pharmaceutical industry's direct involvement in practices that can contribute to addictive behaviors. * **Examples of Dopamine Stimulation:** Specific examples include sugar and high fructose corn syrup in processed foods, and social media platforms like Facebook using "likes" to trigger dopamine release and encourage user engagement. * **Health Deterioration:** Chronic overstimulation of dopamine pathways is directly linked to a wide range of severe health issues, including obesity, metabolic syndrome, increased risk of cancer, cardiovascular disease, diabetes, and neurological impairments like decreased cognitive ability and memory loss. * **Mental Health Impact:** The "dopamine-seeking" cycle also significantly contributes to addiction and depression, as the pursuit of pleasure can biochemically inhibit the brain's capacity for peace and calm. * **Role of Cortisol:** Stress and sleep deprivation elevate cortisol levels, which lower overall mood, intensifying the craving for dopamine-stimulating activities and further exacerbating the negative cycle by inhibiting serotonin. * **Massive Healthcare Cost Burden:** Dr. Lustig estimates that 75% of the $4 trillion U.S. healthcare budget is spent on treating diseases that are direct consequences of this corporate "hacking" of the American mind, underscoring the immense economic impact. * **Public Health Threat:** The video frames profit-driven corporate practices as a major, yet often overlooked, public health enemy, suggesting a need for greater awareness and potentially systemic changes to address these issues. * **Serotonin-Boosting Activities:** To counteract dopamine overstimulation, the video briefly mentions activities that promote serotonin, such as consuming tryptophan-rich protein, fostering positive relationships, engaging in service to others, and practicing prayer or meditation. Tools/Resources Mentioned: * **Book:** "The Hacking of the American Mind" by Dr. Robert Lustig * **Article/Interview:** CNBC interview with Chamath Palihapitiya (early Facebook employee) where he admitted to Facebook's intentional design to stimulate dopamine. Key Concepts: * **Dopamine:** A neurotransmitter associated with pleasure, reward, and euphoria, but also leading to cravings and tolerance. * **Serotonin:** A neurotransmitter associated with contentment, peace, and calm, promoting stable mood. * **Cortisol:** The primary stress hormone, which can lower mood and exacerbate dopamine-seeking behaviors. * **Metabolic Syndrome:** A cluster of conditions — increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels — that occur together, increasing your risk of heart disease, stroke and type 2 diabetes. * **Dopaminergic Pathways:** Neural pathways in the brain that are activated by dopamine, often associated with reward and addiction.

4.6K views

41.2

13:47

'America's Bitter Pill' by Steven Brill... Contemporary History of Healthcare in America

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Jun 20, 2021

This video provides an in-depth exploration of the book "America's Bitter Pill" by Steven Brill, offering a contemporary history of healthcare in America with a specific focus on the creation and implications of the Affordable Care Act (ACA), or Obamacare. Dr. Eric Bricker, the speaker, positions the book as essential reading for anyone in healthcare finance, highlighting Brill's extensive access to key political figures, industry leaders, and administration officials during the ACA's development. The presentation delves into the complex political and economic forces that shaped the legislation, revealing insights that challenge common perceptions about healthcare reform and its outcomes. The core themes explored include the pervasive influence of corporate lobbyists on both Democratic and Republican politicians, the often-unseen power players behind major policy decisions, and the internal ideological schisms within the Obama administration regarding healthcare reform. Dr. Bricker emphasizes Brill's findings that the "coverage team" ultimately triumphed over the "cost reduction team," leading to an ACA designed more for expanding access to the existing high-cost system rather than fundamentally lowering costs. The video also highlights the surprising lack of cooperation and trust between the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), despite CMS being a division of HHS, which has significant implications for future federal reform efforts. A central argument presented is that federal action to significantly lower healthcare costs is highly improbable because high healthcare costs directly translate into jobs, which politicians are unwilling to jeopardize. This perspective frames the American healthcare system as, in essence, a massive jobs program. Dr. Bricker concludes by discussing Brill's proposed solutions, which include hospitals selling their own insurance to eliminate the current health insurance industry middlemen, and implementing price controls for the pharmaceutical and medical device industries, drawing parallels to the "perverse incentives" of the fee-for-service model. Key Takeaways: * **Pervasive Corporate Lobbying:** Contrary to popular belief, corporate lobbyists exert significant influence over both Democratic and Republican politicians in Washington D.C., particularly evident during the crafting of Obamacare where medical device companies like Medtronic and Zimmer Biomet influenced policy decisions to avoid certain taxes. This underscores the deep entanglement of industry interests with legislative processes. * **Hidden Power Brokers in Policy:** The individuals publicly perceived as driving major healthcare reform (e.g., Kathleen Sebelius, head of HHS) were often not the true power players. Key decisions were frequently made by less-known figures within the administration and Senate, such as Nancy-Ann DeParle, Gene Lambrew, and Liz Fowler, indicating that public narratives may not reflect the actual dynamics of policymaking. * **Internal Administrative Divisions:** The Obama administration itself was deeply divided between a "cost team" (including Peter Orszag, Larry Summers, Ezekiel Emanuel, Bob Kocher) focused on reducing healthcare costs and a "coverage team" (Nancy-Ann DeParle, Gene Lambrew, Liz Fowler) prioritizing expanded access. The coverage team ultimately prevailed, leading to an ACA that expanded access without fundamentally addressing the underlying cost structure. * **ACA's Intentional Design for Coverage, Not Cost Control:** The legislation, according to Brill, was not a failure in controlling costs due to poor implementation, but rather was designed through a series of political deals with pharmaceutical, medical device, and health insurance industries that inherently prevented significant cost reduction. This suggests that the rising healthcare costs post-ACA were an anticipated outcome. * **Healthcare as a "Jobs Program":** A critical insight is that federal efforts to lower healthcare costs are highly unlikely because high costs equate to income for a substantial portion of the U.S. economy (20%), thereby creating jobs. Politicians are disincentivized to support measures that would reduce jobs and potentially lead to their removal from office, aligning political self-interest with maintaining high healthcare spending. * **Inter-Agency Distrust and Dysfunction:** There is significant distrust and lack of cooperation between the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), even though CMS is a department within HHS. This internal friction, exemplified by CMS withholding information about the botched ACA website from HHS, poses a major impediment to any future federal healthcare reform efforts. * **Ineffectiveness of Certain Cost-Control Mechanisms:** Initiatives like Accountable Care Organizations (ACOs), often touted as cost-control measures, were never truly intended to lower costs within the ACA framework. They were designed to "sound good" and "look like" they were controlling costs, but were undermined by the political deals made to expand coverage. * **Brill's Proposed Solutions:** Steven Brill suggests two radical solutions: A) Hospitals should sell their own insurance, effectively eliminating the health insurance industry as a middleman, and B) Price controls should be imposed on the pharmaceutical and medical device industries, especially given the monopoly power granted by patent protections. * **Perverse Incentives of Fee-for-Service:** The video implicitly and explicitly critiques the fee-for-service model and the role of various "middlemen" (like the health insurance industry) for creating perverse incentives that drive up costs without necessarily improving care. * **High Recommendation for Industry Professionals:** Dr. Bricker strongly recommends "America's Bitter Pill" for anyone working in healthcare finance, emphasizing its ability to provide a foundational understanding of the complex forces at play in the American healthcare system. Tools/Resources Mentioned: * **Book:** "America's Bitter Pill" by Steven Brill * **Book:** "16 Lessons in the Business of Healing" by Dr. Eric Bricker * **Website:** AHealthcareZ.com Key Concepts: * **Obamacare (ACA):** The Affordable Care Act, a comprehensive healthcare reform law enacted in the United States in 2010. * **Fee-for-Service:** A payment model where services are unbundled and paid for separately. This gives providers an incentive to provide more treatments because payment is dependent on the quantity of care, not the quality. * **Lobbying:** The act of attempting to influence decisions made by officials in a government, most often legislators or members of regulatory agencies. * **Medical Device Tax:** A tax on the sale of medical devices, which was part of the ACA but faced significant industry opposition. * **Accountable Care Organizations (ACOs):** Groups of doctors, hospitals, and other healthcare providers who come together voluntarily to give coordinated high-quality care to their Medicare patients. The goal is to ensure that patients, especially the chronically ill, get the right care at the right time, while avoiding unnecessary duplication of services and preventing medical errors. * **Price Controls:** Government-mandated maximum or minimum prices that can be charged for specific goods or services, discussed in the context of pharmaceutical and medical device industries. Examples/Case Studies: * **Corporate Influence:** Medtronic (Minnesota-based medical device company) and Zimmer Biomet (Indiana-based medical device company) were cited as examples of companies that successfully lobbied against the medical device tax through their respective Democratic senators and congressmen. * **Healthcare Institutions:** Cleveland Clinic, Columbia Presbyterian, New York Presbyterian Hospital, Geisinger, UPMC were mentioned as examples of hospitals whose presidents were interviewed by Steven Brill. * **Insurance Industry:** The CEO of United Healthcare was interviewed by Steven Brill, and the company was later cited as potentially executing Brill's strategy by acquiring doctors and facilities. * **Key Figures in Obama Administration/Senate:** * **Nancy-Ann DeParle, Gene Lambrew, Liz Fowler:** Identified as the true power players in crafting Obamacare. * **Peter Orszag, Larry Summers, Ezekiel Emanuel, Bob Kocher:** Members of the "cost team" within the Obama administration who ultimately lost the internal debate over cost control. * **Senator Max Baucus:** Spearheaded health reform in the Senate. * **Kathleen Sebelius:** Head of HHS, but had limited influence on Obamacare's creation.

3.3K views

43.2

24:01

Implementing an eISF

MANA Risk Based Monitoring

/@Manarbm

Jun 10, 2021

This video explores the critical role and advantages of implementing an Electronic Investigator Site File (eISF) in modern clinical trials. Featuring Clinical Trials Expert Everett Lambeth, the discussion highlights how a cloud-based eISF system replaces cumbersome manual binders, offering a centralized electronic repository for all study documentation, including regulatory, subject source, and reference documents. The conversation emphasizes the eISF's utility in facilitating remote and decentralized trials, particularly in the context of increased flexibility necessitated by events like the COVID-19 pandemic. Key benefits such as significant time savings, enhanced remote real-time oversight for monitors, streamlined archiving, and improved inspection readiness are thoroughly discussed. The video also delves into essential eISF features, including integration with Learning Management Systems (LMS), customizable metadata for efficient document search and reporting, and robust mechanisms for protecting Protected Health Information (PHI) through role-based access and secure archiving. A significant portion is dedicated to the importance of 21 CFR Part 11 compliance, specifically regarding certified electronic copies and electronic signatures, which ensure document integrity and provide crucial audit trails. Ultimately, the eISF is presented as an indispensable tool for risk-based quality management, enabling proactive tracking of missing documents and real-time review of subject source data to enhance study quality and compliance. Key Takeaways: * **eISF as a Cornerstone for Modern Clinical Operations:** The eISF is presented as an essential, cloud-based solution that centralizes all clinical trial documentation, significantly improving efficiency and adaptability for traditional, virtual, and decentralized trials. * **Critical Regulatory Compliance (21 CFR Part 11):** Adherence to 21 CFR Part 11 is paramount, particularly through the implementation of certified electronic copies for paper-based documents and electronic signatures, which establish document authenticity and provide vital audit trails. * **Enhanced Operational Efficiency and Quality:** eISF systems drive operational improvements by saving time in document management, enabling remote real-time oversight, facilitating proactive identification of missing documents, and supporting continuous inspection readiness. * **Integrated Data and Document Management:** The value of eISF is maximized through integration with Learning Management Systems (LMS) and the effective use of customizable metadata, allowing for comprehensive tracking, reporting, and quick access to critical information. * **Robust PHI Protection:** Secure management of Protected Health Information (PHI) within the eISF is achieved through role-based access controls, dedicated secure folders, and optional de-identification/redaction processes, ensuring patient privacy and compliance. * **Facilitating Risk-Based Quality Management:** The eISF empowers risk-based quality management by providing real-time access to documents, enabling continuous monitoring, and allowing for immediate review of subject source documents, thereby enhancing overall study quality and data integrity.

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