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Why I Decided to SKIP Medical School | Watch this If you are on the Fence About Medical School
kyyah abdul
/@kyyahabdul
Aug 19, 2022
This video details the speaker's deliberate decision to forgo a career in medicine, opting instead for a path in public health and clinical research regulatory affairs. The core of the video revolves around a re-evaluation of career impact and personal fulfillment, moving away from the traditional individual patient care model of a physician towards a broader, population-level influence within the life sciences industry. The speaker articulates a shift in perspective, realizing that a greater impact could be achieved by shaping the development and regulation of medicines rather than directly treating patients. The speaker elaborates on the chosen alternative, highlighting the role of clinical research regulatory affairs. In this capacity, they explain the opportunity to work directly on the medicines that doctors prescribe, influencing how research is conducted and how patients are engaged in clinical studies. This career choice is presented as a means to contribute significantly to public health by impacting a larger population through systemic contributions to drug development and regulatory oversight. This contrasts sharply with the per-patient impact typically associated with medical practice, offering a different avenue for making a meaningful difference in healthcare. Furthermore, the video touches upon the personal and cultural pressures that often steer individuals towards specific professions like medicine. The speaker recounts the common expectation among West African children to pursue careers as lawyers, doctors, or engineers, driven by parental aspirations for financial stability and success in America. However, this traditional view was challenged by a pragmatic assessment of financial realities. By comparing the average earnings in regulatory affairs with those of doctors, the speaker found a compelling financial argument that ultimately solidified the decision to abandon the medical school dream, demonstrating a practical approach to career planning that balances passion, impact, and economic considerations. Key Takeaways: * **Population-Level Impact vs. Per-Patient Care:** The speaker's primary motivation for skipping medical school was the realization that a greater impact on patients' lives could be achieved at a population level through public health and regulatory work, rather than through individual patient interactions. This highlights a strategic career choice focused on systemic change. * **Clinical Research Regulatory Affairs as an Impactful Career:** The video positions clinical research regulatory affairs as a vital and impactful field within the life sciences. Professionals in this area contribute to the development of medicines, influence research methodologies, and shape patient engagement in clinical studies, directly affecting public health outcomes. * **Direct Influence on Medicine Development:** Working in regulatory affairs provides a unique opportunity to "work on the medicines that doctors prescribe," offering a direct hand in the pharmaceutical pipeline and ensuring the safety and efficacy of treatments reaching patients. * **Shaping Research Conduct:** A role in regulatory affairs allows individuals to "have a say in how research is done," implying involvement in ethical considerations, study design, and compliance, which are crucial for robust and reliable clinical trials. * **Patient Engagement in Research:** The speaker emphasizes the ability to influence "how we engage with patients to engage in clinical research," underscoring the importance of patient-centric approaches in clinical development and the ethical considerations involved. * **Challenging Traditional Career Expectations:** The video addresses the cultural and familial pressures, particularly among immigrant communities, to pursue specific high-earning professions like medicine. It encourages individuals to critically evaluate these expectations against personal aspirations and alternative career paths. * **Strategic Career Self-Reflection:** The speaker's act of sitting down and asking "why do I want to be a doctor?" after completing a Master's in Public Health exemplifies the importance of deep self-reflection in career planning, ensuring alignment between personal values and professional goals. * **Financial Realism in Career Choices:** A practical comparison of average earnings in different fields (regulatory affairs vs. medicine) played a significant role in the speaker's final decision, demonstrating that financial considerations can be a valid and influential factor in career path selection. * **Value of Public Health Background in Life Sciences:** The speaker's Master's in Public Health provided a foundational understanding that led to the realization of population-level impact, highlighting the relevance and utility of public health education for careers in the pharmaceutical and biotech sectors. * **Diverse Paths to Impact in Healthcare:** The video implicitly suggests that there are multiple, equally valuable ways to contribute to healthcare and patient well-being beyond direct medical practice, particularly within the vast ecosystem of the life sciences industry.
A Complete Submission Publishing Solution for Life Sciences 2022 Demo
Phlexglobal - a Cencora PharmaLex company
/@Phlexglobal
Aug 17, 2022
This video explores PhlexSubmission, a comprehensive solution for electronic regulatory submissions (eCTD, NeeS, VNeeS) in the life sciences. The speaker demonstrates how the platform streamlines the entire submission lifecycle, from document management and compilation to publishing and validation. Key themes include automation for efficiency, ensuring regulatory compliance, global reach, and user guidance. Throughout the video, the presenter highlights features such as automated eCTD tree creation, intelligent document auto-compilation based on metadata, an integrated 21 CFR Part 11 compliant document management system (Flex DMS), and built-in compliance checks for hyperlinks and PDF properties, often with automatic resolution. The system supports incremental test publishing with integrated FDA eCTD validation (Lorenz validator) and productive publishing, ensuring regulatory adherence. PhlexSubmission also offers capabilities for managing document versions, reusing submissions across different regions, and is delivered as a private SaaS solution, emphasizing global accessibility and unlimited publishing. The "Vera" virtual assistant guides users through complex processes, enhancing user experience and efficiency. Key Takeaways: * **End-to-End Regulatory Submission Management:** PhlexSubmission provides a complete solution covering document management (21 CFR Part 11 compliant), eCTD compilation, publishing, and validation, which is crucial for pharmaceutical and life sciences companies navigating complex regulatory landscapes. * **Automation for Efficiency and Compliance:** The platform leverages automation for eCTD tree creation, metadata-driven document auto-compilation, and automatic detection/replacement of document versions, significantly reducing manual effort and potential errors in regulatory submissions. * **Global Scalability and Reusability:** The system supports managing submissions for multiple health authorities worldwide and allows for easy copying and adaptation of submissions across different regions, enhancing global regulatory strategy and operational efficiency for multi-national life sciences clients. * **User-Centric Design with AI-Assistance:** Features like the personalized user dashboard and "Vera," a virtual electronic regulatory assistant, guide users through complex tasks, making the submission process more accessible and reducing the learning curve, demonstrating a practical application of intelligent assistance in a regulated environment. * **SaaS Model for Accessibility and Flexibility:** Delivered as a private SaaS solution, PhlexSubmission offers web-browser accessibility from anywhere, unlimited test and productive publishing, and readiness for eCTD version 4, providing a flexible and future-proof solution that resonates with modern software development practices.
Orthopedic Surgery--Major Changes in Hospital Care and Payment
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Aug 13, 2022
This video provides an in-depth exploration of the dramatic and rapid shift in orthopedic surgery, specifically total knee and hip replacements, from traditional hospital inpatient settings to outpatient hospital departments and Ambulatory Surgery Centers (ASCs). Dr. Eric Bricker, from AHealthcareZ, meticulously details how this seismic change, occurring largely between 2017 and today, was primarily driven by changes in payment policy from the Centers for Medicare & Medicaid Services (CMS) and significantly accelerated by the COVID-19 pandemic. He emphasizes that clinical site-of-service decisions were dictated by payment rules rather than solely patient need, leading to profound financial implications across the healthcare ecosystem. The presentation begins by illustrating the historical context, where 100% of total knee replacements in 2017 were performed in an inpatient setting. Following CMS's removal of total knee replacements from its "Inpatient Only List" in 2018 (and total hip replacements in 2019), and the subsequent disruption caused by COVID-19, inpatient volumes plummeted. Today, only 25% of total knee replacements and 37% of total hip replacements occur in inpatient settings, with the vast majority now performed in hospital outpatient departments (39% knee, 40% hip) and ASCs (33% knee, 21% hip). This shift means patients often go home the same day, challenging the previous assumption that an overnight stay was clinically necessary for such procedures. Dr. Bricker then delves into the significant financial ramifications for various stakeholders. Employers benefit from lower facility fees at ASCs, which can be as much as $60,000 less per surgery compared to hospitals. Conversely, hospitals face substantial revenue losses as lucrative commercially insured patients, who represent the highest reimbursement rates, increasingly choose ASCs. This shift severely impacts hospitals' "payer mix," leaving them with a higher proportion of lower-reimbursing traditional Medicare patients for these procedures. The video highlights Tenet Healthcare's strategic pivot from a hospital-centric company to the largest operator of ASCs, with ASC revenue growing from 5% to 42% of its total revenue between 2015 and 2021, as a prime example of industry adaptation to this change. Finally, the analysis touches upon the stark difference in joint replacement rates between traditional Medicare and Medicare Advantage, attributing the significantly lower rates in Medicare Advantage to prior authorization requirements. Key Takeaways: * **Dramatic Site-of-Service Shift:** Total knee and hip replacements have rapidly moved from 100% inpatient in 2017 to a combined majority in outpatient hospital settings and Ambulatory Surgery Centers (ASCs) today. Inpatient volumes are now only 25% for knees and 37% for hips. * **Payment Drives Clinical Decisions:** The primary catalyst for this shift was CMS removing total knee (2018) and total hip (2019) replacements from its "Inpatient Only List," allowing Medicare to pay for these procedures in outpatient settings. This demonstrates how payment policy, not just clinical necessity, dictates care delivery models. * **COVID-19 as an Accelerator:** The pandemic further propelled this transition, as hospitals faced staffing shortages and infection concerns, leading orthopedic surgeons to move elective procedures to ASCs where scheduling was more reliable and risks of cancellation were lower. * **Significant Cost Savings for Employers:** ASCs offer substantially lower facility fees (often less than $15,000) compared to hospitals ($30,000-$75,000+), resulting in significant cost reductions for employer-sponsored health plans. * **Revenue Loss for Hospitals:** Hospitals are experiencing a substantial decline in revenue from these procedures, particularly losing the highly profitable commercially insured patient volume, which negatively impacts their overall "payer mix." * **Rise of Ambulatory Surgery Centers:** ASCs, both independent and hospital-owned, have seen massive growth. Tenet Healthcare's strategic shift to become a dominant ASC provider (310 centers, 42% of revenue from ASCs in 2021, up from 5% in 2015) exemplifies this industry trend. * **Payer Mix Deterioration for Hospitals:** Commercial insurance patients, who offer higher reimbursement, are disproportionately choosing ASCs (64-69% of ASC volume), leaving hospitals with a higher percentage of lower-reimbursing traditional Medicare patients (51-65% of hospital outpatient/inpatient volume). * **Impact of Medicare Advantage Prior Authorization:** Despite 45% of Medicare beneficiaries being enrolled in Medicare Advantage (MA) plans, MA patients undergo significantly fewer total knee and hip replacements compared to those with traditional Medicare, largely due to stringent prior authorization requirements. * **Implications for Medical Device Manufacturers:** Companies producing orthopedic implants and related devices must adapt their commercial strategies, sales force targeting, and market access approaches to effectively engage with and serve the growing ASC market. * **Future of Healthcare Change:** The impending removal of the "Inpatient Only List" for all surgical procedures by 2024 signals that similar shifts will occur across other surgical specialties, further accelerating the move to outpatient and ASC settings. * **Rapid Change is Possible:** The orthopedic surgery example demonstrates that while healthcare change is often perceived as slow, significant and rapid transformations can occur when changes in payment policy align with external catalysts like a pandemic. Tools/Resources Mentioned: * The Gist Newsletter * Stratasan (healthcare analytics firm) * Chartis (insights) * Healthcare Dive (news) Key Concepts: * **Inpatient Only List:** A list maintained by CMS specifying procedures that Medicare would only reimburse if performed in an inpatient hospital setting. * **Ambulatory Surgery Center (ASC):** A distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. * **Payer Mix:** The proportion of patients covered by different types of insurance (e.g., commercial, Medicare, Medicaid), which significantly impacts a healthcare provider's revenue. * **Prior Authorization:** A requirement from an insurance company that a healthcare provider obtain approval before providing a service or prescribing a medication to be covered by the plan. Examples/Case Studies: * **Tenet Healthcare's Strategic Shift:** One of the largest for-profit hospital systems, Tenet, has strategically pivoted to become the preeminent provider of ambulatory surgery center services for musculoskeletal care, with ASCs accounting for 42% of its revenue in 2021, up from 5% in 2015.
Is this Stock Better Than Salesforces Inc? | Veeva Systems Inc (NYSE:VEEV)
Learn With Stanley
/@learnwithstanley
Aug 11, 2022
This video provides an investment analysis of Veeva Systems Inc., detailing its origins, core offerings, market dominance, and growth trajectory within the life sciences industry. The speaker explains how Veeva was founded to address the specific cloud-based CRM needs of life sciences companies, which were not adequately met by general platforms like Salesforce. The discussion highlights Veeva's two main ecosystems: the Commercial Cloud, providing CRM and analytical services, and Veeva Vault, a suite of applications for managing clinical trials, industrial regulations, and other critical data points. The video underscores Veeva's position as the de facto cloud service provider for the global life sciences sector, enabling drug companies to develop products, enhance sales and marketing, and ensure regulatory compliance. It also covers Veeva's impressive customer growth, high revenue retention rates, and future revenue projections, attributing its success to a first-mover advantage and the continuous demand for specialized solutions in a highly competitive market. Key Takeaways: * **Specialized Industry Focus:** Veeva Systems' success stems from its targeted approach to the life sciences industry, demonstrating the critical need for specialized cloud-based CRM and data management solutions beyond generic enterprise platforms. * **Comprehensive Platform for Life Sciences:** Veeva offers two key ecosystems: the Commercial Cloud for CRM and analytics, and Veeva Vault for managing clinical trials, regulatory compliance, and other crucial data, covering a broad spectrum of pharmaceutical operations. * **Market Dominance and Entrenchment:** Veeva is identified as the "de facto cloud service provider" for the global life sciences industry, indicating a strong first-mover advantage and significant market share in a highly regulated and specialized sector. * **Addressing Core Industry Needs:** Veeva's solutions directly support drug companies in three vital areas: effective product development and market entry, efficient marketing and sales to healthcare professionals, and maintaining strict compliance with industry and government regulations. * **High Customer Retention and Growth Drivers:** The company's impressive customer growth (over 1,000 customers including major pharma giants) and high revenue retention rates (around 120%) reflect the ongoing demand for its services, driven by intense competition and regulatory requirements within life sciences.
Veeva: Company Details, Growth, & Culture
VentureFizz
/@Venturefizz
Aug 9, 2022
This video explores Veeva Systems' role as the "operating system for Life Sciences," detailing its company structure, growth, and culture through an interview with Steve Harper, SVP Product Management. Veeva, founded in 2007 and serving 47 of the top 50 pharmaceutical companies, offers a combination of software, implementation services, and data services. The discussion highlights Veeva's dual focus on the commercial side of pharma and extensive work in research and development, including drug development, quality processes, clinical trials, and regulatory compliance. A key cultural aspect is their "two in the box" model, pairing technology experts with industry experts to build highly specific and effective products. The video also delves into Veeva's "Digital Trials Platform," aiming to make clinical trials 25% faster and cheaper by 2025 through digitization, and showcases Boehringer Ingelheim as a customer leveraging Veeva's integrated platform across their development process for significant savings and reduced complexity. Veeva's substantial growth, flexible work environment, and recent transition to a Public Benefit Corporation (PBC) status, emphasizing mission-driven work beyond profit, are also discussed as factors attracting talent and customers. Key Takeaways: * **Veeva as the Life Sciences Operating System:** Veeva positions itself as the foundational software platform for the life sciences industry, serving nearly all major pharmaceutical companies with a comprehensive suite of software, services, and data solutions across both commercial and R&D operations. * **Strategic "Two in the Box" Model:** Veeva's core product development and cultural strategy involves pairing technology experts with industry experts. * **Focus on Clinical Trial Digitization:** A major initiative is the "Digital Trials Platform," designed to significantly enhance the efficiency and cost-effectiveness of clinical trials by removing paper-based processes and improving data flow between all participants, aiming for a 25% improvement in speed and cost by 2025. * **Integrated Platform Adoption:** Customers like Boehringer Ingelheim are adopting an "all-in" strategy with Veeva, using its integrated products across their entire development process (clinical, regulatory, quality). This demonstrates the value of a unified platform for reducing complexity and automating data flowai to assist clients with integration and optimization. * **Stability and Mission-Driven Growth:** Veeva exhibits strong growth and stability within the life sciences sector, contrasting with broader tech industry slowdowns. Its conversion to a Public Benefit Corporation (PBC) underscores a commitment to employees, customers, and the community, aligning with a growing industry demand for ethical and impactful technology solutions.
Hospitals Measure Doctors By How Much Revenue They Generate
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 31, 2022
This video provides an in-depth exploration of how hospitals financially evaluate physicians, focusing on the revenue doctors generate rather than patient outcomes. Dr. Eric Bricker, from AHealthcareZ, begins by presenting data from a 2016 Merritt Hawkins survey of hospital CFOs, revealing that the average physician drives $1.56 million in hospital revenue annually through tests, procedures, and orders. This establishes a core theme: hospitals, operating within a fee-for-service system, are highly attuned to physicians as revenue drivers, a metric that often overshadows quality-of-care indicators. The presentation delves into the specifics of revenue generation across different medical specialties. Orthopedic surgeons were found to be the highest revenue generators, bringing in $2.75 million per year, followed by interventional cardiologists ($2.45 million) and general surgeons ($2.17 million). Even family practice doctors, who primarily operate in outpatient settings, contribute significantly, generating $1.5 million annually, largely through ordering outpatient labs and imaging that flow to the hospital system. Dr. Bricker highlights how hospitals strategically employ primary care physicians to capture this revenue, demonstrating a calculated business approach where physician salaries are an investment to secure a larger revenue stream. Further analysis in the video compares physician salaries to the revenue they generate, framing it as a "commission" or return on investment (ROI). For instance, orthopedic surgeons, paid an average starting salary of $500,000, yield a net revenue of $2.25 million for the hospital, representing an 18% "commission." Family practice doctors, with a $198,000 starting salary, net $1.3 million, equating to a 13% "commission" but a higher ROI of 7.5x compared to 5.5x for orthopedists. This favorable ROI explains why family practice and internal medicine physicians have consistently been the most sought-after recruits for hospitals. Dr. Bricker critically observes that hospital CEOs and CFOs are acutely aware of these revenue metrics, often recalling them offhand, while rarely discussing patient quality metrics like infection rates or readmission rates, underscoring a systemic prioritization of financial gain over patient well-being. However, the video concludes with a hopeful counter-narrative, showcasing examples of hospitals that are actively shifting their focus from revenue to patient-centric quality metrics. University Hospitals in Cleveland, under the leadership of Dr. Peter Pronovost (Chief Clinical Transformation Officer), is presented as a prime example. This institution won a major award for quality transformation from the American Hospital Association, demonstrating an 80% reduction in central line-associated bloodstream infections and a 33% decrease in Medicare costs through quality initiatives. This case study illustrates that by measuring and managing patient-centric values, hospitals can dramatically improve quality and even reduce costs, challenging the notion that high revenue must come at the expense of patient care. Dr. Pronovost's quote, "hospitals are filled with mismanagement," is used to emphasize that a revenue-first approach can lead to systemic inefficiencies and suboptimal patient outcomes. Key Takeaways: * **Physicians as Hospital Revenue Drivers:** Hospitals view physicians as significant revenue generators, with an average doctor bringing in $1.56 million annually through ordered tests, procedures, and referrals, highlighting the financial engine of the fee-for-service model. * **Specialty-Specific Revenue Impact:** Revenue generation varies significantly by specialty; orthopedic surgeons are the highest contributors ($2.75M/year), followed by interventional cardiologists ($2.45M/year), and general surgeons ($2.17M/year). * **Outpatient Revenue Contribution:** Even primary care physicians, predominantly working in outpatient settings, drive substantial hospital revenue ($1.5M/year) by ordering outpatient labs and imaging, which are often processed by hospital systems. * **Strategic Physician Employment:** Hospitals strategically employ primary care physicians to consolidate revenue streams. By acquiring independent practices, hospitals can capture the entirety of a physician's generated revenue rather than just a portion. * **Physician Compensation as Investment:** Physician salaries are viewed by hospitals as an investment to secure larger revenue streams, with the "commission" (salary as a percentage of revenue) varying by specialty. * **Return on Investment (ROI) for Physicians:** Family practice physicians offer a higher ROI (7.5x) for hospitals compared to orthopedic surgeons (5.5x), making them highly sought after for recruitment due to their favorable financial leverage. * **Revenue-Centric Management:** Hospital CFOs and CEOs are acutely aware of revenue-per-doctor metrics, often prioritizing these financial figures over patient quality indicators like infection rates, readmission rates, or post-operative complication rates. * **Fee-for-Service System's Intent:** The current fee-for-service healthcare system is described as a "well-oiled machine" intentionally designed to maximize healthcare spending and revenue generation, rather than focusing on cost containment or patient outcomes. * **Misplaced Prioritization:** The emphasis on revenue metrics can lead to "mismanagement" within hospitals, diverting focus away from patient well-being and quality of care. * **Hope for Quality Transformation:** There is a growing movement towards changing hospital metrics to prioritize patient quality and outcomes over revenue, demonstrating that improved quality can also lead to reduced costs. * **Case Study: University Hospitals Cleveland:** This institution successfully reduced central line-associated bloodstream infections by 80% and Medicare costs by 33% through quality initiatives, proving that patient-centric metrics can drive significant improvements in care and financial efficiency. * **Impact of Measuring Quality:** When hospitals measure patient-centric, quality-focused values, it leads to dramatic improvements in management, patient safety, and overall healthcare delivery, challenging the traditional revenue-driven model. Examples/Case Studies: * **Merritt Hawkins Survey:** A 2016 survey of hospital CFOs by physician recruiting firm Merritt Hawkins provided the core data on physician revenue generation. * **University Hospitals in Cleveland:** Featured as an example of a hospital system that successfully shifted its focus to quality, achieving an 80% reduction in central line-associated bloodstream infections and a 33% decrease in Medicare costs. * **Dr. Peter Pronovost:** Chief Clinical Transformation Officer at University Hospitals in Cleveland, recognized for his work in making hospitals safer and more patient-focused.
Top 5 Stocks to BUY NOW Part 2 (High Growth Stocks)!
YT Finance
/@ytfinance
Jul 28, 2022
This video, part of a series on top growth stocks, provides an investment analysis of Palantir Technologies, Upstart, and Veeva Systems. While Palantir and Upstart are discussed for their general AI and data analytics capabilities in government/commercial and financial lending sectors respectively, a significant portion of the video is dedicated to Veeva Systems. The speaker highlights Veeva's crucial role as a cloud-based software provider for the pharmaceutical and life sciences industries, emphasizing its use by 18 out of the top 20 pharmaceutical companies. The video positions Veeva as a "defensive" and "recession-proof" stock due to the indispensable nature of its software, which optimizes clinical data management, various operations, regulatory compliance, and customer data analytics within the life sciences sector. Key Takeaways: * **Veeva's Pervasive and Critical Role in Pharma:** The video strongly affirms Veeva Systems as an essential technology partner for the pharmaceutical industry, with its software being "imperative and critical" for daily operations and used by nearly all top pharma companies. * **Stability and Growth in Life Sciences Tech:** The characterization of Veeva as a "recession-proof" company with sustainable demand underscores the inherent stability and growth potential within the life sciences technology sector, particularly for solutions that support critical business functions.
RIM Implementation in times of IDMP - Asphalion Webinar
Asphalion
/@Asphalion.
Jul 26, 2022
This video explores the critical intersection of Regulatory Information Management (RIM) system implementation and the ongoing transition to ISO Identification of Medicinal Products (IDMP) standards. The speaker details the current uncertainties surrounding IDMP, the phased rollout of EMA's SPOR project (including PMS and the DADI web form), and the profound impact these changes have on the pharmaceutical industry. A central theme is how RIM systems serve as essential tools to navigate IDMP compliance, emphasizing the need for digitalization, robust data governance, and strategic data migration during implementation. Key Takeaways: * **IDMP as a Digitalization Catalyst:** ISO IDMP is presented not merely as a regulatory requirement but as a significant driver for comprehensive digitalization and the establishment of strong data governance frameworks within pharmaceutical companies, necessitating standardized and interoperable data. * **RIM Systems are Core for IDMP Compliance:** Regulatory Information Management (RIM) systems are highlighted as indispensable for IDMP compliance, facilitating efficient data collection, organization, and communication. Future RIM systems are expected to directly support data submission to EMA's PMS via fire messages, evolving beyond current xEVMPD processes. * **Data Quality and Governance are Foundational:** Successful IDMP compliance and RIM implementation are contingent upon high-quality, harmonized data. Companies must prioritize data cleaning, enrichment, and mapping, integrating IDMP requirements from the initial planning stages of any RIM project. * **Navigating Phased IDMP Rollout Complexity:** The EMA's phased implementation of IDMP through the DADI web form (starting with Centrally Authorized Products (CAPs), then Nationally Authorized Products (NAPs)) introduces a complex transitional period. Organizations must plan to manage the coexistence of legacy and new systems and processes effectively. * **Strategic Implementation is Crucial:** Regardless of company size or portfolio, a well-defined strategy for IDMP compliance and RIM implementation is vital. This involves a thorough assessment of existing data structures, internal processes, technological capabilities, and future expectations to select the most compatible RIM system and implementation approach.
Amazon Buys One Medical... It's In the News Everywhere!!
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 24, 2022
This video provides an in-depth analysis of Amazon's acquisition of One Medical, an advanced primary care company, for $3.9 billion. Dr. Eric Bricker, the speaker, dissects the financial performance and strategic implications of this deal, highlighting key observations about the evolving healthcare landscape. He begins by introducing One Medical as a digital health startup with 188 clinics across 17 major U.S. cities, detailing its IPO history and significant stock price decline prior to the Amazon acquisition. The core of his analysis revolves around One Medical's dual business model and the contrasting revenue generation from its "enterprise" clients (employer contracts and individual subscriptions, fee-for-service) versus its "Medicare Advantage risk" business (capitated payments, acquired through Iora Health). Dr. Bricker meticulously breaks down the revenue disparities, revealing that One Medical's Medicare Advantage segment, despite having significantly fewer members (39,000 vs. 728,000 enterprise members), generated almost equal revenue in Q1 2022 ($120 million vs. $130 million). This translates to a staggering 17 times more revenue per member annually for the capitated Medicare Advantage beneficiaries ($12,300) compared to enterprise members ($714). He points out One Medical's struggles with organic member growth (only 28% year-over-year) and consistent quarterly losses, suggesting that its growth rate for a "money-losing business" was not steep enough to satisfy Wall Street or its board. The analysis then shifts to Amazon Care, Amazon's own digital health and telemedicine service, which Dr. Bricker argues has also struggled due to an "undifferentiated offering" in a market already saturated with telemedicine incumbents. He emphasizes that Amazon's decision to acquire One Medical, a substantial $3.9 billion investment (seven times more than all AWS acquisitions combined), indicates a recognition that building a competitive healthcare solution internally was not proving successful. Dr. Bricker concludes by framing the acquisition as a "fantastic opportunity for a pivot" for Amazon. He suggests that Amazon should de-emphasize or sunset One Medical's less profitable enterprise business and focus heavily on the high-revenue, capitated Medicare Advantage risk model, emulating successful players like ChenMed and Oak Street Health. This strategic pivot, he argues, is where the "healthcare money is," particularly among older, sicker individuals who are high utilizers of healthcare services. Key Takeaways: * **Amazon's Strategic Healthcare Entry:** Amazon's acquisition of One Medical for $3.9 billion signifies a significant commitment to the healthcare sector, indicating a strategic shift and potentially a recognition of challenges with its internal Amazon Care initiative. This large investment suggests a long-term play in healthcare delivery. * **One Medical's Dual Business Model:** One Medical operates two distinct business lines: an "enterprise" model (employer/individual subscriptions, fee-for-service) serving a large member base, and a "Medicare Advantage risk" model (capitated payments) serving a smaller, but significantly more lucrative, member base through its Iora Health acquisition. * **Revenue Disparity in Primary Care:** The capitated Medicare Advantage business generates substantially more revenue per member (approximately $12,300 annually) than the enterprise fee-for-service model (approximately $714 annually), highlighting the financial attractiveness of value-based care for older, higher-utilizing populations. * **Challenges of Digital Health Utilization:** One Medical's enterprise business struggles with only 40% "activation/utilization" among employees, a common "achilles heel" for many digital health programs. This low engagement rate makes it difficult to impact the 5% of employees who drive 50% of healthcare costs. * **Importance of High-Utilizer Focus:** The video strongly advocates for monetizing advanced primary care through "high utilizers"—sicker, older individuals who are typically covered by Medicare Advantage plans. These individuals have significantly higher healthcare expenditures ($18,400+ per year for 65+ vs. $4,400 for 19-44). * **Amazon Care's Undifferentiated Offering:** Amazon Care faced market challenges due to an "undifferentiated offering" compared to existing telemedicine incumbents. This lack of a "10x better value proposition" made it difficult to unseat established providers. * **Acquisition as a Pivot Opportunity:** The One Medical acquisition presents an opportunity for Amazon to "pivot" its healthcare strategy. The speaker suggests de-emphasizing the struggling enterprise business and focusing on the more profitable Medicare Advantage risk model, leveraging One Medical's Iora Health experience. * **Benchmarking Against Successful Models:** Companies like ChenMed and Oak Street Health are cited as successful examples of advanced primary care providers that exclusively focus on capitated Medicare Advantage risk, demonstrating the viability and revenue potential of this model. Oak Street Health, for instance, serves 114,000 people with $1.4 billion in annual revenue. * **Healthcare as a Viable Niche:** Despite the complexities, healthcare is a massive industry (nearly 20% of the U.S. economy), offering significant opportunities for companies, including tech giants like Amazon, to carve out profitable and value-adding niches. * **Value-Based Care for Monetization:** The most effective way to monetize advanced primary care is through capitated payments for Medicare Advantage beneficiaries, as this model aligns incentives with managing the health of high-cost patients and allows providers to retain savings from improved outcomes. Key Concepts: * **Advanced Primary Care:** A model of primary care that often integrates digital health tools, focuses on comprehensive patient management, and may involve different payment structures beyond traditional fee-for-service. * **Digital Health:** The use of information and communication technologies to help improve human health and healthcare services. * **Capitated Payments:** A payment arrangement for healthcare service providers where a fixed amount is paid per patient per unit of time, regardless of the number or type of services provided. This shifts financial risk to the provider. * **Fee-for-Service:** A payment model where services are unbundled and paid for separately. In healthcare, it gives an incentive for physicians to provide more treatments because payment is dependent on the quantity of care, not the quality. * **Medicare Advantage (MA):** A type of private health insurance plan in the United States that provides Medicare benefits. These plans are offered by private companies approved by Medicare and often include additional benefits like vision, hearing, and dental. * **Utilization/Activation:** Refers to the rate at which members or patients engage with or use a healthcare service or program. Low utilization is a common challenge for many digital health solutions. * **Organic Growth:** The increase in revenue or membership that a company achieves through its own operations, without relying on acquisitions or mergers. Examples/Case Studies: * **One Medical:** An advanced primary care company with 188 clinics, acquired by Amazon. Its business model includes enterprise clients (fee-for-service) and Medicare Advantage risk (via Iora Health acquisition). * **Iora Health:** An advanced primary care company acquired by One Medical, specializing in taking Medicare Advantage risk through capitated payments. * **Amazon Care:** Amazon's internal digital health and telemedicine service, which struggled with market differentiation and adoption before the One Medical acquisition. * **ChenMed:** A private company cited as a successful example of a primary care provider focused on capitated Medicare Advantage risk. * **Oak Street Health:** An advanced primary care practice that exclusively focuses on capitated risk for Medicare Advantage beneficiaries, serving 114,000 people with $1.4 billion in annual revenue, demonstrating the financial viability of this model.
Veeva post Implementation.
Prana Life Sciences
/@pranalifesciences1
Jul 21, 2022
This video explores strategies for optimizing Veeva Vault post-implementation support within the life sciences industry. The speaker, a technical expert from Prana Life Sciences, discusses common challenges and presents practical solutions for improving efficiency, reducing costs, and ensuring compliance in regulated GxP environments. Key themes include the automation of user and access management, streamlining configuration support, and enhancing clinical operations processes within Veeva CTMS and eTMF. The presentation emphasizes a continuous improvement approach, leveraging technology to address manual bottlenecks and accelerate project delivery. Key Takeaways: * **Automated User & Access Management:** Significant efficiency gains can be achieved by automating Veeva user creation and deactivation. This can be done by integrating with identity management systems (e.g., SalePoint, Azure Active Directory) or using custom development (Python, Java SDKs), drastically reducing manual effort and ensuring timely access/deactivation. * **Streamlined Configuration Support:** Improving configuration support involves proactive categorization of incoming tickets to quickly identify potential change requests. Initiating change management and validation (CSV) processes earlier, along with engaging users through quick Proof-of-Concepts (POCs) during design, can reduce lead times and enhance SLA adherence. * **Enhanced Clinical Operations Efficiency:** Automation can substantially reduce the resource burden in clinical support. Specific examples include automating user provisioning and access changes for studies/sites within Veeva CTMS and eTMF, as well as automating the generation of reports for milestones and sites, leading to significant resource optimization (e.g., reducing support from 2 full-time resources to 0.5). * **Continuous Improvement in Regulated Environments:** Adopting a continuous improvement mindset, supported by regular reporting on support activities and Service Level Agreements (SLAs), is crucial for maintaining high efficiency and customer satisfaction in GxP-regulated settings, ensuring processes are consistently optimized. * **Addressing Deactivation Complexities:** While automating user deactivation can present challenges, particularly with active workflows, these can be managed by generating reports of users with active workflows, allowing for targeted reassignment of tasks before full deactivation, thus maintaining process integrity while still benefiting from automation.
An Industry Ontology for the Identification of Medicinal Products (IDMP)
Biomedical Ontology World
/@biomedicalontologyworld
Jul 18, 2022
This video introduces the Pistoia Alliance's IDMP Ontology project, which addresses the critical challenge of inconsistent interpretations of the ISO Identification of Medicinal Products (IDMP) standards within the pharmaceutical industry. Currently, IDMP standards are published as PDFs, leading to varied implementations across companies and regulatory agencies, hindering automated data processing, quality, and semantic interoperability. The project aims to augment these standards with a formal ontology, creating a semantically aligned and governed data model that acts as a "connecting bridge" for data interpretation across internal departments, suppliers, and regulators. The speaker emphasizes the importance of contextualizing complex concepts like "active moiety" to accommodate diverse scientific and regulatory perspectives, ensuring accurate representation while allowing for different expert views. The ontology is being developed collaboratively with major pharma companies and validated against real-world data from sources like FDA's GSRS, demonstrating its ability to answer specific competency questions and facilitate cross-organizational data integration for improved drug safety, innovation, and operational efficiency. Key Takeaways: * **Semantic Interoperability for Regulatory Compliance:** The IDMP Ontology directly tackles the lack of semantic alignment in pharmaceutical product data, a crucial step for achieving consistent regulatory compliance (FDA, EMA) and enabling automated data processing across the life sciences ecosystem. * **Ontologies as Foundational Data Bridges:** The project highlights the strategic value of ontologies in creating a unified "connecting bridge" for data interpretation, essential for harmonizing information flows within and between pharma companies, suppliers, and regulatory bodies. * **Contextualized Data Modeling for Complex Concepts:** The approach to modeling concepts like "active moiety" with contextual roles (e.g., regulatory, scientific, patent exclusivity) demonstrates a sophisticated method for managing inherent ambiguities and diverse expert perspectives in pharmaceutical data. This advanced data modeling is critical for developing robust custom software and AI solutions. * **Industry-Wide Collaborative Standard Setting:** The Pistoia Alliance's collaborative model, involving leading pharma companies (Bayer, Merck, GSK, Novartis, J&J) and regulatory agencies (FDA, EMA), underscores the industry's commitment to developing shared data standards that drive collective innovation, efficiency, and patient safety. * **Real-World Validation for Practical Application:** The project's emphasis on testing the ontology with actual data (e.g., FDA GSRS, pharma company data) and specific use cases ensures its practical applicability and demonstrates tangible value for solving real-world data integration and interpretation challenges, a key aspect of delivering effective consulting and software development.
Primary Care Innovation at Scale
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 17, 2022
This video, presented by Dr. Eric Bricker of AHealthcareZ, provides an in-depth analysis of ChenMed's highly successful "reimagined primary care at scale" strategy. Based on a presentation by ChenMed CEO Dr. Chris Chen to the Department of Health and Human Services, the video details how ChenMed has achieved the "triple, quadruple, quintuple aim" of increasing quality, decreasing costs, and improving physician satisfaction. Operating 130 primary care centers across 40 cities and 14 states with 5,000 employees, ChenMed takes on full capitated risk from Medicare Advantage plans, making them wholly responsible for all patient care costs, including specialty, hospitalizations, surgical, and medication expenses. This model primarily serves economically disadvantaged and minority elderly populations, with 40% of patients being dual-eligible for Medicare and Medicaid. A cornerstone of ChenMed's strategy is the intensive retraining of its primary care physicians. Dr. Bricker highlights ChenMed's belief that traditional medical school and residency training are inadequate for effective primary care. Consequently, new physicians undergo a 9-12 month fellowship focusing on leadership, influencing patient behavior change, customer service, the economics of healthcare, and documentation for care (rather than solely for billing). This specialized training addresses the 80% of health outcomes determined by patient behavior and social determinants, moving beyond the traditional 20% focus on pills, procedures, and referrals. ChenMed emphasizes proactive disease management for conditions like diabetes and congestive heart failure, shifting from reactive treatment to continuous health maintenance. Central to ChenMed's operational success is its robust technological and data infrastructure. The company developed its own proprietary Electronic Medical Record (EMR) system, which functions less as a record-keeping tool and more as an "ERP/CRM for patient care." This custom-built system hardwires effective clinical workflows directly into the software, ensuring consistent, outcome-driven care. Complementing this, ChenMed employs nearly 400 data scientists—almost 10% of its workforce—to rigorously analyze patient data. This significant investment underscores their philosophy that "data is the mother of medicine," driving evidence-based decisions rather than relying on opinions. The model further emphasizes building profound trust and providing comprehensive team-based support. Physicians manage small patient panels, typically one doctor for every 400 patients, enabling monthly visits and direct access via personal cell phone numbers, fostering strong patient-physician relationships. Each physician leads a comprehensive team including nurses, case managers, and care coordinators. On-site pharmacies dispense 90% of patient medications, significantly improving adherence. Additional services like door-to-door transportation via ChenMed minivans address logistical barriers to care, while on-site classes (e.g., tai chi, zumba, cooking) and monthly birthday celebrations combat loneliness and promote overall well-being. Physician compensation is aligned with outcomes, offering a market-comparable base salary plus a 20-30% bonus based on patient results, which has proven highly effective in recruiting top talent. The impressive outcomes include a 30-50% reduction in hospitalizations and ER visits, a 70% decrease in congestive heart failure admissions, and a 22% reduction in strokes, demonstrating the efficacy of this holistic, data-driven approach. Key Takeaways: * **Full-Risk Capitation Drives Accountability:** ChenMed's model of taking full capitated payments from Medicare Advantage plans for all patient care costs creates a powerful incentive for proactive, high-quality, and cost-effective care, aligning financial success with patient outcomes. * **Physician Retraining is Essential for Modern Primary Care:** Traditional medical education is deemed insufficient; ChenMed invests in a 9-12 month fellowship to train physicians in leadership, patient behavior influence, customer service, healthcare economics, and documentation for care, not just billing. * **Proprietary EMR as a Workflow Engine:** ChenMed's custom-built EMR system is more than a record keeper; it's an "ERP/CRM for patient care" that hardwires effective clinical workflows, ensuring consistent, data-driven care delivery and operational efficiency. * **Significant Investment in Data Science:** With nearly 400 data scientists (10% of its workforce), ChenMed emphasizes that "data is the mother of medicine," using rigorous analytics to translate patient data into actionable clinical insights and workflow improvements. * **Trust-Building Through Small Patient Panels and Direct Access:** Physicians manage small patient loads (1:400 ratio), conduct minimum monthly visits, and provide direct cell phone access, fostering deep trust and strong patient-physician relationships crucial for behavior modification. * **Comprehensive Team-Based Care:** The physician leads a multidisciplinary team including nurses, case managers, and care coordinators, ensuring holistic patient support that extends beyond the doctor's direct interaction. * **Outcome-Based Physician Compensation:** Physicians receive a market-comparable base salary plus a 20-30% bonus tied directly to patient outcomes, effectively aligning financial incentives with quality care and attracting high-caliber talent. * **Focus on Social Determinants of Health and Behavior Modification:** Recognizing that 80% of health is determined by behavior and social factors, ChenMed's training and care model proactively addresses these areas, moving beyond traditional clinical interventions. * **Proactive Disease Management:** The strategy shifts from reactive treatment to proactive management of chronic conditions like diabetes and congestive heart failure, aiming to prevent exacerbations and hospitalizations through continuous engagement. * **High Medication Adherence via On-Site Pharmacies:** Dispensing 90% of patient medications directly at the clinic significantly improves compliance, addressing a major barrier to effective treatment and reducing hospitalizations. * **Addressing Non-Clinical Barriers to Care:** Services like door-to-door transportation and on-site social activities (e.g., tai chi, birthday celebrations) tackle practical and social barriers like mobility issues and loneliness, which significantly impact patient health. * **Quantifiable Positive Outcomes:** The model consistently delivers impressive results, including 30-50% reductions in hospitalizations and ER visits, a 70% decrease in CHF admissions, and a 22% reduction in strokes, validating its effectiveness. * **Scalable and Replicable Methodology:** Dr. Chen's generous sharing of the ChenMed methodology suggests that these principles and systems can be adapted and scaled to improve primary care outcomes more broadly. **Tools/Resources Mentioned:** * **ChenMed's Proprietary Electronic Medical Record (EMR) System:** Described as an "ERP/CRM for patient care" that hardwires clinical workflows. **Key Concepts:** * **Full Capitation:** A payment model where a healthcare provider receives a fixed amount per patient per period, regardless of the services provided, making them financially responsible for all care. * **Patient-Centered Medical Home:** A model of care where a patient's primary care physician leads a team that coordinates all aspects of the patient's care. * **Triple/Quadruple/Quintuple Aim:** Frameworks for optimizing health system performance, typically focusing on improving patient experience, improving population health, reducing per capita cost of healthcare, and improving the work life of healthcare providers. * **Social Determinants of Health:** Non-medical factors that influence health outcomes, such as socioeconomic status, education, neighborhood, and access to transportation. * **Proactive Care:** An approach to healthcare that focuses on anticipating and preventing health issues before they become severe, rather than reacting to acute problems. * **Data Science as the Mother of Medicine:** The philosophy that rigorous data analysis and evidence-based insights should drive medical practice and decision-making, rather than opinions or traditional practices.
Why your business needs a cloud-based quality management system
Qualio
/@QualioHQ
Jul 11, 2022
This video provides an in-depth exploration of the critical shift from paper-based to cloud-based quality management systems (QMS) within the life sciences industry. Presented by Kelly Stanton, Director of Quality at Qualio, at the American Biomanufacturing Summit 2022, the session highlights why digital, cloud-powered QMS solutions are no longer just an option but an indispensable necessity for quality-conscious businesses aiming to bring life-saving products to market faster. Stanton, drawing from her two decades of experience in pharmaceutical and medical device sectors, underscores the inefficiencies of traditional paper systems and champions a lean, efficient, and compliant approach to quality management that prioritizes actual regulatory requirements over excessive, often unnecessary, documentation. The presentation systematically breaks down the challenges posed by paper-based quality systems, such as the creation of organizational silos, the inordinate amount of time spent on administrative tasks like manual data entry into spreadsheets, and the inability to effectively analyze and leverage critical data for improvement. Stanton reveals compelling statistics, noting that 38% of companies still rely solely on paper and spreadsheets for quality work, with 25-50% of a working day spent on administrative tasks and 50-53% on gathering and tracking information for QA, auditing, and training. She argues that this focus on manual control prevents organizations from dedicating resources to quality improvement, hindering their journey towards a "world-class" quality posture where processes actively support activities and patient safety. Transitioning to the benefits, the speaker elaborates on how cloud-based eQMS solutions address these pain points by uniting teams, processes, and data. Key advantages include enhanced data availability, reduced manual data entry, and the power of API integrations to consolidate information from disparate tools like learning management systems, ERPs, Jira, Asana, and Git repositories into a central source of truth. This flexibility, configurability, and remote accessibility are crucial in today's globalized and often remote work environments. Stanton also provides practical migration tips, emphasizing the importance of asking the right questions, electing a change champion, and avoiding the "paving the cow path" pitfall—where existing, inefficient paper processes are merely digitized without being optimized for the new electronic environment. She illustrates these concepts with case studies of pharmaceutical manufacturers, Irresist and Expression Therapeutics, demonstrating successful transitions and the resulting efficiencies and audit readiness. The discussion culminates with a focus on audit best practices and regulatory acceptance. Stanton asserts that an electronic QMS ensures perpetual audit readiness, eliminating the weeks of preparation typically associated with gathering physical documents. It facilitates easier information flow, controlled access via permissioning, and real-time tracking of audit findings and corrective actions (CAPAs), significantly reducing administrative overhead and meeting times. In the Q&A segment, she addresses the critical issue of regulatory acceptance, confirming that agencies globally, including those outside the U.S. and under PICS, generally accept electronic systems, provided the control of data, information, and configuration can be clearly demonstrated. She also offers valuable advice on managing quality touchpoints with a heterogeneous network of partners (CROs, suppliers), advocating for a risk-based approach in procedures rather than overly prescriptive requirements for specific e-signature tools, thereby promoting flexibility and trust in vendor qualification. Key Takeaways: * **Imperative for Digital Transformation:** A significant portion of life science companies (38%) still rely on paper and spreadsheets for quality management, leading to substantial inefficiencies and hindering progress towards quality improvement. * **Inefficiencies of Paper Systems:** Paper-based systems create organizational silos, demand excessive administrative time (25-50% of a workday on data entry/reporting), and prevent effective data analysis, diverting resources from critical quality improvement initiatives. * **Cloud-Based eQMS Benefits:** Electronic Quality Management Systems (eQMS) facilitate faster operations, unite teams and processes, make data readily available for analysis, and eliminate the need for manual data transcription, thereby enhancing overall efficiency. * **Strategic API Integrations:** A robust eQMS acts as a central source of truth, leveraging API integrations to pull data from other essential tools (e.g., LMS, ERP, Jira, Asana, Git), allowing different teams to work in their preferred systems while maintaining quality oversight. * **Flexibility and Accessibility:** Cloud-based eQMS offers flexibility, configurability, and remote access, which are crucial for distributed teams, outsourced operations, and adapting to evolving business structures, especially in a post-pandemic world. * **Audit Readiness and Efficiency:** An eQMS ensures constant audit readiness by centralizing documentation, providing controlled access, and streamlining the tracking and resolution of audit findings and CAPAs, significantly reducing preparation time and administrative burden. * **Avoiding "Paving the Cow Path":** When migrating to an eQMS, organizations should seize the opportunity to re-evaluate and optimize existing processes rather than simply digitizing inefficient paper-based workflows, which can lead to long-term pain and customization issues. * **Importance of a Champion:** Electing a respected internal champion is vital for managing the cultural change associated with adopting a digital quality system, fostering buy-in, spreading awareness, and securing senior management support. * **Regulatory Acceptance:** Regulatory agencies worldwide are increasingly accepting of electronic quality systems, provided companies can demonstrate robust control over data, information, and system configuration, focusing on the intent of regulations rather than specific methodologies. * **Managing Heterogeneous Partner Systems:** When dealing with multiple partners using different quality or e-signature systems, procedures should be written to accept compliant electronic signatures generated in a compliant manner, rather than restricting to specific tools, leveraging vendor qualification and risk assessment to ensure data integrity. * **Risk-Based Approach to Procedures:** Procedures should focus on areas of true risk where patient safety or product quality could be compromised, avoiding overly prescriptive details that can stifle efficiency and collaboration without adding significant value. * **Qualio's Lean Philosophy:** Qualio advocates for a "lean" quality system that focuses on what is actually required by regulations, aiming for efficiency, simplicity, and ease of use to make quality management more effective and even "fun." **Tools/Resources Mentioned:** * **Qualio:** A cloud-based quality management software. * **Jira, Asana, Git:** Examples of tools that can be integrated with an eQMS via APIs, particularly for software development and project management. * **Adobe Sign, Docusign:** Examples of electronic signature methodologies discussed in the context of partner integrations. * **G2 Reviews:** A platform where customers can review software, mentioned as a source of customer feedback for Qualio. **Key Concepts:** * **Cloud-based Quality Management System (QMS):** A system for managing quality processes and documentation hosted on cloud infrastructure, offering remote access, scalability, and integration capabilities. * **Electronic Quality Management System (eQMS):** A digital system that automates and manages quality processes, documentation, and records, replacing traditional paper-based methods. * **"Paving the Cow Path":** A term describing the mistake of digitizing existing, often inefficient, manual processes directly into a new system without first optimizing or redesigning them. * **Lean Quality System:** An approach to quality management that focuses on efficiency, eliminating waste, and adhering strictly to essential regulatory requirements rather than excessive or redundant documentation and processes. * **API Integrations:** The ability of software systems to communicate and exchange data with each other, allowing for a unified view of information across different platforms. * **Regulatory Compliance (FDA, EMA, PICS):** Adherence to standards and regulations set by bodies like the U.S. Food and Drug Administration, European Medicines Agency, and Pharmaceutical Inspection Co-operation Scheme, which are critical in the life sciences. **Examples/Case Studies:** * **Irresist:** A pharmaceutical manufacturing company with 75 users, producing OTC products. They transitioned from a paper-based system to Qualio's eQMS, expanding quality participation from 6 core QA staff to 60 people across the organization. This shift enabled them to efficiently maintain documentation for hundreds of specialty therapeutics and become continuously ready for FDA audits. * **Expression Therapeutics:** A company that built a new 43,000 square foot manufacturing facility and proactively adopted an eQMS from day one, going paper-free from the start. This allowed them to focus their time and resources on developing their manufacturing processes, as their quality system processes (like document control and training) were already efficiently managed electronically.
Employer Healthcare Priorities: 1) Lower Deductible, 2) Behavioral Health, 3) Expand Virtual Care
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 10, 2022
This video provides an in-depth exploration of employer healthcare priorities for the 2023 plan year, drawing insights from the Mercer Employer Survey. Dr. Eric Bricker, the speaker, begins by establishing the context: despite widespread public and media focus on high healthcare costs, the vast majority of employers are strategically prioritizing benefit enhancements over cost reduction. This counter-intuitive finding is attributed to the current low unemployment rate (3.6% as of June 2022), which makes employee attraction and retention (A&R) a paramount business challenge for organizations across all sizes. The presentation then delves into the top three ways employers plan to enhance their healthcare benefits. The primary enhancement is making healthcare more affordable for employees, often by offering lower deductible plans or even copay-only options, signaling a potential shift away from the consumer-directed high-deductible health plans that gained prominence post-2007 financial crisis. Secondly, employers are focusing on behavioral health, predominantly through "enhanced" Employee Assistance Programs (EAPs) and the introduction of self-service technology resources like websites and apps. Lastly, virtual care is being expanded beyond traditional telemedicine to include virtual behavioral health visits and virtual primary care, viewed as a benefit enhancement rather than a cost-cutting measure. Dr. Bricker emphasizes that these employer priorities stand in stark contrast to popular healthcare finance discussions, which often center on price transparency and Pharmacy Benefit Manager (PBM) controversies. He argues that employers, who collectively pay more for healthcare than any other entity in the U.S., are not strategically prioritizing these cost-containment efforts. This observation leads to a crucial piece of advice for digital health companies, brokers, and consultants: to succeed in the employer-sponsored benefits market, it is essential to "bend with the trend" and align offerings with the current employer focus on affordability, behavioral health, and virtual care enhancements, rather than solely pushing cost-reduction narratives. The video concludes by highlighting the inconsistent nature of employers as a force for change in healthcare, noting that their priorities tend to shift towards cost containment only during economic downturns and high unemployment, making them an unreliable long-term driver of systemic change. Key Takeaways: * **Employer Priority Shift:** For the 2023 plan year, 70% of employers are prioritizing benefit enhancements over lowering healthcare costs, a significant departure from common public discourse on healthcare finance. * **Attraction & Retention (A&R) as a Driver:** The primary reason for this strategic shift is the acute need for employee attraction and retention, fueled by a historically low unemployment rate (3.6% as of June 2022). * **Focus on Affordability:** The number one way employers are enhancing benefits is by making healthcare more affordable for employees, with 41% offering lower deductible plans or even copay-only options, moving away from the high-deductible health plan trend. * **Enhanced Behavioral Health Access:** Employers are addressing behavioral health needs through enhanced Employee Assistance Programs (EAPs) and by adding self-service technology resources (e.g., websites, apps), often as a low-marginal-cost approach to expanding access. * **Expansion of Virtual Care:** Virtual care is being expanded beyond traditional urgent-care-focused telemedicine to include virtual behavioral health and virtual primary care, positioned as a benefit enhancement rather than a cost-saving strategy. * **Disregard for Cost-Containment Buzzwords:** Despite widespread media attention, employers are not prioritizing price transparency initiatives or addressing PBM controversies as strategic priorities for their 2023 health plans. * **Market Alignment for Digital Health Companies:** Digital health companies, brokers, and consultants are advised to align their offerings with current employer priorities (affordability, behavioral health, virtual care enhancements) to gain market traction, rather than solely focusing on healthcare cost reduction. * **Inconsistent Force for Change:** Employers are not a consistent force for change in the healthcare system; their priorities fluctuate with economic cycles, shifting to cost containment primarily during recessions when unemployment is high. * **Opportunity for AI/Software Solutions:** The emphasis on "self-service technology resources" for behavioral health and the expansion of "virtual care" presents an opportunity for AI and software development firms to create innovative solutions that align with these employer priorities. * **Understanding Client Context:** For firms serving the pharmaceutical and life sciences industries, understanding that their client companies (as employers) are focused on employee benefits and retention is crucial, as this impacts overall operational strategy and investment capacity. Tools/Resources Mentioned: * Mercer Employer Healthcare Survey (2023 Plan Year) * Bureau of Labor Statistics (BLS) unemployment data * KFF (Kaiser Family Foundation) health benefits survey Key Concepts: * **A&R (Attraction & Retention):** The strategic business imperative for employers to attract and keep skilled employees, heavily influencing benefit design. * **Enhanced EAP (Employee Assistance Program):** Expanded or improved versions of traditional EAPs, often incorporating new technologies or broader service offerings for mental health and well-being. * **Virtual Care vs. Telemedicine:** Virtual care is presented as a broader concept encompassing ongoing virtual relationships (e.g., virtual primary care, virtual behavioral health), distinct from traditional telemedicine which often refers to episodic, urgent virtual visits with no continuity. * **Consumer-Directed Health Plans (CDHPs) / High Deductible Health Plans (HDHPs):** Health plans with higher deductibles, often paired with Health Savings Accounts (HSAs), which gained popularity as a cost-containment measure but are now being re-evaluated by employers. * **PBM (Pharmacy Benefit Manager):** Companies that manage prescription drug benefits for health plans, often criticized for practices like spread pricing and rebate structures. Examples/Case Studies: * **Shift from HDHPs:** The video notes a historical shift where CDHPs/HDHPs grew from 2% to 33-35% of employee plans since 2007, but employers are now "dialing it back" by offering lower deductible options. * **Recessionary Shifts:** Historical examples include the pivot to HDHPs during the Great Financial Crisis (2007-2009) and the rise of Health Maintenance Organizations (HMOs) in the early 1990s, both driven by recessions and a focus on cost containment.
Flex Databases eTMF – electronic Trial Master File
Flex Databases
/@Flexdatabases
Jul 8, 2022
This video provides an in-depth demonstration of Flex Databases' electronic Trial Master File (eTMF) system, designed to offer comprehensive 24/7 visibility and management of all trial documentation within clinical research. The presentation walks through the system's user interface and core functionalities, emphasizing its role in streamlining clinical operations, ensuring data integrity, and maintaining regulatory compliance. The speaker's approach is a feature-by-feature walkthrough, showcasing how users can navigate, manage, and report on trial documents from a high-level dashboard down to individual file details, all while highlighting the system's configurability and user-centric design. The demonstration begins with an overview of the cross-project dashboard, which presents customizable widgets and reports, along with a centralized area for eTMF messages and personal activities. This initial view allows users to quickly grasp their tasks and project statuses across all allocated projects. The system then transitions to a deeper dive into individual project work, illustrating how an eTMF provides an instant understanding of project progress through a structured view of document completion percentages and statuses. Key functionalities for document interaction are highlighted, including quick search filters, detailed document information (size, author, last updated), options for review, metadata management, and in-system editing and version control. A significant portion of the demonstration focuses on the system's robust document handling and compliance features. This includes the ability to send documents directly from the system with an audit trail, OCR recognition for text search within scanned documents, and a secure recycle bin for deleted files. The video also details various upload methods, including drag-and-drop and email integration, and showcases the system's electronic signature capabilities, which add a compliant extra page with date, time, signatory, and reason. The presentation concludes with an exploration of reporting tools, including master reports and TMF fulfillment reports, and the administrative area for managing user permissions, configurable metadata sets, and document templates, such as those recommended by the DIA (Drug Information Association). The emphasis on comprehensive logging for archiving, emails, and electronic signatures underscores the system's readiness for audits and inspections. Key Takeaways: * **Centralized Trial Documentation Management:** The Flex Databases eTMF system offers a unified platform for managing all clinical trial documentation, providing 24/7 visibility and a "helicopter view" of eTMF processes, which is crucial for large-scale clinical operations. * **Customizable Dashboards and Reporting:** Users are greeted with a personalized dashboard featuring configurable widgets and reports, allowing for immediate insights into cross-project activities, messages, and individual task lists, enhancing daily workflow efficiency. * **Granular Project Overview:** Within individual projects, the system provides an instant understanding of progress through a structured view that displays document completion percentages and statuses, enabling proactive management and identification of bottlenecks. * **Advanced Document Interaction and Metadata Management:** The eTMF supports comprehensive document lifecycle management, including quick search by various criteria (name, country, site, completeness, type), detailed document information, in-system editing, version control, and configurable metadata fields, some of which are auto-sourced. * **Integrated Communication and Collaboration:** The system facilitates collaboration by allowing users to start chats or leave comments directly on documents, streamlining communication among team members and stakeholders. * **Robust Compliance and Audit Readiness:** Critical compliance features include audit trails for sent documents, a secure recycle bin for deleted files (ensuring nothing is permanently lost), and comprehensive logs for archiving, emails, and electronic signatures, preparing organizations for audits and inspections. * **Compliant Electronic Signatures:** The system generates electronic signatures that are compliant with regulatory requirements, adding an extra page to signed documents detailing the date, time (UTC), signatory name, and reason for signature (e.g., reviewed, approved). * **Efficient Document Upload and OCR:** Multiple convenient methods for document upload are available, including drag-and-drop and emailing documents directly into the system, with automatic allocation based on email subject. OCR recognition enables full-text search within scanned documents, improving discoverability. * **Configurable Permissions and Access Control:** The administrative area allows for detailed management of user permissions, enabling access rights to be set per user and per folder, ensuring data security and adherence to roles-based access control. * **Templates and Placeholders for Standardization:** The system supports the use of templates, including those recommended by organizations like the DIA, and placeholders, which guide users on expected document types and naming conventions, promoting standardization and consistency across trials. * **Export and Archiving Capabilities:** Users can export all documents from a project for offline work or download the entire TMF as a ZIP file with its original structure, providing flexibility for external review or long-term archiving. * **Dedicated Auditor/Inspection Access:** A "TMF Master copies" section can be configured to provide auditors or inspectors with access only to final, approved documents, preventing them from seeing drafts or internal communications, thus streamlining the inspection process. **Tools/Resources Mentioned:** * **Flex Databases eTMF:** The primary electronic Trial Master File system demonstrated. * **Flex Databases CTMS, LMS, PM& Budgeting, EDC, Pharmacovigilance automation systems:** Other products offered by Flex Databases, indicating a broader suite of clinical trial management solutions. * **HR database:** A supportive module mentioned for sourcing email addresses when sending documents. * **DIA (Drug Information Association) templates:** Referenced as a source for recommended document templates within the system. **Key Concepts:** * **eTMF (electronic Trial Master File):** A digital system for managing all essential documents of a clinical trial, ensuring they are complete, accurate, and readily available for regulatory inspection. * **Cross-project area:** A centralized dashboard view that aggregates information and activities across all clinical projects a user has access to. * **Metadata:** Data that provides information about other data. In an eTMF, this includes details like document author, date uploaded, version, and specific trial-related attributes, all of which are configurable. * **OCR (Optical Character Recognition):** Technology that enables the system to recognize text within images or scanned documents, making the content searchable. * **Audit Trail:** A chronological record of system activities, including document uploads, edits, deletions, and electronic signatures, essential for regulatory compliance and accountability. * **Electronic Signatures:** Digital signatures that are legally binding and comply with regulatory requirements (e.g., 21 CFR Part 11), providing proof of review or approval with specific details like date, time, and reason. * **Placeholders:** Predefined slots or markers within the eTMF structure that indicate where specific documents are expected, helping to track completeness and guide document submission. * **TMF Master Copies:** A designated section within the eTMF, typically for final, approved documents, which can be selectively shared with external parties like auditors or regulatory inspectors.
What is Veeva Vault RIM? | Implementation of Veeva Vault RIM into a Life Science Company
kyyah abdul
/@kyyahabdul
Jul 5, 2022
This video provides an in-depth exploration of Veeva Vault RIM, a critical cloud-based platform designed to streamline global regulatory processes within life science companies. The speaker, a regulatory professional, offers a user-centric perspective, demystifying the platform's functionalities and highlighting its transformative impact on document management and regulatory compliance. She emphasizes that while Veeva's official definition might seem convoluted, Vault RIM essentially functions as a comprehensive, centralized document management system for all regulatory-related documents within an organization. The presentation delves into the core components of the Veeva Vault RIM suite, which includes the Vault Platform, Vault Quality Docs, Vault Regulations, and Vault Submissions. The speaker contrasts this integrated solution with the fragmented and often inefficient systems previously used in the industry, such as Liquid Insight, Rosetta Phoenix, GDMRS, and even basic tools like Google Docs. She recounts personal experiences where smaller companies struggled with quality control and version management due to disparate applications and manual processes, particularly for large regulatory documents like protocols or briefing books. Veeva Vault RIM addresses these challenges by consolidating various tools—from housing documents and SOPs to building the eCTD backbone—into a single, unified application. A significant portion of the video is dedicated to explaining the practical application and workflow benefits of Veeva Vault RIM. The speaker details how the platform facilitates critical regulatory processes, such as authoring, pre-publishing, and final approval of documents. She illustrates an "authoring workflow" where medical writing initiates a document for review, allowing multiple stakeholders to collaborate simultaneously within the document while maintaining stringent version control. The system ensures that only changes made directly within the Vault are reflected, preventing issues arising from downloaded or externally modified files. Once a document is approved, it becomes locked, and any subsequent changes trigger an "up-versioning" process (e.g., from version 1.0 to 1.1 or 2.0), creating a clear audit trail. The platform also allows for flexible categorization of documents, typically by product, ensuring all related submissions and materials are easily accessible. The speaker also notes its capability to manage quality documents and SOPs for training, similar to specialized systems like MasterControl, but within a broader, integrated framework. Key Takeaways: * **Veeva Vault RIM's Core Purpose:** Veeva Vault RIM is a cloud-based platform that centralizes and streamlines global regulatory processes for pharmaceutical and life science companies, enhancing visibility, data quality, and agility in document management. * **Consolidated Document Management:** The platform serves as a comprehensive document management system, housing all regulatory documents, SOPs, and related materials in one unified application, eliminating the need for multiple disparate tools. * **Addressing Legacy System Challenges:** It solves common problems faced with older systems like Liquid Insight, Rosetta Phoenix, GDMRS, or even Google Docs, which often led to poor version control, quality inconsistencies, and workflow inefficiencies, especially for large regulatory documents. * **Integrated Suite Components:** The Veeva Vault RIM suite comprises several key tools, including the Vault Platform, Vault Quality Docs, Vault Regulations, and Vault Submissions, offering a holistic solution for various regulatory needs. * **Streamlined Regulatory Workflows:** The platform supports end-to-end regulatory workflows, from initial document authoring and collaborative review to pre-publishing formatting and final approval processes, ensuring a structured and controlled progression. * **Robust Version Control:** A standout feature is its advanced version control system, which allows multiple users to edit documents simultaneously while ensuring all changes are tracked and saved within the system, preventing external modifications from disrupting the official record. * **"Up-Versioning" for Audit Trails:** Once a document is approved, it becomes locked. Any subsequent changes automatically trigger an "up-versioning" (e.g., from 1.0 to 1.1 or 2.0), providing a clear, auditable history of all modifications and approvals. * **Broad User Adoption:** Veeva Vault RIM is widely used by regulatory professionals across all levels, from entry-level associates to senior managers, underscoring its essential role in daily operations within life science companies. * **Flexible Document Categorization:** The platform allows companies to categorize documents effectively, typically by product, making it easy to locate all submissions and materials related to a specific therapeutic area or product line. * **Quality Document Management:** Beyond regulatory submissions, Vault RIM also functions as a quality document management tool, capable of housing SOPs and supporting training processes, similar to specialized systems like MasterControl. * **Organizational Adoption Considerations:** While highly beneficial, smaller companies (5-15 people) might find the initial expense of a Veeva system prohibitive. Organizations are advised to inquire about informational sessions as they grow to determine if it's a suitable investment. * **Career Pathway for Individuals:** For individuals interested in careers in submissions management or regulatory operations, understanding and gaining proficiency in Veeva Vault RIM is invaluable, as it is a prevalent tool in the industry. **Tools/Resources Mentioned:** * Veeva Vault RIM * Veeva Vault Platform * Veeva Vault Quality Docs * Veeva Vault Regulations * Veeva Vault Submissions * Liquid Insight (legacy tool) * Rosetta Phoenix (legacy tool) * GDMRS (Global Document Regulatory System - legacy tool) * Google Docs (legacy tool for small companies) * MasterControl (quality document management system, compared to Vault Quality Docs) **Key Concepts:** * **Regulatory Information Management (RIM):** The systematic process of managing and tracking all information and documents related to regulatory submissions, approvals, and compliance throughout the product lifecycle in the life sciences. * **Cloud-based Platform:** A software system hosted on the internet, accessible from anywhere, offering scalability and centralized data management. * **Version Control:** A system that manages changes to documents over time, allowing users to track revisions, revert to previous versions, and ensure document integrity. * **eCTD Backbone:** The electronic Common Technical Document structure, a standardized format for submitting regulatory information to health authorities, which Veeva Vault RIM helps build and manage. * **Authoring Workflow:** A structured process for creating and reviewing documents, involving multiple contributors and reviewers, with defined roles and deadlines. * **Pre-publishing Workflow:** The stage where documents are formatted, checked for compliance with submission standards, and prepared for final submission. * **Approval Process:** The final stage in document management where designated authorities review and formally approve a document, often locking it from further changes without a new version. * **Quality Documents (QDocs):** Documents related to a company's quality management system, such as Standard Operating Procedures (SOPs), quality manuals, and training records.
Digital Health Sales and Marketing... Stop Wasting Money
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 2, 2022
This video provides an in-depth exploration of the critical challenges and effective strategies for sales and marketing within the digital health sector. Dr. Eric Bricker, the speaker, begins by highlighting a significant paradox: despite an astronomical surge in investment in digital health companies—totaling $85.6 billion between 2011 and 2021, with $29 billion in 2021 alone—the commensurate improvement in patient health and healthcare outcomes has not been realized. He attributes this disconnect largely to an inadequate understanding and execution of sales and marketing strategies, emphasizing that without getting these right, the substantial investments risk being entirely wasted. The core of his argument is that digital health sales and marketing is not a monolithic process but rather requires mastering three distinct and interconnected funnels. The presentation meticulously breaks down these three essential sales and marketing funnels: the Employer Funnel, the Broker/Consultant/Carrier Funnel (representing the broader ecosystem), and the Plan Member Funnel (the end-user). For each funnel, Dr. Bricker outlines both the marketing and sales components. Marketing, he explains, is about gaining attention through both inbound (content-driven, educational) and outbound (interruption-based, advertising, cold calling) approaches. The sales process, particularly for the B2B funnels, is framed using the Miller Heiman methodology, which identifies three crucial buyers: the technical buyer (who uses the solution daily), the outcome buyer (who seeks strategic results like employee attraction/retention), and the financial buyer (concerned with costs and ROI). This structured approach underscores the complexity of selling digital health solutions, which often requires navigating multiple stakeholders with diverse motivations. Dr. Bricker further elaborates on the unique dynamics of each funnel. The Employer Funnel targets benefits managers, HR VPs, and C-suite executives, each requiring a tailored value proposition. The Ecosystem Funnel emphasizes the necessity of winning over brokers, consultants, and insurance carriers, not just the employer directly. Here, the financial buyer within the ecosystem is paramount, as these entities need to see how promoting a digital health solution will increase their own income or market share. Finally, the Plan Member Funnel addresses the B2B2C nature of digital health, where even after a solution is implemented, adoption and utilization by the end-user remain a significant hurdle. This requires a dedicated marketing and sales effort to a heterogeneous population, leveraging early adopters and management endorsement to drive engagement and ensure the investment translates into actual patient benefit. Key Takeaways: * **Digital Health Investment vs. Impact Discrepancy:** A staggering $85.6 billion was invested in digital health companies between 2011 and 2021, with $29 billion in 2021 alone. However, this massive investment has not yet translated into a proportional improvement in patient health outcomes, suggesting a significant inefficiency in how these solutions are brought to market. * **Sales and Marketing as a Critical Success Factor:** The primary reason for the underperformance of digital health investments is often attributed to inadequate understanding and execution of effective sales and marketing strategies. Getting this right is paramount to prevent wasted time and money. * **Three Distinct Sales and Marketing Funnels:** Digital health sales are not a single process but require mastering three separate funnels: the Employer Funnel, the Broker/Consultant/Carrier Funnel (the ecosystem), and the Plan Member Funnel (the end-user). All three must be successfully addressed for a solution to gain traction and achieve impact. * **Dual Marketing Approaches:** Effective marketing involves both inbound strategies (creating educational or entertaining content that attracts attention) and outbound strategies (interruption-based methods like advertising, emails, cold calling, or conference booths). Both are complementary and essential. * **Miller Heiman Sales Methodology for B2B:** When selling to employers or the ecosystem, it's crucial to identify and sell to three distinct buyer types: the Technical Buyer (e.g., benefits manager, account manager) who uses the solution daily, the Outcome Buyer (e.g., VP of HR, subject matter expert) who seeks strategic results, and the Financial Buyer (e.g., CEO, CFO, producer) who controls the budget and seeks financial returns. * **Winning Over the Ecosystem is Essential:** Digital health companies cannot succeed by only selling to employers; they must also win over the ecosystem of brokers, consultants, and insurance carriers. These entities need to understand the financial incentive for them to promote the digital health solution, such as increased sales or added value for their clients. * **B2B2C Nature of Digital Health:** Digital health solutions operate on a business-to-business-to-consumer (B2B2C) model. Even after an employer or carrier adopts a solution, a dedicated sales and marketing effort is required to engage the end-users (plan members) to ensure high utilization and adoption. * **Tailored Member Engagement Strategies:** Engaging plan members requires diverse inbound and outbound marketing tactics (e.g., customer service integration, targeted emails, texts, calls, apps, social media, open enrollment campaigns) that are tailored to the heterogeneous nature of employee populations (e.g., millennials, Gen Xers, baby boomers, different genders). * **Leveraging Internal Champions for Member Adoption:** To drive member adoption, it's critical to identify and sell to early adopters within the employee population. These early adopters can then become advocates, convincing more conservative employees to use the service. Additionally, engaging and securing endorsement from management (from direct supervisors to the CEO) significantly boosts trust and encourages utilization. * **Focus on Time and Attention for Member Sales:** While members often face no direct out-of-pocket cost for digital health solutions, they must still invest their time and attention. The "sale" to the member involves convincing them that this investment is worthwhile and will simplify or improve their lives. Tools/Resources Mentioned: * **Rock Health:** A venture fund that provides insights and data on digital health funding, cited as the source for investment statistics. Key Concepts: * **Digital Health:** A broad term encompassing technologies that connect and empower consumers, patients, and caregivers to manage their health and wellness. * **Sales and Marketing Funnels:** A multi-stage process that guides potential customers from initial awareness of a product or service through to conversion and adoption. * **Inbound Marketing:** A strategy focused on attracting customers by creating valuable content and experiences tailored to them (e.g., educational articles, videos). * **Outbound Marketing:** A traditional marketing strategy where a company initiates the conversation and pushes its message out to an audience (e.g., advertising, cold calls, emails). * **Miller Heiman Methodology:** A sales framework that emphasizes understanding the different roles and motivations of buyers (technical, outcome, financial) within a complex B2B sales process. * **B2B2C (Business-to-Business-to-Consumer):** A business model where a company sells its product or service to another business, which then provides it to individual consumers. In digital health, this often means selling to an employer or insurer, who then offers the solution to their employees or members.
TMF Reference Model Training Part 2
TMF Reference Model
/@TMFReferenceModel
Jun 20, 2022
This video provides a comprehensive training on the Trial Master File (TMF) Reference Model, defining its purpose, structure, and application in clinical trials. Speakers Chole Xi Van and Donna Dorzinski, both members of the TMF Reference Model Steering Committee, explain how the model standardizes TMF content, naming, structure, and metadata, expanding upon ICH GCP Chapter 8 and EU Regulation 536/2014. The discussion covers the model's 11 functional zones, the classification of artifacts and sub-artifacts, and how the model facilitates consistent filing, rapid retrieval, and regulatory compliance. It also highlights the benefits of implementing the model, such as reduced customization, simplified CRO engagement, and improved integration of TMFs. Key Takeaways: * **Standardized Regulatory Compliance:** The TMF Reference Model provides a critical framework for clinical trial documentation, ensuring compliance with regulations like EU Regulation 536/2014 and ICH GCP. Its four-fold purpose (standard content, naming, structure, and metadata) is essential for demonstrating the conduct and data quality of a trial during audits and inspections. * **Structured for Efficiency and Retrieval:** The model's detailed organization into 11 functional zones, sections, artifacts, and sub-artifacts, complete with definitions and ICH codes, enables consistent filing and rapid retrieval of documents. This structured approach is vital for operational efficiency and audit readiness in clinical operations. * **Industry Consensus and Reduced Customization:** As an industry-driven initiative, the TMF Reference Model offers a consistent interpretation of TMF requirements, reducing ambiguity and avoiding scope creep. Its adoption helps limit company-specific customizations, aligning organizations with broader industry standards and simplifying collaboration with CROs. * **Foundation for Data Management and Integration:** By standardizing content and metadata, the model facilitates the exchange of information across the industry and simplifies the integration of multiple TMFs into a single, unified structure. This structured approach is foundational for robust data engineering and business intelligence initiatives within clinical data management. * **Enabling Digital Transformation:** While not explicitly mentioning AI, the emphasis on standardized structure, naming, and metadata within the TMF Reference Model creates an ideal environment for the implementation of electronic TMF (eTMF) systems and future AI/LLM solutions.
Health Insurance Carrier Stock Performance
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
May 30, 2022
This video provides an in-depth exploration of the remarkable stock performance of major health insurance carriers in the United States since the passage of the Affordable Care Act (ACA) in 2010. Dr. Eric Bricker, the speaker, begins by highlighting the exceptional compounded annual growth rates (CAGR) of companies like UnitedHealth Group (26%), Anthem (21%), and Cigna (20%), significantly outperforming the S&P 500 (11.7%) and even matching Apple's growth during the same period. He emphasizes that for publicly traded companies, stock price performance is their "raison d'être" or reason for existing, making this financial success a critical indicator of their market power and strategic effectiveness. The core of the video's analysis centers on the concept of "network effects" as the primary driver behind the health insurance carriers' financial success. Dr. Bricker explains that these carriers function as crucial financial intermediaries, much like Visa or Mastercard, facilitating transactions between healthcare providers (doctors, hospitals, pharmacies, pharmaceutical companies, medical device companies) and the ultimate payers (federal and state governments, and employers). This intermediary role, by connecting a vast network of participants, allows them to extract significant value and maintain escalating stock prices due to the inherent power of their established networks. UnitedHealth even refers to itself as a "healthcare services company," underscoring this broader role beyond traditional insurance. However, the video then pivots to discuss the inherent weakness or "Achilles' heel" of all network effects: the ability for participants to bypass the network. Dr. Bricker posits that if a network is disliked or perceived as inefficient, human ingenuity will find ways to go around it. He provides examples of emerging direct care models, such as on-site clinics, near-site clinics, direct primary care, and virtual primary care, which enable providers to receive payment directly from employers or governments without the traditional health insurance intermediary. He draws parallels to historical network effect industries like railways and cable TV, which were largely marginalized by alternative systems (interstate highways/air travel and the internet, respectively). The implication is that a shift from variable, claims-based costs mediated by insurance carriers to fixed-cost direct care models can ultimately shrink the overall healthcare spending pie for payers, as demonstrated by early adopters like municipalities and school systems in high-cost states like Indiana and Wisconsin. Key Takeaways: * **Exceptional Financial Performance of Health Insurance Carriers:** Major health insurance companies like UnitedHealth Group, Anthem, and Cigna have demonstrated extraordinary stock growth since 2010, with CAGRs ranging from 20% to 26%, significantly outpacing the S&P 500 and even matching tech giants like Apple. This highlights their immense financial power and market dominance within the healthcare sector. * **Network Effects as the Core Value Driver:** The success of health insurance carriers is largely attributed to their powerful network effects. They act as essential financial intermediaries, connecting a vast ecosystem of healthcare providers (including pharmaceutical and medical device companies) with payers (governments and employers), thereby facilitating transactions and extracting value. * **Health Insurance as a "Healthcare Services" Business:** Companies like UnitedHealth Group position themselves as "healthcare services companies," indicating their broader role beyond just risk management. This emphasizes their function in managing and orchestrating the flow of funds and services across the healthcare system. * **Inherent Vulnerability of Network Effects:** Despite their power, all network effects possess a fundamental weakness: the ability for participants to bypass the network. If the intermediary is perceived as inefficient or undesirable, alternative pathways will emerge to circumvent it. * **Emergence of Direct Care Models:** A growing trend involves the adoption of direct care models such as on-site clinics, near-site clinics, direct primary care, and virtual primary care. These models allow employers and governments to contract directly with providers, bypassing traditional health insurance carriers and their claims-based systems. * **Shift from Variable to Fixed Costs:** Moving healthcare spending from variable, claims-driven costs (mediated by insurance carriers) to fixed-cost direct care arrangements can lead to overall cost reductions for payers. This represents a fundamental shift in healthcare financing and delivery. * **Historical Precedent for Network Disruption:** The video draws parallels to industries like railways and cable TV, which were once dominant network effect businesses but were eventually marginalized by alternative systems (e.g., interstate highways, air travel, the internet). This suggests a potential future for the health insurance industry if direct care models gain widespread adoption. * **Payers Seeking Alternatives:** Employers and government entities, facing escalating healthcare costs and often fixed revenue streams (like tax revenue for municipalities), are actively seeking and implementing solutions that bypass traditional insurance networks to achieve cost savings. * **Relevance for Pharmaceutical and Medical Device Companies:** As key providers within the healthcare ecosystem, pharmaceutical and medical device companies must understand these evolving financial dynamics. Shifts towards direct care and changes in intermediary roles can significantly impact market access strategies, commercial operations, and patient engagement models. * **Stock Price as a Public Company's "Raison d'être":** For publicly traded companies, their stock price performance is the ultimate measure of success and their reason for existence. This perspective underscores the intense focus on financial outcomes within the healthcare industry and the drivers behind them. * **Early Adopters and Regional Trends:** Municipalities and school systems in states with high healthcare costs, such as Indiana and Wisconsin, are noted as early adopters of on-site clinics. These localized trends can serve as indicators of broader shifts in healthcare delivery and financing. * **Implications for Future Healthcare Finance:** The ongoing success of health insurance carriers, coupled with the emerging trend of network circumvention through direct care, points to a dynamic and potentially disruptive future for healthcare finance, where traditional intermediary roles may be challenged. Tools/Resources Mentioned: * MarketSmith.Investors.com * Netcials.com * Yahoo Finance * Fidelity Contra Fund (as a benchmark for successful mutual funds) Key Concepts: * **Network Effects:** The phenomenon where the value of a product or service increases with the number of users or participants. In healthcare, it refers to the value created by health insurance carriers connecting providers and payers. * **Financial Intermediary:** An entity that acts as a go-between for two parties involved in a financial transaction. Health insurance carriers serve this role between healthcare providers and payers. * **Compounded Annual Growth Rate (CAGR):** The mean annual growth rate of an investment over a specified period longer than one year, assuming the profits are reinvested. * **Raison d'être:** A French phrase meaning "reason for existing," used to describe the primary purpose of a public company (i.e., maximizing shareholder value through stock performance). * **Variable Costs:** Costs that change in proportion to the activity of a business, such as claims paid by an insurance company, which vary with the utilization of healthcare services. * **Fixed Costs:** Costs that do not change regardless of the level of activity, such as the administrative fee (PEPM - Per Employee Per Month) for an on-site clinic. * **On-site Clinics/Near-site Clinics:** Healthcare clinics located at or very close to an employer's premises, offering direct primary care services to employees. * **Direct Primary Care (DPC):** A healthcare model where patients pay a monthly or annual fee directly to their primary care provider for a defined set of services, bypassing insurance. * **Virtual Primary Care:** Primary care services delivered remotely via telecommunication technologies. Examples/Case Studies: * **Health Insurance Carriers:** UnitedHealth Group, Anthem, Cigna, CVS Aetna (including Aetna) are highlighted for their exceptional stock performance post-ACA. * **Comparative Stock Performance:** Apple (matching UnitedHealth's CAGR), S&P 500 (significantly lower CAGR), and Fidelity Contra Fund (successful mutual fund with lower CAGR but including UnitedHealth in its holdings) are used for comparison. * **Historical Network Disruption:** The railway system (marginalized by interstate highways and air travel) and cable TV (marginalized by the internet and streaming services) are presented as historical examples of network effects being circumvented. * **Direct Care Adoption:** Municipalities and school systems in Indiana and Wisconsin are cited as real-world examples of payers adopting on-site clinics to reduce healthcare costs due to high costs and fixed tax revenues.
Healthcare is Slow to Change... Why??
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
May 22, 2022
This video provides an in-depth exploration of why the healthcare industry is notoriously slow to change, attributing this inertia to the inherent resistance within healthcare organizations and the individuals in positions of power. Dr. Eric Bricker, the speaker, begins by establishing that the problem isn't new, referencing organizational research from as far back as 1969 which identifies social dynamics and established relationships as the primary barriers to change. He emphasizes that the challenge lies with people and their reluctance to alter existing social structures. The presentation then delves into contemporary behavioral economics to explain the underlying psychological reasons for this resistance. Dr. Bricker highlights several key phenomena: "loss avoidance," where the fear of failure or loss outweighs the potential thrill of success, leading to a preference for the status quo; "hyperbolic discounting," which causes individuals to heavily devalue long-term benefits in favor of immediate results, hindering the adoption of strategic changes with delayed payoffs; and the observation that many leaders reach the top by *avoiding* failure, fostering a conservative "if it ain't broke, don't fix it" mentality that stifles innovation and risk-taking. Shifting from diagnosis to prescription, the video draws upon insights from McKinsey & Company to outline five actionable solutions for accelerating organizational speed. These include decentralizing authority by distributing decision-making power and financial control, fostering an entrepreneurial mindset that actively encourages and learns from failure, and requiring leaders to visibly lead by example through taking risks and openly experiencing setbacks. Effective persuasion through compelling stories, rather than dry statistics or generic mission statements, is also presented as a crucial communication strategy. Finally, the video advocates for optimizing operational efficiency by conducting small, short, and virtual meetings to minimize time waste. Dr. Bricker illustrates these principles with the compelling case study of Nomi Health, a digital health startup founded in 2019. Nomi Health rapidly scaled to manage significant COVID-19 testing and treatment programs for multiple state governments, airports, schools, and cruise ships, performing 4% of all COVID tests in America within three years. Its success is attributed to its inherent agility, decentralized authority, embrace of failure, and efficient communication, demonstrating that speed is achievable even in healthcare. The video concludes with a biblical analogy of "new wine into old wineskins," suggesting that while established organizations can carve out "bubbles of newness," true transformative speed often comes from new entities or significant internal restructuring to overcome rigid, established relationships, emphasizing that speed is a powerful competitive advantage, often more valuable than vast capital. Key Takeaways: * **Healthcare's Resistance to Change is Human-Centric:** The core reason healthcare is slow to change lies in the people and established social relationships within organizations, not just the complexity of the industry itself. * **Behavioral Economics Drives Inertia:** Key psychological factors like "loss avoidance" (fear of failure outweighs desire for success) and "hyperbolic discounting" (devaluing long-term gains for immediate results) significantly contribute to resistance to change. * **Leadership's Role in Stagnation:** Many leaders achieve their positions by avoiding failure, which can inadvertently create a culture that discourages risk-taking and innovation, perpetuating the status quo. * **Decentralize Authority for Agility:** To accelerate change, organizations must move away from centralized command-and-control structures, empowering more individuals with decision-making authority and financial control. * **Embrace an Entrepreneurial Mindset:** Cultivate a culture where failure is not just tolerated but actively encouraged as a vital learning opportunity, mirroring the approaches of successful innovators like Elon Musk and Jeff Bezos. * **Leaders Must Lead by Example:** For change to permeate an organization, leaders must visibly take risks, experience setbacks, and learn from them, demonstrating that failure is a part of the growth process. * **Persuade Through Stories, Not Statistics:** Effective communication for change relies on compelling narratives that resonate emotionally and persuade individuals, rather than relying solely on data or generic mission statements. * **Optimize Meetings for Efficiency:** To enhance organizational speed, adopt a strategy of holding small, short, and virtual meetings, minimizing time waste associated with large, long, or travel-dependent gatherings. * **New Entities Possess a Speed Advantage:** Startups and new organizations, unburdened by established relationships and rigid structures, can achieve remarkable speed and growth, as exemplified by Nomi Health. * **Carve Out "Bubbles of Newness" in Large Organizations:** For established entities, fostering change may involve creating autonomous, entrepreneurial units or "new wine skins" within the larger organization to circumvent existing rigidities. * **Speed is a Competitive Differentiator:** The ability to move quickly and adapt is a profound competitive advantage, often more impactful than sheer financial resources, enabling rapid market penetration and innovation. Tools/Resources Mentioned: * Harvard Business Review (1969 article on resistance to change) * Health Affairs (article on behavioral economics in healthcare change) * McKinsey & Company (article on solutions for organizational speed) * Nomi Health (digital health startup as a case study) Key Concepts: * **Loss Avoidance:** A behavioral economics principle where individuals are more motivated to avoid a loss than to acquire an equivalent gain. * **Hyperbolic Discounting:** A cognitive bias where the subjective value of a future reward decreases more rapidly as the delay in receiving it increases, leading to a preference for immediate gratification over long-term benefits. * **Entrepreneurial Mindset:** A way of thinking and acting characterized by innovation, risk-taking, and the ability to turn challenges into opportunities, often involving learning from failure. * **Decentralized Authority:** A management approach where decision-making power is distributed throughout a hierarchy rather than being concentrated at the top. Examples/Case Studies: * **Nomi Health:** A digital health startup founded in 2019 that rapidly scaled to become a major provider of COVID-19 testing and treatment programs for state governments, airports, schools, and cruise ships, demonstrating the power of organizational speed and agility. * **Elon Musk & Jeff Bezos:** Cited as examples of leaders who embrace failure as a critical part of their entrepreneurial journey and learning process, encouraging risk-taking and innovation.
Forge Biologics Fireside Chat: Accelerating Quality Manufacturing
Veeva Systems Inc
/@VeevaSystems
May 13, 2022
This video features a fireside chat with Meghan Leonard, VP of Quality Management at Forge Biologics, an emerging CDMO specializing in gene therapy manufacturing. She discusses Forge's journey in implementing Veeva Vault Quality solutions (Quality Docs, Training, and QMS) to establish a robust and compliant quality management system from its inception in 2020. The conversation highlights the critical factors for selecting a modern cloud-based QMS, the benefits realized in terms of efficiency and compliance, and strategies for maintaining speed in a rapidly innovating field while upholding strict quality standards. Key Takeaways: * **Strategic QMS Implementation for CDMOs:** Forge Biologics prioritized implementing a robust, user-friendly electronic Quality Management System (eQMS) early on, recognizing the stringent regulatory and compliance requirements inherent to being a CDMO in the gene therapy space. * **Leadership Commitment to Quality:** A strong commitment from the leadership team to fostering a quality culture and making the necessary financial and operational investments in quality systems was crucial for successful adoption and perceived value, even in a startup environment. * **Key Evaluation Criteria for eQMS:** Critical factors for selecting a QMS included the vendor's industry experience and reputation, minimal initial configuration and validation effort, ease of ongoing system administration, rapid implementation timeline, and a positive end-user experience. * **Efficiency and Compliance Benefits:** Modern eQMS solutions like Veeva Vault enable significant improvements in staff efficiency through features like collaborative authoring and remote approvals, drastically reducing document review and issuance times compared to traditional paper-based systems. They also provide real-time data metrics and quality reporting for actionable insights and KPI tracking. * **Enhanced External Collaboration:** The ability to leverage external user licenses within the QMS facilitates robust supplier quality management programs and allows clients secure access for document control, change control, and issue escalation, streamlining collaboration across the supply chain. * **Agile Implementation with Out-of-the-Box Solutions:** For new or rapidly growing organizations, utilizing out-of-the-box configurations with minimal customization can accelerate QMS implementation and validation, enabling faster market access for therapies without compromising quality.
TMF QC Discussion
Power of Work
/@powerofwork6914
May 10, 2022
This video provides a practical guide to Trial Master File (TMF) Quality Control (QC), focusing on the meticulous review process essential for regulatory compliance and inspection readiness in clinical trials. The speaker details the critical steps involved in QC, from verifying document legibility and completeness to ensuring accurate metadata entry within systems like Veeva eTMF. The discussion highlights the significance of adhering to Good Clinical Practices (GCP) principles, specifically ALCOA-C, and identifies common documentation errors such as missing signatures or incorrect dates. Furthermore, the video delves into the interdependencies of various clinical trial documents, including FDA Form 1572, financial disclosure forms, training logs for Site Initiation Visits (SIVs), monitoring reports, and investigational product shipment forms, underscoring the collaborative effort required from study teams, monitors, and clinical trial assistants (CTAs) to maintain an accurate and up-to-date TMF. Key Takeaways: * **TMF QC is paramount for regulatory inspection readiness:** The primary purpose of TMF QC is to ensure documents meet regulatory requirements (e.g., FDA) and are prepared for audits, preventing delays in drug approval. * **Adherence to ALCOA-C principles is fundamental:** TMF documents must be Attributable, Legible, Contemporaneous, Original, Accurate, and Complete to ensure data integrity and compliance, a core tenet of Good Clinical Practices (GCP). * **Comprehensive document review involves multiple checks:** QC encompasses verifying legibility, page inclusion, required signatures, correct dates, accurate document titles, classification, linking, and expiry status, often by comparing physical documents to system metadata. * **Veeva eTMF is a key platform for TMF management:** The video explicitly references the Veeva eTMF home screen and metadata sections, indicating its widespread use in the industry and the importance of understanding its functionalities for effective TMF QC. * **Interconnectedness of clinical trial documentation:** Various documents like monitoring reports, follow-up letters, training logs (especially for Site Initiation Visits), and investigational product shipment forms are interdependent and must be reviewed as a complete packet to ensure study integrity. * **Site training and turnover impact TMF quality:** Effective training during Site Initiation Visits (SIVs) and proactive management of site staff turnover are crucial for maintaining high-quality documentation and preventing errors due to lack of knowledge or experience. * **The Clinical Trial Assistant (CTA) role is foundational:** CTAs play a critical role in managing and QCing TMF documents, highlighting the need for robust processes and training for entry-level positions in clinical operations.
Multiple Sclerosis for the Employee Benefits Professional
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
May 8, 2022
This video, presented by Dr. Eric Bricker of AHealthcareZ, provides a detailed explanation of Multiple Sclerosis (MS) specifically tailored for employee benefits professionals. Its primary purpose is to educate this audience on the nature of MS, its prevalence, the significant financial and personal impact it has on individuals and health plans, and the crucial role of comprehensive support systems. Dr. Bricker emphasizes that understanding MS goes beyond just its medical definition, delving into the complex biopsychosocial challenges faced by patients and their families. The presentation begins by defining Multiple Sclerosis as an autoimmune disease where the body's immune system attacks the brain and spinal cord, specifically targeting the myelin sheath around neurons. This damage disrupts electrical impulses, leading to varied neurological symptoms such as weakness, numbness, muscle spasticity, bladder problems, visual disturbances, and even temporary blindness. The disease often manifests in a "relapsing and remitting" pattern, with periods of symptom flares followed by quiet phases. Dr. Bricker highlights the prevalence of MS, noting that approximately 914,000 Americans live with the condition, translating to about 1 in every 286 adults, with initial diagnoses typically occurring between ages 20 and 40. He illustrates this with a practical example: an employer-sponsored health plan with 1,000 adult members would statistically have about three individuals with MS. A significant portion of the video is dedicated to the financial implications and treatment modalities for MS. Inpatient hospitalizations for severe flares, often involving IV steroids or plasmapheresis (a blood purification procedure), can range from $10,000 to over $100,000 per stay. For long-term management, various outpatient medications are available, including IV infusions, injections, and pills designed to minimize relapses. Dr. Bricker specifically mentions Gilenya and Tecfidera as common oral medications. He details the high cost of these specialty drugs, citing Gilenya at roughly $9,500 per month without insurance, and explains how manufacturer copay assistance programs (e.g., covering up to $18,000 in out-of-pocket costs) can reduce patient burden but still leave the health plan responsible for substantial costs (e.g., $48,000 annually for Gilenya after a typical 20% co-insurance). He also notes that Tecfidera now has a generic equivalent (dimethyl fumarate) at a significantly lower cost of about $640 per month. Beyond the disease-modifying therapies, the video underscores that MS patients frequently require a host of additional medications and services to manage co-occurring conditions and symptoms. These include treatments for bladder issues, depression (which is highly prevalent among MS patients), pain, fatigue, and muscle spasticity. Physical therapy is also a common and often ongoing need, frequently exceeding typical plan limits of 16 visits per year. Dr. Bricker emphasizes the "biopsychosocial model of disease," explaining that MS profoundly impacts not only the individual's physical health but also their family, work, income, and mental well-being. He concludes by stressing the critical need for employee benefits professionals to utilize data analytics (e.g., ICD-10 codes) to identify plan members with MS and ensure they receive consistent, high-quality case management, nursing support, and healthcare navigation with frequent interactions, advocating for a "friend-like" level of support due to the complexity of the condition. Key Takeaways: * **Prevalence and Demographics of MS:** Multiple Sclerosis affects approximately 914,000 adults in the U.S., or 1 in every 286 adults, with initial diagnosis most common between the ages of 20 and 40. This means most large employer health plans will have members living with MS. * **Nature of MS and Symptoms:** MS is an autoimmune disease attacking the brain and spinal cord's myelin sheath, leading to a wide range of neurological symptoms including weakness, numbness, visual problems, muscle spasticity, and bladder issues, often in a relapsing-remitting pattern. * **High Costs of Inpatient Care:** Hospitalizations for MS flares, involving treatments like IV steroids or plasmapheresis, can incur significant costs ranging from $10,000 to over $100,000, depending on the severity and duration of the stay. * **Expensive Outpatient Medications:** Disease-modifying therapies (DMTs) for MS, particularly specialty pharmaceuticals like Gilenya (brand-only), are extremely costly, with Gilenya priced around $9,500 per month without PBM negotiation. * **Impact of Copay Assistance Programs:** While manufacturer copay assistance programs can significantly reduce patients' out-of-pocket expenses (e.g., up to $18,000), they shift the majority of the drug cost burden directly onto the health plan, which can still pay tens of thousands annually per patient. * **Generic Options and Cost Savings:** The availability of generic equivalents, such as dimethyl fumarate for Tecfidera, offers substantial cost savings, being approximately one-eighth the cost of brand-name alternatives. * **Multifaceted Treatment Needs:** MS patients often require a comprehensive treatment approach beyond DMTs, including medications for co-morbidities like depression, pain, bladder dysfunction, and muscle spasticity, as well as ongoing physical therapy that may exceed standard plan limits. * **Biopsychosocial Impact:** MS is a complex condition with profound biopsychosocial implications, affecting not only the patient's physical health but also their mental well-being, family dynamics, ability to work, and financial stability. * **Importance of Case Management and Navigation:** Due to the complexity of MS and its treatment, robust and frequent case management, nursing support, and healthcare navigation are crucial for patients and their families to ensure adherence, manage symptoms, and coordinate care. * **Data-Driven Patient Identification:** Employee benefits professionals (and by extension, pharmaceutical companies) should leverage data analytics, specifically ICD-10 codes, to identify plan members with MS and proactively offer tailored support and resources. * **Managing Medication Side Effects:** The numerous medications taken by MS patients often come with their own side effects, requiring careful management in addition to treating the underlying disease. * **Need for Continuous Support:** The chronic and relapsing nature of MS necessitates ongoing, personalized support and advocacy, rather than episodic interventions, to help patients navigate their complex medical journey. Tools/Resources Mentioned: * LinkedIn (for video requests) * Mayo Clinic (mayoclinic.org) - Source for MS symptoms/causes * HealthWarehouse.com - Source for Tecfidera pricing * PharmacyChecker.com - Source for Gilenya pricing * National MS Society (nationalmssociety.org) - Sources for MS medications and prevalence data * "16 Lessons in the Business of Healing" by Dr. Bricker (book) Key Concepts: * **Autoimmune Disease:** A condition in which the body's immune system mistakenly attacks its own healthy tissues. * **Myelin Sheath:** The insulating layer around nerves, including those in the brain and spinal cord, that allows electrical impulses to transmit quickly and efficiently. Damage to this is central to MS. * **Relapsing-Remitting MS:** The most common form of MS, characterized by clearly defined attacks (relapses) of new or increasing neurological symptoms, followed by periods of partial or complete recovery (remissions). * **Plasmapheresis:** A medical procedure that involves removing blood plasma, separating it from blood cells, and replacing it with a substitute fluid (like albumin) before returning the blood cells to the body. Used to remove antibodies in autoimmune diseases. * **Corticosteroids:** A class of steroid hormones used to reduce inflammation and suppress the immune system. * **Specialty Pharmacy:** A pharmacy that dispenses high-cost, high-touch, and often complex medications for chronic or rare conditions. * **Copay Assistance Program:** Programs offered by pharmaceutical manufacturers to help patients afford their medications by covering a portion of their out-of-pocket costs (e.g., co-pays, co-insurance). * **PBM (Pharmacy Benefit Manager):** A third-party administrator of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, and other government-sponsored programs. They negotiate drug prices. * **Biopsychosocial Model of Disease:** A framework that recognizes the interconnectedness of biological, psychological, and social factors in understanding health, illness, and healthcare delivery. * **ICD-10 Codes:** International Classification of Diseases, 10th Revision, a standardized system used to classify diseases and health problems for clinical and administrative purposes, including identifying patient populations. * **Case Management/Healthcare Navigation:** Services that help patients coordinate their care, understand their treatment plans, access resources, and navigate the complex healthcare system. Examples/Case Studies: * **Prevalence Example:** A statistically average employer-sponsored health plan with 1,000 adults would have approximately 3 members with MS. * **Patient Case:** A 19-year-old gentleman presenting with sudden weakness in one hand, illustrating a classic initial presentation of MS. * **Drug Cost Examples:** Gilenya (brand-only) costing ~$9,500/month; Tecfidera (with generic dimethyl fumarate) costing ~$640/month. * **Copay Assistance Scenario:** A patient with 20% co-insurance on a $5,000 PBM-negotiated drug price would owe $1,000/month, totaling $12,000/year, which could be covered by an $18,000 copay assistance program, leaving the plan to pay $48,000/year.
VEEVA CRM Training – VEEVA CRM Online Training – (VEEVA CRM Certification Tips)– VEEVA CRM Course
MaxMunus Training
/@maxmunustraining
Apr 19, 2022
This video provides an overview of Veeva CRM training, emphasizing its specific design and application within the life sciences industry. The speaker details a comprehensive course content covering Veeva CRM architecture, administration, data security, application configuration, custom object creation, and various functionalities like call management, cycle plans, sample management, data loading, and reporting. The discussion also highlights the benefits of Veeva CRM for life sciences, such as coordinating planning, boosting productivity while ensuring compliance, and driving continuous improvement. Furthermore, the video addresses career opportunities and certification for Veeva CRM professionals, showcasing significant global demand for these skills. Key Takeaways: * **Life Sciences Specialization:** Veeva CRM is presented as the premier multi-channel CRM solution explicitly designed for the unique needs of the life sciences industry, including drug companies, medical institutions, and healthcare organizations, enabling integrated 360-degree planning and execution. * **Extensive Configuration Capabilities:** The detailed course content underscores the depth of Veeva CRM's configurability, from foundational elements like system architecture and admin console to advanced features such as custom objects, data access security, call management, sample management, and territory management. * **Compliance and Productivity Focus:** A core benefit highlighted is Veeva CRM's ability to enhance commercial operations by improving collaboration, optimizing sales utilization, and ensuring field teams engage compliantly with healthcare providers * **High Market Demand for Expertise:** The video demonstrates a robust global job market for Veeva CRM professionals, with numerous openings and competitive compensation, indicating a critical need for specialized skills in implementation, configuration, and ongoing management of the platform. * **Implementation-Level Training:** The training emphasizes a practical, implementation, and configuration-level approach, aiming to make participants "project-ready" from day one. This suggests that hands-on, deep technical expertise is paramount for successful Veeva CRM deployment and optimization within client environments.