Medical & Commercial

Developing a Clinical Outcome Assessment (COA) strategy too late can compromise endpoints, delay timelines, and devalue study evidence. Join these experts to explore practical strategies for early COA planning, instrument selection, global linguistic validation, and meeting regulatory evidence expectations before locking your endpoints.

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For life sciences companies, having data isn't the same as having the right data. In this webinar, experts explain what "fit for purpose" really means in real-world data, and why assuming a single dataset works across all studies is a costly mistake. They'll also discuss where AI fits in, and where it doesn't, when it comes to extracting and harmonizing RWD without losing the epidemiological rigor that sound evidence generation demands.

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Explore how patient-generated insights strengthen real-world evidence — improving data quality, closing gaps, and driving better clinical and commercial decisions.

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Join this webinar to explore how policy shifts under the IRA intersect with health equity, what challenges remain, and what strategies stakeholders are using to promote fairness in access and affordability.

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Discover how NMA enhances comparative effectiveness research, informs healthcare policies, and drives optimized patient outcomes in an evolving treatment landscape.

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Join us to learn more about the importance of laboratory sustainability, how the industry can work together to create a culture of sustainability in science and ways sustainability can support the growth of your business.

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There are over 7,000 orphan and rare diseases known to impact approximately 1 in 17 individuals globally, or 50 million in the EU and USA alone. The development of safe, effective, and accessible therapies against these diseases has been challenged by manufacturing, clinical and regulatory hurdles. Despite these obstacles, increased awareness, greater funding, and new research technologies are driving discoveries in this area. Watch to learn how various research groups are working in this space.

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In this webinar, ICON experts discuss strategies for managing EU Joint Clinical Assessment (JCA) requirements and their impact on local health assessments.

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Real-world evidence (RWE) is revolutionizing healthcare, but harnessing the power of routine patient health records for regulatory-compliant RWE studies presents unique challenges.

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In this webinar, experts present an overview of systematic literature reviews, detailing their purpose, execution, decision-making criteria, and suitability for addressing key questions in the pharmaceutical industry.

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Watch to hear the techniques of survival analysis, their application in economic evaluations, and lessons learned from conducting survival analysis on immature data, addressing the challenges of analyzing different outcomes.

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Watch the speakers delve into how early attention to market access can significantly influence value creation for biotech and pharmaceutical companies, as well as investors, with this panel sharing their own experiences.

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This webinar, hosted by experts from Panalgo and OM1, looks at the scientific and operational details behind study replication, using vitiligo and alopecia areata as an example.

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In this webinar, Dr. Joseph Zabinski discusses the digital phenotyping process and several concrete applications to demonstrate how AI can add value to analyses of the patient journey across the life sciences spectrum.

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Keep your finger on the economic pulse of the RWE, HEOR, and Market Access fields. This session focuses on the latest salary and bonus trends for professionals in the field, including a comprehensive overview of the ways industry, job level, location, demographics, and more factor into compensation.

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Hear this panel's discussion on the strategic use of external control arms and, if done correctly, how they can help bring products to market in a shorter time and for lower costs.

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In this webinar, experts deep dive into Delphi panel methods, their implementation, and pharmaceutical industry insights on the panels' use and outcomes.

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This event illuminates the intricacies of animal welfare legislation, specifically comparing and distinguishing differences between EU, UK, and North American standards.

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In this webinar, panelists address integrating patient-centered research into real-world studies, focusing on diversity, equity, and inclusion (DEI), and developing systemic approaches for a more equitable research ecosystem.

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Hear four panelists discuss the role of integrated evidence generation in healthcare, focusing on its impact on patient outcomes and healthcare decision-making.

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In this event, we focus on the Asia Pacific region, uncovering the landscape of animal welfare legislation and its implications for pharmaceutical and biotech players.

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Watch this webinar on addressing early onset cancer through strategic trial design, targeted launch indications, and increased trial access to speed up the delivery of impactful treatments.

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Watch as we delve into the nuances of animal welfare legislation in North America, specifically addressing the needs of clients and suppliers in the pharmaceutical and biotech sectors.

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This webinar delves into the dynamic landscape of COAs, examining their historical use and significance, current uses and best practices, and making a case for greater standardization in their implementation.

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This panel discusses several policy aspects regarding the current challenges and implications of the EU Health Technology Assessment (HTA) regulation.

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This webinar discusses how early stage planning taking into account commercial production, logistics, reimbursement, and health inequities can lead to successful approvals and market adoption.

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Watch this webinar exploring real challenges and solutions for generating patient-centered real-world evidence (RWE) in the context of rare diseases to support clinical development through commercial post-approval.

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Christopher Perry, PhD discusses how his laboratory aims to discover mechanisms by which metabolic dysfunction causes muscle weakness and apply these findings to develop new therapies for muscle disorders. Homira Osman, PhD provides a particular focus on leveraging scientific findings for practice and policy and linking trainees with patient communities.

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As science has enabled care for previously untreatable, ultra-rare conditions, health systems and governments are struggling with ways of financing research and development of these therapies. What are the solutions when the science has progressed, but the economics haven't?

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Our present healthcare system focuses on treating people when they are ill rather than keeping them healthy. We have been using big data and remote monitoring approaches to monitor people while they are healthy to keep them that way and detect disease at its earliest moment presymptomatically. We use advanced multiomics technologies (genomics, immunomics, transcriptomics, proteomics, metabolomics, microbiomics) as well as wearables and microsampling for actively monitoring health. Following a group of 109 individuals for up to 13 years revealed numerous major health discoveries covering cardiovascular disease, oncology, metabolic health and infectious disease. We have also found that individuals have distinct aging patterns that can be measured in an actionable period of time. Finally, we have used wearable devices for early detection of infectious disease, including COVID-19 as well as microsampling for monitoring and improving lifestyle. We believe that advanced technologies have the potential to transform healthcare and keep people healthy.

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In this webinar, Evidera experts present guidance on why strong connections with registry groups and stakeholder populations are important for generating relevant real-world evidence to advance treatments.

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ICON's COA Linguistic Validation Leaders highlight the importance of Linguistic Validation and how equivalence should be a key focus during the development of Clinical Outcome Assessment translations.

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As the volume of the real word evidence data increases, the mechanisms to collect and translate the data into meaningful insights for pharmaceutical organisations becomes increasingly complex. Advances in technologies such as artificial technology have delivered global excitement, but mastering how to leverage AI for meaningful patient outcomes remains uncracked.

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The political issues circling the FDA this year could potentially ripple into biopharma on a scale that's never been seen before. All eyes are on the FDA's response to recent court rulings around the abortion pill mifepristone — and the potential effects on other approvals that might be questioned. What does the future look like, exactly? Join Endpoints' Senior Editor Zachary Brennan in an expert panel to unpack what may come next. We'll also touch on how the FDA is looking for new ways to spur more rare disease drug development with a fireside chat.

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Market access is the bridge between clinical and commercial functions, and plays a pivotal role in product launch. Success in market access is defined by the outcome of payer decisions - whether nationally or regionally. While measuring global market access performance has been on the agenda for some time, understanding success is becoming a priority at board and leadership level.

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Join Jonathan Edelheit, Chairman and Co-founder of the Corporate Wellness Association as he talks about the Certified Corporate Wellness Specialist and find out if it is the right certification for you. The Certified Corporate Wellness Specialist program is designed to help organizations improve the health and well-being of their employees while also reducing healthcare costs. The program includes 11 modules that cover topics such as leadership, culture, cost savings, mental health, wellness technology, employee well-being, diversity, equity, and inclusion. It also covers the essentials of program design, delivery, and evaluation.

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The L7|LIVE SF seminar will explore the ways in which digital technologies, such as unified platforms, are revolutionizing the biotech and life science industries, transforming business models, breaking down data silos, reducing turnaround times, and creating more consistent and reproducible processes. Our panel of experts will share their insights and experiences on these needed cutting-edge technologies and the trends laying the foundation for the future of life sciences.

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The promise of improving patient care and outcomes through RWD has been understood for some time, but overcoming the fragmentation and inaccessibility of disparate data sources across disease states has proven to be a hard challenge across the industry. We're not learning fast enough— this is where clinical expert-led AI can help. By using AI to standardize unprecedented volumes of data, uncover clinical details that have previously been hidden in free text notes, and represent full patient journeys in near real-time, researchers can ask and answer complex questions for targeted populations like never before.

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A panel discussion will examine how connected communities using data-driven, virtual and automated technologies are advancing and refining population health strategies. Discover ways health leaders can advance interoperability, intelligent processing and data security so their organizations can respond to consumer demands and take on risk.

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Watch a panel of OM1's clinical experts in cardiometabolic disease, immunology, and mental health as they explore how Artificial Intelligence (AI) can find phenotypic patterns and unlock insights hidden in real-world data.

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Health systems are reimagining the hospital of the future. New technologies like real-time asset tracking, artificial intelligence, and applied virtual/augmented reality will be integral to delivering next-generation, interventional care with real-time insights at the point of care. But an infrastructure transformation will be necessary to deliver those capabilities and power innovation roadmaps.

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Join us as we discuss how the healthcare landscape is changing in technology and clinical trial innovation, including diversity improvement, leveraging real-world evidence, comparative arms, and decentralized clinical trials.

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Looking to empower your organizations with high quality patient data? Human abstraction has long been considered the gold standard for extracting high quality information from EHR data. With the rise of NLP, large language models, and machine learning, the question becomes: how should we evaluate these new technologies against the traditional abstraction methods?

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In this webinar presented by EXL Health, you'll hear engaging discussions from industry leaders on how healthcare organizations can harness the power of data to achieve a sustainable business advantage. Centered around the building blocks of data-led value creation, cloud enabled solutions, and enterprise architecture, you'll discover the steps needed to turn your data into a trusted, strategic asset.

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Siloed systems, data and processes are stalling digital transformation. For healthcare organizations to truly gain a 360-degree view of their patients and providers, critical data currently scattered across various systems needs to be brought together in one place.

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The International Agency for Research on Cancer (IARC) published a report called "Global Cancer Observatory" which shows that in 2020, almost 20 million new cancer cases were reported worldwide, leading to almost 10 million deaths. The prevalence of cancer worldwide over a five-year period exceeds 50 million cases. According to the same report, by 2040, the number of new cancer cases per year is expected to reach 30.2 million, representing a 57% increase compared to 2020.

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Patients have been very clear: They want care that is convenient and accessible, personalized and streamlined — and often, delivered outside of the hospital. By 2025, expenditures on in-home care services for Medicare fee-for-service and Medicare Advantage beneficiaries could reach $265 billion, creating new challenges and opportunities for the technology that powers the distributed care model.

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We've all seen the studies showing data-driven organizations grow faster, are more profitable, and have a faster time to market. Why does gaining insights from data seem to take so long? In this webinar, we will review practical and successful approaches to executing on a doable data strategy.

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Hear expert panelists bring their perspectives on critical issues around support for Medicare Part D products' fair market prices.

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RFA-AG-24-009 invites applications for the Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) Real-World Data (RWD) Platform initiative. This Platform aims to transform the AD/ADRD research enterprise by serving as a central hub of research access that seeks to: 1) improve applicability and generalizability of findings through larger datasets that include more diverse populations; 2) capture more complete information through linking a variety of data sources; 3) increase the speed at which scientific questions can be answered; and 4) improve researchers' ability to answer questions that cannot be feasibly or readily answered via clinical trial.

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The European Union Medical Device Regulation (EU MDR) governs the production, distribution of medical devices in Europe, and compliance is mandatory for companies who wish to sell medical devices in European markets. These regulations have significant implications across the medical device product lifecycle including product design & development, commercialization and post-market surveillance.

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The Centers for Medicare and Medicaid Services (CMS) has proposed a new rule for improving patient and provider access to health information and streamlining processes related to prior authorization for medical items and services. It is key for all payers and providers to stay up-to-date on all the latest information in order to be fully prepared. Prior authorizations are intended to manage high-quality care, yet existing prior authorization processes have failed to deliver efficiency and scalability. Join us for this important one-hour discussion to explore what improvements are being mandated, the latest solutions available for eliminating inefficiencies, how to yield tangible improvements for both your organization and your partners, strategies to implement now to ensure compliance, and more.

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Join three panelists who provide a practical overview of how and why to use data from Medicare for real world studies.

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Hear Pamela Landsman-Blumberg and Rick Chapman highlight the importance of SDOH and discuss examples of how claims data and EMR linked with SDOH can inform use cases.

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Sure, you've used claims and electronic health records in your research. But have you ever explored linking phenotypic and genomic or other -omic data to assess the full view of the patient journey? In this fireside chat with experts from Optum Life Sciences and DNAnexus, learn how longitudinal, linked data sets enable life sciences companies to discover new druggable targets, identify potential treatment populations, understand the genetic testing landscape and barriers to access, and more.

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This panel of real-world evidence (RWE) experts explore the economic impact and role of RWE in improving representativeness of research.

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Join us to discover how leveraging dynamic workflows to review, query, track, and collaborate cross-functionally in a clinical trial can result in better trial conduct, potential study amendments, and evolving clinical strategies.

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The clinical trial landscape has evolved in such a way that it's more challenging to find sites and patients than ever before. Data and analytics combined with deep therapeutic and operational expertise can bring therapies to patients faster. In this webinar, therapeutic and data science experts will discuss how real-world and clinical trial data inform the end-to-end clinical development strategy.

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The CVS- Oak Street Health deal is just the latest example of major players in health care expanding their reach and Payvider capabilities. Clearly this is a tipping point for providers and payers to gain more control to deliver high-quality, cost-effective, consumer-centric care.

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It's no secret that Phase 4 trials are incredibly time consuming, costly, and pose major challenges for sponsors and CROs alike. Whether it's Long Term Follow Up (LTFU), Rollover, and Observational studies, or Registry and Consumer Health studies, sponsors often struggle to recruit and retain large numbers of participants. They also have difficulties addressing post-marketing commitments to assess long term drug safety and efficacy.

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Hear several experts address systematic literature review issues that can negatively affect your Global Value Dossiers (GVDs) and how automation can improve your product's market access.

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In this interactive webinar, brought to you by IQVIA, we will explore the critical role for mutually beneficial partnership between the pharmaceutical industry and the NHS in helping to deliver better outcomes for patients, especially as critical efficiencies need to be identified in the wake of this global pandemic.

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Hear from a panel of Life Science experts on the latest advancements and innovative modalities paving the way in the global vaccine development space. What has been COVID-19's impact on drug development and the regulatory landscape? Key factors contributing to Asia Pacific being recognised as the hub for vaccine development and opportunities for biotech's to leverage. Key considerations for pre-clinical and clinical planning to accelerate vaccine development, supporting a robust global strategy.

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NTT DATA and Snowflake will discuss how to navigate the challenges of newly available health plan pricing transparency data due to the CMS Transparency in Coverage ruling. Our data model powered by Snowflake provides a comprehensive solution that allows provider negotiation teams to use this data to their competitive advantage and ensures high value utilization through easy consumption. We will walk through the three most important components of this solution that enable users to compare negotiated rates down to the procedure code level across facilities with incorporated metrics. The session includes a live demo of the sample executive reports that can be produced per client basis followed by an informative discussion on Snowflake's strategy in the healthcare space.

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On Demand (Subscribers)

In this free webinar, learn how to leverage real-world data and existing digital health data to develop and validate digital biomarkers. Attendees will learn what to look for in a digital biomarker and what it takes to validate one. The featured speakers will discuss key success factors in reusing existing digital health data and some of the regulatory and clinical decision-making considerations. Attendees will also learn how to manage patient privacy issues.

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In this webinar, we will discuss the differences and commonalities among major global agencies, including US FDA, EMA, and China NMPA. Building upon that, we will discuss approaches to build a robust data package that satisfies expectations from global health authorities for clinical and commercial regulatory filings. We will share real-world case studies of how WuXi STA supported clients with their China filing strategies and expedited development and commercialization in China.

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In this webinar, experienced revenue cycle operators will discuss the new report's findings, common issues related to payer adjudication and the gaps seen in revenue cycle processes that often lead to underpayments. Speakers will also provide an overview of effective resolution strategies that have been deployed across more than 200 hospitals nationwide to tackle these very problems.

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Self-pay accounts are far more time-consuming and costly to collect on than those billed to commercial payers. Unfortunately, they're on the rise. To protect your margins in unpredictable financial times, it's crucial to find available coverage whenever and wherever you can.Â

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Real-World evidence (RWE) has recently received increased attention to provide supplementary evidence to support health technology assessment (HTA) submissions, especially as another source of insight into the real-world performance of novel therapeutic products, particularly when traditional randomized controlled trials (RCTs) are impractical or lack generalizability. This webinar will focus on understanding how different HTA bodies view the use of RWE to estimate comparative treatment effects for HTA submissions. A case-study using RWE identified through an ongoing International Society for Pharmacoepidemiology (ISPE) funded project will be presented to the representatives of different HTA bodies to understand how they might evaluate the credibility of such evidence in the context of the HTA process with emphasis on issues around data quality and methodological rigor. An interactive discussion between the presenters will provide an opportunity to discuss trade-offs between data availability, quality and applicability of RWE use in HTA submissions, along with challenges in the interpretation of such evidence for healthcare decision making.

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Deepak Sahu, MBA, explains how HEOR studies are important for generating useful effectiveness data for success of medical technologies.

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In this webinar, experts provide an overview of causal inference, along with step-by-step guidance to designing these studies using real-world healthcare data.

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In this webinar, brought to you by the company behind A Life in a Day, patient centricity experts will draw from their own experiences to debate questions around how and why to measure these initiatives. Is it important to measure impact and prove outcomes, or is it enough to improve the patient experience for its own sake? Is it even possible to create meaningful measurements for patient centric activities, and if so, what do those measurements look like?

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In this free webinar, learn about the value of real-world data as a critical business tool to guide brand strategy and find the right patients for best outcomes. Attendees will get answers to common questions pertaining to the access of, application and process behind working with real-world data. The featured speakers will discuss how to build confidence when working with real-world data to extract insights for aligned and informed business processes.

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In this webinar, representatives from different stakeholder groups (patients, physicians, health economists and industry) will discuss the value of increasing the use of non-OS endpoints in reimbursement decision-making to their stakeholder groups. Using the example of multiple myeloma, the speakers will discuss how and when non-OS endpoints should be used, to support a future in which assessments of novel therapies are more fit-for-purpose.Â

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The news that a prominent insurer had decided to cover a digital therapeutic for opioid disorder spurred national headlines recently. In this case, the therapeutic had a breakthrough designation from the FDA. That payer decision underscored the potential as well as the challenges that have arisen around developing and marketing digital therapeutics, which have become a fast-growing segment within digital healthcare. DTx delivers clinical interventions directly to patients via software to treat, manage or prevent disease - ranging from behavioral health conditions to diabetes. We'll take a close look at this burgeoning field and see where we're headed in the years to come.

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Hear four experts from ICON and Kap Code provide insights on how to collect, use, analyze, and interpret social media data in different contexts. These experts share knowledge from over fifteen years of successfully developing and adapting algorithms to treat this kind of data.

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Experts provide a deep dive into what Health Technology Assessment (HTA) agencies do and the types of literature reviews they do.

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In this free webinar, learn about the importance of real-world evidence (RWE) as an end-to-end capability. Attendees will gain insights into meaningful ways to leverage RWE for business growth today and in the future. The featured speakers will discuss obstacles and roadblocks to future success and implementation.

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Insights are the foundation to make smarter, data-driven, customer-centric business decisions that accelerate growth commercial success and build your commercial powerhouse. But there are still gaps in the way we handle the end-to-end insight processes: from capturing the insights that field forces generate to processing data and forming easy-to-action analytics; and from closing insight loops to meeting customer needs.

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At this workshop, hosted by Penn State's Clinical and Translational Science Institute (CTSI) and Institute for Computational and Data Sciences (ICDS), three research groups from the College of Medicine will discuss why and how they have applied AI methods in their research. Attendees will also learn about the resources available to all Penn State researchers through CTSI and ICDS, which include access to anonymized electronic health records data, cloud-based analysis tools, and a computational consulting team that supports data science and AI throughout the University.

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Evidence Matters is a virtual one-day summit that brings the literature review community together from different industries to learn, engage, and solve ever-pressing evidence-based research challenges.

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Join us for this webinar covering common research questions and best practices. We will address questions academic researchers face and provide solutions to these common questions. Experts from IQVIA will also discuss RWD best practices.

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Watch experts from PHAR, Novartis, and Bausch Health discuss the Delphi panels and how the results are used.

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Experts present opportunities for using agile platforms and fit-for-purpose engagement models that can drive an iterative approach to obtaining payer insights and developing impactful evidence generation strategies.

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As we adjust to the post-COVID environment, hear from industry leaders about the biotech global investment and drug pipeline environment. In addition, we'll look at why biotech companies are increasingly exploring clinical opportunities in APAC, to achieve FDA accepted data and what actionable strategies can be implemented to leverage APAC's streamlined regulatory processes and accelerated clinical development. Our Regulatory affairs leaders from North America and Australia will share insight into processes supporting a robust clinical program, and how Phase 1 FDA accepted data from Australia, specifically, can launch global drug development programs.

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Watch this panel discussion to hear experts from patient advocacy, health literacy, and Health Economics and Outcomes Research (HEOR).

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This webinar, led by the task force co-chairs, will focus on why a joint HTAi-ISPOR Task Force was formed to develop guidance, they will present the minimum set of considerations on the use of deliberative processes in HTA (checklist), and the approach used. During the webinar, participants will have the opportunity to discuss what efforts could be made to ensure the appropriate use and uptake of the guidance, potential gaps and what more might be needed.

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Hear ICON experts give an in-depth overview of infectious disease modeling with a focus on assessment of interventions and its challenges.

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Despite all of their promise, newer medicines, especially those based on advanced technologies, have been met with unprecedented challenges in scaling up manufacturing, quality control and commercial launch. Hear how developers have approached different aspects of the manufacturing process to bring new and innovative treatments to patients.

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Join us for the Signal event on September 27, 2022 to learn about the Danish experience with ATMP valuation approach and development of an innovative outcomes-based pricing agreement between pharma and payers. You will gain insight into the practicalities of stakeholder involvement and data requirements, and overall learnings from the outcomes-based pricing agreement experience from a multistakeholder perspective.

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Join Drs. Nitin Baliga and Thomas Brown for an in-depth discussion on utilizing real-world data, machine learning, and systems biology for benefiting therapeutic development.

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This solution-focused, truth-packed session is a great fit for market access marketers, brand marketers and sales leaders who are interested in making their brands' market access a top advantage over the competition.

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On Aug 7th, 2022, the US House of representatives passed a bill on budget reconciliation which included a section on US Drug pricing reform (Part B). The reform requires federal government to negotiate drug prices under Medicare to ensure significant discounts on branded therapies and eliminate annual price increases. The bill further requires pharmaceutical companies to pay rebates if drug prices rise faster than inflation for Medicare and private insurances.

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Join Precision ADVANCE and Endpoints News as we kick off Cell & Gene Day, where we'll convene three expert panels to find out where the field stands today and explore funding, development and launch strategies to smooth out the ride to commercialization.

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Join Dr. Greg Johnson, CEO of Hospital Medicine and Chief Diversity Officer at Sound Physicians, for an engaging discussion where he will share how to confront these care gaps and advance health equity in hospital medicine.

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