Lauren Broffman, PhD

Catch up on this Guest Column from Michael Sicilia (Forian Inc.), where he describes how #dataanalytics capabilities have uncovered significant patterns in the accessibility and effectiveness of GLP-1 therapies, shedding light on how #socioeconomic factors such as race and wealth impact #patientoutcomes. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #medicalaffairs #hta #healthtechnologyassessment #healthdata #healthequity #obesity #weightloss #glp1 #socialdeterminantsofhealth

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Prior authorization has a negative connotation and justifiably so. The way the U.S. government was founded on checks and balances, prior authorizations offer this to keep the payor's best interest in mind and create some aligned accountability. It is, in theory, a tool for checks and balances to determine medical necessity. In reality, it is a means to deny care in fully-insured models and to divert care (on the rx side) to the most rebate and GPO fee friendly drugs. Even prior authorizations done by transparent PBMs still have the risk to frustrate providers and worsen patient outcomes. What are the chances a patient's care is significantly delayed until their next visit or abandons any treatment whatsoever? They are two dimensional, determining if the patient qualifies for the drug (typically fitting characteristics of those enrolled in the clinical trials) and offering an approved or denied stamp. Even if approved, there might be more cost-effective options that achieve the same outcome. If denied, what clinical individuals are working with the provider to find alternative solutions? Is anyone trying to deescalate therapy when possible or should we just reauthorize drugs without a second look? We've got to do better. #apothicorwellness #pharmacists #priorauthorization

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Memorial Sloan Kettering Cancer Center discusses efforts to increase #diversity in #oncology trials, including multiple myeloma research. Discover how Judi for Eligibility combined with Judi for Adjudication supports a pivotal Phase 2 CAR-T multiple #myeloma trial, and more, on our Insights page. Judi.io.

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Sanjay Juneja, M.D. interviews David Hysong and Katherine Arline from Shepherd, a precision oncology platform. They discuss the limitations of traditional cancer treatment guidelines and the need for a more personalized approach. Shepherd uses multiomic data, including RNA sequencing, to assess a patient's unique tumor characteristics and recommend tailored therapies. They also consider collateral medications and potential side effects. #patientcentric #cancercare #oncology

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Remember 2020, when we thought the pandemic would usher in the era of fully virtual clinical trials? I do (along will virtual conferences, a bridge we are yet to cross). Suvoda's CEO Jagath Wanninayake touched on this in an interview with Elena Filimonova earlier this year. While many of us can visualize a tech-enabled, fully virtual clinical trial powered by a central platform, experts in trial conduct can see the impracticality of a “one-size-fits-all” model. In the article, Mr. Wanninayake explains how virtual elements of trials can help increase access for patients, but that there is a need for a pragmatic, measured approach to applying these advances. It’s refreshing to see a tech CEO call for what I'll describe as "sensible disruption." It shows a focus on the customer. This makes a lot of sense from a company with roots in #IRT, one of the most complex, sponsor-focused areas of the industry. Expertise will always be part of successful clinical trials. It's the companies that can build all-star teams to support sponsors and infuse this experience into their product development that will bring real change to the industry. I saw this firsthand at Phlexglobal - a PharmaLex company now part of Cencora with major #TMF experts like Karen Roy, Eldin Rammell, Marion Mays, Aaron Grant and so many others helping shape a best-of-breed product while providing worldclass customer service. As the AI hype machine builds, (literally - ever wonder how much of the content is written by AI? ) keep an eye out for the experts and support their contributions! https://lnkd.in/edHKbD2Z #DCT #decentralizedclinicaltrials #patientengagement #AI #clinicaltrials

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It's always great to be in the presences of other Clinical Trial Transparency Experts talking about how we can further the cause and best practices throughout the sponsor ecosystem. Thanks to Citeline for hosting this conversation and for my co-panelists for a great discussion. https://lnkd.in/esFdnmrm

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I think compelling problems - ones that can hold your attention and effort for years on years - sit at the intersection of Challenging, Solveable, and High Impact. For me Physician Engagement in Clinical Research rings that bell. So does working out how to connect our existing healthcare infrastructure to our existing clinical trials infrastructure in a way that serves patients and empowers physicians. We are dealing with two appropriately conservative industries prioritizing safety and privacy, while also trying to advance human health and wellness. IF large physicians groups and health systems adopt clinical trials with the goals of patient value, mission-service and/or service expansion - well that would be a path to something better than what we have now. Telephones polls still serve a useful function - but when capacity became the issue (and in drug development, everything is at capacity) the solution wasn't just more telephone polls, it was cell towers. That's what non-academic health systems and high scale physician groups represent - a wholly different capacity and opportunity for patients and their doctors. But how to reconcile the data privacy / security, physician bandwidth, economic realities and myriad other concerns of scaled healthcare institutions with the timelines and process-requirements of Sponsors and CROs? Well... if it were easy, would it be any fun? Like every other problem sitting at that intersection, the answers are all long-form: trust building, infrastructure management, high-competence... and time. So that's what I continue to plug away at optimistically but pragmatically...how bout you?

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🦃 The only thing fatter than turkeys in November are unwieldy clinical trials! 💡Join me for an insider perspective on strategically eliminating bloat in your trials. Together, we’ll uncover how to focus your resources on what matters most—your primary and secondary objectives. Are you ready to bring your clinical trial to life but would like expert guidance and a team that can deliver a robust, compliant protocol in 5 days? Our team is here to support you. Book a quick 15-minute consultation with me (link above)—let’s discuss how to streamline your process and bring your trial to life. #ClinicalTrials #LeanResearch #InnovationInHealthcare #EfficiencyMatters #EZDocs Gerald Minuk Niels Hurst Rajat Mukherjee Enzo P. Paresh Shah Anna-Liisa Parts

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See below regarding employers' knowledge of #PBM rebates. Here's an alternate (evil) hypothesis: Employers know precisely what they are doing. They primarily use rebates to offset overall healthcare costs and reduce general premiums, rather than reduce the out-of-pocket prices paid by the patients whose prescriptions generated the rebate funds. They therefore only look at premiums, not at "rebates" or the financing mechanics behind premiums. Lower premiums attract younger and healthier employees, whereas high out-of-pocket costs discourage sicker and older employees. So, maybe they don't really need or want to know about rebates? P.S. Pass through data are consistent with Pharmaceutical Strategies Group - PSG data that I discussed here: https://drugch.nl/3YBRdHr

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Carevive by Health Catalyst™ is excited to be participating in this year's IMPACCT Real World Evidence (RWE) Summit, October 29-31, in Boston, MA. Aaron Galaznik, MD, will be featured in a panel discussion with other leading experts in RWE.   Carevive by Health Catalyst™ has developed an industry-leading set of cancer registries that are focused on the longitudinal patient experience, with more than 30 cancer types available. Not limited to EMR and claims data, Carevive SMARTData® also features weekly patient reported outcomes data (PROs) on symptoms, physical function, quality of life, and treatment bother (Carevive SMARTData®) merged with a complete set of EMR-derived datapoints. As such, Carevive SMARTData® empowers life science companies to put our data into action across the enterprise and improve the patient experience. Carevive SMARTData® will help shed light on how to optimize common data models in a new and unique way.   Aaron Galaznik Keri Collette Mordecai Kramer Emelly Rusli  #carevive #digitaloncology #cancer #cancercare #oncology #patientreportedoutcomes #oncologydata #clinicalinnovation #drugcommercialization #RWD #RWE #smartdata 

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A recent analysis from Biomedtracker of clinical trial phase transitions between 2014 and 2023 suggests biopharma development success rates are falling. This poses several questions: what are the underlying reasons dragging success rates down and what does this mean for R&D productivity and the return on investment on pipeline spend? https://lnkd.in/ezX4Dsmb Citeline Commercial #biopharma #clinicaltrials #RnD

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Regeneron is facing a critical strategic decision: Should they persist with the failed #strategy of cannibalizing Eylea 2mg sales with Eylea HD, or should they focus on protecting their $4.5B market share in Eylea 2mg from the onslaught of biosimilars by deploying aggressive incentive programs? In their recent conference call, Regeneron highlighted “stickiness” as a defense for retaining the Eylea 2mg market share—referring to the combination of brand loyalty and switching costs. However, as Ben Franklin wisely said, “To persuade, appeal to incentives, not reason.” For Regeneron, “stickiness” alone is unlikely to outweigh the power of incentives. So, will Regeneron choose to defend Eylea 2mg with incentives, or will they continue with their current strategy, risking significant market share loss? I’m not optimistic. As Charlie Munger aptly put it, “The inconsistency avoidance bias is a strong driver of human decision-making.” #retina #pharmaceuticals #ophthalmology

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While GLP-1s have revolutionized the obesity treatment landscape, their high cost and supply issues have raised concerns about affordability and accessibility. These challenges mirror similar obstacles faced in oncology, where innovative therapies often come with a hefty price tag and limited access. In a recent webinar hosted by HIMSS - The Evolving Landscape of Innovations for More Equitable Obesity Care and Weight Loss Management - Ipsos' Jackie Ilacqua joined panel guests from the American Diabetes Association, private healthcare, and telehealth services to discuss facilitating equitable obesity care and the necessary adaptations in health management systems. Key topics covered: - Disease burden and the potential of GLP-1s to improve health outcomes, drawing parallels to innovative oncology treatments - GLP-1 usage trends, patient outcomes, and the impact of affordability and access, similar to challenges faced in oncology - Innovations facilitating access to weight loss treatments, e.g., telehealth, and their potential applications in oncology - Medical device & digital health company adaptation to changing patient loads, a crucial aspect in both obesity care and oncology This discussion is also relevant to those working in oncology, as the insights shared can be applied to address similar challenges in cancer care, such as ensuring equitable access to innovative therapies and leveraging digital health solutions to improve patient outcomes. To watch the recording, click the link below. A must for all those passionate about advancing healthcare equity and accessibility! https://lnkd.in/e5gsRK8b For any further information about this discussion or Ipsos' research studies in oncology and other therapeutic areas, please contact Jackie Ilacqua #Obesity #GLP1 #GLP1Agonist #Ipsos #HIMSS #OncologyInnovation #HealthcareEquity"

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Does private equity have too much influence in healthcare and is private equity bad for patients and providers? Congress has a few thoughts... Led by Sen. Elizabeth Warren (D-Mass.), this week, a group of U.S. Senate and House Democrats released legislation meant to curb #privateequity’s influence on the healthcare industry. The bill, the "Stop Wall Street Looting Act", is an update of legislation previously offered by Sen. Warren and others.    The bill would: ➡️ Cap dividend payments at 10% of total debt and limit how much money PE firms can extract from companies; ➡️ Close a loophole #PE firms use to hide some assets from bankruptcy courts; ➡️ End legal immunity for PE firms when their portfolio companies break the law; ➡️ Prevent PE firms from walking away when a company fails; ➡️ Require PE firms to disclose fees, returns, and other information about their funds and the corporate loans they make; ➡️ Impose new restrictions on real-estate investment trusts’ involvement in #healthcare and ➡️ Require new disclosures from private-equity firms that accept any federal money.   A year ago, I wrote a piece for MedPage Today asking whether PE was good for the healthcare industry. While these firms can provide needed capital, increase productivity, and drive operational efficiencies, I argued that policymakers need to enact rules and legislation that promote competition and prevent excessive consolidation. This goes for #verticallyintegrated healthcare entities as well. These moves would maintain patient choice and ensure healthcare providers are not unfairly disadvantaged by large, PE-backed organizations.    With the 118th Congress winding down, Sen. Warren’s bill has no chance of getting approved this year (particularly with the House in GOP control). This issue is one that lawmakers are increasingly paying attention to, however, so expect more to come in 2025.    Read more about Sen. Warren’s bill at this link: https://lnkd.in/davQZjhY. Read my Medpage Today piece at this link: https://lnkd.in/dJ4QvpBt #KiFrontiers24 MBA@UNC UNC Kenan-Flagler Business School ESCP Business School Meroka #regulation #consolidation

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WOW a number of great perspectives and insights as to what health care will look like in 10 years. Big driver,as we know is aging of the boomers and Medicare funding. 1). Better and more personalization, genomics 2). More digital interaction and data collection, AI (duh) 3). More flexibility around care delivery (including a trend to care delivery in advanced primary care, home and virtual) and 4). Increased interoperability across all the entire ecosystem (person, provider, payer, ecosystem partners). Buckle up and enjoy the ride. #vbc #valuebasedcare #advancedprimarycare https://lnkd.in/g7am7eCp

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