Kimberly Westrich

HTA evaluates the value of medical technologies, but too often, patient perspectives are left out of the process. Including patient input ensures decisions reflect their needs, leading to better outcomes and greater health equity. Explore how Patient-Centered HTA is shaping a more inclusive healthcare system in this blog by Xanthia Lam, MPH candidate at Columbia University and Center Patient Engagement Intern: https://ow.ly/oTZe50UBybT #HealthEquity #PatientEngagement #HTA #HealthcareInnovation

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Who Will Pay for Prescription #Drugs in 2032: Four Takeaways from the New Government Forecasts DCI's analysis of the latest Centers for Medicare & Medicaid Services projections ==> https://drugch.nl/3xX6QQM

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Rho's latest blog post, by Kimberly Koehn, PhD, features recommendations on how to present a product's benefit-risk assessment within FDA's own structured benefit-risk format as part of your marketing application. Have you thought about this for your product(s) in development? Check it out here: https://bit.ly/3yD9V8y

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As part of AstraZeneca’s focus on sustainable science, we have set ourselves the ambitious goal to introduce electronic product information (ePI) across all medicines, while ensuring flexibility for patients to access product information through alternative ways if needed. The introduction of ePI brings with it a host of benefits for the planet, patients, and healthcare systems, including: 🌍 Improved accessibility to the most up-to-date information on medicines, available in multiple different languages. 💊 More efficient and wider availability of medicines through digitalisation of labels and quick implementation of label changes. 🍃 Lower environmental impact. If ePI was introduced across all AstraZeneca products, it could potentially save an average of 500,000 trees and 1.6bn litres of water each year. Learn more: https://lnkd.in/gJC-fwtd #WhatScienceCanDo

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John Tozzi, Nice wrap up. Today may be a win for Medicare, but I am not so sure this is a win for working Americans or employers. Leaders at drug producers impacted by these "negotiations" will now attempt to recover lost profits by increasing the prices on other items they produce. It's their job. Employers beware! Your drug prices are about to go up. Drug pricing is complex. But you don't need a Nobel prize in economics to understand that using policy change to foster free market competition would have more lasting overall effects. Yes, it takes longer but these steps should have taken place decades ago. In the coming hours, several "expert" consultants will attack the savings projection as overstated. Rebates and other forms of cost mitigation were not obviously included in the price basis. Then will come the political "experts" claiming government overreach or grandstanding in an election year. But drug pricing is a serious problem recognized by bipartisan committees. Americans deserve lasting policy reforms that reduce healthcare cost by improving free market conditions more attractive to new competitors. Only then will costs go down, stay down, and all Americans will win. I hope we see this soon.

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Many innovative ideas can become obscured when communicated, which was a significant challenge for Patient Blood Management #PBM as it was introduced to benefit those suffering from #anemia, in hopes of enabling surgery without the use of donated blood upon leaving the ER (Emergency Room). The PBM educational approach supports bloodless surgical procedures. To reduce this obscurity, we are simplifying the message and increasing awareness, benefiting #researchers, manufacturers, and healthcare practitioners. Most importantly, we are enhancing the patient experience and raising public awareness. We are confident that many global organizations, healthcare providers, and blood management surgical equipment manufacturers will support our efforts as we continue to be pioneers in building a bridge of engagement for public access, which will benefit this field of medicine. Remember our medical icons, just in case one day you need direction to the OR. #Bloodlines #BBTS #Blood #SABM

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Deepak Sirdeshmukh, MS, PhD Gregory Skalicky, MBA Maria Bucceri Kirsch Lindsay Reel Jim Barry Lisa Thompson Harrison Managing complex therapies, their dosage regimens, precise dosing at the right time, before meal or after a meal is critical for a better clinical outcome. A clinical outcome depends on dose adherence, compliance, managing, monitoring, and reporting. In order to manage a complex drug therapy, the communication between the physician, patient, pharmacist, and family members is very critical. We need a better solution that can manage, monitor, and report these key clinical outcomes to the clinicians, payors, pharmacists, and families. We all know that a better clinical outcome has many favorable clinical economic, and social benefits. Sensal Health is missioned with the enhancement of these very critical health metrics through their patented device and MyAide App that they developed and tested at several clinical forums. I myself tested and validated their use in benefiting a complex dosage regimen. It is definitely differentiated and a better solution that can surely improve the critical clinical outcomes. Following is the website for you to explore to find information.

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FDA’s Endorsement: The Marvel of MRD Minimal Residual Disease (MRD) “Elevating MRD to the Forefront” and Revolutionizing Cancer Treatment Approaches The FDA’s Oncologic Drugs Advisory Committee’s recent meeting in April 2024 has cast a spotlight on Minimal Residual Disease (MRD), underscoring its critical role in the advancement of cancer therapies. Here’s how the FDA’s recognition is reshaping the future: 1. Multiple Myeloma: The FDA’s committee has officially recognized MRD as a valid endpoint for accelerated drug approvals. This pivotal decision by the FDA is a testament to MRD’s potential in changing the treatment paradigm for multiple myeloma. 2. Acute Lymphocytic Leukemia (ALL): MRD serves as a vital prognostic indicator, and the FDA’s stance influences treatment choices and regulatory approvals of new medications. It’s a significant step forward, with the FDA’s backing enhancing the credibility of MRD in clinical settings. 3. Chronic Lymphocytic Leukemia (CLL): The MRD status is integral to treatment planning, and the FDA’s consideration is crucial during the approval process of new treatments. The FDA’s involvement ensures that MRD remains a key factor in CLL therapy strategies. 4. Acute Myeloid Leukemia (AML): MRD is being considered by the FDA as a potential surrogate endpoint in trials, which could expedite the approval of innovative AML therapies. The FDA’s support could pave the way for quicker access to new treatments. These examples underscore the vital role of MRD as a clinical endpoint across various cancer types. It’s not just a measure; it’s a movement towards enhancing patient care and fast-tracking the introduction of innovative treatments. The FDA’s Oncologic Drugs Advisory Committee’s discussions and decisions highlight the indispensable role of MRD, now backed by the FDA’s authoritative support. It’s a monumental stride in enhancing patient care and introducing cutting-edge treatments more swiftly, all through the FDA’s visionary lens. For more details, please contact, [email protected] #oncology #oncolotrials #clinicaltrials #pharma #drugapproval #FDA #minimalresidualdisease #cancer #approval #aacr #esmo #ash Dr. Simone SeiterMoussa Ahmed AmerMou ChatterjeeAnshu Mittal Roy PhD (She/Her)Reena KhuranaKarnik RampalKriti ArnejaMolekule Consulting LLCDavid AldermanAmaninder Singh DhillonVikas SarangalRicha S.Nidhi DhingraYogesh VadepalliBruno LarvolAmit GuptaDr.Hamid Hasan Faridi, MD MBAMichele SpinettaRobert F. Siegmund, PhD MBASabih BeckDr. Timos PapagatsiasSalvador CarlucciDIWAKAR JHA, M.PHARM, M.B.A

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It’s undeniable that the current health disparities at the local levels are increasing, and more individuals are falling through the cracks. Now, more than ever, we must harness innovation and collaboration to address these health disparities and improve equitable access to care for everyone. In my recent interview with Michael Gibney from PharmaVoice, we explored how AI is becoming a game-changer in tackling health disparities in cancer care. From pioneering screening initiatives to data-driven insights, the opportunities in leveraging AI to bridge the gap in health outcomes is endless. Innovation isn't just about developing ground-breaking treatments; it's about making sure those breakthroughs reach all populations who needs them. Everyone, regardless of their ZIP code, deserves access to cutting-edge cancer treatments. AI presents a tremendous opportunity to address these disparities head-on. Collaborating with diagnostic companies and AI innovators, we're using data to expose the disparities in care and address screening and access issues head-on. Our goal is steadfast: to leave no one behind in the battle against cancer. Together, we can eliminate the ZIP code lottery in cancer care and pave the way for a more equitable healthcare system. Read more from my recent interview here: https://lnkd.in/eEg5h_pv #HealthEqutiy #AI #Innovation #Leadership

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Today, we’re talking about transparency in Health Technology Assessment (HTA) and why it’s essential for healthcare. Transparency: ✔️ Builds trust between patients, providers, and policymakers. ✔️ Engages stakeholders for better decisions. ✔️ Ensures accountability for improved outcomes. Share your thoughts in the comments! And remember, BioXplore is here to support your HTA and market access strategies. 🔍 Listen here: https://lnkd.in/eTeM9sVD #HealthcareInnovation #HTA #HealthTech #TransparencyInHealthcare #PatientCare #MarketAccess #MedicalInnovation #HealthcareTrust #BioXplore #HealthEquity #StakeholderEngagement #HealthcareSolutions

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📨 Potential implications exist in regard to #LCM and #strategies regarding market exclusivity, see below, the latest from the FTC, sending warning letters to ten major pharma companies in an attempt to continue challenging and cracking down on #JunkPatents. 📂 The claims are around 'inaccurate or improper' patents in place which essentially block competition and keep drug prices high. Many big-name prescription brands are included in this round of probes. 2️⃣ 0️⃣ : "The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate." 🤔 Are your brands affected? ❓ How might actions against you or your competitors affect your LCM strategy? https://lnkd.in/eVuapvWJ #LifeCycleManagement #RegulatoryAffairs #Policy #FTC #FederalTradeCommission #OrangeBook #PharmaPatents #AntiTrust #Pharma

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For more than ten years, sponsors and researchers have discussed "patient-centric drug development," but clinical trials have mostly stayed the same. To genuinely improve patient experiences and health outcomes, it's essential to go beyond minor innovations and adopt a comprehensive paradigm shift. https://gag.gl/wE0cVC #DrugDevelopment #FortreaConsulting John Doyle, Dr.P.H.

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Recent news about counterfeit HIV medications highlights a persistent danger in our pharmaceutical supply chains. This issue goes beyond brand protection - it's a direct threat to consumer health and safety. Key challenges: 1. Consumers, the end-users, are disconnected from the supply chain. 2. There's no reliable way for consumers to verify a product's authenticity. 3. Current systems lack a secure, tamper-proof link between physical items and digital verification services. The root of the problem? The absence of a non-mutable, tamper-proof hyperlink connecting the physical product to the manufacturer's digital verification services. A potential solution: Hmidtags.com has developed technology to address this critical gap. Their system creates a secure bridge between physical products and digital verification, empowering consumers to authenticate their medications. As we move forward, it's crucial that we explore and implement innovative solutions to protect public health and maintain trust in our pharmaceutical supply chains. What are your thoughts on this issue? How can we better involve consumers in the verification process? #PharmaceuticalSafety #SupplyChainSecurity #ConsumerProtection #HealthTech #Gilead https://lnkd.in/e7DMd-X3

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Oncology clinical trials are crucial for advancing cancer treatment and can help patients get access to cutting-edge therapies. Yet, the latest data show that the clinical trial enrollment rate for patients with cancer in the U.S. is just 7%. At Private Health Management, we understand the clinical and scientific complexity of identifying and prioritizing appropriate trials, as well as other barriers to access. In PHM’s new whitepaper, “The Importance of Clinical Trials in Cancer Care,” my colleagues, Natalya Gertsik, PhD, Tommy Axford, and I discuss how PHM’s approach to clinical trials can help to ensure access for all patients and present an analysis of clinical trial enrollment for our cancer patients over the last decade. Remarkably, the enrollment rate for PHM patients with cancer is 25% — nearly four times the rate of the general population. Patients across all cancer stages and over 20 cancer types enrolled in trials, demonstrating PHM’s commitment to ensuring access for all patients, even when few trials are available. By identifying suitable trials, supporting logistical needs of providers and patients, and educating patients about clinical trials, PHM helps overcome obstacles surrounding clinical trial access. Learn more here: https://lnkd.in/gz-3gaVP #clinicaltrials #employeehealth #cancer #oncology #healthequity #clinicalresearch #cancercare #employerbenefits #employerhealthplans

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A great day for patient access in ESRD! CMS Policy Update announced Monday November 25, 2024. Beginning in January 2025, CMMI’s Kidney Care Choices (KCC) value-based care model will carve out Transitional Drug Add-on Payment Adjustments (TDAPA payments) from financial calculations such as benchmarks, performance year expenditures and USPCC trend rates, allowing ESRD patients participating in a KCC to have increased access to certain innovative new drugs https://lnkd.in/gpFQ2RS6

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How do you think about data quantity vs. data quality when it comes to RWD? COTA's Sandy Leonard recently sat down with Karla Feghali, MBA of Deloitte and shared how the quantity-versus-quality question has evolved in clinical research. "When RWE was emerging, companies were focused on accessing as much data as they could. The idea was that if you had the entire haystack, you were bound to find the couple of needles that were important for your study. For years, data buyers and researchers were focused almost entirely on quantity. I think the industry has evolved significantly as companies have gained more exposure to different types of data and now have technologies that can help improve the quality of the data. A company no longer needs to start with a large quantity in order to get to quality. Targeted data from the right 300 patients might be more useful than a cohort of 10 million patients." https://lnkd.in/dX8euKAF #rwd #realworlddata #oncologyresearch

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In this edition of the New Medicines, Novel Insights newsletter, Stacy Hurt, M.H.A., M.B.A., Chief Patient Officer, Kristina Reeder, Director, Patient Insights, and Nichola Gokool, Vice President, Customer Strategy and Innovation, Medical Communications, review the critical importance of the patient's voice throughout clinical development. Learn why this is so important in oncology trials, steps for understanding and amplifying patient perspectives, and how Parexel experts are tailoring research processes to the people the therapies are intended to serve. Read the full article and subscribe to receive the latest #NovelInsights each week! https://lnkd.in/dS3cti6f #Oncology #PatientsFirst #PatientPerspectives #PatientVoice

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Don't Stop Believin': Mastering CTAs and Budgets for Clinical Trial Success About ten years ago, we set an ambitious goal: to establish Master CTAs with at least half of the sponsors PCRS Network work with. We met that goal! Well, sort of. Having worked with all the major Pharma companies and many smaller ones, we knew that therapeutic areas within larger companies operate in silos. This presents significant challenges when trying to standardize legal or budgeting processes. Even when a master CTA was approved at the corporate level, legal teams in each silo often wanted to negotiate their own versions. Fortunately, in every instance, we were able to facilitate communication between these teams and resolve the issues efficiently. At the same time we set the goal for the master CTA, we also set a more conservative target for master budgets. The concept of a master budget is straightforward: pre-negotiate standard items to minimize the number of negotiable items study-to-study. As we anticipated, sponsors were generally receptive to this approach. Moving forward, our long-standing relationships with sponsors facilitated smooth negotiations on future studies, often with just a brief conversation or email exchange. Although we continue to experience some delays because of the silos, we remain committed to implementing master CTAs and budgets wherever possible. We've learned not to be discouraged by occasional refusals. Our experience shows that having master agreements and budgets, or just standardized language for key clauses, even if they need periodic revisions, saves both sponsors and sites valuable time. Encouraging the industry to adopt master agreements as a standard practice can significantly improve the study startup timeline, contributing to saving and improving lives. Supporting Insights A 2021 article from Applied Clinical Trials highlights the importance of master CTAs, stating, "Master CTAs streamline the contracting process, reducing administrative burden and accelerating study startup times." Another study from Clinical Trials Arena in 2022 found that "adopting master agreements can lead to a 30% reduction in study startup timelines, enhancing overall efficiency." Call to Action Let's work together to streamline clinical trials and bring treatments to patients faster. If you’re interested in learning more about how master CTAs and budgets can benefit your organization, reach out today. Together, we can rise to new heights of efficiency and success in clinical trials. Citations 1. "Streamlining Clinical Trials with Master CTAs," Applied Clinical Trials, 2021. 2. "Efficiency Gains in Study Startup with Master Agreements," Clinical Trials Arena, 2022. 3. Lyric reference from "Don't Stop Believin'" by Journey, 1981.

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Insights from NABP Decommissioning Pilot: The technology and regulatory frameworks exist to scan products, including existing scan systems, in order to verify product identifiers and decommission serial numbers at or near the point of dispense. o Adoption of End-of-Commerce scans requires non-regulatory incentives o Early adopters could be in narrow, high-counterfeit target areas NABP should expand its work and collaboration across the supply chain. Dispensers need flexible approaches allowing the capture of events at the most efficient points and integration into existing workflows and systems. Enabling the capture and sharing of decommissioning data could have prevented or limited counterfeit events that involved reusing serial identifiers by providing immediate decommissioning visibility of counterfeit threats.

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