Rachel Salomonsen, MPH, PhD

How can sponsors prioritize diversity and inclusion of underrepresented populations in clinical trials and adhere to new guidelines from the U.S. Food and Drug Administration? Learn about strategies and recommendations for success in our latest publication: https://lnkd.in/egiDZtEg #ClinicalTrialInclusion #ClinicalTrialDiversity #ClinicalTrials

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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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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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My friends in biopharma are increasingly worried about the headwinds to the industry’s traditional business model. The impact is real - constant organizational transformation and layoffs. We predicted the challenge in our book - Redefining Innovation, and suggested pathways to new business models. However, we also understand the inertia and the inability to change. Overall, we foresee the industry becoming more like the utilities- regulated and price capped. As individuals passionate about the industry, it is time to rethink how we will disrupt and innovate ourselves, for our own viability. That in turn might be the impetus for large scale organizational transformation the industry needs now.

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The ESSENCE Festival of Culture is not just a time for fun and celebration, but also a platform for important conversations. Dr. Adrelia Allen, Executive Director of Clinical Trial Patient Diversity at Merck, highlighted the urgent need for greater representation in clinical trials, particularly for African Americans, who are disproportionately affected by various diseases and cancers. Clinical trials are crucial for testing new medical, surgical, or behavioral interventions in people, and it is essential that these trials reflect the diversity of the population to ensure that treatments are safe and effective for all. However, according to a 2021 study by Johns Hopkins Medicine, only 8% of research participants are African-American, while we make up 13% of the U.S. population. Here is my latest for The Atlanta Voice / Voice News Network! https://lnkd.in/dbfdCeed

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Looking forward to attending #ASH2024 this year. Let's connect and I can share with you how TD2 can support your next trial. 🔗https://hubs.li/Q02YXgqv0 #HematologyOncology #ClinicalTrials #OncologyCRO #BloodCancerResearch #DrugDevelopment #PrecisionOncology #ClinicalTrialSolutions

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Gilead Sciences today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women. PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV). Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants. “With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We look forward to additional results from the ongoing PURPOSE clinical program and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.” “Twice-yearly lenacapavir for PrEP, if approved, could provide a critical new choice for HIV prevention that fits into the lives of many people who could benefit from PrEP around the world—especially cisgender women,” said Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Centre at the University of Cape Town, South Africa, and past President of the International AIDS Society. “While we know traditional HIV prevention options are highly effective when taken as prescribed, twice-yearly lenacapavir for PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule.” The use of lenacapavir and the use of Descovy for the prevention of HIV in cisgender women are investigational and have not been determined to be safe or efficacious and are not approved anywhere globally. #HIV #HIVprevention #lenacapavir #Gilead 👉 Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention

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#innovationtakesallofus Learn more at ventures.abbvie.com! For #preclinical #investment opportunities in AbbVie's strategic areas of interest, please email our #Ventures team with a concise description of the investment opportunity and accompanying non-confidential supporting materials at [email protected]!

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Both trials missed their primary endpoints. The studies compared the change in the Positive and Negative Syndrome Scale (PANSS) total score, a measure of schizophrenia symptoms, after six weeks of receiving placebo or one of two doses of emraclidine. #psychiatry #nurses, #nursesonlinkedin, #medication #knowledgeispower, #professionaldevelopment, #patientsafety, #standards, #evidencebasedpractice, #nurseexecutive, #cno, #mentalhealth

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Very tough week for the Parkinson's community with back-to-back failures of Roche's prasinezumab and UCB's minzasolmin, both targeting alpha-synuclein proteins: https://lnkd.in/dHfwzyjg A lot of data remains to be unpacked, but prasinezumab now qualifies as one of the most heavily studied Parkinson's drugs ever. Over the past 11 years, it has been tested in >900 patients, including some who have been on it for >4 years in an open-label extension. In 2025, we’ll join the rest of the Parkinson's community in reflecting on what these results teach us about alpha-synuclein’s role in Parkinson’s disease—and, more broadly, how to improve the process of drug development for Parkinson’s going forward. One big missing piece is the lived experience of patients who participated, especially those in the 4+ year open-label extension. I hope their stories emerge in the coming months. 🧠

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In #NeurodegenerativeDisease news, specifically on an experimental treatment for #ALS, with this new #strategic partnership is penned between Dewpoint Therapeutics and Mitsubishi Tanabe Pharma America. ⚛️ The asset is the former's drug, designed "to address the accumulation of a protein into toxic structures that lead to neuronal dysfunction in people with ALS." 🤝 The alliance would grant MTP exclusive rights to license, upon achieving certain developmental milestones. ⚕️ This would add to MTP's existing US-marketed ALS treatment, #Radicava https://lnkd.in/evayrVv4' #Dewpoint #Mitsubishi #Pharma #Biopharma #Healthcare

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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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In this edition of the New Medicines, Novel Insights newsletter, Paul Bridges chats with clinical experts from Parexel and Health Advances about the critical decision points in the pre-clinical phase that can ultimately determine the success of your product. Learn how these experts are helping biotech companies reduce risk by advocating for better coordination among departments, with a clear patient focus, at the earliest stages. Create success by planning for it ✅ Read the full article below and subscribe for our latest #NovelInsights #ParexelBiotech #ClinicalDevelopment #EarlyPhase #DrugDevelopment

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There was no better time for our annual Youth & Community Summit held last week in Denver, Colorado. An opportunity for us to connect with community partners across the US to re-ignite a sense of urgency in our collective effort to end the #HIV epidemic. I sat down with Princess Jauan D. to talk about the importance of involving community in everything we do. Within research and development at ViiV Healthcare, it’s so important that we understand evolving needs and continue to develop innovative options that will meet community where they are. By listening to community voices, we’ve been able to develop breakthrough options that have transformed the landscape of HIV care. From the world's first two-drug HIV treatment regimens to the introduction of long-acting medicines, we’ve been at the forefront of innovation for decades, providing people with options to meet their diverse needs. We firmly believe that with more treatment and prevention options, combined with our commitment to ending health disparities in partnership with communities across the US—we can #EndTheEpidemic. From drug development to advocacy, the communities we serve are the engine of our innovation. We must continue to listen, meet evolving needs, and support the community as they develop and implement the solutions that work best for them. Together we will continue to innovate and imagine what is possible. #EndingHIV #ImagineTheImpossible #WeWontStop

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What's the best approach to value-based care in oncology? When everything is said and done, the answer is personalization --every patient's health journey is different and intense. Knowing how to separate one patient from another – and therefore anticipate their symptoms from another's – is crucial to a more comfortable care experience. #Oncology #Personalization #Metrics #PatientCare

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⚔ Battle of the anti-#FcRNs in myasthenia gravis... 📑 Johnson & Johnson touts its recent nipocalimab PIII data showcased at the #EAN: European Academy of Neurology Conference, possibly competitively positioned well vs. argenx's #Vyvgart. ⏩ Forward looking: 👥 To leverage efficacy as a differentiator; across a range of antibody-positive gMG patients (i.e., MuSK+, anti-LRP4+, and anti-AChR+) 🗓 Regulatory filing est. by EOY #gMG #GeneralizedMyasteniaGravis #Clinical #MedicalAffairs #Nipocalimab #ActivitiesOfDailyLiving #Autoimmune #Neurodegenerative #Pharma #Healthcare

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