Julie Daves, MSHS, CCRP

#AvalereExpert Mark Gooding moderated a panel at #BIO2024 on access and affordability considerations for patients and manufacturers in a post-#IRA world. Read highlights from his conversation with Anna Hyde, Valerie Reynolds, and Eric Gascho: https://lnkd.in/e_F3NZqM #patients #patientsupport #healthpolicy #healthcare #InflationReductionAct

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Association of Northern California Oncologists (ANCO)’s ASCO24 highlights panel discussion with Eric Small American Society of Clinical Oncology (ASCO) #ANCO #ASCO #ASCO24 #Cancer #OncoDaily #Oncology

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The annual meeting of the American Society of Clinical Oncology (ASCO) ended this week. Members of our team were there. Here's brief summary of the key themes that stood out from the meeting >> https://lnkd.in/ePVjs2ZH Authors: Mary Lee, Shankar Sundar, & Tahel Noy #oncology #cancerresearch #biotech #pharmaceuticals #ASCO2024 #ASCO24

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New Friends findings in Clinical Cancer Research shows an increase in post-marketing commitments and requirements (PMR/Cs) for race and ethnicity since 2020, which aligns with signals that FDA wants to ensure trials are more representative.    Additionally, Friends’ Grace Collins will presented an analysis at #DIA2024’s poster session entitled “Evaluation of PMR/Cs for Assessing Data in Racial and Ethnic Populations Underrepresented in Pivotal Clinical Trials.”     The findings from both show certain approval characteristics may lead to the issuance of a Postmarketing Requirement/Commitment (PMR/C) to conduct a study that is more representative of the racial and ethnic diversity of the U.S. or intended patient population.    As shown in the graphic below, the increase in racial and ethnic (R/E) PMR/Cs aligned with the release of key FDA guidance and policy on enhancing diversity in clinical trials. These findings provide critical insights about strategies for ensuring #clinicaltrials are more inclusive and representative of the intended patient population and general population.    Friends’ data dashboard includes data on the R/E PMR/Cs evaluated in this publication and poster as well as an additional 700 PMR/Cs issued to oncology drugs approved 2012-2023. Use the resource to interact with these data and explore trends across different approval years, drug classes, indications, and more.    Read our publication in Clinical Cancer Research here:  bit.ly/4cl3RAh    To explore trends in these data, visit Friends’ PMR/C data dashboard here: https://lnkd.in/epsf4HNz      Grace Collins , Hillary Andrews, PhD, Brittany Avin McKelvey , Carrigan Rice, Jeff Allen, Mark Stewart. American Association for Cancer Research

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OLS's Advantage Purchasing Program Partner Highlight: Fisher Scientific Fisher Scientific offers members-only discounts on essential lab supplies and services through group purchasing. Here's the value our members have accumulated in 2023 from Fisher Scientific: Deep Discounts: Members averaged a 58.3% discount off list price in 2023. Save on Shipping Costs: Members received over $218K in free freight last year. Annual Rebates: Utilize the Fisher Scientific agreement and earn annual rebates. One member received a $17K credit in Q1 alone! If your organization is incented to deliver State or Federal Sustainability credits, Fisher Scientific’s Greener Choice Program is available. https://lnkd.in/gpfn5B5G Contact us any time with any questions you have about membership or the advantage purchasing program: https://lnkd.in/gN2dDiqg #OhioLifeSciences #AdvantageProgram #GroupPurchasing

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Advocating for Regulatory Flexibility in Rare Disease Therapies Yesterday, FDA’s biologics chief Peter Marks and former deputy commissioner Janet Woodcock discussed the pressing need for regulatory flexibility in rare disease drug development. They emphasized balancing adherence to regulations with the flexibility required to bring life-saving therapies to market faster. Key highlights: - The importance of smart regulatory flexibility to focus on patient needs while staying compliant. - Challenges with insurance coverage for costly new therapies. - The critical need for investment in gene therapy manufacturing to reduce costs. It's inspiring to see leaders in the field championing innovation and patient-centric approaches. Let's support these efforts to bring hope to those battling rare diseases. #RareDisease #GeneTherapy #FDA

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COTA and FDA Extend Collaboration to Advance Use of Real-World Data in Cancer Research - HIT Consultant Title: COTA and FDA Collaboration for Cancer Research #COTAandFDA Summary: COTA, a healthcare IT company, has extended its collaboration with the FDA to advance the use of real-world data in cancer research. The partnership aims to leverage real-world data to improve patient outcomes and inform regulatory decision-making. #RealWorldData #CancerResearch Key Points: 1. COTA's collaboration with the FDA focuses on utilizing real-world data to enhance cancer research. 2. The partnership aims to improve patient outcomes and provide valuable insights for regulatory decision-making. 3. By leveraging real-world data, researchers can gain a better understanding of cancer treatment effectiveness and patient outcomes. 4. The collaboration between COTA and the FDA highlights the importance of utilizing ai.mediformatica.com #cota #research #collaboration #data #cancer #oncology #realworlddata #cancerresearch #administration #analytics #cancertreatment #foodanddrugadministration #digitalhealth #healthit #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/4bLTPrE)

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