Ahead of the BioTalent x The CGT Circle exclusive women's only summer event on 6th June, we wanted to shine a spotlight on the fantastic panel. Next up we have Charlotte Smerdon, Senior Director of Clinical Operations at Purespring Therapeutics. For all-important details and to sign up, join The CGT Circle group here: https://lnkd.in/ecBy2z7n Don't miss out on this fantastic opportunity to connect with industry peers and experts! We hope to see you there!
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Brian J. Miller, MD, MBA, MPH, practicing hospitalist; Nonresident Fellow at the American Enterprise Institute
Super excited and honored to testify in front of the U.S. House Committee on Small Business on Wednesday, May 8th at 10 AM EST at their hearing on "Stifling Innovation Examining the Impacts of Regulatory burdens on Small Businesses in Healthcare." As an internist every day on service I am acutely aware that pharmaceutical products help me treat patients and alleviate their symptoms or cure disease. Many times it is small scrappy companies that are responsible for the fountain of innovation. These small companies are also the canaries in the coal mine and can tell us when regulatory policy is oppressive and burdensome. I look forward to talking about ways that we can continue to modernize the FDA in order to support entrepreneurs and small businesses bringing innovative products to market to help patients. Tune in here: ------------- https://lnkd.in/emUtgnzT Written testimony available here: --------------------------------- https://lnkd.in/eapmZBvC Views are my own and not those of any employers or affiliations Luke Wallwork Ryan Long Barrett Tenbarge Clare Paoletta Janet Woodcock Grace Graham Tom Romeo, MPH Nina Owcharenko Schaefer Heidi Overton Joe Antos Joseph Ballard Colin Rom James Stursberg Terra Marie Jouaneh John O'Brien Garrett Daniel Samuel West Anthony DiGiorgio, DO, MHA Lisa Grabert Deborah Williams Gail Wilensky Leck Shannon Grace-Marie Turner Marc Lanoue Henning Schulzrinne Sheila Ann Mikhail William Starling Brian M. Fahey Tina Reed #healthpolicy #fda #innovation #drugpricing #regulation #smallbusiness #raredisease #cancer
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Technology has solved problems across industries and healthcare is no exception. For those that are responsible for, or interested in driving change in how we operate and design #clinicaltrials - this webinar is for you. Secure your seat today.
In an industry hesitant about change, we need to ensure that change yields positive outcomes and works in practice. Join Flatiron Health and OneOncology on Tuesday, December 12th at 2PM EST for a live BioPharma Dive #webinar where experts in the field plan to share use cases and recommendations for change that will allow sponsors and sites to more efficiently operate #clinicaltrials, drive inclusivity, and expand research opportunities. Register today: https://lnkd.in/eRk2Q388
Challenging the Status Quo: The Future of Oncology Research Is More Efficient and Inclusive
event.on24.com
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Join our upcoming webinar focused on use cases and recommendations for how to successfully drive efficiencies and inclusivity in clinical trials. #clinicalresearch #oncologytrials
In an industry hesitant about change, we need to ensure that change yields positive outcomes and works in practice. Join Flatiron Health and OneOncology on Tuesday, December 12th at 2PM EST for a live BioPharma Dive #webinar where experts in the field plan to share use cases and recommendations for change that will allow sponsors and sites to more efficiently operate #clinicaltrials, drive inclusivity, and expand research opportunities. Register today: https://lnkd.in/eRk2Q388
Challenging the Status Quo: The Future of Oncology Research Is More Efficient and Inclusive
event.on24.com
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Left the Milken Institute's #MIHealthSummit "No Turning Back: Protecting the Progress for Biomedical Innovation" session with lots to think about. Panelists: Amy Abernethy of Verily Christopher Austin of Flagship Pioneering and Vesalius Therapeutics Silvia Taylor of Novavax Janet Woodcock of FDA Great questions and points raised: 💉Patients are saying "I don't want a COVID19 vaccine, I want a COVID23 one!!!". Long way to go on messaging and communication around innovations. 🚫 Need to break free from the archaic belief in how science should be artisanal, hands on, and non-collaborative. Incentive structures need to change. 💲 When resources are limited, “everyone feeds their family first”, they don’t collaborate. How do we collaborate, despite historic crash of early stage biotech funding? 🏥 Community/rural hospitals are overlooked but can have higher patient recruitment as the incentive structure is more collaborative. “Number of subjects recruited is inversely proportional to number of professors.” ⚕ Patients more likely to trust results if they see themselves represented in the clinical trials. To build trust with communities, important to do something "with" the community rather than "to" the community.
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Medical Innovation, Strategy & Operations Intern @ AstraZeneca | Consulting @ Segal | Co-founder @ Insight Into Industry | PharmD Candidate @ UNC Eshelman School of Pharmacy
"In the USA, while minority racial and ethnic groups represent almost 40% of the population, a staggering 75% of the 32,000 participants in FDA-approved trials for 53 novel drugs in 2020 were white." 🔍 So, why is this happening, right? This whole issue of not having enough diversity in clinical trials has been a big concern in drug research. There are several causes, such as a long history of distrust, a lack of resources to find trials, challenges in getting access to medical institutions for research, and indirect costs like loss of income. Just to give you an example, there was this BECOME study that found something shocking: around 40% of Black patients dealing with metastatic breast cancer were never informed about appropriate clinical trials. Can you believe that? This is happening even though Black women are more likely to be diagnosed with more advanced-stage breast cancer. 💡 Now, why is diversity in clinical trials important? It enables us to compile thorough data that accurately depicts the general population's response to therapies. Additionally, it helps us better understand and tailor treatments for different communities and speed up innovation in drug development. 🌟 How can we solve this challenge? It starts with building trust among underrepresented communities by adopting inclusive enrollment practices and having a diverse pool of investigators and staff that promote confidence in new treatments. We must encourage fairness by removing barriers to participation, such as limited access to medical centers, and investigating alternate recruitment strategies, such as mobile outreach and transportation support. Let's make sure everyone's voice is heard! #DiversityInClinicalTrials #HealthEquity #PharmacyStudents #PharmaceuticalIndustry #ClinicalResearch
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At last month’s Society of Hematologic Oncology 2023 Annual meeting, we presented data from the REVIVE Phase 2 study, which evaluated a novel, investigational hepcidin mimetic in patients with polycythemia vera (PV). ICYMI, view our poster here: #SOHO23 | #hematology | #bloodcancer
Targeted Therapy of Uncontrolled Erythrocytosis in Polycythemia Vera with the Hepcidin Mimetic, Rusfertide: Blinded Randomized Withdrawal
protagonist-inc.com
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Accessibility Champion, Patient Advocate Powerhouse: Amplifying Rare Disease and Disability Voices | Shaping Policy, Transforming Lives
Looking forward to participating in a panel discussion on #disability and rare neuroimmune disorders at the 2023 Virtual RNDS!
Join community members Cyrena Gawuga, PhD, MSW, Maria Cerio, Aidan Morse, and Leah Campbell for a talk on #disability and rare neuroimmune disorders at our 2023 Virtual RNDS! This session will be moderated by SRNA's GG deFiebre, PhD, MPH. Any questions for our panelists can be sent in advance to info@wearesrna.org. Register today at: https://lnkd.in/ghFuBa9r This event is supported in part through education grants from Alexion Pharmaceuticals, Inc., Horizon (now Amgen), Genentech, and UCB Pharmaceuticals.
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Thanks #BMS for sharing that collaborations with Black Health Matters for clinical trial recruitment are effective!!! "Sharma gave another example of a prostate cancer study in process, which in the past would have likely enrolled about 9% Black men. For the newer study, however, BMS worked with Black Health Matters, which helped design the protocols, created culturally appropriate education and informational materials and helped with outreach to drive more patient awareness. The result is that the latest study enrollment is made up of 18% Black men. Black men are 50% more likely than white men to develop prostate cancer and twice as likely to die from it, according to data from Memorial Sloan Kettering Cancer Center." https://lnkd.in/eV2A6m4m #clinicaltrials #blackhealthmatters #blackhealth
Bristol Myers notches diversity gains after revamping its clinical trial location strategy
https://endpts.com
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近期,台灣癌症病人面臨的新藥治療經濟負擔成為了重要的公共政策議題。這種經濟壓力被稱為「財務毒性」,它不僅包括直接的醫療費用,還包括間接的經濟影響,如失業和減少的工作效率。學者de Souza於2014年提出了一種衡量財務毒性的工具——COST量表,以病人自我報告的方式來評估其經濟壓力的程度。我們的研究發現,在台灣,年紀愈輕的癌症病人更易受到財務毒性的影響。目前台灣尚缺乏多元性的市場型病人支持系統,使���政府必須承擔大部分醫藥費用。因此,我們提出了幾點建議:開發多元化的財務支持計劃,提高公眾對財務毒性的認識,並加強資訊公開和創新減負策略。此外,進行更深入的實證研究以解決這一問題至關重要。 發表於台灣新社會智庫雜誌, 2024 Recently, the financial burden of new cancer drug treatments has become a significant public policy issue in Taiwan. This economic pressure, known as "financial toxicity," encompasses not only direct medical costs but also indirect economic impacts, such as unemployment and reduced work efficiency. In 2014, scholar de Souza introduced the COST measurement, a tool to assess the degree of financial stress through patient self-reporting. Our research finds that financial toxicity more severely affects younger cancer patients in Taiwan. We currently lacks a comprehensive market-based patient support system, leading to the government bearing most medical costs. Therefore, we suggest developing diversified financial support plans, raising public awareness about financial toxicity, enhancing transparency, and adopting innovative strategies to reduce the burden. Moreover, conducting more in-depth empirical research to address this issue is crucial Published in Taiwan SIG, 2024
解決癌症負擔的當務之急─ 從影響自費病人財務毒性相關因素談病人支持計畫
taiwansig.tw
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As part of our comprehensive non-clinical research capabilities, we offer an innovative technology platform for oncology drug development based on the generation of patient tumor replicas in avian embryos (avian embryo patient-derived xenografts: AVI-PDX). We invite you to read our new study conducted in collaboration with Dr. Pierre Sujobert and supported by the ANR, the French National Research Agency, now available in Leukemia, prestigious peer reviewed journal. This publication is dedicated to the use of the Follicular Lymphoma AVI-PDX models as a unique opportunity to develop functional oncology strategies in follicular lymphoma to further our understanding of this disease and improve patient outcomes. 👉Click here to access the publication https://lnkd.in/efK2xRUU For a full access: https://lnkd.in/eardPN-2 To learn more, please contact Romain Teinturier, Project Manager, ERBC Group, Oncofactory, Valerie Castellani Lincontang, PhD, Founder and Associate Scientific Director of Oncofactory, Céline Delloye-Bourgeois, PhD, Founder and Associate Scientific Director of Oncofactory and @Natalia Niemir-Deveaux, Business Developer, ERBC Group, Discovery Referent. #Oncology #lifescience #nonclinical #CRO #drugdevelopment #PDXmodel #clinicaltrials #personalizedmedicine #3Rs #ethical #NAM
[𝗡𝗲𝘄 𝗽𝘂𝗯𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗶𝗻 𝗟𝗲𝘂𝗸𝗲𝗺𝗶𝗮 (𝗦𝗽𝗿𝗶𝗻𝗴𝗲𝗿 𝗡𝗮𝘁𝘂𝗿𝗲), 𝗽𝗿𝗲𝘀𝘁𝗶𝗴𝗶𝗼𝘂𝘀 𝗽𝗲𝗲𝗿 𝗿𝗲𝘃𝗶𝗲𝘄𝗲𝗱 𝗷𝗼𝘂𝗿𝗻𝗮𝗹, 𝗹𝗮𝘁𝗲𝘀𝘁 𝗿𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗶𝗻 𝗳𝗼𝗹𝗹𝗶𝗰𝘂𝗹𝗮𝗿 𝗹𝘆𝗺𝗽𝗵𝗼𝗺𝗮] 📑"Functional precision oncology for follicular lymphoma with patient-derived xenograft in avian embryos", on #Follicularlymphoma AVI-PDX models for predicting response to treatment, conducted in collaboration with Dr. Pierre Sujobert (HCL, Centre Hospitalier Lyon Sud and CIRI Centre International de Recherche en Infectiologie/ Lyon 1 University) and supported by the ANR, the French National Research Agency, is now available in Leukemia. Discover how the FL-AVI-PDX model is a platform for functional precision oncology in primary follicular lymphoma cells. This model replicates patient responses to treatment, capturing both inter- and intra-patient heterogeneity in clinical responses to complex therapeutic regimens. It provides a unique opportunity to better understand the biology of follicular lymphoma, discover combination therapies, and identify biomarkers that predict sensitivity or resistance, opening perspectives for new drug development. 👉Click here to access the publication https://lnkd.in/efK2xRUU For a full access: https://lnkd.in/eardPN-2 To learn more, please contact Romain Teinturier, Project Manager, ERBC (European Research Biology Center) Group, Oncofactory, Valerie Castellani Lincontang, PhD, Founder and Associate Scientific Director of Oncofactory, Céline Delloye-Bourgeois, PhD, Founder and Associate Scientific Director of Oncofactory and Natalia NIEMIR-DEVEAU, PhD, Business Developer, ERBC Group, Discovery Referent. #Oncology #lifescience #nonclinical #CRO #drugdevelopment #PDXmodel #clinicaltrials #personalizedmedicine #3Rs #ethical #NAM
The latest scientific achievements of the Oncofactory team in Leukemia, Nature
https://www.oncofactory.com
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Regulatory Strategic Enabler & Disruptor / Leadership Coach & Mentor for Biotech Start-ups 😎 Helping you attract funding & begin your development pathway to commercialisation with confidence, clarity and credibility 😎
1moLooking forward to meeting you Charlotte Smerdon especially as we seemed to have just missed each other in the past!