A HUGE SHOUT OUT to Emily Castellanos, Brett Wittmershaus and the rest of the Flatiron Team for this transparent and insightful publication focused on how Flatiron curates fit-for-purpose real-world oncology data: Raising the Bar for Real-World Data in Oncology: Approaches to Quality Across Multiple Dimensions. It includes an accompanying editorial by the FDA: The Bar Is High: Evaluating Fit-for-Use Oncology Real-World Data for Regulatory Decision Making If you love RWD as much as I do, these are well worth a read!!
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Looking for a trusted partner for your next oncology clinical trial? 🤝 If you are a drug development company that is heavily involved in running oncology trials, it is vital that you find the right clinical research organization (CRO) who is well experienced in the oncology therapeutic area. With unique challenges to overcome due to the complexity of oncology trials, selecting the right CRO will help you achieve your goals of improving patient lives. Oncology trials face many challenges in the collection, analysis and reporting of study data, and selecting a partner that specializes in data instead of a traditional full-service CRO can make all the difference in your studies success. Our global team of biometric experts are here to help as your trusted partner, with experience in all phases of research and development from pre-clinical analysis to clinical and post-marketing support across a wide range of oncology therapeutic area indications. Our focus on high-quality, client-specific solutions ensures your trial runs smoothly and delivers valuable data. From top tier pharmaceutical giants through to niche biotechnology and device companies, Quanticate has become the Oncology CRO of choice for many companies. Our Oncology Experience: ✅ 80 successful studies across all clinical phases (I-IV); including post-surveillance 🦠 45 different therapeutic indications, including Carcinoma, Leukemia, Lymphoma, Myeloma and Sarcoma 📅 30+ years of oncology experience combined across our 50 experts Learn more about our Oncology services: https://hubs.ly/Q02prXwJ0 #OncologyTrials #ClinicalResearch #CRO #Biometrics #DrugDevelopment #PartneringForSuccess
Oncology Clinical Research Organization (CRO) | Oncology Trials
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In this recent webinar, our digital health sciences and #oncologyresearch experts Anthony Todd Everhart, MD FACP and Bill Byrom discussed the use of patient-reported outcome measures throughout oncology drug development. Watch the recording and review the recap here: https://bit.ly/49RUVRS
Considerations for incorporating PROs in oncology trials
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Clinical pathways help physicians and payers streamline treatment decision-making, standardize evidence-based care, and improve patient outcomes. In Fierce Biotech, The Dedham Group’s Sophia Xin Tan, PhD covers the challenges and opportunities for biopharma companies in the clinical pathways landscape. Click to read the article for insights that biopharma companies need to know about clinical pathways: https://ow.ly/l1Uv50QIEPo. #Biopharma #ClinicalPathways #Oncology #BiopharmaceuticalCompanies
Unlocking the Pathway Puzzle: How Biopharma Can Navigate the Clinical Pathways Landscape
fiercebiotech.com
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Onco-This-Week (OTW) is here with the oncology clinical development weekly updates. 📁Subscribe to get your OTW newsletter directly weekly to your inbox at: https://lnkd.in/e3WDGyVz 💊 DRUG APPROVALS 📌FDA approves Merck KEYTRUDA+Carboplatin+Paclitaxel for Endometrial Carcinoma 📌AstraZeneca Truqap+ Fasloex for ER+ve breast cancer approved in EU based on CAPItello-291 results 📌FDA approves Bristol Myers Squibb KRAZATI + Cetuximab for KRAS G12C-Mutated CRC 📌Takeda FRUZAQLA in CRC approved in EU based on Ph 3 FRESCO-2 Trial 📌Dizal Pharmaceutical Golidocitinib approved in China for R/R Peripheral TCL 🔬REGULATORY NEWS 📌EMA validates extension application for SC formulation for BMS Opdivo including liquid formulation and new strength across previously approved indications 📌Johnson & Johnson SC amivantamab BLA submitted to FDA for NSCLC 📌EMA approves to initiate first-in-human Ph1 trial with Cereno Scientific CS014 📌NMPA approves Genfleet IND for GFH375 Ph 1/2 CT for Solid Tumor with KRAS G12D Mutation 📢TRIAL RESULTS 📌FAILED TRIAL: AstraZeneca CAPItello-290 Ph 3 Truqap + chemo in TNBC with PI3KCA/AKT1/PTEN alterations did not meet the dual PE of OS improvement 📌New survival data for Tempest Therapeutics Amezalpat 1L HCC study demonstrated a six-month improvement 📌100% partial response or better announced in MM Interim, Top-line Data from Starton Therapeutics STAR-LLD Ph 1b CT 📌Data from XBiotech USA, Inc. 1-BETTER Ph 1/2 Natrunix + ONIVYDE/5-FU for pancreatic cancer announced 📌Favorable Efficacy and Safety Data from Complete Waldenstrom Macroglobulinemia Cohort of Ph 1/2 CT of Mustang Bio MB-106 Announced 📊TRIAL STATUSES 📌Erasca, Inc. SEACRAFT-2 Pivotal Ph3 Trial Naporafenib + Trametinib Initiated for NRAS-Mutant Melanoma 📌FDA places partial clinical hold on Zentalis Pharmaceuticals Ph 1 ZN-c3-001 in solid tumors, Ph 2 ZN-c3-005 (DENALI) in PROC & Ph 2 ZN-c3-004 study in USC of azenosertib 📌Allogene Therapeutics Pivotal Ph2 Trial of Cemacabtagene Ansegedleucel 1L in LBCL initiated 📌US FDA puts partial clinical hold on BioNTech SE BNT326/YL202 trial 📌iTeos Therapeutics & GSK GALAXIES Lung-301 Ph3 CT Belrestotug & Dostarlimab in 1L NSCLC initiated 📌First Patient Dosed in Aprea Therapeutics ACESOT-1051 Ph1 Trial of Oral WEE1 Inhibitor APR-1051 💼BUSINESS NEWS 📌Day One Biopharmaceuticals Expands Pipeline with Potential First-in-Class Clinical-Stage ADC Targeting PTK7 in Solid Tumors 📌Basilea Pharmaceutica partners oncology drug candidate lisavanbulin with Glioblastoma Foundation 📌Lead Selection for Medigene AG MDG2021 Announced, Expanding TCR-T KRAS Library Targeting Solid Tumors 📌Lixte Biotechnology Holdings, Inc. announces collaboration on a New Colon Cancer Clinical Trial ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD and Anusha Jayaraman, PhD, Managing Editors Himanshi Agarwal, PhD and Siftjit Kaur, PhD, Social Media Managers
Stay up-to-date with oncology clinical development news on OTW
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🚀 Exciting news! Labcorp has finalized the acquisition of select assets from Invitae, and we couldn't be more thrilled to welcome them to the Labcorp family. Invitae's best-in-class hereditary cancer testing portfolio is a fantastic addition to our capabilities. At Labcorp Oncology, our vision is clear: to become the single-source solution for patients, providers, healthcare systems, and biopharma. We've been strategically building our portfolio of precision oncology testing, starting with the acquisition of OmniSeq, followed by #PGDx (Personal Genome Diagnostics), and now Invitae. With these combined assets and the innovative tests and solutions currently in our developmental pipeline, we are steadily moving closer to leading the precision oncology space for both centralized testing and FDA-authorized kitted solutions for CGP testing. When you pair this with our core oncology testing, including surgical pathology, flow cytometry, and cytogenetics, we offer comprehensive testing to support patients fighting cancer. Additionally, our strong clinical testing portfolio, covering essential labs like CBCs, chemistry, and microbiology, ensures Labcorp is the easiest group to work with for all oncology patient testing. In a world of fragmented testing solutions where providers often must send patient tests to multiple labs, Labcorp Oncology stands out. Our mission is to be the single-source solution for all your oncology testing needs, ensuring you have the right information at the right time to make the best treatment decisions. Welcome, Invitae, to our journey towards transforming oncology care! #LabcorpOncology #PrecisionOncology #HereditaryCancer #Invitae #HealthcareInnovation #OncologyTesting #PatientCare Adam Schechter
Labcorp Finalizes Acquisition of Select Assets of Invitae
prnewswire.com
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Learn about the important role that real-world data plays in oncology research and development of cancer treatment therapies in Deloitte’s blog post featuring an interview with Sandy Leonard, Chief Commercial Officer at COTA, Inc – a technology company that curates and analyzes clinical data. @Karla Feghali #OncologyResearch #RealWorldData
Balancing Quantity and Quality of Data in Oncology Research
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Encouraging news to see that Merck has teamed up with Acclinate to gain access to their NOWINCLUDED platform to enroll more African American patients in their cancer drug studies. I hope to see more sponsors follow Merck's lead in 2024. "Community engagement is a key step toward increasing diversity in clinical trials. We're excited to collaborate with Acclinate to raise awareness among the Black/African American community of available clinical trials for people with cancer. It is important that our research appropriately reflects the communities we serve. " - Adrelia Allen (Executive Director, Clinical Trial Patient Diversity at Merck) https://lnkd.in/dzeHggKj #clinicaltrials #diversitymatters #pharmaceutical #clinicaldata #phase1 #phase2 #clinicalresearch #diversity #diversityandinclusion #drugdevelopment #cancer #cancerresearch Nexagen Search
Acclinate Collaborates with Merck to Increase Clinical Trial Diversity
prnewswire.com
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Adaptive trial designs offer oncology studies the flexibility and efficiency crucial for multi-regional clinical trials (MRCTs). Discover the complexities and advantages of these designs, from diverse regulatory landscapes to cultural nuances, in our blog: https://ow.ly/bVhf50SURWy
Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies
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New Post: Oncology Clinical Trials Market: Forthcoming Developments and Opportunities Insights 2032 - https://lnkd.in/dH7v7T5i
Oncology Clinical Trials Market: Forthcoming Developments and Opportunities Insights 2032
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Prognos is constantly evolving to meet patient needs by unlocking the power of data to improve health. Listen to our webinar tomorrow morning to learn more about this exciting development!
Prognos Health is excited to announce the launch of Prognos Oncology, giving life sciences and pharmaceutical customers unprecedented access to cancer diagnostics data. This powerful platform empowers pharmaceutical companies to achieve excellence in commercial launch planning and activation, ultimately expediting access to life-saving therapies for patients in need. Learn more here: https://bit.ly/496TuPd To hear the details about this unique and exclusive offering, join Prog Mark Reis in partnership with the Genomic Testing Cooperative tomorrow, February 8, 2024 at 11:00am Eastern Time / 8:00am Pacific Time for a webinar. Register here to attend and receive event recording: https://bit.ly/3usLAkj This launch furthers our mission to unlock the power of data to improve health across complex clinical populations facing challenging and life-altering conditions. #healthcareinnovation #rwd #healthoutcomes #realworlddata
Unprecedented Access to Cancer Diagnostics Data with the Launch of Prognos Oncology
prognoshealth.com
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