Jennifer Ghith

The traditional model of #clinicaltrials, while essential, often faces challenges in representing diverse patient populations and real-world scenarios. Recent advancements highlighted in an article published in NEJM Evidence emphasize the potential of #RWD to bridge these gaps. In this interview with Neal Meropol, Vice President of Research Oncology at Flatiron Health, we explore how these data-driven approaches are transforming #oncology trials, improving #patientoutcomes, and addressing disparities in health care. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #realworldevidence #realworlddata #regulation #regulatoryaffairs #healthdata #healthequity #healthpolicy

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🔑 "The key to advancing precision oncology is to democratize the data." 🔑 I cannot tell you how excited I am to contribute to our New Medicines, Novel Insights report on behalf of patients/caregivers/advocates. This is everything our stakeholder community has been saying to empower us in shared decision making! It's OUR data! I highlight three things we MUST do to ensure all patients can potentially benefit from precision oncology. What do you think is important? Comment below 👇 Read the report here: https://lnkd.in/en6FwHk6 #PatientData #Oncology #NovelInsights #ASCO24 #advocacy #cancer

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A recent analysis from Biomedtracker of clinical trial phase transitions between 2014 and 2023 suggests biopharma development success rates are falling. This poses several questions: what are the underlying reasons dragging success rates down and what does this mean for R&D productivity and the return on investment on pipeline spend? https://lnkd.in/ezX4Dsmb Citeline Commercial #biopharma #clinicaltrials #RnD

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Exciting News from Next Level: Advancing Oncology Data Standardization!     We’re thrilled to share the launch of the immune-related Adverse Events (irAE) data elements within the USCDI+ Cancer framework—a pivotal advancement for oncology data standardization. Developed in collaboration with the Assistant Secretary for Technology Policy, National Cancer Institute (NCI), and FDA, this release is a significant step forward in capturing and managing critical adverse event data in oncology. Your feedback is essential to ensure these elements fully support the needs of the oncology community.     The irAE use case introduces structured data elements to signal common immune-related adverse events, primarily within Electronic Health Records (EHRs). These data elements enable consistent, FDA-compliant reporting, facilitating safer patient care and driving clinical research. Designed to integrate with key frameworks such as the Enhancing Oncology Model (EOM), Cancer Registry, and Clinical Trials Matching (CTM), this dataset allows precise tracking of immune-related toxicities throughout patient care.     Multiple USCDI+ Cancer comment periods are open now, offering the chance to provide input across key oncology datasets:    irAE Public Comment Period: November 4, 2024 – January 10, 2025  CTM Public Comment Period: Open now through December 20, 2024     How to Provide Feedback:  Visit the USCDI+ platform and create an account.   Review the irAE and CTM knowledge articles.   Review the irAE and CTM datasets.   Submit your feedback under the irAE or CTM comment period options.      Together, we’re transforming oncology data infrastructure, empowering technology to foster better outcomes for cancer patients worldwide.     Ready to learn more? Dive into the irAE USCDI+ Cancer data elements today and help set the standard for interoperability in oncology.     #USCDIPlus #Oncology #HealthIT #DataStandards #Interoperability #CancerCare 

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🔬 The Power of AI in Oncology Research The landscape of oncology is evolving at an unprecedented pace, propelled by the transformative power of artificial intelligence (AI). In a recent interview with Targeted Therapies in Oncology, Christopher E. Mason, PhD, sheds light on the inevitable expansion of AI in cancer management and treatment. AI is revolutionizing how we process vast amounts of data, offering unprecedented insights and transforming the way healthcare providers access information. From AI-assisted tools like Tempus One to handheld devices like DermaSensor, the integration of AI is reshaping the oncological landscape, enhancing clinical decision-making and patient outcomes. Mason highlights the pivotal role of AI in basic research, particularly in DNA sequencing and spatial transcriptomics, where algorithms play a crucial role in deciphering complex tumor profiles. By harnessing the power of AI, researchers can analyze millions of data points simultaneously, uncovering intricate patterns within tumors and unlocking new frontiers in precision medicine. 🚀 Pioneering AI-Powered Oncological Tools Even now, AI-assisted oncological tools are gaining FDA premarket approval, such as Tempus One, the first generative AI-enabled clinical assistant. This platform, in collaboration with Lens Data Analytics, leverages advancements in generative AI to seamlessly analyze patient data, providing invaluable insights for clinicians worldwide. 🔍 Navigating Challenges and Ensuring Responsible AI Implementation Despite its remarkable potential, the widespread adoption of AI in oncology comes with its own set of challenges and concerns. From bias in algorithms to privacy implications, it's essential to tread carefully and ensure that AI technologies are deployed responsibly. #oncology #AI #ArtificialIntelligence

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Roche on Thursday inked its second research collaboration deal with Dyno Therapeutics to advance next-generation gene therapies for neurological diseases. Under the terms of the agreement, Roche will make an upfront payment of $50 million and pledge more than $1 billion in preclinical, clinical and commercial milestones, plus royalties on net sales of any product that arises from the partnership. Roche will gain even greater access to Dyno’s in vivo gene therapy delivery platform, which uses AI to optimally and rapidly synthesize adeno-associated virus (AAV) capsids. According to the biotech’s website, this approach can sidestep the common limitations of naturally occurring capsids—which existing gene therapies use—such as problems with existing immunity, payload size and manufacturability. #biotech #biopharma #pharma #genetherapy

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Fast track for FDA by June 30 will release its verdict on #Rocket Pharmaceuticals’ BLA for #Kresladi (marnetegragene autotemcel), an investigational #gene therapy the New Jersey-based biotech is proposing as a treatment for severe #leukocyte adhesion deficiency-1 (LAD-1). Severe LAD-1 is a rare #pediatric disorder caused by mutations in the #ITGB2 gene, which encodes for a crucial component of the CD18 protein. Under healthy circumstances, #CD18 helps leukocytes exit blood vessels to combat infections. In severe #LAD-1, which typically manifests during early childhood, patients suffer from recurrent and unresponsive bacterial and fungal #infections.

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We’ll have the latest breaking data in our hands to deliver to our clients. If you’re looking to reimagine your congress experience, learn how NoeticInsight can deliver actionable insights. #NoeticInsight #breastcancer #oncology #SABCS24

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Good science alone can't guarantee a market success. So many drugs these days are heaped on the #pharma "junk pile" after an underperforming launch, and life sciences companies need to build their pipelines and portfolio management teams to account for it. Trinity Life Sciences CEO Leslie Orne has some tips for avoiding an underwhelming go-to-market. Read at PharmaVoice, with insight also from EY's Arda Ural, MSc, MBA, PhD and Numab Therapeutics AG CEO David Urech.

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On World Hepatitis Day, we're highlighting the critical work being done in viral research and treatment. 🌍🧬 This episode of KGI's Industry Speaker Series features two remarkable leaders from Regeneron who are at the forefront of combating viral diseases: Dr. Lisa Purcell, Senior Manager, Clinical Sciences, Immunology and Inflammation Dr. Alina Baum, Senior Staff Scientist While much of their work has focused on COVID-19, their expertise extends to various viral infections, including hepatitis. Dr. Baum's team, in particular, is developing novel therapies for viral infections such as hepatitis B. In this insightful conversation with KGI Board of Trustees Chairman Ross Grossman, Drs. Purcell and Baum discuss: 1️⃣ Innovative approaches to treating infectious diseases 2️⃣ The intersection of immunology and virology in drug development 3️⃣ Regeneron's commitment to addressing global health challenges As we observe World Hepatitis Day, it's crucial to recognize the ongoing research and development efforts aimed at combating viral diseases. The work of scientists like Drs. Purcell and Baum gives us hope for a future where hepatitis and other viral threats can be effectively managed and potentially eliminated. Revisit this important discussion: https://kgi.link/13e #WorldHepatitisDay #ViralResearch #BiotechInnovation #KeckGrad #GlobalHealth

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MMIT experts will be at #ASCO24 to discuss why the right tools and real-world data can help uncover insights into the #oncology patient journey. Book a meeting with MMIT: https://ow.ly/zo1I50Ryx1W.

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The FDA has just approved Johnson & Johnson's amivantamab (Rybrevant) in combination with carboplatin and pemetrexed for patients with advanced or metastatic non-small cell #lungcancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations following progression after an EGFR TKI. The approval was based on data from the MARIPOSA-2 trial, which showed that the combo therapy significantly extended progression-free survival compared to carboplatin and pemetrexed alone (6.3 months vs. 4.2 months). It also had a much higher overall response rate (53% vs. 29%). This is an important step forward for patients with NSCLC, offering a new option to improve outcomes after first-line treatments have failed.

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As we continue to make clinical advances in Alzheimer’s disease (AD) research, recognizing the nuances of clinical endpoints is vital to interpreting data. That’s one of the many reasons why we design our clinical studies to ensure results reflect real-world AD populations. Hear from experts on the real-world implications of study design in AD: https://ow.ly/Fgte50RxC4F #AlzheimersDisease #Dementia #ClinicalTrials

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🔍 Learn about the safety of JAK inhibitors for rheumatic diseases and the key risk factors for selecting the right therapy. 🩺 Boost your confidence in choosing JAK inhibitors based on risk stratification 📊. Click: http://ms.spr.ly/6040mOuQQ #Rheumatology #JAKInhibitors

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In 2024, 5 emerging BTK inhibitors are undergoing late-phase clinical investigation for #multiplesclerosis. Most clinicians are likely unaware of the clinical data regarding their use in MS. Dive into the data and earn free #CME here: https://bit.ly/4gViIVp #MedEd #FOAMed

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The lung cancer community urgently needs the #biotech industry to adopt innovative strategies that push the boundaries of scientific progress. In a blog post with MassBio, Jeff Jones, MD, MBA, Chief Medical Officer, discusses the importance of leaning into a “clinician’s mindset” and embracing collaboration to deliver new standards of care for people living with lung cancer and their families. Read the full article: https://bit.ly/40XgxuK #LungCancerAwarenessMonth #LCAM 

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Hereditary Angioedema: Rare diseases can be difficult to diagnose, and day-to-day management can be complicated. The Revvity Omics community aims to increase awareness and understanding of the significant impact these conditions can have on patients. Explore our genetic testing options today! http://ms.spr.ly/6044lHLY0 For more details, reach out to us at [email protected] #RevvityOmics #WGS #Genetictesting #NGS #rarediseaseawareness

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NEW: In a wide-ranging interview, I talked with GSK's chief scientific officer Tony Wood on everything from AI and M&A in R&D to the pharma's "careful" and "emerging" cancer ambitions to the second-order effects of GLP-1's. Check out my latest Endpoints News Q&A — diving deep into the R&D worldview of Wood, just as passed the two-year mark as CSO:

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