Ram Gupta

https://lnkd.in/ggRMWiJi Gross microbiological contamination but we wait almost a year to warn you? What happened to all those drugs made before, during and after the inspection that captured the evidence of gross contamination? These and many more questions paint a picture of why the agency even bothers to issue Warning Letters almost a year after the inspection that show significant risk to the consumer. This Warning Letter belongs to the latest batch just released by the agency, so it shows the current state of risk monitoring and mitigation. Not much urgency and not much mitigation, but much exposure. The best we can hope for, the gross current FDA recall process to kick in.

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Improving how we develop and deliver clinical research through technology - Emmes is leading the way forward https://lnkd.in/gNWUjEpE #PatientsNeedOptions #PatientsNeedResearch

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Hot off the press ➡ Pharmaceutical Technology hears from ArisGlobal's RaviKanth Valigari and Ramesh Ramani about how Large Language Models (LLMs) are transforming safety and regulatory requirements in a drug development context. Read their perspectives here: https://bit.ly/3xRgAvR #lifesciences #genAI #LLMs #AI #safety #regulatory #regulatoryoperations #regulatoryaffairs #drugdevelopment #clinicalresearch

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According to the latest analysis from BiopharmIQ by Amp, Pennsylvania holds the #3 position in CGT ecosystems for companies with under 50 employees. However, as these companies grow, I hope they choose to mature in Philadelphia. Recently, I've had numerous conversations about the region's shortage of leadership/ executive talent. It's intriguing considering that 80% of Big Pharma is located within 90 miles of the city. What the CGT sector needs is more experienced leadership, and Big Pharma could serve as an excellent source for it. For the latest updates on Life Science and Biotech news in the Philadelphia region, join The Informal Philadelphia Life Science Group below!

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Value-based payment arrangements are crucial for expanding patient access to cell and gene therapies. That’s why I am in Washington, DC, to advocate for the Medicaid Value-based Payments for Patients (MVP) Act at the Alliance for Regenerative Medicine’s Cell & Gene Congressional Fly-In July 15-16. #CGFlyIn24 #MVPACT #celltherapy #genetherapy #cellandgenetherapy #advancedtherapies #regenerativemedicine #policy #valuebasedpayments #patientaccess #biotech #biotechnology #lifescience #lifesciences #advocacy #payments #congressionalsupport Erica Cischke #facilitatepatientaccess #removebarriers

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If you're a gene synthesis provider, screening is a competitive advantage. Aclid just highlighted recent legislation that mandates screening certifications for any vendor working with US govt agencies, academic institutes, and federal contractors. At the recent Ginkgo Bioworks, Inc. Ferment conference, several panelists mentioned the White House is more concerned about genetic data than any other kind. To gain the competitive advantage, take a read...

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The proposed Biosecure Act aims to restrict U.S. reliance on Chinese contract research organizations like WuXi AppTec and BGI Group, impacting NIH-funded institutions and biotech firms that depend on them for research. This legislation could disrupt supply chains and R&D efforts crucial for drug development, highlighting vulnerabilities in outsourcing strategies within the pharmaceutical sector. I believe that embracing digital solutions such as chemical coding languages and date repos in molecule design and manufacturing could foster resilience, transforming how the industry navigates global supply chain challenges. #Biotech

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How is the weather in Boston warmer than Los Angeles right now? Headed to the plenary session at #BIOIT - if you're here, let's connect! I'm here through Wednesday. #BioIt #Bioinformatics #PrecisionMedicine

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Learn from top clinical leaders how AI can foster a symbiotic relationship with stakeholders, enhancing decision-making, improving operational efficiency, facilitating real-time insights, personalising interactions and rethinking patient engagement.

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By leveraging AI with vast genetic databases, we are not only quickening the pace of identifying potential drug targets but also enhancing the accuracy of clinical diagnostics and predictive modeling. Recently, I had the privilege of discussing the profound impact AI is having on pharmaceutical R&D with Kim Branson, GSK's SVP Global Head of Artificial Intelligence and Machine Learning. Listen on Raising Health: https://lnkd.in/g6QUm2-A

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#LanternPharma announced a strategic AI-driven collaboration with #OregonTherapeutics to optimize the development of its first-in-class protein disulfide isomerase (PDI) (1) inhibitor drug candidate XCE853 in novel and targeted cancer indications. https://shorturl.at/alnoZ #TechNews #StayInformed #StayAhead #dailydose #followus #staytuned #stayconnected #technews #technology #trending #trendingnow #trendingnews #explore #explorepage #techdogs

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🎧 Check out the Mendelspod podcast episode, "Two Industry Leaders on Dealing with the Growing Complexity of Genomic Cancer Data," featuring JAX's Cara Statz & Illumina's Erica Schnettler discussing the landscape of oncology research, oncology testing and variant interpretation:

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Today's latest AI Driven Oncology Considerations ! A recent survey led by Andrew Hantel, MD, and colleagues from Harvard Medical School, identified three key ethical considerations for integrating AI into cancer care: Ethical AI Use: Oncologists emphasize AI models must be explainable and transparent, with patient consent for AI-driven treatment decisions and safeguards against biases from narrow data sources. Patient-Centered Decision Making: Over a third of oncologists would defer to patient preferences when AI recommendations conflict with their own, highlighting AI's supportive role in clinical decision-making. Challenges and Opportunities: The survey revealed a gap in oncologists' confidence in recognizing AI biases, underscoring the need for enhanced training and ethical guidelines. In CA: A Cancer Journal for Clinicians, experts like Shiraj Sen, MD, PhD, discussed AI's future in oncology: Treatment Personalization: AI could enhance treatment customization by integrating patient factors and biomarkers. Radiographic Response Assessment: AI-assisted trials are assessing treatment responses and may predict tumor behavior for personalized treatments. Clinical Trial Access: AI may improve access to clinical trials by matching patients with suitable studies, potentially enhancing outcomes for advanced cancer patients. Both Hantel and Sen stressed the importance of structured AI education and ethical frameworks to ensure responsible AI integration in oncology.

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Protocol-based disease registries are purpose-built for research, making them one of the most clinically rich sources of RWD - learn how to leverage them in this on demand webinar.

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Heading to the EPHMRA Annual Conference? Don’t miss Senior Director Tom Winter’s presentation with Bismay Mishra from Gilead Sciences.​ Using a recent case study example of a project conducted with respondents involved in working among, interacting with, and advocating for underserved communities, each with unique perspective, Tom and Bismay will outline how market research was able to identify who the underserved populations for PrEP are, the specific barriers they faced, and provide actionable recommendations that Gilead could work with to drive better access to PrEP among these communities. ​ If you’d like to learn more about this presentation or would like to meet with us at the conference, click here: https://lnkd.in/emVM7J5e #EphMRA #EphMRA2024 #MarketResearch #BusinessIntelligence #Pharma #Pharmaceuticals #Healthcare #HealthEquity #HIV

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Checkout this video for out initial thoughts on the final rule for LDTs.

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I really appreciate the title of this Lancet commentary article on Micron's positive Phase 1/2 MR data as it resonates so strongly with what we are doing -- giving new hope to reach the unreached children. Micron Biomedical, Inc.'s recent press release links to this insightful commentary article and can be found below for those interested in reading.

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What a pleasure to see Alexandra Snyder, MD and share insights on how #AI is revolutionizing the #drugdevelopment industry, with its ability to surpass human intelligence and generate new ideas. Thank you HCW for hosting the AI panel discussion, with partners at Nasdaq. ❓️how can we take advantage of this technology? Defining your requirements to the target, to a novel molecule, and setting expectations to clinical development are crucial to successfully deploying AI in #clinicalresearch. ❓️Can we cure #cancer with #AI? The heterogeneity of disease in a single cancer sub-set of population is mind-blowing, let alone in multiple cancers. The power of AI is evident in its ability to capture the extent of this heterogeneity and help with strategic development path of a program. ❓️What do we need to be able to use AI? To fully appreciate its potential, we need the infrastructure and tools to deploy information and analytics. #ArtificialIntelligence #healthcare and ##drugdevelopment #innovation #endpoints and #analytics

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This will have far-reaching implications for clinical labs offering #LDTs and operating under #CLIA. The rule will raise many questions and challenges for #clinicallabs.

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