Louis Garguilo

A Curative Solution: How Cell & Gene Therapies Support Patients & NJ’s Life Sciences Industry https://ow.ly/xOPe50UnvNc #CellTherapy #GeneTherapy #LifeSciences #Biotech #HealthcareInnovation #PatientCare #NewJerseyLifeSciences

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🚨 Webinar Announcement: Improving Outcomes and Access to Precision Medicine🚨- https://lnkd.in/eSvkPZPG Despite groundbreaking advances in precision medicine, a critical gap remains: the lack of diverse representation in genomic data, leading to unequal healthcare outcomes—especially for people of color. 🔬 What is the impact? Genomic testing is a cornerstone of modern medicine, yet current databases are largely based on data from individuals of European descent. This leaves underrepresented populations at a disadvantage, with less effective treatments and limited access to life-saving innovations. 💡What you’ll learn: 1️⃣ Understanding the genomic testing gap and the structural barriers in healthcare 2️⃣ How to advance precision medicine for all, ensuring inclusivity 3️⃣ Practical strategies for improving access, including policy changes, community engagement, and innovative healthcare models 📅 Date: Thursday, 21st November, 2024 ⏰ Time: 12:00pm - 1:00pm ET 📍 Location: Zoom (Register Here https://lnkd.in/eSvkPZPG) Let’s work together to create a healthcare system that serves everyone. #PrecisionMedicine #GenomicTesting #HealthEquity

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While #ASCO24 is at an end, it was great following all of it on social media. If you were at ASCO and interested in potential collaborations with the journal Technology in Cancer Research & Treatment, please feel free to reach out. Thanks for sharing OncoDaily! #cancer #oncology #cancerresearch #oncodaily

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'BioRationality—How to Promote Science to Secure Waiver of Comparative Efficacy Testing for #Biosimilars' "A recent Biosimilars Council Position Paper presented arguments that “#Comparative #Efficacy #Studies Are Usually Unnecessary” if analytical, functional, and pharmacokinetic methodologies are sufficient to detect clinically meaningful differences. The paper also suggested that the #FDA require clinical efficacy testing “only when scientifically justified and unique risk-based considerations are identified considering, for example, the mechanism of action, the complexity of the product, or the delivery mechanism.” "The #USFDA has admitted that our current clinical trial system is broken. "The #UKMHRA United Kingdom’s Medicines and Healthcare products Regulatory Agency has already concluded and stated that: “Although each biosimilar development needs to be evaluated on a case by case basis, it is considered that, in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach.” "The #EMA European Medicines Agency has called for a position paper to adopt a similar policy, calling for comments by April 30. A reflection paper is anticipated soon." Read more on these interesting developments in this article. https://lnkd.in/gXeehuCA Biocon Biologics Sandeep Athalye

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Alexa B. Kimball, and colleagues review the current research on targeted therapies for hidradenitis suppurativa, including FDA-approved biologics and therapies in phase III and II trials. #hidradenitisSuppurativa #biologics #JAKinhibitors https://lnkd.in/g-SNJNhY

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#Randomizedcontrolledtrials are the gold standard for #clinicalresearch; however, in many areas, like #oncology, they are infeasible because new therapies often target rare tumors and, therefore, the indicated population is small. During the 2024 DIA #RealWorldEvidence Conference (October 24–25, 2024, Philadelphia, PA, USA), Ulka Campbell (Head of Scientific Strategy, Aetion) explored this topic in the presentation, “Beyond #ExternalControlArms: Utility of #RealWorldData in Oncology #Regulatory Applications.” Here, we take a Deep Dive into the session, summarizing the six oncology case studies used to illustrate how #RWD can support regulatory decision-making. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #healthoutcomes #rwe #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy #valueassessment #clinicaltrials #RCT #singlearmtrial #rarediseases #orphandrugs

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Hear from John McDermott, VP of Scientific Consulting, on how the application of our #TranslationalPharmaceutics® platform as #RapidFACT® can help increase the probability of a program's success while accelerating its timelines overall. Learn more: https://lnkd.in/gYDK9b_U

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Commercialization can be particularly difficult for smaller manufacturers. https://ow.ly/bAil50Ubm7z This case study details how one small biopharma company partnered with MMIT to track coverage and restrictions for its first commercial launch in the rare disease space. Access the case study at the link in this post. #Biopharma #RareDiseases #Pharmaceuticals #LifeSciences

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[Article] KOL Engagement Dynamics - KOL Activities by Phase In this part 2 of 3 on "Navigating KOL Engagement Dynamics", we present our second key insight from our KOL engagement strategy report. This article addresses the type of activity pharmaceutical companies seek from KOLs who possess specific experiences suited to support the activities of the pharmaceutical organization during particular times within a product lifecycle Read on here: https://lnkd.in/eZRZxgUg #medicalaffairs #msl #msls #thoughtleader #pharmaceuticalindustry #healthcare

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🧑‍🔬 A huge shoutout to our partners for their incredible support of the Maryland Antibody Therapeutics Xchange 2024! 🌟 Your commitment to advancing antibody therapeutics is invaluable, and we’re excited to collaborate in pushing the boundaries of healthcare innovation.🧫 🧬 🥇 Our Partners: Bio-Rad Laboratories Bio-Rad Antibodies WuXi Biologics evitria AG IPA (ImmunoPrecise Antibodies) Integral Molecular Haven’t registered yet? There’s still time to secure your COMPLIMENTARY pass and be part of this ground-breaking event. Join us in shaping the future of medicine! https://lnkd.in/eN96iM4f Only available for Senior Scientists and above, from Bio and Pharma companies with a drug pipeline. 💊 #AntibodyTherapeutics #Biopharma #HealthcareInnovation #ML2024 #LifeSciences #MedicalInnovation #BiotechInnovation #FutureOfMedicine #Pharma #MLEvents #PartneringForSuccess #TherapeuticInnovation #AntibodyEngineering #BiotechnologyLeadership #DrugDevelopment #HealthcareSolutions #ClinicalResearch #PharmaceuticalScience #PrecisionMedicine #LifeScienceCommunity #BiotechCommunity #HealthcareEcosystem #BiotechResearch #AntibodyDiscovery #NextGenTherapeutics #PharmaInnovation #hubXchange #Xchanges #Roundtable #FreePass #RegisterNow #ComplimentaryPass

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Point-of-care (#POC) facilities, especially in #cellandgenetherapy applications, are experiencing a significant surge in interest because of an increased focus on capacity needs and specialized processing facilities close to the actual patient. BioProcess Resources LLC.'s Maik Jornitz details challenges, considerations, technological advancements, and future trends driving POC #manufacturing. #pointofcare #CGT #celltherapymanufacturing https://lnkd.in/eSa2aj8z

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【KBIC Company Topic】 Healios Concluded License Agreement with Astellas Pharma Concerning RPE Cell Production Method HEALIOS K.K. (“Healios”) today announces that it has entered into a License Agreement with Astellas Institute for Regenerative Medicine (“AIRM”, Location: Westborough, MA; President: Erin Kimbrel, PhD), a subsidiary of Astellas Pharma Inc. (Head Office: Chuo-ku, Tokyo; President and CEO: Naoki Okamura), that investigates novel pluripotent stem cellderived therapeutic products, concerning the patent on a Retinal Pigment Epithelial (RPE) cells* 1 production method shared with RIKEN, National Research and Development Agency in Japan, and Osaka University, National University Corporation in Japan, and the patent on a method for purification of RPE cells shared with Osaka University (“Patents”)*2 . Healios grants AIRM a non-exclusive license in the countries where the patents are filed outside of Japan. Read more: https://lnkd.in/gq5TxqMs #kbic #fbri #kobe #kansai #japan #healthcare #lifescience #innovation #regenerativemedicine #celltherapy

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Breast cancer research shows no signs of slowing. We dug into the data from Citeline’s Trialtrove to give you key insights from active #breastcancer clinical trials. https://hubs.ly/Q02SsbPn0 #oncology #clinicaltrials #drugdevelopment

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PTC was excited to learn, share and collaborate with other leading RNA experts at the recent 7th Annual RNA-Targeted Drug Discovery & Development Summit in Boston, MA, and the RNA at the Bench and Bedside IV conference in La Jolla, CA. Anu Bhattacharyya, Kerstin Effenberger, and Marla Weetall from our research team presented on ways PTC is leveraging its leading splicing platform to identify promising therapies for rare diseases with high unmet need. Learn more about our splicing platform here: https://bit.ly/4fi4w6L

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