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DTSTART;TZID=America/New_York:20250626T120000
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SUMMARY:Clinical Development Webinar
DESCRIPTION:Master Protocols in Clinical Trials: Driving Innovation\, Efficiency & Patient-Centric Research \n\n\n\nThursday\, June 26 | 12:00 p.m.-1:30 p.m. | Webinar \n\n\n\n\nRegister Today for Free!\n\n\n\n\n\n\nMaster Protocols in Clinical Trials \n\n\n\n“Master protocols are innovative clinical trials designed with multiple sub-studies\, subgroup-populations\, and subprotocols. They aim to explore or evaluate multiple therapies or multiple subpopulations in parallel under a single overarching protocol\, with the characteristics of improving efficiency and establishing uniformity through standardization of procedures in clinical trials. Master protocols could help address scientific\, operational\, and competitive challenges in the existing drug development model.” ~AppliedClincialTrialsOnline.Com \n\n\n\n\n\nJoin us for an insightful FREE webinar exploring how Master Protocols are transforming the clinical trial landscape. Designed to increase efficiency and flexibility\, Master Protocols offer a unified approach to studying multiple therapies\, diseases or Patient subgroups under a single overarching framework. \n\n\n\nIn this session\, you’ll:  \n\n\n\n\nGain efficiency with Master Protocol\n\nOptimize resource allocation\n\n\n\nStreamline trial execution\n\n\n\n\n\nAccelerate drug development\n\nExpand quickly across indications\n\n\n\nSupport multiple launches \n\n\n\n\n\nEnhance Patient journey\n\nEncourage sub-studies within the same trial to assess variations of Patient treatment options\n\n\n\nBalancing innovation around validity and relevance with Patient-centered approaches\n\n\n\n\n\n\nLearning objectives include:  \n\n\n\n\nDefine the Master Protocol in drug development\n\n\n\nOutline key elements of a successful Master Protocol\n\n\n\nArticulate the regulatory considerations related to the FDA Guidance on Master Protocols\n\n\n\nAdapt the Master Protocol design for oncology to other therapeutic areas\n\n\n\n\nWhether you’re a clinical operations professional\, researcher or sponsor\, this webinar will equip you with strategic insights to drive innovation while keeping Patients at the center of trial design. \n\n\n\nSpeakers \n\n\n\n\nLincy George\, PharmD\, Vice President\, Global Regulatory Affairs\, Oncology\, Specialty Care Business Unit\, Sanofi  \n\n\n\nDr. George is a seasoned regulatory affairs professional with more than 20 years’ experience in large global pharmaceutical companies securing drug approvals for several high priority brands. She has broad cross functional experience with diverse teams in both development and commercial organizations\, working on launch brands as well as products in development. \n\n\n\n\n\n\n\n\n\nBradley Smith\, Ph.D.\, Vice President\, Translational Medicine\, IQVIA  \n\n\n\nDr. Smith is a recognized leader in biomarker and companion diagnostic development\, bringing deep experience across laboratory research\, clinical implementation and Patient care. He is a subject matter expert in drug and diagnostic strategy\, leading commercial planning and the integration of companion diagnostics in oncology and other therapeutic areas. His responsibilities include regulatory\, technical and scientific oversight ― including U.S. registration. \n\n\n\n\n\n\n\n\n\nKatherine Sugarman\, M.D.\, Senior Vice President\, Clinical Development Strategy\, Genmab \n\n\n\nDr. Sugarman possesses a wealth of experience and expertise in oncology clinical development\, both from academia and the pharmaceutical industry. As part of Genmab’s ongoing evolution in R&D\, Dr. Sugarman oversees the clinical development strategy of their pipeline\, ensuring strategic trial design\, and providing scientific\, medical and statistical analysis insights for the interpretation of clinical data to drive promising molecules forward to address high unmet medical needs for Patients.​  \n\n\n\n\n\n\n\n\n\nModerator: Prasad Subramaniam\, Ph.D\, PMP\, sMBA\, Associate Director\, Portfolio & Program Management\, Genmab \n\n\n\nDr. Subramaniam is currently Associate Director within the Development Program Management function at Genmab\, supporting late-stage oncology and hematology programs. He is an experienced drug development leader with over 12 years of combined academic and industry experience spanning program and stakeholder management\, product development and strategic insights and competitive intelligence across hematology\, immuno-oncology and solid tumors. \n\n\n\n\n\n\n\n\n\nChris Pullion\, DO\, Medical Director\, Soligenix \n\n\n\nDr. Pullion oversees Soligenix’s study protocol design and implementation\, safety and pharmacovigilance; assists with clinical operations and regulatory interactions; and reviews all study related reports\, assessments and data analysis. He has been the clinical lead on numerous research programs over the years\, including most recently Soligenix’ two Phase 3 studies where he oversaw everything from protocol design and conception through to drafting clinical study reports and preparation for new drug applications. \n\n\n\n\nDon’t miss this opportunity to advance your understanding of the future of clinical trials. Click here to register for free and join us on June 26!
URL:https://bionj.org/event/clinical-development-webinar/
CATEGORIES:BioNJ Event
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