Last week, Mike Baker, Ignazio Di Giovanna and Kendyl Dixon represented ARG at the 3rd Annual ALS Drug Development Summit in Boston. They met and networked with ALS experts from all over who share one common goal — improving outcomes for ALS patients. #ALS #ClinicalStudies #DrugDevelopment #ALSAwarenessMonth #ARG20Years
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AI technologies have been used in real-world situations for a while, but since last year, AI is front-and-center in any product. Dragan Mileski and Bradley F. can show you some insights into GenAI and real-world studies here.
Gain exciting insights on the topic of GenAI in Real-World Studies in our upcoming Climedo Connect Webinar. On June 27, Dragan Mileski, Co-Founder and CTO of Climedo, will share exclusive insights on how to apply GenAI effectively in clinical studies. Dive deep into understanding the fundamentals of GenAI, explore various use cases applicable in post-market studies, such as drug safety monitoring and comparative effectiveness analysis, and discover best practices for seamlessly incorporating GenAI into your clinical research endeavors. Register for free: https://lnkd.in/efe9tsaE #GenAI #RWE #ClinicalTrials
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At #PatientsEU2024, Anders Blaedel Lassen, Lundbeck will discuss how to use patient-centric 'integrated evidence' approaches to plan and build a patient voice strategy throughout a development cycle to inform drug development decisions, including: - For treatments that truly address user needs and expectations, the patient voice can’t be an ‘add on’ - Working with integrated evidence approaches can help putting the patient perspective at the center of drug development Learn more - https://lnkd.in/gtPN3xZP #PatientsasPartners #ClinicalResearch #ClinicalTrials #DrugDevelopment #PatientVoice #PatientFeedback #PatientInvolvement #PatientEngagement #PatientAdvocacy
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🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory
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Early/Late Phase and Regulatory Strategy, RWE & RWD, Market Access, Logistics at Parexel Biotech
🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory
How to find the least burdensome regulatory path for a co-developed CDx
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🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory
How to find the least burdensome regulatory path for a co-developed CDx
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🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory
How to find the least burdensome regulatory path for a co-developed CDx
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Vice President (Technical) | Chemistry, Manufacturing & Controls (CMC) and regulatory affairs consultant | Ex-MHRA regulator | Pharmacist
🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory
How to find the least burdensome regulatory path for a co-developed CDx
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🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory
How to find the least burdensome regulatory path for a co-developed CDx
share.parexel.social
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🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory
How to find the least burdensome regulatory path for a co-developed CDx
share.parexel.social
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🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory
How to find the least burdensome regulatory path for a co-developed CDx
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