Just wrapped up an insightful keynote with Dr. Klaus Romero at #Certainty! Dr. Romero, CEO and CSO of the Critical Path Institute (C-Path) discussed "The Regulatory Scientist Perspective on MIDD," highlighting how quantitative methods are shaping regulatory reviews. He covered key concerns of regulatory scientists and the critical questions models need to address, using industry examples and case studies. Thanks, Dr. Romero, for your expertise! #Certara #CertaraCertainty #DrugDevelopment #RegulatoryScience #MIDD
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Congratulations to our esteemed Principal, Dr. Vinod Kumar Gauttam, for the remarkable achievement of publishing a review article in Drug Target Insights with an impressive impact factor of 3.6! Your dedication to advancing scientific knowledge and contributing in this field is truly commendable. Your expertise shines through in every word, inspiring us all to reach new heights. Here's to many more successes ahead! #Congratulations #ResearchExcellence #DrugTargetInsights" Vinod gauttam
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Managing Partner at LeapAhead Solutions | Optimizing Life Science Regulatory Affairs, Clinical Operations and Quality including AI / Automation and Data Strategy and Governance
RECORDING & SLIDES POSTED (for DIA members): June 26 #diarim #intelligentautomation meeting where Wim DHaeze, PhD, ELS from Sarepta Therapeutics facilitated a discussion of Adoption of AI-Driven Automation in #rim Systems. Lots of good nuggets and experiences in here about what's working, not working, challenges companies are facing after the proof-of-concept stage, etc. Let me know if you have any questions or would like to discuss further. Slides for DIA members only - https://lnkd.in/ecX6SJWq Recording for DIA members only - https://lnkd.in/eh7mXPtH #ai #automation #regulatory #regops #pharma
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Accountability for unethical behavior is essential in the life sciences industry.
Executives Depart Cassava, Maker of Disputed Alzheimer’s Drug
nytimes.com
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1. Starting drug discovery with an unmet medical need ✅. 2. Few years into development it's time to move the new drug to clinics ✅. 3. With all the available data out there today, do we have the optimal target-indication fit?? 🤔 💡 Find out on how to de-risk this decision with our novel approach! ➡️ Attend our webinar: Register at https://lnkd.in/deEW6Tkt Why Multiomics? The context data to the targets and diseases simply speak Multiomics. – Bringing data and biology into harmony – – 1st time academic entrepreneur – – Join me on my journey –
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Q: What lessons learned from 2023 will play a role in the way scientists approach future research for #celltherapy + #genetherapy treatments? In our latest #PatientEducation Community Quick Takes module, Dr. Peter Marks (FDA CBER) emphasizes the importance of making full use of platform technology and better global regulatory convergence, in addition to the pilot program he mentions below.
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The interest in decentralized clinical trials (DCTs) is booming, driven by both industry and regulators. But how can we ensure these innovative trials deliver robust scientific data? Meet Alex Sverdlov from Novartis at Data Driven, Hybrid and Full Decentralized Clinical Trials as he discusses the ICH E9(R1) estimand framework to guide decisions around DCT components and how this helps researchers: 🌟 Evaluate the true scientific value of decentralization, beyond operational benefits. 🌟 Systematically consider potential impacts on each aspect of the estimand 🌟Uncover scientific opportunities, assumptions, and risks associated with DCT design. Alex will illustrate this approach with a real-world DCT case study, showing how it reveals new target estimands by addressing more granular questions. REGISTER YOUR PASS HERE: https://lnkd.in/eTv2jXAx 🗓️ April 16-17, 2024 📍Hilton Philadelphia at Penn's Landing, Philadelphia #clinicaltrials #decentralizedtrials #estimandframework #innovation
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Patel and the team have compiled various computational tools to aid drug design and discovery. This manuscript has been gaining wide attention worldwide since 2022. https://lnkd.in/dC9zF8MP #telemedicine #DHPSP #DigitalHealth #DHPSP2024 #Machinelearning #Artificialintelligence
View of A Review on Computational Software Tools for Drug Design and Discovery
igjps.com
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Cognitive data can save research teams significant time and cost during drug development when applied for targeted Go/No-Go decision-making. A publication with co-authors including Cogstate’s Chris Edgar & Paul Maruff—discusses how to implement cognitive data for the specific stage of development, mechanism of action, and design of the trial. See a sample algorithm the researchers developed for Go/No-Go decision-making here 👉https://lnkd.in/eg4x4Npj #ClinicalTrials #CognitiveAssessment #AlzheimersDisease
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Life Sciences Leader & Valuation Partner at Weaver | Med Device Co-Founder & Board Member
Regulatory approval serves as an important differentiator of risk within the life science industry, but the FDA special review pathways and the associated implications of each confuse and disorient passive, life science admirers and experts alike. That's why we crafted this new guide to offer a better understanding of each designation. Enjoy and save this guide to refer back to in the future! Weaver #lifescience #FDA #regulatorystrategy #healthcare
FDA special review designations often sound similar but hold distinctively different connotations. In a new article, Tyler Ridley, MSc, CPA explains the differentiators of risk for drug development to help you maintain comprehensive life science literacy. Read more here: https://lnkd.in/e7UhP4-t
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Did you read the latest op-ed by President Biden and Bernie Sanders promoting #prescriptiondrug #pricecontrols? Read the latest brief from PRI's Center for Medical Economics and Innovation to learn why Biden and Sanders have it all wrong on drug costs and price controls. https://lnkd.in/gMCgYqxX
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CEO at Critical Path Institute (C-Path)
3moIt was an honor to be part of this event! Thanks to evryone at Certara for the invitation. I greatly enjoyed the innovative and collaborative atmosphere. Looking forward to keeping our partnership strong!