Caidya’s Post

The value of real-world evidence has been on everyone's mind now more than ever! Eleanor (Tyler) Maughan, PhD talks to us about how we can better leverage RWE to drive innovation in early research, clinical trials, regulatory approvals, commercialization and post-market surveillance. Read more here: https://rb.gy/yuboa0

🎉 Get ready to unlock the keys to success in the small biopharma sector with Jerry W., Associate Director at Ascentage Pharma, LIVE at the 20th Biopharma Clinical Trials Nexus Conference! 🌟 Join Jerry as he delves into the dynamic world of "Effectively Steering Your Clinical Trials for Success in the Small Biopharma Sector." 🚀🔬 Dive deep into actionable strategies, insider tips, and real-world case studies tailored specifically for small biopharma innovators. 💡 Don't miss this exclusive opportunity to learn from one of the industry's brightest minds and gain the competitive edge you need to drive your clinical trials to success. 🎤 #BiopharmaClinicalTrials #Innovation #SuccessSecrets #SanDiegoConference

There’s still time to register for our upcoming Copenhagen workshop – Patient-focused by design: uncovering the supply strategies shaping a new era of drug development. Register today and get set to discover how innovative, patient-centric supply strategies, including direct to patient distribution and Just in Time Manufacturing, along with Qualified Person processes and Managed Access Programmes, are helping to shape a new era in drug development. https://hubs.li/Q02swRBF0

“A one-size-fits-all approach to biopharma R&D no longer fits the technology-savvy, diversified world of drug development.” In a newly published article in the DIA Global Forum, Mary Lynn Mercado (Novartis) and Madhavi Gidh-Jain (Sanofi) share their opinions about the evolving landscape of clinical trials, emphasizing TransCelerate's pivotal role in the collaborative partnership with EU-PEARL - EU Patient- cEntric clinicAl tRial pLatforms, which enabled adaptive platform trials through advanced tools and frameworks such as the master protocol template. The article also features perspectives from Peter M. (Novartis) and Cecile Spiertz (Exscientia) on the efforts and development of this protocol. Learn more about the TransCelerate and EU-PEARL collaboration: https://lnkd.in/efzuDWWS

What were the highlights of the recent clinical trial supply conferences N-SIDE attended?   We haven't finished listing them yet! From reconnecting with familiar industry peers to engaging with new prospects seeking stress-free and sustainable clinical supply planning, our N-SIDE Life Sciences team had a fulfilling experience at conferences across Europe and the US over the past few months!   However, one may particularly stand out: the co-presentation in Barcelona featuring our experts Amaury Jeandrain and Sasha Van Heuverswyn alongside our esteemed partner Sanofi, represented by Arnaud DOURLENS, Head of Clinical Supply Operations. We shared how innovation and data processing combined with a strong culture of performance allowed to double from 35 to 70% the proportion of drug ultimately dispensed to patients and a reduction by up to 50% in the total quantities of drugs required to conduct a trial. This resulted in significant improvements notably in patient service levels, cost savings, and reduced carbon footprint, ultimately enhancing Sanofi's overall performance in clinical trial supply. N-SIDE revolutionizes clinical trials, drastically reducing timelines and enhancing efficiency. Connect with us at our upcoming conferences and discover how we are transforming the industry 👉 https://lnkd.in/e5SgGCFF #LifeSciences #Pharma #Biotech #ClinicalTrials #Conference 

Join our COO, Chris Schoonmaker and me at the Spring MIT Forum (June 17, 2024) for an exciting panel discussion on regulatory approvals and many other discussions. The conference brings together leaders in our field for a productive 2-day in-person dialogue on several key topics. Approvals are the grand finale of the work we do and I wake up every day with renewed energy to support yet another drug/biologic/therapeutic option for patients globally. At #OneMMS, this is our passion and expertise, working with regulators and sponsors to enhance efficiencies one submission at a time while maintaining our data-focused efforts. #dataCRO #biometrics #submissions

In this episode of “Transforming Biopharma,” we explore how pharma companies can build deep, collaborative partnerships with clinical trial sites to drive success. Maria Whitman talks with Lauren Wall of the University of Chicago and Caroline Smith of Charter Research about the importance of patient-centric trial design, investing in site engagement and understanding site challenges to improve the clinical trial process.

With the FDA’s recent draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” greater emphasis is being placed on increasing clinical study enrollment of historically underrepresented populations. Conducting diverse clinical trials is both a regulatory and ethical imperative that offers strategic advantages to pharma and biotech companies. By including a more representative patient population in studies, companies can ensure the development of assets that improve health outcomes for a larger cross-section of the population and, in turn, strengthen their position in the market with a drug tailored to ensure a more universally safe uptake. Click the link below to learn more. https://lnkd.in/efwn-Wya #clinicaltrials #FDA #diversityinclinicaltrials #diversityactionsplans Subscribe here to receive our latest insights and newsletters: https://lnkd.in/eGAaapyA

Early consideration of diversity and inclusion (D&I) can generate critical knowledge about the response to investigational treatments for underrepresented groups -- broadening access to experimental therapies, and addressing essential regulatory requirements. https://bit.ly/4bfuI0d #drugdevelopment #clinicaldevelopment #clinicaltrials #diversity

💥 Join us for our first webinar of 2024 as we discuss the value of digital measures in drug development 💊🧪 with Maulik Majmudar, Ariel Dowling and Erwin De beuckelaer. 👀 We’ll take a look at insights from our latest report with Biofourmis and ask, how can we come together to ensure better utilisation of digital measures in clinical trials? During the webinar we’ll discuss: 💬 What are the biggest barriers to the adoption of digital endpoints in drug development? 💬 What is required to shift towards using digital measures as primary endpoints and supporting label claims in the future? 💬 Where does it make sense to leverage digital endpoints and for what purpose? Register now ➡️ https://lnkd.in/e5eFMVEB #drugdevelopment #digitalmeasures #digitalhealth