Anne Hummler-Réaud

Jennifer Riter, Vice President, Analytical and Development Services, Kindeva Drug Delivery Contributed an article "Transforming Pharma Analytics Through Innovation" “The goal is always the same, to accelerate development while ensuring the safety, quality, and effectiveness of the product for patients” says Jennifer Riter. Read More : https://lnkd.in/gqi39QjW #PharmaceuticalLeadership #AnalyticalServices #PatientSafety #RegulatoryCompliance #InnovationInPharma #CombinationProducts #CrossFunctionalTeams #DrugDevelopment #QualityScience

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The Pharmacopeial Discussion Group (PDG) has announced that the Korean Pharmacopoeia has been selected for admission as a Candidate Participant, an early step in the process towards admittance for full membership. The addition of the Korean Pharmacopoeia to PDG – of which USP is a member – reflects strong alignment between its member organizations and demonstrates PDG’s mission to promote global harmonization of pharmacopeial standards.  Since launching its initial pilot program in 2022, PDG’s global membership initiative has advanced efforts to increase convergence of harmonized pharmacopeial standards worldwide. Following the successful addition of the Indian Pharmacopoeia Commission to PDG in 2023, the Korean Pharmacopoeia’s admission marks another important milestone in ensuring consistency of quality standards for medicines and other health products around the world.  With this momentum, the PDG now brings together five leading pharmacopeias —European Directorate for the Quality of Medicines and HealthCare, Indian Pharmacopoeia Commission, Japanese Pharmacopoeia of the Ministry of Health, Labour and Welfare, Korean Pharmacopoeia, and the United States Pharmacopeia (USP) — with the World Health Organization as an observer. USP welcomes the Korean Pharmacopoeia as a Candidate Participant to PDG and looks forward to working together to protect people’s health and patient safety around the world. Read more: https://lnkd.in/eNZci9cg   

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🚨 The European Medicines Agency has validated the marketing application for T-DXd in HER2+ metastatic solid tumors — regardless of tumor type. 🔬 Backed by data from DESTINY trials across breast, lung, colorectal, ovarian & more ✅ Could become the first tumor-agnostic HER2 therapy in the EU 📈 Follows accelerated FDA approval for a similar indication 👉 Read the full article https://lnkd.in/etKBGGZU

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Exploring the strategic value of Data Governance in clinical trials......New Hot Topic Announced...... Join us on 27th August, where Yu Meng of Innovent Biologics will lead the next ACDM: Association for Clinical Data Management Hot Topic discussion, “ICH E6 R3 Data Governance – Self Reflection”. This session introduces Data Governance as a new standalone chapter in ICH E6 R3, marking a shift in clinical trial quality management. It covers the guideline’s key framework, including data life cycle, system requirements, and risk-based principles. With reflections on its strategic value, the session calls for collaboration to drive this transformation. Topics include the need for ICH E6, R2 vs. R3 comparisons, core components of Data Governance, and its relevance today. Secure your place today for this essential session: https://lnkd.in/edc5mhCb ACDM Board: Robert King, Sverre Bengtsson, Nina Reyes, Eva Alder, Richard Davies, Nicola Götz, Anita Kratchmarov, Ashley Howard, Amelie Spieser, Lisa Moneymaker, Yuvarajan P. #clinicalresearch #clinicaltrials #clinicaldatamanagement #clinicaloperations #ACDM

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The State of Clinical Trials: Charting the Path to 2030 – Executive Summary Now Available In May, 150 leaders from across the clinical research ecosystem came together to explore what’s working, what’s not, and what’s next for clinical trials. Now, we’re sharing the executive summary from that meeting, capturing the key themes, bold ideas, and actionable opportunities that emerged.    Whether you’re a sponsor, site, regulator, patient advocate, or tech partner, this summary offers important insights and next steps for advancing clinical trials.    Read the executive summary and join us in shaping a more efficient, patient-centered future for clinical research: https://ow.ly/AUBc50WyFEw

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The volume of life sciences publications is doubling every 14 years. How do we keep up and ensure the evidence we rely on is trustworthy? Systematic literature reviews (SLRs) are the answer. Our new whitepaper explores how to conduct SLRs with rigor and transparency, supporting better decisions in pharma, clinical research, and regulatory work. Download the guide: https://ow.ly/gtc950WHosF #LifeSciences #EvidenceBasedMedicine #SLR #PharmaInnovation #ClinicalResearch

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Did you know? ~90% of drug candidates fail in clinical trials, often because the biological targets prove unreliable or lack translational potential. TargetPro addresses this challenge by integrating 22 multimodal data sources into disease-specific models that learn which targets are most likely to reach clinical testing. It identifies context-dependent patterns by disease and achieves higher accuracy than other target ID models. TargetBench 1.0 is the first standardized benchmark for target discovery, built to evaluate target identification models, including LLMs. By building an AI system that outperforms general-purpose models and widely used public resources, we are generating actionable intelligence not just predictions. Combined with TargetBench 1.0, this framework sets a new standard for reliability and transparency, enabling biopharma companies to move faster and smarter toward breakthrough therapies. 📄 Paper: https://lnkd.in/eJzVyUYa #AI #DrugDiscovery #TargetDiscovery #GenerativeAI #PharmaAI

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Genedata automates NGS workflows to help biopharma teams accelerate development — even in GMP-compliant environments. In this webinar, Ludwig Macko shows how the platform streamlines sample registration, data processing, and reporting across diverse applications and modalities. With built-in support for validated environments, Genedata enables faster delivery of safe treatments to patients. Watch now: https://lnkd.in/dUZEXcec #AutomateToInnovate #DigitalizingBiopharma

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