Hospitals on FHIR’s Post

In the latest collaboration from ACRO and TransCelerate BioPharma Inc., Nicole Stansbury of Premier Research and Madeleine Whitehead of Roche discuss the impact that ICH E6(R3) will have on Good Clinical Practice and implications for innovation. Read the feature in pharmaphorum: https://bit.ly/3UIQAvm

🌟Happy National Clinical Trials Day!🌟 Today, we at Kerlo Research are proud to celebrate the pivotal role of clinical trials in advancing medical knowledge and improving patient care. As a dedicated Site Management Organization, we understand that each trial is a step towards a healthier future for all. 🔬 Why Clinical Trials Matter: Clinical trials are the backbone of medical innovation, providing the data needed to develop new treatments and therapies. They ensure that medications and procedures are safe and effective for public use. Without the tireless efforts of researchers, healthcare professionals, and participants, groundbreaking medical advancements wouldn't be possible. 👥 Our Commitment: At Kerlo Research, we are committed to excellence in managing and supporting clinical trials. Our team works diligently to ensure that every trial runs smoothly, ethically, and efficiently. We partner with healthcare providers, pharmaceutical companies, and researchers to bring cutting-edge treatments from the lab to the patients who need them most. 🙏 Thank You! - To our dedicated staff, who work relentlessly behind the scenes. - To the brave participants, whose contribution is invaluable. - To the healthcare professionals and researchers, whose expertise drives progress. Today, let's acknowledge and appreciate the incredible impact of clinical trials on global health. Together, we are making a difference, one trial at a time. #NationalClinicalTrialsDay #ClinicalTrials #MedicalResearch #HealthcareInnovation #KerloResearch

Learn more about the progress made so far by the c4c network and plans for the future ☝️

Unveiling the Potential: The Attractiveness of R&D in the Netherlands Today I had the pleasure to participate in a panel discussion about "Research & Development: How Attractive is the Netherlands?" organized by Axon Healthcare and hosted by J&J Innovative Medicine Nederland. This meeting brought together over 180 participants from the healthcare and pharmaceutical sectors, both in-person and online, to delve into the opportunities and challenges within the Dutch R&D landscape. The event was kicked off by Michel van Agthoven, who emphasized the Netherlands' commitment to fostering an innovative ecosystem for drug development. Speakers such as Wiesje van der Flier and Jos GW Kosterink highlighted the Dutch academic excellence, the synergy between academic institutions and industry, underscoring the pivotal role of this collaboration in maintaining the Netherlands' position at the forefront of pharmaceutical innovation. Discussions centered on several compelling statements, facilitated by Hans Schikan of Health~Holland, including the enhancement of clinical development through better understanding of multinational study complexities and the critical nature of quality data delivery. The dialogue extended to potential risks, such as the impact of focusing solely on cost reduction which could lead to a decline in local R&D activities. Notable contributions came from Annemiek Verkamman and Benien Vingerhoed - van Aken, who discussed the strategic importance of clear regulatory frameworks but also partnerships between universities, hospitals, and the industry to secure the Netherlands as a leader in patient access to innovative treatments. The collective panel insights showed a robust infrastructure well-suited to the rapid advancements in medicine, making the Netherlands a prime location for international studies. Looking forward, it is clear that the Netherlands is set to not only continue but to enhance its role in the global R&D arena. With the Dutch Clinical Research Foundation soon to be launched National Actionplan Clinical Research we look forward to accelerating the next steps. Thank you to all the participants and speakers who made this event so full of insights and ideas. Look foreatd to continue to engage and expand the network to further the advancements in sustainable healthcare. Your thoughts and participation in upcoming discussions are highly valued as well so please engage! #clinicalresearch #healthcareinnovation #sustainablehealthcare #clinicaltrials

🚨 The European Commission has just accepted commitments offered by Viforpharma in what will be - once published - the first EU decision addressing anticompetitive disparagement (“dénigrement” in French). 😵💫 We understand that Vifor disseminated “potentially misleading information about the safety of Monofer” i.e. information “that is neither based on Monofer’s label nor derived from clinical trials specifically designed to compare” Vifor’s drug and Monofer, its closest competitor. It particularly targeted healthcare professionals. 🤝 Rather than imposing a financial penalty, the Commission decided to accept commitments offered by Vifor to address its concerns. The commitments are tailored to the specific practices at stake and aim at undoing the effects of the disparaging practices. 🙋♂️ What legal test applied by the European Commission and how does it compare to the test applied by the French Competition Authority (Autorité de la concurrence) in its long-standing decisional practice? We will have to wait for the final decision… and also the decision in the Teva Pharmaceuticals case which has a disparagement component.

James Lind is not a name most of us recognise and yet we all owe him a huge debt of gratitude. His comparison of potential remedies for scurvy back in 1747 is widely considered the first ever randomised clinical trial and a turning point in the history of medical research.   International Clinical Trials Day continues to shine a light on his groundbreaking legacy and rightly so. To this day, the relentless pursuit of evidence-based medicine and robust clinical trial design underpins our industry’s efforts to develop life-changing medicines for the people who need them most. That is why, as a member of the board of the European Federation of Pharmaceutical Industries and Associations (EFPIA), I am so passionate about the importance of reversing downward trends in Europe’s R&D and clinical trial investment. To restore Europe’s reputation as an innovation powerhouse, we must fast-track smarter, more patient-centric trials and increase the global share of clinical trials in Europe.   While the pace of medical advancement has completely transformed the healthcare landscape since the 18th century, I see Lind’s curiosity, thirst for knowledge and quest for scientific rigor in my own Astellas colleagues as we seek to advance innovations with the greatest potential to transform lives.   #ClinicalTrialsDay #CTD2024

Join us at the ASMA Summit for a transformative session titled "Reimagining Medical Affairs - How to Empower Yourself for Strategic Leadership."

FDA/CDER’s Quantitative Medicine Center of Excellence Announces the Availability of New Resources The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE) was founded on March 25, 2024 to foster integration of quantitative methods across CDER and help advance therapeutic medical product development and inform regulatory decision-making. To fulfill, in part, the mission of the QM CoE to: 1) spearhead QM-related policy development and best practices; 2) facilitate systematic outreach; and 3) coordinate QM education and training, the QM CoE is pleased to announce the availability of the following new resources: A quick reference Fact Sheet, providing a high-level overview of the QM CoE The recording and slides for the April 25, 2024 FDA public workshop entitled Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence A list of Frequently Asked Questions regarding the purpose, scope and upcoming activities of the QM CoE, as well as information on how to get involved An Educational Resources hub that features an assortment of educational content including free, web-based training modules on model-informed drug development (MIDD) developed by the FDA Office of Translational Sciences in collaboration with the Critical Path Institute (C-Path) and experts in the community. The series includes eight modules with 29 presentations and more than 10 hours of content on a variety of MIDD topics. #fda #clinicalpharmacology #centerofexcellence #resources #quantitativemedicine https://lnkd.in/giN6NxZh

Ioannis Kotsiopoulos, PMP, MSc, PhD, General Manager at PIF Greece participated at the 1st Health Forum organised by the Institute of Scientific Studies (Panhellenic Medical Association) and highlighted that “There is a pressing need for a long-term pharmaceutical policy designed to resolve current deadlocks. Beyond necessary funding, incentives must be created to attract clinical trials, accelerating digital transformation and developing tools like patient registries and therapeutic protocols to ensure that prescribing follows specific scientific guidelines. At the same time, it is crucial to focus on the ongoing education of healthcare professionals, as they must remain updated on the latest scientific developments". #pifgreece #innovation

Excellent initiative! Will definitly fulfill needs of many healthcare stakeholders