Franjo Hanzl’s Post

Continuing our focus on upcoming conferences, we take a look at the DIA Real-World Evidence Conference taking place October 24–25, 2024 in Philadelphia, PA, USA. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy

🔍 Do pharmacogenomic tests have clinical validity? 👩⚕️ Healthcare providers often wonder about the reliability of pharmacogenomic tests. Are they truly predictive of drug response? Do they have solid scientific evidence backing them up? ✅ Yes, they do! Here's why: 📚 CPIC and Dutch Working Group guidelines: These reputable organizations provide evidence-based guidelines for pharmacogenomic testing, ensuring its clinical validity and relevance. 💊 >376 drugs with PGx biomarkers in FDA labeling 🔬 PubMed articles: A wealth of scientific literature supports the clinical validity of pharmacogenomic tests, with numerous studies demonstrating their predictive value in guiding treatment decisions. 💡 Pharmacogenomic tests offer valuable insights into individual drug response, enabling personalized treatment approaches for better patient outcomes. Let's continue to leverage this powerful tool in clinical practice! #Pharmacogenomics #PrecisionMedicine #HealthcareInnovation

FDA's CDER: A Year of Breakthroughs in Drug Development! 2024 was a monumental year for innovation in medicine, as the FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel drugs, offering new hope to millions of patients worldwide. 🌟 🏥 Rare Diseases in Focus Over half (52%) of these approvals targeted unmet needs in rare diseases, providing life-changing therapies for underserved communities. ⏩ Speeding Up Development With 74% of novel drugs approved on the first cycle and 94% meeting or exceeding PDUFA goals, CDER continues to prioritize efficiency without compromising safety. 🌎U.S. Leading the Way A remarkable 68% of these therapies were approved first in the U.S., underscoring America's pivotal role in global medical advancements. 🚀 Power of Expedited Pathways 66% of approvals leveraged expedited programs, bringing transformative treatments to patients faster than ever before. 🔬 First-in-Class Innovations Nearly half (48%) of the novel approvals were first-in-class therapies, redefining the boundaries of medical science. From groundbreaking immunotherapies to advanced genetic treatments, here are some standout examples: ✨ Anktiva ✨ Crenessity ✨ Lumisight ✨ Voydeya and many more..... These milestones reflect the incredible collaboration between researchers, regulators, and the healthcare ecosystem, all working toward one goal: better outcomes for patients. Let’s celebrate the science, innovation, and dedication that made this progress possible. Here's to more breakthroughs in 2025! 🎉 #FDA #CDER #DrugApproval #RareDiseases #Innovation #MedicalAdvancements #Healthcare #ScienceForPatients

📢 Innovate Research is Proud to Announce a Significant Achievement We are excited to announce the successful completion of the Post-Marketing Surveillance clinical study for Asthma. As a leading Contract Research Organization (CRO), Innovate Research has once again demonstrated its exceptional expertise in clinical trials. 👨💼 A special thanks to Dr. Devesh Kumar, Dr. Piyush Kumar Pandey, Poonam Gupta, Rajat Singh Rathore, Pushkar raj Chandel, and Vaibhav Gupta for their unwavering dedication and hard work. We also extend our gratitude to our partners and participants for their invaluable contributions, which were essential in successfully managing 177 out of 178 patients. The utilization of in-house tools for efficient data handling and security #Clinsoft and #PageOne further streamlined the study process. 🫁 This achievement marks a major advancement in the Respiratory therapeutic area, and we take pride in our ongoing commitment to driving innovation in healthcare. Choose Innovate Research for unmatched expertise, streamlined execution, and meticulous project management across pharmaceutical, biotechnology, nutraceuticals and medical device studies. Let’s keep advancing the frontiers of healthcare innovation! 🌟 #ClinicalTrials #CROExcellence #InnovateResearch #HealthcareInnovation #Vaccines #medicalwriting #datamanagement #regulatoryservices #projectmanagement #successful #completion #clinicaloperations #sitemanagement #biostatistics #biospecimen #studyfeasibility #research #cro #biospecimen #pharmaceuticals #drugsafety #drugdevelopment #clinicaltrials #Asthma #RespiratoryDiseases

The FDA Center for Drug Evaluation and Research (CDER) has announced the launch of the Center for Real-World Evidence Innovation (CCRI). This initiative will transform how real-world data (RWD) is used in regulatory decision-making, helping advance safe and effective medicines for unmet needs. As patient health data grows in volume and complexity, CCRI will serve as a hub to coordinate efforts, integrate emerging technologies, and streamline drug development. This aligns with global efforts, like EMA's regulatory science strategy, highlighting the critical role of RWD/RWE in shaping the future of healthcare. Exciting times ahead for RWE innovation! https://lnkd.in/gV9dj96x

Don't miss out, less than a week away! Brand new webinar by #EUCROF on one of the hottest topics in the field of pharma development - #ClinicalTrial Budgets. Clinical stage is the most expensive stage of drug development. Wisely composed study budget is essential for a successful study both for #CROs and pharma. Key take-aways from this webinar: • A complete check-list of hidden costs with the guidance where to look for them • Real case studies on a successful budget planning • Optimization guide: to cut or not to cut • real world stats on the budget exceeding, matching or being below the planned budget • Trial Design – The importance of maintaining sight of programmatic goals to avoid a “bloated” program • How to stay on Track without deviation? The webinar will be delivered by Dr. Philip Raeth, Managing Director at palleos healthcare, and Polina Shatrova, Head of Budgets and Proposals, palleos healthcare. 📅 October 29 | 10:00 AM to 11:30AM (CET) Follow the link to register https://lnkd.in/efbfMwfw #contractresearch #clinicaltrials #pharmaresearch

The Tufts Center for the Study of Drug Development (Tufts CSDD) partnered with the Digital Medicine Society (DiMe) and several industry leaders to conduct a study quantifying the net financial impact of deploying digital endpoints in clinical trials. The goal was to evaluate whether digital endpoints are delivering on their promise and address whether digital endpoints are worth the investment. An excerpt from the published article reveals that for phase II trials, the increase in eNPV varied from $2.2 million to $3.3 million, with ROIs between 32% and 48% per indication. The net benefits were substantially higher for phase III trials, with the increase in eNPV varying from $27 million to $40 million, with ROIs that were four to six times the investment. The use of digital endpoints in clinical trials can provide substantial extra value to sponsors developing new drugs, with high ROIs. For more insights on digital endpoints, please read the article here: https://lnkd.in/eQhb_vs8

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

Medical research is progressing rapidly to keep up with the increase in complex diseases and new treatment options. This has highlighted the need for innovation in clinical trials to facilitate enhanced communication and collaboration between various stakeholders (clinicians, researchers, patients, etc.). By way of open dialogue and communication, this can accelerate the development of novel therapies in order to improve patient outcomes in complex diseases while also providing means to efficiently exchange insight. Read more about the Center for Clinical Trial Innovation to know more about how the US FDA is working towards enhancing communication and collaboration & overall innovation in the space of clinical trials! https://lnkd.in/gQfyyaSh Meet us at BIO and DIA to discuss your requirements for clinical trials! 🤝 Meet us at BIO International: https://lnkd.in/gJt7Vxwv 🤝 Meet us at DIA Global: https://lnkd.in/grrwWGU6 #BIO2024 #DIA2024 #pharma #clinical #trial #innovation #regulatoryservices #USFDA #medical #research

The Tufts Center for the Study of Drug Development (Tufts CSDD) partnered with the Digital Medicine Society (DiMe) and several industry leaders to conduct a study quantifying the net financial impact of deploying digital endpoints in clinical trials. The goal was to evaluate whether digital endpoints are delivering on their promise and address whether digital endpoints are worth the investment. An excerpt from the published article reveals that for phase II trials, the increase in eNPV varied from $2.2 million to $3.3 million, with ROIs between 32% and 48% per indication. The net benefits were substantially higher for phase III trials, with the increase in eNPV varying from $27 million to $40 million, with ROIs that were four to six times the investment. The use of digital endpoints in clinical trials can provide substantial extra value to sponsors developing new drugs, with high ROIs. For more insights on digital endpoints, please read the article here: https://lnkd.in/e2fkts33