EVERSANA’s Post

Register for the webinar: https://ow.ly/8N7L50S0LU1 Join EVERSANA’s Marty Culjat for an insightful webinar on #PDURS and the #FDA's new framework for incorporating software into drug labels! This #webinar, hosted by pharmaphorum will take a deep dive into the FDA's proposed framework that allows #pharmaceutical manufacturers to add software to drug labels, provided they can demonstrate clinical benefits. This innovative move is set to revolutionize the way we look at drug labeling and patient care. #PrescriptionDrug

🚀 Enhancing #pharma drugs with health software: come learn about the FDA's PDURS Framework and how we can help navigate it on July 9th! 💊📱 💡 The FDA’s Prescription Drug Use-Related Software (#PDURS) framework is a true game-changer in the pharmaceutical industry. This innovative approach allows #pharma manufacturers to include software in a drug label, provided it demonstrates added clinical benefits. 💊📱By integrating digitally-delivered interventions together with pharmaceutical treatments, we can significantly improve health outcomes for a wide range of diseases. This strategy not only impacts health outcomes and could boost patient and healthcare provider experiences, but also enhances brand differentiation and extends lifetime value. 👉 Join pharmaphorum's expert webinar, moderated by Jonah Comstock and featuring EVERSANA's SME Marty Culjat and Edward Cox, Head and General Manager of Digital Health and Medicines at Pfizer, to delve deeper into this transformative approach. Don't miss out on this opportunity to stay ahead in the ever-evolving pharma and health innovation landscape! 🗓 Register here: https://lnkd.in/dHB6XwXT #PharmaInnovation #HealthTech #PDURS #FDA #healthinnovation #MDSW #DMD

The FDA’s new framework for adding software to drug labels: what you need to know 💊 📱 The US FDA has recently introduced a draft framework that allows pharmaceutical manufacturers to add software to drug labels, provided it demonstrates a clinical benefit. This Prescription Drug Use-Related Software (PDURS) framework would allow for the pairing of a companion app with a drug, supporting greater clinical value, brand differentiation, and extended lifetime value. The PDURS framework is set to revolutionize how the pharma industry approaches companion apps, digital medicines, and digital therapeutics. This is a significant advancement, enabling pharma to deliver enhanced value to patients by combining drugs with innovative software solutions. Join for a webinar hosted by pharmaphorum and EVERSANA on Tuesday, July 9th. Industry experts Jonah Comstock, Marty Culjat, and Edward Cox will delve into the essentials of the PDURS framework and its transformative potential for the pharmaceutical industry. Register for the webinar: https://ow.ly/8N7L50S0LU1 Webinar topics include: The status quo for drug-related software Overview and current status of the PDURS framework The regulatory and clinical requirements to achieve promotional and FDA-required labeling of PDURS software The potential commercial impact of PDURS on brands How to engage functional groups in pharma companies of all sizes to pursue PDURS Various use cases for PDURS software How to engage with the FDA on PDURS #pharmainnovation #digitalpharma #digitalhealth #digitaltherapeutics #pharmatech

Navigating the Regulatory Landscape: FDA Guidance on Charging for Investigational New Drugs Under IND In this era of technological revolution, the pharmaceutical and medical device industries are at the forefront of embracing cutting-edge innovations. The Food and Drug Administration (FDA) acknowledges the pivotal role that Advanced Manufacturing Technologies (AMT) play in shaping the future of healthcare. This blog post delves into the significance of the FDA’s Advanced Manufacturing Technology … Read more: https://lnkd.in/e3XmXSu7

Interesting article from EVERSANA on pharmaphorum about the FDA's Prescription Drug Use-Related Software (PDURS) framework.   PDURS is software that:   1. Is disseminated by or on behalf of a drug sponsor, and 2. Provides information that supports, explains, or is related to one or more of the sponsor’s drugs.   This framework does create value for the pharma industry, while also creating new GTM opportunities for digital health software, but most importantly, should bring real clinical benefits to patients.   However, considering the turbulent times pharma has had with digital health, I hope this framework doesn't add unnecessary complexity that could make these software applications less effective or accessible.   It will be interesting to see how this unfolds and to watch regulatory developments outside the US.

The Prescription Drug Use-Related Software by the @FDA could help improve #patientcare and #healthoutcomes by bridging the gap between digital solutions and pharmaceuticals. By incorporating software that includes the drug's clinical benefit on the label, the #PDURS enables more precise drug personalization through tailored dosing and real-time side effect management. #DigitalHealth #RxBenefits

Huge news in the Clinical Trial Supply space as Myonex acquire the packaging and bioservices business of Creapharm. The idea is to combine Myonex's drug sourcing and clinical trial prescription services with Creapharm's clinical packaging and distributions capabilities. This is really big for Myonex and I think it will take them to the next level for sure! #clinicaltrials #packaging #pharmaceuticals #biologics

Selecting the ideal CDMO partner for late phase clinical trials is important for a smooth and successful drug development journey. Here are 3 key criteria to consider: 1. Expertise: Does the CDMO have a proven track record and relevant experience in your therapeutic area? 2. Capabilities: Do they offer the necessary technology, facilities, and resources to meet your specific needs? 3. Communication & Collaboration: Do they prioritize open communication, transparency, and a collaborative working style? You can find a CDMO partner that aligns with your project goals and empowers you to bring life-changing treatments to market faster by carefully evaluating these factors. Read more- https://lnkd.in/dggDHejp #cdoselection #drugdevelopment #pharmaceutical #partnership #clinicaltrials #renejixpharma

Check out the latest insights from ELIQUENT Life Sciences on the efforts to increase clinical trial diversity among biopharmaceutical companies. The recent survey highlights the challenges faced globally and in the U.S. It emphasizes the need for more guidance from the FDA to achieve diversity goals effectively. #ClinicalTrials #Diversity #FDA #LifeSciences #Healthcare #RegulatoryAffairs By Tanvi Mehta Manager, Regulatory Affairs & Policy, ELIQUENT Life Sciences

The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of medicines requires the close collaboration with regulators, emphasizing innovation, partnership, and a continued dedication to addressing patient needs. This transformation holds the potential to guide significant advancements in the development and delivery of medicines, leading to improved healthcare outcomes for patients. The Regulatory, Compliance and Quality (RCQ) track planned for the 2024 ISPE Annual Meeting & Expo, taking place 13-16 October, in Orlando, Florida, USA. will feature industry and regulatory experts in a variety of topic areas. Read more in this iSpeak article by program committee members, Ciby J. Abraham, Ph.D., David Churchward, Connie Langer, and Silas Tamufor: https://hubs.ly/Q02K-41P0 #ISPE #pharma #pharmaregulatory #pharmaconference #biotech #pharmaceuticalmanufacturing