The ALS Association’s Post

In the dynamic landscape of life sciences, patient centricity has emerged as a key component, transforming the entire ecosystem. Patients are increasingly recognized as active participants in their healthcare journey, influencing key industry stakeholders. Sponsors and Clinical Research Organizations are leveraging advanced technologies to enhance patient engagement, ensuring smoother trial processes and improved data collection. Regulators are emphasizing the importance of patient-reported outcomes, shaping guidelines that prioritize patient perspectives. Investigators are adopting patient-centric trial designs, focusing on real-world evidence and biopharma companies are aligning their strategies with patient needs, from drug development to post-market surveillance. At RWS, we play a pivotal role in providing clear and patient-friendly communication throughout the life sciences continuum. We empower stakeholders to convey critical information through precise translation services, fostering genuine patient engagement and advancing patient-centric initiatives. For more info, reach out today! https://hubs.ly/Q02fhn610

Real-world data and real-world evidence are beginning to impact almost every step of the drug or therapeutic lifecycle, accelerating approvals and access to medicines. Faster, more economical, and with the power to bridge gaps in unmet medical needs, they are reshaping traditional #clinicaltrials. Explore how regulators are ensuring the international collaboration and synchronization of #RWD and #RWE-based approaches: https://ow.ly/USHJ50QkJrl

Data on treatment effectiveness for inflammatory bowel disease (IBD), rheumatoid arthritis and other immune-mediated diseases (IMDs) are insufficient, particularly among ethnic groups who are disproportionately underrepresented in clinical research. With nearly 30 million people living with IMDs worldwide, finding equitable solutions is crucial. Innovators who have unique solutions to increase diverse representation in global clinical trials for IMDs are invited to apply to the Leveraging Technology to Drive Representative Clinical Trials #QuickFireChallenge for the chance to receive grant funding from a total pool of $250K, access to the global Johnson & Johnson Innovation – JLABS network, and mentorship from experts across Johnson & Johnson by 09.13.24: https://jji.jnj/IMMDEI24.

Join us on June 27 for our next #ClimedoConnect webinar as we explore the role of GenAI in healthcare! Discover practical insights about how GenAI can enhance Real-World Evidence (#RWE) studies with Dragan Mileski, Co-Founder and CTO of Climedo. The session will be hosted by our Business Development Manager Bradley F. What to expect: 1️⃣ Understanding GenAI: Explore its fundamentals and potential in transforming RWE studies. 2️⃣ Use Cases: Learn how GenAI can improve post-market studies, from drug safety monitoring to comparative effectiveness analysis. 3️⃣ Best Practices: Gain actionable strategies for incorporating GenAI into your clinical research. Don't miss this opportunity and sign up now: https://lnkd.in/deSqH-MR #GenAI #ClinicalTrials

Announcing the Launch of a QuickFire Challenge to Leverage Technologies to Increase Representation in Immune-Mediated Disease Clinical Trials. Data on treatment effectiveness for Inflammatory Bowel Disease (IBD), Rheumatoid Arthritis (RA) and other Immune-Mediated Diseases (IMDs) are insufficient, particularly among ethnic groups who are disproportionately underrepresented in clinical research. With nearly 30 million people living with IMDs worldwide, finding equitable solutions is crucial. Innovators who have unique solutions to increase diverse representation in global clinical trials for IMDs are invited to apply to the Leveraging Technology to Drive Representative Clinical Trials #QuickFireChallenge for the chance to receive grant funding from a total pool of $250K, access to the global Johnson & Johnson Innovative Medicine – JLABS network, and mentorship from experts across Johnson & Johnson by 13th September 2023 at https: https://jji.jnj/IMMDEI24 #MyCompany

Announcing the Launch of a QuickFire Challenge to Leverage Technologies to Increase Representation in Immune-Mediated Disease Clinical Trials..... Data on treatment effectiveness for Inflammatory Bowel Disease (IBD), Rheumatoid Arthritis (RA) and other Immune-Mediated Diseases (IMDs) are insufficient, particularly among ethnic groups who are disproportionately underrepresented in clinical research. With nearly 30 million people living with IMDs worldwide, finding equitable solutions is crucial.    Innovators who have unique solutions to increase diverse representation in global clinical trials for IMDs are invited to apply to the Leveraging Technology to Drive Representative Clinical Trials #QuickFireChallenge for the chance to receive grant funding from a total pool of $250K, access to the global Johnson & Johnson Innovative Medicine – JLABS network, and mentorship from experts across Johnson & Johnson by 13th September 2023 https://jji.jnj/IMMDEI24.

Transforming healthcare starts with putting patients first. By integrating patient insights from the beginning, we can revolutionize drug development and commercialization, leading to significantly better health outcomes. At Envision Pharma Group, we elevate patient advocacy and incorporate real-world data to develop therapies that truly address patient needs. This approach goes beyond regulatory requirements—it's about making a real impact on lives. Check out our latest blog on how we're driving this patient-centric approach.

Understanding and integrating patient perspectives is no longer an option—it's necessary, with the FDA and EMEA increasingly requiring PROs and RWE. Luckily, patient insights and experiences significantly enhance the drug development process and ensure we deliver treatments that meet their needs, improving health outcomes and cost-reduction efforts. We can further advance this approach through effective and appropriate application of AI and advanced analytics.   Check out the following piece from my colleagues, Dominic Marasco and Jessica Krauser, on how this strategy enhances the patient experience and accelerates time-to-market for new therapies, reducing overall development costs.

Recently, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) began participating in three new collaborative communities in the medical device ecosystem: 1) AI Global Healthcare Initiative Collaborative Community:  * Seeks to advance current approaches to improve patient health, product quality, and process improvement through the power of artificial intelligence (AI) and collaboration. 2) Infection Management Collaborative Community:  * Aims to accelerate the development, availability, and adoption of safe and effective medical devices to prevent, diagnose, and manage infection; treat sepsis; and support sepsis patients and survivors. 3) Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD):  * Seeks to describe the same diagnostic test the same way anywhere it is used in the health care ecosystem. MedTech Innovator MedTech Innovator Asia Pacific LSI MedTech Strategist Lifeblood | Capital + Talent Med-Tech World

Are #Decentralized clinical trials even good? Jen Yip, Associate Director, Digital Trials & Patient Engagement at Novartis will be exploring this controversial statement in more detail at the Disruptive Technology for Clinical Trials Summit on 8 October 2024 in Boston, MA. Her roundtable discussion will enable #ClinicalTrial technology leaders from across the US to unite in an informal and collaborative setting, as they share and discuss their biggest challenges associated with decentralized trials and how to combat them. Download the event agenda: https://lnkd.in/eHyJkZRu #AMGWorld #DisruptiveClinicalTrials #PatientExperience #ClinicalTrials #ClinicalInnovation