Michelle Lukens, SHRM- CP, PHR’s Post

"A single outcome doesn’t tell my whole story"   These powerful words from a patient advocate at the #DPHARM2024 conference truly hit home. In 2024, it’s hard to understand why most clinical trials still rely on a single primary endpoint to determine which treatments may reach the market, especially when this approach doesn’t reflect the complex, multi-dimensional needs that patients experience.   DPHARM was an incredible event, filled with inspiring and insightful talks (a special shoutout to Sarah Zenner-Dolan, Capt. Sully Sullenberger, Ken Getz) and disruptive innovations designed to elevate clinical research to the next level. The focus on patient centricity was palpable throughout, with every conversation reinforcing the need to put patients' voices and experiences at the forefront of innovation.   At One2Treat, we believe it’s time to transform how we assess the value of new treatments. Instead of narrowly focusing on a single outcome, why not ask the broader, more important question: "Does this treatment truly meet the holistic needs of patients and clinicians?"   By incorporating multiple, patient-relevant outcomes into the primary endpoint of clinical trials — and grounding them in the priorities of both patients and physicians — we can redefine what "success" looks like in clinical research.   It’s time to listen more closely to the voices that matter most and drive the change that makes healthcare truly patient-focused. #DisruptiveInnovation #ClinicalResearch #PatientCentricity #TrialDesigns

Praxis is kicking off a busy few weeks starting with #DPHARM2024! Nina Taylor and Karen Renzi are in Philadelphia, joining industry leaders to explore the latest innovations transforming clinical trials. We're eager to learn more about new advancements that are shaping the future of patient recruitment and trial modernization. #ClinicalTrials #AlwaysConnecting #PatientRecruitment

Join the team for Lifebit's upcoming webinar, "3 Strategies for Addressing Real-World Data (RWD) Challenges in Clinical Research and Trials." The webinar will take place on April 25th, 2024, and will feature an insightful discussion on the transformative power of real-world data (RWD) in healthcare. RWD, derived from sources beyond clinical trial settings, provides invaluable insights into real-world patient experiences and outcomes. During our webinar, we will delve into the following topics: - Strategies for ensuring RWD security, quality and interoperability - Navigating the complex regulatory landscape surrounding RWD usage - Enabling secure access to RWD for clinical research and trials I'm really looking forward to this one! Expert speakers will share practical insights and actionable strategies. Don't miss out on this chance to stay ahead of the curve in precision medicine. Reserve your spot today: https://bit.ly/4bbl52y #PrecisionMedicine #RealWorldData #RWD #ClinicalResearch #ClinicalTrials #LifebitWebinars #Lifebit

A couple of days on from Patients as Partners and what has really stuck with me are three key takeaways: The importance of measuring the impact of patient engagement, we have to prove this stuff works (there are still naysayers), if we are to truly implement long term change in the industry. Zack Pemberton-Whiteley spoke about this in the Impact measurement framework that Novartis have implemented. Bringing the patient in early on is critical, only then can we design studies that have meaningful patient led endpoints. Lea-Isabelle Proulx summarised this nicely, we have to be patient-centric not science-centric in how we design our protocols. We need to start treating designing the patient experience as a hard science, on a par with the molecule design. DE&I continues to be a hugely important topic, and one that should be at the forefront of every initiative. The panel led by Dr Heidi Green , discussing the 4 myths around DE&I was superb, and great to hear from Robina Weermeijer on what companies like Boehringer are doing here. Thanks to all the amazing speakers and patient advocates that made another great event. April Campbell (née. Veasey) Victoria Wright Sarah McKeown-Cannon #PatientEngagement #ClinicalTrials #PatientsEU2024

I hope you have registered for our NCPDP PGx webinar scheduled for tomorrow 1:00pm ET!! Katie Pizzolato, PharmD, BCGP and I are excited to share ideas and guage some great discussion to move us forward with our goal of educating stakeholders and in the standardization of PGx!!! If you have not registered- there is still time! Registration is FREE for NCPDP members!!! I think we all can agree there has been A LOT of talk around the need for standards- and now is the time we commit to the collaboration needed to create a standardized solution!!! #NCPDP #PGx #standardizedpgx #standards #Standardization #valuebasedcare #precisionmedicine #personalizedmedicine

Reimagining Clinical Trials – A thought-provoking panel moderated by the Managing Principal of Axiom Healthcare Strategies, featuring exertise among physicians and industry leaders: Hossein Borghaei, Corey Langer, Shruti Agrawal, Robert LaCaze, Alan Bash, and Nicholas Davies. Explore innovative approaches transforming traditional trial models. To learn more about our work supporting innovation in study designs, reach out to our Chief of Strategy, Anne Cherry, at ac@axiomhcs.com Watch the full panel here: https://lnkd.in/gbS9MWNY #ClinicalTrials #FutureOfClinicalTrials #InnovatingResearch #ClinicalTrialsReimagined #AxiomSummit

Great to be at #cmosummit360 in Boston and to hear Gary Pisano’s keynote this morning. So many great points, not least the challenge of bringing together two such different worlds; Business and Science. I think that there’s a third arm to this challenge - doing it in such a way that fits best with the day to day needs of those who ultimately receive the medicine - patients. The science and the business model needs to deliver the difference that patients actually want and value, as this is the real win/win and will ultimately increase the asset value hugely. #patientfocus #biopharma #assetvalue #patientinsights #patientengagement Origins - The Patient Focused Specialists RESONANT GROUP

The future of clinical trial site selection is evolving fast. No longer confined by traditional models, we're turning the trial selection process on its head. See our approach - driven by #RWD that's connected to patient counts at more than 7,000 #healthcare sites in the TriNetX network - and learn three key benefits on our blog. https://ow.ly/rgMr50U0At3

Now at #InnovationDublin24 is the “How to Create an Effective Clinical & Medical Strategy” panel session moderated by Fabienne Hirigoyenberry-Lanson, PhD, Senior Consultant at HTI - Healthcare & Technology International:   ●     Chuck Carignan, Executive Chairman, CAIRDAC ●     Franz Bozsak, CEO, Sensome ●     Michel Therin, President, MT2 Consulting Q: How do you create an effective clinical and medical strategy? A: At each and every stage, we have to ask ourselves what evidence we need to convince stakeholders of our value. A: Start early. If you need 10,000 patients to run a clinical trial, you might not be able to fund that as an early-stage start-up. You need to know this up front. Remain informed on new articles, conference updates and more with our helpful medtech community newsletter. Subscribe here: https://bit.ly/42KHJKI

🔍 Immerse yourself in the game-changing impact of Real-World Data and Evidence (RWD/RWE) in clinical research and trials with Lifebit's latest blog. Discover how RWD is reshaping methodologies, enhancing generalizability, optimizing approval timelines, and maximizing cost efficiency, ultimately improving patient outcomes. This blog also addresses challenges such as data quality limitations, interoperability issues, and secure data access. By acknowledging these obstacles, we pave the way for future discussions on overcoming hurdles and unlocking the full potential of RWD in clinical research. Join us in exploring the transformative power of RWD/RWE in driving innovation and improving patient care. Read more here: https://bit.ly/49R5g0H #HealthcareInnovation #RWD #RWE #Lifebit