Bracken

With the first 10 drugs already negotiated under the Inflation Reduction Act’s (IRA) drug pricing provisions slated to go into effect next year, the law has already become status quo, according to one industry expert. Phil Sclafani, a principal at PwC US, said, We’ve seen an attitude of, ‘OK, the IRA is here — we’re going to keep the drugs that were selected, and we’re going to negotiate in good faith and go forward.’” But, with a new administration in the White House, things could be set to change. This article looks at the short- and long-term future of the IRA and its impact on pharma: https://hubs.la/Q038mSlr0 #DrugDev #Pharma

The FDA has rolled out several new and updated guidance since the start of the year. This guidance covers topics such as: - Developing drugs for optical imaging - Revised guidance on weight management products - Lead levels in processed food intended for babies and young children - Tissue biopsies in clinical trials The breadth of these updates reflects the FDA’s ongoing efforts to enhance regulatory clarity and ensure public health safety across various sectors. Read our summary of the guidance in this article and access links to the documents in full: https://hubs.la/Q038mH940 #FDA #Compliance

?? Exciting News! Bracken’s own Colin Miller, PhD, FIPEM, CSci will be a featured speaker at the upcoming webinar: Critical Imaging Risks in GLP-1 and Neurology Studies: What You Need to Know. ?? April 3 | 11 AM EST ??Hosted by Clinical Leader Don't miss this opportunity to hear from industry experts on overcoming hurdles in medical imaging for GLP-1 and neurology studies. ?? Register now and secure your spot: #Webinar #MedicalImaging #Neurology #GLP1 #BrackenExperts

Big ideas, bold insights, and a bit of banter—that's #FractalsLifeScienceConversations. From clinical development to medical imaging to digital health marketing, we explore the intersections of science, strategy, and success—with plenty of humor along the way. ?? Tune in to all episodes streaming now on Spotify or Apple Podcasts! ??

The health disparity between men and women starts early and compounds over a lifetime. Conditions like endometriosis, autoimmune disorders, and other female-specific or female-predominant diseases are underdiagnosed and undertreated. Clinical research has routinely excluded women or failed to segment findings by sex, leading to significant blind spots in treatment paradigms. These blind spots aren’t just a women’s issue—they also carry a real economic cost, with entire economies suffering from lower productivity, lost earnings, and higher healthcare expenditures. Yet a new report from WEF/McKinsey found that comprehensive action could yield $400 billion in annual GDP, and $1 trillion in annual incremental economic growth by 2040. What is driving these gains, what work has already been done, and what global solutions to do we need to close the gap? This article seeks to answer those questions and more: https://hubs.la/Q038mJpM0 #HealthTech #FemTech

Gen Z doesn't trust Big Pharma—true or false? According to a recent report, only 43% of Gen Z said pharma companies care about them. In the past, young, healthy patients often weren’t a priority to the pharma industry. But, as this generation prioritizes their health in ways that others didn’t during this stage in their lives, pharma companies have an opportunity to embrace Gen Z as loyal consumers. And they’re open to the idea: https://hubs.la/Q038mD6l0 #Pharma #Marketing

Today's the day! Don't miss the interactive virtual panel on ICH GCP E6 (R3) & Imaging in Clinical Trials with #PINTaD. ?? Join us at 11 AM EST for an insightful discussion chaired by Colin Miller, PhD, FIPEM, CSci, featuring expert insights from: ?? Dr. Peter Eggleton ?? Darshan Kulkarni, Esq. ?? There’s still time to register—sign up now! #ClinicalTrials #ICHE6R3 #GCPCompliance #MedicalImaging #PINTaD

If we could sum up the next year in healthcare in one word it would be "transformation". From groundbreaking technologies to evolving regulations and a renewed focus on patient-centered care, 2025 promises to redefine the industry. Read about the specific trends here: https://hubs.la/Q034GJ2B0 #Healthcare

AI in nuclear medicine. Game-changing biomarkers. Clinical trial innovations. The medical imaging field is evolving—and staying ahead means understanding the trends shaping the future. Bracken’s experts break it all down in these selected episodes of #FractalsLifeScienceConversations. From overcoming industry challenges to redefining success in clinical trials, members of our medical imaging team share real-world insights on the current landscape, and what's on the horizon for tomorrow. Listen Now: ?? Alexander (Sandy) J.B. McEwan, MB, MSc, FRCPC on The Radiobiological Impact and the Necessity of Nuclear Medicine: https://lnkd.in/e_86SVen https://lnkd.in/ecFXj9WD ?? Brad Wyman, MS, PhD on Engineer's Mindset to Medical Imaging: https://lnkd.in/efn8ZYsZ ?? Deepak Behera, MD on Problem-Solving for Clinical Development, Product Success, & Diversifying Clinical Trial Access: Access all episodes of Fractals at www.thebrackengroup.com and stream via your favorite podcast platform. #MedicalImaging #ClinicalTrials #Radiopharmaceuticals #NuclearMedicine #HealthcareAI #ClinicalDevelopment #ProjectSuccess

Imaging in clinical trials is advancing, and regulatory updates under ICH GCP E6 (R3) could introduce new requirements and challenges. Are you prepared? Join Colin Miller, PhD, FIPEM, CSci as he leads a virtual panel discussion featuring: ?? Dr. Peter Eggleton ?? Darshan Kulkarni, Esq. ?? Wednesday, February 26th ?? 11 AM EST ?? Virtual Event - Via Microsoft Teams This session will begin with key presentations on the evolving requirements and challenges, followed by an open discussion with the PINTaD group. RSVP below to mark your calendar! #ClinicalResearch #MedicalImaging #ICHE6R3 #RegulatoryCompliance #PINTaD