Adrian McCarthy’s Post

Great perspective by Dr Vivek Subbiah, MD Subbiah on the current challenges in healthcare, where he proposes collaborative measures for improving access to precision medicine for everyone. While we have a long way to go, addressing funding, policies, and collaborative efforts can bring us closer to making precision medicine a reality.

Congratulations to my colleague and good friend, Dr. Virginia Solitano 💗, on her newest publication, co-authored with Professors Christopher Ma, Silvio Danese, and Vipul Jairath, in the high-ranking journal #CGH. 👉 It’s an enjoyable read: 👩⚕️ The paper, titled “The Future of Clinical Trials in Inflammatory Bowel Disease,” explores the evolution of clinical trials for #IBD, focusing on both challenges and innovations in the field. 👩⚕️ Discuss how advanced therapies and targeted treatment strategies for #Crohn’s disease and #ulcerative colitis have transformed medical management, driven by pivotal #randomized controlled trials. 👩⚕️ Despite these advances, trials face significant hurdles related to cost, feasibility, and patient recruitment. 👩⚕️ Highlight the need for innovative methods to improve trial efficiency, such as exposure-driven pharmacokinetics, measuring target engagement, and minimizing randomization to placebo using #Bayesian frameworks or master protocols. 👩⚕️ Emphasize the importance of including diverse patient populations and using more efficient, #patient-centered trial designs. 👩⚕️ These strategies aim to enhance the #sustainability, #generalizability, and clinical #relevance of future IBD trials.

Sharing my prospective on how Quest fits in to the complex world of precision medicine.

Have you watched any of our trial-overview videos, such as the STELLAR-305 study, designed to engage patients and empower them to start conversations with their care providers? Learn more here: https://buff.ly/4bKB08r #carcinoma #research #clinicaltrials #pharma #biotech #oncology CancerCare

Congrats to the entire TSTrials and Equipo Ciencia team for their commercial launch. Our team has been privileged to have been working alongside this team over last several months and it has been nothing short of amazing to be part of their story. Our team is looking forward to witnessing their continued impact on #globalpublichealth! Follow TSTrials for the latests updates and developments! #ClinicalResearch #TrialInnovation #TSTrials #EquipoCiencia #PublicHealth #clinicaltrials #sitemanagement

Last Saturday, during the peak of the American Heart Association’s prestigious annual scientific sessions, Uwe Tigör, MD Tigör, Chief Medical Officer of Auxilius Pharma, presented the second part of the core data from the successfully completed Phase 1A study of AUX-001 in healthy volunteers. This portion of the study emphasized not only hemodynamic stability but also the effects of the company’s lead R&D asset on the EKG profile and the cardiac electrophysiologic stability of the trial participants. The moderated poster session presentation co-authored by Dawid Chabowski, Ph.D. Scientific & Operations Manager of Auxilius and primary investigator Marlene Fonseca, MD, PhD, Phase I Clinical Director at BlueClinical Ltd. to an interested audience highlighted that the data overall hint at the potential that an extended-release variant of nicorandil, the active ingredient in AUX-001 might have safety and tolerability benefits over the currently available immediate-release version of nicorandil used in Europe, Asia and Australia. Reach out to us if you want to learn more details

Updates and Next Steps in Our Ongoing Clinical Trial

🌍✨ We have successfully completed our first clinical trial beyond our borders, collaborating with the Clínica FOSCAL team in Colombia! 🇨🇱🇨🇴 In simple terms, we isolated umbilical cord cells from newborns in Chile, expanded them in our Cells for Cells GMP lab, and shipped them to Colombia for this study. This clinical collaboration explored the potential of umbilical cord mesenchymal stromal cells (UC-MSCs) in treating knee #osteoarthritis (OA). Our randomized, double-blind pilot study demonstrated that a single injection of Cellistem™OA significantly improved pain, stiffness, and overall function in patients—outperforming traditional corticosteroid treatments—all with a strong safety profile and no severe adverse events. A big shoutout to the committed teams of Clinicians and Scientists #Colombia and #Chile for making this possible. 🖇 link of the original article published in Cytotherapy https://lnkd.in/eqBkX4UZ #ClinicalTrial #InternationalCollaboration #Osteoarthritis #cellandgenetherapy #stemcells #StemCellTherapy #CellistemOA

This week, we reaffirmed our 2024 strategic priorities, and we have an exciting 2H ahead! Our top priority remains preparing for commercialization, and we look forward to bringing the investigational ARC-EX® System to the Spinal Cord Injury (SCI) Community in the US later this year. *   Here’s more detail:  ➡️ ARC-EX® commercial launch. We intend to launch our ARC-EX Therapy for people with SCI in the US in Q4 2024, pending Food and Drug Administration (FDA) clearance.   ➡️ ARC-IM ® interim data publication. We expect a peer-reviewed publication in a top-tier medical journal detailing the results of the first 10+ patients implanted with investigational ARC-IM Therapy to address blood pressure instability after SCI. ➡️ ARC-IM pivotal study commencement. We are preparing to launch our global pivotal study, called Empower BP, for investigational ARC-IM Therapy to address blood pressure instability after SCI, pending FDA Investigational Device Exemption approval.  ➡️ ARC-BCI™ Therapy advancement. Clinical and development activities for our investigational ARC-BCI System continue and several additional ARC-BCI System implants are expected in 2H 2024 and 1H 2025 as part of the ongoing clinical feasibility study with partners at .NeuroRestore and @CEA-Clinatec.  Here are our unaudited Q2 2024 financial highlights: ✅ We plan to publish our Half Year 2024 financial statements on September 10, 2024.  ✅ The net cash balance on June 30, 2024, was EUR 32.1 million.   To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit www.ONWD.com    *All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.  #EmpoweringMovement #SCI #StrategicPriorities d4871b2d-3d8c-4e4b-99fd-2774a1714fb6 (onwd.com)   

“When a specialized field of medicine has long been quiet, a buzz of breakthrough can seem like a sudden development. The reality is more nuanced,” writes Jula Inrig, M.D., chief medical officer at Travere. Check out her recent article about #RareKidneyDisease and #IgAnephropathy in Fierce Biotech. #InRareForLife https://bit.ly/3BGDsA3