Blue Persimmon Group

What a great summer working with our curious, agile, and persistent summer interns Delaney Saccoach and Melinda Hicks. We learned so much from you and are excited to see what you do next! #nextgenleaders #sellmeaglassofwater #genz #internships

🎧Interested in real-world evidence, real-world data, & how FDA continues to promote reliable evidence to support the safety & effectiveness of drug products? Listen to the latest “Q&A with FDA” podcast with Dr. Hilary Marston, FDA’s Chief Medical Officer: https://lnkd.in/gRPen-HS

Great meeting today hosted by FDA bringing together people with lived experience, clinicians, and researchers to explore how to evaluate the negative symptoms that are so impactful in Schizophrenia. https://bit.ly/3A955AL. Our researchers work every day to amplify the voice of those most impacted. Inspiring to be with so many people dedicated to supporting this community to not just survive but to thrive. #PFDD #voiceofthepatient #fitforpurpose #schizophrenia #thrive #roadtorecovery Schizophrenia & Psychosis Action Alliance Holly Krasa Jessica T. Markowitz, PhD Melinda Hicks

How can we find better treatments for the “negative” symptoms of #schizophrenia? A U.S. Food and Drug Administration meeting tomorrow will convene researchers, drug developers and advocates to discuss the challenges of developing these medicines. Negative symptoms refer to a loss of normal functions in people with schizophrenia, such as social withdrawal, loss of interest in activities, emotional “flatness” and limited speech. Up to 60% of people with schizophrenia experience them, but current medicines do little to help. See the meeting agenda here: https://bit.ly/3A955AL; Zoom info is provided for those who want to dial in. Our Voice of the Patient Report (https://bit.ly/3Qswinf) shared heartbreaking stories from people living with schizophrenia and their families about the severe disability negative symptoms can cause. We applaud FDA for listening to our community.

C-Path’s Global Impact Conference is THE event that drug developers cannot afford to miss. Hosted this September 9-11, in Washington, D.C., we are thrilled to announce the first of our impressive lineup of speakers. These experts bring unparalleled insights across various diseases and therapeutic areas. With a roster featuring the best and brightest minds in drug development, and with the early-bird 🦅 registration rate expiring at 11:59 p.m. ET, Monday, July 22, why wait? 🔗 Register now and learn more: https://lnkd.in/g4TqwJVR. ▶ Join FDA Center For Drug Evaluation and Research Director Patrizia Cavazzoni, M.D., for a focused session on how we can maximize the impact of CDER-led efforts for clinical trial modernization, while retaining scientific and clinical rigor. ▶ Teresa Buracchio, MD, Director of the Office of Neuroscience, CDER, FDA, will be a panelist discussing biology-based disease staging approaches. ▶ Naomi Knoble, PhD, Ph.D., Associate Director of Rare Disease Measurement Science in the Division of Clinical Outcome Assessment, Office of New Drugs, CDER, FDA, will join us for the fireside chat, “Navigating the patient-focused drug development roadmap: update on the RD-COA Resource.” We look forward to seeing you at #CGIC2024! Klaus Romero Kristen Swingle Kevin Perkins Collin Hovinga Diane Stephenson Joseph Hedrick #CPath #CGIC2024 #GlobalImpactConference #drugdevelopment #datasharing #collaboration #neurology #pediatrics #raredisease

Did you miss the workshop on Enhancing Adoption of Innovative Clinical Trial Approaches? Trying to keep pace with the ever-changing drug development landscape? This public workshop that Duke-Margolis Institute for Health Policy convened with FDA explored opportunities to support and advance innovation in clinical trials. Check out the summary which includes the recommendations from the panel discussion about how to foster the adoption of clinical research innovations: https://lnkd.in/eCJnR-UJ Other event information is also available online: https://lnkd.in/eCUA9PcK

This should be interesting! FDA/NIH joint workshop on Implanted Brain-Computer Interface COAs this September 19-20th.

A Call to Action: Transitioning to a Brain-Positive Economy This Deloitte paper presents a stark reality: the potentiality of a brain-negative economy. With a projected cumulative cost of nearly US$14 trillion by 2040 due to unaddressed mental health inequities, the economic burden is not just a health issue—it’s a matter of economic, national, and democratic security. This stark data sits alongside the recent The Lancet Institute for Health Metrics and Evaluation data showing over 1 in 3 people affected by neurological conditions, the leading cause of illness and disability worldwide --> https://lnkd.in/gvAfE7T5 This massive economic cost outlined by Deloitte is a clarion call for advanced economic approaches to foster a brain-positive economy. It’s time for a societal-wide call to action that spans policy, investment, science, technology, and ignites a social movement. We outlined this approach recently via The Brookings Institution --> https://lnkd.in/giEbHSXY The mental health crisis should be treated as urgent, requiring a cross-sector approach that includes the active participation of private and commercialized industries. Corporate responsibility is key to addressing unjust issues affecting the workforce and enabling access to treatment. As we stand at the crossroads, let’s choose the path towards a healthier, more resilient society. Let’s commit to the necessary equitable mental health outcomes and avoid the dire future projected in the report. It’s time to build a brain-positive economy for the prosperity of all. #MentalHealth #EconomicImpact #BrainPositiveEconomy #HealthEquity #SocialMovement A/Professor Jo-An Occhipinti (née Atkinson) Rice University's Baker Institute for Public Policy Rice University Brain Capital Alliance Baker Institute Center for Health and Biosciences University of California, San Francisco BrainLat UAI Shiva Dustdar Paweł Świeboda William Heisel McKinsey Health Institute Rym Ayadi William Hynes Nathan Cook https://lnkd.in/gPK6ruAR

📣Join FDA & the Foundation for the National Institutes of Health on June 24-25 for a hybrid public workshop to discuss the effective integration of Digital Measures into clinical trials and medical product development. Learn more and register today ➡ https://lnkd.in/eVcmAmN6