Inkef’s Post

One quote in Ryan Cross' outstanding story of Eli Lilly and Company's decades-long pursuit of new treatments for #Alzheimer's Disease caught my attention: “...there were times where a reasonable person might have just said, ‘Hey, something’s wrong with the theory. It’s not right. It’s not working. We can’t win here.’” While histories like this are often framed in the context of persistence, perseverence, and products needing "champions" and "time," that construction misses the underlying dynamic that the supporting research matures over time and that an established body of science and technology (i.e. "technology readiness") is requisite for successful product development. In 2015 study titled Patterns of Innovation in Alzheimer's Disease Drug Development: A Strategic Assessment Based on Technological Maturity in Clinical Therapeutics, we used an analytical model of technology maturation to assess the maturation of amyloid research circa 2013, the period in time that Lilly's solanezumab and other candidate products of that era failed in clinical trials. The success of #donanemab may be less about Lilly's fortitude, than the fact that the science underlying the amyloid hypothesis has now matured to the point that drug developers have sufficient understanding of the pharmacodynamics and clinical trial designs necessary for success. https://lnkd.in/eSfcZJAM Center for Integration of Science and Industry at Bentley University, Bentley University Center for Health and Business, Bentley University, #innovation, #pharmaceuticals, #strategy

"If we listen to our sites and leverage existing site platforms, there may not be a need to invest in new technology or vendor services to implement DCTs or hybrid studies... The site-centric approach also decreases complexity and principal investigator (PI) oversight burden." — Noelle Gaskill, Head of Clinical Research Collaborations at Mirati Therapeutics. Read more insights in the ACRP blog > https://bit.ly/3T5ahLX Learn more during Noelle's #ACRP2024 session > https://bit.ly/3T5ahLX #GoForIt #GoForEducation #ClinicalResearch #ClinicalTrials #DecentralizedClinicalTrials #DCTs

Yesterday, I attended the "𝗣𝗿𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗣𝗮𝘁𝗵𝘄𝗮𝘆𝘀: 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗮𝗻𝗱 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 𝘁𝗼 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗲 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰𝘀" webinar led by Hakan Sakul, Elaine Katrivanos and Lauren Silvis. Tempus AI The session was focused on the evolving FDA regulatory landscape within oncology diagnostics. We explored strategic approaches to regulatory submissions, new requirements, and how these pathways can accelerate diagnostic developments and precision medicine initiatives. A key takeaway was the emphasis on collaboration – Hakan emphasised that diagnostic providers, drug developers, and the FDA must work closely throughout the process. “𝗢𝗽𝗲𝗻 𝗰𝗼𝗻𝘃𝗲𝗿𝘀𝗮𝘁𝗶𝗼𝗻 𝗶𝘀 𝗯𝗲𝘀𝘁…𝘁𝗵𝗲𝘆 𝘀𝗵𝗼𝘂𝗹𝗱 𝗯𝗲 𝗰𝗼𝗻𝗻𝗲𝗰𝘁𝗲𝗱 𝗮𝘁 𝘁𝗵𝗲 𝗵𝗶𝗽𝘀”. This collaborative approach ensures that regulatory submissions are efficient and aligned with market needs. It was a truly engaging and informative session; thank you. If you have any thoughts or insights, I’d love to discuss these with you! 👇 #OncologyDiagnostics #PrecisionMedicine #RegulatoryAffairs #FDARegulations #DiagnosticsInnovation #HealthcareCollaboration

Health tech developers: Are you prepared for the implementation of HTAR in 2025 and how it will impact you? ProPharma offers expert support for EMA's new regulations and requirements. Discover more in our recent blog series.

Patient Quality of Life is an important pilllar of drug development

Good to see the due diligence...

Turn Uncertainty into Action: Join the Fight for Better Treatments Facing a sarcoidosis diagnosis without approved treatments can feel overwhelming—but there’s hope and a way forward. Together, we can drive change and advance treatments for our community. We’re thrilled to share a video featuring Dr. Francis Collins, former Director of the NIH, discussing how to partner with the FDA on drug development. This is part of the National Organization for Rare Disorders’ (NORD®) Drug Development Series, created in collaboration with the FDA and Critical Path Institute. This FREE, three-part online course empowers patients, leaders, and advocates to shape the drug development process. 🔑 What You’ll Learn: The drug development process from start to finish The value of natural history studies and understanding disease progression How to navigate regulatory pathways Real-world experiences from patients and advocates How your data and insights can drive research forward Whether you’re new to the rare disease journey or a long-time advocate, this series offers tools to make a tangible impact. Let’s work together to ensure a brighter future for those affected by sarcoidosis. Watch the video and join us in shaping the future of treatment development! 📽️https://loom.ly/6ptePFA #SarcoidosisAwareness #DrugDevelopment #PatientAdvocacy #FSR

The biopharma company Cassava Sciences announced today its experimental Alzheimer’s disease drug simufilam showed no signs of working in a phase 3 clinical trial. Volunteers who took the drug performed no better in cognitive or everyday-life activities than those who received a placebo. The announcement appears to mark the end of the company’s development of simufilam for Alzheimer’s, which has been marked by scandal and controversy. https://lnkd.in/gcKucZSk

So what's the common thread between successful biotech CEOs ? In preparing for this panel I thought doing 1-1 calls ahead of time would be a cool way to get to know a set of accomplished CEOs from the New England biotech community. The odds of getting everyone on one Teams call seemed pretty low right ? Well, let me say these calls have been an absolute highlight of the past month for me. The most important takeaway observation (if you can't make it to COG New England next week): The passion these CEOs have for the underlying patient challenges is what gets them moving each day. The fundraising and clinical data journey isn't easy. These CEOs press forward through that difficult journey because they understand they have an opportunity to help bring cures and treatments to the people that need them.

Exciting News! Our CEO, Janet Qi, was recently featured in a Clinical Leader article discussing the FDA advisory committee's critique of Lykos Therapeutics' MDMA studies. Despite the 9-2 vote against the validity of MDMA-assisted therapy trials, this highlights the crucial need for rigorous and well-designed clinical trials in the psychedelic field. At PurMinds, we remain committed to advancing the scientific and clinical understanding of psychedelic compounds. Our focus on meticulous research and innovative formulations, such as our proprietary psilocybin and non-hallucinogenic novel chemical entities, drives us forward. We believe in the potential of psychedelics to revolutionize neurological care and are steadfast in our pursuit of evidence-based therapies. Read the full article to learn more about our perspectives and the future of psychedelic clinical research: link in comments! #PurMinds #Psychedelics #MentalHealth #ClinicalResearch #Innovation #FDA #MDMA #PTSD