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Gene&Cell Therapy >> EyePoint poaches medical chief from Apellis; Sandoz CFO, longtime BioNTech exec to retire: Ramiro Ribeiro After six years as head of clinical development at Apellis Pharmaceuticals, Ramiro Ribeiro is joining EyePoint Pharmaceuticals as CMO. “The retinal community is relatively small, so everybody knows each other,” Ribeiro told Endpoints News in an interview. “As soon as I started to talk about EyePoint, I got really good feedback from KOLs and physicians on its scientific standards and quality of work.” Ribeiro kicked off his career as a clinician in Brazil, earning a doctorate in stem cell therapy for retinal diseases. He previously held roles at Alcon and Ophthotech Corporation, now known as Astellas’ M&A prize Iveric Bio. At Apellis, Ribeiro oversaw the Phase III development, filing and approval of Syfovre, the first drug for geographic atrophy secondary to age-related macular degeneration (AMD). The complement C3 inhibitor went on to make $275 million in 2023 despite reports of a rare side effect that only emerged after commercialization. Now, Ribeiro is hoping to replicate that success with EyePoint’s lead candidate, EYP-1901 for wet AMD, which is set to enter the Phase III LUGANO trial in the second half of the year after passing a Phase II test in December. Ribeiro told Endpoints he was optimistic about the company’s intraocular sustained-delivery tech, which he said could help address treatment burden and compliance issues seen with injectables. He also has plans to expand the EyePoint team. “My goal is not just execution of the Phase III study — of course that’s a priority — but also looking at the pipeline and which different assets we can bring in to leverage the strength of the team that we have,” Ribeiro said. — Ayisha Sharma Remco Steenbergen → Sandoz CFO Colin Bond will retire on June 30 and board member Remco Steenbergen will replace him. Steenbergen, who will step down from the board when he takes over on July 1, had a 20-year career with Philips and has held the group CFO post at Deutsche Lufthansa since January 2021. Bond joined Sandoz nearly two years ago and is the former finance chief at Evotec and Vifor Pharma. Investors didn’t react warmly to Wednesday’s news as shares fell by almost 4%. The Swiss generics and biosimilars company, which finally split from Novartis in October 2023, has also nominated FogPharma CEO Mathai Mammen to the board of directors. The ex-R&D chief at J&J will be joined by two other new faces, Swisscom chairman Michael Rechsteiner and former Unilever CFO Graeme Pitkethly. On Monday, Sandoz said it completed its $70 million purchase of Coherus BioSciences’ Lucentis biosimilar Cimerli sooner than expected. The FDA then approved its first two biosimilars of Amgen’s denosumab the next day, in a move that could whittle away at the pharma… #lucidquest #genetherapy #celltherapy

Great review on the challenges of #drug development in #IBD In addition to discussions on clinical progress, there's a provocative analysis of how advances in #machinelearning and tissue engineering could be used at the preclinical stage. ....and a plea to stop using #DSS and #TNBS as pre-clinical models.

Eli Lilly just as active on the deal front as GSK... At least in advanced therapies. This was from last week but interesting to see Eli Lilly's deal with QurAlis for QRL-204, their ASO program for ALS and dementia. Eli Lilly is also quite active in making deals across the advanced therapies landscape. ALS is an indication that has a bit of attention across advanced therapies. WaVe Life Sciences had a program with Takeda (discontinued due to lack of efficacy signal in early clinical). There are also a number of companies approaching the indication with AAV-based approaches. While advanced therapies are exciting and hold tremendous promise, there's something to be said for "safer" bets and antisense oligos sure look to be that within the realm of "advanced" therapies at least. Keep an eye out for a partnership map we're putting together in the oligo space and in the meantime, reach out to chat all things pipeline, strategy, or production / manufacturing related! #ASO #drugdevelopment #healthcare https://lnkd.in/gniQHpJt

Clinical Trials Market to Grow $73.2 Billion by 2028 Download Sample PDF Report-https://lnkd.in/dTiYUy2a The global clinical trials market in terms of revenue was estimated to be worth $48.2 billion in 2023 and is poised to reach $73.2 billion by 2028, growing at a CAGR of 8.7% from 2023 to 2028. Companies Working in the Market    ERT Advarra Blueprint Medicines Loftware Rochester Regional Health     Owkin Westat Sangamo Therapeutics, Inc. ObvioHealth Cerner Enviza  Froedtert Health Biofourmis NeoGenomics Laboratories     Rho WCG Fusion Life Sciences Technologies LLC Emmes Cardiovascular Research Foundation     Pharmacyclics, an AbbVie Company    WEP Clinical Science 37 Intone Marshfield Clinic Health System      ACROBiosystems Blackrock Neurotech  MaxisIT Inc. RQM+  Thinkitive Technologies  Massive Bio Clincierge      Castor Cryoport Systems BrainsWay  TransCelerate BioPharma Inc.   Metabolon, Inc. SpringWorks Therapeutics   Texas Oncology Vial Cleerly

The future of cardiology unfolds at ESC 2024: is pharma ready to adapt? As prevention takes center stage at #ESCCongress 2024, our latest media analysis reveals a major shift: screening & AI-driven detection are dominating the cardiology debate. Yet, many pharma giants still focus on treatments. Are they missing a critical opportunity? With AI revolutionising patient screening and drugs like Ozempic leading the way in prevention, is your comms strategy aligned with this new narrative? 🎯 Discover how GE HealthCare, Novo Nordisk , and AstraZeneca are leveraging this shift—and where most are falling behind. Dive deeper into our full analysis by following the link in the comments 👇 #Pharma #Cardiology #AI #Prevention #ESC2024 European Society of Cardiology Bayer Pfizer Roche Sanofi

📣 Important News! 🩸 Takeda and Protagonist Therapeutics have signed a groundbreaking worldwide license and collaboration agreement, propelling PV treatment into a new era. 👉🏻 Rusfertide, a transformative hepcidin mimetic currently in a pivotal Phase 3 trial (VERIFY), showcases promising results in sustained hematocrit control, reduced phlebotomy needs, and enhanced patient outcomes. 🌐 This collaboration is a beacon of hope for the MPN community. 📲 Dive into the details in our latest blog article: https://lnkd.in/dd_yqdjv Ruben Mesa, MD; Srdan Verstovsek #GlobalMPNSF #Rusfertide #MPN #MPNsm #AskPatients #MPNResearch #ClinicalTrials #MPNClinicalTrials

🚀 Exciting Partnership Announcement! 🚀 We're thrilled to announce that GenXys Health Care Systems has partnered with Applied DNA Sciences to enhance precision prescribing decisions by interpreting and reporting their TR8™ pharmacogenomic (PGx) test! 🔍 What This Means: Precision Prescribing: Utilizing our clinical decision support software, we'll help healthcare providers interpret the TR8 PGx test results, which analyze 120 genetic variants affecting drug response. Improved Patient Outcomes: By tailoring prescriptions based on genetic factors, we aim to enhance therapeutic efficacy and patient compliance and reduce adverse drug reactions. Cost Efficiency: Precision prescribing can significantly lower healthcare costs by reducing trial-and-error approaches and rehospitalizations. 🧬 The TR8 PGx test, approved by the New York State Department of Health, is a game-changer in pharmacogenomics, targeting a wide range of medicines, including cardiac, pain management, cancer, and psychiatric drugs. 💬 From Dr. James Hayward, Ph.D., President & CEO of Applied DNA: "PGx-enabled precision prescribing offers numerous benefits to patients, payors, and the healthcare system as a whole. We're excited to partner with GenXys to bring best-in-class PGx clinical integration services to market." #GenXys #AppliedDNA #PrecisionMedicine #Pharmacogenomics #HealthcareInnovation #PatientCare #Healthcare #Biotech

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> Gilead, Kite shorten Yescarta manufacturing by two days in 'incremental' improvement: Gilead and Kite announced Tuesday it received FDA approval to shorten its manufacturing process for the cell therapy Yescarta, a move expected to reduce the time patients need to wait for the treatment by two days. The shortening, measured by what’s known as “median turnaround time (TAT),” will fall from 16 days to 14 days, Gilead estimates. David Porter, the director of cell therapy and transplants at Penn Medicine, told Endpoints News any improvement in median TAT is good, but Tuesday’s update represents one that is “incremental.” “It is important to get patients their cells back as soon as possible,” Porter said. “Now, does a difference between 16 days and 14 days make a big difference? I would tell you that’s not likely to be clinically significant. “Any time is good,” he added. “You don’t want to give the cancer time to grow. But shortening from 16 days to 14 days probably is not that major of an advance.” The 14-day process encompasses collection of patients’ cells, the manufacturing of genetically re-engineered cells and testing to ensure the new cells work. Previously at #ASH23, Gilead and Kite executives had told Endpoints they were working on reducing the manufacturing and re-engineering component from seven days to five days. Chris McDonald Chris McDonald, Kite’s global head of technical operations, said in an interview last week that the companies had figured out how to “optimize” that manufacturing process and cut it by two days. The move should reduce the overall costs and increase the manufacturing capacity at their two US plants in California and Maryland. “We’re essentially reducing the manufacturing time by two days, which is going to reduce some of our quality control testing and some of the processing steps,” McDonald said. The specifics of what is being optimized will remain a secret, he added, noting Gilead and Kite want to maintain their “competitive intelligence.” This improvement will also take more time to be implemented outside the US, as additional regulatory approvals will be needed. McDonald noted this update is solely for Yescarta and not the pair’s other approved cell therapy, Tecartus. Gilead already had the fastest turnaround times for its two cell therapies before Tuesday, with Yescarta taking a median 16 days and Tecartus needing 15 days. Bristol Myers Squibb, the manufacturer of Abecma and Breyanzi, can produce the treatments in “less than 30 days,” according to a spokesperson. Asked about the turnaround time for Johnson & Johnson’s Carvykti, a spokesperson pointed to the treatment’s marketing website, which described the re-engineering process as four to five weeks long. And regarding Novartis’ cell therapy… #lucidquest #genetherapy #celltherapy

Health Tech World recognizes that the Click Therapeutics, Inc. data report-out bodes well for people with #migraines, and the ability to generate significant science is a needed proof point that the #digitalhealth sector must recognize as a gold standard to be taken seriously by payers and providers. HITLAB Galen Growth | Insights You Can Trust Stan Kachnowski PHD MPA, Julien de Salaberry, David Benshoof Klein

💊 Exciting Collaboration Alert: AbbVie Partners with Celsius Therapeutics! 🌟 AbbVie is joining forces with Celsius Therapeutics to develop cutting-edge treatments for inflammatory bowel disease (IBD), aiming to enhance patient outcomes and advance medical research in this critical area. 🌐 🔍 Key Highlights: -Strategic Collaboration: AbbVie and Celsius Therapeutics will leverage their combined expertise to innovate IBD treatments, potentially transforming the therapeutic landscape. -Focus on Humira: With Humira's legacy in treating IBD, this partnership aims to build on its success and introduce novel therapies. -Research and Development: The collaboration underscores the commitment to advancing R&D efforts, exploring new avenues for addressing complex medical conditions like IBD. This partnership is a significant step forward in the fight against IBD, promising innovative solutions and improved quality of life for patients worldwide. Stay tuned for more updates on this groundbreaking collaboration! 🚀 #AbbVie #CelsiusTherapeutics #IBD #Humira #MedicalInnovation #HealthcarePartnership #Biotech #ResearchAndDevelopment #PatientCare #HealthcareAdvancements