Dolca Thomas, MD

When considering drugs for approval, the FDA should… Evaluate clinically meaningful outcomes rather than rely on surrogate outcomes. Restrict accelerated approval only to drugs that represent innovative treatment approaches or that have demonstrated robust clinical benefits. Withdraw market authorization for all drugs approved through the accelerated approval process that do not go on to meet pre-specified clinical effectiveness endpoints in post-marketing studies. The FDA should, but it often doesn’t. Stop depending on the FDA. As an employer you need to implement a system to independently assess the clinical benefits of drugs. #evidencebasedmedicine #valuebasedhealthcare #employeebenefits

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Thoughtful commentary from my former Lumanity (Cello BioConsulting, Defined Health) colleague Joel Sandler, Ph.D. It will be very interesting to see how all this plays out in terms of therapeutic index, ease of use, manufacturing, and value (clinical benefit versus price) between CAR-T, cell engagers, cancer vaccines, next gen IO antibodies and maybe oncolytic viruses. #immunooncology #immunotherapy #cancer #oncology

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STAT reports on pharmaceutical giant Roche’s recent acquisition of experimental obesity medication CT-388; a GLP-1/GIP target. The once-weekly injectable drug resulted in an average placebo-adjusted weight loss of 18.8% after 24 weeks, in a phase 1b study.  96 patients were scheduled to be recruited, though the actual number is not reported. More impressive is at week 24, 100% of CT-388 treated participants achieved a weight loss of >5%, 85% achieved >10%, 70% achieved >15%, and 45% achieved >20%. Levi Garraway, Roche’s chief medical officer said ‘…We are very pleased to see the significant and clinically meaningful weight loss in people treated with CT-388.’ The drug CT-388 was acquired through Roche’s purchase of Carmot Therapeutics, Inc. for $2.7 billion upfront. https://lnkd.in/eJ78dqqY

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Think about the impact of being able to introduce a vaccine that can eradicate a life-threatening disease a full year earlier! 🌎 Julia O'Neill, Principal Consultant of Direxa Consulting, and former Distinguished Fellow at Moderna Therapeutics, shares her expertise on accelerating vaccine development using Design of Experiments (DOE): Many believe that DOE is time-consuming, but it actually accelerates development. By using DOE, planning early, and understanding constraints, experiments become more efficient and effective, allowing us to reduce the experimental timeline for a traditional vaccine by half. Learn more from Julia O’Neill’s experiences and insights: https://go.jmp/45jsmM5 #DOE #VaccineDevelopment #Pharmaceuticals #StatisticalAnalysis #JMP

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As we continue to await the FDA’s long-promised guidelines for clinical trial diversity, I want to highlight the work ZS is already doing to make trials more representative. To start, our teams are helping clients incorporate the patient perspective in clinical trial design through advanced analytics, primary research, partnerships with advocacy groups and other patient-first strategies. We’re also collaborating with clients to explore how approaches like decentralized clinical trials can reduce disparities by removing social and environmental barriers—including traveling to a trial site—from the equation.  I’m excited to share ZS’s work to address disparities in clinical trials and in healthcare more broadly, which you’ll find in our new 2023 ESG report linked in the comments.  #clinicaltrials #ESG #DEI https://lnkd.in/dNRm7JJi  

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Fred Hutch Receives $5.25M from the Kuni Foundation to Propel Innovative Adult Oncology Research https://lnkd.in/gPUhtv5d Principal investigators working at Fred Hutch Cancer Center and UW Medicine secured $5.25 million in grants from the Kuni Foundation for a diverse lineup of projects to advance our understanding of tumor regression and improve care for an array of adult cancers, including by reducing the cost of therapy. The projects will explore why some cancerous tumors shrink or disappear without treatment; test whether the immunotherapy nivolumab works when given less often and at lower doses; investigate what drives disparities in breast cancer screenings; evaluate a method to detect and treat liver tumors earlier by selectively delivering radiation to tumor cells; and lay the groundwork for personalized hyperthermic peritoneal chemotherapy (HIPEC) for cancer on the lining of the abdomen. Each awardee will receive $1,050,000 over three years. The post Fred Hutch Receives $5.25M from the Kuni Foundation to Propel Innovative Adult Oncology Research appeared first on Life Science Washington . Click here to view original post Click Here to Publish/Feature Your Company or Product News with Biotech Networks

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We are on the ground at American Society of Clinical Oncology (ASCO) 2024 Annual meeting taking place in Chicago,IL.   Our CEO and founder Pahini Pandya will be presenting key findings from a blind validation study of our PANProfiler Breast UKCA and CE-marked solution for HER2, ER, and PR biomarker profiling from H&E-stained breast cancer specimens.   Drop by our poster or get in touch if you are interested in meeting with Pahini to discuss our results and how our deep learning approach can deliver faster, more accessible molecular testing, leading to earlier diagnosis and personalised treatment, ultimately improving patient outcomes.   See the full details here: https://lnkd.in/gffqsErj #ASCO24 #oncology #precisionmedicine #diagnostics #multiomics

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key changes emphasize the importance of working with a partner with regulatory expertise in this field to help develop and execute the optimal gene therapy testing program.

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#seladelpar for #rare liver disease primary biliary cholangitis (PBC) and new data pointing to its long-term efficacy and safety. Two-year data from the #ASSURE study, reported at the #EASL congress this week, showed “rapid and sustained improvements” in biomarkers for the disease as well as a clinically meaningful reduction in #itching (pruritus) – one of the most debilitating symptoms of PBC – with the #PPAR delta agonist. The results are good news for #Gilead, which acquired seladelpar as part of its $4.3 billion takeover of #CymaBay earlier this year and said at the time it believed that the drug has a “best-in-disease” profile for #PBC, which affects around 1 in 1,000 women over the age of 40 in the US. It has been submitted to the FDA as a second-line treatment for adult PBC patients, without cirrhosis or with compensated cirrhosis, who do not respond or are intolerant to standard #first-line therapy with #ursodeoxycholic acid (UDCA), with an FDA decision due by 14th August. #regulatoryaffairs #medicalaffairs #innovation #Drugdevelopment

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💲 Neuroscience biotech LB Pharmaceuticals, Inc. is prepping for an IPO...as the antipsychotics #competitive space ramps up its developments. ❔ What is LB's differentiator? From Endpoints News: 💊 "LB is in mid-stage testing with an #oral treatment candidate for #schizophrenia. Named 'LB-102', the company has described it as a new and improved version of the decades-old medicine amisulpride, a D2 and D3 antagonist that has been sold in many countries but never approved in the US as an antipsychotic. LB has previously said it expects to run multiple Phase 3 trials in 2025 and ask for FDA approval in 2028. It could also test the drug candidate in patients with depression, bipolar depression and other indications." #Antipsychotics #MDD #Schizophrenia #IPO #BipolarDisorder #Biotech #RegulatoryAffairs #Pharma #Healthcare

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At Johnson & Johnson Innovative Medicine, we’re constantly seeking new ways to be on the cutting edge of #drugdiscovery. On the heels of a recent collaboration to advance the discovery and optimization of small molecule medicines, we’re entering into another new collaboration with BigHat Biosciences for strategic antibody discovery and design in #neuroscience.   Why is this so game-changing? This collaboration will combine our expertise in drug discovery, clinical development and #datascience with BigHat’s #machinelearning technologies that are integrated with a high-speed wet lab to accelerate the design of therapeutic proteins with more complex functions and better biophysical properties – with the ultimate goal of bringing novel innovations in neuroscience to patients around the world faster and more efficiently.   The team at J&J is looking forward to integrating this collaboration into our efforts to lead where medicine is going. Shout out to our amazing teams that has made this effort possible, including Mark DePristo, Elizabeth Schwarzbach, Peyton Greenside, and the team at BigHat, as well as the amazing cross-functional team at J&J across #DataScience & #DigitalHealth, #Discovery, #Neuroscience and J&J #Innovation, including David Apfel, Michael Bemben, PhD, Julian Bertschinger, Elena Diez Cecilia, PhD, MBA, Andrea Houghton, Ekaterine (Eka) Kortkhonjia, Sarah Lively, Tommaso Mansi, Bill Martin, PhD, Emma R Parmee, Justin Scheer, Richard Tillyer, Gayle Wittenberg, Ph.D. and many more. Learn more about this collaboration: https://bit.ly/3Whk04X

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As the healthcare industry continues to evolve, one of the most promising areas of innovation is the development of GLP-1-based therapies. These treatments, crucial for addressing conditions such as obesity, type 2 diabetes, and high cholesterol, are currently experiencing a rapid expansion in clinical trials, indicating a robust future pipeline. A standout in this space is Real Chemistry and its Iris platform, which illuminates the significant progress being made across more than 110 active GLP-1 agonist clinical trials. With 53 of these trials in advanced phases, the potential for new therapeutic options is immense, covering over 60 disease states. This progress underscores the need for strong commercial readiness as companies prepare to bring these innovative solutions to market. At Rockland Immunochemicals, Inc. Immunochemicals, and through our brand antibodies-online.com, we are committed to supporting this exciting field. Our teams are actively expanding antibodies and assays that are integral for studying GLP-1 pathways and designing more effective treatments. These tools are not only pivotal for understanding the basic physiology of GLP-1 and its receptors but are also essential in our race to enhance efficacy and minimize side effects. I am enthusiastic about the potential of our GLP-1 antibodies to contribute to improved patient outcomes and am keen to explore how we can leverage these innovations to support the healthcare community further. Discover more about our GLP-1 research tools here:  https://lnkd.in/eUHwvxuU #GLP1 #DiabetesTreatment #ObesityManagement #HealthcareInnovation #ClinicalTrials #RocklandImmunochemicals #AntibodiesOnline

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This content is for US audiences only.   Yesterday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that our IO treatment met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial results with an overall tolerable safety profile.   Those potential benefits cannot be understated, as the majority of this patient population faces a disease recurrence even after surgery and chemo.   This announcement is welcome news to patients thanks to its flexibility before or after surgery and more time to live without progression or recurrence. Our patients are relying on us to deliver new powerful therapies that will allow them to live longer and better – and we won’t let them down. We look forward to our continued work with the FDA and the potential to bring safe, powerful treatments to even more patients facing a cancer diagnosis. Read more: https://bit.ly/46h4YiN   #USOnly #AstraZenecaUS

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📊 𝑬𝑳𝑨𝑽𝑨𝒀 𝐔𝐧𝐯𝐞𝐢𝐥𝐬 2024 𝐎𝐧𝐜𝐨𝐥𝐨𝐠𝐲 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐑𝐞𝐩𝐨𝐫𝐭: 𝘋𝘳𝘪𝘷𝘪𝘯𝘨 𝘐𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘰𝘯 𝘢𝘯𝘥 𝘈𝘥𝘷𝘢𝘯𝘤𝘦𝘮𝘦𝘯𝘵𝘴 𝘪𝘯 𝘊𝘢𝘯𝘤𝘦𝘳 𝘛𝘳𝘦𝘢𝘵𝘮𝘦𝘯𝘵 Archo Advocacy, LLC, proudly presents this comprehensive report highlights the latest trends, innovations, and top contributors in oncology, emphasizing advancements in cancer treatment from patient perspectives. Key Areas Include ⬇ ☑ Partnership Support ☑ Policy Activities ☑ Corporate Reputation ☑ Health Equity & Social Determinants of Health. Discover top performers like The Janssen Pharmaceutical Companies of Johnson & Johnson, Pfizer, and Merck, and gain strategic insights essential for driving success in the oncology landscape. 📈 #OncologyResearch #CancerTreatment #HealthcareInnovation #PatientAdvocacy #HealthcareInnovation #Pharma #Biotech

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Both Biocon and partners Samsung Bioepis/Biogen have reason to cheer: The FDA approved their respective #aflibercept #biosimilars, Yesafili™ (aflibercept-yszy) and Opuviz™ (aflibercept-jbvf) on May 20. The FDA approved both as #interchangeable biosimilars, which further confuses the issue of biosimilar interchangeability, both in terms of exclusivity and applicability. #Eylea #Regeneron #ranibizumab #Xbrane #Xlucane #Yesafili #Opuviz Amgen Celltrion Inc Formycon AG https://wp.me/p7gt6c-7uS

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The road to success is rarely straightforward, but today we celebrate a significant milestone in the fight against Alzheimer's. A #donanemab has shown promising effectiveness, bringing hope to millions of patients and their families. This breakthrough is a testament to the relentless dedication of researchers and medical professionals worldwide. Let's continue to support and drive innovation in medical research, for a future where Alzheimer's is a challenge we have conquered. #AlzheimersResearch #MedicalInnovation #HopeForTheFuture

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