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In this recent webinar, our digital health sciences and #oncologyresearch experts Anthony Todd Everhart, MD FACP and Bill Byrom discussed the use of patient-reported outcome measures throughout oncology drug development. Watch the recording and review the recap here: https://bit.ly/49RUVRS

FDA ODAC Vote Today: Implications and Insights Watch Chief Medical Officer and former FDA oncology division director, Dr. Harpreet Singh, MD, as she quickly breaks down the upcoming FDA Oncologic Drugs Advisory Committee (ODAC) vote and its potential impact on drug development. Key points covered: • Background on today's ODAC vote on AstraZeneca's lung cancer trial • FDA's concerns about trial design and patient over-treatment • Implications for future perioperative trials in oncology Dr. Singh’s insights: • The importance of trial design in proving treatment efficacy • How this vote could affect drug developers across multiple cancer types • Potential changes in FDA requirements for perioperative trials See what this could mean for patients, providers, and the future of cancer drug development. 💬 What are your thoughts on the FDA's stance? How might this impact your work in oncology drug development? Follow Dr. Singh for more FDA insights and expert analysis #fdainsights #OncologyTrials #DrugDevelopment #ClinicalTrialDesign

FDA ODAC Vote Today: Implications and Insights Watch Chief Medical Officer and former FDA oncology division director, Dr. Harpreet Singh, MD, as she quickly breaks down the upcoming FDA Oncologic Drugs Advisory Committee (ODAC) vote and its potential impact on drug development. Key points covered: • Background on today's ODAC vote on AstraZeneca's lung cancer trial • FDA's concerns about trial design and patient over-treatment • Implications for future perioperative trials in oncology Dr. Singh’s insights: • The importance of trial design in proving treatment efficacy • How this vote could affect drug developers across multiple cancer types • Potential changes in FDA requirements for perioperative trials See what this could mean for patients, providers, and the future of cancer drug development. 💬 What are your thoughts on the FDA's stance? How might this impact your work in oncology drug development? Follow Dr. Singh for more FDA insights and expert analysis. #fdainsights #OncologyTrials #DrugDevelopment #ClinicalTrialDesign

Important work being presented here at #AACR: improvement in a RECIST-based surrogate endpoint like PFS or ORR does not consistently translate into OS benefit. This is why FDA is beginning to request higher quality evidence from clinical trial sponsors. The Accelerated Approval pathway is important, and there is a clear need for surrogates that are clinically meaningful.

2seventy bio and Bristol Myers Squibb "are expanding their Abecma treatment site footprint to help more patients access the treatment, 2seventy said. Part of that push will include renewed physician education—especially on treatment sequencing and the emerging data supporting the use of BCMA-directed CAR-Ts before other BCMA-targeted therapies. Further, 2seventy wants to help doctors recognize the significance of Abecma’s real-world safety and efficacy." The former is anticipating FDA's decision for Abecma which could potentially move it to 3L use, as it is currently approved as 5L therapy. 2Seventy will also pass along their R&D assets to Regeneron #2SeventyBio #Biotech #Pharma #BMS #BristolMyersSquibb #CART #CellTherapy #AdvancedTherapeutics #Abecma #Innovation #Cancer #Oncology #Healthcare

We must acknowledge the financial forces that shape cancer care and research. The pharmaceutical industry now funds more than 90% of systemic therapy RCTs or randomized clinical trials. Although many pivotal treatment advances come from pharmaceutical company–led RCTs, industry now controls the research agenda. The pharmaceutical industry is the most profitable industrial sector on the planet; oncology drugs are major contributors to these revenues as the industry has massively shifted to cancer drug development. In addition to funding trials, the pharmaceutical industry also supports clinicians, research networks, patient organizations, advocacy groups, and even hospitals, creating a complex network of incentives that are not necessarily aligned with patient and societal needs. For randomized clinical trials or RCTs to answer questions that matter to patients there needs to be significant reinvestment in academic cooperative trials groups by government funders and health system payers.

Stifel is proud to present its Oncology Market Report. This publication features trends in the oncology market, a summary of recent deal activity, and new developments from the American Society of Clinical Oncology conference. Click below to learn more: #oncology #marketupdate #dealactivity #ASCO

-Solid information for Smart Decisions- ONCOLOGY NEWS LINKS Curated News | Direct Links | JUNE 2024 Stay connected to the latest Food and Drug Administration information — • Up-to-date drug approvals in Hematology/Oncology • Current information on Drug Shortages and Discontinuations  FOCUS FEATURE: ACCESSING CANCER DRUGS: ONGOING CHALLENGES  #STRATEGIESONCOLOGYMAGAZINE #ONCOLOGY #cancercare #profitdrivendrugs #BREAKTHROUGHTREATMNENT  #PBM #patientassistanceprograms #medicalsoftware https://lnkd.in/gjSDywH5

Introducing our Oncology Clinical Development Experts: Part 1 #tranScripTeamTuesday Oncology drug development stands at the forefront of medical innovation, a field marked by unparalleled complexity and fierce competition. In an era teeming with groundbreaking opportunities and newfound hope for patients, the path to market success has never been more challenging. At tranScrip, we leverage our extensive experience to design and deliver comprehensive oncology programmes. Our expertise spans targeted therapies, immunotherapies, vaccines, cell-based products, and novel cytotoxics. We empower our clients to seize opportunities, overcome challenges, and achieve their product development and lifecycle management objectives through the adoption of novel approaches and regulatory pathways. Our physicians and scientists, together with our regulatory, clinical and commercial experts, offer truly flexible bespoke solutions helping to expedite the development and commercialisation of products for the benefit of patients worldwide. #MeetTheExperts #MeetTheTeam #Oncology #ClinicalDevelopment

Consider checking out this important conference (February 15 & 16) on optimizing dose in cancer clinical trials sponsored by both the FDA and AACR Journals: https://lnkd.in/gEWgUaDU.