Tim Roberts

The fourth quarter of 2024 is critical for the biotech industry, with 5 major FDA approval decisions on the horizon. These upcoming verdicts could impact everything from treatments for #cancer to #rarediseases 🧬 Stay ahead of the latest in #biotech and learn how these #FDA decisions could shape the future of healthcare.

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In the latest issue of IBI Journal, Sarah McAliskey from Almac Clinical Services shares invaluable insights on leveraging technology and expertise to protect clinical trial supply. Her expertise highlights the critical impact of these practices on the pharmaceutical industry. Don't miss her feature on pages 56-58! Read more here:https://hubs.li/Q031G_0N0

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Breast cancer research shows no signs of slowing. We dug into the data from Citeline’s Trialtrove to give you key insights from active #breastcancer clinical trials. https://hubs.ly/Q02SsbPn0 #oncology #clinicaltrials #drugdevelopment

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𝐑𝐄𝐆𝐔𝐋𝐀𝐓𝐎𝐑𝐘 𝐑𝐎𝐔𝐍𝐃𝐔𝐏 ⚛️ The FDA has released new draft guidance recommending best practices for multi-regional clinical trials (MRCTs) in oncology. Sponsors are encouraged to ensure that the outcomes of global oncology clinical development programs are understandable for US patients in support of marketing applications. 🌐 The FDA's final guidance on decentralized clinical trials (DCTs) clarifies several concerns raised by clinical experts and industry stakeholders regarding the earlier draft. This includes detailed requirements for maintaining a task log for healthcare providers, guidelines for physical inspections, and addressing challenges related to data variability in DCTs. 🤖 As the use of artificial intelligence (AI) tools, particularly generative AI, expands, experts remind regulatory professionals to prioritize the human aspect. Although these tools offer significant benefits, they necessitate human oversight and interpretation to be fully effective. During the opening plenary session, experts discussed how AI can be utilized across various sectors, the potential of this technology, and the hurdles in achieving its full benefits. Panelists included Ryan Kurtzman from the City of Long Beach, Bradley Thompson of Epstein Becker Green, Michelle Jump from MedSec, and Jay Mashburn from Recursion Pharmaceuticals, with moderation by Megha Iyer of Thermo Fisher Scientific. 🧬 As biosimilars gain market presence, they are generating competition with original products. However, patient adoption of biosimilars varies based on demographics, location, care setting, prescriber specialties, and types of insurance, according to two recent studies in Health Affairs. 🌐 The FDA has observed a rise in complete response letters (CRLs) issued to sponsors of biologics license applications (BLAs) over the last decade, with facility deficiencies being the most common reason cited, according to Leslie Rivera Rosado, a supervisory interdisciplinary scientist at the agency's Center for Drug Evaluation and Research (CDER). #Pharmaceuticals #Biotechnology #LifeSciences #PharmaNews #Biotech #HealthcareInnovation #DrugDevelopment #ClinicalResearch #Biopharma #PharmaTech #MedicalResearch #Healthcare #BioPharmaceuticals #PharmaIndustry #BiotechIndustry #PharmaCareers #MedicalInnovation #NewDrugs #Genomics #BiotechNews

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This edition of EBR’s BIO-Europe Supplement features a thought leadership article authored by Kipp Kreutzberg, VP, Consulting, Syneos Health that discusses the key to accelerated global expansion. Read the full piece on page 14: https://ow.ly/IJg930sHHI4

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Discover the latest enhancements to Labcorp Global Trial Connect, designed to streamline site workflows and boost clinical trial efficiency. These updates, driven by insights from collaboration with sponsors and sites, aim to empower investigator sites to focus more on what truly matters, patient care. Your commitment to patient care is why we’re committed to redefining clinical trial delivery. Learn more: https://lnkd.in/eavYncMz #ClinicalTrials #GlobalTrialConnect

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What an interesting read on the shift from traditional patient recruitment methods in rare disease! Learn more about how to optimize patient-driven site engagement in my team member’s blog: https://bit.ly/4eHoBn4

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Prepare now! Insightful checklist to aid your strategic planning and ensure patient safety. #Pharmacovigilence

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Facing staffing reductions in Biopharma? Discover how strategic FSP resourcing can help Biotech firms navigate talent shortages and achieve clinical trial success. Read now 👉 https://hubs.li/Q02F-yMb0 #biopharma #biotech #clinicaltrials

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Project Optimus is revolutionizing early oncology trials, aiming to ensure more effective and safer cancer drugs and improve patients' quality of life. Parexel experts have identified three strategies to help sponsors overcome challenges in achieving dose-optimization requirements. Here’s what we know works: 1️⃣ Design an integrated first-in-human study 2️⃣ Reach agreement with FDA at each step 3️⃣ Challenge guidelines with a compelling rationale Let me know your thoughts below and read more in our New Medicines, Novel Insights report! https://lnkd.in/dmYADu-n #ProjectOptimus #Oncology #NovelInsights

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Developing successful cell and gene therapy clinical trials is a complex process due to many operational challenges and regulatory scrutiny. Our CAGT Study Management team can help biotech sponsors anticipate and navigate site selection and start-up, regulatory considerations, and logistical complexities. https://bit.ly/4cBODGI #biotech #genetherapy #CAGT #celltherapy #clinicaltrials

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Looking forward to joining fellow industry leaders at this year’s IDDST-International Drug Discovery Sciences & Technology Congress in Budapest! I am particularly excited to discuss how drug development in women’s health can uniquely leverage female biology to customize delivery methods and durations for optimized outcomes. If you are attending or will be in the area, let’s connect and talk all things #womenshealth!

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Boehringer Ingelheim and Circle Pharma, Inc. are tackling one of the most complex challenges in #CancerTreatment with a groundbreaking approach. Their recent collaboration, valued at up to $607 million in milestone payments, aims to develop a first-in-class cyclin inhibitor that targets uncontrolled cell growth—a key factor in many cancers. By utilizing Circle Pharma's innovative macrocycle platform, this partnership is poised to address difficult-to-treat tumors, offering new hope for patients and advancing the boundaries of precision medicine. Leading Circle Pharma, Inc.’s strategic vision is David J. Earp, JD, PhD, CEO, with Paul Park, Chief Business Officer, driving business development efforts. Together, they are shaping the future of cancer therapeutics with a focus on delivering transformative solutions for unmet clinical needs. #Biotech #CancerResearch #PrecisionMedicine #Innovation #Oncology #DrugDevelopment #Pharma #MacrocycleTherapies #LifeSciences

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🔬 Biopharma Layoffs: Navigating Challenges in a Shifting Landscape Recent trends in biopharma layoffs have left many scientists reeling. Here are key takeaways from a recent STAT article: 67% of life science layoffs in H1 2024 were at large biopharma companies (>$1B annual sales), up from 47% in 2021-2023. Job postings in biotech dropped from 21,366 to 12,300 between early 2021 and 2024. Scientists face unique challenges in job searches, including maintaining confidentiality about previous work. Visa constraints add pressure for international workers, limiting job search time. Networking remains crucial: Some successful companies are hiring primarily through personal connections. The industry sees this as part of a cyclical pattern, influenced by patent expirations and acquisitions. Despite these challenges, opportunities still exist. Adaptability, networking, and a broader job search approach are key for scientists navigating this evolving landscape. What strategies have you found effective in weathering industry changes? Share your thoughts below! #BiopharmaJobs #CareerTransition #LifeSciences #Networking

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🗞 Breaking news 🤩 Genezen acquire uniQure's commercial GT manufacturing ops in Lexington!! This strategic acquisition will enable Genezen to deliver late-phase and commercial gene therapy development and manufacturing services to customers around the world. Check out full article below👇 #CDMO #Genezen #GeneTherapy

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Over my 20+ years in the pharmaceutical industry, I’ve seen many trends come and go, but today’s shift stands out as one of the most profound: moving from stand-alone service providers and equipment suppliers to integrated solutions that truly serve the customer. At Ellab, we’re not just adapting to this shift—we’re driving it. By combining cutting-edge equipment with deep expertise, we are creating solutions that reduce complexity and build trust. This isn’t just about providing products; it’s about taking responsibility for validation and compliance, so our customers can focus on what they do best: delivering safe, effective products to patients. This shift has made me reflect on how much progress we’ve made as an industry—and the challenges we still face. Simplifying processes and aligning diverse teams and technologies is no easy feat. But every time we help a customer work more confidently and efficiently, it reaffirms why this transformation matters. How is your industry tackling complexity, building trust, or driving meaningful transformations? I’d love to hear your insights. #Ellab #IntegratedSolutions #CompliancePartner #PharmaValidation #LifeSciencesLeadership #CustomerSuccess #PharmaInnovation

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Join us for a webinar discussing the implications of the FDA & EMA's latest guidance on Decentralized Clinical Trials (DCTs). Learn practical strategies for implementation, and gain insights into study design considerations and regulatory compliance. Register here ⇢ https://lnkd.in/e7WwvtCM

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