Mark Brown, MBA

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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Did you know that Worldwide partners with over 115 rare disease organizations around the globe to help leverage shared expertise so we can improve patient outcomes and accelerate breakthroughs in drug development? Learn more about these partnerships and how these organizations are helping make an impact on rare disease clinical research in our blog: https://bit.ly/3Z4Junj

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In #NeurodegenerativeDisease news, specifically on an experimental treatment for #ALS, with this new #strategic partnership is penned between Dewpoint Therapeutics and Mitsubishi Tanabe Pharma America. ⚛️ The asset is the former's drug, designed "to address the accumulation of a protein into toxic structures that lead to neuronal dysfunction in people with ALS." 🤝 The alliance would grant MTP exclusive rights to license, upon achieving certain developmental milestones. ⚕️ This would add to MTP's existing US-marketed ALS treatment, #Radicava https://lnkd.in/evayrVv4' #Dewpoint #Mitsubishi #Pharma #Biopharma #Healthcare

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Looking forward to attending #ASH2024 this year. Let's connect and I can share with you how TD2 can support your next trial. 🔗https://hubs.li/Q02YXgqv0 #HematologyOncology #ClinicalTrials #OncologyCRO #BloodCancerResearch #DrugDevelopment #PrecisionOncology #ClinicalTrialSolutions

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For more than ten years, sponsors and researchers have discussed "patient-centric drug development," but clinical trials have mostly stayed the same. To genuinely improve patient experiences and health outcomes, it's essential to go beyond minor innovations and adopt a comprehensive paradigm shift. https://gag.gl/wE0cVC #DrugDevelopment #FortreaConsulting John Doyle, Dr.P.H.

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💥 SUPER MSL: The Quest to Become the TOP MSL on Your Team💥 Don't miss this weeks MSL Talk podcast with Daniel Snyder, Ph.D., Senior Medical Affairs & HEOR Leader who discusses the differentiators for MSLs that will make you stand out and become the top MSL on your team. Learn more about….   👉 The qualities and differentiators of a “Super MSL” 👉 The skills and attributes that make MSLs stand out relative to their peers 👉 What common mistakes do MSLs need to avoid to 👉 What MSL Team leader should do to encourage and entice ideal MSL skills The MSL Talk Podcast is available on all podcast platforms and the MSL Talk YouTube Channel.     MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions.   #msl #medicalaffairs #medicalscienceliaison #MSLtalk #careers  

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💥 SUPER MSL: The Quest to Become the TOP MSL on Your Team💥 Don't miss this weeks MSL Talk podcast with Daniel Snyder, Ph.D., Senior Medical Affairs & HEOR Leader who discusses the differentiators for MSLs that will make you stand out and become the top MSL on your team. Learn more about…. 👉 The qualities and differentiators of a “Super MSL” 👉 The skills and attributes that make MSLs stand out relative to their peers 👉 What common mistakes do MSLs need to avoid to 👉 What MSL Team leader should do to encourage and entice ideal MSL skills The MSL Talk Podcast is available on all podcast platforms and the MSL Talk YouTube Channel. MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions. #msl #medicalaffairs #medicalscienceliaison #MSLtalk #careers

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Looking to empower your oncology trials with specialized CRO training? Our latest white paper dives into the critical role CRAs play in managing advanced oncology trials and how specialized training can help set up your trial for success. Download your copy today! https://bit.ly/48k1RHG

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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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Latest blog on approaches to participant recruitment in #RWE! Patients are at the heart of our real-world evidence research. But what to do if you craft a fabulous study design, in collaboration with patients and KOLs, and then start to look at the part of the design concerning the recruitment pathways?! ❓ How to do it? ❓ What are the options? ❓ What do you need to think about? Have a read to see the possible approaches to participant recruitment in real-world evidence research. #patientcenteredresearch #patientrecruitment

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The FDA has approved Merck's V116 (CAPVAXIVE™), a 21-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumonia in adults. V116 targets serotypes responsible for 84% of such diseases in adults over 50 and has shown superior immune responses compared to the existing PPSV23 vaccine. This approval marks a significant advancement in adult pneumococcal vaccination, promising to reduce disease burden and improve public health outcomes. For more details, read the full article here: https://lnkd.in/eh-TF_GG #Vaccines #PneumococcalDisease Merck #FDAApproval #PublicHealth #Healthcare #VaccineDevelopment #MedicalNews HCPLive

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Reflecting on #CDISCUS2024, it was inspiring to see so much energy around making clinical data standards work better for our industry and the patients we serve, and to connect with nearly 500 peers in Scottsdale, who are equally passionate about advancing drug development. Chris Decker’s keynote which included his personal experience during Hurricane Helene was a powerful reminder of the importance of exhibiting a sense of urgency in our line of work, as well of prioritizing doing the right thing over constantly asking the ROI question. At Bioforum’s booth, we had exciting conversations about JetConvert™—a tool that offers real-time, live SDTM conversion, making clinical data submission-ready without requiring extra programming. JetConvert, which centralizes clinical data in one accessible place, lets sponsors catch data anomalies and submission issues early, simplifying data management and helping reduce study timelines and budgets. Thank you to CDISC and everyone who stopped by and joined us for sessions. It’s clear that the need for faster, more accessible data solutions in clinical trials is a shared goal, and Bioforum is proud to be part of this community. #CDISC #ClinicalTrials #ClinicalResearch #ClinicalDataManagement #JetConvert #SDTM #SCDM #Bioforum #BionData

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Attention Life Science Professionals! 🔥 ANOTHER HOT TOPIC ALERT! 🧪🔬 Some More Good News in the Life Sciences! Check out the summary below regarding the 3,000 jobs created in Boston area in 2024. Share your thoughts in the comments! And if you are looking for folks, please let us know! hashtag #lifesciences #biotech #pharma #medicaldevice #diagnostics #hiring2024 #boston The Richmond Group USA

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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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PA clinical development expert, Kelsey Jakee talks with Rob Goodwin, SVP of Clinical Development and Operations at Pfizer, and industry advisor Craig Lipset to paint a picture of the future of clinical trials, where patients can easily control their data sharing and receive feedback on its use, fostering greater patient engagement. https://bit.ly/3V7YfmR

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Delve into the Cutting-Edge of Cell and Gene Therapy (CGT) Drug Development Processes In case you missed it: Our detailed whitepaper unravels the intricate journey of introducing CGT treatments to the market, spanning from crafting analytical strategies to implementing cGMP-compliant cryogenic storage options. Learn how Alcami lends its comprehensive support for your complete CGT requirements with over four decades of proficiency in analytical testing and regulatory insights. Whether addressing QC hurdles, forging new methods, or conducting extensive stability assessments, our team is poised to assist at each juncture. 🔬 To gain further insights, download the whitepaper here➡️ https://gag.gl/DVC7t6 #CellAndGeneTherapy #CGT #PharmaInnovation #Biotech #DrugDevelopment #AnalyticalTesting #cGMP

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A great day for patient access in ESRD! CMS Policy Update announced Monday November 25, 2024. Beginning in January 2025, CMMI’s Kidney Care Choices (KCC) value-based care model will carve out Transitional Drug Add-on Payment Adjustments (TDAPA payments) from financial calculations such as benchmarks, performance year expenditures and USPCC trend rates, allowing ESRD patients participating in a KCC to have increased access to certain innovative new drugs https://lnkd.in/gpFQ2RS6

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Every single time I talk to one of these writers, I learn something new. Their advice is geared towards regulatory submission specialists, but the core lessons will speak to all kinds of team leaders. Hope to see you there!

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Partnerships start with collaboration and an understanding of client culture. It is important to understand if a potential vendor shares the same values through a comprehensive RFP that also measures problem solving and personality traits. It is not about what you have....It is how you are going to customize an approach that best serves the client.

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