Nicole Doherty

One for my Diagnostic network - I'm interested to hear thoughts on the FDA's plan to bring LDTs into its regulatory fold over the next 4 years? What impact is this going to have on the market? 👇 ✏ #FDA #IVD #diagnostics #LDTs #labdevelopedtests #IVDS

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Every time I think things are on the rebound I see something like this. When are things finally going to stabilize and head in the right direction? If there is anyone that may be affected by this, let's connect and have a discussion about your career. #career #discussion #connect

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𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐬𝐢𝐭𝐞𝐬 𝐬𝐞𝐞𝐧 𝐚𝐬 𝐡𝐨𝐭 𝐩𝐫𝐨𝐩𝐞𝐫𝐭𝐲 𝐟𝐨𝐫 𝐏𝐄 𝐢𝐧𝐯𝐞𝐬𝐭𝐦𝐞𝐧𝐭 Private equity is increasingly investing in clinical trial sites due to industry demand for larger networks, as shown by PitchBook's analysis of first quarter 2024 deal activity. Contract research organizations (CROs) are acquiring trial sites to enhance their service offerings, exemplified by American Clinical Research Services acquiring Elixia and Alcanza Clinical Research's focus on sites in Hispanic areas. This trend is part of a broader movement towards vertical and horizontal consolidation, aiming to create end-to-end drug development capabilities. #privateequity #clinicalresearchsites

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One of the highlights of Mental Health Awareness Month at Genentech was a companywide watch party for the documentary Like, followed by an interactive, live-streamed Q&A with director Scilla Andreen. This short film examines the reasons why we’ve become so dependent on our mobile devices and recommends small steps we can take to create healthier boundaries with technology. A must-watch for grownups and kids alike, we’ve made Like available on demand at no cost to our employees and their family members through the end of the year. How do you ensure technology enhances rather than detracts from your life? Let me know in the comments!

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As we recognize Friedreich Ataxia (FA) Awareness Month, I am inspired by the courage and determination of the FA community. FA is a rare and debilitating neuromuscular disorder, with symptoms typically appearing in childhood. I am proud of the work we do at Biogen to support the FA community and bring awareness to the disease.  #FriedreichAtaxia | #FAAwarenessMonth | #TeamBiogen

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𝗗𝗮𝗶𝗹𝘆 𝗡𝗲𝘂𝗿𝗼-𝗯𝗶𝘁𝗲𝘀 🧠: 💵𝘾𝙤𝙣𝙜𝙧𝙖𝙩𝙪𝙡𝙖𝙩𝙞𝙤𝙣𝙨 to CereVasc who secures $70 million series B financing, following FDA approval of STRIDE study 𝗦𝗼, 𝘄𝗵𝗮𝘁 𝗮𝗿𝗲 𝘁𝗵𝗲𝘆 𝗴𝗼𝗶𝗻𝗴 𝘁𝗼 𝘂𝘀𝗲 𝘁𝗵𝗶𝘀 𝗳𝘂𝗻𝗱𝗶𝗻𝗴 𝗳𝗼𝗿? 🧑‍💻Support the clinical and regulatory development of the company’s novel eShunt system ⚕️Fund their upcoming STRIDE pivotal study involving patients with normal-pressure hydrocephalus. 🤔𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗲𝗶𝗿 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗱𝗼? Their eShunt System is a minimally invasive approach to treating hydrocephalus. The System comprises an endovascularly implantable CSF shunt and associated delivery component. This is designed to avoid the need for: ⭐Invasive surgery ⭐General anesthesia ⭐Extended hospitalization ⭐Post-procedure pain management. #hydrocephalus #brainhealth #minimallyinvasive #patientoutcomes #neurovascular https://lnkd.in/e-R5wkkQ https://lnkd.in/enfjKs_E

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More than 750 products were granted emergency use authorization (EUA) during the pandemic. But as the US public health emergency (PHE) comes to an end, products will need to undergo the typical FDA approval process before US distribution can continue. Sponsors need to submit plans to FDA by latest May 11. Read how to prepare, in this short article by my colleague Lynne Ensor, SVP and Head of Strategic Compliance Consulting at Parexel.

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💊 Industry News Roundup 💊 🧠 Scientists, at Epoch Biotech, have discovered a new genetic clue for delaying Alzheimer's - this has been inspiring drug discovery and could be ground-breaking. 💲 Emergent BioSolutions sold their Baltimore facility for $30M to Bora Pharmaceuticals, which included 350 of Emergent's employees 🔥 Novo Nordisk office building in Denmark, set fire again. This is the third time in the last month - everyone was safe. ➕ Zealand Pharma hits early efficacy goal for amylin weight loss candidate - another movement in the obesity space 👀 😢 Cara Therapeutics have had to cut their workforce after trial failure 😍 iOnctura raises 80M to advance early-stage eye cancer treatment 👁 ❤️ Silence Therapeutics plc siRNA candidate for cardiovascular disease is continuing to deliver in Phase 2 trials!!! 💲 The target is set for new obesity biotech UroGen Pharma, aiming to raise over $107M 🐥 A tweet about a gene led a start-up called Marea raise $190M to develop a drug to lower a type of cholesterol, a new way of maybe attacking cardiovascular disease An exciting time in the biotech space, and if you haven't already - give our podcast The BioHub Podcast a follow.

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Will your current (or upcoming) global clinical development program need a Diversity Action Plan? We’re evaluating the FDA’s latest Diversity Action Plan draft guidance and sharing our thoughts: https://lnkd.in/gQm-T7ry #diversityinclinicaltrials #diversityequityandinclusion #diversityinhealthcare #healthequity #advancinghealthequity #clinicaltrials #clinicalresearch #FortreaAlwaysOn

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2024 Best Places to Work in Biopharma - BioSpace BioSpace's annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace. Each organization’s merits are considered with particular emphasis on culture, career growth and development opportunities, leadership and innovation. The list includes 60 employers with U.S. operations based on the votes and ratings of thousands of life science community members, with 30 ranked in large and small employer categories respectively. Don't miss our interview with our top large and small company winners on what they do that makes them a great place to work. Here are the top rated companies to work for, both large and small, across the U.S. https://lnkd.in/eq9x5fxm

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If that hire in the Regulatory, Clinical, Quality Assurance or Program Management function is giving you trouble call Gabrielle Sacco on the HireMinds team for back-up. She's regularly engaging with top active and passive talents to find them relevant opportunities with the best biotechs across the U.S. #regulatoryaffiars #clinicaloperations #qualityassurance

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I can't say it any other way, 2024 is proving to be challenging. 🤯 Many people are out there looking for a job. 🕵‍♂️ Many people are out there unhappy in their current job and company. 🙇‍♀️ Depression is increasing. 💔 So, even though I'm going through some difficult times, I am very grateful and feeling blessed to be working at IQVIA. 🙏 We are for the third consecutive year ranked #1 in Health Care: Pharmacy on the Fortune® World's Most Admired Companies™ List https://lnkd.in/d7teUHHn And it's not just a ranking, a stamp, a trophy. For me it's the reality. IQVIA has so much to offer, I'm working with the most amazing leadership, colleagues, technology and benefits. 🍎 It makes everything just that little bit easier, while I figure out my life, knowing that I have an amazing work environment and that I can prioritize my health right now. 🧘‍♀️ So I hope everyone will find that job opportunity and work environment where they can take care both of their professional ambitions as well as personal well being. 💙 To a year of transformation, a better future and creating a healthier world together! 🌍 What are you doing to improve your health right now?❓❔ #health #wellbeing #WeAreIQVIA #transformation #benefits

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🦠 Bristol Myers Squibb (BMS) and Cellares announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies in a transaction valued up to $380M. Cellares will optimize, automate, and tech-transfer select BMS CAR T cell therapies onto its automated and high-throughput manufacturing platform, the Cell Shuttle™. Cellares will dedicate multiple Cell Shuttle and Cell Q™ systems with fully automated, high-throughput quality control for BMS’ exclusive use. This strengthens BMS’ existing global network of cell therapy manufacturing facilities and provides increased agility, improved scalability and potential to improve turnaround time to support the company’s CAR T inline and pipeline assets 🦠 Legend Biotech announced that the European Commission has granted approval of CARVYKTI® for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, have demonstrated disease progression on the last therapy and are refractory to lenalidomide. 🦠 Vertex Pharmaceuticals and TreeFrog Therapeutics announced that Vertex has obtained an exclusive license to TreeFrog's proprietary cell manufacturing technology, C-StemTM, to optimize production of Vertex's cell therapies for type 1 diabetes (T1D). C-Stem™, is designed to mimic the natural microenvironment, allowing cells to grow exponentially in 3D. The technology will enhance Vertex's ability to generate large amounts of fully differentiated cells for its portfolio of T1D cell therapies 🦠 TScan Therapeutics announced closing of upsized public offering. The gross proceeds to TScan from this offering were approximately $150.1 million, prior to any exercise of the underwriters’ option to purchase additional shares of voting common stock and before deducting underwriting discounts and commissions and other estimated offering expenses payable by TScan. The company intends to use the net proceeds from the offering for general corporate purposes. TScan expects its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026. 🦠 SCG Cell Therapy and the A*STAR - Agency for Science, Technology and Research in Singapore launched joint laboratories to advance the development of iPSC technology to produce novel cell therapies that meet GMP standards. The collaboration is supported by $22 million under Singapore’s Research, Innovation and Enterprise 2025 Plan. The joint laboratories leverage SCG’s and A*STAR’s proprietary technologies to develop scalable GMP-grade iPSC and therapeutic products

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In our New Medicines, Novel Insights Oncology report, Dr. Gwyn Bebb reflects on the paradoxes and challenges we encounter while striving to make precision oncology a reality and his vision for the future. Hear from Dr. Bebb on the complexities of treating each patient with the exact right medicine ─ and why we must realize the vision: https://lnkd.in/gxHdpNX2 #CancerResearch #Oncology #NovelInsights

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Driven by a unified purpose to impact the lives of people living with advanced cancers, Novartis is working to create a future where every eligible patient can receive radioligand therapies (RLTs) not just today—but into the future.   Learn more about this commitment to RLT: https://lnkd.in/g8JcTs7A   #ASCO24 #NovartisTogether

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