Dimitri Dobroskok

The Biopharma Job Market in 2024: A Reality Check I feel compelled to address some misconceptions about the current job market. While some recruiters may be expressing optimism about hiring picking up or the market turning around, the data tells a different story. Let's look at the facts: Layoff Trends: Q2 2024 saw a significant increase in biopharma layoffs, with at least 7,616 workers impacted. This is more than triple the 2,398 layoffs reported in Q1 2024. Major Players Affected: Industry giants like Novartis, Indivior, CureVac, and Takeda have all announced substantial job cuts in recent months. Ongoing Restructuring: Many companies are still in the midst of restructuring efforts, with some planning layoffs that will continue into late 2024 and beyond. Biotech Volatility: While there are pockets of growth, particularly in well-funded startups, the overall biotech sector remains volatile. What This Means for Job Seekers: Be Cautious: Exercise caution when hearing overly optimistic projections from recruiters. Always verify claims with industry data. Stay Informed: Keep abreast of industry trends, company financials, and pipeline news to make informed decisions. Diversify Your Search: Consider roles in emerging biotech startups or adjacent industries that value pharma experience. Enhance Your Skills: Focus on developing skills that are in high demand, such as data analytics, digital health, or regulatory affairs. Network Strategically: Build relationships within the industry, not just for immediate opportunities but for long-term career growth. As recruiters, our role is to provide accurate, data-driven insights to both clients and candidates. While we all hope for market improvement, it's crucial to approach the current landscape with realism and strategic thinking. What strategies are you employing in this challenging market? Let's discuss in the comments. #PharmaceuticalIndustry #BiotechJobs #CareerAdvice #RecruitmentTrends

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👨‍🔬💬 𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐍𝐞𝐰𝐬: 𝟏𝟐𝐭𝐡 𝐍𝐨𝐯𝐞𝐦𝐛𝐞𝐫 𝟐𝟎𝟐𝟒 👩‍🔬💬 🧬 The University of Texas MD Anderson Cancer Center has launched the Institute for Cell Therapy Discovery & Innovation with over $80 million in funding. The institute will focus on developing cell therapies for cancer, autoimmune diseases, and infections, collaborating with biotech and pharma partners. This initiative aims to create accessible, off-the-shelf cell treatments to reduce hospital stays and costs. The center is working towards a $150 million funding goal to support further research and clinical trials. 🦠 Atamyo Therapeutics have received IND clearance from the FDA for ATA-200, a gene therapy targeting limb-girdle muscular dystrophy Type 2C/R5 (LGMD2C/R5), allowing it to enter Phase 1b/2b clinical trials in the US. This therapy aims to deliver a functional gene to treat this debilitating childhood disease, which leads to progressive muscle weakness. Atamyo plans to open its first US trial site by year-end and begin enrollment in Q4 2024. 🧬 Belief Biomed announced that the FDA has granted Orphan Drug and Rare Pediatric Disease designations for their gene therapy BBM-D101 for Duchenne Muscular Dystrophy (DMD). BBM-D101, a recombinant AAV gene therapy, is designed to deliver a therapeutic gene to muscle tissue and is already in clinical trials. 🦠 Neurotech Pharmaceuticals announced that the FDA has delayed their BLA review for NT-501 eye cell therapy implant review by three months to March 18, 2025, citing the need for additional data review. NT-501, designed for treating macular telangiectasia type 2 (MacTel), contains retinal pigment epithelium cells that produce proteins for continuous, targeted therapy. The implant demonstrated safety and effectiveness in Phase III trials, reducing disease progression by 56.4% and 29.2% across two protocols. 🧬 Maravai LifeSciences has signed an agreement to acquire the DNA and RNA business of Officinae Bio, enhancing its nucleic acid manufacturing capabilities. Officinae Bio uses AI-enabled methodologies for nucleic acid design, particularly for mRNA therapies. The integration of Officinae Bio’s technologies will support innovative nucleic acid therapies, accelerating drug development for patients. The deal is expected to close in early 2025, subject to regulatory approvals 🧬 Mustang Bio has received Orphan Drug Designation from the FDA for its HSV-1 oncolytic virus, MB-108, to treat malignant glioma. Mustang is developing MB-108 in combination with MB-101, a CAR-T cell therapy, to treat recurrent glioblastoma. Preclinical data suggests that this combination could reshape the tumor microenvironment and improve treatment efficacy. 🛎 My aim is to be the messenger when it comes to your CGT news. Follow #mCGT to stay updated! #celltherapy #genetherapy #ATMP

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📢 Nuclein Submits Combo COVID-19/Flu Point-of-Care RT-qPCR Test to FDA for 510(k) Clearance! 🦠🔬 Exciting news from Nuclein! The company has officially submitted its innovative combo COVID-19 and Flu point-of-care RT-qPCR test to the FDA for 510(k) clearance. This groundbreaking test aims to enhance diagnostic capabilities and streamline the process for detecting both viruses simultaneously. Key Highlights: 🔹 Dual Detection: Combines COVID-19 and Flu testing in one efficient and accurate RT-qPCR test. 🔹 Point-of-Care: Designed for rapid results at the point of care, improving patient management and treatment decisions. 🔹 Regulatory Milestone: The submission marks a significant step towards providing advanced diagnostic tools to combat respiratory illnesses. "By integrating COVID-19 and Flu testing, we are aiming to provide healthcare professionals with a powerful tool to efficiently diagnose and manage these prevalent respiratory infections," said Nuclein's CEO. #HealthcareInnovation #Diagnostics #PCRTesting #COVID19 #Flu #FDA #Biotech #PointOfCare #MedicalDevices #Nuclein #PublicHealth

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🌍 FDA Issues Draft Guidance on Global Cancer Clinical Trials! 🎗️ The FDA has released draft guidance to help sponsors plan and conduct multiregional cancer clinical trials effectively, ensuring they meet U.S. approval standards. The guidance focuses on selecting trial sites 🌎, analysing regional data 📊, and ensuring results are applicable to U.S. patients. FDA's Richard Pazdur emphasises the need for diverse, global participation to ensure new oncology treatments meet American standards of care. #CancerResearch #FDA #Oncology #ClinicalTrials #GlobalHealth #MedicalInnovation

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Navigating layoffs in clinical research can be challenging, but it's also an opportunity for growth and reinvention. Here are six tips to help you through this transition: 1. Update Your Resume and LinkedIn Profile 2. Network Actively 3. Consider Further Education or Certifications 4. Seek Support from Professional Associations 5. Look for Contract or Freelance Opportunities 6. Stay Positive and Persistent Feel free to share any additional tips, resources, or personal experiences that have helped you or someone you know overcome a layoff. Let's support each other through these changes! Don't forget to sign up for the BWICR Conference 2024: https://lnkd.in/dGWYkg_y #ClinicalResearch #CareerTransition #LayoffSupport #Networking #ProfessionalGrowth #bwicr #clinicaltrial #clinicalresearch #clinicalresearcHER #clinicalresearchassociate 

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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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CRAs Looking for tips on what to include on your resume? I've got you covered The clinical research associate job market is about as competitive as it can get. As a former Life Science recruiter let me share the key details employers wanted to have answered via applicant's resumes - How many studies do you typically have at one time - How many sites do you typically manage at one time - What systems CTMS or ADC's have you worked with - Which therapeutic area do you feel strongest in as a travelling CRA - What other therapeutic areas would you note as strengths - What phases have you monitored as a travelling CRA - How much risk-based monitoring experience do you have - Have you worked within an FSP model - How many years of on-site monitoring do you have - How many years of specific "Industry" (CRO, Pharma, Biotech) experience do you have You don't need me to tell you that it's tough getting a call back these days. So... The more of these questions you can answer using your resume the better. (P.s You can download my resume template via the comments - it's free) ♻ Do feel free to share with your CRA network #jobseekers #jobsearch #clinicalresearch

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Exciting times in the world of immuno-oncology! 🎉 Kumquat Biosciences and Takeda join forces in a groundbreaking pact with over $1.2 billion at stake. 🤝🔬 This alliance brings together a pioneering biotech and a pharmaceutical giant, spotlighting a promising small molecule inhibitor. As Kumquat completes phase 1 trials, Takeda stands ready to propel development and commercialization to new heights. 💡 The potential here is immense - not just in financial terms with up to $130 million in near-term payments for Kumquat, but in the true value that such medical advancements can bring to cancer treatment. 🌟 A testament to strategic collaborations, this partnership reiterates our collective commitment to innovation in the battle against cancer. 🔍💊 #ImmunoOncology #PharmaPartnerships #Innovation #Takeda #KumquatBiosciences

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The Ongoing Battle Over Tirzepatide: What Does It Mean for Pharma and Compounding Pharmacies? The recent lawsuit by the Outsourcing Facilities Association (OFA) against the FDA marks a pivotal moment for the pharmaceutical and biotech industries. On October 2, 2024, the FDA removed Eli Lilly and Company's tirzepatide (#Mounjaro for diabetes and #Zepbound for weight loss) from its official drug shortages list—setting off significant waves across healthcare providers, patients, and stakeholders. Key Takeaways: - Legal Challenge: The OFA claims the FDA's move was "reckless and arbitrary," arguing the #tirzepatide shortage persists. They accuse the agency of bypassing proper rule-making procedures. - Impact on Compounding Pharmacies: With tirzepatide off the shortages list, large 503B compounding pharmacies can no longer produce the drug. This poses a financial hit and could limit patient access. - Eli Lilly's Position: The FDA maintains that Eli Lilly can meet national demand for tirzepatide. However, some supply issues may persist. Market Dynamics: - Tirzepatide’s Popularity: Known for its effectiveness against diabetes and obesity, tirzepatide's demand continues to soar. - Pricing: Zepbound costs $1,060 per month, while Novo Nordisk's #Wegovy, still in shortage, is priced around $1,350. To make tirzepatide more affordable, Eli Lilly has introduced vials starting at $399. - Corporate Strategy: Both Eli Lilly and Novo Nordisk are fighting back, filing lawsuits against compounding pharmacies and wellness centers distributing unauthorized versions of their drugs. Regulatory Nuances: - 503A vs. 503B Compounders: Under the Drug Quality and Security Act, 503A pharmacies can only compound drugs for specific patients, while 503B facilities can compound during drug shortages. With the shortage lifted, 503B production must cease. Implications: - Patient Access & Affordability: Without compounded versions, patients may face higher costs. - Regulatory Precedents: This lawsuit could reshape the FDA’s authority and set precedents for balancing public health needs with pharmaceutical profits. - Market Competition: Fewer compounding options could reduce competition, potentially impacting prices. This is more than just a legal case—it’s a debate about drug shortages, patient access, and the future of compounding pharmacies. What are your thoughts on this evolving issue? Let’s discuss the implications for healthcare, policy, and innovation. #Pharma #FDA #CompoundingPharmacies #HealthInnovation

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🚀 Biotech Q3 Scorecard: 19 Stock-Moving Events to Watch! 📊 Exciting times ahead in the biotech world! Here are key developments to keep on your radar: Alnylam Pharmaceuticals vutrisiran vs BridgeBio acoramidis for ATTR-CM: ESC presentation in August Novo Nordisk's monlunabant for obesity: Phase 2 results (watch Skye Bioscience Inc. and Corbus, LLC too!) Viridian Therapeutics, Inc.'s VRDN-001 for thyroid eye disease: Phase 3 readout in September Sage Therapeutics' Sage-324 for essential tremor: Mid-stage study results Apellis Pharmaceuticals' Empaveli for kidney diseases: Phase 3 VALIANT study results early Q3 Eli Lilly and Company's bimagrumab for obesity: Phase 2 results mid-year UCB and Biogen's dapirolizumab for lupus: Phase 3 results Neurocrine Biosciences's NBI-1117568 for schizophrenia: Phase 2 results Elevation Oncology's EO-3021 for gastric/pancreatic cancers: Data update Plus: • AstraZeneca's Imfinzi FDA panel (July 25) • Potential approvals for Alzheimer's drugs: Eisai US/Biogen's Leqembi (EU) • Multiple FDA decisions including Gilead Sciences, Regeneron, Syndax Pharmaceuticals, Roche, and Bristol Myers Squibb 🔬 The biotech sector is buzzing with potential breakthroughs. Which company or development are you most excited about? Share your thoughts below! 👇 #Biotech #PharmaTrends #ClinicalTrials #DrugDevelopment

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With #ASCO2024 closing today, what have been the most impressive results that were presented? Certainly, the Phase 2b data that Jazz Pharmaceuticals presented for its bispecific antibody, 𝘇𝗮𝗻𝗶𝗱𝗮𝘁𝗮𝗺𝗮𝗯, in treating HER2-positive 𝗯𝗶𝗹𝗶𝗮𝗿𝘆 𝘁𝗿𝗮𝗰𝘁 𝗰𝗮𝗻𝗰𝗲𝗿 (BTC) has generated a lot of optimism among the audience! In fact, BTC has limited treatment options and a poor prognosis, making these findings particularly significant. 𝗧𝗵𝗲 𝘁𝗿𝗶𝗮𝗹: 👩‍⚕️ The trial included 87 patients with advanced or metastatic BTC who had progressed on prior therapies. Zanidatamab demonstrated a median overall survival (OS) of 15.5 months, a notable improvement compared to the typical 6-9 months observed with standard chemotherapy. Additionally, the objective response rate (ORR) was 41.3%, with 17.4% of patients achieving complete responses (CR). These outcomes are promising, especially considering the aggressive nature of BTC. 𝗧𝗵𝗲 𝘀𝗰𝗶𝗲𝗻𝗰𝗲: 👩‍🔬 Zanidatamab functions by binding to two distinct sites on the HER2 receptor, enhancing its ability to inhibit cancer cell growth and signal the immune system to attack the tumor. This dual mechanism may account for the robust responses seen in the trial. 𝗔𝗽𝗽𝗿𝗼𝘃𝗮𝗹? 🤞 The FDA has granted zanidatamab priority review, with a decision expected later this year. If approved, zanidatamab will be the first HER2-targeted therapy for BTC, potentially transforming the treatment landscape for this challenging cancer. #biologics #clinicaltrials #BTC #biliarytractcancer #oncology https://lnkd.in/eAsjMnGn

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Your TMF isn't just telling you a story - it's SCREAMING insights about your clinical trials. Last week, I helped a sponsor uncover a pattern in their TMF that revealed why 40% of their sites were consistently behind on regulatory submissions. The culprit? Not what anyone expected. Here's the truth: If you're only using your TMF for compliance, you're missing 80% of its value. Your TMF contains critical indicators of: 📊 Site performance trends ⚠️ Early risk indicators 💡 Process bottlenecks ⏱️ Resource optimization opportunities I would LOVE to hear from your experiences. Want to know what your TMF is telling you? I'm one DM away. Happy TMF Tuesday Tip Day!

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🔬 Advancing Precision Oncology in Metastatic RCC New findings highlight the potential of longitudinal ctDNA monitoring as a predictive biomarker for treatment response and progression-free survival in metastatic renal cell carcinoma (RCC). This study demonstrates high concordance between ctDNA dynamics and clinical outcomes, paving the way for more personalized approaches to therapy and surveillance. Discover how these insights could impact the future of RCC management. 📖 Read the full study here: https://lnkd.in/ejQhtz6H #RenalCellCarcinoma #ctDNA #PrecisionMedicine #CancerResearch #OncologyInnovation

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If you work in the life sciences industry, you should know EXACTLY what statistical calculations are doing for the clinical trial. I want to help you understand this at its most basic level: Clinical Trials are tools used to show that a new drug is efficacious and safe. Statistics is the tool within the clinical trial that allows us to make these claims objectively. Specifically, statistics is used in a Proof By Contradiction where we first assume something to be true, and we then use data to show that the assumption we made cannot be true. We are using statistics to answer this question: - If there is no difference between two populations, what this the probability of randomly selecting samples with a difference as large or larger than actually observed? Braking this question out in simple steps: 1. Assume no difference between the two treatment samples 2. Collect data on the two treatment samples 3. Calculate the actual difference between the two treated samples 4. Use statistics to calculate how likely we are to get the result we actually got in step 3 if the assumption in step 1 is true (if there truly was no difference between the two groups - what is the chance we randomly sampled and got the difference we got) 5. If the probability is low enough (meaning there is a very low chance we would have been able to get the result we got if the assumption in step 1 was true) we can reject the assumption made in Step 1 and say there is a difference between the two treatment populations If that is not super clear (I don't blame you), here is a more detailed example: 1. I assume the population I give my drug to and the population I give placebo to will have the same systolic blood pressure result at week 2 of the trial 2. I treat the two populations accordingly and I measure the systolic blood pressure at week 2 and I calculate the average blood pressure at that time 3. My calculations of the average systolic blood pressure at week 2 is DIFFERENT at week 2 4. I USE STATISTICS TO CALCULATE THE PROBABILITY OF GETTING THE RESULT I GOT IN STEP 3 ASSUMING THERE ACTUALLY IS NO DIFFERENCE BETWEEN THE TWO POPULATIONS 5. If the calculated probability (also known as a P Value) in step 4 is less than 5% (typically) I can claim that my assumption in step 1 is NOT TRUE It's step 4 where statistics is applied and I have a course coming out in the near(ish) 😎 future that will break down how you actually do step 4 in concert with all the other steps. Until then, I recommend you check out my website (link in Bio) for a ton of free material around biostatistics, statistical programming, and how these two functions work in the regulated industry of the life sciences. Happy Reading and Happy Tuesday.

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🦠 Breaking News in Viral Surveillance! 🧬 Introducing the Viral Surveillance Panel v2 - your new ally in the fight against emerging diseases! Expand your viral surveillance capabilities with the new Viral Surveillance Panel v2, a cutting-edge NGS-based assay that: • Identifies over 200 high-risk viruses • Supports crucial genomic surveillance • Enhances zoonosis monitoring Ready to level up your viral surveillance game? Learn more at illumina.com/VSP #ViralSurveillance #PublicHealth #NGSTechnology #EmergingDiseases

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𝐅𝐃𝐀 𝐃𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐍𝐞𝐰𝐬! The FDA has granted a priority review for Roche's inavolisib, in combination with fulvestrant and Pfizer’s Ibrance (palbociclib), for treating PIK3CA-mutated, HR-positive, HER2-negative breast cancer. This decision sets a date of 27 November for the FDA to evaluate the therapy. The therapy targets adult patients with locally advanced or metastatic breast cancer, especially those experiencing recurrence within 12 months of adjuvant endocrine treatment. Inavolisib, an oral PI3 kinase inhibitor, disrupts PI3K/Akt/mTOR pathway signaling, crucial for cell growth and survival. It also recently received breakthrough therapy designation. The priority review is based on promising results from the Phase III INAVO120 trial, where the combination therapy showed a progression-free survival of 15 months compared to 7.3 months with the standard fulvestrant and Ibrance regimen. Roche is also pursuing regulatory approval in other regions, including with the European Medicines Agency. More detailed data will be presented at the upcoming ASCO Annual Meeting in Chicago from 31 May to 4 June. in other FDA news, Eli Lilly and Company have secured accelerated approval for Retevmo, their treatment for pediatric cancers. Follow Warman O'Brien for all the latest news in life sciences! #oncology #goodnews #fdaapproval #nextsteps

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Sports as a CRA? When? 🤪🥴 Another simple lifestyle-related aspect to consider for CRAs is training 🏋️ It might sound easy and very straight forward but if you are constantly traveling and on the go, when and how will you realistically find time and space to do sports and keep a healthy lifestyle? 🤔 Some Clinical Research Associates (CRAs) start running, it’s easier to take your running shoes and sports gear anywhere you are, even when traveling. 🏃‍♀️ Others prefer to use the hotel facilities to do some sports but so often, they are very small, have bare minimum equipment and have opening schedule that matches precisely your schedule to be onsite. ⌚️ So, CRAs in our community, how do you ensure you keep a healthy lifestyle while still having a high paced monitoring visits week? Do you want to learn more tips and tricks for CRAs? Join CRAConnect Community where we have daily continuous discussions among CRAs, courses and monthly masterclasses. See you there! Join here 👉 https://lnkd.in/e2XEyhgZ #clinicalresearchassociate #clinicaltrials #clinicalresearch #community #timemanagement

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