Doug Lytle, PhD, MBA, JD

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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From #labcentral to #kendallsquare, nothing beats a day of client visits in the heart of #Boston #biotech Meeting people face-to-face puts it in perspective for me: >>>This market has challenged both clients and candidates. >>>Control your controllables: Patience (with yourself & others), discipline & diligence, and a positive attitude. >>>Great science 🔬 is driven by great 👩‍🔬 people 👨‍🔬. Always do your best & success will follow. Comment below with your own thoughts:👇

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🎉 Big News from NeoGenomics Laboratories! 🧬💡 NeoGenomics just secured New York State Department of Health approval for its Neo Comprehensive and NeoType DNA & RNA Lung NGS tests! 🎯 These advanced tests are now available to oncologists in New York, aiming to enhance diagnostic precision and cost-effectiveness for cancer treatment. The Neo Comprehensive panel covers 517 genes across multiple tumors, while NeoType focuses on actionable mutations in lung cancer. #CancerResearch #NGSTesting #LungCancer #PrecisionOncology #NeoGenomics #InnovationInHealthcare #Genomics #PersonalizedMedicine

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🚨 Pfizer & Flagship Pioneering Expand Their Billion-Dollar Collaboration! 🚨 Pfizer and Flagship are doubling down on obesity and lung cancer with innovative partnerships: 💡 Ampersand Biomedicines: Leveraging their AND platform to target metabolic pathways for obesity treatment. 💡 Montai Therapeutics: Using computational tools to decode biological pathways and develop precision small molecules for lung cancer. This marks the 3rd & 4th partnerships under their 10-program pact, showcasing a new Innovation Supply Chain in biopharma. #Biotech #Collaboration #Innovation #Pfizer #FlagshipPioneering #Healthcare

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I and other members of the Science 37 team will be in Philly for CRAACO: Clinical Research as a Care Option, Mobile in Clinical Trials, and DPHARM: Disruptive Innovations to Modernize Clinical Research the week of 15 September. Let's connect to discuss doing what we do, not because it's easy but because it's the right thing to do to advance access to life changing therapies! #decentralizedtrials #patientcentric #patientaccess

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Big news in lung cancer treatment! A new drug called ivonescimab from China appears to be effective against non-small cell lung cancer (NSCLC) 🇨🇳 This bispecific antibody is the first to outperform Keytruda, the current market leader, in a head-to-head trial #NSCLC #Keytruda Here's the breakdown: -Ivoncimab significantly extended progression-free survival (PFS) in patients compared to Keytruda -Experts are interested to see if this translates to an overall survival benefit, which is crucial for FDA approval #FDA -MSD , maker of Keytruda, acknowledges the potential of ivonescimab but highlights the need for more data #drugdevelopment The challenge? Ivoncimab was only tested in China, and the FDA may require additional trials for US approval #clinicaltrials This is a significant development in lung cancer treatment, and it will be interesting to see how it unfolds. Stay tuned for further updates! #cancerresearch #innovation

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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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Do you have the right people to get FDA approved? After having a conversation with someone who has worked on the other side of the fence, they identified that the small businesses in biotech who are filing for approval have a common theme attached. The majority seem to lack regulatory experience and do not have someone on board who has a deep enough understanding or exposure to the full A-Z lifecycle. Larger companies seem to have much more experienced staff and resources to assist in the filing, making the approval smoother and more seamless. (Cash and Man Power) They went on to say "The nuances of regulation is hard. The scope of therapeutics has become so broad and so quick, its hard to move things in the right direction with minimal man power." The lack of experience in the smaller biotechs, even though there is a tonne of guidance is costly and time consuming - Having someone on your side who is well versed in navigating these waters is priceless! Getting too caught up in the early development has shown to be the reason the outcome has not been what they imagined. 𝗙𝗿𝗼𝗺 𝘁𝗵𝗶𝘀 𝗰𝗼𝗻𝘃𝗲𝗿𝘀𝗮𝘁𝗶𝗼𝗻, 𝘁𝘄𝗼 𝗸𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀 𝘄𝗲𝗿𝗲: Thinking 12-18 months ahead is not enough. Think Bigger and quicker! Systems and processes should be setup from the start, not when you start to require them Having someone on your side, who has many successful programs/projects under their belt is a price worth paying - if you think they are expensive, the cost of clinical holds are higher! #MasonHarding #Biotech #RegulatoryAffairs #MedicalAffairs #FDA

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Do you have the right people to get FDA approved? After having a conversation with someone who has worked on the other side of the fence, they identified that the small businesses in biotech who are filing for approval have a common theme attached. The majority seem to lack regulatory experience and do not have someone on board who has a deep enough understanding or exposure to the full A-Z lifecycle. Larger companies seem to have much more experienced staff and resources to assist in the filing, making the approval smoother and more seamless. (Cash and Man Power) They went on to say "The nuances of regulation is hard. The scope of therapeutics has become so broad and so quick, its hard to move things in the right direction with minimal man power." The lack of experience in the smaller biotechs, even though there is a tonne of guidance is costly and time consuming - Having someone on your side who is well versed in navigating these waters is priceless! Getting too caught up in the early development has shown to be the reason the outcome has not been what they imagined. 𝗙𝗿𝗼𝗺 𝘁𝗵𝗶𝘀 𝗰𝗼𝗻𝘃𝗲𝗿𝘀𝗮𝘁𝗶𝗼𝗻, 𝘁𝘄𝗼 𝗸𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀 𝘄𝗲𝗿𝗲: Thinking 12-18 months ahead is not enough. Think Bigger and quicker! Systems and processes should be setup from the start, not when you start to require them Having someone on your side, who has many successful programs/projects under their belt is a price worth paying - if you think they are expensive, the cost of clinical holds are higher! #MasonHarding #Biotech #RegulatoryAffairs #MedicalAffairs #FDA

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💊 Amgen's Monthly Obesity Drug, MariTide: Phase 2 Results Are In! 🌟 Amgen has unveiled phase 2 data for MariTide, its innovative monthly obesity treatment. While the results show promising weight loss efficacy, investors remain cautious. Here's a snapshot: ✅ Efficacy Highlights: 20% average weight loss over 52 weeks at the 280-mg dose for individuals without type 2 diabetes. 17% weight loss in participants with type 2 diabetes. No weight loss plateau observed, suggesting potential for continued reductions beyond a year. ✅ Why It Stands Out: Monthly or less frequent dosing vs. weekly options like Eli Lilly’s Zepbound or Novo Nordisk’s Wegovy. Clinically meaningful cardiometabolic improvements (e.g., blood pressure, triglycerides, C-reactive protein). Minimal side effects, with nausea/vomiting being transient and mild, and no changes in bone mineral density reported. 🤔 The Investor Perspective: Analysts see results as “on par” with Zepbound, but differentiation is limited to dosing frequency. Shares fell 10% after the announcement, reflecting the need for stronger competitive advantages. 🚀 What’s Next: Amgen is advancing to phase 3 trials under the MARITIME program, aiming to explore obesity and related conditions further. With progressive weight loss, improved HbA1C, and patient-friendly dosing, MariTide could still emerge as a compelling option in the growing obesity treatment market. 💬 What do you think about the potential of monthly dosing as a game-changer in obesity treatment? #PharmaInnovation #ObesityTreatment #Amgen #ClinicalTrials #WeightLoss #GLP1 #HealthcareTransformation

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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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80% of Massachusetts Bioscience graduates are being pulled into careers outside of Life Sciences! This years headlines have been dominated by layoffs, but whilst the industry continues to recover and companies begin to hire again, the demand for talent will only increase. MassBioEd CEO, Sunny Schwartz claims “Some of them may be thinking that the only option is med school". As a Biochemistry graduate who went from an MSc, straight into a career of Life Science recruitment, with the main reason being I had no idea what else was out there! Nine years on, I can safely say I made a great choice, but had I known what else was out there, maybe I would've taken a different path? How can we go about increasing the awareness of the fantastic careers that Biotech can offer for our next generation of graduates? #Biotech #lifesciences #MassBioEd

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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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🌟 Promising New Data for Monthly MASH Treatment! 🌟 Boston Pharmaceuticals’ Phase II readout shows strong results for efimosfermin alfa, its once-monthly injection for metabolic dysfunction-associated steatohepatitis (MASH). This FGF21 analog demonstrated significant fibrosis improvements and MASH resolution rates, while offering a more convenient schedule than weekly treatments. With a low side-effect profile and high patient tolerance, efimosfermin alfa could shape the future of MASH treatment. 🧬💉 #BostonPharma #MASH #FibrosisTreatment #ClinicalTrials #InnovationInHealth #FGF21 #MonthlyDosing

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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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Aviceda Therapeutics has raised $207 million in a Series C funding round, aimed at advancing its drug for geographic atrophy through Phase 3 clinical trials. This huge investment underscores the growing interest and potential in therapies targeting age-related macular degeneration. #Biotech #Funding #Quality #SeriesC #GxP

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A big thank you to HBA NY Tri-State region's Central NJ chapter and Sanofi for hosting an exceptional event on market access in the pharmaceutical industry. The panel did an outstanding job educating attendees on the crucial role market access plays within pharma organizations. 📝 Key takeaways⭐️: 📓Commit to learning: If you're considering market access as part of your career path, don't just dip your toes in. Dedicate 2-3 or more years or more to truly understand the field's complexities. ❓Cultivate curiosity: Success in market access hinges on asking the right questions. Develop a mindset of continuous inquiry to excel in this role. 🏃‍♂️‍➡️Stay adaptable: The market access landscape evolves rapidly. Be prepared to keep learning and adjusting your strategies as the field changes. This event reinforced the importance of market access in shaping the future of pharmaceutical companies and patient care. Negelle Morris Nazanin Mehin Olivier Bogillot Garrett Ingram Lalitha P. Chandrashekhar #MarketAccess #Pharma #ProfessionalDevelopment #HBACentralNJ #Sanofi

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