Denise (DeeDee) DeMan

Drug Safety is one of the highest-stakes leadership hires a growing biotech will make. As programs advance and regulatory complexity increases, this role requires far more than pharmacovigilance expertise. It takes strategic leadership, strong cross-functional partnership, regulatory depth, and the ability to scale systems without ever losing sight of patient safety. We recently partnered with an innovative San Diego–based clinical-stage biotech to help secure this critical leader. The process was highly collaborative, with clear alignment on culture, stage, and long-term vision — exactly what it takes to get leadership hires right. Grateful for the trust. If you’re building or strengthening leadership across Drug Safety, Clinical, Regulatory, or Quality, let’s connect Thorough Group Sean Burroughs Michael Buckley Hari Dhurjaty Chad MacDonald Raquel Marquez

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Bioscience Wins: Clean Culture, Brain Health, Microbiome & tRNA Triumphs Here’s a sharp roundup of today’s top bioscience breakthroughs: 🔹Nu-Tek BioSciences is making waves with animal-free cell media at the BIO Convention. 🔹MBX Biosciences, Inc. brings precision peptide data to the ADA Scientific Sessions for post-bariatric hypoglycemia. 🔹Enveric Biosciences, Inc. new patent paves the way for non-hallucinogenic psychiatric drugs. 🔹32 Biosciences "Three Squared" secures $6M in funding to drive gut microbiome diagnostics and therapy forward. 🔹Tevard Biosciences appoints a powerhouse CSO to push tRNA-based therapies toward the clinic. Huge congrats to these teams fueling progress across cell therapy, metabolic disease, mental health, microbiome innovation, and genetic medicines. The future of bioscience is brighter because of your work! #Bioscience #Biotech #Innovation #CellCulture #Neuroscience #Microbiome #tRNA #DrugDevelopment #HealthTech

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Large firms bring scale. Boutique firms bring signal. In life sciences recruiting, nuance matters: • Regulatory pathway experience • Modality expertise • Phase-specific leadership • Scientific credibility We don’t just scan resumes, we understand pipelines, platforms, and pressure points. In highly specialized markets, precision beats volume. #precision #lifesciences

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🔥 iPSC Therapies: Is the "Off-the-Shelf" Revolution here?? And if it is, 𝘄𝗵𝗼 𝘄𝗶𝗹𝗹 𝗟𝗘𝗔𝗗 𝗶𝘁? The momentum is undeniable. Q4 2024 - H1 2025 delivered pivotal moments: 🧬 Fate Therapeutics Inc. nabbed FDA RMAT for iPSC CAR-T in Lupus (SLE) (Apr '25) - a landmark beyond oncology! Also pushing FT522 (CAR-NK) & FT825 (CAR-T) in trials. 🧠 BlueRock Therapeutics (Bayer) advancing its iPSC-neuron therapy (bemdaneprocel) for Parkinson's to Phase 3 (H1 '25 initiation expected)! Plus, OpCT-001 (iPSC-photoreceptors) IND cleared with FDA Fast Track (Feb '25). ❤️ Heartseed Inc. (partnered with Novo Nordisk) completed Ph1/2 enrollment for its iPSC-cardiomyocytes (HS-001) in heart failure in Japan (Feb '25). 💰 Kenai Therapeutics, backed by a key $82M Series A (Feb '24), advances its iPSC-dopamine progenitors for Parkinson's. 📈 Century Therapeutics, Inc launched Ph1 of CNTY-101 (iPSC-iNK) in autoimmune diseases (CALiPSO-1 trial ongoing, data expected 2025). 👁️ Cynata Therapeutics: Ph3 for iPSC-MSCs (CYP-004) in osteoarthritis ongoing (results expected 1H '26); Ph2 for GvHD (CYP-001) also progressing (results late '25). 🔬 Aspen Neuroscience, Inc.: Ph1/2a for autologous iPSC-neurons (ANPD001) in Parkinson's active, with positive 6-month data from first patients (May '25). And many more in the pipeline: Shinobi Therapeutics, Cytovia Therapeutics, Shoreline Biosciences, Inc., Vita Therapeutics, Clade Therapeutics, Avery Therapeutics, Inc., CellOrigin Biotech, Editas Medicine, Cellistic all driving iPSC innovation! The ecosystem is also maturing with specialized CDMOs & platforms (I'll do a separate round-of of those in a post shortly!) 🏭 and these are KEY to enabling GMP iPSC production. This overall growth of activity creates a critical challenge: 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘇𝗲𝗱 𝗶𝗣𝗦𝗖 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽 𝗶𝘀 𝗦𝗖𝗔𝗥𝗖𝗘. Translating iPSC science into scalable, GMP-compliant "living drugs" needs leaders who GET: ✅ Complex iPSC differentiation at scale. ✅ Novel regulatory pathways for these unique products ✅ Industrializing diverse iPSC workflows (for CDMOs), ✅ Pioneering clinical trials in new autoimmune/neuro indications. The race is on, not just for clinical data, but for the TALENT to deliver these therapies. Understanding the iPSC leadership landscape is now business-critical. 📌 I've analyzed the key players, recent breakthroughs, and specific talent bottlenecks (for both developers & CDMOs!) in a dedicated section of my CGT Talent Report 2025: Focus on iPSC Therapies. If you're building, investing in, or leading an iPSC-focused organization and need to understand the talent dynamics shaping this field: ➡️ Drop a comment or DM me "iPSC Report" for a confidential copy. What's the #1 leadership role iPSC companies are struggling to fill right now? 👇 #iPSC #CellTherapy #BiotechLeadership #CMC #GMP #StemCells #DrugDevelopment

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NAYA Therapeutics Partners With IONETIX to Build a US Production & Supply Network for Astatine-211 Targeted Alpha Therapies We're thrilled to partner with the wonderful team at Ionetix and their proven isotope production expertise in our quest to unlock broad patient access to astatine-211 targeted alpha therapies, which show great potential to address challenges in residual & metastatic cancer. Read more about the partnership here: https://lnkd.in/gGYzauCP David Eve Thuy A. Tran Milton Lönnroth Manmeet Ahluwalia, MD, MBA, FASCO Ely Benaim Rahul Singhvi Rachit N. Pascal Touchon Marc-Olivier Turgeon Olivier Madar 🎗️ 🧡 Amy Liu C. Ola Landgren, M.D., Ph.D. Stephen Nimer Aman Singh Chauhan Prakash Raman Laurent F. Chemla Romain Afflelou Eric de La Fortelle Etienne Gillard Eugenio Briales Gomez-Tarragona SABELA RINCON VAZQUEZ Corine Busson-Benhammou Henry Gazay Edouard Cukierman Laurent Audoly Laurent Choppe Melissa Fensterstock Thomas Horn Iman Ghavami Luc Dochez Josh Sharan Vidisha Mohad Lyn Falconio Raquel Cabo David Setboun, Pharm.D., MBA Yutian Feng Chris Nowers Magdalena Leszczyniecka, PhD MBA C. Ola Landgren, M.D., Ph.D. #astatine211 #211at #targetedalphatherapy #radiopharmaceuticals #gpc3 #hepatocellularcarcinoma #hcc

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🔬 New Service Launch: Contractor (Dispatched) Talent Solutions for Cell & Gene Therapy and Regenerative Medicine Greenstaff Life Sciences is proud to introduce a new service offering: specialized contractor (dispatched) talent solutions focused exclusively on the Cell & Gene Therapy (CGT) and Regenerative Medicine sectors. We provide experienced, project-ready professionals on a contract (dispatched) basis across key functional areas: • CMC (Chemistry, Manufacturing & Controls) • Translational Research • Regulatory Affairs / Quality (QA/QC) • Business Development (BD) This solution enables biotech startups, academia, and VC-backed ventures to flexibly secure high-caliber talent throughout the development lifecycle—from discovery to clinical launch and beyond. ⸻ ✅ Benefits for Global Biotech and Pharma Clients • Best-in-Class Talent in Frontier Modalities Access contractors with real-world expertise in AAV, CAR-T, mRNA, iPSCs, exosomes, and other emerging platforms. • Flexible, Scalable Deployment Adjust quickly to changing priorities, financing milestones, or pipeline pivots—whether for short-term projects or long-term strategic functions. • Seamless Adaptability to R&D Shifts Easily transition contractor resources based on changes in research focus or program direction. • CapEx-Friendly Cost Structure In many cases, contractor (dispatched) labor can be classified as Capital Expenditure (CapEx), allowing for strategic R&D investment while minimizing fixed Operating Expenses (OpEx). • Support for Globalization Deploy bilingual (JP/EN) contractors to assist with global clinical development, Japanese market entry, or cross-border partnerships. ⸻ 🧪 Use Cases for Contractor (Dispatched) Talent 🔹 CMC & Regulatory • CMC Program Managers for IND-enabling projects • Tech Transfer Engineers coordinating with CDMOs • QA/QC professionals familiar with GMP, ISO13485, and regulatory filings 🔹 Research & Translational Support • Cell Culture Specialists (CAR-T, iPSC, AAV, etc.) • Research Technicians & Lab Assistants for team expansion • Pharmacology Contractors (in vivo / in vitro) for preclinical studies 🔹 Business Development & Clinical Operations • BD Contractors for licensing, alliance management, and partnering • Clinical Planners to support protocol design and trial readiness ⸻ At Greenstaff Life Sciences, we enable scientific progress through people. By connecting exceptional talent with innovative biotech organizations, we help accelerate therapies and bring science closer to patients worldwide. ⸻ #CGT #RegenerativeMedicine #ContractTalent #DispatchedProfessionals #CMC #TranslationalResearch #CapExStrategy #BiotechInnovation #AdvancedTherapies

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Check out our latest article by Katie Leath, which explores the trend of early-stage biotechs looking beyond U.S. Borders to launch cost-effective clinical trials. Read more: https://ow.ly/pIx050W6Wba #clinicaltrials #clinicaloperations #clinicaldevelopment #lifesciences #biotech #pharma #prestigescientific

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