The success of a radiopharmaceutical starts with selecting the right radionuclide. But where do you find reliable nuclear decay data? Whether you're working on targeted alpha therapy, PET imaging, SPECT tracers, or dosimetry calculations, having access to evaluated decay data is essential. There are two repositories that every radiopharmaceutical scientist should know: 1️⃣ Evaluated Nuclear Structure Data File (ENSDF) Maintained by the National Nuclear Data Center (Brookhaven National Laboratory) on behalf of the International Nuclear Structure and Decay Data Network. Through NuDat, ENSDF allows you to search, filter, visualize, and compare nuclear structure and decay data for thousands of radionuclides. 2️⃣ Decay Data Evaluation Project (DDEP) Maintained by the Laboratoire National Henri Becquerel. DDEP provides detailed, evaluated decay data sheets as downloadable PDFs, making it an excellent reference when you need comprehensive decay characteristics and recommended values. 📌 Both repositories are worth bookmarking as valuable references for anyone working with radionuclides. Which resource do you find yourself using most: ENSDF/NuDat, DDEP, or another? #Radiopharmaceuticals #NuclearMedicine #TargetedAlphaTherapy #Dosimetry #MedicalPhysics #NuclearPhysics #Radiochemistry
TRACER
Biotechnologisch onderzoek
Groningen, Groningen 4.164 volgers
Accelerating your clinical trial by generating early accurate in-human data on your drug | Molecular imaging
Over ons
At TRACER we are specialized in first-in-human studies with the use of nuclear and optical molecular imaging techniques. By labeling an antibody, small molecule, peptide, nanoparticle, protein, or any other compound of interest with a fluorescent dye or a radionuclide, fast in human data can be obtained with an indication of the potential efficacy of the novel drug, even before the classical phase 1-3 clinical trials. This can lead to a more efficient and less costly drug development process. We assist our sponsors in the labeling of their lead compounds and execute first-in-human studies to visualize and quantify the biodistribution and pharmacokinetics of the compound. With this information a “ go/no-go” decision can be made before the compound proceeds to the next phase in clinical development where costs are larger and time is valuable. Early in-human studies are approved by the EMA and FDA through the so-called principle of microdosing. It allows you to often skip (large) animal models and go straight into the patient population.
- Website
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https://www.tracercro.com
Externe link voor TRACER
- Branche
- Biotechnologisch onderzoek
- Bedrijfsgrootte
- 11 - 50 medewerkers
- Hoofdkantoor
- Groningen, Groningen
- Type
- Particuliere onderneming
- Opgericht
- 2017
- Specialismen
- molecular imaging, nuclear imaging, optical imaging, drug development, clinical trials, microdosing, in-human data, Proof of Concept (PoC) study, Phase I study, Phase II study, Phase III study, clinical development, Fluorescent imaging, Tracers, oncology, Infection diseases, Cardiovascular diseases en Inflammatory diseases
Locaties
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Primair
Routebeschrijving
Aarhusweg 2-1
Groningen, Groningen 9723 JJ, NL
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Routebeschrijving
xx
San Diego, CA 00000, US
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Routebeschrijving
Berg en Dalseweg 63
2nd floor
Nijmegen, Gelderland 6522 BB, NL
Medewerkers van TRACER
Updates
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Should you combine Phase 0 and Phase 1 into a single, adaptive study or run them as separate trials? The answer depends on your drug program, research question, and the strength of your preclinical evidence. In our latest blog, we explore the key considerations, advantages, and trade-offs of adaptive, combined Phase 0/1 designs versus separate Phase 0 and Phase 1 studies. An adaptive trial requires only a single study submission, site initiation, and start-up, which can significantly shorten overall development timelines. However, when combining Phase 0 and Phase 1, the more extensive preclinical requirements needed to initiate a Phase 1 trial apply. In contrast, conducting separate studies allows a Phase 0 trial to begin earlier, as a more limited preclinical package is sufficient. Read the full comparison in the blog: 👉 https://lnkd.in/eiEDvyrz #ClinicalTrials #DrugDevelopment #Phase0 #Phase1 #AdaptiveDesign #ClinicalResearch
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Why include an interim analysis when using nuclear imaging in clinical trials? Nuclear imaging techniques such as PET and SPECT provide insights that other analytical methods cannot. Most importantly, with PET and SPECT it is possible to visualize and quantify biodistribution and target engagement over time. But nuclear imaging also adds complexity and cost: - more scans; - more visits to the clinic; - higher participant burden; - higher costs. That’s why an interim analysis can be so valuable in early-phase trial design. By reviewing imaging data after a predefined number of participants, you can optimize the study while it is ongoing. This may allow you to: - reduce the number of scans by identifying the optimal imaging time point; - adjust radioactive dose levels based on image quality; - decrease participant burden and radiation exposure; - improve recruitment and retention. Nuclear imaging generates both visual and quantitative longitudinal data. With multiple scans, researchers can: - assess biodistribution over time; - calculate volume of distribution at different timepoints; - perform dosimetry calculations. An interim analysis helps determine which measurements still add value and which may no longer be necessary. In adaptive Phase 0 trial designs, the benefits can go even further. For example, a study may initially enroll patients across multiple tumor types. Based on interim results, you may decide to: - continue enrollment for specific indications; - stop less promising cohorts; - open new cohorts. If these adaptations are predefined in the protocol, they can often be implemented without a protocol amendment, improving both efficiency and timelines. There are many opportunities to make early-phase imaging trials smarter and more patient-friendly. At TRACER, we’re always happy to discuss possibilities. #DrugDevelopment #DrugDiscovery #ClinicalTrials #NuclearImaging #PET #SPECT
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How do biotech companies create “multiple shots on goal”? A comparison of platform-based biotech companies vs companies with a single asset. The World Cup final is this weekend, and to get you in the spirit, we're going to take a look at how biotech can create multiple scoring opportunities for itself. Platform-based companies have a core technology that gives them the ability to generate multiple assets from their system or technology. This offers them flexibility and diversification compared to non-platform-based companies. However, do the flexibility and diversification lead to better outcomes? Read it in our latest article, here on LinkedIn. #biotech #drugdiscovery #drugdevelopment
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Astatine production in Europe is about to expand... Astatine-211 is a promising radioisotope for targeted alpha therapy, but, as with many promising radionuclides, production capabilities are a limiting factor in development and eventual clinical practice. With expansion in production facilities in Europe, this bottleneck may gradually ease over the coming years. At-211 is primarily produced in medium-energy accelerators (cyclotrons or linear particle accelerators (LINACs)). According to the February 2026 review (10.1186/s41181-026-00428-0), cited in the image, three facilities in the EU currently perform routine At-211 production (marked in green). 📍 Denmark, Copenhagen University Hospital - Scanditronix MC 32 cyclotron - Maximum capacity of ca. 3 GBq at end of bombardment (EOB) per production - 5 productions per week 📍France, Nantes, Arronax - IBA Cyclone® 70 cyclotron - Maximum capacity of ca. 2 GBq EOB per production - 1 production per week 📍Germany, Jülich - IBA C30XP cyclotron - Maximum production capacity of ca. 5.6 GBq EOB per production - 3–4 productions per week With a half-life of 7.2 hours, it typically limits distribution to a 300-450 kilometres radius, represented in the image by the circles around the sites, depending on transport logistics and processing time. So, it's good news that several additional production sites are under development or expected to become operational in the coming years, including: 📍 Poland, Warsaw 📍 Czechia, Rez 📍 United Kingdom, Birmingham 📍 Finland, Jyväskylä But that's not all. New accelerators specifically for At-211 are on their way. Such dedicated At-211 cyclotrons can provide a production capacity of 500 GBq/week. The review discusses future dedicated LINAC concepts with projected annual production capacities approaching 10⁶ GBq EOB annually. Production capacity is only one part of the equation. In the Netherlands, UMC Utrecht has installed an Atley C100 platform. The system does not produce At-211 itself, but is used for purification and subsequent radiopharmaceutical synthesis, supporting clinical translation of At-211-based therapies. Are you aware of additional At-211 production initiatives or facilities not shown here? Feel free to share with the community in the comments. #Astatine211 #At211 #Radiopharmaceuticals #Radiopharma #Cyclotron
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Have you worked with iLINCS? iLINCS is a web-based platform for the analysis of omics data and cellular perturbation signatures, making it a valuable resource for drug discovery and drug repurposing. One of the key questions in systems biology is: What happens to gene and protein expression when a cell transitions from a healthy to a diseased state? By analysing transcriptomic and proteomic signatures, researchers can gain insights into disease mechanisms and identify compounds that may reverse disease-associated changes. This is where LINCS and iLINCS come in. The Library of Integrated Network-Based Cellular Signatures (LINCS) is an NIH-funded consortium that generated large-scale datasets describing how cells respond to perturbations such as drugs, gene knockdowns, and gene overexpression. iLINCS (integrative LINCS) is a platform that integrates LINCS signatures with other public omics datasets and provides tools to analyse, compare, and interpret them. LINCS Consortium --> Generates perturbation data LINCS signatures --> Capture cellular responses iLINCS --> Analyse, search, compare, and interpret signatures Using the iLINCS web interface, researchers can: - Upload a disease gene-expression signature - Compare it against LINCS drug signatures - Identify compounds producing opposite signatures - Explore pathways and potential therapeutic targets This signature-based approach can support both novel drug discovery and drug repositioning by linking cellular perturbations to phenotypic outcomes and potential therapeutic interventions. Have you used iLINCS or LINCS in your research? What has been your experience, or, if not, do you think it’s worth trying? #DrugDiscovery #DrugDevelopment #Bioinformatics #SystemsBiology #Omics #Transcriptomics #Proteomics #DrugRepurposing #LINCS #iLINCS
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Do you know The Virtual Brain? The Virtual Brain (TVB) is an open-source neuroscience simulation platform that creates personalized whole-brain models based on real subject data. By reproducing communication pathways in TVB, researchers can explore pathological changes, investigate disease mechanisms, and evaluate potential interventions in a virtual environment. What makes it particularly interesting is its versatility. The platform has applications across multiple neurological and psychiatric conditions, including: - Epilepsy - Stroke - Multiple sclerosis (MS) - Dementia - Schizophrenia Unlike models that focus on isolated regions, TVB enables researchers to study the brain as an interconnected network. TVB assists in the identification of crucial points involved in disease and recovery processes and can serve as a tool in clinical trials. And perhaps one of the most powerful aspects: it’s free to use. The broader the adoption, the more advanced and valuable the ecosystem becomes for both research and innovation. A fascinating example of how computational neuroscience and real-world clinical data can converge to deepen our understanding of the brain. #Neuroscience #DigitalHealth #BrainResearch #ComputationalNeuroscience #AIinHealthcare #Neuroinformatics
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Radiopharmacy is a rapidly evolving field, and events such as the workshop organized by the Dutch Society for Clinical Radiochemistry (NKRV) contribute to this advancement. When experts from different disciplines come together, valuable discussions are guaranteed. Here are some of the key topics from the lectures and workshop we attended: - The morning lecture focused on Astatine-211 and its future clinical evaluation for targeted alpha therapy at UMC Utrecht. - Development of tracers to predict treatment response for (lung) cancer, which may also benefit the research we conduct for our sponsors at TRACER. During the breakout sessions, we joined the roundtable on dosimetry and personalized medicine. A key discussion centered on balancing patient burden (additional imaging) with optimizing treatment dosing. For example, what should be done when dosimetry reveals low tumor uptake while organ uptake remains well below acceptable limits? Research increasingly shows that optimizing treatment schemes can lead to longer progression-free survival. Another important topic was how dosimetry findings influence drug development. If a new radiopharmaceutical demonstrates insufficient target uptake or excessive accumulation in critical organs, simply adjusting the dose may not be enough. In some cases, the compound itself—or its chelator or linker—may need to be redesigned. From our perspective as a CRO, we contributed practical insights into what these findings mean for development programs. Optimizing a treatment strategy can require protocol amendments, extended timelines, and increased development costs—or, in the worst-case scenario, a return to the preclinical stage. It’s at events like these that you really realize just how essential the collaboration between clinicians, researchers, and development partners is. #DutchSocietyforClinicalRadiochemistry #NKRV #Radiopharmacy #Radiopharma
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PET is not just an imaging modality, but a translational tool across the entire drug development pipeline. From preclinical development to clinical trials, PET offers in-vivo visual, quantitative, and longitudinal insights through repeated imaging at multiple time points. Unlike many endpoint assays, PET enables assessment of biological activity in the same subject over time, allowing developers to monitor target engagement, pharmacodynamic response, and treatment effects dynamically. PET can be used in two main settings: by labeling the investigational new drug (IND) with a radionuclide, or by using an unlabeled IND combined with an existing tracer that binds to the same target. When the IND is radiolabeled, whole-body biodistribution can be visualized and uptake in target organs, tissues, and off-target sites quantified. With an unlabeled drug, whole-body biodistribution cannot be visualized directly. However, target engagement and receptor occupancy can still be quantified through competitive binding with a targeted PET tracer. For drug developers, understanding which PET methodologies are most informative at different stages of development is increasingly important. Especially in a multi-omics approach, where functional PET data can be integrated with other molecular methods to provide a more complete understanding of the compound, the indication, and the relationship between the two. #PETimaging #DrugDevelopment #NuclearMedicine #DrugDiscovery
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This month, our CEO, Go van Dam, gave a presentation at the NIH in Washington, DC, discussing the growing potential of photoimmunotherapy. Near-infrared probes are used clinically in many diagnostic and research applications, and for therapeutic use, there is an increasing body of preclinical evidence and clinical data. As with many promising therapies, translation from the preclinical stage to clinical, in-human applications comes with challenges. For photoimmunotherapy, standardization and dosimetry remain important areas of focus. At the same time, recent approvals in Japan mark an important milestone. As clinical experience grows, expansion into additional indications, such as glioblastoma, may follow in the coming years. Based on our long-standing experience and expertise in imaging and clinical translation, this is a topic that has our interest. We look forward to working with scientists in this field. #Photoimmunotherapy #Immunotherapy #NIH #TranslationalResearch #MedicalImaging
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