In Precision Medicine, biomarker identification is essential to revolutionizing how we diagnose and treat patients. In the fiercely competitive drug development arena, comprehending your compound’s mechanism of action, showcasing target engagement, and pinpointing biomarkers are more crucial than ever. These endeavours pave the way for confidently entering the market with a therapy tailored to the precise patient population.
At AcelaBio, we amalgamate leading clinical and scientific leadership with state-of-the-art translational technologies, expediting any drug development initiative. Our adept team collaborates with biotechnology and pharmaceutical companies, furnishing expertise and project oversight across the entire drug development trajectory. From strategic planning of biomarker approaches to seamless integration of sample collection and exhaustive data analysis, we work together to unravel insights into your compound’s pharmacokinetics and pharmacodynamics.
Our objective is delivering unparalleled-quality precision medicine services, and empowering informed decisions.
Service Areas
Project Oversite And Delivery
Our accomplished team, comprising Ph.D. scientists and seasoned project managers, excels in executing precision medicine strategies within clinical trials. We offer comprehensive project management and vendor supervision with meticulous attention to detail, employing standardized workflows and validated systems that adhere to industry norms and excellence benchmarks.
Your study remains our foremost focus, and we commit to consistently delivering updates to uphold punctual deliverables. Our streamlined communication channels ensure a seamless process from project initiation to completion, guaranteeing transparency and efficiency every step of the way.
Biomarker Consulting
Whether you seek protocol insights, have specific inquiries, or require a comprehensive biomarker development plan, our tailored biomarker consulting services deliver professional guidance at every stage of clinical development. Backed by a team of seasoned Translational Scientists, we collaborate with you to curate an optimal panel of biomarkers and methodologies. These tools are instrumental in elucidating mechanisms of action, validating target engagement, and assessing the efficacy and safety of your therapeutic agent.
Entrusting your decision-making process to our Precision Medicine team streamlines your path forward. We prioritize understanding your Precision Medicine queries, offering expert guidance rooted in our extensive expertise. Our diverse experience empowers us to explore inventive and personalized solutions tailored to your compound, clinical program, or study objectives.
Digital Image Analysis
Leveraging cutting-edge AI and deep learning methodologies in digital image analysis (DIA), we tackle intricate scientific inquiries by quantifying tissue biomarkers within entire tissue sections or designated regions of interest. Our adept team of DIA-trained scientists collaborates seamlessly with board-certified pathologists, ensuring the resilience of your project across all phases, from inception to data interpretation. Whether you opt for our pre-validated algorithm repertoire or require tailored AI algorithm development, we guarantee streamlined high-throughput analysis, yielding consistently reproducible and top-tier results.
Precision
Quantitative analysis is performed across the entire tissue section, within designated regions of interest, and/or specific tissue compartments. Results are expressed through variables such as the proportion of positive cells, density of positive cells, and staining intensity.
Reproducibility
Algorithms are securely locked down to ensure consistent analysis throughout.
Automated quantitative analysis maintains consistency across all slides from the beginning to the end of batch processing.
Standardized, Efficient Workflows
Expert pathologists contribute to the input, review, and approve method development.
We maintain comprehensive quality control of images and results from start to finish.
High-throughput analysis of images without any constraints on the quantity of images processed.
Standardized, Efficient Workflows
DIA algorithms can be developed for image analysis of:
- Immunohistochemistry assay (brightfield)
- Immunofluorescence assay
- Multiplex staining
- Tissue Microarrays
Bioinformatics And Data Analysis
AcelaBio prioritizes robust experimental design as the foundation of effective data analysis. From project initiation, we engage with our clients to delineate scientific queries or project objectives, such as validating predictive or pharmacodynamic biomarkers, elucidating mechanisms of action, or optimizing drug dosage.
Our assistance extends to defining crucial parameters, including sample types, subject numbers, controls, and downstream analysis plans, which are essential for addressing these questions comprehensively within clinical trial design.
We employ cutting-edge bioinformatics and statistical techniques to quantify disparities in genes, proteins, or other measured molecules derived from your experiment during the analysis phase. Moreover, we offer advanced bioinformatic analyses that transcend individual genes, delving into pathway-level assessments to unveil underlying processes and pathways, providing deeper insights into mechanisms of action.
Through data integration, whether it involves correlating with clinical endpoints or establishing links between markers in various assays, we offer enhanced mechanistic understanding to support your data-driven decision-making process. We collaborate closely with you to deliver data in formats tailored for publication, presentation, or further exploration, adapting to your preferences.
Translational Research And Lab Services
Acknowledging the critical role of optimized and validated methods in exploring research questions during drug development, we collaborate closely with you to establish customizable solutions. We assist in identifying biomarkers and profiling the molecular landscape pertinent to your compound and target indication, ensuring sample quality and integrity throughout the process.
Precision Medicine lies at the heart of our approach, where we amalgamate expertise with state-of-the-art translational technologies to expedite your drug development endeavours. Through techniques such as immunohistochemistry, RNA sequencing, assay development, transcriptomics, and flow cytometry, we facilitate biomarker discovery to advance toward more precise diagnostic and treatment modalities, thereby enhancing patient care.
We prioritize delivering high-quality data, empowering you to make well-informed decisions swiftly. Our Precision Medicine team collaborates with you to identify the most suitable technology and offers customizable solutions tailored to your project’s needs. We provide comprehensive research solutions, including biomarker strategy planning, custom translational assay development, digital imaging method validation, proof of concept studies, and real-world investigations.
Partnering with our experienced Precision Medicine specialists ensures meticulous attention to detail at every stage, facilitating the optimization and validation of methods crucial for advancing your drug development program.
Clinical Pharmacology
Defining the nuances behind patients’ diverse responses to therapies is paramount for ensuring the delivery of safe and efficient treatments. Our specialized services offer invaluable insights into fundamental inquiries concerning the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of various therapeutic agents, encompassing both small molecules and large molecules (biologics). Our expertise extends to tailoring clinical pharmacology strategies across all phases of drug development. From constructing population PK and PK-PD models to conducting dose simulations and creating predictive dosing tools, we are adept at crafting customizable approaches to facilitate precision medicine, enabling the precise administration of the appropriate treatment to each patient precisely when needed.
AcelaBio works closely with its sister company, Alimentiv, to offer comprehensive Precision Medicine services to its clients.
About Alimentiv Inc.
Alimentiv is a global gastroenterology-focused contract research organization (CRO) providing clinical trials, central image management, precision medicine, and real-world evidence services to the pharmaceutical and biotechnology industries. Headquartered in London, Ontario, Alimentiv employs more than 500 people across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America. The organization’s unique model combines the efforts of internationally recognized academic researchers and operational experts to offer integrated solutions to customers. Over the past 20 years, Alimentiv has become a recognized expert in clinical trial design, central image management solutions, outcome measure development, and precision medicine for drug development in GI. Today, Alimentiv provides services in more than 50 countries worldwide, collaborates with leading universities and academic institutions across the globe, and works with many leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients. Alimentiv is committed to investment in medical research and development, focusing on identifying barriers to drug development and pursuing solutions that advance GI research. The research findings are operationalized into an efficient clinical trial methodology for clients that aligns with emerging regulatory standards. In collaboration with leading experts, Alimentiv has pioneered the development, validation, and standardization of outcome measures and technology, shaping the evolving clinical trial landscape for multiple indications and providing meaningful long-term consequences for patients, their treatment, and society. For more information, visit: alimentiv.com
