• About
    • About Biorasi
      • Meet Biorasi

        Biorasi, founded in 2002, has partnered with global
        sponsors to enable FDA, EMA, and multi-venue
        approvals for numerous small molecules and
        biologics. Headquartered in Miami, Florida,
        Biorasi maintains office-based teams
        around the globe.

    • Our People
      • Cultivating The Future

        Biorasi hires the best – from industry and regulatory agency veterans to promising young talent on the rise. Biorasi’s leadership is made up of forward-looking visionaries with an unparalleled commitment to excellence in the services we provide to our sponsors and partners.
    • Our Board
      • Leading the Industry

        Our board is comprised of some of the most brilliant minds working in biopharma. Our directors and advisers help guide the company and act as a vital strategic asset both for Biorasi and our sponsors.
    • Careers
      • Careers

        We are looking to hire the best from inside and outside the industry. If you have an unparalleled commitment to excellence, a passion for making life better, and a drive for success, we’d like to talk to you.
  • Services
    • Study Rescue
      • Study Rescue


        Biorasi has a long track record of being able to
        right faltering programs. We have worked both
        as an integrated CRO, adding our strengths
        to a trial’s incumbent CRO, as well as a
        transition CRO, by assuming primary
        study management responsibility
        from the incumbent organization.

        Read how Biorasi can
        help rescue your trial

    • Clinical Services
      • Clinical Services

        The Biorasi clinical team achieves unconventional results from rapid site startup, through successful completion of enrollment and the timely lock of the study database.

    • Project Management
      • Project Management

        We believe that only fundamentally sound project management can ensure trial success, and that only properly trained project managers, backed up by industry-leading processes, and innovative tools, can ensure sound project management.

    • Regulatory Services
      • Regulatory Services

        Regulatory affairs strategy is one of the biggest hurdles in running clinical trials. Increased trial complexity, regulation, and the need for multi-venue approval are driving this trend. Biorasi’s regulatory team has worked with regulatory agencies around the globe, including the most difficult venues.

    • Safety
      • Safety and Pharmacovigilance

        Biorasi’s best-in-class processes and technologies help our team identify safety trends and risks in sponsor studies quickly, and give us insight on how to resolve them without risking the trial. Fast detection, fast response, and fast resolution ensure our trials always stay on time.

    • Data Science/Biometrics
      • Data Science & Biometrics

        We make trial data an integral part of guiding trial success. Biorasi builds out standard data structures from the beginning and uses big data-style analytics to make your data immediately useful. This front-loaded approach saves sponsors time and money and minimizes risks.

    • Quality Assurance
      • Quality Assurance

        Biorasi is constantly evolving and improving, always under the guidance of quality first. Our quality team audits our internal functions as well as our sponsor studies to make sure that plans and SOPs are adhered too.

    • Program Development
      • Program Development

        We look at your projects in a global context. Biorasi’s consulting services are built around the idea that trials only realize their maximum value when they part of an optimized and effective holistic drug development program.

  • Therapeutic Areas
    • Autoimmune
      • Autoimmune

        Autoimmune is one of the fastest-growing areas of clinical research, due to increased recognition and incidence of autoimmune diseases i. Biorasi can help with all aspects of managing your next autoimmune trial.

    • Dermatology
      • Dermotology

        Dermatology trials have some very unique challenges. From difficulty in enrolling to compliance in a patient population that is typically much younger than other trials, Biorasi knows how to make your dermatology trial a success.

    • Nephrology
      • Nephrology & Pain

        Biorasi is a leading CRO in nephrology and dialysis-dependent CKD populations. No one understands the nuances of research in the dialysis population better than we do, and no one conducts these studies with our level of professionalism, and attention to the special needs of these patients.

    • Neurology
      • Neurology Trials

        Biorasi’s project managers and clinicians understand the complexities of neurodegenerative, pain, and psychiatric disorders. Our unique positioning and experience, coupled with our strong network and relationships with specialized sites give us an unparalleled advantage in neurology trials.

    • Oncology
      • Oncology Trials

        Many CROs specialize in oncology, however few have the versatility to offer full-service trial management like Biorasi. Find out how our integrative approach to oncology makes a real difference in the success of your next oncology trial.

    • Women's Health
      • Women’s Health Trials

        Trusting your women’s health trials to an expert like Biorasi guarantees every trial you run will be optimized. With years of experience and a broad portfolio of past studies, Biorasi is your best partner in women’s health clinical research.

    • Medical Devices
      • Medical Device Trials

        Medical devices are a unique field with a unique approach to regulatory approvals and clinical trials. Biorasi combines deep expertise in the specialized area of medical devices, and combines it with decades of therapeutic area excellence with our industry leading methodology.

  • Technology
    • Talos Technology

      An increasingly connected world can make your clinical trials better or just more complex. Our TALOS™ Technology Platform is built to take connections and turn them into insights, increase efficiencies and help us deliver optimized solutions for every sponsor.

      Learn More

  • Resources
  • Contact

Immunoglobulin A (IgA) is an antibody manufactured by the body’s immune system to protect against invaders. Immunoglobulin A nephropathy (IgAN) is a common kidney disease where too much IgA is deposited into the kidneys causing severe inflammation and damage to the tissues. While IgAN remains benign in a large number of patients, up to 40% develop end-stage renal disease (ESRD) within 20 years of diagnosis, requiring either dialysis or a kidney transplant for survival. Early intervention is key to treating those at risk of developing ESRD and saving their kidneys before it’s too late.

The exact cause of IgAN and mechanism of how IgA deposits itself into the kidneys remains a mystery, however researchers believe IgAN is an autoimmune kidney disease with a complex genetic component and strong environmental influences. While the prevalence of IgAN varies among ethnic groups and between genders, genes specifically contributing to IgAN have yet to be identified. Mapping genes for complex diseases is challenging. Still, discovering specific IgAN susceptibility genes may open doors to novel therapeutic approaches including genetic diagnosis, selection of optimal kidney transplant donors and ultimately, targeted therapies.


IgAN-omics Precision Medicine in Nephrology
The “omics” strategy uses a big data approach to identify genetic biomarkers, measurable substances that are indicators of a specific physiologic or pathologic process, to develop targeted therapies and diagnostic tools. This consists of high-throughput analysis of the genome (genomics), transcriptome (transcriptomics), proteome (proteomics), metabolome (metabolomics) and glycome (glycomics) to quantify and integrate genetic effects and better understand the flow of information through cellular networks. This approach considers the effects of DNA variants on RNA transcription, protein synthesis, metabolic function and ultimately disease phenotypes and is ideal to study the complex architecture of IgAN. Specifically for IgAN, ideal biomarkers, based on molecular mechanisms involved in symptoms of the disease, can accurately predict the risk of developing ESRD and monitor the patient’s response to therapy for future adjustment.

There is a significant amount of research devoted to these biomarkers. For example, a large genome wide association study (GWAS) was performed on a population with high rates of IgAN and researchers identified the two genes C1GALT1 and C1GALT1C1 significantly more common in people with IgAN. In another study, researchers identified possible biomarkers of IgAN such as alpha-1-antitrypsin, apolipoprotein A-I, CD44 antigen and kininogen. Additional GWAS are currently underway to identify other genetic variants that interact with the environment causing or triggering IgAN. Additional markers show significant promise in early detection and diagnosis of IgAN:

  • TGF-β1: a protein encoded by the gene TGFB1 on chromosome 19q13.1 by releasing pro-inflammatory cytokines that cause inflammation
    • Developing drugs targeting activated TGF-β1 signaling pathways could influence the expression of fibrosis-related genes preventing and slowing the progression of IgAN.
  • Gd-IgA1: a galactose deficient variant of IgA1 that binds to other antibodies forming immune complexes seen in IgAN patients
    • Effective kidney filtration depends on O-glycosylation. Glycan targeted drugs that neutralize Gd-IgA1 have the potential to inhibit abnormal glycosylation of IgA1 and deplete Gd-IgA1 cells
    • Increased serum levels could be a diagnostic biomarker and determine risk of clinical progression
  • MicroRNAs (miRNAs): a recent study showed that miR-3613-3p and miR-4668-5p are correlated with the severity of IgAN and miR-3613-3p may be involved with activation of B cells and participate in the disease’s pathogenesis. Further clinical studies on miRNA expression may reveal the underlying mechanism in IgAN, leading to a cure.


A Kidney-omics Future
The concept that individuals with the same disease may need different therapies is not new and is in fact the basis of the rise of precision medicine – in which medical treatments are tailored to patients based on individual characteristics such as genetic makeup. Specific biomarkers are also needed to track the success and predictive capability of potential treatments across diverse IgAN affected populations. Genetic studies have identified potential candidate genes for IgAN pathogenesis yielding insights into the role of environment, however more data is needed to draw definite conclusions. Omics-based drug discovery studies in nephrology are still lacking and more are needed to validate the numerous biomarkers associated with IgAN. For genetic research studies in IgAN to be successful, physicians and researchers must work together to refer patients and systematically biobank blood, serum, and kidney tissue for further analysis.

Biorasi is an award-winning contract research organization accelerating drug and device development for small- and mid-sized life sciences companies around the world. Biorasi has over 200 employees in its headquarters in Miami, Florida, and in regional offices around the globe.


© Copyright 2018 Biorasi, LLC. All rights reserved.

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