• 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
    • 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.

    • 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.

    • Clinical
      • 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.

    • Regulatory
      • 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 Sciences
      • 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.

    • 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

  • Therapeutic Areas
    • Dermatology
      • Dermatology

        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.

    • 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.

    • 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

In the clinical trial world, we spend a lot of time focusing on phase I-IV trials, and it’s easy to forget about the very important preclinical, basic science studies that go into drug development.


Many pharmaceuticals are developed from basic science studies, or studies that attempt to define molecular pathways in the body. When we don’t know enough about the basic science, it’s hard to pick a good drug target. One of the problems with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) has been a lack of understanding of the basic science. Up until the past few years, the treatment approach outside of changing lifestyle factors (i.e. diet and exercise) has been to repurpose old drugs that were used for metabolic syndrome or type 2 diabetes, since these diseases overlap in many ways. There have not been any FDA approvals for these drugs to treat NAFLD/NASH, and as a result, many of them are prescribed off label.


Pharmaceutical companies have finally caught on to the gap in research for NASH, a more severe form of NAFLD in which the liver is inflamed and begins to scar, but there are still only a handful of drugs that have made it to phase III trials.


A few of the main categories of NASH drug targets include:

  • Peroxisome proliferator-activated receptor (PPAR). PPARs are proteins that exist in and around the nucleus of cells, receiving signals to up- or down-regulate transcription of certain genes. These nuclear receptors, a subtype of transcription factors, are a very strategic target for drugs. An example currently in phase III trials for NASH is elafibranor.


  • Farnesoid X receptor (FXR). Similarly to PPARs, FXR is also a nuclear receptor and transcription factor that very closely regulates cholesterol and bile acid metabolism, but it also has a less well-defined function in regulating liver triglyceride (fat) levels, hence its role as a target for NAFLD/NASH drugs. An example currently in phase III trials for NASH is obeticholic acid (trade name Ocaliva).


  • Glucagon-like peptide (GLP). GLP-1 is a hormone that regulates insulin secretion and satiety, among many, many other things. GLP-1 receptor agonists, or drugs that activate the pathway that GLP-1 acts on, have been traditionally used for type 2 diabetes and weight loss but have incidentally been found to have positive effects in patients who also have NASH. An example is liraglutide which had a successful phase II trial and even a successful phase IV trial last year for NAFLD.


All of these targets have in common that they mediate central pathways in metabolism, especially metabolism of fats and carbohydrates. For this reason, they are also implicated in dyslipidemia, metabolic syndrome, obesity, and type 2 diabetes. Another commonality is where you find them: they are expressed in many places in the body, not just in the liver. This is not very convenient because when a drug acts on multiple tissues in the body, including those that are not part of the disease mechanism, that can be a reason for side effects or for a lack of efficacy. None of the above-mentioned drug targets are tissue-specific (or liver-specific) for NASH or NAFLD, but some labs are working to develop more specific targets.


In recent news, Allergan’s cenicriviroc was expected to show strong anti-inflammatory effects via chemokine receptors CCR2/CCR5 because of success in animal studies. However, as is the case with many animal studies, the findings were not replicated in humans: another great example of when animal studies are not predictive of human studies. This drug did show benefit in ways besides the proposed CCR2/CCR5 anti-inflammatory mechanism, including antifibrotic activity, and this may prove to be even more clinically meaningful for NASH patients.


Combinations of drugs are beginning to be tested and are speculated to be the most clinically meaningful option for patients, even though this may require collaboration between competing pharmaceutical companies. In support, the FDA’s director of the Center for Drug Evaluation and Research, Dr. Janet Woodcock, was recently quoted saying that she believes the clinical trial system direly needs to move towards master protocols, or trials that incorporate multiple therapies, including combination therapies, and/or multiple indications in one go. This, of course, would be a better use of resources, but as with any adaptive trial design, there are additional considerations, such as advanced statistical oversight and extensive use of data and safety monitoring boards.


There may be a solution for NASH right around the corner, or there may not be. Regardless, it is still worth our resources to continue to study the basic science behind the disease and the drugs designed to treat it so that better, more specific drugs may be developed in the future. This information may also prove helpful for other less well-defined diseases that share some of the pathology with NASH.

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Biorasi is a full-service, global CRO whose vision is a future where data, process, and technology work together seamlessly to accelerate drug development for the benefit of our sponsors and their patients’ lives.

We are 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.

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