MENUMENU
  • 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

        PUTTING STALLING TRIALS BACK ON TRACK

        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

Just in time for our final follow-up to the two previous articles on non-alcoholic steatohepatitis (NASH), the FDA released a new draft guidance for drugs being developed to treat the disease. In this blog, we present a couple of highlights from the guidance.

 

The new draft guidance very heavily pushes for development of less invasive biomarkers that can be used to diagnose and prognose NASH. For those who study liver disease, it is well known that a liver biopsy is the gold-standard method to diagnose NASH, since there are histological indications that differentiate it from NAFLD or cirrhosis. There are many reasons why both a physician and a patient would be hesitant to approve this procedure, including risk of infection and complications from the surgery, so this recommendation is not news, but it is very important.

 

Along the same lines, sponsors are not actually required to enroll participants in NASH trials based on liver biopsy diagnosis; in some cases, it will be acceptable to use imaging techniques in combination with patient history to identify risk factors that will nearly predict development of NASH. This method is not as cut-and-dry as a biopsy, but it will bypass the risks associated with a biopsy requirement, including a patient’s unwillingness to participate if they have to go through that procedure. There are many different imaging techniques that are making their way to the forefront of diagnosing NAFLD and NASH, and as methods are further developed, imaging may eventually replace biopsies as the gold standard.

 

These trials that use histological endpoints will be very long in duration, a minimum of 12-18 months as suggested by the guidance. This is because tissue changes take longer to manifest than do other endpoints. If the invasiveness of a liver biopsy isn’t a good enough impetus to develop better biomarkers of NASH, then this will certainly help drive that need to measure disease progression and effects of these drugs more easily.

 

Since drugs are often metabolized and even sometimes activated in liver tissue, liver diseases present unique challenges when studying pharmacokinetics (PK) and pharmacodynamics (PD) of a drug. If the liver is diseased, the lost liver function may interfere with a drug’s efficacy or safety depending on the PK/PD properties of the drug. For this reason, the FDA included a special section on PK, stating that, “the sponsor should study the effects of hepatic impairment on the drug’s pharmacokinetics early during the drug development program in a dedicated hepatic study to support appropriate dosing and dose adjustment across the spectrum of NASH liver disease.” While this does somewhat contradict the FDA’s previous recommendations to implement adaptive trial designs in order to reduce the resources required for clinical trials and the drug’s timeline to market, PK studies can be smaller-scale studies and may additionally function to explore efficacy in other unintended indications or endpoints.

 

The guidance recommended that sponsors communicate directly with the FDA in several scenarios before initiating trials, including adaptive design trials that combine phase II and III studies. One important point is that, according to the guidance, trials should include roughly the same proportion of individuals with comorbidities (e.g. type 2 diabetes or metabolic syndrome) as is seen in the general population. This will help generate more real-world evidence, but the caveat is that these overlapping factors will need to be carefully accounted for statistically in sample size calculations and in final analyses to determine efficacy and safety; drugs may behave differently in someone who also has diabetes, so it will need to be measured in people with and without such comorbidities, adding to the total number of participants. It is thus important for sponsors and investigators to communicate with the FDA to ensure that they are on the right track for future regulatory approval. While including patients with comorbidities may allow for a larger recruiting pool, enrollment may still be challenging since there are strict criteria outlined in the rest of the guidance about which stage each comorbid disease can be in for acceptance into a trial of this nature.

 

There are clearly many things to consider when designing NASH trials, and even one missed criterion can result in rejection by regulatory bodies when it’s finally time to submit clinical trial data for market approval. Ensure that these trials are well-thought-out before taking the plunge, and don’t be afraid to partner with regulatory experts to make sure all the bases are covered.

Got a question?

We have Experts available to answer your questions
Complete the form on the right or give us a call.

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.

© Copyright 2019 Biorasi, LLC. All rights reserved.  |  +1 786-383-0454

Download a Sample Rescue Trial Report

Please provide your email address so we can email your sample rescue trial report.