Featured Trial Design Editorial

  1. The Father And CEO Who Climbed A Mountain To Raise Awareness
    12/21/2017

    How far would most CEOs go to raise awareness of the diseases they are attempting to treat? Tim Miller, CEO of Abeona Therapeutics, climbed more than 14,000 feet to the top of Mt. Rainier to raise awareness for Sanfilippo Syndrome, a rare and deadly genetic disease that impacts children.

  2. Beat AML Utilizes Innovative Master Trial Configuration
    12/15/2017

    Acute myeloid leukemia (AML) is a cancer that develops in bone marrow where new blood cells are created. It quickly moves into the blood, where it can be fatal in a matter of months. A new trial using a Master Trial configuration will provide hope for patients.

  3. The Role Of Modeling & Simulation In Clinical Trials
    12/12/2017

    Modeling and simulation (M&S) in the drug development process is an industry-proven scientific approach used to inform crucial drug development decisions such as dosing, drug-drug interaction (DDI), and other critical safety and efficacy questions. The FDA has shown a strong commitment to utilizing M&S in the drug development process.

  4. Cell Therapy Trials Present Unique Challenges For Pharma
    12/7/2017

    Maria Fardis, CEO of Iovance Biotherapeutics, has spent 18 years working in the pharma industry. Although most of her experience has been in small molecules and proteins, she now works in the cell therapy space and notes these treatments are a new and exciting space with meaningful differences in how clinical trials are conducted.

  5. J&J Announces First Efficacy Study For HIV-1 Preventive Vaccine
    12/6/2017

    On the eve of World AIDS Day 2017, the Bill & Melinda Gates Foundation and the National Institutes of Health (NIH) have joined forces with Johnson & Johnson (J&J) to advance a potential “global vaccine” that could prevent a wide range of viral strains responsible for the world’s HIV pandemic.

  6. Tissue Modeling May Cut Clinical Trial Time
    12/5/2017

    In the neuromuscular space, Fulcrum Therapeutics is using tissue donated from patients with facioscapulohumeral (FSH) muscular dystrophy, an incurable form of the disease, to find a treatment. The tissue is used to create research models that look and respond much like natural human tissues

  7. Trial Aims To Kill Cancer Without Chemotherapy Side Effects
    11/20/2017

    Getting a new oncology drug to patients involves navigating an obstacle course of costs, timelines, safety and effectiveness data, and regulations. Starting the clinical process with a molecule that has already been proven to kill cancer cells and be safe for patients will eliminate much of the risk. That is exactly what NanOlogy, a clinical-stage oncology company, is attempting to do.

  8. Does Your Clinical VP Have The Right Aptitude And Attitude?
    11/17/2017

    For a small biotech company, making the transition from discovery to clinical is where the rubber meets the road. This is where all your endless hours of planning pay off and where you will be challenged to put your risk and mitigation plans to the test. During this time, no position will be more important than your director of clinical development.

  9. Clinical News Roundup: New Alzheimer’s Drugs Reach Clinical Trials
    11/3/2017

    Clinical news roundup for the week of October 30, 2017 with information on new Alzheimer’s disease trials, clinical monitoring salaries and turnover, emphasizing patient-centric trials, and GDPR compliance concerns.

  10. Turning A Ship: How Janssen Is Changing Its Culture For Patients
    11/1/2017

    For years, pharma has had a model in place for dealing with sites and patients: Design a trial protocol, hand it to sites and patients, and tell them what they need to do. While that model seemed to work, it also created patient and investigator recruitment problems that were never solved. Addressing those issues is a primary goal of Janssen’s patient and investigator engagement group.