Featured Trial Design Editorial

  1. J&J Announces First Efficacy Study For HIV-1 Preventive Vaccine

    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.

  2. Tissue Modeling May Cut Clinical Trial Time

    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

  3. Trial Aims To Kill Cancer Without Chemotherapy Side Effects

    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.

  4. Does Your Clinical VP Have The Right Aptitude And Attitude?

    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.

  5. Clinical News Roundup: New Alzheimer’s Drugs Reach Clinical Trials

    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.

  6. Turning A Ship: How Janssen Is Changing Its Culture For Patients

    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.

  7. Rare Diseases Require Unique Approaches In Clinical Trial Design

    The vast majority of rare diseases have no approved treatments available, despite the fact that research related to these diseases has expanded significantly in the past 20 years. A key reason may be the many unique challenges researchers face when developing drugs to treat rare diseases, including difficulties designing and executing effective and appropriate clinical trials.

  8. AMO Pharma Addresses Rare Childhood Disease

    “Rare diseases are bad enough, but the ones that affect children are even more heartbreaking,” says Mike Snape, CEO of AMO Pharma, a virtual biotech focused on rare disease. “The medical need in these areas is greater than ever. They also present challenges for drug developers, especially with clinical trials.”

  9. Samus Therapeutics Expands Clinical Development Program

    Samus Therapeutics is a privately-held, biopharmaceutical company focused on developing novel therapeutics and diagnostics targeting the epichaperome, a foundational protein complex emergent from multiple disease states, including oncology and neurology. “We are the ‘anti-epichaperome company,’ says Jonathan Lewis, the company’s executive chairman and CEO. “Following various forms of cellular stress, chaperome units are rewired into the epichaperome network. Targeting and disrupting the epichaperome in cancer results in cell death  and in neurologic diseases, neuronal survival,  with no apparent effect on normal cells.”

  10. 3 Protocol Design Strategies To Enhance Patient Recruitment

    How many of the clinical trials that your company has conducted have met the initial recruitment timelines? How often have you seen recruitment issues increase costs or cause delays in your company’s operational objectives? Nearly 80 percent of clinical trials experience delays or even early termination due to recruitment issues.1 These delays not only negatively affect the sponsor company but also keep patients from getting potentially life-saving treatments in a timely manner (if at all).