Articles By Ed Miseta

  1. Can Smarter Study Design Relieve The Recruitment Challenge? 9/18/2021

    Recruitment has always been a challenge for companies conducting clinical trials. Sponsor companies seeking new ways to engage and recruit patients have seen varied success. But could that challenge be mitigated or eliminated with smarter study design?

  2. An Oral Cancer Therapy Hopes To Treat Multiple Tumors And Lymphomas 9/7/2021

    Cyclacel Pharmaceuticals recently announced the first patient dosed in its Phase 1/2 study of oral fadraciclib in patients with advanced solid tumors and aggressive lymphomas. The trial used a streamlined study design and will determine the recommended Phase 2 dose.

  3. Traditional Trials Are Dead – Virtual Trials Are The Future 9/3/2021

    It’s no secret that decentralized clinical trials, also known as virtual trials, are one of the hottest technology trends in the clinical space. Although this trial model has been touted by vendors for many years, it took the emergence of the COVID-19 pandemic in 2020 to get many companies scrambling to implement the new approach.

  4. Liver Disease Requires A Patient-Centric Approach To Trials 9/1/2021

    89bio is focused on two large markets which CEO Rohan Palekar believes are underserved. The first is fatty liver disease, which in its late stages is called non-alcoholic steatohepatitis (NASH). The second is severe hypertriglyceridemia, or high levels of fat in the blood. Creating trials for these diseases required a patient-centric approach.

  5. A Stem Cell Company Overcomes The Challenges Of International Trials 8/26/2021

    Performing global trials presents challenges that drug developers do not face in the U.S. Those challenges need to be considered and addressed in the planning process. Jim Joffrion, senior director of clinical development and operations for Athersys, discusses the challenges and the importance of the CRO selection process.

  6. Could An Incentive-Based Pricing Model Improve CRO Performance? 8/24/2021

    When speaking to clinical executives, I will often ask about their likes and dislikes around various pricing models they have experienced. I also ask about those features they would most like to see in a pricing model, especially if they had the opportunity to design one from scratch. Here is some of the feedback I received.

  7. How An External Control Arm Changed Phase 3 Trials For Brain Cancer 8/19/2021

    Glioblastoma multiforme (GBM) is an aggressive and fatal form of brain cancer that can form in the brain or spinal cord. Unfortunately, drug development for patients with the disease has not seen much progress in decades. Dr. Fahar Merchant, president and CEO of Medicenna Therapeutics, a clinical stage immunotherapy company, is hoping to change that.

  8. Was FDA Wrong? Annovis Bio Shows Strong Data And No Side Effects 8/17/2021

    Maria Maccecchini, CEO of drug developer company Annovis Bio, has been working on disorders of the brain, including Parkinson’s disease and Alzheimer’s, for more than 12 years. She believes that experience allows her to see the brain a little differently than others. She also believes a treatment Annovis is working on will yield results not seen in any prior study.

  9. The Four Essential Pillars of Successful Patient Centric Trials 8/12/2021

    Praxis Precision Medicines is a drug development company using genetic insights to focus on treatments for patients with CNS disorders. Praxis has patient centricity infused throughout the organization and believes taking care of patients and producing successful trials comes down to four essential factors: staff, sites, CROs, and patient insights.

  10. Can Revive Overcome Long Odds With A Small Molecule COVID Treatment? 8/10/2021

    Revive Therapeutics has come a long way since it was launched in 2014. It went from repurposing a drug for gout to working on a licensed delivery system for CBD. But when the COVID pandemic began sweeping the world in 2020, the company looked into a small molecule treatment for those patients. The company is now on the verge of making that dream a reality.