Articles By Ed Miseta

  1. 3 Steps To Address Diversity In Clinical Trials 6/23/2021

    The COVID pandemic in 2020 brought to light the significant disparities that exist in healthcare. But those same disparities also exist in the way clinical trials are structured and conducted. The Harvard Business Review recently published an article that outlines three recommendations for creating representative patient data.

  2. ICER: FDA Has Failed In Its Responsibility To Protect Patients From Harm 6/15/2021

    A recent report from Bloomberg Intelligence was not kind to the FDA’s approval of aducanumab for the treatment of patients with Alzheimer’s. A white paper released by the group states the approval would be met with more questions than answers and could bring a loss of credibility to the regulatory agency. Now, the Institute for Clinical and Economic Review (ICER) has issued a statement on the approval, which is no kinder to the agency or its approval. 

  3. A Drug Developer's First Experience With Decentralized Trials 6/1/2021

    When the FDA released new guidance for companies in May, it seemed every drug developer was scrambling to convert their clinical trials to a decentralized approach. Advicenne was no exception.

  4. The Future of Clinical Research Is Bright 6/1/2021

    This is an exciting time to be involved in clinical trials. I feel like I have been saying that for the more than eight years that I have been writing about clinical research, and every year seems to bring new technologies and new opportunities.

  5. Why Has There Been A Shift In Power In Pharma Partnering? 6/1/2021

    When it comes to partnering models in drug development, Syed Kazmi, CEO of Jubilant Therapeutics, believes there has been a dramatic shift in the thinking of pharma companies.

  6. Digital Technologies Will Continue To Drive Patient Outcomes 6/1/2021

    While other companies scrambled to implement clinical trial-related technology to deal with the pandemic, Otsuka was an early adopter of tools such as eCRF and eConsent.  Christoph Koenen, EVP and chief medical officer at Otsuka Pharmaceutical Companies (U.S.) explains how digital technologies will continue to drive patient outcomes.

  7. Janssen's Innovation Strategy To Target Immune-Mediated Disease 4/15/2021

    Tom Cavanaugh believes there is a tremendous unmet need in the industry for treatments that target patients suffering from immune-mediated diseases. Cavanaugh, the president of immunology for Janssen in the U.S., notes that unmet need is a primary factor that drives the work he and his team perform. 

  8. From Medical Researcher To CEO 2/1/2021

    Yan Chen used her industry experience and interest in immunology to start Elpis Biopharmaceuticals, a company hoping to find cures for difficult-to-treat cancers.

  9. Research Report Shows Phase II/III Spending Will Increase 1/14/2021

    Research firm Industry Standard Research recently published its Phase II/III Study Trends and Market Outlook report. The goal of this report is to provide readers with a high-level view of the Phase II/III clinical development space to illustrate current market dynamics and inform strategic planning. 

  10. AI And Machine Learning Prepare Pharma For The Data Onslaught 12/1/2020

    When I reached out to several clinical executives in my network for their thoughts on trends that will impact trials in the coming year, the two mentioned most frequently were AI and decentralized trials.