Articles By Ed Miseta

  1. How CVS, Walgreens, And Walmart Will Improve Clinical Trial Recruitment 11/30/2022

    A new development could potentially change the patient recruitment challenge. In 2022, CVS, Walgreens, and Walmart officially entered the clinical trials space. The patient access capabilities of all three organizations may change the way drug developers access patients while also solving the patient diversity problem.

  2. What Astellas Has Learned About Decentralized Trials 11/28/2022

    When the COVID pandemic hit in the spring of 2020, many companies were unprepared for the changes that were about to impact their studies. Astellas is one company that was better prepared than most. The company had initiated a formalized, internal project on decentralized clinical trial (DCT) technologies and their use in clinical trials about nine months prior to the pandemic.

  3. Portage Biotech Creates A New Drug Development Model 11/21/2022

    While working for BMS, Ian Walters noticed a disturbing trend in the industry. Big Pharma companies would often lament that small biotech firms do not develop drugs the same way it is done at large companies. He is now working to change the biotech model.

  4. Needed: An AI Revolution In The Rare Disease Space 11/11/2022

    Quris has developed a treatment for Fragile-X Syndrome, the most common inherited cause of autism and intellectual disabilities worldwide. Isaac Bentwich M.D., the founder and CEO of Quris, believes the rare disease space, in general, is a difficult one to navigate.

  5. Tips To Overcome The 4 Major Barriers To Patient Diversity 11/9/2022

    As companies look for ways to increase diversity in their patient populations, I am reminded of a presentation I attended at the 2016 SCRS Global Solutions Summit. Ola Akinboboye, a cardiologist, gave one of the best presentations I have heard on how to increase the participation of African Americans and other minorities in clinical research.

  6. Walmart's Healthcare Research Institute Is Ready To Aid Underserved Communities 10/26/2022

    On October 10, 2022, Walmart announced its Healthcare Research Institute (WHRI) with the mission to improve care for underserved communities. WHRI offers the opportunity for patients in rural and underserved communities to participate in clinical research.

  7. What Your Sites Love And Hate About DCTs 10/25/2022

    For years, sponsor companies have had access to new and emerging technologies that would ease the participation burden of patients in clinical trials. While these emerging technologies helped sponsor companies keep their trials on track, they have also been a burden for the clinical sites having to deal with the changes required to keep up with them. Do you know where your sites stand on the adoption of hybrid trials and DCTs?

  8. What Is A Risk-Based Approach To CRO Oversight? 10/20/2022

    Ian Wyglendowski, head of strategic clinical partnering at UCB, recommends taking a risk-based approach to CRO oversight. The first step is understanding the risk that exists. If an inspector walked in today and asked how you, the sponsor, could ensure that an activity you have outsourced complies with ICH GCP regulations, would you know how to answer that question?

  9. Janssen and Stand Up To Cancer Collaborate For Oncology Patient Diversity 10/12/2022

    In June 2022, Stand Up To Cancer® (SU2C) announced sponsorship of an initiative with the Janssen Pharmaceutical Companies of Johnson & Johnson to increase the participation of patients from medically underserved communities in oncology early phase clinical trials.

  10. Market Outlook: How Should You Select A CRO Partner? 10/4/2022

    Research firm Industry Standard Research has released the latest edition of its Phase II/III Study Trends and Market Outlook (2022-2026) report. The goal of the 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.