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. AstraZeneca Goes All-In On Biomarker Testing & Education 6/17/2021

    Recent breakthroughs in precision medicine are revolutionizing cancer care and biomarkers are a key part of the puzzle. Scientific data has been generated that will help researchers understand the biology of cancer and more specifically, tumor profiles at the molecular level. Despite immense scientific advancements in recent years, biomarker testing is not always the standard of care for most people living with cancer. AstraZeneca hopes to change that.

  3. 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. 

  4. How Lyndra Uses Trial Partners To Reinvent Medicine 6/11/2021

    If you say that Lyndra Therapeutics is manufacturing a line of treatments around an extended-release capsule, don’t be surprised if someone from the company corrects you. Referring to their technology as an extended-release capsule is a gross understatement. Learn how Lyndra is applying its technology and partnering approach to reinvent medicine.

  5. What Does Biogen's Drug Approval Mean For Alzheimer's Patients? 6/8/2021

    The FDA’s approval of aducanumab for patients with Alzheimer’s disease seems to have surprised some in the industry. There are several take-aways from the decision, and senior industry analysts Marc Engelsgjerd and Sam Fazeli of Bloomberg Intelligence have captured those ideas in a new white paper. 

  6. How To Educate Payers And Reduce Your Risk Of Failure 6/3/2021

    With large drug developers leaving the space, the heavy lifting with antibiotics has been largely left to small biotech companies. Some of them have found success, only for them to be failed when it comes to commercialization of the product. RedHill Biopharma has a plan to educate payers and ensure success.

  7. Severe Disease Increases Necessity For A Patient-Centric Approach 5/28/2021

    Spinal muscular atrophy (SMA) is a disease caused by a genetic deficiency in a gene known as SMN1, which leads to patients being unable to perform basic tasks such as standing or walking. Scholar Rock recently completed a Phase 2 proof-of-concept trial and is excited about the results and the potential it represents for patients with SMA.

  8. Discussions On Diversity – How To Solve Pharma's Patient Problem 5/26/2021

    PAREXEL has released a report titled Discussions on Diversity, which contains learnings from an extensive series of global surveys, focus group sessions, interviews, and Patient Advisory Council meetings. The report highlights feedback from patients, the general public, and physicians who were willing to engage in candid discussions on the topic of racial and ethnic diversity in clinical trials.

  9. What You Must Know About APAC Before Deploying Your Next Clinical Trial 5/24/2021

    Right now, no place in the world is a hotter spot to conduct clinical trials that the Asian-Pacific region (APAC). I spoke to industry consultant and Clinical Leader Editorial Board member, Michael W. Young, principal at biomedwoRx: Life Sciences Consulting, for his take on the growing clinical popularity of the region.

  10. How Soon Should You Start Planning For Drug Commercialization? 5/20/2021

    At some point, every pharma and biotech company hoping for a regulatory approval will have to start planning for commercialization. That planning can start at different phases of the drug development process, but historically has often been delayed until clinical trials were well underway. At least one executive believes that planning should happen earlier in the development cycle.