Articles By Ed Miseta

  1. A Proactive Approach To Preparing For The Release Of ICH E6 8/5/2021

    Approximately 25 years ago work began on a document intended to revolutionize and improve the efficiency of new drug development. The document, dubbed ICH E6, was intended to provide guidance for clinical trials conducted around the world. ICH E6 is quickly becoming a reality and sponsor companies need to be prepared for it.

  2. How Otsuka Uses Decentralized Trials & Real-World Evidence 8/3/2021

    Prior to joining Otsuka in 2019, Christoph Koenen spent two years with GSK, 10 years with Novo Nordisk, and eight years with BMS. I recently spoke to him about some of the key lessons he’s learned over the years and how Otsuka is applying new clinical trial strategies and technologies, especially for the treatment of patients in mental health trials.

  3. Otsuka Believes Digital Technologies Will Drive Patient Outcomes 7/29/2021

    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.

  4. Consultants, PPAs, And Loyalty: Trends In Phase II/III CRO Benchmarking 7/27/2021

    ISR Reports recently released the 13th Edition of its Phase II/III CRO Benchmarking report. Many sponsor companies turn to CROs for the heavy lifting of their clinical development programs. Still, finding the service provider best suited to meet trial needs and performance expectations is a difficult task.

  5. No CMOs Or CROs: A Unique Approach To Cell Therapy Development 7/22/2021

    Cartesian Therapeutics has just 20 employees, but the company performs all its preclinical and regulatory work and clinical operations in-house. A few years ago, Cartesian also built a GMP manufacturing facility from the ground up. That gives the company its own quality management system and quality control labs. Learn how they do it.

  6. The Right Precision Medicine Partner Is Essential For Trials And Patients 7/20/2021

    Patient recruitment is a challenge for all pharma and biotech companies. Despite the advances made in patient centricity and decentralized trials, the recruitment remains challenging. Part of the reason might be that the advent of precision medicine is paradoxically not making the recruitment challenge any easier.

  7. How One Biotech Is Taking An Innovative Approach To Alzheimer's Disease 7/15/2021

    Drug development in the Alzheimer’s space is difficult and has been plagued by successive failures over the last 18 years. One company working in that space felt it was time to take a new and innovative approach to find a treatment for patients.

  8. Merck's Efforts To Increase Patient Diversity 7/12/2021

    The barriers to minority participation in clinical research are well-known. Despite our knowledge of these barriers, the issues continue to exist. “It’s clear we need to do more of our research in the sites and communities that have access to the patients we are hoping to recruit,” says Luther Clark, deputy chief patient officer for Merck. “I believe one of the reasons pharma efforts to recruit a more diverse patient population have failed is because of our approach."

  9. A Drug Developer's First Experience With Decentralized Trials 7/1/2021

    When the FDA released new guidance for companies in May 2020, it seemed every drug developer was scrambling to convert its clinical trials to a decentralized approach. Advicenne was no exception. Robbie McCarthy, general manager, U.S. for Advicenne, hoped to determine how patients could participate in the trial without a mandatory hospital stay. That led to him seeking out CROs and technology service providers that offered a decentralized approach to trials.

  10. The Right Payment System Makes Bayer Healthcare A Sponsor of Choice 6/29/2021

    Companies hoping to become a sponsor of choice have a lot to consider. They must think about how to improve interactions with patients, sites, CROs, and other service and equipment providers. When Bayer decided to go down the sponsor-of-choice path, there was one aspect of partnering they knew they had to get right: site payments.