Ed Miseta - Chief Editor, Clinical Leader & Outsourced Pharma
From Fusion Energy To Med Device … To Drug Developer?
TAE Life Sciences wanted to create a combination product that brought together its neutron beam with a drug that delivers boron to cancer cells. But, the company didn’t want to be in a position where it relied on another company for the drug needed. Continue Reading..
3 Steps To Address Diversity In Clinical Trials
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. Continue Reading..
ICER: FDA Has Failed In Its Responsibility To Protect Patients From Harm
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... Continue Reading..
The Future of Clinical Research Is Bright
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. Continue Reading..
Why Has There Been A Shift In Power In Pharma Partnering?
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. Continue Reading..
A Drug Developer’s First Experience With Decentralized Trials
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. Continue Reading..
Digital Technologies Will Continue To Drive Patient Outcomes
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. Continue Reading..
Janssen’s Innovation Strategy To Target Immune-Mediated Disease
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. Continue Reading..
Research Report Shows Phase II/III Spending Will Increase
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. Continue Reading..