Ed Miseta - Chief Editor, Clinical Leader & Outsourced Pharma
How To Become A Sponsor Of Choice For Your CRO Partners
Becoming a true sponsor of choice involves much more than simply saying the words. Drug discovery is a tough business and there are many parts that must seamlessly interact to get a product to regulatory approval. Continue Reading..
Takeda’s Mission To Improve Communication With Patients, Sites, And CROs
Being a better partner for your patients, sites, and CROs begins with effective communication. When Karen Correa joined Takeda as VP, head of global clinical operations, she made improved communications her top priority. Continue Reading..
Do Patients Really Want Hybrid Clinical Trials?
“Decentralized and hybrid trials offer convenience, but that convenience must be balanced with individual preferences. We are entering an age of more personalized and customized participant experiences, and we have to figure out how to manage that,” says Ken Getz of CISCRP. Continue Reading..
Is Janssen’s Pathway Approach The Future Of Drug Development
Two Janssen execs talk about the future of what they call a pathway approach to developing new medicines, which attempts to match the biology of a pathway to unmet medical need for patients, across a broad range of immune-mediated, inflammatory disease. Continue Reading..
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..