ARTICLES BY ED MISETA
Takeda Takes A Strategic Approach To TMF6/21/2022
Over the past five years, Takeda has been perfecting its all-in model for TMF, where both Takeda and its CRO partners collaborate in Takeda's eTMF. This enables transparency into TMF health across the partnership and drives more effective, proactive collaboration.
What Should You Look For In A CRO Partner?6/16/2022
In May 2022, ISR Reports released the 14th edition of its Phase II/III CRO Benchmarking Report. The landscape for outsourcing clinical research changes every year, and the goal of the report is to help sponsor companies make educated decisions and to help CROs understand how they stack up against competitors when it comes to brand positioning and performance metrics.
SCRS Puts A Spotlight On Diversity6/9/2022
When asked about patient diversity in clinical trials, Diana Foster likes to reflect back to 2016. Foster, VP, strategy and special projects & diversity awareness program lead at the Society for Clinical Research Sites (SCRS), notes that was the year a group of individuals from approximately 40 organizations gathered in Washington D.C. to discuss diversity.
AstraZeneca’s Oncology Goal: Separate Efficacy And Toxicity6/6/2022
Matthew Ellis, SVP of Early Oncology R&D for AstraZeneca, is helping lead the charge in what he calls the company's oncology revolution. Ellis deals with the complicated process of going from the discovery of a potential therapeutic target or mechanism to the discovery and development of potential medicines, the triage of those medicines, and working out the right risk-benefit profile so they can be administered to humans.
How To Operationalize Diversity In Clinical Trials5/31/2022
Changes are quickly taking place regarding the push for patient diversity in clinical trials. For years, sponsor companies have been trying to increase the number of ethnic and diverse patients in their studies. Soon, they will face tougher oversight. Here is how one company is overcoming the challenge.
Igniting Innovation Through Global Collaboration: DIA 20225/17/2022
DIA's Global Annual Meeting is the largest gathering of regulators, industry experts, healthcare practitioners, life science researchers, and patients. This June, DIA will bring this community to Chicago for an in-person meeting which promises to be a celebration and reunion.
Is Janssen's Pathway Approach The Future Of Drug Development?4/25/2022
The last 20 years have provided Janssen with insights that are evolving how it thinks about disease. The company has learned that the molecular underpinnings of disease offer a new way of classifying disease. Janssen now has more of a molecular or taxonomic way of looking at disease and the molecular pathways that are dysfunctional, especially in immune-mediated diseases that cut across many different organ systems.
Developing A Plan For Patient Diversity? The FDA Shares Advice4/25/2022
The FDA has released a draft guidance discussing patient diversity. The guidance recommends that sponsor companies include a plan to increase diversity in the clinical trial designs they propose to the agency.
What Does The Future Hold For Decentralized Clinical Trials?4/20/2022
What can we expect to see from decentralized trials in the next three years, and what are the challenges sponsor companies will need to overcome? A webinar hosted by IBM Watson hoped to answer that question and many others.
The Next Three Years Of Clinical Trials: DCTs, RWE, And Beyond4/18/2022
Recent years have seen unprecedented innovation in the clinical space. Precision medicine, cell and gene therapies, decentralized trials, real-world data, and the promise of artificial intelligence (AI) and machine learning (ML) are just a few of the reasons to be excited about the future of clinical research.