ARTICLES BY ED MISETA
Is A Preferred Provider Agreement Right For You?1/14/2022
A preferred provider and/or a strategic provider is a vendor company, often a CRO or other specialty service provider, that has achieved priority status in the awarding of contracts by pharma/biotech companies. With the growing complexity of clinical research, the preferred provider is gaining popularity with many companies. Clinical Leader's Chief Editor, Ed Miseta, talks with Jennifer Johnson of UCB in this Q&A.
Is Janssen’s Pathway Approach The Future Of Drug Development?1/6/2022
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.
Trends To Watch In 2022: RWD, DCTs, And Cell & Gene Trials12/16/2021
As we prepare to close out 2021 and look ahead to 2022, it’s a good time to think about the trends that will impact clinical trials in the new year. At this time of year, I receive numerous emails from companies outlining predictions for the coming year from some of their executives. Here are a few I'd like to share.
Report Reflects Huge Growth of Clinical Trials In China12/14/2021
China has been a hot topic in the clinical space for several years, and companies locating clinical trials in the APAC region is now a trending topic in the life sciences. A new report from Global Data shows the degree to which China has been attracting studies.
DiMe Reports Significant Growth In Digital Endpoints12/9/2021
In October 2019, the Digital Medicine Society (DiMe) launched its crowdsource library of digital endpoints. The library is an open resource that anyone can access. When it launched the library had 34 unique endpoints from 12 sponsor companies. The library has seen significant growth since then. By September 2021 it had 225 unique endpoints from 69 sponsor companies.
The State of Real-World Data – And Where We Go From Here12/7/2021
There are many questions that a lot of clinical executives have about real-world data (RWD) and real-world evidence. There are questions about the quality and completeness of the data, the new digital apps generating data, patient privacy, its use in synthetic control arms, and the impact it might have on the patient diversity problem.
One Year In, DTRA Meets Goals & Looks To The Future12/1/2021
In November 2021, the Decentralized Trial & Research Alliance (DTRA) held its annual meeting in Boston. The DTRA was formed in 2020 with more than 70 founding members from pharma companies and their technology and service partners. I took this opportunity to speak with Craig Lipset, DTRA’s co-chair, about the progress the organization has made and its vision for the future.
Why Every Biotech Needs Qualified Drug Hunters11/29/2021
Christopher Kirk, co-founder, president, and CSO of Kezar Life Sciences, believes every biotech needs a good drug hunter. “This is an industry that is rife with failure,” says Kirk. “Every failure will cost companies a lot of time and money. Every company needs their scientists focused on meaningful drug discovery research with the goal of reducing this failure rate.”
A Lesson Learned From Big Pharma: Don’t Be Afraid To Go Global11/19/2021
The rheumatic diseases Kezar Life Sciences is attempting to treat have racial disparities across the world that create different outcomes and incidence rates of autoimmune disorders. Those considerations must come into play when thinking about trial design. The company has learned you should not be afraid to go global as early as possible.
Clinical Trials Enter A New Digital Era11/17/2021
The life sciences industry has been undergoing a transformation. Its seen advancements in how therapies are developed and improvements in how the industry works together. One development that has helped the industry evolve is the shift to digital technologies.