Matheus BD Connections 2020 Person of the Year

Without a doubt the work done by the pharmaceutical, biotech, clinical research, drug development industry and the Food and Drug Administration is worthy of this distinction for 2020. What was accomplished is just short of miraculous.

The federal government (FDA) and the corporations cut no corners. I have no doubt that everything was done according to established good clinical principles. What was done was the speeding up of the regulatory processes; decreasing the workflow processing time. Turn around time on data review and decision making was the focus. The researchers and the reviewers of the data had Covid-19 treatments and vaccines at the forefront of their priorities.

The typical time for vaccine development to get approved is 4 years. The first two approved were done within 12 months!! There are several more in development.

We are now beginning to see the impact the vaccine is having in the US in terms of the decline of daily new cases. Many people have had their second dose.  The United Kingdom began vaccinating their population one week earlier than the US and you can see the impact to their daily new cases as well. This has me very encouraged. I’m hopeful that by Memorial Day, we’ll be back to dining out and meeting in person, traveling to conferences, vacations, etc.

US Daily New Cases Jan 18, 2021

 

 

 

 

 

 

 

UK Daily New Cases, Jan 18, 2021

Impressive improvements in study start-up time

A report issued in July of this year, featured the use of a Just-in-Time (JIT) approach to speed up patient enrollment in oncology clinical trials. Collaboration between Cancer Treatment Centers of America and a division of PPD has been able to shorten site activation from a typical 8 months down to 2 weeks! This improves patient access to potentially life-changing therapies while speeding up the ability to evaluate treatments to conquer cancer.

https://www.ppdi.com/news-and-events/news/2019/july-16-optimal-cancer-trials

The JIT approach is based on establishing a community of sites with prenegotiated contracts and terms, which provides immediate engagement by sites to search for patients. Patients are identified first, triggering the activation of sites, enabling patients to be enrolled within two weeks. As a result of the efficiencies of this process, there are zero non-enrolling sites.

This is a huge improvement. Faster startup will allow the pharma/biotech companies to more quickly assess if a drug candidate is working or not. This is a better and more efficient use of everyone involved in conducting a clinical trial, vastly improving productivity of the process.

LaunchBio NC Networking

LaunchBio (LaunchBio) holds events on the first Thursday of the month in Durham, NC.  They are held in the Chesterfield Building in the downtown area.  The building was formerly a cigarette manufacturing building.  It has now been converted and there is incubator lab space for drug discovery and development.

It is a great opportunity for networking with people involved in the clinical research industry.  Here I am enjoying conversation with Peter Weiman with MedNet Solutions (MedNet Solutions) and David Holland with Cmed (Cmed Research).

LaunchBio_August_2018_Web-10