clinical trials | Matheus BD Connections, LLC

Summary of GLSA FOCM Event

Minutes of the GLSA – FOCM Meeting of May 20, 2021

So, it finally happened, on that glorious day which shall long be remembered, these minutes will be heretofore submitted to the USA Library of Congress, the Smithsonian Institute and for reasons unknown, to the Sydney Opera House on the northside bulletin board for public postings.

On May the 20, in the year 2021 of the Gregorian calendar, it was noted that the GLSA (Global Life Sciences Alliance) and FOCM (Friends of Chris Matheus) Networking organization did hold an online (virtual) networking event. The meticulously planned event went terribly awry when but half of the positive RSVPs failed to show up. That said, it was a resounding success for the initial such event. A total of 21 attended.

The meeting started off with an acknowledgement that it was Global Clinical Trials Day and a toast was given to the clinical research industry for saving the world from Covid-19 and to James Lind, the Scottish doctor who initiated the first controlled randomized clinical trial on May 20, 1747 aboard a sailing ship. Dr. Lind divided twelve sailors sick with scurvy into six groups of two. They all received the same diet but, in addition, each group was given a different treatment. Only the two sailors who received citrus fruits improved and returned to work.

Chris then introduced the GLSA members to the FOCM community. After a bit of general discussion, several polls were taken. About half of the group is reluctant to resume conference travel immediately, preferring to wait a few more months. Slightly more than half have been vaccinated or acquired immunity through catching the virus. An interesting opinion was voiced that perhaps as members of the clinical research industry, we should set the example by all being vaccinated. I, for one and I believe I speak for many of the others have the utmost confidence that not a step was missed, not a shortcut taken in the development of the available vaccines. Given the prioritization and urgency of vaccine development, we were able to speed up the data review process. The one thing that the sped up development lacked is longer term safety and side effect data. However, vaccine side effects rarely (I can’t think of any) change the longer from the time of injection.

Then it was time for speed networking! The assertion has been made by Chris that each of us in the clinical research industry are within 2 degrees of separation from each other. We had 4 different sessions. Attendees were randomly put into different “rooms” with the assignment to each introduce themselves to the group, sharing where they’d worked the previous 10-20 years and what they’re doing now to see if they could identify who they knew in common. Good information was exchanged and several new connections were made which can improve the management of clinical trials.

Join us next month – June 16.

Attendees:
David Holland, Cmed Research
Jon Matheus, Pancrazi Real Estate
Sheila Mahoney-Jewels, Life Science Hub
Eric Nier, Block Clinical
Lynne Becker, Power of Patients
Nadia Bracken, Medidata
Christine Ver Straate, GLSA
Mitchell Efros, Verified Clinical Trials
Cassandra Hui, HealMary
Denise McNerney, GLSA
Joe Buser, GLSA
Tom Ryan, GLSA
Kalyan Ghosh, Inference Inc
Marty Frazier, GLSA
Tanusree Bhattacharyya, Inference Inc
Zulma Varela, GLSA
Mike O’gorman, Life Science Marketplace
David Gibboni, DJGibboni Consulting
Eric Mayer, EDP Biotech
Craig Fernandes, EDP Biotech
Maria Frane, C3 Research

Selling clinical trial services

One of my sales principles is this: be wherever the users/decision makers/decision influencers of what you’re selling gather. By “gather” I mean the conferences they attend; be they large (national) or small (regional). I have had fellow sales people tell me these small, local/regional meetings are a waste of time.

I should have put this disclaimer at the start, but it’s my website, so I’ll put it here. Disclaimer: It is acknowledged that I’m not the stereotypical salesperson. Type A personality I am not; highly competitive I am not. When selling services, I believe that people buy/purchase/select services and solutions from someone they know and trust; also known as relationship selling.

So all that is to demonstrate through this short story:
I recently attended a virtual and regional conference on managing clinical supplies for clinical trials. There were ~80 people in attendance. I noticed one or two salespeople for manufacturing and packaging companies, none from drug supply management software companies. At the end of the meeting, a request is made of the attendees for topics they’d like to hear about at the fall meeting. A specific request was made on the topic of managing study drug pooling by the drug management software. The leader then asked if anyone had recommendations on who could speak to this.

Posted in the chat window was this: the name of one of the software companies followed by the names of two of that companies’ project managers.

I trust the moral of this story is obvious.

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.

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).