September Networking Event Summary

The GLSA | FOCM Networking Event on Wednesday, September 21, 2022 at 5:00 PM EST was a fascinating presentation by Patrick McCarthy and Steve Galen of Validcare about a disruptive approach to the conduct of clinical trials. Recent advances in technology and learning to do things remotely due to COVID-19 helps make this possible. Not only is it possible, it is being done and Validcare is at the forefront.

https://validcare.globallifesciencesalliance.com/

The current clinical trial paradigm is broken. Decentralized clinical trials are proving not to be the solution. They’re merely a bolt-on expense that helps with patient access and engagement. DCTs do not reduce costs nor delays caused by inefficient data management, staffing and software systems. Validcare’s Digital 1st CRO Experience succeeds where DCTs do not. Finally we have the ability to fix the CRO Model and put an end to low-ball proposals to win the project followed by significant change orders shortly after study start-up.

Validcare’s platform puts the entire study in one cloud environment. This has been built by experienced industry insiders who knew that to fix the CRO model it had to be re-engineered from the outside. The platform has been designed on these principles:

  • Transparency
  • High performance
  • Low maintenance
  • Turn-key

As such it provides for predictable financial performance allowing for a fixed price for study conduct.

To nobody’s surprise, we couldn’t stay away from discussing the Fall conference schedule and who was intended to go to which events. It looks like a full return to in-person events with DPharm, SCDM, OCT New England, CNS Summit, MAGI West, CTS East Coast, etc.

Andrew Mulchinski stated that Symbio hasn’t fully adapted to DCT yet, sparking the post-quarantine observations of many regarding the transition to decentralized and hybrid studies.

Let’s continue to reinforce our collective goal to improve patients’ lives across the globe. If you would like to present on an educational life sciences topic and spur our event discussions, please leave a comment below and I’ll reach out as soon as possible.

Attendees (first time attendees in bold):

Julia Love, CEO, Love Contracts
Candy Dupree, National Sales Director, AdamsBridge Global
Himanshu Desai, Global Head PV QA, Novartis
Mike O’Gorman, CEO Life Science Marketplace
Mindy Bertram, Owner, CMB Consultants
Andrew Mulchinski, Business Development, Symbio Research
Wayne Whittingham, Vice President, Regulatory,  Cardio Pharma
Duncan Shaw, CEO, DTS Language Services
Katherine Cloninger, Senior Director, Brand Marketing, Parexel
Ravi Luthra, Clinical Research Coordinator

GLSA:
Chris Matheus
Joe Buser
Holly Cliffe
Denise McNerney
Sally Haller
Hannah Lloyd-Clark

A few screenshots are below:

Screen Shot #3

August Networking Summary

Buying and Selling with Great Technology!

The GLSA | FOCM Networking Event on Wednesday, August 17th, 2022 at 5:00 PM EST was expectedly light in attendance with many of our friends and colleagues taking a well-earned break during these summer months. 

Our guest speaker, Michael O’Gorman, CEO of Life Science Marketplace, treated us to a demonstration on how to use his innovative pricing tool for Sponsors and Vendors to connect and access more information, providing a more competitive bidding experience and allowing vendors to highlight their strengths and set themselves apart from the majority. 

Our own Chris Matheus and Denise McNerney were attending a live event that GLSA and FOCM Networking were co-hosting with ProTrials Research in Raleigh, NC at the AC Hotel Level 7 Rooftop Bar and thus did not join our virtual meeting. 

For those who missed the event and would like to learn how to buy and sell with Michael’s platform, please feel free to watch the video:

Insert video link here:

 

For more information or to schedule a more in-depth demonstration please contact “>Hannah Lloyd or fill out this form and we will be happy to assist you.

Let’s continue to reinforce our collective goal to improve patients’ lives across the globe. If you would like to present briefly on an educational life sciences topic and spur our event discussions, please leave a comment below and I’ll reach out as soon as possible. Our next event is scheduled for September 21 and CoolChain has been invited to discuss how how to ship and maintain temperature controlled shipments with eco-friendly reusable cold chain shipping containers. 

Attendees included people from these organizations:

biomedWorx,  Life Science Marketplace, Cmed Clinical Services, Curebase,  EmVenio as well as several GLSA staff.

Photos of the event:

Engaged attendees
Capture of the action

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

Virtual Conference Observations

Observations on Virtual DIA 2020

2020, the year of the COVID-19/Protests/Riots/Presidential Election and the year the clinical research industry’s annual convention went virtual.

The noteworthiness of this made me think to jot down my observations.

I have been attending DIA since 1997. That year it was held in Montreal. Last year was in San Diego, which is probably the best place to have it in terms of weather.  The conference is always in the 3rd or 4th week of June.  The heat and humidity in Chicago, Philadelphia, Baltimore, and Boston has often been close to unbearable.

The biggest differences for me were:

  • I didn’t get to co-host the FOCM Networking event with my friends from Zymewire
  • I missed seeing everyone! Not seeing friends in person (this event is very much an industry reunion) and not getting to socialize with them makes it more difficult to maintain relationships
  • Seeing so few friends in the virtual exhibit hall (Thanks Adriana Grado and Amy Zastawney for taking time to meet with me). Every year I make a point to walk the entire exhibit hall to make sure I see and catch up with as many people as I can and to see what new and innovative products and services are available
  • I didn’t stay out too late (there was no virtual Transperfect party or vendor parties of any kind)
  • I didn’t drink too much.
  • I didn’t have a Fireball shot at the Barrington James exhibit.
  • I didn’t welcome any new FOCM members and hold any card ceremonies (I’ll have to re-write the card ceremony SOPs – the handshake may have to be eliminated)
  • Here it is the last day and I’m not exhausted.

As I have often told people younger and/or with less conference experience than me, at DIA – you will stay out too late and drink too much.  I point out that you HAVE to do this (it might even be in the SOP binder), because if you don’t, it wouldn’t be the tradition that it is.

A couple months ago I held a virtual FOCM Networking event with about 10 industry friends. I asked them if DIA were to be held in person, who would travel to DC for it.  The answer was no one.  Comments made were: it’s too risky, I don’t want to get on a plane, stay in a hotel, take a cab or Uber and go to a conference with 5000+ people.

We in this industry are proud of the role we’re playing and demonstrating to the world the value, the need and the method for discovering treatments for COVID-19. The need to utilize recent innovations in big data, AI, high throughput screening, lighten cumbersome regulatory hurdles will serve the world well for developing new treatments for all diseases.

 

 

Get involved through Mentoring

Sharing with you a mentorship program I’ve gotten involved with at the University of North Carolina Wilmington.  FuseCR (Center for Clinical Research Workforce Development) is a collaborative designed to connect UNCW with the field of clinical research.  FuseCR is providing  local clinical research talent with powerful career and industry enhancing services.  One such program is MentorCR which pairs undergraduate students majoring in clinical research with experienced industry professionals in a formal, structured partnership.

My mentee is Keith Reid, https://www.linkedin.com/in/keithtreidjr/ .  Keith is a Junior in the Bachelor’s Degree in Clinical Research program.  While going to UNCW, Keith works as an Advanced EMT at New Hanover Regional Medical Center.  Like many others in the clinical research industry, Keith feels drawn to this as a career having lost both his grandfather and father to heart disease at the age of 50.

Keith and I will meet monthly or more often as needed.  Given my passion for connecting people, some of you can expect to hear from me requesting some of your time to talk with Keith on career path options and to share your experience and perspective.

The UNCW Clinical Research degree program is impressive in preparing students for entering into the clinical research industry.  Keith has already completed the following certifications:

  • Medidata Classic Rave EDC Essentials for clinical research coordinators | March 2019
  • TransCelerate Essential Documents | February 2019
  • TransCelerate IRB/IEC Responsibilities & Informed Consent | February 2019
  • TransCelerate Facilities & Equipment | November 2018
  • TransCelerate Investigator Oversight Informational Program | November 2018
  • TransCelerate Delegation & Training | October 2018
  • Medidata EDC Inspection Readiness for Clinical Sites | June 2018
  • CITI Biomedical Research Certification | 2018

For more information on UNCW FuseCR and the MentorCR program, read on or go to the links shown.

FuseCR (Center for Clinical Research Workforce Development) is a collaborative designed to ignite a new synergy between UNCW and the field of clinical research. By fusing resources and knowledge from academia and industry, FuseCR is energizing the local clinical research talent with powerful career and industry enhancing services.

https://uncw.edu/chhs/community/fusecr/index.html

  • Build Connections between Academia and Industry
  • Enhance Our Existing Workforce
  • Prepare Students for the Workplace
  • Educate the Next Generation of Talent

The general objectives of these programs and services are as follows:

FuseCR was formed by UNCW faculty from the School of Nursing’s Clinical Research Program and the Math and Statistics Department, in partnership with the NC Biotechnology Center Southeastern Office and the NC Coast Clinical Research Initiative.  This project was partially funded by a grant from the Duke Energy Foundation to strengthen the workforce for the local clinical research industry.

MentorCR for Industry Professionals: FuseCR Mentoring ProgramMentorCR pairs undergraduate students majoring in clinical research with experienced industry professionals in a formal, structured partnership. Engagement opportunities and leadership seminars are offered to further the student’s careers and the industry professional’s mentorship skills, while building professional relationships within the clinical research industry.

https://uncw.edu/chhs/community/fusecr/mentor.html

Mentors meet with their students 2-3 times per month and have opportunities to attend leadership seminars to further their careers while building networks within the industry. This program advances UNCW’s goal of workforce development in health-related fields for our regional community and provides crucial applied learning opportunities for our clinical research students.

Mentors have the opportunity to:

  • Support UNCW students by orienting them to the industry and helping them to build networks
  • Help the local economy by preparing better trained students
  • Experience the personal and professional benefits of being a mentor