clinical trials | FOCM Networking

February Networking Event Summary

On February 16, 2022, the Global Life Sciences Alliance along with FOCM Networking held its monthly online drug and medical device development industry networking event. This was the second event of 2022 and like the January event, we again had 3 first-time attendees. Thank you to super-connector and FOCM member, Nadia Bracken for sharing our event with others.

We spent the first 15 minutes with introductions and general discussion about the weather in various attendees’ cities.

This event featured a presentation by Kalyan Ghosh, Founder and CEO of Inference, Inc (https://inferenceinc.com/). Inference, a GLSA client, was formed in 2017 by Kalyan. He has over 25 years experience in clinical biostatistics, having worked at both big pharma (Merck and BMS) and CROs (Vislation, INC Research and West Coast Clinical Trials). Kalyan is an accomplished presenter and presented an overview of biostatistics and the role that data management and biostatistics have in drug development.

Please join us next month on March 16 at 7:00 p.m. Wessam Sonbol, CEO of Delve Health, an e-clinical technology platform service provider and client of GLSA will spend 10 – 15 minutes talking about their approach to patient-centered hybrid and decentralized studies in drug development.

ATTENDEES (bolded names were first time attendees):

Kalyan Ghosh, Inference Inc,
Andy Mulchinski, Symbio
Justin Gundelach, Mayo Clinic
Pauline Luong, Creative Clinical R & D
Chris Bergey, NaviDx
Brian Langin, Matrix Medical
Ravipal Luthra, University of Miami College of Medicine
Jon Matheus, A.T. Pancrazi Real Estate Services, Inc.
Chris Matheus, Global Life Sciences Alliance & FOCM
Denise McNerney, Global Life Sciences Alliance
Joe Buser, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance
Holly Cliffe, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance
Hannah Lloyd, Global Life Sciences Alliance
Todd Nielson, Global Life Sciences Alliance

Screenshots of the attendees can be seen here: https://globallifesciencesalliance.com/february-networking-meeting-summary/

Observations: CNS Summit Conference 2021

The CNS Summit, a year-round community with an annual in-person Summit was held at the Encore Resort Boston Harbor. It was very well-attended with over nine hundred registered. There was a feeling of pent-up need for networking and reconnecting. It is quite apparent that participants at this meeting are enthusiastic to be attending in person. The joy and happiness of seeing friends, colleagues (past and current) and being able to freely move about and make new connections was palpable. There is such a willingness to hear about what each other is up to, has learned and is doing different since the last time we gathered in person.

Rapid antigen testing was conducted rapidly for Covid-19, and a negative test result (within about 15 minutes) indicated by a wristband provided, allowing access to the Summit. The testing was provided by CNS Summit in partnership with Care Access. The process went off flawlessly, a great testament to the Care Access and CNS Summit staff involved.

There were many exhibitors, patrons and sponsors. To see which companies participated, I recommend you go to the website: https://cnssummit.org/

Digital Biomarkers, Artificial Intelligence, Machine Learning, Big Data, Patient Diversity, Real World Data were among many Spotlight topics. As an example, Sharecare and UCB presented real-world data on patients with Myasthenia Gravis. The insights learned, the new endpoints discovered and the capabilities of the smartphone in such trials was impressive.

Below is the expanding list of companies that define themselves as DCT clinical trial service providers. Go to https://www.dtra.org/ Decentralized Trials & Research Alliance to fully appreciate the expansion of companies and organizations in and/or getting into the decentralized research segment of our industry.

Curebase	Circuit Clinical
Medable	Science 37
TrialBee	Thread
CaptureProof	Care Access
Clinical Ink	DataCubed Health
Medocity	Medidata
ShareCare (SmartOmix)	Science 37
	SiteRx

If you are interested in the CNS Summit community and the opportunity for interacting within it year round, you can apply at the organization website, which is listed above in paragraph 3.

And on a sad note, Medidata co-founder, Glenn DeVries who attended and presented at the conference passed away November 11 in a private plane crash in New Jersey.

Meeting Summary of FOCM & GLSA Event

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 22 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

FOCM Networking Person of the Year for 2020

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 decline of daily new cases. Many people have now received 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.

FOCM Networking Meeting Minutes

Can you believe it? These are the meeting minutes from the November 5, 2018 event in Boston. Many of the attendees were in town for the Outsourcing in Clinical Trials New England meeting. My sparse notes indicate that this was held at the lobby bar in the Westin Boston Waterfront.

We had great attendance with my hastily written down names on a piece of paper indicating the following individuals were in attendance:

Roy Ovel (we worked at ICON Clinical and have known each other 13 years)
Scott Keddy (known each other for 6 years)
Mike (last name not written down, so its clearly a good friend who I should remember or predict)
Matt (going to guess this is Matt Comstock – known each other 5 years and attended the same high school in Yuma, AZ)
Vicky Martin (known each other 16 years; also worked together at ICON)
Kate Mullis (known each other for 4 years)
Bonnie Phillips (known each other for 3 years, met via networking in NC)
Daniel Frederick (known each other for 3 years, met via networking in NC)
Bryan Clayton (known each other for 7 years, worked at YPrime together)
Katherine Cloninger (known each other 20+ years, worked at Quintiles together)
Ted Gastineau (known each other 20+ years, worked at Quintiles together)
Bill Taaffe (known each other 18 years, worked at ICON together)
Brian Langin (known each other 20+ years, worked at Quintiles together)
Chris Utterback (known each other 4 years and we the same birthday)
Susan Cook (known each other 2 years, I think we met that night, Brian Langin invited her, I believe)
Adam Blackburn (known each other 7 years, worked at YPrime together)
Cory Winters (known each other for 3 years, Vicky Martin brought him into FOCM)
Dave Rosa (known each other 11 years)
Paul Eisenmann (known each other 20+ years, worked at Quintiles together)
Jennifer Carpe (looks like an n, then….; could be Carpenter from BioTel; colleague of Cory?)
Lianne Kloppenburg (known each other 9 years)
Kristina Wolfe (although my notes indicate Figueroa was the last name at the time; known each other 3 years, we both live in Wilmington, NC)
Nicole Powell (known each other 5 years)

For those of you in this industry, this list reads like a list of all-stars, right? Unfortunately, photographic evidence of the gathering was not collected that evening.

Ocean-side Networking

The July networking event for the Wilmington Pharma/Bio/CRO Networking Group was held at Dockside in Wilmington. Dockside is located on the west side of the IntraCoastal Waterway. This is the site for this group’s events in the summertime. Wilmington Pharma/Bio/CRO Networking Group can be found on LinkedIn where updates to monthly events are posted.

Fortunately someone snapped a photo at some point so that we have some record of attendance. Not that attendance is ever taken and far too often we forget to take a picture.

L-R: John Cline, Lee King, Andrea Young, Jennifer Hutchison, Jackie Bilobran, Gayle Grandinetti, Chris Smith, Chris Matheus

FOCM Networking Event Meeting Minutes

May 9 found me in Durham, NC for a date with Durham Traffic Court the morning of the 10th. As you know, any excuse for meeting up with friends is kinda my life’s mission.

Notification was sent out to 63 people via Google calendar. 24 people opened the calendar invitation and responded with yes, no or maybe. I believe we had 13 attend. By the time we thought to take a picture, a few had already left. The location was Boxcar Bar & Arcade on Foster Street in Durham.

In attendance were: Don Alexander, Cynthia Edwards, David and Jaclyn Holland, Eric Nier, Gail Fowler, Kris Gustafson, Hillary Whittaker, Lauren Sherwood, Tim Sauls, Jeff Blum, Duncan Shaw and representing the PA Chapter, Vicky Martin.

New FOCM Member

On June 28, 2019 while attending the annual Drug Information Association (DIA) meeting in San Diego, FOCM was busy expanding its network. All new membership ceremonies are significant and strict adherence to protocol is (almost) always followed. This particular ceremony included a new addition to the protocol. FOCM is pleased to announce that Jodi Andrews, Founder and Co-CEO of Pro-Trials Research received her membership card.

This ceremony took place on the exhibit hall floor. What was added to the procedure for this ceremony was a shot of bourbon prior to the handshake, card presentation and photo. Later, a small pour of Fireball was distributed to the new member.

FOCM Surprise Event

It was a typical Halloween Eve evening, weather-wise in Raleigh, North Carolina. It should come as no shock to anyone that it was also October 30. I’d rather hastily organized the 10/30 FOCM event just the day before as Brian Langin was coming to town. Brian has the distinction of receiving the first FOCM card ever handed out. So clearly, he was worthy of me getting people together.

Brian was first to arrive, followed by me and then surprise, surprise, surprise, Paula Brown Stafford joined us. Paula and I have known each other for 22 years when I first started in the clinical research industry working at Quintiles together. She has said to keep her on the FOCM event distribution lists as someday she just might surprise me and show up.

In what can only be described as one of the happiest moments of her life, Paula received her FOCM card.

It was a fun evening. Others in attendance: Rob Sucharski, Duncan Shaw, Peter Payne, Lauren Sherwood, Heather Malinowski*, Steve Young, Peter Weiman*.

*1st time attendees

FOCM Welcomes New Members

On a warm, pleasant evening in October, the 1st day of the month to be precise, a significant event in FOCM history occurred; 4 new members received their cards.

I was in the RTP area to attend the Arena International Clinical Trial Supply Southeast meeting and hosted a FOCM networking event at the Sheraton Imperial Lobby Bar.

Attending that night were long time* members as well as first timers+. As best I can recall, the following people were there: Michael Williams*, Kris Gustafson*, Mike Burrows*, Rosina Pavia*, Paul Oldfield*, Tim Sauls*, David Holland, Carolyn Waff+, Lauren Sherwood, Israel Bocanegra+, Shae Wilkins* (traveled the farthest) .

Receiving their membership cards were: Lauren Sherwood, Carolyn Waff, David Holland and Israel Bocanegra. As you can expect, emotions ran high during the card ceremony, with many people wiping tears from their eyes. The look of sheer joy on their faces the moment they realized they’d completed the sometimes long, sometimes short, but neverthless arduous and rigorous initiation process.

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