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FOCM Membership Ceremony

From the archives – wow how could it be 5 years ago already. Yes I’m that far behind in posting. Starting Global Life Sciences Alliance https://globallifesciencesalliance.com/ in 2020 has kept me very busy. However, one credo* that FOCM lives by is there is no time limit to posting membership ceremonies and we refuse to not share these fine individuals caught in one of the happiest moments of their lives. This is evidenced by my most recent post from 2018 – https://focmnetworking.com/networking/focm-events-happen-spontaneously/

The subject of today’s post is from a FOCM networking event in Houston, TX in September 2019. The event took place on September 10, the night before the Outsourcing for Clinical Trials Texas conference. It was held at Goode Company Armadillo Palace; 5015 Kirby Dr, Houston.

I know a lot of people in the Houston metro area from having worked for ICON Clinical Research’s Interactive Technology Group with its headquarters in Sugarland, TX. So I was happy to be attending an event in Houston – giving me a reason to have a networking event and reconnect former co-workers and friends.

Receiving their membership cards in the traditionally somber ceremony, Trish Jacquet, now with Medidata Solutions and Matt Foster, now with Veeva Systems could not contain their excitement.

*any and all credos are subject to change at the whim of FOCM’s founder

FOCM Events happen spontaneously

What a difference 6 years makes, right? In that era known as PC (pre-Covid), when we were free to move about the country and gather at indoor facilities shoulder to shoulder and still shaking hands and hugging people.

A lot of words to say that I’m way behind in posting FOCM photos. So this is from June 2018 and occurred at Ruckus in Cary. Pictured are Gayle Grandinetti (Illingworth Research), Matt Comstock, Chris Wurst (WEP Clinical) and Entrane Harvey (WEP Clinical). Sadly, Entrane passed away in July 2023.

And get this, Matt and I attended the same high school in Yuma, AZ called Kofa High School. (He was there a few years after me.)

June Networking Event Summary

June 12 FOCM | GLSA Online Networking Event Recap

2024 Mid-year Highlights: A Successful Gathering

On June 12, FOCM and Global Life Sciences Alliance (GLSA) hosted an engaging online networking event focusing on the 2024 mid-year highlights. The event saw a robust turnout with 35 participants, blending familiar faces with new members, fostering a vibrant and dynamic discussion.

Opening Remarks and Industry Updates

Chris Matheus kicked off the event with a warm welcome, introducing new members and setting the stage with industry updates, news, and conference reviews. Participants shared their travel plans, locations, and upcoming trips, adding a personal touch to the professional gathering.

Networking and Collaborative Initiatives

The meeting adopted an open house format, encouraging participants to share their LinkedIn profiles for seamless networking. Chris also promoted the Women of Life Sciences virtual event and called for volunteers to judge the best giveaways at the upcoming DIA, led by Sheila Mahoney-Jewels (smj@lifescihub.com).

GLSA’s Mission and Conference Insights

The GLSA reiterated its mission to provide solutions for clinical trial issues. Michael Young, Brian Langin, Cameron Robinson, and Denise McNerney shared insights from the BIO conference, which boasted over 19,000 attendees. Michael also reviewed the heavily attended ASCO conference, noting a significant presence of first-time exhibitors and attendees.

Business Update and Market Analysis

Chris Matheus presented a detailed analysis of the business performance in the first half of the year. He discussed the initial surge in activity, followed by a slowdown in decision-making and funding optimism. Chris also covered the recent Federal Open Market Committee meeting, touching on global uncertainties and their potential impact on market trends, including the upcoming US presidential election and geopolitical tensions.

Advances in Drug Approvals and Precision Medicine

Recent advancements in drug approvals for NASH/fatty liver and Alzheimer’s were highlighted, with Michael Young discussing precision medicine’s role in oncology drug development. Notable Labs’ blood test and Keliomics’ ex vivo tumor models, presented at ASCO, were showcased as revolutionary innovations that could transform early-stage development.

AI and ML Applications in Clinical Trials

Chris Matheus explored the applications of AI and machine learning in clinical trials. He highlighted the potential for large-scale simulations and AI tools to predict patient enrollment and rank doctors. Despite enthusiasm, participants expressed skepticism regarding the current state of these technologies, particularly in patient enrollment and regulatory validation.

Challenges in Patient Enrollment and Hiring Trends

The discussion also addressed the challenges in patient enrollment post-COVID and hiring trends. Michael Young and Chris Matheus were optimistic about the resurgence of in-person conferences, citing high attendance at recent events. Lisamarie O’Brien highlighted the difficulties in hiring, emphasizing the need for smarter recruitment strategies and the role of AI in applicant tracking systems.

AI in Language Translation and Clinical Studies

Duncan Shaw highlighted the challenges of using AI for language translation and clinical studies, stressing the need for exactness and precision. The group echoed these sentiments, agreeing on the importance of patience and caution in evaluating AI’s potential in these areas.

AI and Budget Building Challenges

Mike O’Gorman shared concerns about AI’s capabilities in budget building, while Ira Snyder emphasized the limitations in obtaining precise budgetary details due to data quality issues.

Site Negotiations and Challenges

The slow progress in securing site contracts was discussed by Michael Young and Jane Myles, with Viljena Trask highlighting the competitive nature of oncology site selection. Eliana R. Burke shared an encounter with a highly experienced clinical trial site, and Ira Snyder emphasized the need for balanced negotiations for successful collaboration.

If you would like a copy of the slide set, email me at chris@focmnetworking.com

or if I did this correctly you can get it here: https://globallifesciencesalliance.com/wp-content/uploads/2024/06/2024-Mid-year.pdf

Looking Ahead

The next GLSA event is scheduled for July 17, with the subject yet to be determined. To stay updated on GLSA | FOCM events, sign up here. Stay tuned for more updates and we look forward to seeing you at our next event!

ATTENDEES:

(First time attendees in bold)

Judy Woods

Jane Myles

Viljena Trask

Bill Dirkes

Tom Lo

Lauren Sherwood

Ira Snyder

Cameron Robinson

Eliana Rivera Burke

Jared Byer

Joan Chambers

Lori Leathers

Jon Carlson

Christine Martin

Hiro Matsushima

Duncan Shaw

Lauren Merante

Lisa Marie O’Brien

Michael Young

Marlyn Brookins

Dr. Syed Rooh ul Arifeen Naqvi

Irene Rivera

Julia Oxley

Yuko Terasawa

GLSA

Denise McNerney

Jim Sarene

Kelvin Izevbekhai

Rocio Rayna Reyes

Timmina Williams

Chris Matheus

Wilmington Life Sciences Event May 23

We had a great turnout at the May 23 Wilmington Pharma/Bio/CRO Networking event.

We had a great turnout at the May 23 Wilmington Pharma/Bio/CRO Networking event. Thanks to all who were there. Mishelle Smith with the Cystic Fibrosis Foundation Raleigh office was able to share with many attendees information about the Wilmington “Pipeline to a Cure” fundraiser taking place on August 3rd.

https://events.cff.org/ncpipelinetoacure

We also had a good turn out from out of towners: from Raleigh: Duncan Shaw of DTS Language Services, Brian Horan of SupplyRx, Kalyn Dozier of IDDI, Brian Stigall of BioBridges and from New Jersey, Mike O’Gorman with Life Science Marketplace and SeeMedX.

Others in attendance: Steve and Sandie Simpson, Brittany Hayes Savoca, Tracey Hopkins, Sandy Agrella, Emma Eckler, Wayne Whittingham, Michael Barron, Doug Denny, Liz Luke. A few photos were taken:

Doug Denny, Precision for Medicine and Wayne Whittingham, CardioPharma

Wayne Whittingham, CardioPharma and Brian Horan, SupplyRx

May 15, 2024 GLSA | FOCM Networking event

The May FOCM and GLSA Networking event featured Boreas Monitoring’s innovative answer to protecting biologic material stored in liquid nitrogen.

Fifteen people attended our May event.

We opened with input from others about recent attendance at a variety of conferences. Whereas the first quarter of the year had conferences exceeding typical attendance and a buzz of activity, the 2nd quarter seemed flat, with typical attendance and the feeling of a lull in activity. As discussed in one of our events this past fall, so much uncertainty in the world causes people to be conservative and hold back in spending money and starting projects. Those factors are:

Israel – Hamas war
Ukraine – Russia war
US Inflation
US Interest rate
US Presidential election
Predictions of recession

The presentation title was: Proactive vs Reactive Cryotank Management and Will Baird, a co-founder at Boreas Monitoring was the presenter. Boreas was founded in Wilmington, NC. Chris Matheus had seen Will present at an entrepreneurship/venture funding event at the Marine Biotech Center at UNC Wilmington in 2023.

Boreas was founded by lab professionals with over 80 years of industry experience owning/operating fertility laboratories. The CryoScout system was developed while the founders managed cryotanks, identifying inherent flaws in the temperature-based monitoring systems commonly used throughout the industry. It was accelerated by two high profile tank failures in 2018 that resulted in millions of dollars in lawsuits and catastrophic loss of patient samples, destroying people’s hopes & dreams of having children. They developed and patented a weight-based monitoring system — the most reliable method of determining the evaporation rate of a cryotank. It can detect a failure up to 84 hours earlier than temperature-based methods, giving labs a data-driven solution to monitor their tanks, along with enough time to save samples from being destroyed.

As a reminder, treat these events as an “open house” – drop in when you can and leave when you need to. The link to get notifications of our future online and live events is: https://bit.ly/3UTb8hL

As our passion is to connect people and companies we know, like and respect to other people and companies we know, like and respect we always have everyone put the link to their LinkedIn profile in the chat to allow for easy connecting and future follow up.

GLSA’s LinkedIn page can be reached here: http://www.linkedin.com/company/global-life-sciences-alliance/

A reminder that Global Life Sciences has a select network of 50 clinical research service providers and we want to be seen as a resource to you and to the industry. So when you run into an issue or have a need, give us a call. It’s what motivates us, we quickly reach out to our contacts to find the solution you’re looking for.

The next event will be on June 12, a week earlier than normal due to the DIA Annual Meeting. The focus will be on a review of the first half of the year – comparing to last year and seeing what the sense of the industry is: trends, changes, etc.

ATTENDEES:

Will Baird	Boreas Monitoring
Jeanne Schow	Bleu Sales Leadership
Michael Young	biomedwoRx
Steve Sisson	MLM Medical Lab
Allie Ash	Colorado State University
Brandon Cantwell	Clinical Project Manager
Cameron Robinson II	Mustard Seed PMO
Eliana Rivera Burke	GreenLight Clinical
Joan Chambers	Tufts
Karen Tkaczyk	Vistatec
Lakshmi Ethirajan	Smabio
GLSA
Denise McNerney
Chris Matheus
Alex Hoppe

October 2023 Networking Event Summary

As our passion is to connect people and companies we know, like and respect to other people and companies we know, like and respect, we open the meeting by asking everyone to put the link to their LinkedIn profile in the chat window. This facilitates future communication and connections.

Before we started on the focus of the evening’s session we shared industry information, gossip and news. Some people were preparing to attend OCT New England and CNS Summit.

At this point, we had 23 attendees and we turned to the topic at hand. What is causing the industry slow down? We chose the topic as we’d been hearing from various sources about how slow things are. One 200 person CRO, in business for 15 years said they’ve never seen it so slow with no pending proposals and no RFPs being issued. People in job search mode have stated that open positions don’t seem to be getting filled. Recruiters in our industry state that job hiring decision are being slow walked. One CRO said they’ve been awarded a project six months ago and study start up activities are moving at a snail’s pace.

A number of factors were discussed and are bulleted below. Overall it comes down to uncertainty about the near term future.

Unintended consequences of the Inflation Reduction Act and the impact of Medicare mandated price negotiations
2024 is a US presidential election year
The war between Ukraine and Russia
The war between Israel and Hamas
Inflation
Concerns over a recession
All this makes for tight capital markets

The presentation which was put together ahead of time and subsequently additional pieces of information were added and if you would like a copy of it, please email me at chris@focmnetworking.com

After discussion of this, we had enough time to move into break-out rooms of 2-4 people for about 10 minutes and did this two or three times.

It was announced that the November 15 event would feature a focus on patient recruitment with iEnroll Digital leading the discussion.

Attendees:
Joseph Cheng, PiVOT
Lauren Merante, UNC Graduate pursuing a career in the clinical research industry
Steve Sisson, MLM Central Labs
Matt Stumm, Stark/Raving
Gabrielle DeBoer, Stark/Raving
Sarah Ebner, Investigator Support Services
Mike O’Gorman, Life Science Marketplace
Sara Tylosky, Farmacon
Violet Votin, Machaon Diagnostics
Lakshmi Ethirajan, SmaBio Labs
Maggie Phipps, SUNY Graduate pursuing a career in the clinical research industry
Viljena Trask, Syneos Health
Joan Chambers, Greater Gift
Gideon Adjorgenu, PharmD, Fresenius Kabi
Brian Langin, Consultant
Eliana Rivera-Burke, GreenLight Clinical
Ira Snyder, Consultant

GLSA Attendees:
Megan Hoffman
Jeff Sedgley
Denise McNerney
Charity Dube
Timmina William
Chris Matheus

Reminder of the meetings’ guidelines:

Think of this as an open house event – drop in when you can and leave when you need to;
When we have a presenter we have them start when we have assembled a strong amount of respondents – usually 10-15 minutes after the start.
Presenters’ topics are not sales pitches – the focus is on an aspect of clinical trials; where in the process their services are used and aspects of that step.
The link to get the GLSA newsletter and notifications about future live and virtual events: http://bit.ly/3UTb8hL
We ask everyone to put their LinkedIn link into the chat to facilitate connecting and future follow up.
To read the May summary https://globallifesciencesalliance.com/the-may-focm-glsa-networking-event/

FOCM Membership – New Member

Is it possible I’m almost 10 years behind in posting membership photos??!!?? Why yes, yes, it is possible and entirely true. But with my dogged persistence, in the end we’ll be all caught up.

Whilst (I love using this old-timey word whenever I remember to throw it in) I wish I were more caught up, sometimes its nice to see things from long ago. Remember taking your film to be developed and then waiting for the pictures to be ready. Sometimes it would days to months since the time the photo was taken.

So here is Gracelyn McDermott pictured with her FOCM membership card which I mailed to her as I was out of them at the (I think it was) DIA 2014 and mailed it to her. Grace and I worked together at ICON for about 10 years.

She took a photo of herself with the card so that I could post it. I assure you that when she learned that she was getting her membership card, she was exuberantly happy and delighted. FOCM is proud to say that her career has skyrocketed ever since. Grace is now the

FOCM Networking a cold night

So on March 12, 2018 having given much more notice than usual, the plan was to have a FOCM networking event the night before the Outsourcing in Clinical Trials Southeast event. As fate would have it – the original location – Serenas on Highway 55 and Page Road in Durham was closed due to projected inclement weather (snow!). So last minute announcement went out to move it to Mez. These brave souls weathered (pun intended) the conditions and showed up. Their standing in FOCM was cemented with that effort.

FOCM Event at Mez (Drew Harrison, Derrick Ferrar, (name needed), Steve Caravaglio, me, Chad Pollio, Carol Miller, Pippa Wilson, Bernie Linner, (name needed)

Observations of DIA 2023

The first Drug Information Association (DIA) Annual Conference that I attended was the one in 1997 in Montreal. If one could look back at each of them through time lapse photographs quite a story it would tell. In bullet format:

The growth of the CRO industry through mergers and acquisitions
Scirex was the late night party sponsor
Fax and OMR/OCR data collection was a high-tech blip on the screen until –
EDC appeared with much noise but took longer than necessary to be adopted due to the inherent risk-aversion in the industry
Global trials for phase III studies
Patient recruitment via advertising had great stories to tell of saving trials
Transperfect is the late night party sponsor
Randomization and Drug Management system advances led to the ability to do increasingly complex trials and save millions of dollars in reducing drug waste
ePRO proved that paper diary data wasn’t reliable
Patient recruitment adjusted to pay for results (randomized patients)
eTMF vendors increase
Risk-based monitoring software appears
Integration of multiple sources of data
CluePoints is the late night party sponsor
Forced by Covid-19 we learned how to conduct decentralized trials, remote monitoring visits, mobile sites, tele-visits
Figuring out how to get EHR/EMR data into clinical trial databases
Insurance claims data allowing for Real World Evidence trials
The importance of patient diversity in clinical trials
AI gives a peek at our new future incredibly shortening study start-up: scan of protocol creates informed consent, eCRFs & edit checks, site instructions in 30 minutes not 8 – 12 weeks

These advances promise a brighter future for the population with illnesses seeking to be healthy and maximize quality of life.

I make a point of walking the entire exhibit hall every year. It allows me to sense the change in the needs of the industry, the new products, new services. I can also run into people who may have changed companies since our previous interactions. When I talk at the first time attendee orientation on Monday morning, I recommend everyone visit the exhibit hall and to be inquisitive – look at what the exhibitors are doing, ask questions, find opportunities to be helpful and/or build relationships and connections.

The content presented at DIA is prepared, submitted and presented by industry members who voluntarily do so. I encourage fellow industry members to submit an abstract. Abstract submissions are due September 14. The topics of interest and the instructions for submitting an abstract can be found here: https://www.diaglobal.org/abstract/meeting-details?productID=13251490&productcode=24001CFA

As a speaker, you receive a significant discount on the conference registration. It’s also a good addition to your career experience and can help you in networking and being seen as a key industry expert.

We hope to see you at DIA 2024 in San Diego.

May 2023 Networking Event Summary

May 17, 2023

As our passion is to connect people and companies we know and respect to other people and companies we know and respect, we open the meeting asking everyone to put the link to their LinkedIn profile in the chat. This facilitates future communication and connections.

Before we had our featured presenter begin, we shared industry info and upcoming events. A newish conference called: Clinical Research as a Care Option took place in Raleigh in mid-May. We mentioned that we’d be holding a networking event the night prior. It was stated that Joan Chambers would be attending. Joan recently joined Greater Gift as the CEO. Greater Gift’s mission is to increase awareness of clinical trials, especially among unrepresented communities, like women, ethnic minorities, individuals from diverse socio-economic and educational backgrounds. ds.

At this point, we had 21 attendees and we turned over the meeting to Steve Galen, PhD with Validcare. The focus of the presentation was to talk about how not to run out of funding before you get a read on the success of your product. Validcare has the tools and technology to forward plan a trial, find potential bottlenecks and prepare for them. With so many eclinical tools available, the predictability of the cost of a trial is greatly improved. This disruptive change shakes up the traditional and archaic approach of CRO’s low-bidding a project only to begin issuing change orders shortly after the study starts. Such an approach prevents the biotech from managing their financial spend. Steve is an experienced clinical research professional having worked at Merck, Covance, PRA, Syneos and Navitas.

Reminder of these meetings’ guidelines:

Think of this as an open house event – drop in when you can and leave when you need to;
When we have a presenter we have them start when we have assembled a strong amount of respondents – usually 10-15 minutes after the start.
Presenters’ topics are not sales pitches – the focus is on an aspect of clinical trials; where in the process their services are used and aspects of that step.
The link to get the GLSA newsletter and notifications about future live and virtual events: http://bit.ly/3UTb8hL
We ask everyone to put their LinkedIn link into the chat to facilitate connecting and future follow up.
To read the April summary https://focmnetworking.com/networking/april-2023-networking-event-summary/

Attendees:
Steve Galen, PhD, Validcare & the evening presenter
Ira Snyder, Consultant
Holly Jochims, Adaptive Clinical Systems
Joan Chambers, Greater Gift
Brian Langin, Diligent Pharma
Mike O’Gorman; Life Science Marketplace
Kevin Boos; Aixial Group
Amy Lee, PharmD
Michael Young, biomedwoRx
Ali Hussein, Science 37
Viljena Trask, Syneos Health
Sumitra Sheeri, S-Clinical

GLSA Attendees:

Katie Barrett
Joe Buser
Chris Matheus
Denise McNerney
Hannah Lloyd
Timmina Williams
Charity Dube
Jordan Brown
Sally Haller
Ori Geshury
Liz Mirra

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