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.
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:
Kalyn Dozier, IDDIDoug Denny, Precision for Medicine and Wayne Whittingham, CardioPharmaWayne Whittingham, CardioPharma and Brian Horan, SupplyRx
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.
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.
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.
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.
Gracelyn McDermott membership
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 Vice President, Marketing Sales and Business Development at Kaiser Permanente.
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)
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.
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.
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
The April FOCM | GLSA Networking event started out with welcoming everyone and reminding attendees of the meetings guidelines (shown at the end of this blog post).
Joseph Cheng – of PiVOT was then introduced to the attendees. Joseph caught everyone’s attention with a trivia questionnaire featuring a variety of famous and not so famous Philippine individuals. A sampling of them were: Manny Pacquiao, Lea Salonga, Erik Spoelstra, R’Bonney Gabriel, Dave Bautista and Nicole Scherzinger. This was followed up with facts about the Philippines, such as: English is the official language, cars are driven on the same side as in the US, 4 % of registered nurses in the US are Filipinos, non-communicable disease causes of mortality break out as: 38% cardiovascular, 18% cerebrovascular, 16% cancer and 12% diabetes. The population of the Philippines is 113 million people, with 1.5 million new births annually with an average population age of 25.
A concerted effort was put into the clinical trial landscape such that the Food and Drug Administration of the Philippines approves studies and product imports in 60 days with ethics approvals coming in 45 – 90 days. PiVOT is the leading and largest Philippine CRO with over 100 employees and have recruited over 40,000 patients into clinical trials across Cardiology, Pediatric Vaccines, COVID-19 trials (vaccines and interventions). Rheumatology, Gastroenterology and Pulmonology (Tuberculosis).
Joseph’s presentation was followed by Q and A, after which we broke into breakout sessions for small group networking. These have been well received, allowing individuals to meet with others, learn about and from each other and identify ways in which they can be helpful to each other.
Event 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 receive 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.
Attendees:
Joseph Cheng; PiVOT and the evening presenter Stacey Richardson; FHI Clinical Amy Lee, PharmD; Kaiser Permanente Mike O’Gorman; Life Science Marketplace Peter Payne, Consultant Gabrielle DeBoer, Consultant Michael Young, biomedwoRx Andrew Mulchinski, Symbio Research Rodmar Pulido, PiVOT Susan Jalbert, Oracle Amanda Pexa Weber, Merit CRO Mike Minor, IMA Clinical Research Carlos Martinez, America’s Health Foundation Cherey Bigay, PiVOT Ella Mae Ortegha, PiVOT Kim Lupo, Portrett Pharmaceuticals Mark Borndahl, Zymewire Loretta Cipkus Dubray, Global Clinical Connections Arati Bhosale, Sieve Health
GLSA Attendees:
Joe Buser Chris Matheus Denise McNerney Hannah Lloyd Timmina Williams Charity Dube Jordan Brown Sally Haller Ori Geshury Liz Mirra
The recent discovery of photos from past events continues to bring back good memories. These photos are from a September 28, 2017 Wilmington Pharma/Bio/CRO Networking Event at Johnny Luke’s Kitchen Bar, 5500 Market Street, Wilmington, NC.
This group meets monthly, usually on the last Thursday of the month, but can be changed due to travel and other interruptions. We get anywhere from 8 – 30 people attending. The event is held at different restaurants in Wilmington, allowing us to meet explore other restaurants, brew pubs and food trucks. The group is on LinkedIn and announcements of events are published there.
Abby Richmond Melville sent the photos to me.
Lee King, Ryan Manuel, Mark Aikman and myself are identifiable in the photos. That Abby sent them to me might indicate that Margaret Richmond was in attendance as well.
Lee King and Chris MatheusWilmington Pharma/Bio/CRO Networking
Yes, this is proof that some news improves with time. I have developed an AI algorithm which determines the best time to post stories and events. It’s not always important to be timely. Just as the best wines are aged to perfection, so too, does FOCM apply the same principle.
In June of 2015 at the annual Drug Information Association (DIA) conference, Megan O’Keefe received her FOCM membership card. At the time Megan was working for Synteract. I believe (this is where the aging of posts’ algorithm has a bug – my memory can be fuzzy) we were introduced by Erin Tabet and Kim Martinez at that conference. I am pretty sure that is Kim behind me.
