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.
The March FOCM | GLSA Networking event started out with welcoming everyone and reminding attendees 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.
In GLSA news: it was announced that co-founder, Denise McNerney had moved from Virginia to Florida. She is enjoying pointing out the weather to those north of where she now lives. I gotta say, she’s enjoying it a bit too much.
Cass Hui – founder of Heal Mary was then introduced to the attendees. She shared her story of how she came from the tech industry into the clinical research industry. Her mom first and then two sisters all had breast cancer. Cass encountered frustrations in finding clinical trials for them to consider and decided to apply her experience and skills to making this easier for others. Rather than becoming a patient recruitment company, she provides her service in the software as a service (Saas) model. Multiple patient advocacy and disease foundations are using her platform to inform people about clinical trials. https://healmaryapp.com/search
Cass utilized the kahoot.it platform to poll/question the attendees about clinical trial recruitment information. This was a fun way to get people thinking about the topic and led to a lively question and answer session.
After the Q&A, we broke into separate breakout rooms for people to introduce themselves, their companies and their needs to the others in the room.
The April event will feature Joseph Cheng with PiVOT CRO on the demographics, clinical research experience and capabilities of the Philippines.
Attendees: Cassandra Hui; Heal Mary and evening presenter Stacey Richardson; Parexel Mike O’Gorman; Life Science Marketplace Dave Gibboni, Beigene Amy Lee; Kaiser Permanente Loretta Cipkus Dupray; Global Clinical Connections Peter Payne; Consultant Matthew Plaud, Consultant Nancy Zeleniak; Advocate Health Joseph Cheng; PiVOT Jean-Pascal Rugiero; SVM Pharma Rodan Zadeh; Consultant Kim New, ClinChoice Duncan Shaw; DTS Language Services Maria Frane; Corlexia Gabrielle DeBoer; Consultant Arti Bhosale, Sieve Health
GLSA Attendees: Holly Cliffe Sally Haller Hannah Lloyd Jordan Brown Joe Buser Timmina Williams Megan Hoffman Charity Dube Chris Matheus Denise McNerney Ori Geshury Liz Mirra Alex Hoppe Shiquita Hinton Whitney Davis
The February 15, 2023 FOCM | GLSA Networking event started out with welcoming everyone and reminding attendees 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 good number of people – usually 10-15 minutes after the start.
Presenters’ topics are not sales pitches – the focus is on an aspect of clinical trials, where their services are used and what they offer.
The link to get 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.
In GLSA news: it was announced that we have added PiVOT Health – a Philippines headquartered CRO and Sieve Health, (tonight’s presenter) to our list of clients.
We discussed the recent SCOPE conference and two of the attendees had attended and shared their impressions as well as opinions from others we’d talked with. Mike o’Gorman attended and said that the exhibit hall was full and busy, reminiscent of pre-Covid days. David Holland also attended and felt that the conference meeting portal was challenging as people who were replying to meeting requests did not show up. David felt that the exhibit hall was primarily filled with e-clinical exhibitors. He couldn’t find people to network with as there was a small pool of Pharma people. While in-person conference attendance is recovering from Covid shutdowns, it does appear that pharma and biotech companies are not sending as many people as they used to. Kate Findlen confirmed what David saw and Brian knows happens – anyone with a sponsor company is a target for the Business Developers, inundating them with meeting requests.
Arati Bhosale with Sieve Health was then introduced to the group and she talked about the struggles of finding patients for clinical trials. She co-founded Sieve because of the inefficiency of finding patients for clinical trials. The time it took study coordinators wading through EMR/EHR data which was not designed for easy sorting/filtering was staggering. That drove her to find a better, more efficient way using the newest technology. The result is a reduction in the time to do this effort by around 75%. This is making sites happy as their study coordinators can better allocate their time to the trial and patient tracking. The timing of her service is important. Decentralized trials has increased the burden on study coordinators leading to burnout and turnover.
Each of the new attendees were able to introduce themselves to the group. We then ended the meeting as there weren’t enough people to go into separate break-out rooms.
Attendees:
Arati Bhosale; Sieve Health Nadia Bracken; Clinical Project Management Consultant Mike O’Gorman; Life Science Marketplace Brian Langin, Diligent Health David Holland; cMed Research Ravi Luthra; University of Miami, Miller School of Medicine Kate Findlen; Nimbus Therapeutics Joseph Cheng; PiVOT Cassandra Hui; Heal Mary Duncan Shaw; DTS Language Services Michael Young; biomedwoRx
GLSA Attendees: Holly Cliffe Sally Haller Hannah Lloyd Jordan Brown Joe Buser Timmina Williams Megan Hoffman Charity Dube Chris Matheus
A couple snapshots from the event are below:
February 15 Screen Shot #1February 15 Screenshot #2
The January FOCM | GLSA Networking event started out with welcoming everyone and wishing everyone a Happy New Year!
A review of the events guidelines was stated – think of this as an open house event – drop in when you can and leave when you need to; when we have a topic and presenter we have them start when we have assembled a good number of people and that’s usually 10-15 minutes after the start. Presenters’ topics are not sales pitches – the focus is on an aspect of clinical trials, where their services are used and what they offer.
The link to get notifications about our future live and virtual events>> http://bit.ly/3UTb8hL
As our passion is to connect people and companies we know and like to other people and companies we know and like, we asked everyone to put into the chat the link to their LinkedIn profile. This allows for quick and simple connecting and facilitates future follow up.
We opened the event sharing industry updates, news, and/or gossip that anyone wanted to bring up. Then the focus of this event was on cold chain logistics. Loretta then began the presentation portion with an overview of managing cold chain shipments. There are several categories of temperature control: ambient (room temperature), refrigerated, frozen and sub-zero. The regulations and guidelines for handling temperature excursions was reviewed. Examples of the financial and product losses that have occurred from situations where the temperature was not maintained were discussed. Then Rafa and Victor shared how CoolChain’s products and services are used to maintain temperature across all the categories. The boxes that they use can maintain a temperature for any of the ranges for up to 120 hours (5 days). A key benefit is that a refrigerated truck container isn’t needed and you can transport products in one shipment that are from each of the temperature categories. Another very important part is to minimize waste. Rather than use single use containers, CoolChain’s shipping containers are reclaimed and can be re-used for up to 2 years.
I am determined to not get more than 10 years behind on posting membership events. I think this was at Carolina Ale House at Brier Creek Shopping Center in Raleigh, NC.
Early investor in FOCM, Bill Newcomb was instrumental in this event happening. As such, you’ll see that his wife Joan received her FOCM membership card. Bill and I worked closely together at Quintiles from 1996 to 2001.
Travis Jackson received his membership card. I’ve known Travis for well, I guess probably over 10 years. His wife Alison Greenwood connected us.
Nithiya Ananthakrishnan, in addition to getting his membership card also got the award for traveling the furthest to the event. He traveled from India. Nithiya and I have known each other for 18 years (that I’m 9 years behind in posting the pictures from this event makes the time I’ve known these people even more impressive) having worked together at ICON Interactive Technologies Group.
The December FOCM | GLSA Networking event started out with welcoming everyone and a review of these meetings’ agendas summarized in the paragraph below.
For the newcomers, think of this as an open house event – drop in when you can and leave when you need to; when we have a topic and presenter we have them start when we have assembled a good number of people and that’s usually 10-15 minutes after the start.
There were several (ahem) great looking holiday sweaters and several pets were seen on camera as well. Candy Dupree won best outfit hands down. The link to get notifications about our future live and virtual events>> http://bit.ly/3UTb8hL
As our passion is to connect people and companies we know and like to other people and companies we know and like, we asked everyone to put into the chat the link to their LinkedIn profile. This allows for quick and simple connecting and facilitates future follow up.
We opened the event sharing industry updates, news, and/or gossip that anyone wanted to bring up. Chris shared that GLSA has contracted with two new clients: Validcare and Cool Chain to help the in their promotional and sales efforts. Validcare is disrupting clinical research with an all digital approach and fixed price study management. Cool Chain has shipping containers that can maintain a specified internal container temperature for 120 hours, be that sub zero frozen, frozen, refrigerated or room temperature. One of our clients Heal Mary, a SaaS AI enhanced patient recruiting platform has been awarded a project from a company we introduced them to and that will begin in February.
The group chose not to go into smaller breakout sessions, so we stayed in one room and talked about the holidays and what people’s plans were. We acknowledged the industry begins to get quite busy by the third week of January and we’re bracing for it.
Participants at the The GLSA | FOCM Networking event that took place on November 16, 2022 were treated to a presentation from Chuck Bon with Biostudy Solutions. Chuck is a recognized industry expert in the area of pharmacokinetics and biostatistics. Chuck has served on FDA Expert and Blue Ribbon panels on Topical Corticosteroids and Population and Individual Bioequivalence. Biostudy Solutions has expertise in trial design of Phase 1 PK Bioequivalence (BE) studies as well as Therapeutic Equivalence Trials. The company specializes in the analysis of PK studies, bioequivalence studies and results from alternative in-vitro testing.
A discussion about the therapeutic equivalence of generic drugs to the original branded product took place. There is a tolerance range of bioavailability when comparing to the standard. The bioequivalence range for the Test-to-Reference ratio in both PK and clinical endpoint trials is 80% to 125%.
There was discussion over the ongoing mergers and acquisitions among small CROs to lift themselves into the mid-size CRO ranks.
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 discussions, please leave a comment below and I’ll reach out as soon as possible.
Attendees (first time attendees in bold): Dan Weddle, Senior Strategic Alliance Director, AltaSciences Jill Curtis, Director of Project Management, Worldwide Clinical Trials Duncan Shaw, President, DTS Translation Services Ashley Clark, Regulatory Affairs Consultant Ryan McCarthy, Government Markets Manager, Velocity BioGroup David Holland, Senior Director of Business Development, cMed Clinical Jim Lyon; Professor of Clinical Research; UNC – Wilmington Nancy Zeleniak, Enterprise Strategic Partnerships and Participant Engagement, Atrium Health Judy Carmody, Founder, Carmody Quality Solutions Michael Young, Founder & Principal, biomedwoRx Josh Lang, Associate Director, Business Development, Asymchem Group Loretta Cipkus Dubray, Founder, Global Clinical Connections Ravi Luthra, Clinical Research Coordinator Mike O’Gorman, Founder, Life Science Marketplace
GLSA: Joe Buser Hannah Lloyd Denise McNerney Sally Haller Chris Matheus Megan Hoffman Charity Dube Timmina Williams
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.
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
I recall a much simpler time. I know this confession will highlight my years of experience (nicer way to say “old age”). In my working life time there was a 2 decade period where people could get in touch with you 1 of 3 ways: call you at your home phone number, contact you via a pager to call them or an answering service or mail you a letter/memo through internal company mail or US Postal service if you were remote.
So this realization hit me when I was going back through text messages to find pictures from past FOCM networking events for posting here. These are from 2017 at the Society for Clinical Data Management conference in Orlando. Nowadays (you don’t hear this word often enough – add another digression, as my friend Kevin Boos says, another phrase that we don’t use much any more is: “all the live long day”), you can be reached or reached out to via:
email (and you probably have more than 1 email address – I have 5)
Instagram message
Facebook messenger
Cellphone call
Text to cellphone
LinkedIn Message
WhatsApp
Instagram
Twitter
GoogleChat
Venmo
Paypal
and the above are just the ones I know of – which means you can also be reached out/called out on MeWe, Telegram, Rumble, NextDoor and many others I am sure. Oh how could I forget the one I have to tend to the most: my OnlyFans account!! So many requests for pictures of my feet – barefoot, in sandals, huaraches, etc. But with each follower paying the monthly subscription fee, I’m netting around $10/month. I don’t have to tell you that over twelve months that’s around $120 straight to the bottom line.
Okay, back to the topic at hand, no more chasing shiny objects;
SCDM 2017 was held in Orlando. FOCM card carrying member Brian Langin with card # 00000001 encourages me to have a FOCM Networking event at Bob Marley – A tribute to Freedom in Universal CityWalk Orlando. And therefore, I do.
Entering into evidence the following two pictures:
Vicky Martin, Jennifer Price, Hugh Levaux, Karen McPoyle, Joby John, Tina Pietropaolo, Susan Howard and Karen Hicks.
The Brain Trust; Photo assumed to be taken by Brian Langin
Apologies for the darkness of the picture of Brian – at the time he was keeping a low profile due to some criminal or civil investigation of one type or another.
