February Networking Event Summary

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.

Newsletter and event notification sign-up link: https://bit.ly/3UTb8hL

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:

January 2023 Networking Event Summary

January 18 2023 Networking event

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.

Attendees:

Rafa Martin-Alos	Cool Chain
Victor Camacho	Cool Chain
Loretta Cipkus Dubray	Global Clinical Connections
Joseph Cheng	PiVOT
Mike O’Gorman	Life Science Marketplace
Brian Langin	Diligent Pharma
Liz Mirra	Mirraponte
Ori Geshury	Mirraponte
Duncan Shaw	DTS Language Services
Scott Robertson	Mednet
Griffin Robertson	Mednet
Jeff Page	Consultant
Kate Mullis	ICON GPHS

GLSA Attendees:

Denise McNerney
Chris Matheus
Joe Buser
Charity Dube
Hannah Lloyd
Sally Haller
Daryl Oberg
Holly Cliffe
Timmina Williams

A screenshot from the event is below:

Excuses to Avoid Networking

So when I was working for YPrime, I met a tall fellow named Andy Russell. He had quite a CV (that’s Curriculum Vitae for those who don’t know) {Another side note, that reminds me of a great t-shirt I saw: People say I’m condescending: that means I talk down to people}. But let’s get back to the key features of Andy’s CV:

Taller than the average man
Quarterback candidate for the NC State Wolfpack; however, I do not see any mention of NC State on his LinkedIn profile, so my memory may be failing me – maybe it was at Cornell with the Nard Dog or University of Maine, but regardless, I bet this tall guy can toss a football over 60 yards
When fully-bearded and wearing a hoody sweatshirt with back lighting on a web meeting he appears quite intimidating
Goes out of his way to escort venomous snakes out of his basement believing they’re the answer to ending the rodent problems in the greater Philadelphia metro area

But I digress. The real intention of this post was to share his sense of humor. I had invited he and many other YPrime colleagues to go out for some casual networking, he appeared to be less than 100% available. So I gave him excuses in advance:

Getting the house re-roofed?

[AR] – I rent my place

Girlfriend has other plans for me?

[AR] – she’s got BIG plans for me

Family is in town?

[AR] – they were last week

Gotta get home and turn on the lawn sprinklers?

[AR] – I don’t have a lawn but have been known to have to “water my sidewalk” to avoid commitments

Meeting the cable guy at the house?

[AR] – we’re getting rid of cable

Fortune teller advised against it?

[AR] – THIS is my excuse this time

Jury duty?

[AR] – I make sure that my disdain for authority is documented in my Jury Questionnaire so as to never have to go

My plot to take over the presidency of the book club is thickening, and I must stay home to make sure everything is working out smoothly.?

[AR] – I can’t read
I have to go to the post office to see if I am still wanted.?

[AR] – this might be true
Mani/pedi appt?

[AR] – this was the girlfriend’s other plans for me!
Hair cut and color appt.?

[AR] – after joining the software business, I really could use the color treatment…

Now that these responses are from 8-ish years ago – it is possible that a Hair Color for Men Get out the Gray is in order.

2014 FOCM Membership Event

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.

Networking Best Practices

I saw this article by Dorie Clark a strategy consultant, executive coach, and keynote speaker and professor in the Business Schools of Columbia and Duke Universities and liked its key points.

The basics of networking are that it is essential for career development. Making new connections provides us with new information and opportunities to connect others or to collaborate and be helpful.

To connect with high level and experienced people in your industry, you need to give them a reason to want to connect with you. These are the items she points out these 3 key takeaways:

Do not misunderstand the pecking order. Networking with co-workers is simple: follow up promptly, connect on LinkedIn, offer to buy coffee or lunch. Connecting with people in positions higher than yourself is different. If someone in your network has recommended you to this person then mention them in your outreach. I have reached out based on articles I’ve read about certain individuals and I reference that in my email as to why I’m connecting.

Offer to give before you receive. Asking for someone’s time is an imposition unless you can provide a benefit to them. In your outreach, explain why you’d like to connect; at the recommendation of a mutual connection or to get their input for a project/report you’re working on.

Specifically state your value proposition. Highly experienced and sought after people don’t have time to weed through all the requests they get to figure out which are gold. You need to be explicit and quickly, about how you can help. Show you’re familiar with their work and have thought about how you can help them, not the other way around.

Networking has been described as an essential skill and one of the most valuable professional activities we do. So focus on making your reason to connect very clear and of interest.

https://hbr.org/2014/02/three-mistakes-to-avoid-when-networking?utm_source=Socialflow&utm_medium=Tweet&utm_campaign=Socialflow

December Networking Event Summary

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

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.

Attendees:

Mike Burrows	Burrows Life Sciences Associates, PLC
Arti Bhosale	Sieve Health
Duncan Shaw	DTS Language Services
Nancy Zeleniak	Atrium Health
Debbie McCoy	Business Development Consultant
Michael Young	biomedwoRx; Life Sciences Consulting
Eric Nier	Block Clinical
Erica Hill	Marketing Consultant
Judy Carmody	Carmody Quality Solutions
Charles Speno	TrialX
Holly Jochims	Adaptive Clinical Systems
Kim Lupo	Portrett Pharmaceuticals
Nadia Bracken	Clinical Operations Director
Shruti Vashisht	Software Development
Chris Clancy	Medidata
Jon Matheus	A.T. Pancrazi Real Estate
Ori Geshury	Mirraponte
Liz Mirra	Mirraponte
Loretta Dubray	Global Clinical Connections
Mike O’Gorman	Life Science Marketplace
Candy Dupree	Adam’s Bridge Global

GLSA Attendees:

Denise McNerney
Chris Matheus
Joe Buser
Megan Hoffman
Charity Dube
Hannah LLoyd
Sally Haller
Timmina Williams
Holly Cliffe

A few screenshots from the event are below:

November FOCM | GLSA Networking

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.

If you are in need of more information of BioStudy Solutions, please click below: https://biostudysolutions.globallifesciencesalliance.com/

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

A few screenshots are below:

September 21 2022 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:

Networking Pictures from SCDM 2017

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.

August Virtual 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:

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