clinical trials | FOCM Networking

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

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.

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:

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.

Meeting Summary July Virtual Networking

The GLSA | FOCM Networking Event on Wednesday, July 20th, 2022 at 5:00 PM EST was a lively affair boasting a diverse crowd of life science professionals. Many who attended were the previous colleagues and / or the current friends of Chris Matheus (FOCM, President; GLSA Chief Commercial and Networking Officer).

The topic of the day was “Summer Fun” due to the prevalence of the industry to go semi-dormant in July and August to accommodate the well-deserved vacations of its workers. The introduction, led by Chris, briefly spoke of former events which usually involved the related capabilities or education topic of a guest speaker to spur industry-related discussions and aid in collaboration among the group. He expressed the intention of this event to be focused more on the personal activities and vacations of attendees in order to keep our minds on the relaxation of these summer months.

To nobody’s surprise, we couldn’t stay away from discussing work including the most recently held conferences; BIO International Convention in San Diego, CA and DIA Annual Meeting in Chicago, IL with a specific mention about the limited presence of sponsors. An outbreak of Coronavirus at these events and the apparently foul-tasting Paxlovid medicine used to treat moderate cases of COVID sparked conversation about who among us has contracted the virus and the varying degrees by which each individual was affected.

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. Chris noted a number of CRO’s that have changed leadership or have been acquired by other companies.

By far the most celebratory moment of the event was the announcement of the recent success of the Memorial Sloan Kettering Cancer Center in a small clinical trial using immunotherapy. They achieved 100% remission of rectal cancer without the use of surgery, chemotherapy or radiation that can leave patients with life-long effects including infertility and colostomy bags.

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 contact me.

Attendees: (first time attendees in bold)

Kimberly Lupo, MS, MBA, RAC	Founder & CEO at Portrett Pharmaceuticals LLC
Sara Tylosky	CEO, Farmacon
Nadia M. Bracken	Operational Advisor, Medidata
Brian Horan	CEO & Co-founder, SupplyRx
Tina Tran	Director, Business Development, Unlearn.ai
Heather Hollick	Rizers LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Amy Zastawney	Seeking a new executive business development role
Jon Matheus	Commercial Real Estate, A.T. Pancrazi Real Estate Services
Unnat Patel	Founder & President, AnalysisMate
Peter Payne	Life Sciences Executive – Available for Consulting
Griffin Robertson	Partner Account Manager, Mednet
Nancy Zeleniak	Enterprise Strategic Partnerships & Participant Engagement; Atrium Health
Dhruv Wadhwa	Director of Business Development, HUMA
Michael Young	Founder & Principal, BIOMedworx
Scott Robertson	Vice President of Sales, Global Partnerships; Mednet
Ravipal Luthra, MS, BDS	Clinical Research Coordinator, University of Miami, Miller Medical Center
Andrew Mulchinski, MPA, MT, ASCP, CCRC	Business Development; Symbio, LLC
Lani Hashimoto	Associate Director Patient Engagement Management; Novartis
Amanda Putnam	Team Lead Manager; Data Recognition Corporation
Michael O’ Gorman	CEO and Founder at Life Science Marketplace
Eliana Burke	Global Head of Client Engagement & Marketing; Greenlight Clinical
Michael Minor	EVP, Clinical Research; IMA Clinical Research
Vaibhav Sawant	Pharma Marketing Executive
GLSA ATTENDEES
Denise McNerney	Chief Operations Officer
Hannah Lloyd	Account Manager
Zulma Varela	Director of Public Communications
Sally Haller	Operations Manager
Todd Neilson	Account Manager
Joe Buser	Chief Revenue Officer
Chris Matheus	Chief Commercial and Networking Officer
Yutong Liang	Intern, Data Management and Technology

Screen shots of the event follow:

Screen shot at 5:06 Start of the event Screen shot at 5:18 Screen shot at 5:21

Meeting Summary of May Networking Event

On May 18, the GLSA and FOCM held their monthly online networking event. We always start the meeting with some time for people to give an update on any news they’re heard or a significant event that has happened in the past month. Then we move to a featured presenter for 10 – 15 minutes presenting information about themselves, their company or a clinical research topic of relevance to them or to the industry.

This event featured Alison Macpherson, CEO and Founder of Bright Pharmaceutical Services, a full service CRO headquartered in Los Angeles. Bright is celebrating their 20th year in business.
http://www.brightps.com/

Alison talked about her experiences starting out in the clinical trials industry and how that led to her forming Bright with a boutique sponsor-centric approach and a focus on subject recruitment and retention. The company has worked in a variety of therapeutic areas and all phases of research. Its differentiators from other similar sized CRO’s is the very low turnover (less than 5%) over the 20 years in business, which means clients’ projects are supported by only very experienced and engaged staff. Additionally, while much of their experience is in phase I and II North America trials, they have worked in 30+ countries globally. Questions were handled as they came up leading to discussions about Bright’s experience with risk-based monitoring; the new normal of hybrid and decentralized trials; reducing the frequency of subject visits to the sites; and Bright’s experience with trials that require collecting data from wireless, connected devices, e-source data, etc.

After the presentation we had first time participants share their company names and experience. Josh Lang, Mike O’Gorman and Denise McNerney will be attending BIO in San Diego June 13 – 16. Carlos mentioned the networking event they are having on June 12 in San Diego for people interested in Farmacon Global’s August 25 conference focused on conducting clinical trials in Rare Diseases in Emerging Markets.In posing this question to the group – what are you working on and what do you need help with, Heather Hollick (who taught me this approach for successful networking) mentioned she is starting the Institute for Vibrant Leadership and could use connections to leaders, coaches with whom to collaborate as well as writers and virtual assistants. Subsequently, a few potential connection candidates have been sent to her. https://heatherhollick.com/

Attendees (bolded names indicate first time attendees):

Alison Macpherson, Bright Pharma Services
Heather Hollick, Rizers LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Nicole O’Brien, Pain Care Labs
Josh Lang, Asymchem Group
Barbara Hilewsky, BRCR Global
Shane Krauss, Strados Labs
Carlos Martinez, Farmacon Global
David Holland, Cmed Research
Michael O’Gorman, Life Science Marketplace
Keisha Felix, IQVIA
Ludmilla Scodeler
Jim Choi, CRScube
Cesar Serapiao
Chris Matheus, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance
Denise McNerney, Global Life Sciences Alliance
Hannah Lloyd, Global Life Sciences Alliance
Todd Neilson, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance

Several screen shots follow:

Networking from 2017

I am most definitely playing catch up with posts – but I’ve always been a strong believer or follower of the “better late than never” philosophy.

Here’s a picture of Bryan Clayton and Tope Keyes at a January 2017 Healthtech event. I’ve seen them both recently as we’re returning to in -person conferences and networking events.

and this next photo may have been taken at the same event – at least I do know it was also taken in January of 2017. Brian Langin, Nithiya Ananthakrishnan, Deb Jendrasek and Rob Nichols. Please note neither Brian nor Rob have registration badges – it’s possible their attendance involved using the time honored Business Development technique known as “the Strand” or “the Langin”.

Brian Langin, Nithiya Ananthakrishnan, Deb Jendrasek, Rob Nichols

March Networking Event Summary

On March 16, the GLSA and FOCM held their monthly online networking event. We start the meeting with a featured presenter spending 10 – 15 minutes presenting information about themselves and a clinical research topic of relevance to them.

This event featured Wessam Sonbol, founder of Delve Health. Wessam has been in the clinical research industry for 23 years. Many of these years have been in leadership and founding roles in the technology and product development to facilitate trials. He founded Delve Health in 2018. Delve Health provides innovative decentralized clinical trial solutions to improve clinical trial conduct for patients, caregivers, doctors and pharma/device. Offerings include ePRO/eCOA, eConsent, study tasks, wearables and biosensor integration, EMR data collection and Real-world evidence capabilities.

After the presentation, there were questions, answers and discussions. We then allowed newer participants the opportunity to tell us about their history in the industry and the group can be of help.

Attendees (bolded names indicate first time attendees):
Wessam Sonbol, Delve Health
Andrew Mulchinski, Symbio Research
Ravipal Luthra, University of Miami, Miller School of Medicine
Heather Hollick, Rizers LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Michael Young, biomedwoRx: Life Sciences Consulting
Mike O’Gorman, Life Science Marketplace
Edwin Gershom, Noble Life Sciences
Taylor Biche, Global Life Sciences Alliance
Holly Cliffe, Global Life Sciences Alliance
Todd Neilson, Global Life Sciences Alliance
Hannah Lloyd, Global Life Sciences Alliance
Denise McNerney, Global Life Sciences Alliance
Joe Buser, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance

https://globallifesciencesalliance.com/

Please join us on April 20 where the featured presenter will be Amy Baxter, MD; CEO and Founder of Pain Care Labs. PCL’s NIH-funded pain relief device is an ingenious intervention to reduce needle pain and fear – improving patient participation in clinical trials.

Selected screen shots appear below:

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.

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