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.
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:
Break out roomsScreen shot at 5:456:02 p.m. screenshot
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:
Bright Pharma Services
Screenshot of May 18 2022 eventScreen shot of May 18 2022 event
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.
Bryan Clayton and Tope Keyes
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
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
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:
Delve Health PresentingScreenshot #1Screen shot #3Screenshot with Teddy in lower leftScreenshot #2
Yes ’tis true I am only 8 years behind in posting photos of members captured at various conferences.
This photo was taken at ASCO in June of 2014 in Chicago. American Society of Clinical Oncology (ASCO) has been held in June in Chicago for many, many years. It is one of the largest Oncology focused conferences. It draws medical and clinical oncologist, oncology RNs, oncology NPs and PAs. The exhibit hall is huge and takes place at McCormick Center in Chicago.
I was working at YPrime at the time and was fortunate to be selected to attend. One of the things I love about conferences is running into friends and former co-workers. In most cases, its both. This time I ran into two of my favorites: Erica Hill and Sue Ruane. I’d met them both while working at ICON Clinical Research.
