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October 2023 Networking Event Summary

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. 
  • To read the May summary https://globallifesciencesalliance.com/the-may-focm-glsa-networking-event/

FOCM Membership – New Member

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

FOCM Networking a cold night

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)

Observations of DIA 2023

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. 

We hope to see you at DIA 2024 in San Diego.

 

May 2023 Networking Event Summary

May 17, 2023 

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. 
  • To read the April summary https://focmnetworking.com/networking/april-2023-networking-event-summary/

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

 

April 2023 Networking Event Summary

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

A couple snapshots from the event are below:

Screen Shot #1
Screen Shot #2
Screen shot #3

Networking Photos from the past

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 Matheus
Wilmington Pharma/Bio/CRO Networking

FOCM Member Card Recipient Ceremony

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.

Photographic evidence is below:

Megan O’Keefe June DIA 2015

 

March Networking Event Summary

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

A couple snapshots from the event are below:

Screen Shot #1
Screen shot #2
Screen shot #3
Screen Shot #4

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:

February 15 Screen Shot #1
February 15 Screenshot #2