We had a great turnout at the May 23 Wilmington Pharma/Bio/CRO Networking event.
We had a great turnout at the May 23 Wilmington Pharma/Bio/CRO Networking event. Thanks to all who were there. Mishelle Smith with the Cystic Fibrosis Foundation Raleigh office was able to share with many attendees information about the Wilmington “Pipeline to a Cure” fundraiser taking place on August 3rd.
We also had a good turn out from out of towners: from Raleigh: Duncan Shaw of DTS Language Services, Brian Horan of SupplyRx, Kalyn Dozier of IDDI, Brian Stigall of BioBridges and from New Jersey, Mike O’Gorman with Life Science Marketplace and SeeMedX.
Others in attendance: Steve and Sandie Simpson, Brittany Hayes Savoca, Tracey Hopkins, Sandy Agrella, Emma Eckler, Wayne Whittingham, Michael Barron, Doug Denny, Liz Luke. A few photos were taken:
Kalyn Dozier, IDDIDoug Denny, Precision for Medicine and Wayne Whittingham, CardioPharmaWayne Whittingham, CardioPharma and Brian Horan, SupplyRx
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 Vice President, Marketing Sales and Business Development at Kaiser Permanente.
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)
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.
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
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
The recent discovery of photos from past events continues to bring back good memories. These photos are from a September 28, 2017 Wilmington Pharma/Bio/CRO Networking Event at Johnny Luke’s Kitchen Bar, 5500 Market Street, Wilmington, NC.
This group meets monthly, usually on the last Thursday of the month, but can be changed due to travel and other interruptions. We get anywhere from 8 – 30 people attending. The event is held at different restaurants in Wilmington, allowing us to meet explore other restaurants, brew pubs and food trucks. The group is on LinkedIn and announcements of events are published there.
Abby Richmond Melville sent the photos to me.
Lee King, Ryan Manuel, Mark Aikman and myself are identifiable in the photos. That Abby sent them to me might indicate that Margaret Richmond was in attendance as well.
Lee King and Chris MatheusWilmington Pharma/Bio/CRO Networking
Yes, this is proof that some news improves with time. I have developed an AI algorithm which determines the best time to post stories and events. It’s not always important to be timely. Just as the best wines are aged to perfection, so too, does FOCM apply the same principle.
In June of 2015 at the annual Drug Information Association (DIA) conference, Megan O’Keefe received her FOCM membership card. At the time Megan was working for Synteract. I believe (this is where the aging of posts’ algorithm has a bug – my memory can be fuzzy) we were introduced by Erin Tabet and Kim Martinez at that conference. I am pretty sure that is Kim behind me.
The March FOCM | GLSA Networking event started out with welcoming everyone and reminding attendees of the meetings guidelines:
Think of this as an open house event – drop in when you can and leave when you need to;
When we have a presenter we have them start when we have assembled a strong amount of respondents – usually 10-15 minutes after the start.
Presenters’ topics are not sales pitches – the focus is on an aspect of clinical trials; where in the process their services are used and aspects of that step.
The link to get the GLSA newsletter and notifications about future live and virtual events: http://bit.ly/3UTb8hL
We ask everyone to put their LinkedIn link into the chat to facilitate connecting and future follow up.
In GLSA news: it was announced that co-founder, Denise McNerney had moved from Virginia to Florida. She is enjoying pointing out the weather to those north of where she now lives. I gotta say, she’s enjoying it a bit too much.
Cass Hui – founder of Heal Mary was then introduced to the attendees. She shared her story of how she came from the tech industry into the clinical research industry. Her mom first and then two sisters all had breast cancer. Cass encountered frustrations in finding clinical trials for them to consider and decided to apply her experience and skills to making this easier for others. Rather than becoming a patient recruitment company, she provides her service in the software as a service (Saas) model. Multiple patient advocacy and disease foundations are using her platform to inform people about clinical trials. https://healmaryapp.com/search
Cass utilized the kahoot.it platform to poll/question the attendees about clinical trial recruitment information. This was a fun way to get people thinking about the topic and led to a lively question and answer session.
After the Q&A, we broke into separate breakout rooms for people to introduce themselves, their companies and their needs to the others in the room.
The April event will feature Joseph Cheng with PiVOT CRO on the demographics, clinical research experience and capabilities of the Philippines.
Attendees: Cassandra Hui; Heal Mary and evening presenter Stacey Richardson; Parexel Mike O’Gorman; Life Science Marketplace Dave Gibboni, Beigene Amy Lee; Kaiser Permanente Loretta Cipkus Dupray; Global Clinical Connections Peter Payne; Consultant Matthew Plaud, Consultant Nancy Zeleniak; Advocate Health Joseph Cheng; PiVOT Jean-Pascal Rugiero; SVM Pharma Rodan Zadeh; Consultant Kim New, ClinChoice Duncan Shaw; DTS Language Services Maria Frane; Corlexia Gabrielle DeBoer; Consultant Arti Bhosale, Sieve Health
GLSA Attendees: Holly Cliffe Sally Haller Hannah Lloyd Jordan Brown Joe Buser Timmina Williams Megan Hoffman Charity Dube Chris Matheus Denise McNerney Ori Geshury Liz Mirra Alex Hoppe Shiquita Hinton Whitney Davis
The February 15, 2023 FOCM | GLSA Networking event started out with welcoming everyone and reminding attendees of the meetings guidelines:
Think of this as an open house event – drop in when you can and leave when you need to;
When we have a presenter we have them start when we have assembled a good number of people – usually 10-15 minutes after the start.
Presenters’ topics are not sales pitches – the focus is on an aspect of clinical trials, where their services are used and what they offer.
The link to get notifications about future live and virtual events: http://bit.ly/3UTb8hL
We ask everyone to put their LinkedIn link into the chat to facilitate connecting and future follow up.
In GLSA news: it was announced that we have added PiVOT Health – a Philippines headquartered CRO and Sieve Health, (tonight’s presenter) to our list of clients.
We discussed the recent SCOPE conference and two of the attendees had attended and shared their impressions as well as opinions from others we’d talked with. Mike o’Gorman attended and said that the exhibit hall was full and busy, reminiscent of pre-Covid days. David Holland also attended and felt that the conference meeting portal was challenging as people who were replying to meeting requests did not show up. David felt that the exhibit hall was primarily filled with e-clinical exhibitors. He couldn’t find people to network with as there was a small pool of Pharma people. While in-person conference attendance is recovering from Covid shutdowns, it does appear that pharma and biotech companies are not sending as many people as they used to. Kate Findlen confirmed what David saw and Brian knows happens – anyone with a sponsor company is a target for the Business Developers, inundating them with meeting requests.
Arati Bhosale with Sieve Health was then introduced to the group and she talked about the struggles of finding patients for clinical trials. She co-founded Sieve because of the inefficiency of finding patients for clinical trials. The time it took study coordinators wading through EMR/EHR data which was not designed for easy sorting/filtering was staggering. That drove her to find a better, more efficient way using the newest technology. The result is a reduction in the time to do this effort by around 75%. This is making sites happy as their study coordinators can better allocate their time to the trial and patient tracking. The timing of her service is important. Decentralized trials has increased the burden on study coordinators leading to burnout and turnover.
Each of the new attendees were able to introduce themselves to the group. We then ended the meeting as there weren’t enough people to go into separate break-out rooms.
Attendees:
Arati Bhosale; Sieve Health Nadia Bracken; Clinical Project Management Consultant Mike O’Gorman; Life Science Marketplace Brian Langin, Diligent Health David Holland; cMed Research Ravi Luthra; University of Miami, Miller School of Medicine Kate Findlen; Nimbus Therapeutics Joseph Cheng; PiVOT Cassandra Hui; Heal Mary Duncan Shaw; DTS Language Services Michael Young; biomedwoRx
GLSA Attendees: Holly Cliffe Sally Haller Hannah Lloyd Jordan Brown Joe Buser Timmina Williams Megan Hoffman Charity Dube Chris Matheus
A couple snapshots from the event are below:
February 15 Screen Shot #1February 15 Screenshot #2
The January FOCM | GLSA Networking event started out with welcoming everyone and wishing everyone a Happy New Year!
A review of the events guidelines was stated – think of this as an open house event – drop in when you can and leave when you need to; when we have a topic and presenter we have them start when we have assembled a good number of people and that’s usually 10-15 minutes after the start. Presenters’ topics are not sales pitches – the focus is on an aspect of clinical trials, where their services are used and what they offer.
The link to get notifications about our future live and virtual events>> http://bit.ly/3UTb8hL
As our passion is to connect people and companies we know and like to other people and companies we know and like, we asked everyone to put into the chat the link to their LinkedIn profile. This allows for quick and simple connecting and facilitates future follow up.
We opened the event sharing industry updates, news, and/or gossip that anyone wanted to bring up. Then the focus of this event was on cold chain logistics. Loretta then began the presentation portion with an overview of managing cold chain shipments. There are several categories of temperature control: ambient (room temperature), refrigerated, frozen and sub-zero. The regulations and guidelines for handling temperature excursions was reviewed. Examples of the financial and product losses that have occurred from situations where the temperature was not maintained were discussed. Then Rafa and Victor shared how CoolChain’s products and services are used to maintain temperature across all the categories. The boxes that they use can maintain a temperature for any of the ranges for up to 120 hours (5 days). A key benefit is that a refrigerated truck container isn’t needed and you can transport products in one shipment that are from each of the temperature categories. Another very important part is to minimize waste. Rather than use single use containers, CoolChain’s shipping containers are reclaimed and can be re-used for up to 2 years.