Tag: GLSA

June Networking Event Summary

June 12 FOCM | GLSA Online Networking Event Recap

2024 Mid-year Highlights: A Successful Gathering

On June 12, FOCM and Global Life Sciences Alliance (GLSA) hosted an engaging online networking event focusing on the 2024 mid-year highlights. The event saw a robust turnout with 35 participants, blending familiar faces with new members, fostering a vibrant and dynamic discussion.

Opening Remarks and Industry Updates

Chris Matheus kicked off the event with a warm welcome, introducing new members and setting the stage with industry updates, news, and conference reviews. Participants shared their travel plans, locations, and upcoming trips, adding a personal touch to the professional gathering.

Networking and Collaborative Initiatives

The meeting adopted an open house format, encouraging participants to share their LinkedIn profiles for seamless networking. Chris also promoted the Women of Life Sciences virtual event and called for volunteers to judge the best giveaways at the upcoming DIA, led by Sheila Mahoney-Jewels (smj@lifescihub.com).

GLSA’s Mission and Conference Insights

The GLSA reiterated its mission to provide solutions for clinical trial issues. Michael Young, Brian Langin, Cameron Robinson, and Denise McNerney shared insights from the BIO conference, which boasted over 19,000 attendees. Michael also reviewed the heavily attended ASCO conference, noting a significant presence of first-time exhibitors and attendees.

Business Update and Market Analysis

Chris Matheus presented a detailed analysis of the business performance in the first half of the year. He discussed the initial surge in activity, followed by a slowdown in decision-making and funding optimism. Chris also covered the recent Federal Open Market Committee meeting, touching on global uncertainties and their potential impact on market trends, including the upcoming US presidential election and geopolitical tensions.

Advances in Drug Approvals and Precision Medicine

Recent advancements in drug approvals for NASH/fatty liver and Alzheimer’s were highlighted, with Michael Young discussing precision medicine’s role in oncology drug development. Notable Labs’ blood test and Keliomics’ ex vivo tumor models, presented at ASCO, were showcased as revolutionary innovations that could transform early-stage development.

AI and ML Applications in Clinical Trials

Chris Matheus explored the applications of AI and machine learning in clinical trials. He highlighted the potential for large-scale simulations and AI tools to predict patient enrollment and rank doctors. Despite enthusiasm, participants expressed skepticism regarding the current state of these technologies, particularly in patient enrollment and regulatory validation.

Challenges in Patient Enrollment and Hiring Trends

The discussion also addressed the challenges in patient enrollment post-COVID and hiring trends. Michael Young and Chris Matheus were optimistic about the resurgence of in-person conferences, citing high attendance at recent events. Lisamarie O’Brien highlighted the difficulties in hiring, emphasizing the need for smarter recruitment strategies and the role of AI in applicant tracking systems.

AI in Language Translation and Clinical Studies

Duncan Shaw highlighted the challenges of using AI for language translation and clinical studies, stressing the need for exactness and precision. The group echoed these sentiments, agreeing on the importance of patience and caution in evaluating AI’s potential in these areas.

AI and Budget Building Challenges

Mike O’Gorman shared concerns about AI’s capabilities in budget building, while Ira Snyder emphasized the limitations in obtaining precise budgetary details due to data quality issues.

Site Negotiations and Challenges

The slow progress in securing site contracts was discussed by Michael Young and Jane Myles, with Viljena Trask highlighting the competitive nature of oncology site selection. Eliana R. Burke shared an encounter with a highly experienced clinical trial site, and Ira Snyder emphasized the need for balanced negotiations for successful collaboration.

If you would like a copy of the slide set, email me at chris@focmnetworking.com

or if I did this correctly you can get it here: https://globallifesciencesalliance.com/wp-content/uploads/2024/06/2024-Mid-year.pdf

Looking Ahead

The next GLSA event is scheduled for July 17, with the subject yet to be determined. To stay updated on GLSA | FOCM events, sign up here. Stay tuned for more updates and we look forward to seeing you at our next event!

 

ATTENDEES:

(First time attendees in bold)

Judy Woods

Jane Myles

Viljena Trask

Bill Dirkes

Tom Lo

Lauren Sherwood

Ira Snyder

Cameron Robinson

Eliana Rivera Burke

Jared Byer

Joan Chambers

Lori Leathers

Jon Carlson

Christine Martin

Hiro Matsushima

Duncan Shaw

Lauren Merante

Lisa Marie O’Brien

Michael Young

Marlyn Brookins

Dr. Syed Rooh ul Arifeen Naqvi

Irene Rivera

Julia Oxley

Yuko Terasawa

 

GLSA

Denise McNerney

Jim Sarene

Kelvin Izevbekhai

Rocio Rayna Reyes

Timmina Williams

Chris Matheus

May 15, 2024 GLSA | FOCM Networking event

The May FOCM and GLSA Networking event featured Boreas Monitoring’s innovative answer to protecting biologic material stored in liquid nitrogen.

Fifteen people attended our May event. 

We opened with input from others about recent attendance at a variety of conferences. Whereas the first quarter of the year had conferences exceeding typical attendance and a buzz of activity, the 2nd quarter seemed flat, with typical attendance and the feeling of a lull in activity. As discussed in one of our events this past fall, so much uncertainty in the world causes people to be conservative and hold back in spending money and starting projects. Those factors are:

  • Israel – Hamas war
  • Ukraine – Russia war
  • US Inflation
  • US Interest rate
  • US Presidential election
  • Predictions of recession 

The presentation title was: Proactive vs Reactive Cryotank Management and Will Baird, a co-founder at Boreas Monitoring was the presenter. Boreas was founded in Wilmington, NC. Chris Matheus had seen Will present at an entrepreneurship/venture funding event at the Marine Biotech Center at UNC Wilmington in 2023.

Boreas was founded by lab professionals with over 80 years of industry experience owning/operating fertility laboratories. The CryoScout system was developed while the founders managed cryotanks, identifying inherent flaws in the temperature-based monitoring systems commonly used throughout the industry. It was accelerated by two high profile tank failures in 2018 that resulted in millions of dollars in lawsuits and catastrophic loss of patient samples, destroying people’s hopes & dreams of having children. They developed and patented a weight-based monitoring system — the most reliable method of determining the evaporation rate of a cryotank. It can detect a failure up to 84 hours earlier than temperature-based methods, giving labs a data-driven solution to monitor their tanks, along with enough time to save samples from being destroyed.

As a reminder, treat these events as an “open house”  – drop in when you can and leave when you need to.  The link to get notifications of our future online and live events is: https://bit.ly/3UTb8hL

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 always have everyone put the link to their LinkedIn profile in the chat to allow for easy connecting and future follow up.

GLSA’s LinkedIn page can be reached here: http://www.linkedin.com/company/global-life-sciences-alliance/

A reminder that Global Life Sciences has a select network of 50 clinical research service providers and we want to be seen as a resource to you and to the industry. So when you run into an issue or have a need, give us a call. It’s what motivates us, we quickly reach out to our contacts to find the solution you’re looking for. 

The next event will be on June 12, a week earlier than normal due to the DIA Annual Meeting. The focus will be on a review of the first half of the year – comparing to last year and seeing what the sense of the industry is: trends, changes, etc.

ATTENDEES:

Will Baird Boreas Monitoring
Jeanne Schow Bleu Sales Leadership
Michael Young biomedwoRx
Steve Sisson MLM Medical Lab
Allie Ash Colorado State University
Brandon Cantwell Clinical Project Manager
Cameron Robinson II Mustard Seed PMO
Eliana Rivera Burke GreenLight Clinical
Joan Chambers Tufts
Karen Tkaczyk Vistatec
Lakshmi Ethirajan Smabio
GLSA
Denise McNerney
Chris Matheus
Alex Hoppe

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/

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:

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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:

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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

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:

Screen Shot of January 18 event

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:

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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:

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