virtual networking | Matheus BD Connections, LLC

March 2023 Networking

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. https://globallifesciencesalliance.com/

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:

February Networking

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.
https://globallifesciencesalliance.com/

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:

January 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:

December Networking Event

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

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:

November Networking Summary

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:

October Networking Summary

The GLSA | FOCM Networking event that took place on October 19, 2022 was well attended with 17 participants.

With Chris Matheus returning from a trip to Arizona, Denise awkwardly tried to lead the group. After a bit of a rough start, she improved vastly and we’re all quite proud of her ability to make lemons out of limes.

A discussion about decentralized trials and the use of medical professionals to make patient visits proved interesting. Ellen Weiss with PCM Trials discussed how they have played a pivotal role in the use of Certified Mobile Research Nurses.

Michael Young added more good words.

It was nice to have Michelle Ashton and her colleague Sarah Buchholz from IssueTrak join. Michelle worked with GLSA in its early days and we’re big fans of her work ethic and talents.

https://globallifesciencesalliance.com/solutions/

Attendees (first time attendees in bold):
Heather Hollick; Founder of Rizers LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Arti Bhosale, CEO, Sieve Health
Michael Braddock II, Chief Revenue Officer, Frontier Scientific Solutions
Ellen Weiss, Vice President, PCM Trials
Ryan McCarthy, Government Markets Manager, Velocity BioGroup
Edwin Gershom, Business Development Manager, Noble Life Sciences
Candy Dupree, National Sales Director, AdamsBridge Global
Michelle Ashton, Business Development Manager, IssueTrak
Sarah Buchholz, Digital Marketing Strategist, IssueTrak
Michael Young, Founder & Principal, biomedwoRx
Brian Langin, Business Development Consultant
Ravi Luthra, Clinical Research Coordinator

GLSA:
Joe Buser
Holly Cliffe
Denise McNerney
Sally Haller
Megan Hoffman

A few screenshots are below:

September Networking Event Summary

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.

https://validcare.globallifesciencesalliance.com/

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

A few screenshots are below:

May Networking Event Summary

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 Pharmaeutical 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:

March Networking Event Digest

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 sectors to facilitate trials. He founded Delve Health in 2018. Delve Health provides innovative decentralized clinical trial solutions to improve clinical trial conduct for patients, caregivers, doctors and pharma/device. Offerings include ePRO/eCOA, eConsent, study tasks, wearables and biosensor integration, EMR data collection and Real-world evidence capabilities.

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

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

https://globallifesciencesalliance.com/

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

Selected screen shots appear below:

Screenshot with GLSA Mascot Teddy in lower left corner

February Networking Event

On February 16, 2022, the Global Life Sciences Alliance along with FOCM Networking held its monthly online drug and medical device development industry networking event. This was the second event of 2022 and like the January event, we again had 3 first-time attendees. Thank you to super-connector and FOCM member, Nadia Bracken for sharing our event with others.

We spent the first 15 minutes with introductions and general discussion about the weather in various attendees’ cities.

This event featured a presentation by Kalyan Ghosh, Founder and CEO of Inference, Inc (https://inferenceinc.com/). Inference, a GLSA client, was formed in 2017 by Kalyan. He has over 25 years experience in clinical biostatistics, having worked at both big pharma (Merck and BMS) and CROs (Vislation, INC Research and West Coast Clinical Trials). Kalyan is an accomplished presenter and presented an overview of biostatistics and the role that data management and biostatistics have in drug development.

Please join us next month on March 16 at 7:00 p.m. Wessam Sonbol, CEO of Delve Health, an e-clinical technology platform service provider and client of GLSA will spend 10 – 15 minutes talking about their approach to patient-centered hybrid and decentralized studies in drug development.

ATTENDEES (bolded names were first time attendees):

Kalyan Ghosh, Inference Inc,
Andy Mulchinski, Symbio
Justin Gundelach, Mayo Clinic
Pauline Luong, Creative Clinical R & D
Chris Bergey, NaviDx
Brian Langin, Matrix Medical
Ravipal Luthra, University of Miami College of Medicine
Jon Matheus, A.T. Pancrazi Real Estate Services, Inc.
Chris Matheus, Global Life Sciences Alliance & FOCM
Denise McNerney, Global Life Sciences Alliance
Joe Buser, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance
Holly Cliffe, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance
Hannah Lloyd, Global Life Sciences Alliance
Todd Nielson, Global Life Sciences Alliance

Screenshots of the attendees can be seen here:

https://globallifesciencesalliance.com/february-networking-meeting-summary/