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:

Screen Shot #1
Screen Shot #2
Screen Shot #3
Screen Shot #4
Screen Shot #5

 

October 19 Networking Event 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. 

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.

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:

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

September 21 2022 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:

Screenshot #1
Screen Shot #2
Screen Shot #3

Networking Pictures from SCDM 2017

I recall a much simpler time. I know this confession will highlight my years of experience (nicer way to say “old age”). In my working life time there was a 2 decade period where people could get in touch with you 1 of 3 ways: call you at your home phone number, contact you via a pager to call them or an answering service or mail you a letter/memo through internal company mail or US Postal service if you were remote.

So this realization hit me when I was going back through text messages to find pictures from past FOCM networking events for posting here. These are from 2017 at the Society for Clinical Data Management conference in Orlando. Nowadays (you don’t hear this word often enough – add another digression, as my friend Kevin Boos says, another phrase that we don’t use much any more is: “all the live long day”), you can be reached or reached out to via:

  1. email (and you probably have more than 1 email address – I have 5)
  2. Instagram message
  3. Facebook messenger
  4. Cellphone call
  5. Text to cellphone
  6. LinkedIn Message
  7. WhatsApp
  8. Instagram
  9. Twitter
  10. GoogleChat
  11. Venmo
  12. Paypal
  13. and the above are just the ones I know of – which means you can also be reached out/called out on MeWe, Telegram, Rumble, NextDoor and many others I am sure. Oh how could I forget the one I have to tend to the most: my OnlyFans account!! So many requests for pictures of my feet – barefoot, in sandals, huaraches, etc. But with each follower paying the monthly subscription fee, I’m netting around $10/month. I don’t have to tell you that over twelve months that’s around $120 straight to the bottom line.

Okay, back to the topic at hand, no more chasing shiny objects;

SCDM 2017 was held in Orlando. FOCM card carrying member Brian Langin with card # 00000001 encourages me to have a FOCM Networking event at Bob Marley – A tribute to Freedom in Universal CityWalk Orlando. And therefore, I do.

Entering into evidence the following two pictures:

Vicky Martin, Jennifer Price, Hugh Levaux, Karen McPoyle, Joby John, Tina Pietropaolo, Susan Howard and Karen Hicks.

The Brain Trust; Photo assumed to be taken by Brian Langin

Apologies for the darkness of the picture of Brian – at the time he was keeping a low profile due to some criminal or civil investigation of one type or another.

Anonymous Informant – Brian Langin

August Virtual Networking Summary

Buying and Selling with Great Technology!

The GLSA | FOCM Networking Event on Wednesday, August 17th, 2022 at 5:00 PM EST was expectedly light in attendance with many of our friends and colleagues taking a well-earned break during these summer months. 

Our guest speaker, Michael O’Gorman, CEO of Life Science Marketplace, treated us to a demonstration on how to use his innovative pricing tool for Sponsors and Vendors to connect and access more information, providing a more competitive bidding experience and allowing vendors to highlight their strengths and set themselves apart from the majority. 

Our own Chris Matheus and Denise McNerney were attending a live event that GLSA and FOCM Networking were co-hosting with ProTrials Research in Raleigh, NC at the AC Hotel Level 7 Rooftop Bar and thus did not join our virtual meeting. 

For those who missed the event and would like to learn how to buy and sell with Michael’s platform, please feel free to watch the video:

Insert video link here:

 

For more information or to schedule a more in-depth demonstration please contact “>Hannah Lloyd or fill out this form and we will be happy to assist you.

Let’s continue to reinforce our collective goal to improve patients’ lives across the globe. If you would like to present briefly on an educational life sciences topic and spur our event discussions, please leave a comment below and I’ll reach out as soon as possible. Our next event is scheduled for September 21 and CoolChain has been invited to discuss how how to ship and maintain temperature controlled shipments with eco-friendly reusable cold chain shipping containers. 

Attendees included people from these organizations:

biomedWorx,  Life Science Marketplace, Cmed Clinical Services, Curebase,  EmVenio as well as several GLSA staff.

Photos:

Capturing the action
Engaged attendees

Meeting Summary July Virtual Networking

The GLSA | FOCM Networking Event on Wednesday, July 20th, 2022 at 5:00 PM EST was a lively affair boasting a diverse crowd of life science professionals. Many who attended were the previous colleagues and / or the current friends of Chris Matheus (FOCM, President; GLSA Chief Commercial and Networking Officer).

The topic of the day was “Summer Fun” due to the prevalence of the industry to go semi-dormant in July and August to accommodate the well-deserved vacations of its workers. The introduction, led by Chris, briefly spoke of former events which usually involved the related capabilities or education topic of a guest speaker to spur industry-related discussions and aid in collaboration among the group. He expressed the intention of this event to be focused more on the personal activities and vacations of attendees in order to keep our minds on the relaxation of these summer months. 

To nobody’s surprise, we couldn’t stay away from discussing work including the most recently held conferences; BIO International Convention in San Diego, CA and DIA Annual Meeting in Chicago, IL with a specific mention about the limited presence of sponsors. An outbreak of Coronavirus at these events and the apparently foul-tasting Paxlovid medicine used to treat moderate cases of COVID sparked conversation about who among us has contracted the virus and the varying degrees by which each individual was affected. 

Andrew Mulchinski stated that Symbio hasn’t fully adapted to DCT yet, sparking the post-quarantine observations of many regarding the transition to decentralized and hybrid studies. Chris noted a number of CRO’s that have changed leadership or have been acquired by other companies.

By far the most celebratory moment of the event was the announcement of the recent success of the Memorial Sloan Kettering Cancer Center in a small clinical trial using immunotherapy. They achieved 100% remission of rectal cancer without the use of surgery, chemotherapy or radiation that can leave patients with life-long effects including infertility and colostomy bags.

Let’s continue to reinforce our collective goal to improve patients’ lives across the globe. If you would like to present briefly on an educational life sciences topic and spur our event discussions, please contact me.

Attendees: (first time attendees in bold)

Kimberly Lupo, MS, MBA, RAC Founder & CEO at Portrett Pharmaceuticals LLC
Sara Tylosky CEO, Farmacon
Nadia M. Bracken Operational Advisor, Medidata
Brian Horan CEO & Co-founder, SupplyRx
Tina Tran Director, Business Development, Unlearn.ai
Heather Hollick Rizers LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Amy Zastawney Seeking a new executive business development role
Jon Matheus Commercial Real Estate, A.T. Pancrazi Real Estate Services
Unnat Patel Founder & President, AnalysisMate
Peter Payne Life Sciences Executive – Available for Consulting
Griffin Robertson Partner Account Manager, Mednet
Nancy Zeleniak Enterprise Strategic Partnerships & Participant Engagement; Atrium Health
Dhruv Wadhwa Director of Business Development, HUMA
Michael Young Founder & Principal, BIOMedworx
Scott Robertson Vice President of Sales, Global Partnerships; Mednet
Ravipal Luthra, MS, BDS Clinical Research Coordinator, University of Miami, Miller Medical Center
Andrew Mulchinski, MPA, MT, ASCP, CCRC Business Development; Symbio, LLC
Lani Hashimoto Associate Director Patient Engagement Management; Novartis
Amanda Putnam Team Lead Manager; Data Recognition Corporation
Michael O’ Gorman CEO and Founder at Life Science Marketplace
Eliana Burke Global Head of Client Engagement & Marketing; Greenlight Clinical
Michael Minor EVP, Clinical Research; IMA Clinical Research
Vaibhav Sawant Pharma Marketing Executive
GLSA ATTENDEES
Denise McNerney Chief Operations Officer
Hannah Lloyd Account Manager
Zulma Varela Director of Public Communications
Sally Haller Operations Manager
Todd Neilson Account Manager
Joe Buser Chief Revenue Officer
Chris Matheus Chief Commercial and Networking Officer
Yutong Liang Intern, Data Management and Technology

Screen shots of the event follow:

Screen shot at 5:06 Start of the event Screen shot at 5:18 Screen shot at 5:21

Break out rooms
Screen shot at 5:45
6:02 p.m. screenshot

Meeting Summary of May Networking Event

On May 18, the GLSA and FOCM held their monthly online networking event. We always start the meeting with some time for people to give an update on any news they’re heard or a significant event that has happened in the past month. Then we move to a featured presenter for 10 – 15 minutes presenting information about themselves, their company or a clinical research topic of relevance to them or to the industry.

This event featured Alison Macpherson, CEO and Founder of Bright Pharmaceutical Services, a full service CRO headquartered in Los Angeles.  Bright is celebrating their 20th year in business.
http://www.brightps.com/

Alison talked about her experiences starting out in the clinical trials industry and how that led to her forming Bright with a boutique sponsor-centric approach and a focus on subject recruitment and retention. The company has worked in a variety of therapeutic areas and all phases of research.  Its differentiators from other similar sized CRO’s is the very low turnover (less than 5%) over the 20 years in business, which means clients’ projects are supported by only very experienced and engaged staff. Additionally, while much of their experience is in phase I and II North America trials, they have worked in 30+ countries globally.  Questions were handled as they came up leading to discussions about Bright’s experience with risk-based monitoring; the new normal of hybrid and decentralized trials; reducing the frequency of subject visits to the sites; and Bright’s experience with trials that require collecting data from wireless, connected devices, e-source data, etc.

After the presentation we had first time participants share their company names and experience. Josh Lang, Mike O’Gorman and Denise McNerney will be attending BIO in San Diego June 13 – 16.  Carlos mentioned the networking event they are having on June 12 in San Diego for people interested in Farmacon Global’s August 25 conference focused on conducting clinical trials in Rare Diseases in Emerging Markets.In posing this question to the group – what are you working on and what do you need help with, Heather Hollick (who taught me this approach for successful networking) mentioned she is starting the Institute for Vibrant Leadership and could use connections to leaders, coaches with whom to collaborate as well as writers and virtual assistants. Subsequently, a few potential connection candidates have been sent to her. https://heatherhollick.com/

Attendees (bolded names indicate first time attendees):

Alison Macpherson, Bright Pharma Services
Heather Hollick, Rizers LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Nicole O’Brien, Pain Care Labs
Josh Lang, Asymchem Group
Barbara Hilewsky, BRCR Global
Shane Krauss, Strados Labs
Carlos Martinez, Farmacon Global
David Holland, Cmed Research
Michael O’Gorman, Life Science Marketplace
Keisha Felix, IQVIA
Ludmilla Scodeler
Jim Choi, CRScube
Cesar Serapiao
Chris Matheus, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance
Denise McNerney, Global Life Sciences Alliance
Hannah Lloyd, Global Life Sciences Alliance
Todd Neilson, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance

Several screen shots follow:

Bright Pharma Services

 

Screenshot of May 18 2022 event
Screen shot of May 18 2022 event

 

 

Networking from 2017

I am most definitely playing catch up with posts – but I’ve always been a strong believer or follower of the “better late than never” philosophy.

Here’s a picture of Bryan Clayton and Tope Keyes at a January 2017 Healthtech event.  I’ve seen them both recently as we’re returning to in -person conferences and networking events.

Bryan Clayton and Tope Keyes

 

 

 

 

 

and this next photo may have been taken at the same event – at least I do know it was also taken in January of 2017.  Brian Langin, Nithiya Ananthakrishnan, Deb Jendrasek and Rob Nichols. Please note neither Brian nor Rob have registration badges – it’s possible their attendance involved using the time honored Business Development technique known as “the Strand” or “the Langin”.

Brian Langin, Nithiya Ananthakrishnan, Deb Jendrasek, Rob Nichols

April 20 Networking Event Summary

On April 20, the GLSA and FOCM held their monthly online networking event. We always start the meeting with a featured presenter spending 10 – 15 minutes presenting information about themselves and a clinical research topic of relevance to them or to the industry.

This event featured 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.   https://paincarelabs.com/

Amy presented information on research results showing the incidence of needle fear among Americans. Research shows that 25% of Americans are adverse to needles. This is playing a role in the slower than desired vaccination rates against COVID-19.

Needle fear has increased dramatically since 1995 when it was reported that 10% of adults and 25% of children feared needles. Prior to 1980, children’s last vaccination was at age 2, except for DPT boosters every 10 years. Since 1980, children receive booster injections between the ages of 4 and 6, when fears form. A study in 2012 from Canada shows 63% of people born after 2012 have needle phobia. 

Pain Care Labs has developed Buzzy for the management of needle phobia. This combines the distraction of cold with deep vibration which blocks the pain signal. Managing needle phobia is important for increasing vaccination rates among people of all ages. It can also play a role in clinical research if a clinical trial is a vaccine trial or a protocol requiring multiple needle-sticks, Such trials may have higher drop-out rates or decline to enroll due to the subjects’ fear. 

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 ask how the group can be of help. Additionally, after the event Heather Hollick shared observations about what makes the GLSA online networking events work so well is: 

  • Starting with initial casual conversation
  • Having a 15-20 minute learning session
  • Breaking into groups of 2-4 people several times so all can meet each other and share what they’re working on
  • Ending with closing remarks, comments and observations. 
  • Online networking requires light moderation, because we’re missing body language for our cue as to who is to speak next. 

Amy provided a good suggestion that we start these with a general ice breaker, a question or topic each can respond to. We’ll begin implementing that for our July event. The July and August events will be light-hearted and casual, imagine sipping a cocktail on a beachside outdoor deck with friends. In September, we’ll return to focused topics/presentations after the general ice breaker and before break out networking.

Attendees (bolded names indicate first time attendees):
Amy Baxter, MD; Pain Care Labs
Nicole O’Brien; Pain Care Labs
Peter Payne; Consultant
David Rodrin; IMA Clinical Research
Daniel Paszterko; Myonex
Ari Cofini; VeriSIM Life
Neil Banerjee; QMS Integrity
Nancy Zeleniak; Atrium Health
Mike Minor; IMA Clinical Research
Brittany Barber, Syneos Health
Nicole Aubrey; Aubrey Cole Consulting
Maria Frane, Simbec-Orion
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”
Mike O’Gorman, Life Science Marketplace
Edwin Gershom, Noble Life Sciences
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

Screenshots from the event:

Screenshot with Teddy in center square
Amy Baxter, MD; CEO & Founder of Pain Care Labs
Needle Fear Statistics
Buzzy for needle pain
Screenshot of Attendees
Screenshot of Attendees

Karen Key – Larger than Life

 

I’m at the age where family, friends and acquaintances are passing away at greater frequency. It’s a part of life and comes as no surprise. That knowledge  doesn’t make the grief of such events any less painful. Recently the world lost one of its great people – Karen Key. My soul is deeply sad at Karen’s passing.

There are a few people I’ve known in my life that I describe as “larger than life”.  I’d seen that descriptive phrase for years in books I read and didn’t truly grasp the meaning of  it.  My friend, Peter Holthe who was the impetus, actually the creator for FOCM – the website, events, etc was “larger than life”. It was after his passing that I truly appreciated the phrase. At Peter’s memorial service, his college room-mate Byron Pitts was in attendance. In Byron’s autobiography “Step out on Nothing” there is a portion wherein he describes how much Peter helped him in college.

Karen is also a member of this elite group of rare individuals who touch your life and impact it forever. Her consistent kindness, respect for others,  sincere and contagious enthusiasm, love of America coupled with her joy at having fun, smiling and laughing are what I think of and how I will remember Karen.

We met while working at Burroughs Wellcome Co., a unique pharmaceutical company founded in the UK in 1880. It was purchased in 1995 by Glaxo, which subsequently merged with SmithKlineBeecham to become GlaxoSmithKline. I think I met Karen in 1985 while we were both in Sales Representative Trainer Training class. My territory was in southern California and hers was the Raleigh-Durham, NC area.

We both came into the home office/headquarters around the same time. Senior management could tell early on that she was special – one of those people who excel at whatever they are assigned.

We weren’t in touch much in our post-coworker era but our friendship was one of those where that wasn’t necessary. In the most recent 10 years we were back in touch and saw each other more. I had a memorable stay with she and Donna and other BW alumni at their Hyco Lake house. She helped me get my dog Micah into the kayak so I could paddle him around.

Hyco Lake: Karen, Micah and me

The late stage lung cancer diagnosis was a huge shock and she handled it well and fought it with all that her optimism, her doctors and medications could provide.  https://www.clementsfuneralservice.com/obituaries/Karen-Letisha-Key?obId=24530539

Heaven has added another angel. Rest in peace my friend.