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:

Screen Shot #3

August 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 of the event:

Engaged attendees
Capture of the action

April 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:

Amy Baxter, MD; CEO and Founder of Pain Care Labs

 

Needle Fear Data in Children
FDA Approved
Screen shot of Attendees with Teddy in the middle square
Screen shot of attendees

 

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 #1
Screenshot #2
Screenshot #3
Screenshot with GLSA Mascot Teddy in lower left corner

DelveHealth Presentation

CNS Summit Conference 2021

The CNS Summit, a year-round community with an annual in-person Summit was held at the Encore Resort Boston Harbor. It was very well-attended with over nine hundred registered. There was a feeling of pent-up need for networking and reconnecting. It is quite apparent that participants at this meeting are enthusiastic to be attending in person. The joy and happiness of seeing friends, colleagues (past and current) and being able to freely move about and make new connections was palpable. There is such a willingness to hear about what each other is up to, has learned and is doing different since the last time we gathered in person.

Rapid antigen testing was conducted rapidly for Covid-19, and  a negative test result (within about 15 minutes) indicated by a wristband provided, allowing access to the Summit.  The testing was provided by CNS Summit in partnership with Care Access. The process went off flawlessly, a great testament to the Care Access and CNS Summit staff involved.

There were many exhibitors, patrons and sponsors. To see which companies participated, I recommend you go to the website: https://cnssummit.org/

Digital Biomarkers, Artificial Intelligence, Machine Learning, Big Data, Patient Diversity, Real World Data were among many Spotlight topics. As an example, Sharecare and UCB presented real-world data on patients with Myasthenia Gravis. The insights learned, the new endpoints discovered and the capabilities of the smartphone in such trials was impressive.

Below is the expanding list of companies that define themselves as DCT clinical trial service providers.  Go to https://www.dtra.org/  Decentralized Trials & Research Alliance to fully appreciate the expansion of companies and organizations in and/or getting into the decentralized research segment of our industry.

Curebase Circuit Clinical
Medable Science 37
TrialBee Thread
CaptureProof Care Access
Clinical Ink DataCubed Health
Medocity Medidata
ShareCare (SmartOmix) Science 37
SiteRx

If you are interested in the CNS Summit community and the opportunity for interacting within it year round, you can apply at the organization website, which is listed above in  paragraph 3.

And on a sad note, Medidata co-founder, Glenn DeVries who attended and presented at the conference passed away November 11 in a private plane crash in New Jersey.

 

Technology changes so quickly

Maybe the title of this should be “the pace of change”.  Recently while starting a company with people much younger than me, I felt like I had missed several years of involvement in the world.

With the accelerating pace of technological change, many of us find ourselves behind in keeping up with new software, programs, and technological processes implemented in the workplace.

A critical part of adapting to the digital advancements is learning and training. Implementing various types of training systems, such as written instructions and live video training to accommodate different work styles and preferences may be helpful.
In order to be effective, we need to identify the technological changes that will enable us to attain the goals of our future projects and avoid those that could jeopardize their completion.

How can we adapt to the rapid, sometimes unpredictable digital advancements? How do we prepare ourselves for the new technology processes? How do you know if you indirectly resist the changes and how can you solve that?

The Uncertainty about future or current technologies might have nothing to do with the technology itself, but instead with how we respond to the changes.

I don’t know if kids still read Washington Irving’s story of Rip Van Winkle.  https://en.wikipedia.org/wiki/Rip_Van_Winkle  It’s about a man who fell asleep and woke up 20 years later and it was hard to accept all that had changed.  Well, lately, I feel like I’ve been asleep for 10 years and have completely missed some of the digital advances and even the more mundane.

Let’s address the mundane one first, so tonight I stop in at Staples because I’m all out of “business” envelopes – you know  the type, the long envelope that if you wanted to mail an 8.5 x 11 inch letter to someone, you’d fold it in thirds-ish and put it in this envelope. So I confidently stride to the aisle labeled Envelopes and begin looking for business envelopes.  No such thing to be found.  They had boxes of an envelope with the wording Number 10.  So I look at the dimensions and it seems that they would work.  At check out, to confirm I was buying what I needed, I ask the two 20-30 year olds – one was a manager –  at check out, “are these envelopes the same as what I know as “business envelopes”? They, of course, had never heard that term.  So I explained that I was looking for what I know as business envelopes, they said, well, yeah it looks like that would fit as this is 9 and a half inches wide.

Now  to the digital world – so a client of ours texts us to say he’ll be texting us an image that we’re to take a picture of and save for later use in demo’ing his product at a conference. Those simple 6 words: “take a picture of and save”. So that I know what I’m to do I reply with: “just to confirm – by take a picture of and save – do you mean that I’m to use my iPhone and when I see the image I’m to do that iphone thing where I push a button on the side of the phone and at the same time push the round home button such that it takes a screen shot and then once that’s done I click on the screen shot and select “save to pictures”?  He replied, “yes”.  So you see what’s happening here? 59 words of explanation are needed for me to understand, interpret and act on his 6 words.

You should pray for my colleagues, this type of thing happens nearly weekly. You should pray for my colleagues, this type of thing happens nearly weekly.    Quite simple really isn’t it: “take a picture and save it.” *%$”(#*%4”@$(*$*(#@$*(@#)

Matheus BD Connections 2020 Person of the Year

Without a doubt the work done by the pharmaceutical, biotech, clinical research, drug development industry and the Food and Drug Administration is worthy of this distinction for 2020. What was accomplished is just short of miraculous.

The federal government (FDA) and the corporations cut no corners. I have no doubt that everything was done according to established good clinical principles. What was done was the speeding up of the regulatory processes; decreasing the workflow processing time. Turn around time on data review and decision making was the focus. The researchers and the reviewers of the data had Covid-19 treatments and vaccines at the forefront of their priorities.

The typical time for vaccine development to get approved is 4 years. The first two approved were done within 12 months!! There are several more in development.

We are now beginning to see the impact the vaccine is having in the US in terms of the decline of daily new cases. Many people have had their second dose.  The United Kingdom began vaccinating their population one week earlier than the US and you can see the impact to their daily new cases as well. This has me very encouraged. I’m hopeful that by Memorial Day, we’ll be back to dining out and meeting in person, traveling to conferences, vacations, etc.

US Daily New Cases Jan 18, 2021

 

 

 

 

 

 

 

UK Daily New Cases, Jan 18, 2021

Virtual Conference Observations

Observations on Virtual DIA 2020

2020, the year of the COVID-19/Protests/Riots/Presidential Election and the year the clinical research industry’s annual convention went virtual.

The noteworthiness of this made me think to jot down my observations.

I have been attending DIA since 1997. That year it was held in Montreal. Last year was in San Diego, which is probably the best place to have it in terms of weather.  The conference is always in the 3rd or 4th week of June.  The heat and humidity in Chicago, Philadelphia, Baltimore, and Boston has often been close to unbearable.

The biggest differences for me were:

  • I didn’t get to co-host the FOCM Networking event with my friends from Zymewire
  • I missed seeing everyone! Not seeing friends in person (this event is very much an industry reunion) and not getting to socialize with them makes it more difficult to maintain relationships
  • Seeing so few friends in the virtual exhibit hall (Thanks Adriana Grado and Amy Zastawney for taking time to meet with me). Every year I make a point to walk the entire exhibit hall to make sure I see and catch up with as many people as I can and to see what new and innovative products and services are available
  • I didn’t stay out too late (there was no virtual Transperfect party or vendor parties of any kind)
  • I didn’t drink too much.
  • I didn’t have a Fireball shot at the Barrington James exhibit.
  • I didn’t welcome any new FOCM members and hold any card ceremonies (I’ll have to re-write the card ceremony SOPs – the handshake may have to be eliminated)
  • Here it is the last day and I’m not exhausted.

As I have often told people younger and/or with less conference experience than me, at DIA – you will stay out too late and drink too much.  I point out that you HAVE to do this (it might even be in the SOP binder), because if you don’t, it wouldn’t be the tradition that it is.

A couple months ago I held a virtual FOCM Networking event with about 10 industry friends. I asked them if DIA were to be held in person, who would travel to DC for it.  The answer was no one.  Comments made were: it’s too risky, I don’t want to get on a plane, stay in a hotel, take a cab or Uber and go to a conference with 5000+ people.

We in this industry are proud of the role we’re playing and demonstrating to the world the value, the need and the method for discovering treatments for COVID-19. The need to utilize recent innovations in big data, AI, high throughput screening, lighten cumbersome regulatory hurdles will serve the world well for developing new treatments for all diseases.

 

 

Get involved through Mentoring

Sharing with you a mentorship program I’ve gotten involved with at the University of North Carolina Wilmington.  FuseCR (Center for Clinical Research Workforce Development) is a collaborative designed to connect UNCW with the field of clinical research.  FuseCR is providing  local clinical research talent with powerful career and industry enhancing services.  One such program is MentorCR which pairs undergraduate students majoring in clinical research with experienced industry professionals in a formal, structured partnership.

My mentee is Keith Reid, https://www.linkedin.com/in/keithtreidjr/ .  Keith is a Junior in the Bachelor’s Degree in Clinical Research program.  While going to UNCW, Keith works as an Advanced EMT at New Hanover Regional Medical Center.  Like many others in the clinical research industry, Keith feels drawn to this as a career having lost both his grandfather and father to heart disease at the age of 50.

Keith and I will meet monthly or more often as needed.  Given my passion for connecting people, some of you can expect to hear from me requesting some of your time to talk with Keith on career path options and to share your experience and perspective.

The UNCW Clinical Research degree program is impressive in preparing students for entering into the clinical research industry.  Keith has already completed the following certifications:

  • Medidata Classic Rave EDC Essentials for clinical research coordinators | March 2019
  • TransCelerate Essential Documents | February 2019
  • TransCelerate IRB/IEC Responsibilities & Informed Consent | February 2019
  • TransCelerate Facilities & Equipment | November 2018
  • TransCelerate Investigator Oversight Informational Program | November 2018
  • TransCelerate Delegation & Training | October 2018
  • Medidata EDC Inspection Readiness for Clinical Sites | June 2018
  • CITI Biomedical Research Certification | 2018

For more information on UNCW FuseCR and the MentorCR program, read on or go to the links shown.

FuseCR (Center for Clinical Research Workforce Development) is a collaborative designed to ignite a new synergy between UNCW and the field of clinical research. By fusing resources and knowledge from academia and industry, FuseCR is energizing the local clinical research talent with powerful career and industry enhancing services.

https://uncw.edu/chhs/community/fusecr/index.html

  • Build Connections between Academia and Industry
  • Enhance Our Existing Workforce
  • Prepare Students for the Workplace
  • Educate the Next Generation of Talent

The general objectives of these programs and services are as follows:

FuseCR was formed by UNCW faculty from the School of Nursing’s Clinical Research Program and the Math and Statistics Department, in partnership with the NC Biotechnology Center Southeastern Office and the NC Coast Clinical Research Initiative.  This project was partially funded by a grant from the Duke Energy Foundation to strengthen the workforce for the local clinical research industry.

MentorCR for Industry Professionals: FuseCR Mentoring ProgramMentorCR pairs undergraduate students majoring in clinical research with experienced industry professionals in a formal, structured partnership. Engagement opportunities and leadership seminars are offered to further the student’s careers and the industry professional’s mentorship skills, while building professional relationships within the clinical research industry.

https://uncw.edu/chhs/community/fusecr/mentor.html

Mentors meet with their students 2-3 times per month and have opportunities to attend leadership seminars to further their careers while building networks within the industry. This program advances UNCW’s goal of workforce development in health-related fields for our regional community and provides crucial applied learning opportunities for our clinical research students.

Mentors have the opportunity to:

  • Support UNCW students by orienting them to the industry and helping them to build networks
  • Help the local economy by preparing better trained students
  • Experience the personal and professional benefits of being a mentor