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

Essential Skills Training

On March 23, 2019 at UNC-Wilmington (UNCW) Fuse CR site, a 6 hour workshop on Essential Skills was held. I’d gotten involved with this initiative through my desire to use my network to help others.

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.

Working with Tiffany Erichsen and Susan Sinclair, we put on a program for the students in the Bachelor’s and Master’s Degrees in Clinical Research.

The first topic was Effective Leadership Styles presented by Michael Williams. Michael is the Chief Executive Director of the Executive Service Corps of the Triangle. I’ve known Michael for over 30 years. We were room-mates while in training for our first jobs out of college with Burroughs Wellcome Co. He is an excellent presenter. Students learned the DISC profile and its role in leadership and communications.

The second topic was Collaborative Negotiating presented by Jim Sheegog. Jim is a founder of Rowhill Consulting Group. Jim and I have known each other around 20 years. Jim also worked at Burroughs Wellcome Co which is where we met and then by chance I ran into him at a local restaurant about 7 years ago. Jim is well known in the corporate training and leadership development industry with significant work at global organizations.

A representative from the UNCW Career center spoke over lunch regarding professionalism, conference attendance, image and how to navigate a buffet lunch.

The final speaker was Danielle Baxter and she spoke on Branding. Danielle is Director of Business Development for Paragon Global CRS. I’ve known Danielle for 2 years and she is a very impressive speaker.

I was able to help because I keep in touch with people I’ve met from across the spectrum of my career and I put in effort to maintain the relationship – networking.

Branding – Danielle Baxter

Collaborative Negotiation – Jim Sheegog

Leadership – Michael Williams

Leadership Workshop

Leadership Workshop

DIA 2019 Call for Abstracts

The Drug Information Association (DIA) 2019 Call-for-Abstracts is now OPEN!! DIA 2019 will be in San Diego, getting an abstract approved is a great way to get to attend. The registration fee is significantly reduced for those who present content. At the site is also the abstract guidelines and categories.

The submission period is open from August 1 – September 12.

DIA 2019 Call for Abstracts

LaunchBio NC Networking

LaunchBio (LaunchBio) holds events on the first Thursday of the month in Durham, NC.  They are held in the Chesterfield Building in the downtown area.  The building was formerly a cigarette manufacturing building.  It has now been converted and there is incubator lab space for drug discovery and development.

It is a great opportunity for networking with people involved in the clinical research industry.  Here I am enjoying conversation with Peter Weiman with MedNet Solutions (MedNet Solutions) and David Holland with Cmed (Cmed Research).

LaunchBio_August_2018_Web-10