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

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/

November Networking Event Summary

One of the things I thoroughly enjoy about networking is meeting such interesting, fascinating people with different perspectives. This helps us understand and appreciate those differences and helps us re-consider our approach to certain things.

On November 17, the Global Life Sciences Alliance along with FOCM Networking held its monthly online drug and medical device development industry networking event.

Whereas last month we had a featured speaker – Heather Hollick on LinkedIn best practices; this time we just had general discussion and greeting of one another. While there were still a manageable number, I introduced each person and how I know them. There was also discussion and general agreement that when Merck and Pfizer get their oral dose antiviral medicines approved (whether emergency authorization or full approval); the COVID-19 pandemic will become very manageable and the world can return to our new normal; forever impacted but less restricted. (added since the 11/17 meeting – the identification of the Omicron variant may put a slow down on the return; however, early information indicates that while it’s easily transmissible, the symptoms are different and mild, such that as of Nov 30 in South Africa hospital where the doctor found the Omicron variant, no hospitalizations are attributed to it. And now just today, an FDA Advisory panel recommended approval for Merck’s anti-viral pill to treat COVID-19 and reducing hospitalizations.)

We then moved to the evening’s agenda. We had three rooms for people to go to depending on their interests.  The three discussion topics were:

  • Clinical Trial Recruitment and Retention
  • Innovation and Technology
  • Networking

Heather Hollick chaired the Networking room. One discussion centered around how sales/business development people use it and consultant/subject matter experts use it to best fill their connection needs. Interestingly, several participants shared that they control their LinkedIn outreach and purposefully limit their contacts to a more easily managed subset (~1000) to maximize the depth of relationships. Several other participants use a more liberal approach and have grown their networks to over 10,000 contacts who then serve as “private wikis” allowing rapid access to large groups of professionals with multivarious experiences.

Please join us next month on December 15 and if you have a Christmas sweater – wear it!

ATTENDEES (bolded names were first time attendees, I think):

Heather Hollick, Rizers, LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Mike Burrows, Burrows Life Science Associates, LLC
Lacey Clements, IMA Clinical Research
Kevin Boos, Rho
Valerie Roussin-Paradis, SkillPad
Edwin Gershom, Noble Life Sciences
Wessam Sonbol, Delve Health
Michael W. Young, biomedwoRx: Life Sciences Consulting
Nicole Yoon, Mediaiplus
Ires Alliston, Business Coach, Consulting & Marketing
Lindsey Summers, Green Key Resources
Chris Matheus, Global Life Sciences Alliance & FOCM
Denise McNerney, Global Life Sciences Alliance
Joe Buser, Global Life Sciences Alliance
Brandon Huffman, Global Life Sciences Alliance
Holly Cliffe, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance

November 17, 2021 Networking Screenshot
Networking Event Flyer

https://globallifesciencesalliance.com/news/

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.

 

Drug Development Industry Networking Event

One of the things I thoroughly enjoy about networking is meeting such interesting people with different perspectives. This helps us understand and appreciate those differences and helps us re-consider our approach to certain things.

On October 20, the Global Life Sciences Alliance along with FOCM Networking held its monthly pharmaceutical/biotech/clinical research/medical device/drug development industry online networking event (that’s a sentence-full). I know I wrote that in last month’s minutes too, so I promise to acronymize/shorten/bitly it next month, maybe to Pharma/Bio/CRO/Med & DrugDev or PBCMD? Is there a broader term one of you readers can suggest?

While people were arriving into the Zoom room, the first arrivers greeted each other and got their headsets, earphones, etc ready and connected. We started with the acknowledgement that October is National Breast Cancer Awareness Month. The advances in cancer therapies over the past dozen years or so is truly remarkable. With genotyping advances, new drugs are designed/created that work very well.  This allows testing to be done prior to drug administration and know ahead of time that certain patients will respond well.  So instead of having to enroll 300 cancer patients in a study to get enough with the defect in order to show statistical significance, the study can be done with fewer patients and to show significance and speed up the time to FDA approval.

We then moved to our featured speaker, Heather Hollick, a friend of mine for several years and the author of “Helpful, A Guide to Life, Careers and the Art of Networking”. Heather focused the discussion on best practices for using LinkedIn. It is an invaluable tool for networking. There are 8 ways that LinkedIn is beneficial.

  1. LinkedIn is how you present yourself to the industry. At a minimum it is your online resume.
  2. Enhances introductions – you know so much more about who you’re being introduced to.
  3. Refreshes your memory on who a person is, where you know them from and how long you’ve been connected.
  4. It helps you prepare for meetings – review who will be in the meeting and find items of commonality.
  5. Find companies that are hiring
  6. Provides links to other websites aiding in your research
  7. Keep track of who is in your network.
  8. Engage in groups and discussions with others that you share interest with.

I like to include how I met people, as a demonstration of the power and benefits of networking. I was connected to Heather via Tanyss Mason. I admit I’m having a difficult time remembering how Tanyss and I first became connections. Heather was in the midst of writing the book when we first met over the phone. When the book was released and Heather was in the RTP, NC area at a book premier and signing event we got to meet in person. Heather co-presented at the 2021 DIA Annual meeting (virtual) with me on a Networking workshop. We’ll collaborate again on this session for the DIA 2022 meeting being held in Chicago.

We typically go into several breakout sessions of 3-4 attendees for about 12 minutes each but this time, there was so much good discussion about LinkedIn and maintaining, nurturing and freshening one’s network that we showed our flexibility and kept rolling with the topic of interest.

Please join us next month on November 17.

Screen shot of Zoom networking

ATTENDEES (bolded names were first time attendees, I think):

Heather Hollick, Rizers, LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Mike Burrows, Burrows Life Science Associates, LLC
Lacey Clements, IMA Clinical Research
Nadia Bracken, Medidata
Christine Narro, Medical Device Co.
Lewis Kelly, Gunvatta
Chris Bergey, Humphries Insurance Agency
Michael O’Gorman, Life Science Marketplace
Patrick McCarthy, ValidCare
Joe Dustin, Transcelerate Biopharma
Janie St. Pierre, Accellacare
Ellen Bedenko, IQVia
Patrick Champoux, SkillPad
Andrew Mulchinski, Symbio Research
Chris Matheus, Global Life Sciences Alliance & FOCM
Denise McNerney, Global Life Sciences Alliance
Joe Buser, Global Life Sciences Alliance
Daryl Oberg, Global Life Sciences Alliance
Brandon Huffman, Global Life Sciences Alliance
Holly Cliffe, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance

Summary of GLSA FOCM Event

Minutes of the GLSA – FOCM Meeting of May 20, 2021

So, it finally happened, on that glorious day which shall long be remembered, these minutes will be heretofore submitted to the USA Library of Congress, the Smithsonian Institute and for reasons unknown, to the Sydney Opera House on the northside bulletin board for public postings.

On May the 20, in the year 2021 of the Gregorian calendar, it was noted that the GLSA (Global Life Sciences Alliance) and FOCM (Friends of Chris Matheus) Networking organization did hold an online (virtual) networking event. The meticulously planned event went terribly awry when but half of the positive RSVPs failed to show up.  That said, it was a resounding success for the initial such event.  A total of 21 attended.

The meeting started off with an acknowledgement that it was Global Clinical Trials Day and a toast was given to the clinical research industry for saving the world from Covid-19 and to James Lind, the Scottish doctor who initiated the first controlled randomized clinical trial on May 20, 1747 aboard a sailing ship. Dr. Lind divided twelve sailors sick with scurvy into six groups of two. They all received the same diet but, in addition, each group was given a different treatment. Only the two sailors who received citrus fruits improved and returned to work.

Chris then introduced the GLSA members to the FOCM community.  After a bit of general discussion, several polls were taken. About half of the group is reluctant to resume conference travel immediately, preferring to wait a few more months. Slightly more than half have been vaccinated or acquired immunity through catching the virus. An interesting opinion was voiced that perhaps as members of the clinical research industry, we should set the example by all being vaccinated.  I, for one and I believe I speak for many of the others have the utmost confidence that not a step was missed, not a shortcut taken in the development of the available vaccines.  Given the prioritization and urgency of vaccine development, we were able to speed up the data review process. The one thing that the sped up development lacked is longer term safety and side effect data.  However, vaccine side effects rarely (I can’t think of any) change the longer from the time of injection.

Then it was time for speed networking!  The assertion has been made by Chris that each of us in the clinical research industry are within 2 degrees of separation from each other. We had 4 different sessions.  Attendees were randomly put into different “rooms” with the assignment to each introduce themselves to the group, sharing where they’d worked the previous 10-20 years and what they’re doing now to see if they could identify who they knew in common.  Good information was exchanged and several new connections were made which can improve the management of clinical trials.

Join us next month – June 16.

Attendees:
David Holland, Cmed Research
Jon Matheus, Pancrazi Real Estate
Sheila Mahoney-Jewels, Life Science Hub
Eric Nier, Block Clinical
Lynne Becker, Power of Patients
Nadia Bracken, Medidata
Christine Ver Straate, GLSA
Mitchell Efros, Verified Clinical Trials
Cassandra Hui, HealMary
Denise McNerney, GLSA
Joe Buser, GLSA
Tom Ryan, GLSA
Kalyan Ghosh, Inference Inc
Marty Frazier, GLSA
Tanusree Bhattacharyya, Inference Inc
Zulma Varela, GLSA
Mike O’gorman, Life Science Marketplace
David Gibboni, DJGibboni Consulting
Eric Mayer, EDP Biotech
Craig Fernandes, EDP Biotech
Maria Frane, C3 Research

Selling clinical trial services

One of my sales principles is this: be wherever the users/decision makers/decision influencers of what you’re selling gather.  By “gather” I mean the conferences they attend; be they large (national) or small (regional). I have had fellow sales people tell me these small, local/regional meetings are a waste of time.
I should have put this disclaimer at the start, but it’s my website, so I’ll put it here. Disclaimer: It is acknowledged that I’m not the stereotypical salesperson.  Type A personality I am not; highly competitive I am not.  When selling services, I believe that people buy/purchase/select services and solutions from someone they know and trust;  also known as relationship selling.
So all that is to demonstrate through this short story:
I recently attended a virtual and regional conference on managing clinical supplies for clinical trials.  There were ~80 people in attendance.  I noticed one or two salespeople for manufacturing and packaging companies, none from drug supply management software companies.  At the end of the meeting, a request is made of the attendees for topics they’d like to hear about at the fall meeting. A specific request was made on the topic of managing study drug pooling by the drug management software.  The leader then asked if anyone had recommendations on who could speak to this.
Posted in the chat window was this: the name of one of the software companies followed by the names of two of that companies’ project managers. 
I trust the moral of this story is obvious.

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

Impressive improvements in study start-up time

A report issued in July of this year, featured the use of a Just-in-Time (JIT) approach to speed up patient enrollment in oncology clinical trials. Collaboration between Cancer Treatment Centers of America and a division of PPD has been able to shorten site activation from a typical 8 months down to 2 weeks! This improves patient access to potentially life-changing therapies while speeding up the ability to evaluate treatments to conquer cancer.

https://www.ppdi.com/news-and-events/news/2019/july-16-optimal-cancer-trials

The JIT approach is based on establishing a community of sites with prenegotiated contracts and terms, which provides immediate engagement by sites to search for patients. Patients are identified first, triggering the activation of sites, enabling patients to be enrolled within two weeks. As a result of the efficiencies of this process, there are zero non-enrolling sites.

This is a huge improvement. Faster startup will allow the pharma/biotech companies to more quickly assess if a drug candidate is working or not. This is a better and more efficient use of everyone involved in conducting a clinical trial, vastly improving productivity of the process.

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