clinical research | FOCM Networking

February Networking Event Summary

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/

January Networking Meeting Summary

On January 19, 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 first event of the new year and we had 3 first-time attendees.

We kept everyone in one main room and went around the room having each person introduce themselves. There was an open dialog and discussion on a variety of topics: expectations for COVID cases and treatments, the impact on travel and conventions/conferences and hopes for it to lessen and burn out and become similar to seasonal flu. The concern for another variant that could put us into strict measures is real yet the thought of having to deal with that makes us tired.

Heal Mary, (https://healmaryapp.com/) a GLSA client is an oncology patient recruitment platform founded by Cassandra Hui. Cass is from the tech industry and she started Heal Mary driven by her personal story: “My mom was told to go home and get her affairs in order, that there were no other options… I’ve made it my mission to ensure that patients know ALL of their options.” We showed a video of Cass explaining the motivation for starting Heal Mary using her tech and Artificial Intelligence skills to make sure patients know of treatment options available via clinical trials. https://www.youtube.com/channel/UCLB_CmGY3-trX3rKePF0FWw

Please join us next month on February 16. Kalyan Ghosh of Inference, a data management and biostatistics service provider and client of GLSA will spend 10 minutes talking about the role of data management and biostatistics in drug development.

ATTENDEES (bolded names were first time attendees):

Heather Hollick, Rizers, LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Mike Burrows, Burrows Life Science Associates
Kate Findlen, Life Molecular Imaging
Kimberly Lupo, Portrett Pharmaceuticals
Mike O’Gorman, Life Science Marketplace
Andy Mulchinski, Symbio
Brian Langin, Matrix Medical
Charlie Speno, Matrix Medical
Michael W. Young, biomedwoRx: Life Sciences Consulting
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
Hannah Lloyd, Global Life Sciences Alliance

Screenshots of the event follow:

Virtual Networking Meeting Summary

On December 15, the Global Life Sciences Alliance along with FOCM Networking held its monthly online drug and medical device development industry networking event. This was our year-end event and we didn’t have a speaker, topic or theme.

We kept everyone in one room and went around the room asking people to answer a variety of questions. We asked for each person to share what positive or memorable thing happened in 2021 and what they were looking forward to happening in 2022.

A representative answer was that while some had caught COVID and it was a bad illness, no one had anyone in their families get severely ill or pass away from it. The outlook for 2022 was felt to be somewhat tentative with the global rise of infections due to the Omicron variant. It was noted that the annual January JP Morgan conference will be virtual again due to the rise in cases. (Occurring today, December 22, Pfizer’s oral dose anti-viral pill to treat COVID was approved.)
Michael Young shared that 2021 found him becoming a grandfather with the birth of grandson Oliver Kiesing Miller (pictures below attendee listing). Michael’s hopes for 2022 include completing the first draft of a book he’s writing on “Branding”. He also echoed the feelings of many of us – having the opportunity to see clients, customers and friends in person and a return to in-person conferences. (I think this is the equivalent of a blood transfusion for extroverts).
Ires Alliston shared that she is hosting a Female Expert Coaches Summit May 9 – 11 in Daytona Beach, FL. More information is available here: (https://femceosummit.com/).

Movies/TV shows people are watching/recommending:

You
The Unforgiveable
Get Back
Curb Your Enthusiasm
Giri/Haji
Yellowstone

Fountain pens
It turns out that Nadia Bracken has found the hobby of collecting fountain pens. Someone else on the call mentioned a former boss who also did so. There was a discussion about the psychological draw toward collecting such pens. I subsequently found this discussion group (https://www.fountainpennetwork.com/forum/topic/136590-pen-personality/) .The hobby appears to be more associated with introversion based on the non-controlled survey in the discussion group. Another article on the topic is: https://www.inkedhappiness.com/fountain-pen-collecting-the-psychology-behind-my-madness/

Toward the end of the event, two things occurred after some had dropped off:

Dan Weddle sang and played his guitar
Michael Young arrived and showed pictures of his adorable 1^st grandson

Please join us next month on January 19

ATTENDEES (bolded names were first time attendees):
Kevin Boos, Rho
Brian Horan, SupplyRx
Wessam Sonbol, Delve Health
Michael W. Young, biomedwoRx: Life Sciences Consulting
Ires Alliston, Business Coach, Consulting & Marketing
Chris Bergey, Humphries Insurance Agency
Nadia Bracken, Medidata
Dan Weddle, AltaSciences
Mike O’Gorman, Life Science Marketplace
Patrick Champoux, SkillPad
Maria Frane, Simbec-Orion
Sara Tylosky, Farmacon
Brennan Munley, Rho
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
Sally Haller, Global Life Sciences Alliance

Photo Collection

Heralded clinical research industry professionals

Denise, Zulma and Michael concluding the meeting

Oliver Kiesing Miller, grandson of Michael Young

November 17 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 reduce 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 multi-various 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 Allianc
Holly Cliffe, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance

Observations: 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.

FOCM Networking Person of the Year for 2020

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 decline of daily new cases. Many people have now received 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.

FOCM Networking Meeting Minutes

Can you believe it? These are the meeting minutes from the November 5, 2018 event in Boston. Many of the attendees were in town for the Outsourcing in Clinical Trials New England meeting. My sparse notes indicate that this was held at the lobby bar in the Westin Boston Waterfront.

We had great attendance with my hastily written down names on a piece of paper indicating the following individuals were in attendance:

Roy Ovel (we worked at ICON Clinical and have known each other 13 years)
Scott Keddy (known each other for 6 years)
Mike (last name not written down, so its clearly a good friend who I should remember or predict)
Matt (going to guess this is Matt Comstock – known each other 5 years and attended the same high school in Yuma, AZ)
Vicky Martin (known each other 16 years; also worked together at ICON)
Kate Mullis (known each other for 4 years)
Bonnie Phillips (known each other for 3 years, met via networking in NC)
Daniel Frederick (known each other for 3 years, met via networking in NC)
Bryan Clayton (known each other for 7 years, worked at YPrime together)
Katherine Cloninger (known each other 20+ years, worked at Quintiles together)
Ted Gastineau (known each other 20+ years, worked at Quintiles together)
Bill Taaffe (known each other 18 years, worked at ICON together)
Brian Langin (known each other 20+ years, worked at Quintiles together)
Chris Utterback (known each other 4 years and we the same birthday)
Susan Cook (known each other 2 years, I think we met that night, Brian Langin invited her, I believe)
Adam Blackburn (known each other 7 years, worked at YPrime together)
Cory Winters (known each other for 3 years, Vicky Martin brought him into FOCM)
Dave Rosa (known each other 11 years)
Paul Eisenmann (known each other 20+ years, worked at Quintiles together)
Jennifer Carpe (looks like an n, then….; could be Carpenter from BioTel; colleague of Cory?)
Lianne Kloppenburg (known each other 9 years)
Kristina Wolfe (although my notes indicate Figueroa was the last name at the time; known each other 3 years, we both live in Wilmington, NC)
Nicole Powell (known each other 5 years)

For those of you in this industry, this list reads like a list of all-stars, right? Unfortunately, photographic evidence of the gathering was not collected that evening.

Ocean-side Networking

The July networking event for the Wilmington Pharma/Bio/CRO Networking Group was held at Dockside in Wilmington. Dockside is located on the west side of the IntraCoastal Waterway. This is the site for this group’s events in the summertime. Wilmington Pharma/Bio/CRO Networking Group can be found on LinkedIn where updates to monthly events are posted.

Fortunately someone snapped a photo at some point so that we have some record of attendance. Not that attendance is ever taken and far too often we forget to take a picture.

L-R: John Cline, Lee King, Andrea Young, Jennifer Hutchison, Jackie Bilobran, Gayle Grandinetti, Chris Smith, Chris Matheus

FOCM Network Brainstorming Project

A friend and FOCM member in good standing is starting her consultancy company and is looking to find a good and proper name. As an annual dues paying member, she is entitled to this calling forth the idea generation of the FOCM Network.

The option to name it something like: lastname (use Smith as the example) consulting, of course is an option. I proposed we ask this network to do some thinking and see if we could come up with a name that will communicate what it is she can best contribute.

So here’s the background info:
This individual has over 25 years experience as a Clinical Research Scientist, Director of Clinical Operations, Executive Director and VP of Strategic Programs, Alliances and Governance. The past 12 years have been in the area of managing strategic accounts and partnership governance. This is a particularly strong area of expertise and focus.

Let’s use the normal brainstorming rules – no idea is a bad idea, don’t shoot down any other ideas – just want to generate name ideas. I’ll get it started:

CRO/Bio/Pharm Alliance Management, LLC
Alliance Governance, LLC
Clinical Research Partnership Governance, LLC
Smith Consulting, LLC
Clinical Research Alliance Governance, LLC
Clinical Research and Governance, LLC
Strategic Governance, LLC

Reply in comments with your quick, off the top of your head ideas. Many thanks.

New FOCM Member

On June 28, 2019 while attending the annual Drug Information Association (DIA) meeting in San Diego, FOCM was busy expanding its network. All new membership ceremonies are significant and strict adherence to protocol is (almost) always followed. This particular ceremony included a new addition to the protocol. FOCM is pleased to announce that Jodi Andrews, Founder and Co-CEO of Pro-Trials Research received her membership card.

This ceremony took place on the exhibit hall floor. What was added to the procedure for this ceremony was a shot of bourbon prior to the handshake, card presentation and photo. Later, a small pour of Fireball was distributed to the new member.

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