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.
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.
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.
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.
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.
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.
It was a typical Halloween Eve evening, weather-wise in Raleigh, North Carolina. It should come as no shock to anyone that it was also October 30. I’d rather hastily organized the 10/30 FOCM event just the day before as Brian Langin was coming to town. Brian has the distinction of receiving the first FOCM card ever handed out. So clearly, he was worthy of me getting people together.
Brian was first to arrive, followed by me and then surprise, surprise, surprise, Paula Brown Stafford joined us. Paula and I have known each other for 22 years when I first started in the clinical research industry working at Quintiles together. She has said to keep her on the FOCM event distribution lists as someday she just might surprise me and show up.
In what can only be described as one of the happiest moments of her life, Paula received her FOCM card.
It was a fun evening. Others in attendance: Rob Sucharski, Duncan Shaw, Peter Payne, Lauren Sherwood, Heather Malinowski*, Steve Young, Peter Weiman*.
On a warm, pleasant evening in October, the 1st day of the month to be precise, a significant event in FOCM history occurred; 4 new members received their cards.
I was in the RTP area to attend the Arena International Clinical Trial Supply Southeast meeting and hosted a FOCM networking event at the Sheraton Imperial Lobby Bar.
Attending that night were long time* members as well as first timers+. As best I can recall, the following people were there: Michael Williams*, Kris Gustafson*, Mike Burrows*, Rosina Pavia*, Paul Oldfield*, Tim Sauls*, David Holland, Carolyn Waff+, Lauren Sherwood, Israel Bocanegra+, Shae Wilkins* (traveled the farthest) .
Receiving their membership cards were: Lauren Sherwood, Carolyn Waff, David Holland and Israel Bocanegra. As you can expect, emotions ran high during the card ceremony, with many people wiping tears from their eyes. The look of sheer joy on their faces the moment they realized they’d completed the sometimes long, sometimes short, but neverthless arduous and rigorous initiation process.
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 a Durty Bull Lager beer and conversation with Peter Weiman and David Holland (they’re drinking the IPA that was being served).