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.
Once upon a time in a faraway place a long, long time ago, my brother and I volunteered to drive my eldest daughter’s car from Raleigh, NC to AZ. She and her husband would be moving to Tucson and rather than paying to ship it, we thought it would be a fun trip for Jon and I. We took the opportunity to visit friends along the way. Our second night stop was in Houston, TX and a visit with FOCM member and friend from high school, Kristen Meaders. Here are her notes from the Houston FOCM chapter meeting that night:
An impromptu FOCM meeting was held in Houston in July 2012. For security reasons, it was touted as the Annual Genu Varum Society Conference (AGVSC) to avoid the paparazzi, INS, and undesirable party crashers. Large amounts of Mexican food were consumed due to Our Leader’s unwillingness to stray from a mandatory Mexican food theme. No arrests were made but Jon is now on a de-tox program. Stock prices for Patron dropped precipitously since Chris’s discovery that he has “the sugar.” Mimi was crowned Ms Genu Varum Houston 2012. Something happened to the photographic evidence such that I cannot include it.
The following evening we were in Tucson, AZ and had dinner with FOCM member and friend from college, Art Coppola. Art’s notes were in reply to those of Kristen’s.
That must have been a ‘home-cooked’ Mexican meal judging from the surroundings. Here is a shot of the twins at the subsequent FOCM meeting held in Tucson and as you can see, it was held in a dark back room location at a participating Chicken and Waffle house where our leader had his with Jalapeños to continue his insistence on getting back to his roots. For this there was proof of the event:
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.
FOCM is all about connecting with each other for fun, mutual benefit and to be helpful to others. On December 9, 2020 we held a virtual fundraiser, wine tasting and networking event.
FOCM values connections be they new or old. This event certainly crossed that spectrum. The idea for the event – wine, charity and networking – came about from a LinkedIn post that I saw from Amy Berwick. I first met Amy in 1998 when we both worked at Quintiles (nka IQVIA). Amy’s post had to do with the role she had taken on with OneHope Wines and I wanted to find out more and catch up with her. I knew I wanted to do a year end virtual FOCM networking event and thought this might be a fun option.
I met (virtually, of course) with Amy and her OneHope colleague, Shelby Wildgust and learned that in addition to 10% of the wine purchased supports the charity of my choosing, each individual bottle purchased supports a non-profit cause (e.g.; pet adoption, military veterans, reforestation…). I decided this is the event I wanted to have.
When they asked me what charity I’d like to support, I said the Jeffrey Coombs Memorial Foundation. http://www.jeffcoombsfund.org/blog/ This foundation was started by Christie Schmitt Coombs in memory of her husband who died in the 9/11 terrorist attack on America. The Jeff Coombs Foundation was formed to assist Massachusetts families who are in financial need because of a death, illness or other situation that challenges the family budget. I’ve known Christie for 45 years. We both grew up in Yuma, AZ, went to Kofa High School and the University of Arizona.
Attendees and in parentheses, how long I’ve known them were: Deb Jendrasek (15 years), Shelby Wildgust (1 month), Jeff Gould (4 months), Michael D’Amico (3 months), Jon Matheus (his whole life), Zulma Varela (2 months) Christie Schmitt (45 years), Denise McNerney (6 months), Mike Strand (~15 years), Jenny Neurath (my whole life), Greg Cohee (~15 years), Susan Cook (2 years), Amy Berwick (22 years), Wayne and Kay (1 hour), Lauren Sherwood (3 years), Sean (1 hour) and Robin Whitsell (3 years), Amy Matheus (her whole life), Jamison Lloyd (2 years), Lindsay Goldman (her whole life), Nathan Goldman (9 years), Thomas Goldman (3 years), James Goldman (48 hours less than his whole life).
Amy and Shelby made it easy to manage. They drafted the email and messaging content for me to review, they set up the OneHope website specifically to track our fundraising progress and we used their zoom account. We tasted 3 different wines: 1. The Vintner Collection Sauvignon Blanc – this bottle helps reforestation, so far, ONEHOPE has been able to plant over 100,000 trees through the sale of this wine. 2. The Vintner Collection Red Blend – this is a 96 point Award Winning wine that funds Team Rubicon, an organization aimed to reunite Veterans with a sense of purpose in civilian life. 3. The Vintner Collection Pinot Noir – this is a 90 point Award Winning wine that has funded over 96,000 pet adoptions! Purchases made up until January 8 contribute toward the fundraising goal we’d set. Here is the event link to make purchases: https://www.onehopewine.com/event/a366bd14-e43d-446e-94d9-6c44efeae9d9
This year has found all of us adjusting to differences in the way we go about our daily lives. One business industry that I’ve come to realize must be really struggling is the dry cleaning industry.
When was the last time you wore an item of clothing that you typically take to the dry cleaner? So I had this idea of how we can help them hold on during this time of remote work and virtual conferences.
For all of us employed and working from home – let’s pick a day to wear an item of clothing that you take to the dry cleaner to wash. How about Wednesdays?
Remember Andy Griffith’s character Sheriff Andy Taylor of Mayberry, NC. He rarely carried a gun, almost never had one in a holster on his hip. Now I know times have changed since the idyllic 1950’s, but a phone call to a radio station caught my attention. The caller said that X number of years ago, probably in the 1960’s – 1970’s, police forces began learning and training using military type tactics. The caller indicated that people at the top in US police forces all began to adopt similar training.
He stated once upon a time, police were trained and called Peace Officers. The new training teaches them to control and dominate a situation and a suspect.
The situation with Rayshard Brooks could have happened so differently with the mindset of a Peace Officer. And in my mind that’s the policing style of (I know he’s just a TV character) Andy Taylor. So ask yourself in the situation with Rayshard Brooks: what would Andy Taylor do?
The police were talking with Rayshard Brooks for about 30 minutes when they decided they had to arrest him. Rayshard tested positive for DUI with a blood alcohol level of .108. About 30 years ago a person was deemed intoxicated with a level of .10 and then I think all states lowered it to .08. Why he chose to resist arrest and fight so hard when everything was going so calmly is beyond my understanding. No doubt that he’s responsible for the escalation that took place once he resisted arrest. Current police training is to take all measures to control and arrest the individual and if fired upon, end the situation as quickly as possible.
What would Andy Taylor have done – in this case? Possibly talk to Rayshard for an hour, just chattin’ away like Andy liked to do and then re-test him, at which point, his blood alcohol could be down to or below .08. Then perhaps have him go into Wendy’s to get his dinner, eat it there and then go home, by which time he would no longer be above the limit. Another approach after talking to him for a while would be have Rayshard go in and get his dinner and then the police drive him home and Rayshard could get his car the next day. That’s thinking like Andy Taylor, Peace Officer.
And for the future of policing, why they’re not widely using the BolaWrap https://wraptechnologies.com/ boggles my mind. Had they had this when Rayshard ran away, he would have been stopped, like with a spider-man spider web, he would be alive today, his daughter would still have her dad.
I’m not in favor of defunding the police and I applaud and support them for the tough job they have. I think there is room for peace officer training. I realize they do get training in how to de-escalate, they should also have some leeway in how to handle situations like in the case of Rayshard Brooks.
Help in naming a beach condo is today’s crowd-sourcing brainstorming name creation assignment.
In a condominium complex called The Breakers are 4 buildings with 18 units in each building. The four buildings are A, B, C and D. The unit needing a name is unit C-4. I, because I know that C4 is a name of a plastic explosive, always add the tag line “it’s explosive” when I say C4. So when people ask me which unit is ours, I say “C4, its explosive”. Some people don’t get it and look confused, but I don’t care.
So FOCM Team Mission Impossible Branding/Name Generation: your mission if you choose to accept it is to post in the comments section, name ideas for a beach condo in Carolina Beach, in The Breakers complex, the unit C-4. Rules: any name is a good idea, no judging or responding negatively to other’s suggested names.
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, Cory Winters 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.
During this Covid-19 Quarantine/Social Distancing, we’ve all seen an increase in the use of virtual meetings, virtual networking via videoconferencing tools. Zoom, Hopin, GoogleMeet, FaceTime, Microsoft Teams, Free Conference Call are ones that I’ve been involved with to-date.
It is very interesting to hear how people are using these tools in a variety of clever ways. That’s the impressive nature of human-kind: creativity, innovation when circumstances impact us.
I know of families having weekly Zoom calls to stay in touch. One includes playing a trivia game on each call, after catching up with everyone. Whoever wins the trivia game controls the questions for the next game. The Hopin (thanks GCPCafe and Nadia Bracken) tool has limits on the number of people who can be on camera at one time, while many more can participate via chat room to interact with the others. This is good for interactive presentations by a few speakers. It also has a one-on-one video networking that I really enjoyed. You’re put into a “room” and are waiting for someone else to enter the “room” and then you see each other and start talking. It felt like meeting someone new at an industry conference reception without all the background noise and distractions.
I have held four FOCM virtual networking events using both Zoom and GoogleMeet. A friend said, ‘hey you’re the networking guy, you should be doing something during this time of isolation.’ I took it to heart and held events in the evenings on April 16, April 23, April 30 and May 13. Like I do when I would travel (remember that? – airplanes, hotels and rental cars?), I would email everyone I knew in the area to see who could meet up that night for drinks/dinner. So at first I held a FOCM event for the Philadelphia metro area, then for the Raleigh metro area, then the Boston metro area. It was about the April 30 Boston event, that I realized, I was no longer bound by geographic constraints. So the May 13 one was national (I did invite members from Europe, but it would have been 1 a.m. for them).
Attendance was taken, as per FOCM SOP: April 16: Bryan Clayton, Dave Gibboni, Ryan Gibson, Chris McArthur, Chris McCracken, Pete Nieto, Mike Strand
April 23: Mike Burrows, Renee Brown, Brian Horan, Lauren Sherwood, Kate Mulllis (tried)- meeting minutes already published on www.focmnetworking.com/networking
April 30: Paul Bilden, Israel Bocanegra, Mike Burrows, Clint Craun, Scott Freedman, Brian Langin, Dan Weddle, Amy Zastawney Observations: Two people had to exit early to attend other web calls, one for a birthday celebration – perhaps a glimpse of our future; night-time schedules of “virtual” meetings to stay in touch with friends, family and colleagues. I attended a friend’s birthday party on May 2 via Zoom.
May 13: 159 people were sent google calendar invitations, 111 never opened it (do that many people not receive google calendar invitations into their email inboxes? 24 said yes, 10 no and 14 maybe. There were some issues with people being able to talk and/or to see their faces. We were on for an hour. To manage it, we opened with a cheers! Then I called on people to share whatever they wanted on how they were coping or what they were learning. Using the chat feature I let the person who was up next know I’d be calling on them. I know we didn’t get to everyone and I wish we had. It was great to see and hear from so many FOCM members. Kevin Boos, Mike Burrows, Nadia Bracken, Renee Brown, Greg Cohee, Kevin Collier, Scott Freedman, Dave Gibboni, Heather Hollick, Askold Kozbur, Brian Langin, Jon Matheus, Chris McCracken, Lynne McKerlie, Karen McPoyle, Sarah Meister, Lorraine Mercer, Adrian Pencak, Roxann Pinguelo, Lauren Sherwood, Dan Weddle, Wayne Whittingham, Michael Williams.
Screen Grabs of the event were sent to me and they are shown below. The first one was sent to me with the subject line “ScreenGrab Tonight”. Proof that enjoyment of sarcasm and wit are fundamental to the FOCM code of behavior.
I would like to hear of other interesting, unique, clever ways people are using these tools in this current time of reduced in-person gatherings. Use the comments box to share things you’re seeing or doing.
Attendees: Lauren Sherwood Mike Burrows Brian Horan Renee Brown Kate Mullis (tried)
The meeting was called to order at precisely 7:00 p.m. consistent with FOCM SOPs. If there’s one thing that FOCM stands for it’s being on time. No, no, that’s actually not true. If there’s one thing FOCM stands for its socializing/networking.
The meeting was held via Zoom which I’m not familiar with using, such that when Kate Mullis tried to join, I didn’t notice the “Kate Mullis wants in, do you admit her or not” and she had to give up and put children to bed. FOCM’s chairman vows to do better in the future.
It appears we’re all bearing up under the COVID-19 distancing and limited opportunities for going out other than walks, exercise, picking up take out, following the arrows at the grocery stores. There’s a definite reduction in new study start ups, but a lot of work and planning for how to handle ongoing clinical trials. Decisions on new hiring are also delayed considerably.
Will the future of clinical trials be: a return to the way we were doing them with a gradual move toward reducing patient and site burden or will this be the disruption needed to make virtual/hybrid trials the new normal?
Continue washing your hands and staying away from people. I think based on my review of the data, bar graphs, the number of patients in clinical trials and the early reports finding beneficial effects from some of them that by May 8, we’ll be down to under 10,000 daily new cases.