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.
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.
Well, I admit it, my optimistic interpretation of the data was incorrect. I felt strongly that April 4 was the peak of new cases in the US and that stayed true until April 24 when we had a spike of 38,ooo+ new cases reported.
Perhaps that is due to broader availability of testing, which is finding more individuals who test positive for coronavirus. However, the optimist in me did find a brilliantly shining piece of good news – April 26 – the number of new cases reported was 26,509; the 4th lowest daily new cases since April 1.
But my prediction that we’d be dancing around the MayPole on May 1 will not be the case. Yes, some states will be easing restrictions on May 1, but not to the extent I’d hoped. We have to continue to be wise and listen to the scientists, review the data and go forward cautiously. 14 days from April 24 is May 8 and my new prediction (like economists know, if you keep changing your forecast, you’ll eventually be right) is that by May 8, we’ll be having 10,000 or fewer new daily cases. Be optimistic – let’s make optimism be contagious!
April 4 is standing tall as the peak day of new coronavirus cases in the US. We’re now 8 days since that date. Looking at data from other countries, shows that in day 10 – 14 from peak the number of new daily cases is around 20% of the peak.
With over 2,000 patients in clinical trials of drugs that have solid promise based on pre-clinical data, those patients will likely be contagious for shorter periods of time reducing the transmissibility and blunting the number of new cases. Also, the prescribing of hydroxychloroquine and azithromycin in early published trials shows elimination of the virus by day 5 whereas patients with no treatment are still positive for 10-12 days. This, too is probably a significant reason for the decline since April 4.
I truly believe pharmaceutical intervention is playing a big role in flattening the curve. Let’s remember that the US pharmaceutical industry is one of America’s greatest assets and is an important part of our excellent and effective healthcare system.
Well, as you know if you keep changing your prediction you’ll eventually be correct. I had optimistically hoped that the number of new cases would have peaked by March 31; however, I missed it by 5 days. The peak, I believe, occurred on April 4 and in analyzing other countries, by day 10 from the peak, the number of new daily cases will be halved.
Call me an optimist – because I am one. With so many patients being treated in clinical trials with several drugs and vaccines and the availability of the safe (on the market since 1955, side effects well known and manageable) hydroxychloroquine, either alone or in combination with azithromycin, the duration of illness is declining in thousands of patients. This reduces the time they’re contagious. That coupled with social distancing and warmer weather will soon have us back to our new normal.
I think we can all gather around the May pole on May 1 (no one seems to do this any more, do they?) and skip around it, singing, “I’d like to buy the world a coke”. I do recall skipping around a May pole in elementary school. What was the purpose? What is a May pole? Questions for another time perhaps. Or feel free to use the comments section to post a reply.
It is now time to unquarantine all of us and move to quarantining just those who test positive, those who have symptoms or who have had recent contact with someone who tested positive.
And let’s start buying stuff so heavily from one country, maybe even make stuff in America again. I’ve been looking for a toaster oven made in any country but China – no can find!
Okay, so here we are on 3/31, day 15 + 1 from the 15 day social distancing edict. We’ll have to wait a few more days to see if my prediction that our nation-wide effort will result in the US hitting its peak by 3/31. is accurate. It is encouraging to see that the number of daily new cases is increasing but at a decreasing rate. Only 400 new cases reported yesterday.
Troubling though is the quick rise in a few large cities: Detroit, New Orleans, for example.
My day 10 observation of the number of new cases and the groundswell of support for the male identifying members of our society to cease shaving their facial hair until we have two consecutive days of a decline in the number of new cases of the corona virus in the US.
Several good signs in the data, many EU countries have recorded a one day drop from their peak of new cases and two countries have had a two day drop, suggesting that globally we may have hit the peak.
Disclaimer: I am no epidemiologist, but I did stay at a Holiday Inn Express in Burlingame, CA earlier this month. Importantly, I am an optimist with a bit of experience as a data analyst.
I am doing two things in regards to global Covid-19 virus event. First, I am not shaving my facial hair until we have two days in a row of new cases in the US increasing at a decreasing rate. I think that’s the same as having two days after the peak number of reported cases.
Second, since Day 6 I have been giving snippets of my analysis on youtube.
I have learned how to show the beard’s progress without having to do each day’s session in two video snippets. Day 9 is below:
I believe that the combination of hydroxychloroquine and azithromycin will be extremely helpful in flattening the curve and getting the country back to normal. Provided that there’s sufficient quantity of these drugs and if not, that generic companies fire up their plants and start cranking this out. Knocking the virus out in 3-6 days in early studies will reduce transmission to others and reduce the projected number of deaths. My prediction is that in the US we’ll reach our peak number of daily new cases by or before March 31. I am hopeful that we’ll be back to going to work in our offices and dining out the week of April 7.