How to Avoid Jury Duty
Hope you had a good weekend. Mine lasted an extra couple of days since I had an old high school friend talk me into going to Vegas for three days, hence the late release.
Couple of things I learned... on a soft 16 you double against the dealer if they have 4 through 6 and you never hit on 12. Something about a cardinal rule? There's a dealer somewhere in Vegas still laughing at me. Speaking of $$$...
Did you hear? Healthcare is BOOMING. Reaching nearly $40B in total funding in 2021 so far. New deal count record went up 15% from last Q.
In 2020, the Medtech market grew 6.3%, and 94% of Medtech companies are already reporting a stronger 2021 than 2020.
After the uncertainty of the pandemic’s effects, 2022 is looking promising.
Pump Up the Volume-trics
In the last Proxima newsletter, we remarked that surgeons at New York University had successfully transplanted a genetically altered pig kidney into a human under very special circumstances. The recipient was a brain-dead patient with compromised kidney function. The kidney remained outside of the body for three days but was not immediately rejected which was heralded by some but polarized some in the scientific community. Undeniably amazing and serious love going out to the family that wanted her to be an organ donor. <3!!
BTW - the lead surgeon was a recipient of a heart transplant.
Also over 100,000 people on the US organ transplant list. #seriousmedicalneed
On the heels of one of the most major, recent advancments in organ transplant the inventors of 3D printing, 3D Systems, announced the acquisition of Volumetric Technologies, a Houston-based MedTech company co-founded by Drs. Jordan Miller, PhD and Dr. Bagrat Grigoryan, PhD.
Volumetric uses proprietary technology to create regenerative medicine products and hopes to eventually print human organs.
The transaction has an initial purchase of $45M with a potential for $400 million based on future milestones. If this were Sportscenter this is when you would hear Chris "Boomer" Berman yell, Whoop.
Full disclosure, I am on the board, at least for another month or so, but can speak for everyone around here, thrilled for the team at Volumetrics. Keep your eyes on these guys. They’re only getting started.
Second Coming of Califf
Nine months is the longest the FDA has gone without a commissioner at the helm, but that’s soon to change as President Biden is getting ready to nominate Robert Califf, the former FDA Commissioner, right back into the role he formerly occupied at the end of the Obama administration.
Califf is immensely qualified - a Cardiologist out of Duke and a member of the prestigious National Academy of Medicine. He currently serves as the Head of Clinical Policy and Strategy for Verily and Google Health. He’s seen as someone who’s politically safe and could bring back some trust and faith in the FDA during a time of poor public opinion.
However, IMO, it was a missed opportunity. Nothing against Bob. Again, highly, highly qualified. But, the field of medicine is advancing faster than ever before: medical devices with artificial intelligence, genetic engineering, and 3D printed organs to name a few.
The FDA is not evolving fast enough to keep up and safe bets are likely not going to lead to innovation. I seriously think we need someone outside of the industry with serious moonshot-type vision. I'm not nominating Elon or Jeff here. Absolutely not. But what do they say about results when you keep doing the same thing over and over? Opinions are my own as they say on Twitter.
Cancerous Growth of Waste
In a letter published in JAMA Internal Medicine, researchers from Harvard and the London School of Economics are calling on the FDA to reconsider their approach to post-market trials and dangling approvals.
In a three-year span from 2017 to 2019, Medicare spent $220 million on cancer drugs in which the indications were pulled by applicants or the FDA recommended their withdrawal.
Researchers are asking for a change in the way services are conducted. Specifically, researchers are asking the FDA to quicken the pace in requiring timely post-marketing trials, but also in the way in which they pull dangling approvals when confirmatory studies fail.
Failed accelerated approvals lead to hundreds of millions wasted.
In defense of the accelerated pathway, a coalition of rare disease drugmakers raised concerns in August with a call from the nonpartisan MACPAC to increase rebates around drugs that clinch the quick approvals.
The trial has been going on for over two months.
No black turtleneck sightings.
Former defense secretary, James "Mad Dog" Mattis, just finished testifying. Henry Kissinger and Rupert Murdoch are also on the witness list.
Her "love texts" were read in open court.
A (third) juror was just dismissed for playing Sudoko because the trial was boring! One was sent home because of a work issue, the other due because her religious faith did not allow her to believe in punishment.
There are only two alternate jurors left.
The trial is scheduled to go through mid-December.
Can't wait for the finish.
Also (in my brief time as a litigator) other ways I observed folks getting off a jury after the trial has started:
- incessant, uncontrollable crying
- flagrant outbursts (I once had a juror that was quite unsatisfied with the questioning of the prosecution and defense and wanted to ask his own questions.)
- showing up under the influence (This puts you in contempt and is good for at least one day in jail.)
Things that surprisingly won't get you off:
- sleeping during the trial
- medical emergencies (At least acute ones. Judge will often give a continuance. Make it a good one.)
- telling the judge you would not make a good juror (If you go this route, make sure to say you can't be impartial and have a darn good reason.)
16 more days till Turkey day. No judgments if you've started putting your "Christmas/Hanukkah/_______ holiday" lights up. Well... maybe a little.
Very truly yours,
Knowledge Base Highlights:
New FDA Update You MUST Read! Learn the Major Guidance Changes to Artificial Intelligence and Machine Learning from our Director of Regulatory Affairs, Isabella Schmitt, here.
Dental implants are a widely used medical device, but did you the FDA shares guidance for patients unveiling more about dental implants from a use and safety perspective?
Read more here.