Welcome to Trends-in-Medicine, offering independent, cutting-edge articles and information on drugs and devices in development. Our subscribers have access to news and analysis on the latest data, regulatory issues, and trends of interest to the healthcare community.

2022 Medical Conference Calendar

As of January 6, 2022, this is the best information available, and it has been double- and triple-checked, but meeting dates and status (in-person vs. virtual vs. hybrid) are changing almost daily. There is a link to each meeting (in blue). Please be cautious with hybrid meetings because sometimes they are not fully hybrid. A number of 2022 meetings have not announced a date yet, and they are listed at the very end. Starting about mid-year, most of the meetings hope to go all in-person, but don’t count on that. If you do go to a meeting, have a plan for what to do if you test positive for Covid-19 while there – where will you stay, how will you get home, etc.?

Coronavirus Update

Coronavirus and Covid-19 news are everywhere right now. In fact, there is so much news, it is hard to sort through all of it. Here we attempt to bring you up-to-date, all in one place – from headlines, to unanswered questions, to what we do know, along with some industry concerns.

Janet Woodcock on her role at FDA

In an interview that marked the first in a series of virtual installments that make up the Biopharma Congress, sponsored by Prevision Policy and Friends of Cancer Research, Acting FDA Commissioner Janet Woodcock, MD, discussed “Making Tough Decisions at FDA and What’s Next” for her. Here are some of those comments.

FDA Advisory Committee Support Limited Use of Covid-19 Vaccine Booster Doses

The FDA’s Vaccines and Related Biological Products Advisory Committee recommended that the FDA grant emergency use authorization (not full approval) for boosters with Pfizer’s Comirnaty vaccine. The panel was concerned about: insufficient data, too soon, safety in boys age 16-17 because of the myocarditis, and emphasis should be on the unvaccinated. If there are going to be boosters, the panel recommended that they be restricted to people age ≥65, at high risk for severe Covid-19, or whose occupation puts them at risk of Covid-19. However, a senior FDA official told the panel that the FDA does not have to take the panel’s advice and can “tweak” it however it chooses.

FDA Advisory Committee to Consider Covid-19 Vaccine Boosters

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on September 17, 2021, to discuss Pfizer’s application for licensure of a booster dose for people age ≥16 of Comirnaty (BNT-162b2), the Covid-19 mRNA vaccine developed with BioNTech

HIMSS21

If HIMSS is any indication, Epic continues to do well. Many CIOs believe Epic is becoming the “private” EHR and Cerner the “government” EHR, saying Cerner has been neglecting hospitals as it focuses on its government contracts. · Hospital budgets are up an average of ~5% among CIOs questioned at HIMSS, but none is planning any major expenditures. This next year is focused on recovery from Covid-19, refining existing telehealth, interfaces, cybersecurity – and staffing, which is a real issue. There is interest in population health but less than in some past years. · The exhibit floor was sparsely attended, but exhibitors did not appear too unhappy. · Health Catalyst’s acquisition of Twistle looks like a good move as Twistle was getting a warm reception. · Linking retail primary care to EHRs is potentially a big problem for health-care IT.