As humans, in our DNA is the initiative to join together and find solutions to survive and propagate. How can you help in the key milestones to beating COVID-19? For most of us, daily societal changes (See STAGE 1 below) is where we can have an important and immediate impact. Furthermore, I know there are lots of super smart biopharma scientists and executives in our network who can impact some of the more technical milestones. Some of you are already doing this - THANKS! Here's a list of the key milestones and rough timeframes for our society to become COVID-free. We all have a great opportunity now, to look back and say "I MADE A DIFFERENCE." How can you contribute to help us win this fight?
STAGE 1) PPEs AND SAFER SOCIETAL NORMS Better availability of personal protective equipment (PPE) for medical professionals, and more widespread compliance and use of anti-pandemic societal practices and traditional diagnostics; These will gradually enable more daily activities to return, although in a different, safer way. Our distancing and disinfecting measures are a first step. I plan to publish a more detailed article on practical suggestions to take this further, in the coming days. In addition, we have made great strides, quickly in commercial anti-COVID diagnostics. Many of you (my personal friends and network) have worked hard to make this happen (e.g. Thermo-Fisher, Abbott, Roche, Diasorin, etc.) - THANKS! TIMEFRAME - NOW and for upcoming months STAGE 2) POINT OF CARE DIAGNOSTICS Point of care (POC) diagnostics (convenient tests that can be practiced outside a medical setting, with results in minutes instead of hours/days); These will enable more regular activities, like safe air travel and safer work environments, to return. We see Cepheid's (Danaher) rapid test (result to patient in hours not days) getting FDA authorized last week, as well as Mesa's Accula point-of-care device (results in 30 minutes), and BioFire's (BioMerieux) one-hour test. We should see faster, more convenient tests in the coming weeks and months. Here is a statement by the FDA substantiating the importance of POC testing as a next stage to fight the pandemic. Think of the possibilities that POC testing opens up, as you can go to your workplace for example, and not only be tested for a fever, but tested as COVID-free, before you start your workday. TIMEFRAME - days, weeks, months (with faster, simpler, more reliable tests over time) STAGE 3) ANTI-COVID THERAPEUTICS Effective therapeutics to help those who are infected with COVID; These will help those who get infected to survive, stay out of the ICU, and eventually stay out of the hospital. We see repurposed anti-viral drugs in clinical trials now with 100s of patients, and readouts in months. Gilead's Remdesivir, for example, has 6 ongoing clinical trials as of this writing. We plan to launch a database and calendar of ongoing COVID trial readouts on Ampbioresearch.com in the coming days/weeks to help keep people informed. TIMEFRAME - months (with continued improved therapeutics for year(s) until we have an effective vaccine); STAGE 4) ANTI-CORONAVIRUS-SARS2 VACCINES Effective 2019-novel Coronavirus (SARS2-Cov-2) vaccines; These will eventually at worst, make COVID, no more widespread than our current cold and flu season. More robust anti-COVID vaccines should eventually eradicate it, at least in most industrialized countries. For example, see this ongoing Phase 1 nucleic acid-based vaccine trial sponsored by NIAID (Anthony Fauci's organization) with vaccine supplied by Moderna, with some primary safety readouts taking about 1 year after the trial is fully enrolled, and efficacy readouts in about 2 months after enrollment. This is a small 45 patient, Phase 1 trial, which will need to be followed up, if successful in Phase 1, with Phase2/3 trials. Other vaccine trials are underway and many more will be launched in the coming weeks/months especially by commercial vaccine companies. In this pandemic situation, it seems likely that there will be a more rapid regulatory pathway to a conditional approval for SARS-CoV-2 vaccine candidates that prove to be safe and efficacious in early trials. TIMEFRAME - 2021 (with improved vaccines over years)
Manny Vacchiano, JD, PhD
I am a cell biologist/patent attorney who worked as a scientist with recombinant viruses at NIH in the early 1990s, worked as a scientist at a major diagnostics company in the mid-1990s, worked as a patent attorney at biotech law firms, and a major diagnostics/scientific research tools company in the 2000s, and currently helps clients patent biotech inventions including recombinant viruses, and founder of Amp research where our team analyzes the latest biopharma technologies for our public stock investments.
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