Biologics

Biologics and Federal Markets

Our Services 

01 FDA Biologics & Licensure

Our CEO, Lucy Carpenter, provided FDA-invited Biologics and scientific review for Pfizer's  mRNA vaccine EUA and pediatric use license, 2020 and 2021.  For a confidential copy of our review, please email Info@dcstrategicgroup.com.

02 UKRI and EU-Horizon

  • Biotech Modeling and AI-Based Analytics
  • No Cell and InSilica Trial Design and Support
  • Rapid Re-purposing


03 Health Policy & Innovation

  • Pediatric and adult innate immunity
  • Treatment & Cure design and development
  • RBD, AIRE (autoimmune regulator) response, and other components of immunity response
  • Adaptive Immunity and antibodies


Beyond Dexamethasone IV: releasing this steroid for mass Covid usage


Dexamethasone is one of the strongest steroids, least side effects, made. We've suggested to CDC, FDA, and AMA they start wide-spread use of oral dexamethasone for pediatric patients, and anyone else with severe breathing distress. We strongly advocate lifting the restriction on Dexamethasone to IV-only dosing, to allow easier oral and fast-dissolve RX!


Managing RBD, cathepsin, ACE and nicotenic uptake with mega Vitamin D


Sometimes the fastest, easiest intervention or interim treatment is right in front of us, and we don't 'see' it. When we examine how children's different Innate Imunity protect 99.979% of them from Covid worldwide, we see many of the same actors and synergies that strong Vitamin D levels also support, via adult Innate Immunity. Vitamin D exerts strong anti-inflammatory (cytokine) response; protect the lungs, eyes, and heart; and acts as a wonderfully strong, natural antiviral!

Equipping US National Intelligence for Biotech and R&D Global Discovery


Intelligence agencies use data objectively to spot trends or concerns, to save lives and improve national security. Companies use data subjectively to increase earnings or deflect criticism.  Because of the massive amounts of data and emerging scientific review worldwide, that must be assimilated into one coherent model to inform and guide US health policy. And the need for neutrality and accuracy.


Innate Immunity Boosters and Antivirals: Beyond Vaccine Dependency


Children worldwide have a uniform, amazing ability to be hyper-alert to Covid microbials entering their lungs, and then to almost immediately 'clear' Covid entirely from their systems, with minimal health impact, within 3 days. We've joined with EU and UK researchers to show and prove how this amazing child Innate Imunity can be replicated in humans of all ages. Without relying on the use of artificial, live-viral RNA, adaptive vaccines.

Policy Analysis to Inform and Shape Public Health Policy and Research


One of the persistent mysteries of the pandemic that we flagged repeatedly was the striking correlation of matching spikes in vaccination saturation rates, and Covid19 death rates. As vaccines climbed, so did deaths, in many nations that had not 0 covid death rates the first two years of the pandemic. As vaccine rates dropped, so did death rates. 


Were the vaccines causing the new deaths? Or causing lapses in caution that in turn caused deaths? That remains a mystery. The only thing we can say with any certainty, is that children worldwide were near-100% immune to Covid: they contracted the virus but never got sick from it. Their early, nasal passage recognition of covid as a 'dangerous virus' - broad spectrum Innate Immunity viral pattern recognition - kept them safe. (We discuss this in more detail, in our scientific publications.)


But the vaccines were the opposite in action, as Adaptive Immunity response drugs, to the broad-spectrum antiviral mechanism of a child's Innate Immune system. Were the vaccines short-circuiting, or overwhelming the natural pattern recognition that kept many isolated nations and regions; and worldwide, over 98% of all adults and 100% of all children, safe from covid without ANY vaccines or treatment? European research did prove, in 2021-2022, that the Pfizer and Moderna vaccines would 'alter' and possibly destroy, or disable, the natural Innate Immune system - especially in children.


Because the vaccines had to do this, to work: they had to disable our naturally strong, generic pattern recognition that triggers over 200 immediate biological scripts to run, through our Innate Immunity -- "oh gosh, a virus, take action!" -- to allow their lesser, Adaptive, and strain-specific script to run -- "oh, strain b of virus x, y, z;  take this specific back-end action and do nothing else."


Using Modeling and Scientific Approach to Understand Vaccine Risk to Special Populations, and Children


COV-19 is clearly an Innate Immunity attacker. There are two types of immunities; our parent Innate Immunity and our lesser, slower, Adaptive Immunity. Every vaccine is by nature an Adaptive response, and every anti-viral, antibiotic or other treatment is always an Innate response. So the mRNA vaccines are working in opposite molecular action to the body's natural Innate Immunity, which has kept all children worldwide 100% safe. How do we reconcile, from a scientific and health care policy perspective, these two competing response models?

Were the vaccines the best or only response to Covid? We don't think so.


We think that it was immoral, costly, and only a political move to force 100% of any population, to vaccinate with a dangerous vaccine that many, especially those with Immune system issues like Asthma, RA, sickel cell, lupus, or heart conditions could die from,  and at a minimum would be sickened by; to protect the 1% of humans worldwide - less than 1/2 of 1% in the US - who would ever die of Covid.


It's not that Covid was not worth attacking: but the vaccines were:

1 - the wrong type of response (adaptive v. Innate, like an antiviral therapeutic, or antibiotic acting as an antiviral; and

2 - the wrong nature of response, a solution not fitting the facts.


When 99% of all adults and 100% of all humans are ALREADY SAFE from a biological threat: you NEVER force everyone to be treated or vaccinated for that threat, and put them at risk -- for their Innate Immunity was already clearly working. And EU research showed a pattern of worsening impact from the vaccines, children getting sick or dying of covid for the first time ever, after vaccination; and increased mutartions .

The above chart mirrors almost identically, the increase in vaccination saturation rates in the nations shown. The more a nation vaccinates, the more infections climb... WHY?

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