Digital Transformation


Biologics and

Biodefense

 Smarter Therapeutics, Better AI and Product Development


 We provide digital innovation and IT design, cyber, public policy, and biologics intelligence to public and private sector clients worldwide. Our average client account is in the $400 million to $12 billion range.

ARTIFICIAL INTELLIGENCE
FOR EVERY STEP
OF BIOPHARMA RESEARCH 

AND DEVELOPMENT


Our CEO, Lucy Carpenter, was the first Pandemic contractor to obtain FDA permission for non-animal, non-human clinial trial, Covid-19 EUA submission. Her later work included custom design for the first AI-driven drug test / portal construction, using pro bono teams from the US Department of Defense JAIC (Joint Artificial Intelligence Center), Harvard University, and Google.


We offer rapid AI & analytics solution design and implementation.

  • Innate Immunity Research

    Children worldwide have a near-perfect, near-100% built-in, Innate Immunity to Covid in any form. Johns Hopkins has said that, "Children have between a Zero and negligible chance of contracting Covid."


    Chief amongst our pandemic contributions was the concept of leveraging Innate Immunity  as the body's own best therapeutic response to Covid-19, supplemented by broad-spectrum anti-virals before or immediately following viral infection; rather than relying on Adaptive Immunity  vaccine response. In 2020, this was a radical concept. But today, more and more biomed firms worldwide -  including CIA Labs and InQTel accelerators - are advocating this basic paradigm shift - we cannot continue on the same unhealthy, dysfunctional paths and rely on a shot to keep us healthy. But by making serious changes to lifestyle, exercise levels, diet and stress; with broad-spectrum therapeutics when needed - we replenish our natural, Innate Immunity. 


    We believe history proved us correct: worldwide, it was not only the eventual vaccines - some, like Robert Kennedy Jr,  argue it was not the vaccines  as all -  that made the difference with Covid-19.  But it was the containment, sanitation, and Shut Downs that kept people more isolated and also, eventually, less stressed - more time for exercise and better nutritional focus. Because 99% of adults and 100% of all children were already naturally immune to Covid19, e.g. becoming infected but without any adverse effect, before the vaccines. From God's natural Innate Immunity. 



    Which is what antibiotics, anti-virals and anti-worm RX are designed to emulate. How then, could the vaccines themselves add another 99% immunity, to a population that was already immune? Statistically, that is impossible. 

  • Biodefense, Building Materials, and Site Inspections

    Our foundational expertise in  Biodefense, site inspection, and remediation management  includes:


    PINE BLUFF ARSENAL (USAR), AK:  

    Research and site support for the U.S. Army Combat Capabilities Development Command Chemical Biological Center, in partnership with the U.S. Army Chemical Materials Activity , and the US Department of Energy, to  safely destroy aging chemical weapons; and to improve security and environmental storage integrity during the entire process. 


    ROCKY FLATS NUCLEAR WEAPONS PLANT (USDOE),  Denver, CO:   

    Rocky Flats - a SuperFund site -   is managed by DOE-LM under the US  CERCLA/RCR Act. It manufactured the plutonium triggers used in nuclear weapons. 


    FLORIDA STATE & SANFORD COUNTY GOVERNMENT: 

    Stachybotrys chartarum (black mold) and Aspergillus, mold inspection and remediation mangement. Stachy   is a greenish-black mold, and Aspergillus is pinkish-red. Especially during the pandemic, patient susceptability to indoor molds and fungi increased worldwide, as immune systems became more challenged with Covid and other infections, and with the challenges of the vaccines.  People with cancer, asthma, or other immune system deficiency - or on steroids or other immune-compromising RX or treatment - can become seriously ill or die fro fungi exposure. The presence of multiple parasitic infections - e.g. fungi/mold and a parasitic worm or protozoa infection - is also deadly. 

    ______

    Stachy is said to have killed 


    DC GOVERNMENT - Department of Buildings, Public Health - and the US Defense Threat Reduction Agency (DTRA): 

    Construction and code permitting and inspection management and advisory. Site plan, architectural plans, materials  and supply chain review and project management.  Much of the time, using unlicensed contractors or cheap materials or raw materials in commercial or residential contruction, remodeling or building repair is the most common trigger of deadly or injurious harm from biological agents introduced. 


    Cheap laminate flooring or particle board, failure to replace old electrics, or regularly check underground tanks or attic fans , will introduce fungi, allow deadly soil or other  parasites to enter, and make pipes more susceptible to uneven pressure that causes sewage intrusion into drinking water or indoor plumbing. Workers wo may be infected and do not wash hands, and improper remediation of old asbestos or other attic insulation - common in the Washington DC Metro area - are two other culprits.



     

  • VA EHR Modernization - Oracle (Cerner) & Booz Allen

    The US Department of Veterans Affairs (VA) is committed to providing seamless care for Veterans, including access to a comprehensive electronic health records (EHR). 


    In May 2018, the VA awarded Oracle (which purchased Cerner Corp)  and Booz Allen  a contract to replace its aging  Veterans Health Information Systems and Technology Architecture (VISTA) health records systems with Oracle's  Cerner Millennium. Because the US  Department of Defense (DOD) uses Cerner, this would allow active duty military personnel and dependents to transition seamlessly to VA care, without losing interoperability of health records. 


    Booz Allen was awarded the IT modernization  and overall program management work for the contract, which focused primarily on bringing the outdated VA architecture up to par with DOD's DODAF framework. That included transitioning the VA to Cerner's cloud-based, multi-tenant framework and compartmentalized data structure. DC Strategic Group advised  Booz Allen at the sub-contractor level, attached to the VA Washington HQ.

  • Hybrid, Multi-Cloud Environments

    Multi-cloud allows businesses to scale their storage up or down based on an ongoing demand. Ideally, multi-cloud providers work seamlessly together so organizations can invest in any level of capacity, security and protection based on the needs of each data segment. This flexibility howver, brings with it increased security risk, as data  and PPI (Personal Protected Information) is frequently spread across several cloud and on-premises environments, making it almost impossible to harden or even define the surface. 


    Now that the modern Attack Surface is no longer confined to just one network or architecture, but typically includes IOT and mobile devices, two or more cloud providers, and distributed facilities; zero trust and endpoint monitoring becomes a real challenge.  We partner with the best of the best - Oracle, IBM, Splunk, Tenable, and other leaders - to provide security teams the tools they need to visualize, monitor, and protect  across multi-cloud environments, in public and private sectors. 

  • Government Relations & Regulatory

    FDA , CMS (HHS), CDC, and US DOJ regulate pharmaceutical products, clinical labs, and medical devices in the US  to ensure a continuous supply of high-quality products, accuracy in diagnostics, and responsibility and biological risk mitigation in research and medical care. 


    We provide private sector or Federal sub-contractor support to Federal and state agencies, and commercial companies in managing regulatory and SEC compliance. 

    • Original FDA EUA licensure experience, and  FDA Biologics-invited review services provided to FDA for Pfizer and other Covid vaccine hearings;
    • Executive Secretariat NIH federal contracting and advisory in pandemic health policy and R&D; 
    • US Department of Defense Health Agency advisory;
    • Government liaison expertise with local and Federal Government including US Congress, US Cabinet agencies, and local health departments and schools or educational associations; with successful accomplishment of public policy, budgetary, legislative or other goals. 
  • Supply Chain & Sanctions - 2023

    In March 2023, the US Government added 14 more Chinese entities to its "unverified' trade list. The move will force US exporting firms to conduct ‘greater due diligence’ before shipping goods to the, as yet unnamed, companies. At the same time, BIS- Commerce removed Wuxi Biologics, a company used by Astra Zeneca in vaccine manufacture, from the Red Flag unverified list, so that shipments to and from Wuxi are now legal. 


    We specialize in foreign and US trade and compliance sanctions against Russia, China, and North Korea. And provide critical global intelligence and supply chain analytics to OFAC (US Treasury), UK, Canadian, and other US agencies. 


    COST-EFFECTIVE SUPPLY CHAINS

    We also  help biologics companies to: 

    1. Retool their vendor list to leverage economies of scale and reduce overall cost-to-market;  and 
    2. Ensure full compliance with restrictions against Chinese, Russian and other global sanctions. Often, the real issue is not in the finished components, but in the raw materials used by named entities, to manufacture US purchased or exported components. China is one of the largest world suppliers for biologics and clinical lab elements. 


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