What did RW Malone do for Nanotherapeutics, Inc. which was awarded contract W911QY-13-C-0010 by DoD?
What did RW Malone do for Nanotherapeutics, Inc. which was awarded contract W911QY-13-C-0010 by DoD?
$10,000,000,000.00 contract for a period of 20 years
In 2016. RW Malone co-authored a review of Zika Virus: Medical Countermeasure Development Challenges in PLOS Neglected Tropical Diseases | DOI:10.1371/journal.pntd.0004530 on March 2, 2016. He was senior author of this publication. Nanotherapeutics and NANO-ADM Advanced Development and Manufacturing Center, Alachua, Florida, United States of America were involved in this publication.
https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC4774925&blobtype=pdf
https://www.defense.gov/News/Contracts/Contract/Article/606859/ Nanotherapeutics Inc.,* Alachua, Florida, was awarded a $43,249,906 modification (P00020) to contract W911QY-13-C-0010 for research and development of medical countermeasures and their manufacture to counter a chemical, biological, radiological, nuclear and explosives attack against military and civilian targets. Work will be performed in Alachua, Florida, with an estimated completion date of Aug. 15, 2016. Fiscal 2014 research, development, testing, and evaluation funds in the amount of $4,324,906 were obligated at the time of the award. Army Contracting Command, Natick, Massachusetts, is the contracting activity. Potential Completion Date 10/30/23
President and Chief Executive Officer and controlling shareholder of Nanopharmaceutics is James D. Talton, Ph.D. His company's pipeline included dozen clinical-stage (phase 1 through phase 3), proprietary and partnered programs including NanoDOX™, targeting infectious disease. The company was also advancing a large, undisclosed portfolio of preclinical development candidates.
About Nanopharmaceutics, Inc.
Nanopharmaceutics, Inc. is a clinical-stage specialty pharmaceutical company developing oral, topical, and injectable products for cancer, central nervous system (CNS) disorders, and infectious diseases. Leveraging its expertise in nanoparticle and fine-particle formulations, which can specifically be used to improve hard-to-deliver BCS category II and IV drugs, Nanopharmaceutics is focused on formulation development aimed at improving drug absorption and stability.
James D. Talton, Ph.D., is Nanopharmaceutics’ President and CEO as well as the President and CEO of Alchem Laboratories Corporation (affiliate). He also is President of Discovery Cure Institute, Inc., a Florida non-profit Corporation and serves on the Alumni Advisory Board for the University of Florida Department of Materials Science and Engineering. Prior to starting Nanopharmaceutics, Dr. Talton served as the President and Chief Executive Officer of Nanotherapeutics, Inc. for seventeen years. Dr. Talton has developed multiple clinical-stage products, as well as NanoFUSE® DBM, a sterile, FDA-cleared (K062459) easy-to-reconstitute bone graft. Leading multiple successful government programs, Dr. Talton has successfully won over $1 billion in contracts with government partners including NIH, DOD, and BARDA. Dr. Talton is an inventor on thirteen U.S. patents and has authored several peer-reviewed publications and book chapters involved in drug delivery systems with a primary focus in drug analysis and controlled release formulations, pharmacokinetics, and pulmonary drug delivery. On October 19, 2017 a Request for Prototype Proposals (RPP) Under Medical CBRN Defense Consortium (MCDC) OTA Number: W15QKN-16-9-1002 was issued.
What is W15QKN1691002 contract?
For the Joint Science and Technology Office (JSTO), Defense Threat Reduction Agency (DTRA) Through The Joint Program Manager - Medical Countermeasure Systems (JPM-MCS) and the Army Contracting Command – New Jersey Picatinny
Part 1 - Executive Summary
The U.S. Army Contracting Command (ACC) – New Jersey, on behalf of the Joint Project Manager for Medical Countermeasure Systems (JPM-MCS) and the Joint Science and Technology Office of the Defense Threat Reduction Agency through the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) entered into a Section 815 Prototype Other Transaction Agreement (OTA) with the MCDC through its Consortium Management Firm (CMF), Advanced Technology International, Inc. (ATI). The OTA was entered into under the authority of 10 U.S.C. § 2371b, Section 815 of the 2016 National Defense Authorization Act (NDAA), Public Law (P.L.) 114-92. This instrument is not subject to the Federal Acquisition Regulations (FAR).
The total estimated amount of the effort is $10,000,000,000.00 for a period of twenty (20) years.
OTA W15QKN-16-9-1002 was signed between the Government and the MCDC on 8 April 2016. The terms and conditions agreed to under this OTA will serve as the terms and conditions for future Project Agreements and Modifications to the OTA.
In March 2013 after a competitive source selection process, the DoD awarded contract W911QY-13- C-0010 to Nanotherapeutics, Inc. (now Ology Bioservices, Inc.) of Alachua, Florida, to design, establish, and maintain the DoD Medical Countermeasures (MCM) Advanced Development and Manufacturing (ADM) capability.
the DoD awarded contract W911QY-13- C-0010 to Nanotherapeutics, Inc.
The facility is a flexible, multiproduct, multipurpose, 180,000- square-foot facility for biologics development and manufacturing. Based on single‐use technology and disposable equipment, this facility permits development and manufacturing of MCMs faster and more effectively than most current production processes. The Government intends on utilizing the DoD ADM to facilitate lessons learned, to ensure DoD Medical Countermeasure (MCM) product development schedules are not impacted, and to reduce MCM development costs. Select projects, specifically those that include biologics manufacturing activities, will be evaluated on the proposed use of the DoD ADM.
Part 2 – Project by Objective Area
2.1 OBJECTIVE AREA: DETECTION
2.1.3 STATEMENT OF OBJECTIVES (SOO):
The government seeks a platform capable of directly isolating bacteria from a minimum of two (2) matrices (e.g. whole blood and wound swabs) and evaluating directly for bacterial pathogen response to antibiotics to establish categorical agreement (susceptible, resistant, intermediate) relative to the gold standard method, as recommended by the Clinical and Laboratory Standards Institute.
The Awardee shall address the below items in order to meet the requirement for this Statement of Objectives. a. Description of the platform technology.
7 FOR OFFICIAL USE ONLY/ PROCUREMENT SENSITIVE
a. Description of the platform technology
b. Current TRL 3 device and path to achieving TRL 5 at end of Period of Performance shall be described.
c. Extent to which platform has been used for existing product development efforts.
d. Platform benefits.
e. Intellectual Property associated with the platform.
f. Biosafety containment/specialized or unique equipment required to support the platform.
g. Intent to deliver a Pre-Submission application to the Food and Drug Administration (FDA).
h. Ability to obtain, store and meet Centers for Disease Control and Prevention (CDC) criteria for the handling of Biological Safety Level (BSL) 1, 2, and/or 3 agents. If capability to work with BSL-2, 3 agents is absent, state willingness to collaborate with laboratories supported by BSL-2, 3 facilities.
i. Assay reproducibility, specificity and sensitivity will be demonstrated for each pathogen with regard to species identification.
j. Antibiotic sensitivity will examine the response of gram negative and gram positive bacterial pathogens to a range of antibiotics- each at a series of dilutions/concentrations sufficient to establish categorical agreement (susceptible, resistant, intermediate) relative to the gold standard method, as recommended by the Clinical and Laboratory Standards Institute (https://www.fda.gov/downloads/medicaldevices/newsevents/workshopsconferences/ucm575636.p df; https://www.clsi.org/standards/products/microbiology/ ).
k. An FDA Pre-Submission Package for 510(k) approval will be developed based upon data resulting from the subject project.
l. The PoN diagnostic device is intended for use at multiple echelons of care, to include the patient bedside, physician offices, neighborhood clinics and diagnostic laboratories. Relevant characteristics for the prototype include:
No External Hardware or Laboratory Infrastructure Required
Fully Integrated from Sample to Result o Battery Powered or AC adapter o Inexpensive (i.e. incorporation of CMOS optics and/ or a docking station)
Easy to Use
Minimum User Steps
Minimal Training
Docking station reader or visual detection o Sensitivity and Specificity Comparable to Laboratory-based Molecular/PCR Methods m. Rapid: ≤ 2 hours, Sample-to-Result
2.1.5 PROTOTYPE DELIVERABLE(S):
• The prototype resulting from the Government project will be a Single-Molecule-based Point-of-Need antibiotic susceptibility platform that would identify the pathogen and test the response (i.e. changes in gene expression) of two (2) Select Agents (https://www.selectagents.gov/SelectAgentsandToxinsList.html)
and two (2) ESKAPE (see below) pathogens to antibiotics in a pathogen-specific manner (as per CLSI Standards).
• Select Agents pathogens analyzed will include one (1) representative strain of Bacillus anthracis, and one (1) representative strain from one (1) species from the following Burkholderia mallei, Burkholderia pseudomallei, Francisella tularensis and Yersinia pestis. In addition, one (1) representative strain from each of two (2) ESKAPE pathogens shall be analyzed. ESKAPE pathogens include Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.
2.2 OBJECTIVE AREA: DETECTION
2.2.1 SUB-OBJECTIVE AREA (DET 18-02):
Development of Multiplex Molecular Diagnostics Based on CRISPR-Cas and other Synthetic Biology Approaches White Paper Required: Yes 2.2.2
BACKGROUND/DESCRIPTION:
Over the last several years, the mechanism by which resistance to foreign invasive and functional nucleic acid elements (e.g., from viruses) have been conferred to adaptive “immune systems” of prokaryotes. These foreign nucleic acids are integrated into clustered regularly interspaced short palindromic repeat (CRISPR) loci via genome editing controlled by specific RNA processing by a CRISPR endonuclease. Thus, the use of CRISPR in viral detection has been suggested for years; likewise, the targeting of the CRISPR locus has been proposed for bacterial strain genotyping identification. However, both sensitivity and off-target effects (i.e., specificity), limited utility even with Cas9 enzyme used in the construct. Recently, an enhanced CRISPR-Cas13/Recombinase Polymerase Assay (RPA) isothermal method, known as SHERLOCK (Specific High Sensitivity Enzymatic Reporter UnLOCKing) methodology was published (http://science.sciencemag.org/content/early/2017/04/17/science.aam9321.full ) and accomplished attomolar sensitivity and single base mismatch specificity.
2.2.5 PROTOTYPE DELIVERABLE(S):
The prototype resulting from the Government project will be a diagnostic assay and/or device using specified genome editing methods for identification and diagnosis of BWA agents. This prototype is directly relevant to worldwide force protection capability that requires prevention, diagnosis, treatment, and surveillance to protect U.S. Forces against potential infectious disease threats.
2.3 OBJECTIVE AREA: TREATMENT 2.3.1 SUB-OBJECTIVE AREA (TRE 18-03):
Late Discovery and Development of Therapeutics to Treat Symptoms of Exposure to Organophosphorus Chemical Warfare Nerve Agents
White Papers shall be submitted by the date and time specified above using the form located here: DET-18-01: Rapid Single-molecule-based Diagnostic Platform Assessment of Pathogen Susceptibility to Anti-microbial Agent https://secure.ati.org/mcdc/DET-18-01/whitepaper.html DET-18-02: Development of Multiplex Molecular Diagnostics Based on CRISPR-Cas and other Synthetic Biology Approaches https://secure.ati.org/mcdc/DET-18-02/whitepaper.html TRE 18-03: Late Discovery and Development of Therapeutics to Treat Symptoms of Exposure to Organophosphorus Chemical Warfare Nerve Agents https://secure.ati.org/mcdc/TRE-18-03/whitepaper.htm
…
In February 2019, Alchem Laboratory announced Management additions including Robert W. Malone M.D., M.S.:
Alchem Laboratories Announces Expansion of its Screening and Clinical Trial Manufacturing Capabilities
• Management additions including Robert W. Malone M.D., M.S., Chief Medical Officer, Steve Vasile, Ph.D., Director of Discovery and Becky L. Hood, Assistant Director of Discovery.
as well as:
Alchem Laboratories Corporation currently supports seven different five-year contracts with NIH and DOD, including three new contracts for screening and drug product manufacturing awarded in 2019.
Finally, in November Alchem was awarded a 5-year project agreement MCDC1905-001 “Prophylactic and Therapeutic cMCM Libraries, Mid to Late Pipeline Development” (MCDC BASE AGREEMENT NO.: 2019-548 up to $13,371,881) of Advanced Technology International (ATI) contract W15QKN1691002 for Medical CBRN Defense Consortium (MCDC) Other Transactional Authority (OTA).
In February 2019 Alchem published this:
So, basically on February 19, 2020 Alchem Laboratories Announced
1. Key appointments to its management team. The appointments include Robert W. Malone M.D., M.S.
2. Finally, in November Alchem was awarded a 5-year project agreement MCDC1905- 001 “Prophylactic and Therapeutic cMCM Libraries, Mid to Late Pipeline Development” (MCDC BASE AGREEMENT NO.: 2019-548 up to $13,371,881) of Advanced Technology International (ATI) contract W15QKN1691002 for Medical CBRN Defense Consortium (MCDC) Other Transactional Authority (OTA).
On February 19, 2020 Alchem Laboratories announced:
Finally, in November Alchem was awarded a 5-year project agreement MCDC1905-001 “Prophylactic and Therapeutic cMCM Libraries, Mid to Late Pipeline Development” (MCDC BASE AGREEMENT NO.: 2019-548 up to $13,371,881) of Advanced Technology International (ATI) contract W15QKN1691002 for Medical CBRN Defense Consortium (MCDC) Other Transactional Authority (OTA).
“Effort sponsored by the U.S. Government under Other Transaction number W15QKN-16-9-1002 between the MCDC, and the Government. The US Government is authorized to reproduce and distribute reprints for Governmental purposes notwithstanding any copyright notation thereon.”
It is COVID-19 PANDEMIC-VACCINE RAPID ADVANCED RESEARCH & DEVELOPMENT (“ARD”) contract:
https://www.keionline.org/misc-docs/DOD-ATI-Novavax-Contract-W15QKN1691002-25June2020.pdf
ON MARCH 06, 2020 ROBERT MALONE WROTE:
Medical Countermeasures Analysis of 2019-nCoV and Vaccine Risks for Antibody-Dependent Enhancement (ADE)
Darrell O. Ricke * and Robert W. Malone **
https://www.preprints.org/manuscript/202003.0138/v1
ON APRIL 27, 2020 ALCHEM PUBLISHED”
http://web.archive.org/web/20200505074045/http://www.alchem.com/news
As of Saturday, 187 COVID-19 patients in critical status, including many on ventilators, have been enrolled in the trial, which aims for a total of 1174 people. Reports from China and molecular modeling results suggest that the drug, which seems to bind to a key enzyme in the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), could make a difference.
But the hype surrounding hydroxychloroquine and chloroquine—the unproven antimalarial drugs touted by President Donald Trump and some physicians and scientists—has made Tracey wary of sparking premature enthusiasm.
He is tight-lipped about famotidine’s prospects, at least until interim results from the first 391 patients are in. “If it does work, we’ll know in a few weeks,” he says.
Since this study was conducted as a Phase 3 “Multi-site, Randomized, Double-Blind, Multi-Arm Historical Control, Comparative Trial of the Safety and Efficacy of Hydroxychloroquine, and the Combination of Hydroxychloroquine and Famotidine for the Treatment of COVID-19 in Hospitalized Adults,” the results from the clinical study will be submitted to a peer-reviewed journal for publication once the results have been audited according to GCP requirements. It is unethical and medically dangerous to release any results related to any potential improvement in the treatment arms until the GCP audit is complete. Alchem condemns any press or unrelated parties making assumptions before that time.
YES, AND IT'S ALL ABOUT NANO ALL THE TIME.
IT'S NOT ABOUT VIRUSES OR PANDEMICS. THESE ARE JUST PRETEXTS FOR INJECTING, INSTILLING OR INHALING NANOTECHNOLOGY IN ALL THESE PRODUCTS.
THIS IS THE REASON FOR BOTH ADVERSE EFFECTS AND DEATHS: THE TOXICITY OF THIS NANOTECHNOLOGY
This is awesomely horrifying (because for me, frequent mention of the military in tandem with anything nano-related always is) and I'd to make my brain and limited eyesight work overtime to process that sum of money there....
I am, as always though, unsurprised. He's doing the same work he always has, so when I realised that I automatically discounted him a some kind of champion for Humanity. In fact I keep finding out that many of those in the frontline of the supposed freedom fight appear to be nothing more than distraction stooges set up to keep the bulk of us occupied and believing we're making progress when in fact now, many of us are questioning the fact that it's been almost four years and how close are they to stopping the killshots, bioweapon research (btw, is that how they get away with it? By calling it "defense" instead of "warfare"?) and there's the fact that many of these frontline stooges continue to make quite considerable sums of money whilst achieving nothing of note. Attending countless interviews and conferences don't count when they're touting their own books and supplement protocols etc.
Great piece of research here.