Robert Malone - Results

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From the page at this link;

Recent Results:

RW Malone MD, LLC worked intelligently as well as relentlessly to help our clients win over 100 million worth of grants and contracts in 2014. In the past decade, RW Malone MD, LLC has helped win around one billion in contracts. That is success we can all be proud of! Below are a just a sampling of the projects RW Malone MD, LLC has been involved in.

2014 Proposal Wins and Projects

Ebola Vaccine Development-
RW·Malone MD, LLC has had a busy fall, dominated by leading the Newlink Genetics team to develop and submit a contract proposal to the federal Government (BARDA) on a very abbreviated timeline, as well as leading design of both PDP and clinical trials for the leading Ebola vaccine candidate. · With the assistance of our partners,·RW·Malone MD LLC was able to assemble a comprehensive proposal team in days, and to submit the first version of the contract proposal in three days, and a second comprehensive BARDA contract proposal in the record time of two weeks (full technical and cost volumes).· In the course of this work, Robert Malone, MD set up negotiations between Merck and NewLink to buy the rights for developing the Public Health Agency Canada VSV vaccine technology which NewLink had purchased, and which US DoD/DTRA had played a leading role in advancing.·
·
The return on investment for this effort was that NewLink Genetics and Merck received a $30 million (base period) with $40 million option period ($70M total) contract to work on an Ebola vaccine candidate from BARDA in December, 2014.· In addition, the Merck deal will bring at least an additional $50 million dollars into NewLink coffers if the vaccine advances to Phase 2 clinical testing.· This is the largest BARDA Ebola vaccine contract, and the largest Ebola-specific pharmaceutical deal consummated during 2014.· Many thanks to all that assisted with this win, we are proud the work to make this happen!·
·
Clinical Research-
This fall, the CDC awarded Kai Research and Benchmark Research the contract for "Anonymous Pre and Post Influenza Vaccine Sera Panels Solicitation #2014N-15807." Congratulations to the Kai/Benchmark team.·RW·Malone MD, LLC are honored to be on the winning bid!· This small business contract award has already yielded a key finding for the CDC, that being the clinical samples used to predict the mis-match between the currently circulating H3N2 influenza strain and the 2014-2015 vaccine strain.
·
New Vaccine Technology-
In September 2014, Soligenix, with the help of·RW·Malone MD, LLC, won a 25 million dollar NIAID contract for "Development of Vaccine Formulations Effective against NIAID Priority Pathogens."·
·
Commercial Due Diligence-
With support from·RW·Malone MD LLC, SAI Med Partners has been awarded preferred vendor status by one of the largest pharmaceutical companies in the world.· We look forward to continuing our productive collaboration with SAI during 2015 and beyond.

2013 Proposal Wins and Projects

Proposal management sevices for Soligenix: Submission of a large contract to: NIAID Contract Proposal for Thermostable Ricin Vaccine, Fall 2013 -

Proposal management sevices for a large IDIQ contract for a large technology company, including team building, management of the technical proposal and scientific writing.

Conference Organizer and Coordinator: MODELING WORKSHOP, 2013

Due Diligence for a large pharmaceutical company on infuenza vaccines, 2012-2013.

Chairpson and reviewer for NIH/NAIAD Committee on Partnerships in Biodefense Immunotherapeutics, Fall 2011. Robert W Malone, MD, MS

Committee member and reviewer for NIH/NAIAD Committee for Development of Technologies that Accelerate the Immune Response to BioDefense Vaccines., Fall 2011. Robert W Malone, MD, MS

12-14 July 2011 - The World Health Organization (WHO) hosted the second Consultation on the Global Action Plan for Influenza Vaccines. Invited speaker: Robert W Malone, MD, MS "Vaccine Production Strategies: Ensuring Alignment and Sustainability"

Successful submission and funding of a 80 million US government contract to a biotechnology client in 2011 -proposal manager and chief scienctific writer.

Succesful submission of three white papers to a government agency in 2011: two contracts funded.

Medical Director, Vaccines, under contract and consultant with Beardsworth 2009 - 2013

.

Provided significant technical due-diligence for a fortune 500 company pursuing infectious disease opportunities in the fall of 2009.

Proposal manager and editor for URI and Epivax's funded submission of U19 grant for $13 million from the National Institutes of Health to pioneer the development and application of an integrated gene-to-vaccine program targeting emerging infectious diseases. 2009.

Medical director under contract and consultant with Accelovance 2008-2009. While in this position, Accelovance was awarded the title of "Best Contract Research Organization" (CRO) award at the 2009 World Vaccine Congress.

Author, editor and capture manager for Accelovance of funded $3 million CDC contract for influenza vaccine immunogenicity clinical trial.

Proposal manager and editor for Chesapeake PERL's funded submission and funding in October 2009 of the US Army SBIR Grant Year II: Commercialization Pilot Program (CPP), Improved Protein Manufacturing in Insect Expression System - Develop HIV-1 Envelope Proteins as HIV Vaccine Antigen 

Proposal manager and editor for Chesapeake PERL's funded submission and funding in June 2009 of the Department of Energy SBIR Grant Phase II: Identification, Production and Characterization of Novel Lignase Proteins from Termite for Depolymerization of Lignocellulose.

Adjunct professor, Kennesaw University 2009- present.

Public health survey of experts for a large pharmaceutical corporation, regarding governmental vaccination strategies. 2009

Scientific Advisory Board member of a mid-sized biotechnology company. 2006 -to present)

Member, NIH Committee for Biodefense Vaccine Enhancement, 2008.

Public health survey of experts for a large pharmaceutical corporation, regarding governmental vaccination strategies. 2008

Protocol Author and Clinical Director of a large Influenza Phase 1 Clinical Trial: FDA had no revisions on intial IND review. 2007

Proposal manager and editor of a funded submission of an influenza Contract through HHS: total budget 130 million. 2006

Successful submission of a CDC foundation award for TB: total budget one million.

Provided due diligence for a large financial institution involving venture capital for significant late-stage biotechnology investment.Recent Results:

RW Malone MD, LLC worked intelligently as well as relentlessly to help our clients win over 100 million worth of grants and contracts in 2014. In the past decade, RW Malone MD, LLC has helped win around one billion in contracts. That is success we can all be proud of! Below are a just a sampling of the projects RW Malone MD, LLC has been involved in.

2014 Proposal Wins and Projects

Ebola Vaccine Development-
RW·Malone MD, LLC has had a busy fall, dominated by leading the Newlink Genetics team to develop and submit a contract proposal to the federal Government (BARDA) on a very abbreviated timeline, as well as leading design of both PDP and clinical trials for the leading Ebola vaccine candidate. · With the assistance of our partners,·RW·Malone MD LLC was able to assemble a comprehensive proposal team in days, and to submit the first version of the contract proposal in three days, and a second comprehensive BARDA contract proposal in the record time of two weeks (full technical and cost volumes).· In the course of this work, Robert Malone, MD set up negotiations between Merck and NewLink to buy the rights for developing the Public Health Agency Canada VSV vaccine technology which NewLink had purchased, and which US DoD/DTRA had played a leading role in advancing.·
·
The return on investment for this effort was that NewLink Genetics and Merck received a $30 million (base period) with $40 million option period ($70M total) contract to work on an Ebola vaccine candidate from BARDA in December, 2014.· In addition, the Merck deal will bring at least an additional $50 million dollars into NewLink coffers if the vaccine advances to Phase 2 clinical testing.· This is the largest BARDA Ebola vaccine contract, and the largest Ebola-specific pharmaceutical deal consummated during 2014.· Many thanks to all that assisted with this win, we are proud the work to make this happen!·
·
Clinical Research-
This fall, the CDC awarded Kai Research and Benchmark Research the contract for "Anonymous Pre and Post Influenza Vaccine Sera Panels Solicitation #2014N-15807." Congratulations to the Kai/Benchmark team.·RW·Malone MD, LLC are honored to be on the winning bid!· This small business contract award has already yielded a key finding for the CDC, that being the clinical samples used to predict the mis-match between the currently circulating H3N2 influenza strain and the 2014-2015 vaccine strain.
·
New Vaccine Technology-
In September 2014, Soligenix, with the help of·RW·Malone MD, LLC, won a 25 million dollar NIAID contract for "Development of Vaccine Formulations Effective against NIAID Priority Pathogens."·
·
Commercial Due Diligence-
With support from·RW·Malone MD LLC, SAI Med Partners has been awarded preferred vendor status by one of the largest pharmaceutical companies in the world.· We look forward to continuing our productive collaboration with SAI during 2015 and beyond.

2013 Proposal Wins and Projects

Proposal management sevices for Soligenix: Submission of a large contract to: NIAID Contract Proposal for Thermostable Ricin Vaccine, Fall 2013 -

Proposal management sevices for a large IDIQ contract for a large technology company, including team building, management of the technical proposal and scientific writing.

Conference Organizer and Coordinator: MODELING WORKSHOP, 2013

Due Diligence for a large pharmaceutical company on infuenza vaccines, 2012-2013.

Chairpson and reviewer for NIH/NAIAD Committee on Partnerships in Biodefense Immunotherapeutics, Fall 2011. Robert W Malone, MD, MS

Committee member and reviewer for NIH/NAIAD Committee for Development of Technologies that Accelerate the Immune Response to BioDefense Vaccines., Fall 2011. Robert W Malone, MD, MS

12-14 July 2011 - The World Health Organization (WHO) hosted the second Consultation on the Global Action Plan for Influenza Vaccines. Invited speaker: Robert W Malone, MD, MS "Vaccine Production Strategies: Ensuring Alignment and Sustainability"

Successful submission and funding of a 80 million US government contract to a biotechnology client in 2011 -proposal manager and chief scienctific writer.

Succesful submission of three white papers to a government agency in 2011: two contracts funded.

Medical Director, Vaccines, under contract and consultant with Beardsworth 2009 - 2013

.

Provided significant technical due-diligence for a fortune 500 company pursuing infectious disease opportunities in the fall of 2009.

Proposal manager and editor for URI and Epivax's funded submission of U19 grant for $13 million from the National Institutes of Health to pioneer the development and application of an integrated gene-to-vaccine program targeting emerging infectious diseases. 2009.

Medical director under contract and consultant with Accelovance 2008-2009. While in this position, Accelovance was awarded the title of "Best Contract Research Organization" (CRO) award at the 2009 World Vaccine Congress.

Author, editor and capture manager for Accelovance of funded $3 million CDC contract for influenza vaccine immunogenicity clinical trial.

Proposal manager and editor for Chesapeake PERL's funded submission and funding in October 2009 of the US Army SBIR Grant Year II: Commercialization Pilot Program (CPP), Improved Protein Manufacturing in Insect Expression System - Develop HIV-1 Envelope Proteins as HIV Vaccine Antigen 

Proposal manager and editor for Chesapeake PERL's funded submission and funding in June 2009 of the Department of Energy SBIR Grant Phase II: Identification, Production and Characterization of Novel Lignase Proteins from Termite for Depolymerization of Lignocellulose.

Adjunct professor, Kennesaw University 2009- present.

Public health survey of experts for a large pharmaceutical corporation, regarding governmental vaccination strategies. 2009

Scientific Advisory Board member of a mid-sized biotechnology company. 2006 -to present)

Member, NIH Committee for Biodefense Vaccine Enhancement, 2008.

Public health survey of experts for a large pharmaceutical corporation, regarding governmental vaccination strategies. 2008

Protocol Author and Clinical Director of a large Influenza Phase 1 Clinical Trial: FDA had no revisions on intial IND review. 2007

Proposal manager and editor of a funded submission of an influenza Contract through HHS: total budget 130 million. 2006

Successful submission of a CDC foundation award for TB: total budget one million.

Provided due diligence for a large financial institution involving venture capital for significant late-stage biotechnology investment.