As usual, we have a full plate of analytics, commercial intelligence and due-diligence jobs for which we do not share with the public, as per client request.
That said, below are some of the public projects we can disclose. We are proud of the fantastic work we have done and look forward to more great projects in the future.
With the last big project wrapped up, we are actively recruiting our next project. Please feel free to reach out and connect, if you have a project or a lead. We are ready to help!
In 2016, RW Malone MD, LLC principals Dr.s Jill and Robert Malone donated some their resources and efforts into working in the public health sphere to fight against the Zika virus. They founded the Infection Outbreak Response Group (iORG).
iORG began in the winter of 2016. News of Zika was rapidly spreading and the founders of iORG, Dr's Robert and Jill Malone wanted to do something to really make a difference. Having worked in infectious disease outbreak response teams for many years, they realized that the usual governmental response was slow and inefficient. The usual response time just was not a good solution to solve the spread of Zika and to develop a better understanding of the disease, so that treatments could be developed. Dr. Malone spoke to many colleagues and the response was overwhelming. Together, they founded the Zika Response Group with iORG as the parent organization. The was goal was simply to impact on the public health response to make it more efficient and to make a difference. The team of people assembled worked night and day - and accomplished amazing things.
Some of the iORG successes are:
- Under the leadership of RW Malone, Zika Response Working Group wrote a comprehensive meta analysis of Zika and available medical countermeasure options that has helped guide government officials, clinicians and front line public health workers as they are responding to the virus outbreak in January 2016.
- With RW Malone, being lead author, the Zika Response Working Group wrote an extensive review paper on Zika that has helped guide scientists about the virus. Published in PLoS NTD. The paper now has over 40,000 readers and is one of the most cited Zika references.
- Members of the Zika Response Group have performed epitope mapping and computational biology analyses, showing the evolution of the virus - which will lead to a better vaccine and a better understanding of how the disease is causing damage to fetuses, as well as the mechanisms of action of GBS. This effort culminated in two peer reviewed papers being published. The Evolution of the Zika Virus paper, published in the fall of 2016, is one of Wiley's most read scientific articles, and is in the 99% of their top publications- with 72,000 readers having already viewed the paper. Dr. Malone was one of the lead authors of this study.
- Members of our team, including Dr's Malone have extensively consulted with USG and Brazilian government officials on how to control the pandemic.
- Dr. RW Malone traveled to Geneva to consult with the World Health Organization, and foreign public health officials on how to control the pandemic.
- Dr.s Malone have discovered possible anti-viral drugs that are safe for pregnant women and designed clinical trials, and are in the process of procuring funding and building partners in Latin America to move forward with clinical trials!
The iORG website is: http://iorg-news.org/
Ebola Vaccine Development-
RW Malone MD, LLC had a busy fall in 2015, 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 $50 million dollars into NewLink coffers if the vaccine advances to Phase 2 clinical testing. This is the largest BARDA Ebola vaccine contract, and the largest Ebola-specific pharmaceutical deal consummated during 2014. Many thanks to all that assisted with this win, we are proud the work to make this happen!
The CDC awarded Kai Research and Benchmark Research the contract for "Anonymous Pre and Post Influenza Vaccine Sera Panels Solicitation #2014N-15807." Congratulations to the Kai/Benchmark team. RW Malone MD, LLC are honored to be on the winning bid! This small business contract award has already yielded a key finding for the CDC, that being the clinical samples used to predict the mis-match between the currently circulating H3N2 influenza strain and the 2014-2015 vaccine strain.
New Vaccine Technology-
In September 2014, Soligenix, with the help of RW Malone MD, LLC, won a 25 million dollar NIAID contract for "Development of Vaccine Formulations Effective against NIAID Priority Pathogens."
Commercial Due Diligence-
With support from RW Malone MD LLC, SAI Med Partners has been awarded preferred vendor status by one of the largest pharmaceutical companies in the world. We look forward to continuing our productive collaboration with SAI during 2015 and beyond.
In total, RW Malone MD LLC, LLC·helped win four major federal HHS contracts this year!· In total, the value of these contracts adds up to hundreds of millions of dollars, adding to the well over 1B$ in federal awards obtained with our assistance. RW Malone MD, LLC played a major role in all four contracts, by providing proposal development, subject matter expertise, project management assistance and clinical trials design.
Examples of Past Projects and Proposal Wins
Proposal management services for Soligenix: Submission of a large contract to: NIAID Contract Proposal for Thermostable Ricin Vaccine, Fall 2013 -
Proposal management services for a largeIDIQcontract 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 scientific writer.
Successful 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 millionfrom 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.
Below is a list of projects from 2011-2016 that RW Malone MD, LLC has provided direct leadership and involvement in. Totalling ten billion dollars in the last five years.