You are viewing an old version of this page. View the current version.

Compare with Current View Page History

Version 1 Current »

Robert Malone (linkedin)


Robert Malone Experiences - from linked in, pasted below in case it gets removed

CEO, Analyst and Consultant: Proposal Development, Clinical Research, Vaccines and Biologics

RW Malone MD, LLCOct 2001 - Present · 20 yrs 4 mosMadison, VA

    • Proposal development, strategic leadership, partnership development, Consulting services in Government Contracting Consulting services in Commercial Intelligence and due diligence, FDA Phase I, II, and III clinical trials, protocol development and submission, and related regulatory submissions including pIND and IND.
      He has been involved in developing, designing, and providing oversight of approximately forty phase 1 clinical trials and twenty phase 2 clinical trials, as well as five phase 3 clinical trials. He has served as medical director/medical monitor on approximately forty phase 1 clinical trials, and on twenty phase 2 clinical trials, including those run at vaccine-focused Clinical Research Organizations. He has served as principal investigator on some of these. Currently working as a principal consultant for a CRO. Providing business development, proposal management, clinical development, regulatory and medical affairs support for pharmaceutical, vaccines-related and biologics companies.



    • RW Malone MD, LLC
      RW Malone MD LLC is a customer-focused premier consultancy and analytics group, specializing in analytics for the bio-sector, commercial intelligence, opportunity capture, clinical trials and proposal development.

      • CEO

        Atheric Pharmaceutical LLCFeb 2016 - Jan 2017 · 1 yrScottsville, VA

          • CEO and co-founder of Atheric Pharmaceutical LLC. A biopharmaceutical company focused on the rapid development and commercialization of repurposed drugs to prevent and treat Flavivirus disease based (e.g., Nile virus, Dengue Fever and Zika virus) neurological disorders (e.g., Guillain-Barre Syndrome, microcephaly). Atheric™ is committed to providing broad-spectrum medical countermeasures for Zika and other neglected tropical diseases for humankind.
            Zika outbreak medical countermeasure (MCM) strategies have been identified, with the most promising

            Atheric has anti-viral drugs, safe for humans in all three trimesters of pregnancy, for use in protecting against the Zika Virus infection; to prevent development of Zika Virus fetal syndrome and GBS. Provisional patents covering the used of these compounds for Zika and other Flaviviruses have been filed with the US Patent and Trademark Office. Clinical trials to determine correct dosing and proprietary formulations appropriate for the indicated therapies (including prophylactic use) are being rapidly developed. Regulatory discussions with FDA have been initiated.

      • Medical Director, Vaccines

        BeardsworthMar 2010 - Apr 2013 · 3 yrs 2 mos

          • Business development, medical monitoring, proposal management, strategic consulting. This retainer position was contracted under RW Malone MD, LLC.

      • Adjunct Associate Professor

        Kennesaw State University2009 - 2013 · 4 yrs 1 moKennesaw, GA

          • Associate Professor in Biotechnology

      • Editor in Chief

        Journal of Immune Based Therapies and VaccinesFeb 2009 - Jan 2011 · 2 yrs

          • Journal of Immune Based Therapies and Vaccines is an Open Access, peer-reviewed, online journal dedicated to all aspects of therapeutic and prophylactic applications of immunology.

            Journal of Immune Based Therapies and Vaccines aims to advance the understanding and application of specific immunological mechanisms, immune correlates of protection and activity, strategic regulatory and clinical development considerations, and other issues relating to accelerating the advanced development and licensure of efficacious vaccines and immune based therapies (IBTs). The areas of vaccines and IBTs encompass many different disciplines, including infectious diseases, transplantation, cancer, allergic diseases, and autoimmune diseases.

      • Medical Director, Vaccines

        AccelovanceOct 2008 - Oct 2009 · 1 yr 1 moMaryland

          • As a member of Accelovance’s Executive Management team, Dr. Malone combines entrepreneurial business talents and biotech industry expertise on a global scale to support the vision of the company. This retainer position was contracted under RW Malone MD, LLC

      • consultant

        PATH2008 - 2009 · 1 yr 1 mo

          • Consulting in Alternative delivery technologies, including clinical trials consulting and management in Brazil. This retainer position was contracted under RW Malone MD, LLC

      • Senior Director, Vaccines and Therapeutics

        EpiVaxDec 2007 - Oct 2008 · 11 mos

          • Part time service on retainer focused on product development and transition from pre-clinical to clinical development, Business planning and development, and proposal development.

      • Director, Clinical Development/Medical Affairs, Influenza

        Solvay Pharmaceuticals, Inc.Nov 2006 - Dec 2007 · 1 yr 2 mos

          • Responsibilities included leading an extended clinical team (both internal and CRO components), providing project and clinical trials management oversight, serving as primary author on clinical protocols, strategic documents including clinical development plans, all clinical documents required to support IND filing, generating and managing cost projections and budgetary oversight, providing strategic management and serving as a communication hub for clinical aspects of a 300M USD federal contract to develop and license a cell-based influenza vaccine.

      • Senior Medical Director

        Summit Drug Development ServicesOct 2005 - Oct 2006 · 1 yr 1 mo

          • Summit is a drug development services provider addressing due diligence assessments and strategic drug development planning to preparing regulatory submissions and implementing, monitoring, and analyzing clinical trials for its clients. While serving at Summit, Dr. Malone was the primary author of three pIND, two IND, an Appendix M submission and has served as proposal manager and primary author for a 129M USD federal contract submission focused on pandemic influenza.

      • Associate Director, Clinical Research

        Dynport Vaccine Company, LLCOct 2002 - Oct 2003 · 1 yr 1 mo

          • Dynport vaccine company (www.dynport.com) is a government contractor that holds the primary contract for advanced development of biodefense vaccines for the US Department of Defense.
            • Serving as liaison between product development teams and clinical research support group
            1. Preparation of planning documents and product development plans
            2. Identification of new technologies relevant to product development teams, facilitating integration of same in product development plans
            3. Preparing documents for clinical trials including investigator brochures
            4. Preparing proposal solicitations, technical review of subcontractor proposals
            • Serving as senior staff for technology watch program
            5. Technical review of potential subcontractors, new technologies
            6. Preparation of technical reviews for monthly in-house publication
            7. Assisting business development group in strategic evaluation and planning concerning new business opportunities

      • Chief of Laboratory Science and Director of Tissue Banking

        USUHS Dept of Surgery, Clinical Breast Care Program (CBCP)Sep 2000 - Sep 2001 · 1 yr 1 mo

          • • Worked closely with architect firm to design space, set-up laboratory facilities for the Clinical Breast Care Project, including new facilities design (tissue banking facilities, laboratory, animal rooms, animal surgical suite, office suites) at USUHS and Windber Medical Center, PA
            • Hired faculty, technicians, staff for CBCP at both sites, including writing and initiating job descriptions, job interviews, hiring decisions, set-up for re-locations
            • Laboratory Supervisor: Tissue banking immunology, cell culture, gene transfer, genetic vaccination research, animal research.

      • Assistant Professor

        University of Maryland, Baltimore School of Medicine, Dept. ofJan 1997 - Aug 2000 · 3 yrs 8 mos

          • Set-up and ran successful research laboratory in immunology (genetic vaccination) and gene transfer.

      • Assistant Professor , Pathology

        University of California, Davis Department of Medical Pathology,Oct 1993 - Jan 1997 · 3 yrs 4 mos

          • Director and Founder, Gene Therapy Program (pulmonary, dermal, heart, liver, mucosal and parenteral vaccines)

      • Research Fellow

        UC Davis Medical CenterJul 1992 - Sep 1993 · 1 yr 3 mos

          • • Succesful grant writing
            • Research in genetic (DNA) vaccination and gene transfer.
            • laboratory set-up

      • Scientist

        Vical1989 · Less than a year

          • Invented naked DNA and RNA delivery, DNA vaccine technology

      • Graduate Student

        Salk Institute1986 - 1989 · 3 yrs 1 mo

          • Pioneering work in mRNA structure, function, delivery, non-viral gene delivery

      • Foreman, Shingling crew

        Michael Charmichael ConstructionOct 1978 - Jan 1980 · 1 yr 4 mos

          • Leadership of construction crew of 3-4 contractors, assistance with design and implementation of unique private residence located in the Mission Canyon area of Santa Barbara. An on line video clip of the home can be found in the HGTV "Extreme Homes" video library at http://www.hgtv.com/videos/a-whale-of-a-house/3406.html

Robert Malone (Patents)


Patents filed by Robert Malone (pasted below in case it gets removed)

Patents by Inventor Robert W. Malone

Robert W. Malone has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).

  • Compounds and methods for enhancing delivery of free polynucleotide

    Publication number: 20040009947
    Abstract: The discovery of simple, nontoxic, and pharmaceutically defined methods for genetic modification of cells and tissues would enable development of a variety of molecular medicines. “Free”, ‘direct’, or ‘naked’ polynucleotide administration is a simple, apparently safe, and pharmaceutically defined polynucleotide delivery method. Murine, macaque, and clinical human experiments have demonstrated transfection of various tissues, such as respiratory tissues, after direct application of ‘free’ polynucleotide. However, direct DNA transfection is relatively inefficient in comparison to many transduction systems. The invention herein is directed to transfection enhancing agents which augment the transfection activity of ‘free’ polynucleotide, thereby facilitating the development of simple and safe alternatives to tissue transfection, more particularly respiratory tissue transfection.
    Type: Application
    Filed: May 27, 2003
    Publication date: January 15, 2004
    Inventors: Robert W. Malone, Jill G. Malone


  • DNA vaccines for eliciting a mucosal immune response

    Patent number: 6110898
    Abstract: The invention consists of a method for inducing production of a mucosal immune response in a host by administration of an antigen-encoding polynucleotide preparation, comprising DNA or RNA encoding an antigenic epitope to a mucosal inductor site in the mucosal tissue of the host. Naked DNA may be administered directly to mucosa, for instance in saline drops, or in a recombinant gene expression vector. Preferably, the recombinant gene expression vectors are not capable of replication or dessimination. The invention also includes the use of live viral vaccines wherein the viruses include immunostimulatory polynucleotides of the invention. According to a preferred method of the invention, a target protein antigen is administered through its expression by a recombinant gene expression vector.
    Type: Grant
    Filed: May 23, 1997
    Date of Patent: August 29, 2000
    Assignee: University of Maryland, Baltimore
    Inventors: Robert W. Malone, Jill G. Malone


  • Formulations and methods for generating active cytofectin: polynucleotide transfection complexes

    Patent number: 5925623
    Abstract: In the generation of cytofectin:polynucleotide complexes for transfection of cells, formulations, counterions, and reaction conditions for maximizing the transfection include using a cationic amine compound that has the general structure: ##STR1## wherein R.sub.4 and R.sub.5 are a pair of same or different lipoyl moieties selected from a group consisting of an alkyl, alkenyl, alkynyl, alkanoyl, alkenoyl, or alkynoyl groups and for R.sub.1, R.sub.2, and R.sub.3 at least two are hydroxylated, ether containing, or acyloxy containing alkyl, alkenyl, or alkynyl groups or at least one amine bonded halogen containing moiety selected from a group consisting of a halogenated alkyl, alkenyl, or alkynyl group or a mixture of at least one halogen containing moiety selected from a group consisting of a halogenated alkyl, alkenyl, or alkynyl group and at least one hydroxylated, ether containing, or acyloxy containing alkyl, alkenyl, or alkynyl group, and X.sup.- is an oxyanion or halide counterion.
    Type: Grant
    Filed: July 15, 1996
    Date of Patent: July 20, 1999
    Assignee: The Regents of the University of California
    Inventors: Michael H. Nantz, Michael J. Bennett, Rajiv P. Balasubramaniam, Alfred M. Aberle, Robert W. Malone


  • Cationic transport reagents

    Patent number: 5892071
    Abstract: For use in transporting biologically active species into and through membrane barriers, a symmetrical cationic diamine compound having the general structure ##STR1## wherein m=1-10; R.sub.1 is a hydrogen, an alkyl group, an alkenyl group, a hydroxylated alkyl or alkenyl group, or an ether containing alkyl or alkenyl group; R.sub.2 is an alkyl group, an alkenyl group, or an alkyl or alkenyl containing acyl group; R.sub.3 is a hydrogen, an alkyl group, an alkenyl group, a hydroxylated alkyl or alkenyl group, or an ether containing alkyl or alkenyl group; R.sub.4 is a hydrogen, an alkyl group, an alkenyl group, a hydroxylated alkyl or alkenyl group, or an ether containing alkyl or alkenyl group; and X.sup.- is an anion.
    Type: Grant
    Filed: September 15, 1995
    Date of Patent: April 6, 1999
    Assignee: The Reagents of The University of California
    Inventors: Michael H. Nantz, Michael J. Bennett, Robert W. Malone


  • Polyfunctional cationic cytofectins, formulations and methods for generating active cytofectin: polynucleotide transfection complexes

    Patent number: 5824812
    Abstract: Amine containing compounds and their use in the generation of cytofectin:polynucleotide complexes for transfection of cells, formulations, counterions, and reaction conditions for maximizing the transfection include using cationic amine compounds that have the general structure: ##STR1## wherein R.sub.4 and R.sub.5 are a pair of same or different lipoyl moieties selected from a group consisting of an alkyl, alkenyl, alkynyl, alkanoyl, alkenoyl, or alkynoyl groups and for R.sub.1, R.sub.2, and R.sub.3 at least two are hydroxylated, ether containing, or acyloxy containing alkyl, alkenyl, or alkynyl groups or at least one amine bonded halogen containing moiety selected from a group consisting of a halogenated alkyl, alkenyl, or alkynyl group or a mixture of at least one halogen containing moiety selected from a group consisting of a halogenated alkyl, alkenyl, or alkynyl group and at least one hydroxylated, ether containing, or acyloxy containing alkyl, alkenyl, or alkynyl group, and X.sup.
    Type: Grant
    Filed: September 17, 1996
    Date of Patent: October 20, 1998
    Assignee: The Regents of the University of California
    Inventors: Michael H. Nantz, Michael J. Bennett, Rajiv P. Balasubramaniam, Alfred M. Aberle, Robert W. Malone


  • Cationic transport reagents

    Patent number: 5744625
    Abstract: For use transporting biologically active species into and through membrane barriers, a symmetrical cationic diamine compound having the general structure ##STR1##
    Type: Grant
    Filed: May 16, 1996
    Date of Patent: April 28, 1998
    Assignee: The Reagents of the University of California
    Inventors: Michael H. Nantz, Michael J. Bennett, Robert W. Malone


  • Induction of a protective immune response in a mammal by injecting a DNA sequence

    Patent number: 5589466
    Abstract: A method for delivering an isolated polynucleotide such as DNA or RNA, to the interior of a cell in a mammal comprising the injection of an isolated polynucleotide into a muscle of the mammal where the polynucleotide is taken up by the cells of the muscle and exerts a therapeutic effect on the mammal. The method can be used to deliver a therapeutic polypeptide to the cells of the mammal, to provide an immune response upon in vivo translation of the polynucleotide, to deliver antisense polynucleotides, to deliver receptors to the cells of the mammal or to provide transitory gene therapy.
    Type: Grant
    Filed: January 26, 1995
    Date of Patent: December 31, 1996
    Assignees: Vical Incorporated, Wisconsin Alumni Research Foundation
    Inventors: Philip L. Felgner, Jon A. Wolff, Gary H. Rhodes, Robert W. Malone, Dennis A. Carson


  • Delivery of exogenous DNA sequences in a mammal

    Patent number: 5580859
    Abstract: Polynucleotide sequences, comprising DNA and RNA molecules can be directly administered, for example by injection, to tissues, such as muscle, and expressed as a protein, polypeptide or polypeptide. The polynucleotides can be contained within liposomes or the polynucleotides can free from association with transfection-facilitating proteins, viral particles, liposomal formulations, charged lipids and calcium phosphate precipitating agents.
    Type: Grant
    Filed: March 18, 1994
    Date of Patent: December 3, 1996
    Assignees: VICAL Incorporated, Wisconsin Alumni Research Foundation
    Inventors: Philip L. Felgner, Jon A. Wolff, Gary H. Rhodes, Robert W. Malone, Dennis A. Carson


  • Cationic transport reagents

    Patent number: 5527928
    Abstract: For use in transporting biologically active species into and through membrane barriers, a symmetrical cationic diamine compound having the general structure ##STR1##
    Type: Grant
    Filed: September 30, 1994
    Date of Patent: June 18, 1996
    Inventors: Michael H. Nantz, Michael J. Bennett, Robert W. Malone


  • No labels