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

RW Malone MD, LLCRW Malone MD, LLCOct 2001 - Present · 20 yrs 4 mosOct 2001 - Present · 20 yrs 4 mosMadison, VAMadison, 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.
    
    
    
    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, LLCRW 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.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.

• • • CEOCEO

      Atheric Pharmaceutical LLCAtheric Pharmaceutical LLCFeb 2016 - Jan 2017 · 1 yrFeb 2016 - Jan 2017 · 1 yrScottsville, VAScottsville, 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.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, VaccinesMedical Director, Vaccines

      BeardsworthBeardsworthMar 2010 - Apr 2013 · 3 yrs 2 mosMar 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.Business development, medical monitoring, proposal management, strategic consulting. This retainer position was contracted under RW Malone MD, LLC.

    • Adjunct Associate ProfessorAdjunct Associate Professor

      Kennesaw State UniversityKennesaw State University2009 - 2013 · 4 yrs 1 mo2009 - 2013 · 4 yrs 1 moKennesaw, GAKennesaw, GA

      • • Associate Professor in BiotechnologyAssociate Professor in Biotechnology

    • Editor in ChiefEditor in Chief

      Journal of Immune Based Therapies and VaccinesJournal of Immune Based Therapies and VaccinesFeb 2009 - Jan 2011 · 2 yrsFeb 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.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, VaccinesMedical Director, Vaccines

      AccelovanceAccelovanceOct 2008 - Oct 2009 · 1 yr 1 moOct 2008 - Oct 2009 · 1 yr 1 moMarylandMaryland

      • • 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, LLCAs 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

    • consultantconsultant

      PATHPATH2008 - 2009 · 1 yr 1 mo2008 - 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, LLCConsulting 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 TherapeuticsSenior Director, Vaccines and Therapeutics

      EpiVaxEpiVaxDec 2007 - Oct 2008 · 11 mosDec 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.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, InfluenzaDirector, Clinical Development/Medical Affairs, Influenza

      Solvay Pharmaceuticals, Inc.Solvay Pharmaceuticals, Inc.Nov 2006 - Dec 2007 · 1 yr 2 mosNov 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.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 DirectorSenior Medical Director

      Summit Drug Development ServicesSummit Drug Development ServicesOct 2005 - Oct 2006 · 1 yr 1 moOct 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.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 ResearchAssociate Director, Clinical Research

      Dynport Vaccine Company, LLCDynport Vaccine Company, LLCOct 2002 - Oct 2003 · 1 yr 1 moOct 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 opportunitiesDynport 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 BankingChief of Laboratory Science and Director of Tissue Banking

      USUHS Dept of Surgery, Clinical Breast Care Program (CBCP)USUHS Dept of Surgery, Clinical Breast Care Program (CBCP)Sep 2000 - Sep 2001 · 1 yr 1 moSep 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.
          • 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 ProfessorAssistant Professor

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

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

    • Assistant Professor , PathologyAssistant Professor , Pathology

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

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

    • Research FellowResearch Fellow

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

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

    • ScientistScientist

      VicalVical1989 · Less than a year1989 · Less than a year

      • • Invented naked DNA and RNA delivery, DNA vaccine technologyInvented naked DNA and RNA delivery, DNA vaccine technology

    • Graduate StudentGraduate Student

      Salk InstituteSalk Institute1986 - 1989 · 3 yrs 1 mo1986 - 1989 · 3 yrs 1 mo

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

    • Foreman, Shingling crewForeman, Shingling crew

      Michael Charmichael ConstructionMichael Charmichael ConstructionOct 1978 - Jan 1980 · 1 yr 4 mosOct 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