Robert Malone, MD, MS

Current

• Editor in Chief at Journal of Immune Based Therapies and Vaccines
• Consultant at Chesapeake PERL
• Consultant, Vaccines and Biologics at RWMaloneMD.com (Self-employed)

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Past

• Medical Director, Vaccines at Accelovance
• consultant at PATH
• Senior Director, Vaccines and Therapeutics at EpiVax

• Director, Clinical Development/Medical Affairs, Influenza at Solvay Pharmaceuticals, Inc.
• Senior Medical Director at Summit Drug Development Services
• President and founder. at Gene Delivery Alliance, Inc.
• Associate Director, Clinical Research at Dynport Vaccine Company, LLC
• Assistant Professor at University of Maryland, Baltimore School of Medicine, Dept. of
• Assistant Professor , Pathology at University of California, Davis Department of Medical Pathology,
• Research Fellow at UC Davis Medical Center
• Scientist at Vical
• Graduate Student at Salk Institute
• Foreman, Shingling crew at Michael Charmichael Construction

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10 more...

Education

• University of California, Davis - School of Medicine
• Northwestern University - The Feinberg School of Medicine
• University of California, San Diego

• University of California, Davis

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1 more...

Recommended

12 people have recommended Robert

Connections

447 connections

Industry

Biotechnology

Websites

• My Company
• My Website

Robert Malone, MD, MS’s Summary

"From Bench to Bedside"

Dr. Malone has extensive research and development experience in the areas of clinical trials, vaccines, gene therapy, biodefense, and immunology. He has over twenty years of management and leadership experience in academia, pharmaceuticals and biotechnology. His NGO, HHS, NIH, and DoD contract and grant knowledge is extensive, and he has helped many groups and companies to capture and manage multi-million dollar awards with these sponsors..

Dr. Malone is an internationally recognized scientist and is known as one of the original inventors of “DNA Vaccination.”. He holds numerous fundamental domestic and foreign patents in the fields of gene delivery, delivery formulations, and vaccines, has over fifty publications, has served as an invited speaker at over thirty conferences, has chaired numerous conferences and he has sat on numerous US Federal study sections.

Robert Malone, MD, MS’s Specialties:

Specializing in:
Biotechnology
Vaccines
Cell and Gene Therapy
Regulatory Submissions
Clinical Development
Project Planning
Proposal Development and Management (including federal grants and contracts)
Medical and Technical Writing
Due Diligence

Robert Malone, MD, MS’s Experience

• Editor in Chief

  Journal of Immune Based Therapies and Vaccines

  (Biotechnology industry)

  February 2009 — Present (10 months)

  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.

• Consultant

  Chesapeake PERL

  (Biotechnology industry)

  2008 — Present (1 year )

• Consultant, Vaccines and Biologics

  RWMaloneMD.com (Self-employed)

  (Self-Employed; Myself Only; Biotechnology industry)

  October 2007 — Present (2 years 2 months)

  Specializing in vaccines, biotechnology, cell and gene therapy, clinical development, proposal management (federal and philanthropic), medical and technical writing, due diligence, regulatory submissions, project planning.. Service on federal biotechnology/vaccines proposal study sections.

• Medical Director, Vaccines

  Accelovance

  (Privately Held; Biotechnology industry)

  October 2008 — October 2009 (1 year 1 month)

  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.

• consultant

  PATH

  (Biotechnology industry)

  2008 — 2009 (1 year )

• Senior Director, Vaccines and Therapeutics

  EpiVax

  (Biotechnology industry)

  December 2007 — October 2008 (11 months)

  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.

  (Public Company; 1001-5000 employees; Pharmaceuticals industry)

  November 2006 — December 2007 (1 year 2 months)

  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 Services

  (Privately Held; 1-10 employees; Pharmaceuticals industry)

  October 2005 — October 2006 (1 year 1 month)

  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.

• President and founder.

  Gene Delivery Alliance, Inc.

  (Privately Held; 1-10 employees; Biotechnology industry)

  April 2001 — October 2005 (4 years 7 months)

  Consulting, research, development and intellectual property licensing firm.
  • Proposal development, product development planning, clinical development planning (patch-based vaccine delivery)
  • Consulting services for various undisclosed Biotechnology investment firms, 2005 (technical diligence, vaccine development companies)
  • Consulting services for Aeras Global TB Vaccine Foundation, 2004-2005 including service as Director, Business Development and Program Management
  • Consulting services for VaxGen Corporation, 2003-2005
  • Consulting services for EpiVax, 2005 (member, Scientific Advisory Board)
  • Consulting services for Aldevron, LLC.
  
  • Consulting services for Inovio, AS. Business and technology development planning. Intellectual property development
  • Intellectual property development and research at the University of Bern, Switzerland.
  • Consulting services for Molecular Histology, Inc. Title: Medical Director

• Associate Director, Clinical Research

  Dynport Vaccine Company, LLC

  (Public Company; 51-200 employees; Biotechnology industry)

  October 2002 — October 2003 (1 year 1 month)

  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

• Assistant Professor

  University of Maryland, Baltimore School of Medicine, Dept. of

  (Educational Institution; 1001-5000 employees; Biotechnology industry)

  January 1997 — August 2000 (3 years 8 months)

  • Successful grant writing, IACUC protocol writing, budget writing and implementation
  • Set-up and ran successful research laboratory in immunology (genetic vaccination), gene transfer (pulmonary, dermal, heart, liver). See papers/abstract/presentations for more detail.
  • Laboratory set-up and employee hiring/training
  • Training of Graduate students, on selection committee for pathology graduate students
  • Teaching responsibilities (see below).
  • Set-up good laboratory safety practices.
  • Member, Oncology Program, University of Maryland Greenebaum Cancer Center
  • Member, Molecular and Cell Biology Graduate Division, University of Maryland, Baltimore
  • Member, Comparative Medicine Program, University of Maryland, Baltimore

• Assistant Professor , Pathology

  University of California, Davis Department of Medical Pathology,

  (Biotechnology industry)

  October 1993 — January 1997 (3 years 4 months)

  • Director and Founder, Gene Therapy Prog (October 1993 to January 1997).
  • Successful grant writing, IACUC protocol writing, budget writing and implementation
  • Wrote a DOD genetic vaccination contract that totaled over 2 million in monies for UC Davis
  • Set-up and ran successful research laboratory in immunology (genetic vaccination), gene transfer (pulmonary, dermal, heart, liver). See papers/abstract/presentations for more details..
  • Laboratory set-up and employee hiring/training
  • Training of Graduate students
  • Teaching responsibilities (see below).
  • Set-up good laboratory safety practices.
  • Member, Biochemistry and Molecular Biology Graduate Group
  • Collaborative Investigator, California Regional Primate Research Unit.

• Research Fellow

  UC Davis Medical Center

  (Educational Institution; 10,001 or more employees; Hospital & Health Care industry)

  July 1992 — September 1993 (1 year 3 months)

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

• Scientist

  Vical

  (Public Company; 51-200 employees; Biotechnology industry)

  1989 — 1989 (less than a year)

• Graduate Student

  Salk Institute

  (Biotechnology industry)

  1986 — 1989 (3 years )

• Foreman, Shingling crew

  Michael Charmichael Construction

  (Construction industry)

  October 1978 — January 1980 (1 year 4 months)

  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, MD, MS’s Education

• University of California, Davis - School of Medicine

  Medical Internship , Pathology , 1991 — 1992

• Northwestern University - The Feinberg School of Medicine

  1984 — 1991

• University of California, San Diego

  M.S. , Biology , 1986 — 1988

  Activities and Societies:

  • USPHS Pre-Doctoral Fellowship (1986-1988)
  • San Diego Supercomputer Grant for RNA structure modeling (1988)
  Graduate training performed in the Molecular Biology and Virology Laboratories of the Salk Institute under Dr. Inder Verma, focus on gene delivery (retroviral and non-viral), RNA stability and expression.

• University of California, Davis

  B.S , Biochemistry , 1982 — 1984

  Activities and Societies:

  • Dean's List, UC. Davis (1982-1984)
  • President's Undergraduate Fellowship Grant for investigation of oncogene expression in breast tumor tissue. UC. Davis (9/83-6/84)
  • Edmonson Summer Fellowship, Department of Pathology, UC. Davis Medical School (1984)

Additional Information

Robert Malone, MD, MS’s Websites:

• My Company
• My Website

Robert Malone, MD, MS’s Interests:

Vaccine development, Biotechnology, Clinical Development, Polynucleotide delivery, Gene therapy, DNA vaccines, Electroporative delivery, Federal Grants and Contracts, Proposal Development, Regulatory Affairs

Robert Malone, MD, MS’s Groups:

•    On Startups - The Community For Entrepreneurs
•    Pharmaceutical Discussion Group
•    Biotech & Pharma Professionals Network
•    Professionals in Pharmaceutical Industry and Biotech Industry
•    Life Sciences Outsourcing
•    Scicasts B-to-B Science & Technology Network
•    BioTech Regulatory & Quality Professionals Network
•    Pharmaceutical & Biotech Licensing & Business Network
•    FEDERAL BIZ Network - Government Stimulus Teaming Jobs PMI Consulting Funding Sales Opportunities
•    Global Medical Research.org
•    Biotech Cluster Worldwide
•    Horse lovers of the Business world
•    Medical Writing and Affairs Association
•    Clinical Trials Congress
•    GAVI
•    Recombinant-Protein Production/Purification Professionals Network (R4PN)
•    Vaccine Knowledge Network
•    Global Security Challenge (GSC) - Innovation in Security
•    Vaccine Professionals Group
•    THE NANOMATERIALS SOCIETY
•    Global Academic Innovation Network (GAIN)
•    The Global Fund to Fight AIDS, Tuberculosis and Malaria
•    H1N1 Alliance™
•    Deal Flow Source
•    University of Maryland Alumni - Metro Atlanta Area
•    TreMonti Licensing Showcase
•    LHH Atlanta
•    Deal Flow Source: Biotech, Pharma & Healthcare
•    Insect cells
•    The Global Diversity Leaders

Robert Malone, MD, MS’s Honors:

• Listed in Who’s Who in America, 2004, 2005
• Trainee Investigator Award, American Federation for Clinical Research (4/93)
• Bank of America-Giannini Foundation Medical Research. Fellow (6/92 to 6/93)
• Henry Christian Award for Excellence in Research, American Federation for Clinical Res. (5/92)
• UCDMC Medical Scholars Grant (7/92 to 7/93)
• First Place, Northwestern AOA Research Symposium competition for Medical Students (1989)
• USPHS Pre-Doctoral Fellowship (1986-1988)
• San Diego Supercomputer Grant for RNA structure modeling (1988)
• Northwestern University MD../Ph.D. Scholarship (1984-1986)
• Dean's List, UC. Davis (1982-1984)
• President's Undergraduate Fellowship Grant for investigation of oncogene expression in breast tumor tissue. UC. Davis (9/83-6/84)
• Edmonson Summer Fellowship, Department of Pathology, UC. Davis Medical School (1984)

Robert Malone, MD, MS’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• new ventures
• expertise requests
• business deals
• reference requests
• getting back in touch