education



	RW Malone, MD, LLC Robert W. Malone, MD, MS Physician Scientist -Licensed in Maryland
					"From Bench to Bedside" Premier Consulting Services

	Your World is Our World

CURRICULUM VITAE

Robert Wallace Malone, MD, MS

MEDICAL LICENSURE: Physician and Surgeon, State of Maryland

EDUCATION:

Education funded via scholarships, self (part-time work, loans)

Post graduate Fellowship award Bank of America-Giannini Found. Medical Research. (6/92 to 6/93)

University of California, Davis, Medical Center. Clinical Pathology Internship. June 1992

Northwestern University Medical School. Doctor of Medicine. June 1991

University of California, San Diego. Master of Science, Biology. December 1988

University of California, Davis. Bachelor of Science, Biochemistry. June 1984

Santa Barbara City College. Santa Barbara, California. Associate of Arts, General Studies/computer sciences. June 1982 Active in student government, held positions as Senator, Vice President, President of the Associated Students.

EMPLOYMENT:

President and Consultant

RW Malone, MD, LLC, Jasper, GA

2007 - present

Providing consulting services with specialization in vaccines, biotechnology, cell and gene therapy, clinical development, proposal management (federal and philanthropic), medical and technical writing, due diligence, regulatory submissions, project planning and business development. Service on federal biotechnology/vaccines proposal study sections. List of current and past clients available upon request.

Editor-In-Chief

Journal of Immune Based Therpapies and Vaccines

2009 - present

Journal of Immune Based Therapies and Vaccines (JIBTV) is an open access, peer-reviewed, online journal dedicated to all aspects of therapeutic and prophylactic applications of immunology. See http://www.jibtherapies.com

Director, Clinical Development/Medical Affairs, Influenza

Solvay Pharmaceuticals, Inc.

Marietta, GA 30062

11/2006 to 12/2007

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

Rockville, MD 20850

10/2005 to 10/2006

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.

Jefferson, MD 21755

4/2001-10/2005

Consulting, research, development and intellectual property licensing firm.

Consulting services for Iomai Corporation, 2005

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

Proposal development (patch-based vaccine delivery, Tularemia vaccine, CDC contract for clinical trials site development, international government and NGO contract and grant solicitations)

Consulting services for VaxGen Corporation, 2003-2005

Proposal development (plague vaccine- HHS), Technical diligence

Consulting services for EpiVax, 2005 (member, Scientific Advisory Board)

Consulting services for Aldevron, LLC.

Consulting services for MSD, Inc., Business and technology development planning. Activities at MSD inc. included:

1. business and proposal development in the areas of Bioinformatics and Life Sciences (including telemedicine)

2. serving as principal investigator for a NIEHS Toxicogenomics proposal,

3. serving as principal investigator for a NIAID BioInformatics Support Contract proposal

4. serving as principal investigator for a NLM BAA response focused on telemedicine technology development, implementation and testing (collaborative software based).

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

Director, Business Development and Program Management

Aeras Global TB Vaccine Foundation

7500 Old Georgetown Road, Suite 800

Bethesda, MD 20814

8/2004 - 5/2005

Aeras is a non-profit medical research foundation primarily funded by the Bill and Melinda Gates Foundation, and primarily focused on tuberculosis vaccine development and clinical research.

Associate Director, Clinical Research

Dynport Vaccine Company, LLC

10/2002-10/2003

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

o 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

Co-founder, CSO, Board of Director Member

Intradigm, Corp. 1999 (incorp date: 2/2000) to 2001.

Intradigm is a small biotech start up focused on target validation using non-viral gene delivery technology. The core scientific concepts were initially developed in Dr. Malone's laboratory, both independently and in collaboration with Regeneron, Inc.

One of three co-founders

Helped to secure 2.3 million in V.C. funding, including monies from the Novartis Venture Fund, ETP Venture Capital Fund and the State of Maryland.

Facilities set-up, infrastructure set-up

Business and technology development planning, including in-depth business and Scientific plan.

Intellectual Property Development

Chief of Laboratory Science, and Director of Tissue Banking

Dept of Surgery, USUHS, Clinical Breast Care Program (CBCP) through the Henry M. Jackson Foundation (Aug. 2000 to April 2001)

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 equipment and laboratory purchases, including vendor price quotes, equipment specs.

Wrote initial budgets and supervised equipment purchases.

Wrote animal protocols and grants.

Assistant Professor

University of Maryland, Baltimore School of Medicine, Dept. of Pathology (Jan 1997-Aug 2000)

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

University of California, Davis Department of Medical Pathology,

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

Medical Pathology, UC Davis Medical Center. (July 1992 to September 1993)

Succesful grant writing

Research in genetic (DNA) vaccination and gene transfer. See below for more detail.

laboratory set-up

Pathology Resident

Medical Pathology, UC Davis Medical Center. (July 1991 to July 1992)

Successfully completed Internship in pathology

Research Scientist

Vical Inc. (January 1989 to September 1989)

Set up Vical's molecular biology laboratory

Initiated and carried out esearch in non-viral gene therapy and DNA vaccination

Inventor of “naked DNA” gene therapy. See issued patents for details.

Inventor of DNA vaccination. See issued patents for details.

ACADEMIC HONORS:

Listed in Who's Who in America, 2004, 2005, 2006

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)

Outstanding Student at Graduation, SBCC (1982)

Outstanding Computer Science Student, SBCC (1982)

First Place (Business Division), statewide competition, Bank of America California Community College Awards Program (1982)

Service to the College Award, SBCC (1981 and 1982)

MEMBERSHIPS (current and historic):

Gene Therapy/Molecular Biology International Society

Member, New York Academy of Sciences

Member, Bioelectrochemical Society

Member, European Gene Therapy Society

Member, AAAS

TEACHING EXPERIENCE:

University of Maryland, Medical School

Course Director, Fundamentals of Molecular Biology (Graduate Course, Winter 2000)

Host defenses and Infectious Diseases, small group instructor (Year 2 Medical School core curriculum, 1998, 1999)

University of California, Davis.

MD 410A/410B. General Systemic Pathology (1992, 1993, 1994, 1995, 1996).

PTX 202. Principles of Pharmacology and Toxicology-Lecturer (1995, 1996).

BCM 214-414. Molecular Medicine-Lecturer (1995, 1996).

IM 295 Cytokines-Lecturer (1996).

IDI 280. Molecular Basis of Disease-Lecturer (1996).

University of California, San Diego.

Biology 111. Cell Biology (Fall 1988). Teaching Assistant under Dr. M. Montal.

Biology 123. Embryology laboratory (Spring 1988). Teaching Assistant under Dr. C.Holt

Santa Barbara City College

Computer Laboratory (Spring 1981). Teaching Assistant

OFFICES HELD:

EEE Genomics and Bioinformatics Working Group, Participant (2002)

Co-chair, Northern Virginia Technology Council BioMedTech committee (2002- 2003)

Scientific Advisory Board:

(Intradigm, Corp.-a new start-up from Novartis, Inc.) 2000-2001

Scientific Advisory Board and External Portfolio Reviewer:

Novartis, Inc. (GTI/Systemix & Pharmacogenetics), 1999-2001

University of Maryland , Medical School

Pathology Education Policy Committee (1999-2000)

UC Davis

Education Policy Committee (1996-1/97) Graduate Group in Comparative Pathology.

Member, Biochemistry and Molecular Biology Graduate Group (1993-1/97)

Member, Comparative Pathology Graduate Group (1995-1/97)

Boehringer Mannheim

Scientific Advisory Board (1992-93)

Santa Barbara City College:

Associated Student Body, President (1981-1982)

Associated Student Body, Vice President (Spring 1981)

Computer Science Club, Co-Founder and Vice President (1981-1982)

EDITORIAL BOARDS:

Gene Therapy/Molecular Biology International Society (1997-present).

CONSULTANT FOR:

Iomai Corporation, 2005

Farralon Investments, 2005

Aeras Global TB Vaccine Foundation, 2004

VaxGen Corporation, 2003-2005

Gene Therapy Systems, 2005-2006

ID BioMed, 2004

EpiVax, 2005 to present (member, Scientific Advisory Board)

MSD, Inc. Senior Consultant 2002

Inovio, Inc. 2001

Windber Medical and Research Institute, 2000-2001

MDS Capital 2000

Inex Corp. Evaluation of business plan and scientific reviewer. 2000

Gene Therapy Incorporated/Novartis. Consultant and member, Scientific Advisory Board, 1999 - 2001

REVIEWER FOR:

Editor-in-Chief, Journal of Immune Based Therapies and Vaccines (JIBTV) (2009-present)

Nucleic Acids Research (2001-2002)

Molecular Therapy (1999-2001)

Journal of Molecular Medicine (2000)

Human Gene Therapy (1995-present)

Gene Therapy Journal (1997-present).

NIH Study Section K01 Breast Cancer Study Section (July 1997).

NIDDK Special Emphasis Panel Review Committee for competing continuation Program Project (April 1998 and April 1999)

NIAID Study Section “Innovative Grant Program for Approaches in HIV Vaccine Research” June 15-16, 1998

SPECIALITY POST GRADUATE COURSEWORK:

Walter Reed healthcare System, Department of Clinical Investigation 2000 Research Course. Certificate of completion

USUHS Rodent Handling and Techniques Laboratory. Nov 2000. Testing required and passed.

USUHS Animal Protocol Writing Workshop. Oct 2000. Certificate of completion.

CIPP 909 Research Ethics, University of Maryland, Baltimore Spring 1999

Primate handling course: testing required and passed University of Maryland, Baltimore 1999.

Biohazardous training course: testing required and passed University of Maryland, Baltimore 1999.

Chemical training course: testing required and passed University of Maryland, Baltimore 1999.

Radiation Training. Course: testing required and passed University of Maryland, Baltimore 1999.

Computer Programming in C, Anne Arundel Community College, Spring 1999

Annual Course in Flow Cytometry, Bowdoin College. June 6-13, 1998

“The Magic of Conflict” conflict management workshop, Office of Human Resource Services, University of Maryland, Baltimore. Spring 1998

Laboratory animal handling course University of California, Davis, 1994-1997

Biohazardous training courses, University of California, Davis, 1994-1997

Chemical training courses, University of California, Davis, 1994-1997

Radiation Training. Courses-University of California, Davis, 1994-1997

PATENTS ISSUED:

1. Lipid-mediated polynucleotide administration to deliver a biologically active peptide and to induce a cellular immune response. Felgner P, Wolff J, Rhodes GH, Malone RW, Carson D. US Pat. Ser. No. 7,250,404. issued 7/31/07

2. Lipid-mediated polynucleotide administration to reduce likelihood of subject's becoming infected. Felgner P, Wolff J, Rhodes GH, Malone RW, Carson D. US Pat. Ser. No. 6,867,195. issued 3/15/05

3. Generation of an immune response to a pathogen. Felgner P, Wolff J, Rhodes GH, Malone RW, Carson D. US Pat. Ser. No. 6,710,035. issued 3/23/04

4. Expression of exogenous polynucleotide sequences in a vertebrate, mammal, fish, bird or human Felgner P, Wolff J, Rhodes GH, Malone RW, Carson D. US Pat. Ser. No. 6,673,776. issued 1/6/04

5. Methods of delivering a physiologically active polypeptide to a mammal. Felgner P, Wolff J, Rhodes GH, Malone RW, Carson D. US Pat. Ser. No. 6.413.942 issued 7/2/02

6. Induction of a protective immune response in a mammal by injecting a DNA sequence. Felgner P, Wolff J, Rhodes GH, Malone RW, Carson, DA. US Pat. Ser. No. 6,214,804 issued 4/10/01.

7. DNA vaccines for eliciting a mucosal immune response. Malone, RW. and Malone, JG US Pat. Ser. No. 6,110,898 issued 8/29/00.

8. Formulations and methods for generating active cytofectin: polynucleotide transfection complexes Nantz M, Bennett M, Balasubramaniam RP, Aberle AM, Malone RW. US Pat. Ser. No. 5,925,623 7/20/99

9. Cationic Transport Reagents. Bennett M, Nantz M, and Malone RW. US Pat. Ser. No. 5,892,071 issued 4/06/99

10. Polyfunctional cationic cytofectins, formulations and methods for generating active cytofectin: polynucleotide transfection complexes. Nantz M, Bennett M, Balasubramaniam RP, Aberle AM, Malone RW. US Pat. Ser. No. 5,824,812 issued 10/20/98

11. Cationic Transport Reagents. Bennett M, Nantz M, and Malone RW. US Pat. Ser. No. 5,744,625 issued 4/28/98

12. Generation of antibodies through lipid mediated DNA delivery. Felgner P, Wolff J, Rhodes GH, Malone RW, Carson, DA. US Pat. Ser. No. 5,703,055. issued 12/30/97.

13. Induction of a protective immune response in a mammal by injecting a DNA sequence. Felgner P, Wolff J, Rhodes GH, Malone RW, Carson, DA. US Pat. Ser. No. 5,589,466. issued 12/31/96.

14. Delivery of exogenous DNA sequences in a mammal . Felgner P, Wolff J, Rhodes GH, Malone RW, Carson, DA. US Pat. Ser. No. 5,580,859. issued 12/3/96.

15. Cationic Transport Reagents. Bennett M, Nantz M, and Malone RW. US Pat. Ser. No. 5,527,928. issued 6/18/96

PATENTS SUBMITTED:

DNA vaccines for eliciting a mucosal immune response. Malone, J and Malone, RW. Continuation with amended claims of US Pat. Ser. No. 6,110,898 issued 8/29/00.

Method for gene transfection and vaccination through skin using electropermeabilization. Glasspool-Malone J, Drabick, J. and Malone RW Full application filed with US PTO on 3/16/01.

Synergism Between Lipidic and Electroporation-Mediated Polynucleotide Delivery. Malone, RW and King, AD. Full Patent filed Sept. 24, 2000

Electroporative Delivery of Molecules to Organs. Malone RW, Schmid R, Kubisa B, Uduehi A, Ayuni E, Drabick JJ, Glasspool-Malone J. Provisional patent filed (048227-0109) 8/7/2001.

PUBLICATIONS:

1 Byrnes CK, Malone RW, Akhter N, Nass PH, Wetterwald A, Cecchini MG, Duncan MD, Harmon JW. Electroporation enhances transfection efficiency in murine cutaneous wounds. Wound Repair Regen. 2004 Jul-Aug;12(4):397-403.

2 Glasspool-Malone J, Steenland PR, McDonald RJ, Sanchez RA, Watts TL, Zabner J, Malone RW. DNA transfection of macaque and murine respiratory tissue is greatly enhanced by use of a nuclease inhibitor. J Gene Med. 2002 May-Jun;4(3):323-2.

3 Glasspool-Malone J. and Malone RW. Enhancing direct in vivo transfection with nuclease inhibitors and pulsed electrical fields. Methods in Enzymology-Gene Therapy Methods 2002;346:72-91. PMID: 11883098

4 Glasspool-Malone J, Peter Steenland, Ruth McDonald, Rigoberto Sanchez, Tamara Watts, Joseph Zabner and Malone RW, Marked enhancement of macaque respiratory tissue transfection by aurintricarboxylic acid. J Gene Med. 2002 May-Jun;4(3):323-2.

5 Drabick, J.J., Glasspool-Malone J., Somiari S., King A., Malone RW. Increased efficiency of cutaneous transfection and polynucleotide immunization using in-vivo electroporation. Mol Ther 2001 Feb, 3(2). 249 - 255.

6 Somiari S, Glasspool-Malone J, Drabick JJ, Gilbert RA, Heller R, Jaroszeski MJ, Malone RW. Theory and in vivo application of electroporative gene delivery. Mol Ther. 2000 Sep;2(3):178-87.

7 Glasspool-Malone J, Somiari S, Drabick JJ, Malone RW. Efficient nonviral cutaneous transfection. Mol Ther. 2000 Aug;2(2):140-6.

8 Colosimo A, Goncz KK, Holmes AR, Kunzelmann K, Novelli G, Malone RW, Bennett MJ, Gruenert DC. Transfer and expression of foreign genes in mammalian cells. Biotechniques. 2000 Aug;29(2):314-8, 320-2, 324 passim.

9 Ahearn A, Malone RW. Models of Cationic Liposome Mediated Transfection. Gene Therapy and Molecular Biology (Dec., 1999) Vol 4

10 Kisich KO, Malone RW, Feldstein PA, Erickson, KL. Specific inhibition of macrophage TNF-alpha expression by In vivo ribozyme treatment. Journal of Immunology (1999)163(4):2008-16

11 Glasspool-Malone J, Malone RW, “Marked Enhancement of Direct Respiratory Tissue Transfection by Aurintricarboxylic Acid”. Human Gene Therapy (1999) 10:1703-1713.

12 Berlyn KA, Ponniah S, Stass SA, Malone JG, Hamlin-Green G, Lim JK, Fox M, Tricot G, Alexander RB, Mann DL, and Malone RW. Developing Dendritic Cell Polynucleotide Vaccination for Prostate Cancer Immunotherapy. J. of Biotechnology (1999) 73:155-179.

13 Bennett MJ, Aberle AM, Balasubramaniam RP, Malone JG, Malone RW, Nantz MH. Cationic lipid mediated gene delivery to murine lung: correlation of polar domain structure with in vivo transfection activity. J. Med. Chem. (1997) 40(25), 4069-4078.

14 Malone JG, Bergland P, Liljestrom P, Rhodes, GH, Malone RW. Mucosal immune responses associated with polynucleotide vaccination. Behring Inst. Mitt. (1997) 98, 63-72.

15 Freedland SJ, Malone RW, Borchers HM, Zadourian Z, Malone JG, Bennett MJ, Nantz MH, Juan-Hua L, Gummerlock PH, Erickson KL. Toxicity of cationic lipid-ribozyme in human prostate tumor cells can mimic ribozyme activity. Biochem. and Molecular Medicine. (1996) 59,144-153.

16 Bennett MJ, Aberle AM, Balasubramaniam RP, Malone JG, Nantz MH, Malone RW. Considerations for the design of improved cationic amphiphile-based transfection reagents. Journal of Liposome Research (1996) 6(3), 545-565.

17 Aberle AM, Bennett MJ, Malone RW, Nantz MH. The counterion influence on cationic lipid-mediated transfection of plasmid DNA. Biochemica et Biophysica Acta (1996) 1299(3), 281-283.

18 Balasubramaniam RP, Bennett MJ, Aberle AM, Malone JG, Nantz MH, Malone RW. Structural and functional analysis of cationic transfection lipids: the hydrophobic domain. Gene Therapy (1996) 3(2)163-172.

19 Montbriand P and Malone RW. An Improved method for the removal of endotoxin from DNA. J Biotechnol. 1996 Jan 26;44(1-3):43-6.

20 Hickmann MA, Malone RW, Sih TR, Akita GY, Powell JS. Hepatic gene expression after direct DNA injection. Advanced Drug Delivery Reviews (1995) 17(3), 265-271.

21 Schenborn E, Oler J, Goiffon V, Balasubraniam R, Bennett M, Aberle A, Nantz M, Malone RW.

22 Tfx-50 Reagent, a new transfection reagent for eukaryotic cells. Promega Notes (1995) 52, 2-7.

23 Bennett MJ, Nantz MH, Balasubraniam RP, Gruenert D, Malone RW. Cholesterol enhances cationic liposome-mediated DNA transfection of human respiratory epithelial cells. Bios Reports (1995) 15, 47-53.

24 Bennett MJ, Nantz MH, Malone RW. A flexible approach to synthetic lipid ammonium salts for polynucleotide transfection. Tetrahedron Letters (1995) 36(13), 2207-2210.

25 Malone RW, Hickmann MA, Lehmann-Gruinsma K, Sih TR, Walzem R, Carlson D, Powell JS. Dexamethasone enhancement of gene expression after direct hepatic DNA injection. Journal of Biological Chemistry (1994) 269(47), 29903-29907.

26 Hickmann MA, Malone RW, Lehmann K, Sih TR, Knoell D, Szoka FC, Walzem R, Carlson DM, Powell JS. Gene expression following direct injection of DNA into liver. Human Gene Therapy (1994) 5, 1477-1483.

27 Dwarki VJ, Malone RW, Verma IM. Cationic liposome mediated RNA transfection. Methods in Enzymology (1993) 217, 644-654.

28 Wolff J, Malone RW, Williams P, Chong W, Acsadi G, Jani A, Felgner P. Direct gene transfer into mouse muscle in vivo. Science (1990) 247, 1465-1468.

29 Malone RW. mRNA Transfection of cultured eukaryotic cells and embryos using cationic liposomes. Focus (1989) 11, 61-66.

30 Malone RW, Felgner P, Verma I. Cationic Liposome Mediated RNA Transfection. Proceedings of the National Academy of Science USA 86(16), 6077-6081.

31 Gardner MB, Malone RW, Morris D, Young L, Strange R, Cardiff R, Faulkin L, Mitchell D. Mammary tumors in feral mice lacking MuMTV DNA. Journal of Experimental Pathology 2(2), 93-98.

32 Faulkin L, Mitchell D, Young L, Morris D, Malone R, Cardiff R, Gardner M. Hyperplastic and neoplastic changes in the mammary glands of feral mice free of endogenous mouse mammary tumor virus provirus. Journal of the National Cancer Institute (1984) 73(4), 971-982.

PUBLISHED ABSTRACTS: Over 30 published abstracts -Full resume upon request.

BOOK CHAPTERS:

33 Malone RW. "Present and Future Status of Gene Therapy.' Intro Chapter in Advanced Gene Delivery: From Concepts to Pharmaceutical Products. Editor: Allain Rolland. Harwood Academic Publishers (in press 12/98).

34 Malone RW. Toxicology of non-viral gene transfer. Editor, Walsh B. In: Non Viral Therapeutics: Advances, Challenges and Applications for Self-Assembling Systems. Boston: IBC's Biomedical Library Series. (1996) 4.1.1

CHAIRPERSON/ORAL PRESENTATIONS BY INVITATION:

1 Practical application of informatics technology in biomedical research. Malone RW at The BIO IT Coalition First Annual Conference. Titled: The Convergence of Bioscience and Information Technology: from Lab Bench to Marketplace. June 2002. (oral presentator/co-organizer).

2 Safe and efficient gene transfer using pulsed and electrical fields. Malone RW. The Mayo Clinic, The Molecular Medicine Program Seminar Series. May 16th 2002

3 Direct gene delivery: from serendipity to pulsed electric fields. Malone RW, American Society for Gene Therapy, 4th annual meeting. Seattle, WA. May 30-June 3, 2001. (oral presentation).

4 New Technologies and Emerging Opportunities in Gene Delivery and Functional Genomics. Malone RW, NIH, Bethesda, MD Nov 16-18, 2000. (oral presentation).

5 DNA electrotransfer into tissue: theory and applications. Malone RW, Gordon Conference on BIOELECTROCHEMISTRY MD at Queen's College Oxford, UK September 3-8, 2000. (oral presentation/section organizer).

6 In-vivo electroporation: Advances in Gene Delivery and genetic Vaccination. Malone RW Co-chairman and co-organizer of the International Gene Therapy Conference. Rhodes, Greece, August 24-31, 2000. (oral presentation/section organizer)

7 In-vivo electropermeabilization of murine and porcine skin enhances transfection efficiency and immunologic responses. Malone RW, American Society for Gene Therapy. Denver, CO. June 1-6, 2000. (oral presentation).

8 Increased Efficiency of Cutaneous Transfection Using In Vivo Electroporation in Murine and Porcine Models. Malone RW. Cutaneous Gene Therapy: Problems and Prospects. NIH, Bethesda, MD March 23-24, 2000. (oral presentation).

9 Pharmaceutical gene delivery: Past lessons predict clinical opportunities for Electroporation. Robert W. Malone, The Bioelectrochemical Society's XVth Symposium on Bioelectrochemistry and Bioenergetics. Strasburg, France. Sept. 25-27, 1999. (oral presentation).

10 “Aurintricarboxylic Acid (ATA) Strongly Enhances Direct Plasmid Transfection of Respiratory Tissues.” Malone RW, Conference on Gene Therapy. Redwood City, CA, April 14-21, 1999. (oral presentation).

11 Chairman and speaker at the Gene Therapy/Molecular Biology International Society Conference. “Aurintricarboxylic Acid (ATA) Strongly Enhances Direct Plasmid Transfection of Respiratory Tissues.” Malone RW, Conference on Gene Therapy. Crete, Greece, August 7-14, 1999. (chairperson/oral presentation).

12 “Polynucleotide Vaccines: From Direct Intramuscular DNA Injection to Dendritic Cells.” Malone RW. Delivery of Proteins, Peptides and Genes. ECPI (European Centre for Pharmaceutical Information). Forte Posthouse Bloomsbury, London, December, 9-10, 1997 (chairperson/oral presentation).

13 “Dendritic Cell Polynucleotide Vaccination.” Malone RW. New Approaches to Vaccine Development. NAVD 1997, Vienna, December 6-8, 1997 (chairperson/ oral presentation).

14 “Using Free Polynucleotides to Transfect Tissues and Express Proteins.” Malone RW. Developing Self-Assembling Systems. International Business Communications, Annapolis, MD June 23-44, 1997 (scientific advisor/chairperson/ oral presentation).

15 “Comparative Studies of Materials and Dosing on Toxicity for Gene Delivery.” Malone RW. ADDRESS: Cambridge Healthtech's Third Annual ARTIFICIAL SELF-ASSEMBLING SYSTEMS for GENE DELIVERY. San Diego, November 17-19, 1996. (scientific advisor/chairperson/ oral presentation).

16 “Alternative Systems for In Vivo Gene Delivery and Genetic Immunization.” Malone RW. ADDRESS:, Rhodes GH, Hecker, JG. Institute of Human Virology 1996 Annual Meeting. Baltimore. September 7-13, 1996 (oral presentation).

17 “Toxicology of Non-viral Gene Transfer.” Malone RW. Non-viral GENETIC THERAPEUTICS: Advances, Challenges and Applications for SELF-ASSEMBLING SYSTEMS. International Business Communications, Boston, MA June 6-7, 1996 (scientific advisor/chairperson/oral presentation).

18 “Mucosal Immune Responses Associated with Polynucleotide Vaccination.” Malone RW. New Approaches to Bacterial Vaccine Development. Munich Germany, June 1996. (oral presentation).

19 “Structural and Functional Analysis of Cationic Transfection Lipids.” Bennett MJ, Balasubramaniam RP, Aberle A, Crowe LM, Malone JG, Crowe JH, Nantz MH, Malone RW. Cambridge Healthtech Institutes Second Annual Artificial Self-Assembling Systems for Gene Transfer, Boston MA. September 28-29, 1995. (oral presentation).

20 “Genetic Immunization: Effects of Novel Priming and Boosting Strategies.” Malone RW. New Approaches to Vaccine Development, NAVD 95, Vienna, Austria. April 14, 1995 (oral presentation).

21 “Genetic Immunization: Effects of Novel Priming and Boosting Strategies.” Malone RW. Karolinska Institute, Stockholm, Sweden. April 18, 1995 (oral presentation).

22 “Direct in vivo Polynucleotide Transfer into Multiple Tissue Types.” Malone RW. Gene Therapy and Nucleic Acid Vaccine Strategies, Rockville, MD, February 16-17, 1995. (oral presentation).

23 “Inhibition of Prostate Tumor Cell Growth Using Ribozymes Directed Against Interleukin-6.” Freedland SJ, Zadourian Z, Li J-H, Borchers HM, Bennett MJ, Gumerlock PH, Larson T, Malone RW, Erickson KL. American Federation for Clinical Research, Monterey, CA, February 8-11, 1995. (oral presentation).

24 “A Model System to Assess Ribozyme Delivery to Target Cells.” Freedland SJ, Zadourian Z, Bennett MJ, Balasubramaniam RP, Erickson KL, Malone RW. American Federation for Clinical Research, Monterey, CA, February 8-11, 1995. (oral presentation).

25 “Development and Testing of Intramuscular and Mucosal Genetic Vaccines.” Bassler KD, Montbriand P, Torres JV, Malone JG, Luciw PA, Bennett M, Malone RW. American Federation for Clinical Research, Carmel, CA, February 8-11, 1995. (oral presentation).

26 “Ribozyme and mRNA Delivery Using Cationic Lipsomes.” Malone RW. Keystone Symposia on Molecular and Cellular Biology, Breckenridge, CO, January 15-21, 1995. (oral presentation).

27 “Genetic Immunization of Mucosal and Parenteral Tissues.” Malone RW. IBCs Second Annual International Conference on Mucosal Immunization, Genetic Approaches and Adjuvants, Rockville, MD, October 24-26, 1994. (oral presentation).

28 “Direct DNA Injection: A Method For in vivo Transfection Of Solid Tissues.” Malone RW, Hickmann MA, Powell JS. Invited lecture at the Second Annual Conference of the National Cooperative Drug Discovery Groups for the Treatment of HIV Infection (NCVDG-HIV), Developmental Therapeutics Branch, DAIDS, NIAID, NIH, Washington, DC, July 11-16, 1993. (oral presentation).

29 “Regulation of Tumor Necrosis Factor-a Gene Expression Following Transfection: A Genetically Engineered Model for the Treatment of Toxic Shock.” Erickson KL, Kisich KO, Malone RW, Feldstein PA, Powell JS. Keystone Symposium on Molecular and Cellular Biology, Genetically Targeted Research and Ther.: Antisense and Gene Therapy Conference, Keystone, CO, April 12-18, 1993. (oral presentation).

30 “Control of Macrophage TNF-a Gene Expression Following Intraperitoneal Ribozyme Transfection: A Genetic Therapy Model for the Investigation of Toxic Shock.” Kisich KO, Malone RW, Feldstein PA, Jessee J, Gebeyehu G, Powell JS, Erickson K. Cold Spring Harbor Laboratory Conference on Gene Therapy, Cold Spring Harbor, NY, September 22-26, 1992. (oral presentation).

31 “Messenger RNA as a Drug: A Novel Approach for Expressing Foreign Proteins in Cultured Cells and in vivo.” Malone RW. Northwestern University Medical School AOA Research Symposium, Chicago, IL, November 1989. (oral presentation).

32 “A Novel Approach to Study Packaging of Retroviral RNA by RNA Transfection.” Malone R, Felgner P, Verma I. In RNA Tumor Viruses. Cold Spring Harbor Press, Cold Spring Harbor, NY, 1988. (oral presentation).