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Phillip B. Maples, Ph.D.
Undergraduate 1974-1978 B.S. - University of Tulsa, Major - Microbiology
1978-1979 Attended College of Pharmacy of Oklahoma University Health Sciences Center
Graduate 1979-1983 M.S. - Oklahoma University Health Sciences Center, Major - Biochemistry & Molecular Biology
1979-1984 Ph.D. - Graduate College of Medicine of Oklahoma University Health Sciences Center with Dr. Robert H. Broyles, Major - Biochemistry & Molecular Biology
Dissertation Title: “In Vivo Regulation of Hemoglobin Phenotypes During the Development of the Bullfrog, Ranacatesbeiana”.
Workshop on Molecular Endocrinology and Hormone Action, 1981. Department of Cell
Applied Biosystems' Symposium on Automating Your Recombinant DNA Research,
February 23, 1987, Chicago, IL.
Nucleic Acid Probe Technology Workshops, American Society for Microbiology Annual
Meeting, February 28, 1987, Atlanta, GA.
New Molecular Approaches for Identifying and Diagnosing Human Genetic Disorders
and Pathogens, American Society for Microbiology Annual Meeting, February 28-29,
1987, Atlanta, GA.
Lake Tahoe Symposium: Advances in Recombinant DNA Technology, sponsored by
CATCMB, Catholic University of America, September 28-30, 1987, Incline Village, NV.
Oklahoma Biomedical Research Symposium, Sponsored by Presbyterian Health
Foundation, University of Oklahoma Health Sciences Center and Oklahoma Medical
Research Foundation, February 21-23, 1988, Oklahoma City, OK.
DNA Probes: Market Challenges and Opportunities, Communitech Market Intelligence,
October 25, 1988, San Diego, CA.
Practical Aspects of Molecular Probes, Third San Diego Conference of AACC, October
26-28, l988, San Diego, CA.
Biotech USA, Sponsored by Bio/Technology, November 14-16, 1988, San Francisco,
FDA/NIH Conference on Gene Therapy, July 11-12, 1996, Bethesda, MD.
FDA/NIH Conference on Gene Therapy, July 15-18, 1997, Bethesda, MD.
FAHCT Facility Inspection Training, June 3, 1998, Baltimore, MD.
Current Good Tissue Practice Workshop, International Society for Cellular Therapy, May 28-29, 2003, Phoenix, AZ.
1976-1978 Medical Technician, Bacteriology Section, Hillcrest Medical Center, Tulsa, OK. Processing of culture specimens, surveys of antibiotic resistance trends.
1978 Lab Assistant, General and Pathogenic Microbiology courses, Department of Biology, University of Tulsa, Tulsa, OK. Preparation of laboratories, teaching and grading.
1978 Lab Assistant, Biochemistry course, Department of Chemistry, University of Tulsa, Tulsa, OK. Redesign of an undergraduate laboratory course. Preparation of laboratories and teaching.
1978 Microbiologist, Sun Oil Company, Tulsa, OK. Analysis of waste water effluent into Arkansas river, consultant on microbial corrosion, redwood cooling tower destruction, and activated sludge digestion.
1978-1979 Research Technician, Robert H. Broyles, Department of Biochemistry and Molecular Biology, OU Health Sciences Center, Oklahoma City, OK. Maintenance of amphibian facilities, participation in research discussions and experimental planning, microdissection, culture media and reagent preparation, organ culture, polyacrylamide gel electrophoresis, and data analysis.
1979-1982 Graduate Research Assistant, Dr. Robert H. Broyles, Department of Biochemistry and Molecular Biology, OU Health Sciences Center, Oklahoma City, OK.
1982-1984 Graduate Teaching Assistant, Department of Biochemistry and Molecular Biology, OU Health Sciences Center, Oklahoma City, OK.
1984-1986 Research Associate, Dr. Eugene Goldwasser, Department of Biochemistry and Molecular Biology, University of Chicago, Chicago, IL.
1986 Research Scientist, Pharmacology, Corporate Research, Travenol Laboratories, Inc., Round Lake, IL.
1986-1987 Research Scientist, Biochemistry, Life Science Technology Center, Travenol Laboratories, Inc., Round Lake, IL.
1987-1988 Research Scientist, Biochemistry, Applied Cell Biology Center, Baxter Healthcare Corp., Round Lake, IL.
1988-1991 Research Scientist and Group Leader, Molecular Biology, Applied Cell Biology Center, Baxter Healthcare Corp., Round Lake, IL.
Senior Research Scientist and Group Leader, Molecular Biology, Applied Cell Biology Center, Baxter Healthcare Corp., Round Lake, IL.
1993-1994 Senior Research Scientist and Group Leader, Molecular Biology and Facility Quality Manager, Immunotherapy Division, Baxter Healthcare Corp., Round Lake, IL.
1994-1996 Associate Scientific Director, Engineered Cellular Therapies, and Facility Quality Manager, Research Group, Immunotherapy Division, Baxter Healthcare Corp., Round Lake, IL.
1996-1998 Associate Scientific Director, Engineered Cellular Therapies, Technical Affairs Group, Immunotherapy Division, Baxter Healthcare Corp., Round Lake, IL.
1998-2001 Scientific Director, Head of the Molecular/Cell Processing Center, US Oncology, Inc. (formerly Physician Reliance Network (PRN) Research, Inc.), Dallas, TX.
1998-2001 Scientific Director, Mary C. Crowley Medical Research Program Baylor Research Institute and the Mary Crowley Medical Research Center, U.S. Oncology, Inc., Dallas, TX.
2004-2005 Vice President, Clinical Development and Manufacturing and Corporate Officer, Chromos (CHR: TSE; post-merger), Seattle, WA.
2005-2013 Vice President, Technical Operations, Gradalis, Inc. (formerly Murex Pharmaceuticals), Dallas, TX.
2013-2014 Executive Vice President and Chief Technical Officer, Gradalis, Inc., Dallas, TX.
2005-present Consulting Scientist, Mary Crowley Cancer Research Centers, Dallas, TX.
2014-present Executive Director, Laurus Biotechnology, LLC, an independent bioconsulting firm and a founding member of the KLYO Collaborative
2016-present Acting Head of Quality Assurance (part-time), iBio CMO, LLC, in order to establish the Quality Functions of the organization, College Station, TX
CURRENT RESPONSIBILITIES: As the Executive Director of Laurus Biotechnology, LLC, an independent biotechnology consulting firm, I am utilizing my accumulated technical, manufacturing, regulatory and quality assurance expertise to aid companies, universities and non-profits in rapidly developing critical capabilities to meet their key milestones.
As a member of the KLYO Collaborative, our team rapidly brings together solutions across the entire process (product) development spectrum as well as embracing all aspects of facility design, construction, validation and operation using novel, cost-effective, time-saving mechanisms based on both collective experiences and innovative practices. At our core KLYO is a diverse multidisciplinary team of corporate colleagues who have very successfully achieved together and built together.
Most recently I served as Executive Vice President and Chief Technical Officer of Gradalis, Inc. I started at Gradalis as employee number one in 2005. I was responsible for the creation and smooth operation of the Quality Assurance, Quality Control, Assay Development, Product Development and Manufacturing functions. I created cohesive multifunctional teams to rapidly, efficiently and effectively solve problems as we worked with our collaborative research partners and the Mary Crowley Medical Research Center physicians and staff and other independent clinical partner sites to place our cancer treatments into clinical trial settings as quickly and efficiently as possible. We established six open INDs with six active Phase I and five active Phase II clinical trials. Gradalis is now well positioned to move forward into the next phase of product testing and corporate development.
Undergraduate Dean's List 1977-1978, College of Arts and Sciences, University of Tulsa
Dean's List, 1978, College of Pharmacy, OU Health Sciences Center
Graduate Tuition Scholarship for 1982 Summer Embryology Course - awarded by the Marine Biological Laboratory, Woods Hole, MA
National Research Service Award (NRSA) Fellowship to attend Summer Embryology Course, Marine Biological Laboratory, Woods Hole, MA
Tuition Scholarship for 1982-1984 - awarded by the Noble Foundation, Ardmore, OK
Elected Associate Member of Society of the Sigma Xi, April, 1984
PROFESSIONAL SOCIETIES: American Society of Gene and Cell Therapy, 1998 to present
Chair of the Translational Science and Product Development Committee, 2014 to present
Undergraduate Laboratory Assistant, General and Pathogenic Microbiology courses, Department of Biology, University of Tulsa, Tulsa, OK.
Laboratory Assistant, Biochemistry course, Department of Chemistry, University of Tulsa, Tulsa, OK.
Graduate Lecturer, Biochemical Genetics and Molecular Biology, BIOC 6235, Graduate Level Course, Department of Biochemistry and Molecular Biology, OU Health Sciences Center, Oklahoma City, OK. Lectures on immunochemistry and immunological techniques, 1982.
Lecturer, General Biochemistry, BIOC 5215, Graduate Level Course, Department of Biochemistry and Molecular Biology, OU Health Sciences Center, Oklahoma City, OK. Lectures on cell differentiation, organismal development and molecular biology of immunoglobulin gene expression, 1983.
Laboratory, Instructor, Introductory Biochemistry Laboratory, BIOC 5224, Graduate Level Course, Department of Biochemistry and Molecular Biology, OU Health Sciences Center, Oklahoma City, OK. Instruction in analytical biochemical techniques and instrumentation, 1983.
Lecturer, Human Chemistry, DH 2123, to Dental Hygienists, Department of Biochemistry and Molecular Biology, OU Health Sciences Center, Oklahoma City, OK. Lectures on carbohydrate, fat and energy metabolism, 1983 and 1984.
CAREER INTERESTS: My scientific interests are to elucidate the fundamental processes of development - specifically the influence of cell-to-cell interactions and molecular factors on the process of cellular differentiation and gene expression/regulation, especially as it applies to function in the intact organism. These goals are most readily realized in a setting of new technological innovation combined with practical therapeutics development. My goals in industry are to develop (both in a scientific sense and in a business sense) new product concepts and new means of production which will advance the practice of medicine for the betterment of society while simultaneously contributing to the revolutionary field of personalized medicine.
I served as Vice President and Corporate Officer, CellExSys, Inc. and post-merger, held similar positions at Chromos Molecular Systems, Inc. Developed an antigen-specific autologous T cell therapy for Hepatitis B; developed other antigen-specific autologous T cell treatment concepts; established internationally-compliant internal GLP/GMP standards; oversaw Manufacturing, Assay Development, Quality Assurance, Clinical Affairs and Regulatory Affairs; performed international business development and financing operations.
I served as US Oncology, Inc. Scientific Director and developed the Molecular / Cell Processing Center. Enhanced the clinical research program by performing cell processing and gene therapy support functions under GLP / GMP conditions and according to current international clinical cell processing standards / guidelines. Developed GVAX Lung Vaccine manufacturing for Cell Genesys and performed clinical trials for them and other sponsors. Developed other new clinical treatment protocols for internal and external sponsored trials. Brought all research laboratories up to GLP standards in the Mary C. Crowley Research Program at the Baylor Research Institute. Worked with the Mary Crowley Medical Research Center to develop common biosafety and clinical specimen handling programs.
My activities at Baxter Healthcare Corporation included the development of a molecular biology program that was integrated into various business sectors and spurred the development of molecular biology groups within various operating units of the corporation. The molecular biology focus involved the development of nucleic acid-based and recombinant protein-based diagnostics and therapeutics, especially as they related to human hematopoiesis, i.e blood cell formation.
In addition, I functioned as a biotechnology consultant and strategic planner for senior management (both corporate and divisional). In this capacity, I identified and evaluated new technologies and product opportunities both internal and external. This function required the assimilation and review of patents, business plans, technical reports and other relevant information on these potential corporate ventures. I participated in both the discovery/evaluation and the negotiation/closure processes. My experience was both domestic and international (Europe and Asia). I performed assessments of academia, government institutions and both start up and established companies. At Baxter, I was involved in the evaluation of DNA and monoclonal antibody-based diagnostics, nucleic acid amplification technologies, therapeutic proteins, gene therapy opportunities, cell culture constituents and various types of bioreactors.
Research Associate studies included the analysis of the induction of terminal differentiation in transformed erythroid precursors, the biochemical and kinetic characterization of the erythropoietin receptor, the development of insitu hybridization diagnostic techniques to determine the mammalian site(s) of synthesis of erythropoietin and the cloning and further characterization of the erythropoietin receptor.
Ph.D. thesis encompassed the study of the ontogeny of globin gene expression in Ranacatesbeiana in regard to choice of Hb type, RBC morphology, erythropoietic microenvironment (in cellular and molecular terms) and the development of erythropoietic potential in tissues.
PUBLICATIONS: Papers Published, In Press, or Submitted: 1. Broyles, R.H., G.M. Johnson, P.B. Maples and G.R. Kindell. Two erythropoietic microenvironments and two red cell lines in bullfrog tadpoles. Devel. Biol.81: 299-314, (1981).
2. Broyles, R.H., A.R. Dorn, P.B. Maples, G.M. Johnson, G.R. Kindell and A.M. Parkinson. Choice of Hemoglobin Type in Erythroid Cells of Ranacatesbeiana. In Hemoglobins in Development and Differentiation (G. Stamatoyannopoulos and A.W. Nienhuis, eds.), Alan R. Liss, Inc., New York (1981).
3. Parkinson, A.M., A.R. Dorn, P.B. Maples and R.H. Broyles. Improved electrophoretic separation of hemoglobins by standard PAGE with different amino acid buffers. Anal.Biochem.117: 6-11, (1981).
4. Maples, P.B., A.R. Dorn and R.H. Broyles. Coexistence of embryonic and larval hemoglobins during the early development of the bullfrog Ranacatesbeiana. Devel. Biol.96: 515-519 (1983).
5. Maples, P.B., J.C. Palmer and R.H. Broyles. Invivo regulation of hemoglobin phenotypes in Ranacatesbeiana. Devel. Biol.117: 337-341 (1986).
6. Maples, P.B., J.C. Palmer and R.H. Broyles. Determination of Hemoglobin Expression Patterns in Erythroid Cells of Ranacatesbeiana. Comp. Biochem. Physiol.91B:755-762 (1988).
7. Beru, N., P.B. Maples, O. Hermine and E. Goldwasser. Differential expression of alpha- and beta-globin genes in erythroleukemic cell lines. Molec. Cell. Biol.10:3591-3595 (1990).
8. Bender, J.G., K.L. Unverzagt, P.B. Maples, Y. Mehrotra, J. Mellon, D. Van Epps and C.C. Stewart. Functional characterization of mouse granulocytes produced in vitro from marrow progenitors stimulated with Interleukin-3 or GM-CSF. Exp. Hematol.20: 1135-1140 (1992).
9. Smith, S.L., J.G. Bender, P.B. Maples, K. Unverzagt, M. Schilling, L. Lum, S. Williams and D.E. Van Epps. Expansion of neutrophil progenitors produced in suspension cultures of CD34+ cells enriched from cord blood or bone marrow. Exp. Hematol.21: 870-877 (1993).
10. Malech, H.L., P.B. Maples, N. Whiting-Theobald, G.F. Linton, S. Sekhsaria, S.J. Vowells, F. Li, J.A. Miller, E. Decarlo, S.M. Holland, S.F. Leitman, C.S. Carter, R.E. Butz, E.J. Read, T.A. Fleischer, R.D. Scheiderman, D.E. Van Epps, S.K. Spratt, C.A. Maack, J.A. Rockovich, L.K. Cohen and J.I. Gallin. Prolonged production of oxidase corrected granulocytes in vivo following gene therapy of chronic granulomatous disease. Proc. Nat. Acad. Sci. USA94(22):12133-12138 (1997).
11. Robinet E., J.M. Certoux, C. Ferrand, P.B. Maples, A. Hardwick, J.Y. Cahn, C.W. Reynolds, W. Jacob, P. Herve and P. Tiberghien. A closed system for the ex vivo transduction and expansion of human T-lymphocytes. J. Hematotherapy7(3): 205-215 (1998).
12. Hardwick, R.A., B.L. Levine, C.H. June, J. Cotte, H.L. Malech, R.E. Butz, C.S. Carter and P.B. Maples. Development of closed systems for ex vivo cell processing: utility in cell and gene therapy. Published in “Heat and Mass Transfer in Biotechnology”, ASME Press, New York, New York (1999).
13. Tong, A.W., B. Seamour, J.M. Lawson, G. Ordonez, S. Vukelja, W. Hyman, D. Richards, L. Stein, P.B. Maples and J.J. Nemunaitis. Cellular immune profile of advanced cancer patients before and after Taxane treatment. Amer. J. Clin. Oncology23(5): 463-472 (2000).
14. Nemunaitis, J., I. Ganly, F. Khuri, J. Arseneau, J. Kuhn, T. McCarty, S. Landers, P. Maples, L. Romel, C. Heise, B. Randlev, A. Reid, S. Kaye, and D. Kirn. Selective replication and oncolysis in p53 mutant tumors with ONYX-015, an E1B-55kD gene-deleted adenovirus, in patients with advanced head and neck cancer: A Phase II trial. Cancer Research60(22): 6359-6366 (2000).
15. Nemunaitis, J., C. Cunningham, A. Buchanan, A. Blackburn, G. Edelman, P. Maples, G. Netto, A. Tong, B. Randlev, S. Olson and D. Kirn. Intravenous infusion of a replication-selective adenovirus (ONYX-015) in cancer patients: Safety, feasibility and biological activity. Gene Therapy8(10): 746-759 (2001).
16. Nemunaitis, J., D. Sterman, K. Juhn, E. Woo, D. Jablons, G. Jhan, J. Smith, B. Fox, R. Whyte, C. Cunningham, T. Behtash, P. Maples, G. Dranoff and K. Hege. GM-CSF Modified Tumor Vaccine: GVAX Clinical Update in Lung Cancer. Published in "Turning Research into Clinical Reality", Second International Symposium on Tumor Targeted Delivery Systems, the National Cancer Institute and Controlled release Society, Rockville, MD, pages 51-53 (2002).
17. Hardwick, A., D. McMillen, J. Martinez, A. Austin, A. Posey, C. Ave-Teel, P. Maples and S. Schneider. Clinical scale production of antigen-specific T cells directed against Hepatitis B virus. BioProcessing J. 2(4): 27-31 (2003).
18. Tong, A.W., Y.A. Zhang, C. Cunningham, P. Maples and J. Nemunaitis. Potential Clinical Applications of Antioncogene Ribozymes. Clin. Lung Cancer 2(3): 220-226 (2004).
19. Nemunaitis, J, D. Sterman, D. Jablons, J. Smith, B. Fox, P. Maples, S. Hamilton, F. Borellini, A. Lin, S. Morali and K. Hege. GMCSF Gene-Modified Autologous Tumor Vaccines in Non Small Cell Lung Cancer. J. National Cancer Institute96: 326-331 (2004).
20. Nemunaitis, J., Dillman, R., Schwarzenberger, P., Senzer, N., Cunningham, C., Cutler, J., Tong, A., Kumar, P., Pappen, B., Hamilton, C., DeVol, E., Maples, P., Liu, L., Chamberlin, T., Shawler, D. and Fakhrai, H. Phase II study of Belagenpumatucel-L a Transforming Growth Factor 2 (TGF-2) Antisense Gene Modified Allogeneic Tumor Cell Vaccine in Non Small Cell Lung Cancer (NSCLC). Journal of Clinical Oncology24(29): 4721-4730 (2006).
21. Nemunaitis, J., Senzer N, Khalil I, Shen Y, Kumar P, Tong A, Kuhn J, Lamont J, Nemunaitis M, Rao M, Zhang Y, Zhou Y, Vorhies J, Maples P, Hill C, Shanahan D. Proof of Concept for Clinical Justification of Network Mapping for Personalized Cancer Therapeutics. Cancer Gene Therapy14(8):686-695 (2007).
22. Nemunaitis, J., Senzer, N., Sarmiento, S., Zhang, Y., Arzaga, R., Sands, B., Maples, P. and Tong, A. A Phase 1 Trial of Intravenous Infusion of ONYX-015 and Enbrel in Solid Tumor Patients. Cancer Gene Therapy14(11):885-93 (2007).
23. Wallraven, G., J.J. Nemunaitis and P.B. Maples: Letter to the Editor: Compassionate Approval Process for Experimental “Gene” Based Products. Journal of Clinical Oncology26(11): 1899-1900 (2008).
24. Rana, S., P.B. Maples, N. Senzer and J. Nemunaitis. Stathmin I: A Novel Therapeutic Target for Anticancer Activity. Expert Rev. Anticancer Ther.8(9): 1461-1470 (2008).
25. Barve, M., J. Bender, N. Senzer, c. Cunningham, F.A. Greco, D. McCune, R. Steis, H. Khong, D. Richards, J. Stephenson, P. Ganesa, J. Nemunaitis, G. Ishioka, B. Pappen, M. Nemunaitis, M. Morse, B. Mills, P.B. Maples, J. Sherman and J.J. Nemunaitis. Induction of Immune Responses and Clinical Efficacy in a Phase II Trial of IDM-2101, a 10-Epitope Cytotoxic T-lymphocyte Vaccine, in Metastatic Non-Small Cell Lung Cancer. Journal of Clinical Oncology26(27): 4418-4425 (2008).
26. Wallraven, G., P.B. Maples and J. Nemunaitis. Emergency Use Regulatory Approval Process for Experimental Gene Based Therapy. Journal of Clinical Oncology 26(33):5488-9 (2008).
27. Jay, C, Nemunaitis G, Nemunaitis J, Senzer N, Hinderlich S, Darvish D, Ogden J, Tong A, Maples P. Preclinical Assessment of GNE-wt Gene Plasmid for Management of Hereditary Inclusion Body Myopathy 2 (HIBM2). Gene Regulation and Systems Biology 2: 243-252 (2008).
28. Nemunaitis, J., M. Nemunaitis, N. Senzer, P. Snitz, C. Bedell, P. Kumar, B. Pappen, P.B. Maples, D. Shawler and H. Fakhrai: Phase II Trial of Belagenpumatucel-L, a TGF-β2 Antisense Gene Modified Allogeneic Tumor Vaccine in Advanced Non Small Cell Lung Cancer (NSCLC) Patients. Cancer Gene Therapy16(8): 620-4 (2009).
29. Phadke AP, C. Jay, S.J. Chen, C. Haddock, Z. Wang, Y. Yu, D. Nemunaitis, G. Nemunaitis, N.S. Templeton, N. Senzer, P.B. Maples, A.W. Tong and J. Nemunaitis. Safety and in vivo expression of a GNE-transgene: A novel treatment approach for Hereditary Inclusion Body Myopathy-2. Gene Regulation and Systems Biology3:89-101 (2009).
30. Tong A.W., C.M. Jay, N. Senzer, P.B. Maples, J. Nemunaitis. Systemic Therapeutic Gene Delivery for Cancer: Crafting Paris’ Arrow. Current Gene Therapy 9(1): 45-60 (2009).
31. Jay C.M., N. Levonyak, G. Nemunaitis, P.B. Maples and J. Nemunaitis. Hereditary Inclusion Body Myopathy (HIBM2): Review. Gene Regulation and Systems Biology3: 181-190 (2009).
32. Kumar, P. C. Jay, I. Oxendine, J. Nemunaitis and P.B. Maples. TAG Xenograft Vaccine: Xenograft-Expanded Autologous Tumor Vaccine Genetically Modified to Express GM-CSF and Block TGF2. BioProcessing Journal8(1): 30-36 (2009).
33. Maples, P.B., P. Kumar, I. Oxendine, C. Jay, Y.Yu, J. Kuhn and J. Nemunaitis. TAG Vaccine: Autologous Tumor Vaccine Genetically Modified to Express GM-CSF and Block TGF2. BioProcessing Journal8(1): 38-45 (2009).
34. Maples, P.B., P. Kumar, Y. Yu, Z. Wang, C. Jay, B.O. Pappen, D.D. Rao, J. Kuhn, J. Nemunaitis and N. Senzer. FANG Vaccine: Autologous Tumor Cell Vaccine Genetically Modified to Express GM-CSF and Block Production of Furin. BioProcessing Journal8(4): 4-14 (2010).
35. Nemunaitis, J., A.W. Tong, M. Nemunaitis, N. Senzer, C. Bedell, N. Adams, A.P. Phadke, Y. Zhang, P.B. Maples, S. Chen, B. Pappen, J. Burke, D. Ichimaru, Y. Urata and T. Fujiwara. A Phase I Study of Telomerase Specific Replication Competent Oncolytic Adenovirus (Telomelysin) for Various Solid Tumors. Molecular Therapy18(2): 429-434 (2010).
36. Rao, D.D., P.B. Maples, N. Senzer, P. Kumar, Z. Wang, B.O. Pappen, Y. Yu, C. Haddock, C. Jay, A.P. Phadke, S. Chen, J. Kuhn, D. Dylewski, S. Scott, D. Monsma, C. Webb, A. Tong, D. Shanahan and J. Nemunaitis. Enhanced Target Gene Knockdown by a Bifunctional shRNA: A Novel Approach of RNA Interference. Cancer Gene Therapy 17(11): 780-791 (2010).
37. Nemunaitis, G., P.B. Maples, C. Jay, W.A. Gahl, M. Huizing, A.W. Tong, A.P. Phadke, B.O. Pappen, C. Bedell, N.S. Templeton, J. Kuhn, N. Senzer, and J. Nemunaitis. Hereditary Inclusion Body Myopathy (HIBM): Single Patient Response to GNE Gene Lipoplex Therapy. The Journal of Gene Medicine12(5): 403-412 (2010).
38. Olivares J, P. Kumar, Y. Yu, P.B. Maples, N. Senzer, C. Bedell, M. Barve, A. Tong, B.O. Pappen, J. Kuhn, M. Magee, G. Wallraven and J. Nemunaitis. Phase I Trial of TGF-β2 Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine. Clinical Cancer Research 17(1):183-192 (2011).
39. Phadke, A.P., C.M. Jay, Z. Wang, S. Chen, S. Liu, C. Haddock, P. Kumar, B. Pappen, D.D. Rao, N.S. Templeton, E.Q. Daniels, C. Webb, D. Monsma, S. Scott, D. Dylewski, H.B. Frieboes, F.C. Brunicardi, N. Senzer, P.B. Maples, J. Nemunaitis and A.W. Tong. In vivo Safety and Antitumor Efficacy of Bifunctional shRNAs Specific for the Human Stathmin 1 (STMN1) Oncoprotein. DNA and Cell Biology30(9):715-726 (2011).
40. Nemunaitis G, C.M. Jay, P.B. Maples, W.A. Gahl, M. Huizing, T. Yardeni, A.W. Tong, A.P. Phadke, B.O. Pappen, C. Bedell, H. Allen, C. Hernandez, N.S. Templeton, J. Kuhn, N. Senzer and J. Nemunaitis. Hereditary Inclusion Body Myopathy (HIBM): Single Patient Response to Intravenous Dosing of GNE Gene Lipoplex. Human Gene Therapy 22(11): 1331-1341 (2011).
41. Senzer, N., M. Barve, J. Kuhn, A. Melnyk, P. Beitsch, M. Lazar, S. Lifshitz, M. MaGee, J. Oh, S.W. Mill, C. Bidell, C. Higgs, P. Kumar, Y. Yu, F. Norvell, C. Phalon, N. Taquet, D.D. Rao, Z. Wang, C.M. Jay, B.O. Pappen, G. Wallraven, F.C. Brunicardi, D.M. Shananhan, P.B. Maples and J. Nemunaitis. Phase I Trial of “bi-shRNAfurin/GMCSF DNA/Autologous Tumor Cell” Vaccine (FANG) in Advanced Cancer. Molecular Therapy 20(3): 679-686 (2012).
42. Simmons, O., P.B. Maples, N. Senzer, and J. Nemunaitis. Ewing's Sarcoma: Development of RNA Interference Based Therapy for Advanced Disease. ISRN Oncology 2012 11;2012:247657 (2012).
43. Nemunaitis, J, N. Senzer, J. Olivares, P. Kumar, M. Barve, J. Kuhn, T. Nemunaitis, M. Magee, Y. Yu, G. Wallraven, B. O. Pappen and P. B. Maples. Immune Response and Survival of Refractory Cancer Patients who received TGF-β2 Antisense/GM-CSF Gene Modified Autologous Tumor Cell (TAG) Vaccine. Gene Therapy 20(9): 875-879 (2013).
44. Jay, C., C. Ruoff, P. Kumar, H. Maass, B. Spanhel, M. Miller, A. Arrington, N. Montalvo, V.Gresham, D.Rao, C. Evans, Z. Wang, F.C. Brunacardi, S.H. Liu, G. Zhou, N. Senzer, J. Nemunaitis, L.King, B. Weeks, F.Clubb, T.W. Fossum and P.B. Maples. Assessment of Intravenous pbi-shRNA PDX-1 Nanoparticle (OFHIRNA-PDX-1) in Yucatan Swine. Cancer Gene Therapy 20(12): 683-689 (2013).
45. Senzer, N., M. Barve, J. Nemunaitis, J. Kuhn, A. Melnyk, P. Beitsch, M. Magee, J. Oh, C. Bedell, P. Kumar, D. Rao, B. Pappen, G. Wallraven, F.C. Brunicardi, P.B. Maples and J. Nemunaitis. Long Term Follow Up: Phase I Trial of “bi-shRNA furin/GMCSF DNA/Autologous Tumor Cell” Immunotherapy (FANGTM) in Advanced Cancer. Vaccines and Vaccinations4:209. doi: 10.4172/2157-7560.10000209 (2013).
46. Wu,J., S-H Liu, J. Yu, G. Zhou, D. Rao, C. Jay, P. Kumar, R. Sanchez, N. Templeton, N. Senzer, P. Maples, J. Nemunaitis and F.C. Brunicardi. Vertically-Integrated Translational Studies of PDX-1 as a Therapeutic Target for Pancreatic Cancer via a Novel Bifunctional RNAi Platform. Cancer Gene Therapy 21: 48-53 (2014).
47. Nemunaitis, J., M. Barve, D. Orr, J. Kuhn, M. Magee, J. Lamont, C. Bedell, G. Wallraven, B.O. Pappen, A. Roth, S. Horvath, D. Nemunaitis, P. Kumar, P.B. Maples and N. Senzer. Summary of bi-shRNAfurin/GMCSF Augmented Autologous Tumor Cell Immunotherapy (FANGTM) in Advanced Liver Cancer. Oncology87(1): 21-29 (2014).
Abstracts and Presentations: 171 (as of ISBioTech, Spring, 2015)
Patents: Nine U.S. patents issued to date (US5700691, US5888499, US5955357, US6146623, US8603991, US8916530, US9132146, US9157084 and US9273300), as well as their related counterpart foreign and world patents. Eight current patent families pending (under examination) including US patent applications serial numbers 11/601,431, 12/526,239, 12/609,462, 12/856,888, 12/973,787, 12/973,823, 13/111,677 and 13/606,476 (others are in process).
Editorial Advisory Board and Reviewer for:
BioProcessing Journal – 2002 to present
Ad Hoc Journal Reviewer for: ExperimentalHematology, JournalofCellularBiochemistry, ProceedingsoftheSocietyforExperimentalBiologyandMedicine, DevelopmentalBiology and JournalofArtificialOrgans.
Public Funding: Completed Research Support
CPRIT RP101353 PI: Richard Gibbs
Tumor Banking for Genomic Research and Clinical Translation 08/01/10 – 07/31/13
(CPRIT funding period extended/renewal pending)
To develop tissue/plasma bank that will allow for development of markers and algorithms to deconstruct the molecular diversity of cancer and help reformat in a user accessible model (thereby enhancing discovery opportunities), to track the biomolecular correlates of disease progression, and to predict tumor response. Establish and operate Dallas BioBank site.
Completed Research Support
NIH-NCI, PHS 2010 Topic No 255 PI: Maples, Phillip
Anti-stathmin Bifunctional Small Hairpin RNA: Preclinical Development of High Potency, Low Toxicity GMP DNA
Successful completion of SBIR Phase I enabled initiation of advanced preclinical GLP studies in order to file an IND and initiate a Phase I clinical trial for safety testing of a BIV lipoplex modification.
University / Professional Society / Corporate Biotechnology Advisor: Industrial and Academic Partner Advisory Board (IAPAB) for the Texas Therapeutics Manufacturing Workforce Development Initiative, National Center for Therapeutics Manufacturing, Texas A&M University - 2011 to present
Parenteral Drug Association, Gene and Cell-Based Therapies Task Force - 2011 to 2014
American Society of Cell and Gene Therapy, Translational Science and Product Development Committee, 2013 to present. Committee Chair, 2014 to 2016
Various biotechnology, pharmaceutical and medical device companies - 1986 to present
Designed/Built and or Remodeled more than Ten Cell and Gene Therapy Processing Centers and GMP Manufacturing Facilities in the past twenty years (ongoing)
Scientific Meeting Responsibilities:
Co-Chair of the Twelfth International Meeting of the Cell and Tissue BioProcessing Conference, October 29-31, 2007, Austin, Texas.
Co-Chair of the Thirteenth International Meeting of the Cell and Tissue BioProcessing Conference, November 3-5, 2008, Santa Barbara, California.
Organizing Committee for the First Annual Meeting of the International Society for BioProcess Technology (ISBioTech) and Chair of the Cellular Vaccines and Therapies Program, April 4-6, 2011, Norfolk, Virginia.
Organizing Committee and CoChair of the Flexible Facilities and Systems Meeting (ISBioTech), April 5-6, 2012, Rosslyn, Virginia.
Organizing Committee and CoChair of the Cellular Therapeutics Meeting (ISBioTech), March 11-13, 2013, Rosslyn, Virginia.
Organizing Committee of the Flexible Facilities and Systems Meeting (ISBioTech), March 14-15, 2013, Rosslyn, Virginia.
Organizing Committee and CoChair of the Cellular Therapeutics Meeting (ISBioTech), March 10-12, 2014, Washington, D.C.
Organizing Committee and Chair of the Cellular Therapeutics Meeting (ISBioTech), March 9-11, 2015, Washington, D.C.
Co-Chair and Co-Organizer of the ASGCT Annual Meeting, Translational Science and Product Development Committee Symposium “Towards Commercialization”, May 14, 2015, New Orleans, Louisiana.
ASGCT Abstract Review Chair for Clinical Protocol Development, Regulatory Interactions and Ethics, ASGCT Annual Meeting, May 4-7, 2016, Washington, D.C.
Most Recent US FDA IND Numbers: BB-IND 13401 TAG Xenoexpanded Autologous Tumor Vaccine
BB-IND 13650 TAG Autologous Tumor Vaccine
BB-IND 13744 GNE Gene Replacement DNA Lipoplex Treatment
BB-IND 14205 FANGTM Autologous Tumor Vaccine
BB-IND 14918 PDX-1 pbi-shRNATM Lipoplex IV Infusion in Pancreatic Cancer
BB-IND 14938 STMN-1 pbi-shRNATM Lipoplex IT Injection in Solid Tumors