Dr. John Bilello, CSO-GRA Institute, NP

Dr. John Bilello, CSO-GRA Institute, NP

Position:

Accepted Chief Science Officer at our sister non-profit Global Respiratory Advocates Institute and Health Advocate

I am a Ph.D. with extensive experience in the pharmaceutical, biotechnology, academia, and government laboratories. My research interest has been defining the molecular aspects of pathogenesis to impact the diagnosis, treatment, and rational development of therapeutics for chronic and viral-induced diseases. One critical development to improving therapeutics’ early development was my laboratory’s development of predictive in vitro and in vivo pharmacodynamic model systems for evaluating the efficacy and toxicity of antiretroviral therapeutics focused on HIV. Based on my HIV research, I was Senior Therapeutic Area Advisor for Antivirals at GlaxoSmithKline (GSK)). As a member of GSK’s Human Biomarker laboratory, I developed biomarker panels to develop new therapeutics for chronic obstructive pulmonary disorder (COPD) and other chronic diseases. Later, I became the Director of Technology Development in Translational Medicine and Genetics. As an internationally recognized scientist, I was a member of the editorial board for Antimicrobial Agents and Chemotherapy (1995-2009). I started my first company to develop diagnostic tests for neurodegenerative and neuropsychiatric diseases. In addition to an established track record of innovative basic and clinical research, I have extensive experience in project and organizational management. I was a co-founder and Managing Partner of Innovalyst LLC, and in 2018 founder of Innovalyst ICAN LLC, a Life Science small business accelerator focused on catalyzing product innovation.

Education

B.S.  Biology, City College of New York, New York, NY

M.A.  Microbiology, Southern Illinois University, Carbondale, IL

Ph.D. Molecular Biology, Albert Einstein College of Medicine, NY

Professional Experience

2018-Present Principal, Innovalyst ICAN LLC Parkville, MD

2017-2018 Scientific Officer, Atlantic Diagnostics Laboratories, Bensalem PA

2006-2016 President and CSO, Ridge Diagnostics, Durham NC

2002-2005 Director, Technology Development, Translational Med.&Tech. GlaxoSmithKline, RTP NC

2002 Senior Therapeutic Area Advisor, Clinical Phamacol. Experimental Med. GSK, RTP NC

2001 Director Preclinical R&D, VIRCO Lab USA, Rockville, MD

1998-2000 Director Preclinical R&D, SRA Life Sciences, Rockville, MD

1996-1998 Visiting Scientist, SRA Life Sciences, Rockville, MD

1993-1998 Director HIV Laboratories, Dept of Medicine, Division of Clinical Pharmacology, Albany

Medical College, Albany NY

1992-1998 Associate Professor, Dept of Medicine and Dept of Pharmacology Albany Medical College

1989-1992 Associate Professor, Dept. of Medicine, Microbiology, and Program in Oncology, University

Of Maryland School of Medicine, Baltimore, MD

1985-1989 Chief, Molecular Biology Laboratory, VA Medical Center, Baltimore, MD

1983-1989 Assistant Professor, Microbiology and Oncology, Univ. of Maryland School of Medicine

1981-1983 Instructor in Oncology, The Johns Hopkins University, School of Medicine, Baltimore, MD

1977-1981 Wissenschaftlicher Assistant, Dept of Molecular Biology, Institute for Physiological

Chemistry University of Hamburg. Hamburg, Germany

HONORS AND OTHER SCIENTIFIC ACTIVITIES

NY State Scholarship; Special Doctoral Fellowship SIU; NIH Research Fellowship, Albert Einstein Coll. Med.;

Volkswagen Fellowship, University of Hamburg; Bressler Foundation Research Awards (3 separate Awards)

the University of Maryland.

PROFESSIONAL ACTIVITIES

Editor Antimicrobial Agents and Chemotherapy (1995-2012)

Member, IMST-12 SBIR, Devices and Detection Systems Review Panel, NIH, 2009

Member, NIH Challenge Grants Review Panel, NIMH, NIH 2009

Member, HIV/AIDS Clinical Trial Network Review Panel, NIAID, NIH, 2006

Member, HIV/AIDS Prevention Trials Network Review Panel, N IAID, NIH. 2005

Member, SBIR/STTR SSS-2 Study Section on Proteomic Technologies, CSR, NIH 2003-2004

Contributions to Science-Patents Granted

1. My early publications were primarily focused on in vitro laboratory studies on animal viruses which included studies of papovaviruses (SV40), poxviruses (Yaba/monkeypox), and enteroviruses (poliovirus). Working in the Department of Chemotherapy at Hoffman La Roche, we published studies on the mechanism of action of the microbial metabolite gliotoxin in inhibiting poliovirus. I later did my doctoral studies on the oncogenic retrovirus Kirsten Sarcoma Virus at Albert Einstein College of Medicine.—-

• Bilello, J.A., Strand, M. and August. J.T. “Murine sarcoma virus gene expression: transformants which express viral envelope glycoprotein in the absence of the major internal protein and infectious particles.” Proceedings of the National Academy of Sciences 71.8 (1974): 3234-3238. Bilello, J.A., Strand, M. and August. J.T. “Expression of viral envelope glycoprotein and transformation genes in cells transformed by a defective Kirsten murine sarcoma virus.” Virology 77.1 (1977): 233-244.

2. I worked on the translational control of poliovirus and Friend Erythroleukemia Virus in the Department of Molecular Biology, University of Hamburg (Germany). Koch, G., Bilello, J. A., Kruppa, J., Koch, F., and Oppermann, H. (1980). Amplification of translational control by membrane‐mediated events: A pleiotropic effect on cellular and viral gene expression. Annals of the New York Academy of Sciences, 339(1), 280-306.

• Koch, G., C. Weber, and J. A. Bilello. “Alterations in translational control mechanisms in Friend erythroleukemic cells during DMSO induced differentiation.” Modern Trends in Human Leukemia III. Springer, Berlin, Heidelberg, 1979. 295-301.

3. In addition to the contributions described above, with a team of collaborators, I worked on the biology of retroviruses and their inhibition by antiviral agents.

• Bilello, J.A., MacAuley, C., Kort, J.J., Yetter, R.A., Fredrickson, T.N. and Eiseman. J.L. ZDV Delays but does not Prevent the Transmission of MAIDS by LP-BM5 MuLV Infected Macrophage-Monocyte Cells. J. AIDS, 5:571-576 (1992).
• Cohen, O. J., Pantaleo, G., Holodniy, M., Fox, C. H., Orenstein, J. M., Schnittman, S.. Bilello JA.and
• Fauci, A. S. Antiretroviral monotherapy in early-stage human immunodeficiency virus disease has no detectable effect on virus load in peripheral blood and lymph nodes. Journal of Infectious Diseases, 173(4), 849-856. (1996).
• Stein DS, Lyles RH, Graham NM, Tassoni CJ, Margolick JB, Phair JP, Rinaldo C, Detels R, Saah A, and Bilello J, Multicenter AIDS Cohort Study. Predicting clinical progression or death in subjects with early-stage human immunodeficiency virus (HIV) infection: a comparative analysis of quantification of HIV RNA, soluble tumor necrosis factor type II receptors, neopterin, and β2-microglobulin. Journal of Infectious Diseases. 176(5):1161-7. (1997)

4. Perhaps my most substantial contribution to virology was during the AIDS epidemic when my laboratory developed and applied in vitro pharmacodynamic models for determining dose and schedule to studies of antiviral, antitumor, and antimicrobial agents.

• Drusano, G. L., Bilello, J. A., Preston, S. L., O’Mara, E., Kaul, S., Schnittman, S., and Echols, R.
• Hollow-fiber unit evaluation of a new human immunodeficiency virus type 1 protease inhibitor, BMS-232632, for determination of the linked pharmacodynamic variable. The Journal of infectious diseases, 183(7), 1126-1129. (2001).
• Bilello, J. A., Bilello, P. A., Prichard, M., Robins, T., and Drusano, G. L. Reduction of the in vitro activity of A77003, an inhibitor of human immunodeficiency virus protease, by human serum α1 acid glycoprotein. Journal of Infectious Diseases, 171(3), 546-551. (1995).

5. In 2002, I joined GlaxoSmithKline Research and Development as Senior Therapeutic Area Advisor for Antivirals. Later I became the Director of Technology Development in Translational Medicine and Genetics. I worked in several therapeutic areas developing biomarkers for chronic (e.g., COPD, migraine) and viral diseases.

• Pinto-Plata, V., Toso, J., Lee, K., Park, D., Bilello, J., Mullerova, H., … and Celli, B. Profiling serum biomarkers in patients with COPD: associations with clinical parameters. Thorax, 62(7), 595-601(2007). Pinto-Plata, V., Toso, J., Lee, K., Bilello, J., Mullerova, H., De Souza, M., … and Celli, B. Use of proteomic patterns of serum biomarkers in patients with chronic obstructive pulmonary disease: correlation with clinical parameters. Proceedings of the American Thoracic Society, 3(6), 465-466. (2006).
• Hurst, J. R., Donaldson, G. C., Perera, W. R., Wilkinson, T. M., Bilello, J. A., Hagan, G. W., … & Wedzicha, J. A. Use of plasma biomarkers at exacerbation of chronic obstructive pulmonary disease. American journal of respiratory and critical care medicine, 174(8), 867-874. (2006). Ashina, M., Tvedskov, J. F., Lipka, K., Bilello, J., Penkowa, M., & Olesen, J. Matrix metalloproteinases during and outside of migraine attacks without aura. Cephalalgia, 30(3), 303-310. (2010).

6. In 2008, I left GSK to co-found what became Ridge Diagnostics which went from a predominantly research organization to a commercial clinical laboratory operating under CLIA. As CSO of Ridge Diagnostics, I was responsible for planning and directing clinical studies and executing the company’s scientific research agenda in depression and chronic pain.

• Papakostas, G. I., Shelton, R. C., Kinrys, G., Henry, M. E., Bakow, B. R., Lipkin, S. H.,. and Bilello, J. A. Assessment of a multi-assay, serum-based biological diagnostic test for major depressive disorder: a pilot and replication study. Molecular psychiatry, 18(3), 332-339. (2013). Bilello, J. A., Thurmond, L. M., Smith, K. M., Pi, B., Rubin, R., Wright, S. M., .,,and Papakostas, G. I. MDDScore: confirmation of a blood test to aid in the diagnosis of major depressive disorder. The journal of clinical psychiatry, 76(2), 11343. (2015).

Patents Granted

US 8,158,374 – Materials and Methods related to diagnosing a clinical condition in a subject, or determining the subject’s predisposition to develop the clinical condition, using a multi-parameter system to measure a plurality of parameters and an algorithm to determine a disease score.

US 8,450,077 – Materials and methods related to materials and methods for diagnosing or assessing a clinical condition in a subject, or determining a subject’s predisposition to develop a clinical condition, using algorithms to determine a disease score based upon a combination of parameters.

US 8,440,418 – Materials and methods for using combinations of metabolic syndrome and HPA axis biomarkers for monitoring major depressive disorder.

JAPAN 5663314- Materials and Methods for Diagnosing and Monitoring Major Depressive Disorder assessing a clinical condition in a subject,

JAPAN 5658571- Inflammatory Biomarkers for Monitoring Depression Disorders assessing a clinical condition in a patient with a depression disorder.

JAPAN 5540000- Human Biomarker Hypermapping for Depressive Disorders. Materials and Methods for Hypermapping patient data in 3-Dimensional Space.

JAPAN 5767973- Metabolic Syndrome and HPA Axis Biomarkers for Monitoring Major Depressive Disorders. Using multiple biomarkers (MSX and HPA) to monitor the response of patients to treatment of Major Depressive Disorder.

JAPAN 5744063- Multiple Biomarker Panels to Stratify Disease Severity and Monitor Treatment of Depression

WIPO 2337866 – Human Biomarker Hypermapping for Depressive Disorders. Materials and Methods for Hypermapping patient data in 3-Dimensional Space.

Complete List of Published Work in MyBibliography:

https://www.ncbi.nlm.nih.gov/myncbi/john.bilello.1/bibliography/public/