Roberto De Pascalis, M.D.

CBDR, FDA Silver Spring, MD

Candidate for the Council on Microbial Sciences Councilor
Laboratory of Mucosal Pathogens and Cellular Immunology, Office of Vaccines Research and Review, CBER, FDA, Silver Spring, MD
  • Medical Doctor Degree, University of Naples, Italy.
  • Specialty in Microbiology and Virology, University of Naples, Italy
Professional Experience:
  • Resident, Department of Molecular Biology and Pathology, University of Naples, Italy
  • Visiting Fellow, Laboratory of Tumor Immunology and Biology, NIH, Bethesda, MD
  • Visiting Associate, FDA, Bethesda, MD
  • Research Microbiologist, FDA, Silver Spring, MD
ASM Activities:
  • June 2017- present: COMS Councilor
Selected Publications:
  • De Pascalis R, Taylor BC and KL Elkins. Diverse myeloid and lymphoid cell subpopulations produce gamma interferon during early innate immune responses to Francisella tularensis live vaccine strain. Infect Immun. 2008; 76(9):4311-4321.
  • Elkins KL, Colombini SM, Krieg AM, De Pascalis R. NK cells activated in vivo by bacterial DNA control the intracellular growth of Francisella tularensis Microbes Infect. 2009; 11(1): 49-56.
  • De Pascalis R, Chou AY, Bosio CM, et al. Development of functional and molecular correlates of vaccine-induced protection for a model intracellular pathogen, tularensis LVS. PLoS Pathogens. 2012; 8(1) e1002494.
  • De Pascalis R, Chou AY, Ryden P, et al. Models derived from in vitro analyses of spleen, liver, and lung leukocyte functions predict vaccine efficacy against Francisella tularensis mBio. 2014; 5(2): e00936-13.
  • De Pascalis R, Mittereder L, Chou AY, et al. Francisella tularensis vaccines elicit concurrent protective T- and B-cell immune responses in Balb/cByJ mice. PloS One. 2015; 10(5) e0126570.
  • De Pascalis R, Mittereder L, Kennet NJ, and Elkins KL. Activities of murine peripheral blood lymphocytes provide immune correlates that predict Francisella tularensis vaccine efficacy. Infect Immun. 2016; 84(4):1054-1061.
  • Elkins KL, Kurtz SL, De Pascalis R. Progress, challenges, and opportunities in Francisella vaccine development. Expert Rev Vaccines. 2016 May 3:1-14.
  • Kurtz SL, Bosio CM, De Pascalis R, Elkins KL. GM-CSF has disparate roles during intranasal and intradermal Francisella tularensis Microbes Infect. 2016; 18(12): 758-767.
  • De Pascalis R, Hahn A, Brook MH, RydĂ©n P, Donart N, Mittereder L, Frey B, Wu HT, and Elkins LK. A panel of correlates predicts vaccine-induced protection of rats against respiratory challenge with virulent Francisella tularensis. Plos One. 2018; 13(5): e0198140.
  • Rice HM, Rossi AP, Bradford MK, Elkins KL and R De Pascalis. rM-CSF efficiently replaces L929 in generating mouse and rat bone marrow-derived macrophages for in vitro functional studies of immunity to intracellular bacteria. 2019 J Immun Methods. Accepted
Research Interests:
My current research focuses on the nature of vaccine-induced protection determined by Live Vaccine Strain (LVS) of Francisella tularensis, an intracellular bacterium, and aims to establishing clinically predictive correlates of protection. Combining functional in vitro co-culture assays with analyses of mRNA derived from activated leucocytes of mice vaccinated with LVS or LVS variants, which provide differential vaccine protection, allowed the identification of a panel of immunologic markers that correlate with protection. The resulting correlates of protection, which have been established in rodents, are now being evaluated in primates to validate their ability to predict the outcome of novel vaccines’ efficacy. This approach may be applicable to other intracellular pathogens and may ultimately complement vaccine efficacy clinical trials.

To briefly summarize my qualifications, after receiving the M.D. degree, as part of residency program in Microbiology and Virology, I joined the Department of Molecular Biology and Pathology and the Division of Clinical Microbiology where I studied microbiology both at molecular and at clinical level. As a post-doctoral and research fellow at NIH, I was involved on generation, development and characterization of humanized monoclonal antibodies. Currently, I am a Staff Scientist/Research Microbiologist at U.S. Food and Drug Administration, where I pursue research and regulatory activities. My current research focuses on mechanisms of innate and adaptive immunity to intracellular bacteria. My regulatory activities involve the revision of applications related to vaccines as prophylactic agents against microorganisms. In addition, I serve on FDA committees with the purpose to develop consistency in regulatory oversight of bioassay.
I have been an elected councilor for COMS for this past two and half years. In this short period, COMS has been instrumental identifying opportunities, and favoring initiatives and activities. ASM members, through COMS representatives, can set priorities for the Society to address. For instance, the rapid increase of antimicrobial resistance, the impact of nosocomial infection, the lack of protective vaccines against common and less common infection, the potential use of microorganism for terrorism purpose, the preparedness against unexpected epidemics, as well as the hesitancy or opposition against vaccination are the major challenges that the microbial science community faces. Research and policy, backed by ASM, should focus primarily to these major unresolved issues.
I believe that my experiences in basic research and clinical microbiology, as well as my experience in vaccines’ regulation, make me a valuable COMS Representative candidate.

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