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Medical Countermeasures Initiative (MCMi) Preceptors

2013 Preceptors


 Picture of Dionna Green

Dionna J. Green, M.D.
Medical Officer
Pediatric Clinical Pharmacology Group
Office of Clinical Pharmacology
Office of Translational Sciences
CDER

Background:
B.S. in Biology, 2001; M.D., 2005
Pediatric Training, 2008
Clinical Pharmacology Fellowship, 2009
FDA Commissioner’s Fellowship Program, 2009-2011
Biohazardous Threat Agents and Emerging Infectious Diseases 2-Yr Certificate Program, 2011-2013
Total years of FDA employment, 3.5
 

Research Interests:

Pediatric drug development, pharmacogenomics, organ transplantation, medical countermeasure development

Proposed Regulatory Research Project for the FDA Commissioner's Fellow:

The Commissioner’s Fellow’s project will involve (1) describing the past scientific and regulatory pathways used for labeling medical countermeasures for use in the pediatric population; (2) assessing the existing gaps in pediatric dosing for medical countermeasures; and (3) exploration of the role of quantitative tools such as modeling and simulation and physiology-based pharmacokinetics (PBPK) in establishing dosing of medical countermeasures for the pediatric population.

Applicant Requirements:

Pharm.D., M.D., or Ph.D. with training and experience in pharmacokinetics, pharmacodynamics, and modeling and simulation. Pediatric knowledge or experience is not essential, but would be considered favorable.

Selected Recent Publications:

Momper JD, Mulugeta Y, Green DJ, Karesh A, Krudys KM, Sachs HC, Yao YP, Burckart GJ. Adolescent Dosing and Labeling Since the FDA Amendments Act of 2007. JAMA Pediatrics (in press).

Burckart GJ, Green D, Mummaneni P. Applications of Pharmacogenomics to Pediatric Drug Development. In Mulberg AE, Silber SA, van den Anker JN (eds): Pediatric Drug Development, 2nd edition, Wiley-Blackwell, Hoboken, NJ, 2013 (in press).

Burckart GJ, Green D. The personalized medicine revolution: getting it right for children. Pediatric Transplantation 2012 Jan 9. doi: 10.1111/j.1399-3046.2011.01638.x.

Burckart GJ, Figg WD II, Brooks MM, Green D, Girnita DM, Troutman S, Chinnock R, Canter C, Addonizio L, Bernstein D, Kirklin JK, NaftelD, Price DK, Zeevi A, Webber SA. A Multi-Institutional Study of Outcomes After Pediatric Heart Transplantation: Effect of ABCC2 Polymorphisms. American Transplant Congress 2012, Boston, MA, June, 2012.
 


Picture of Sanjai Kumar

Sanjai Kumar, Ph.D.
Senior Biomedical Research Service
Chief, Laboratory of Emerging Pathogens
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
5516 Nicholson Lane, Kensington, Maryland
Center for Biologics Evaluation and Research, FDA

Education: Ph.D.

Professional Experiences:

2002- Present: FDA
1996- 2001: Chief, Blood Stage Malaria Research, Naval Medical Research Center and Adjunct Faculty, School of Public Health, Johns Hopkins University
1996 – 1986: Visiting Fellow and Visiting Scientist, National Institutes of health
 

Research Interests:

Molecular immunology, pathogenesis and detection of infectious agents particularly malaria and Babesia parasites. Special interest in understanding the molecular basis of malaria immunity and mediators of severe disease in experimental models and field studies. Assay development for detection of infectious agents in blood. Genomics studies on Babesia parasites to identify novel antigens for diagnostics and pathogenesis studies.

Proposed Regulatory Research Project for the FDA Commissioner's Fellow:

• Assessment of novel technologies such as next generation sequencing, micoarray platforms and bioinformatics tools for application in multiplex testing of blood donors for existing infectious agents and their novel genotypic and antigenic forms;
• Support the formulation of policies and regulations for the validation and implementation of multiplex platforms that are amenable for rapid modifications for the detection of emerging pathogens such as Chikungunya virus, and the sudden threats from bio-terror agents (e.g., Bacillus anthracis, Ebola virus etc.) in blood donors;
• Develop policies for implementation of novel screening tests for infectious agents including bio-terror agents;
• Review of devices for donor screening for infectious agents;
• Support the writing of guidance documents for safety of blood supply from bio-terror agents.

Applicant Requirements:

Ph.D., M.D. or an equivalent degree in biological sciences.

Selected Recent Publications:

A chemiluminescent-western blot assay for quantitative detection of Plasmodium falciaprum circumsporozoite protein. Kumar S, Zheng H., Sangweme DT, Mahajan B, Kozakai Y, Pham PT, Morin MJ, Locke E, Kumar N. J Immunol Meth 2013 In press.

Radition-induced cellular and molecular alterations in asexal intraerytrocytic Plasmodium falciaprum. Oakley MS, Gerald N, Anantharaman V, Gao Y, Majam V, Mahjan B, Pham PT, Lotspeich-Cole L, Myers TG, McCutchan TF, Morris SL, Aravaind L., Kumar S. J Infect Dis 2013, 2017: 164-174.

Oakley, M. S., N. Gerald, T. F. McCutchan, L. Aravind, and S. Kumar. Clinical and molecular aspects of malaria fever. Trends Parasitol, 2011, 27:442-449.

Oakley, M. S., V. Anantharaman, T. M. Venancio, H. Zheng, B. Mahajan, V. Majam, T. F. McCutchan, T. G. Myers, L. Aravind, and S. Kumar. Molecular correlates of experimental cerebral malaria detectable in whole blood. Infect Immun, 2011, 79:1244-1253.

Mahajan, B., A. Selvapandiyan, N. J. Gerald, V. Majam, H. Zheng, T. Wickramarachchi, J. Tiwari, H. Fujioka, J. K. Moch, N. Kumar, L. Aravind, H. L. Nakhasi, and S. Kumar. Centrins, cell cycle regulation proteins in human malaria parasite Plasmodium falciparum. J Biol Chem, 2008, 283:31871-31883.
 


Picture of Suzanne B. Schwartz

Suzanne B. Schwartz, M.D., M.B.A.
Director Emergency Preparedness/OPs
and Medical Countermeasures
Office of the Center Director
Center for Devices & Radiological Health
Supervisory Medical Officer

Education:
MD, AECOM 1988
MBA, NYU-STERN 2012
National Preparedness Leadership
Initiative, Harvard Kennedy School of
Government & Harvard School of Public
Health, 2012-2013.

Professional Experience:
FDA: total years – 2.5
Medical Officer – ’11 to present
Commissioner’s Fellow, ’10-‘11
Weill Cornell Medical College- New York
Presbyterian Hospital – Assistant
Professor Surgery, 1999-2010
Medical Director, Ortec International, Inc
New York City, 1996-1999
General Surgery and Burn Trauma Training: Montefiore Hospital and New York Hospital, NYC, 1988-1996
 

CDRH Emergency Medical Countermeasures Program (EMCM)

Program Background:

Medical countermeasures (MCM) are drugs, devices – including diagnostics – and other medical interventions that can mitigate the harmful effects of chemical, biological, radiological, nuclear (CBRN) threats as well as those from emerging infectious diseases.

At CDRH, the vision of the Emergency Preparedness/Operations and Medical Countermeasures (EMCM) Program is to ensure that the American people have ready access to safe, effective and secure medical devices at all times – especially before and during response to any natural, accidental or intentional public health emergency.

Research Interests:

Operational improvements across the MCM space; innovation and stakeholder collaboration for MCM development and deployment; MCMs for burn mass casualty incident; public health emergency preparedness & operations via all-hazards approach; building resiliency in medical devices to counter environmental threats from natural disasters such as extreme weather, and to protect against cyberthreats for which certain medical devices may be vulnerable.

Proposed Regulatory Research Project for the FDA Commissioner's Fellow:

Develop MCM device database infrastructure that will integrate with the Center’s Tracking System (CTS) for identifying premarket submissions of potential medical countermeasures and for tracking their progress through regulatory review. The fellow will support establishment of newly-defined metrics that are crucial for enhancing the flow process of MCM submissions through Center review. This integrated system will enable EMCM to better understand and predict potential bottlenecks and be well-positioned to propose streamlining approaches. Further, it will enable EMCM to: (1) keep pace with rapid evolution of MCM device technology; (2) flag submissions that contain a Department of Defense (DOD) or other Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) partner tie in, ensuring rapid attention to those that warrant an expedited review and; (3) respond most efficiently and comprehensively on behalf of the Center to data calls from the Office of the Commissioner, the Department of Health and Human Services, and Congress regarding scope of MCM activities and the Center’s MCM product portfolio. To accomplish this objective:

  • The MCM Fellow will interface across multiple offices throughout the Center in order to gain a thorough understanding of the MCM device landscape from pre-market review through postmarket surveillance and how each Office is engaged in the total product lifecycle. Where the opportunity arises to be involved in a pre-Emergency Use Authorization (preEUA) application, the MCM Fellow may serve as an additional resource to the Center working directly with the specific Branch/Division, the EMCM Director and Center Senior Policy Staff.
  • The MCM Fellow will additionally be expected to actively participate in all CDRH and Agency-wide MCM/Emergency Preparedness seminars so as to inform his/her knowledge of this mission space.
  • Finally, the MCM Fellow will be encouraged to partner with ongoing MCMi funded Regulatory Science research efforts within the Center by adding a novel qualitative research dimension (e.g., through survey questionnaire development and conducting depth interviews or focus groups) to an existing project.

Applicant Requirements:

PhD, MD, or an equivalent degree in engineering or computer sciences. Informatics experience while not essential, would be considered favorable.

Selected Recent Publications:

Schwartz, SB. FDA Regulation of Burn Wound Products: Pathways to Market. 25th Annual Southern Burn Region American Burn Association Meeting – Burn Product Development Symposium, Norfolk, Va, November 2012.

Schwartz SB, Jeng J, Hickerson W et al. Proceedings of the September 2012 FDA Public Workshop: Medical Countermeasures for a Burn Mass Casualty Incident. Manuscript in preparation.

Schwartz SB. Standardized Outcome Measures to Guide Clinical Trials in Burn Patients: An FDA Perspective. American Burn Association Burn Quality Consensus Conference, Washington, DC, February 2012.

Schwartz SB. Advancing Products for Burn Care: Are We Meeting Today’s Needs? A Preliminary Landscape Analysis, 24th Annual Southern Burn Region American Burn Association Meeting, Winston-Salem, NC, December 2011.

Schwartz SB, Rothrock M, Barron-Vaya Y, et al. Impact of Diabetes upon Burn Injury: Preliminary Results from Prospective Study. J Burn Care Res 2011;32:435-441.