USP Global Fellowship Program

USP names its 2015-2016 fellowship recipients. Learn about them and their work here.

Advance New and Innovative Research

The USP Global Fellowship Program presents awards to doctoral and post-doctoral students to advance new research contributing to innovative or updated quality standards for chemical and biological medicines, excipients, dietary supplements, herbal medicines, healthcare quality, and food ingredients. Since the program's inception in 1981, USP has invested nearly $4 million in more than 200 Fellowship awards. 
 

Our 2014-2015 Fellows

Nicholas Myers: Paper-based Iodometric Titration for Quantification of Antibiotics 
 
The Notre Dame graduate student’s research focused on creating paper-based test cards to detect low quality drugs in the developing world and to quantify micronutrients in fortified delivery platforms. Nick was mentored by USP Director of Science & Standards, Biologics, Dr. Maura Kibbey.
 
 
Khaja Muneeruddin: New Mass Spectrometry-based Methods to Characterize Highly Heterogeneous Biopharmaceuticals
 
Muneer, a University of Massachusetts Ph.D. candidate, researched the development of mass spectrometry and liquid chromatography for characterization of structural heterogeneity in protein-based therapeutics and antibody-drug conjugates. Under the mentorship of Principal Scientific Liaison, Dr. Anita Szajek, Muneer’s research culminated in a presentation at USP-Rockville entitled "Ion exchange chromatography and ESI MS to characterize protamine and its interaction with heparin analogues."
 
Ahmed Shalash: Investigation of Performance Descriptor(s) in Carrier-based Dry Powder Inhalers 
 
A postgraduate student at the University of Alexandria, Egypt, Ahmed’s research strives to provide advanced insights into physiochemical properties that control dry powder inhaler performance, particularly the role of carrier surface roughness. With research direction from Catherine Sheehan, USP Senior Director, Science-Excipients, and Dr. Galina Holloway, Senior Scientific Liaison, Ahmed delivered a post-fellowship presentation at USP-Rockville entitled "Investigation of microstructural performance descriptors of dry powder inhalers."
 

 

Research Priorities

Applicants are encouraged to ensure their research aligns with one of these topics:
 

General Research

  • Modernization of monographs (analytical methods): assessment and prioritization of needs, implementation.
  • Particle characterization technologies that could lead to general chapter additions/improvements and/or methods for monograph use.
  • Field portable spectroscopic techniques combined with chemometric approaches for counterfeit detection.
  • Single instrument/measurement approaches to chemical ID and quantitation of materials for food reference standards (e.g., low cost food reference materials/standards).
  • Creation of new topical/dermal dosage formulations as use for reference materials suitable for in vitro apparatus performance verification testing.

Chemical Medicines

  • Development of analytical method(s) for the analysis of inorganic species in drug products and drug substances (similar to what is described in General Chapter <191> Identification Tests—General).
  • Development and validation of orthogonal identification test in drug substance and drug products.
  • Development of performance (e.g., dissolution) test procedures for OTC products.
  • Development of impurity procedures to fully characterize impurities in drug substance and drug products.
  • Replacement of microbial assay with HPLC method.
  • Modernization of monographs-method development validation (replacing titration with HPLC or replacing wet chemistry procedures with chromatography or other instrumental techniques).

Biologics and Biotechnology

  • Flow cytometry in biological applications that could lead to general chapter additions/improvements and/or methods for monograph use.
  • Purity assessment (protein concentration determination assays).
  • Methods to revise the protein content determination and purity assessment.
  • Use of molecular biology techniques for species identification for wheat or other food-based components.
  • Higher order structure characterization for complex materials/molecules.
  • Modernization of activity assays, especially enzymatic assays.
  • Bridging product-specific bioassays.

Excipients

  • Development of rheological methods for the effective characterization of excipients, hydroxyethyl cellulose and carboxymethyl cellulose sodium.
  • Development and validation of orthogonal identification test(s) for excipients.
  • Development and validation of analytical method(s) for excipients used in B&B drugs.
  • Development of procedures that can be used to qualify excipients in a QC setting and determine if fit for intended pharmaceutical purpose.
  • Development and validation of analytical method(s) for nanotechnology derived excipients.
  • Development and validation of authentication/identification and quantitative assay/purity methods that can discriminate adulterated from non-adulterated materials for pharmaceutical components at risk for intentional adulteration.
  • Development and validation of a predictive model to help identify excipients vulnerable to intentional adulteration.
  • Molecular weight distribution determination for water soluble polymeric excipients by SEC/MALDI.
  • Advanced macromolecular excipient characterization to decrease variability in USP excipient standards. 

Dietary Supplements

  • Development of performance standards for dietary supplement in gummies.
  • Development of chemometric approaches for compendial identification tests of botanicals and other natural products with variable composition using fingerprint pattern recognition.
  • Application of databases to compendial tests: Development of methods for sample data comparison with references housed in databases and setting acceptance criteria.

Food Ingredients

  • Modernization of analytical methods (development  and validation for the following Food Chemicals Codex monographs):
    • Quantitative impurity tests and reference standards for synthetic food approved colors.
    • Identification and assay methods of food ingredients with optical isomers.
    • Replacement of wet chemistry methods with modern instrumental analytical procedures in inorganic food ingredients.
  • Development and validation of analytical methods to assess the quality and integrity of any nanotechnology derived food ingredient(s).
  • Development and validation of analytical methods to detect genetically modified organisms (GMO) in food ingredients for labeling purposes.
  • Development and validation of a predictive model to help identify food ingredients susceptible to economically motivated adulteration.

Healthcare Quality Standards

  • Identify the pertinent safety issues in the electronic health environment and develop recommendations for the Healthcare Quality Expert Committee to consider for standards development.
  • Support the development of a classification system database for Medicare Model Guidelines, Allergy and Intolerances value sets and Model Guidelines for all US marketed products.

Eligibility

Applicants must:
  • Have been accepted for full-time study in a Ph.D. or Pharm.D. program, or medical or dental school; or
  • Have been awarded a postdoctoral research (non-faculty) appointment.
 
Non-U.S. applicants must have a background in standards and currently be enrolled in an equivalent educational program. International students must possess the appropriate visa required to participate in the Global Fellowship Program. USP will not assist students to obtain a visa for this purpose. USP may require proof of visa status as a condition of offering a Fellowship to a student.
 
Applicants for Global Fellowships may not currently be in receipt of funds from USP, or directly or indirectly under contract with USP, even if the activity is unrelated to the applicant’s research proposal.
 
The USP Global Fellowship Program allows for subsequent year's funding; however, second and third awards are not automatic. Applications for continued funding must include a progress report on the research up to the time of application.
 

Selection Process

  • Applications are reviewed by a USP internal selection group composed of USP senior scientific staff.
  • Each proposal's significance is ranked on how closely it addresses a specific area of USP research.

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