Global
Fellowship Program

Advance New and
Innovative Research

Guided by ourvision, 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.

2016-2017
Fellowship Applications Now Being Accepted

Application
deadline for 2016-2017 fellowships is October 28, 2016.

APPLY

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.

Spectroscopic techniques combined with chemometric
approaches for counterfeit and fraud detection.

Creation of new topical/dermal dosage formulations as
use for reference materials suitable for in vitro apparatus performance
verification testing.

Continuous Manufacturing: New technologies for both
material characterization and advanced analytical testing in support of
in-process control and real time release testing (RTRT).

Nanomedicines: New analytical technologies applicable to
the measurement of quality attributes and performance tests.

Characterization of the composition of gastrointestinal
fluids in animal species.

General Chapter technique relevance to global health
monographs.

eHealth (digital health) related technology development
that enhances healthcare quality.

Novel development in emerging pharmaceutical
manufacturing technologies including 3-D printing.

Precision medicine (personalized medicine) related novel
development research.

Quantitative NMR technology.

DNA based identification technology.

Novel advanced analytical technologies for on-line
analyses and/or portable comprehensive analysis.

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).

Development and validation of LC-MS or GC-MS procedures
for the analysis of genotoxic impurities.

Use of mass spectrometric analysis of high-throughput
screening of small molecule drug products.

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.

Development and validation of analytical methods for
characterization of vaccines.

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 (e.g., investigate the use of low field NMR as a
new tool for the identity testing of excipients.)

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/MALS.

Advanced macromolecular excipient characterization to
decrease variability in USP excipient standards.

Dietary
Supplements

Establishment of advanced analytical methodologies for
characterization of complex biopolymeric constituents of dietary
supplements.

“Electronic reference”: concept development and
software-driven implementation in pharmacopeial context.

Integration of chemometric analysis into identification
schemes suitable for implementation within pharmacopeial monographs.

“Big data” use in compendial analysis: custom software
solutions to authentication based on collating of numerous streams of
analytical data.

Practical implementation of DNA-based analysis in
supplements derived from plant or animal sources, and its compendial use.

Development of performance standards for dietary
supplement in gummies.

Application of databases to compendial tests:
Development of methods for sample data comparison with references housed
in databases and setting acceptance criteria.

Food
Ingredients

Development and validation of new tools for
assessing risks for food ingredient supply chains to food fraud such as:

Case studies or meta-analysis on the
implementation and validation of food fraud vulnerability assessment and
mitigation tools.
Research to develop and validate
economic anomaly models for anticipating food fraud vulnerabilities.

Research into global industry and consumer trends for
food ingredients to inform future directions and needs for USP standards
in line with USP’s public health mission.

Development and validation of analytical methods for the
following areas:

Non-targeted methods for
fraud/adulteration detection in fraud vulnerable ingredients.
DNA based methods for detecting
fraud in protein-based food ingredients.
Development of new protein
characterization/quantitation methods to help authenticate protein-based
ingredients.

Single instrument/measurement approaches to chemical ID
and quantitation of materials for food reference standards (e.g., low cost
food reference materials/standards).

Healthcare
Quality Standards

Healthcare Information Technology (HIT) and value to
risk reduction in the healthcare environment

Characterize, quantify and
prioritize medication safety issues occurring within electronic health
environments.
“Big data” analytics utilization in
the prevention and reduction of medication errors.

Translation and implementation of published USP
Compounding and Hazardous Drugs Standards

Development of innovative
educational strategies to ensure practitioner competency with performance
of sterile procedures as described by USP <797> (e.g., simulated
training, video training library, observation and training venues).
Development of best practices of
implementation of USP compounding standards within in-patient settings,
including hospitals, long-term care facilities and nursing homes.

Advancements in Healthcare Quality and Safety

Definition of the risk of healthcare
associated infections (HAI) in compounding practice.
The development of continuous
quality improvement tools to support reduction of healthcare associated
infections (HAI) related to medication preparation and administration
practices.
Antibiotic stewardship:
Quantification of the challenge, and draft ‘standard’ for judicious use
of antibiotics.

Modernization of Nomenclature and Labeling

Advances in electronic indexing and
digital information of chemical information and compound structure.
Optimization and standardization of
labeling nomenclature in compendial monographs.

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 senior scientific staff.
Each proposal’s significance is ranked on how closely it
addresses a specific area of USP research.