POSTDOCTORAL FELLOW, Quality of Medical Products at Boston University, USP Quality Institute

Tracking Code9960/E2218 Job Description

Boston University (BU) and the U.S. Pharmacopeial Convention (USP) Quality Institute have partnered to establish a fellowship program. This Request for Applications (RFA) seeks early career scientists and researchers who wish to receive specialized training, conduct novel research, and contribute to the evidence base on the value of quality medicines.

The Fellowship in Quality of Medical Products will foster the research, scholarship, and careers of individuals who are poised to work with academia, government, and industry to advance knowledge about the impact or value of quality medicines. Fellows will have the unique opportunity to engage in real-world training experiences, including interactions with USP scientific staff and other stakeholders.

The USP Quality Institute defines medicine quality as a balanced, risk-based set of pre-specified characteristics, systems, and requirements that consistently ensure a medicine’s delivery of stated and implied clinical outcomes for patients. This definition encompasses all aspects of a medical product’s lifecycle, including design, manufacture, supply chain, storage and distribution, as well as falsification. Excluded from this definition is the quality or appropriateness of treatment guidelines and practices.

Product quality can be designed into, improved, and reinforced all along the medicine continuum, from initial drug research all the way through to the dispensing of the medicines. These interventions differ for different products, product classes, and geographies, and have varying costs, feasibility, and outcomes. Assessing which interventions are most actionable and potentially effective is of critical importance to promote judicious policies and investment aimed at promoting medicine quality. USP has strong, trust-based relationships with quality professionals and healthcare policy makers globally, as well as several well-established offices and training centers in regions throughout the world. These strengthen USP’s understanding of local priorities and specificities, as well as its ability to effectively disseminate robust evidence and recommendations.

Research

The potential consequences of antimicrobial resistance (AMR) are significant and may include massive loss of life, widening socioeconomic disparities, and significant economic shortfalls. Approximately 700,000 people from around the world die each year due to drug-resistant infections.1 Estimates of the potential economic impact of AMR are uncertain, but could be as large as a global, annual GDP shortfall of nearly $3.4 trillion by 2030.2

Antimicrobial resistance is driven, in part, by pathogens’ exposure to medicines of poor quality or delivering sub-therapeutic doses of the active pharmaceutical ingredient. Sub-therapeutic doses drive AMR when drug concentrations in the body are too low to quickly eradicate the infection, but are high enough to create a reproductive advantage for resistant mutants by killing susceptible pathogens, often referred to as the “mutant selection window.” Poor-quality medicines may be the result of (1) products produced under quality standards but degraded due to inappropriate storage or distribution, or (2) products produced under poor-quality standards, whether inadvertently or intentionally. Regardless of the root cause, issues with medicine quality abound, with the World Health Organization recently reporting that approximately 10% of medicines globally are substandard or falsified, and 40% of those are antimicrobials.3

Fellowship applicants are asked to propose a research project that aims to address an important evidentiary gap in demonstrating the value of medicine quality related to issues of antimicrobial resistance. Examples of such gaps may include:

- Measuring the extent to which poor-quality medicines contribute to the rise of AMR

- Understanding how resistance develops and spreads in relationship to poor quality medicines

- Assessing how policies or practices to reduce the prevalence of poor-quality medicines in a healthcare system impacts the onset of AMR (“bending the AMR curve”)

- The benefits of delaying or reducing the onset of AMR for individuals (e.g., health outcomes), societies (e.g., population social mobility), countries (e.g., GDP), or the global community

- The impact of quality-improving interventions at specific points along the medicine continuum

- The resource requirements or costs of assuring antimicrobial medicine quality

- Identifying actionable solutions (i.e., resource, regulatory, or policy) to improving the fraction of quality antimicrobial medicines, and defining strategies and approaches to address hurdles that impede these efforts

Fellows will be expected to analyze data and report findings in peer-reviewed publications and to the broader scientific and policy making community. Data may be accessed from public sources or newly generated. In addition, USP resources referenced above can be made available to fellows in support of their research projects.

Mentorship

The fellowship will provide a research opportunity that includes a co-mentorship team comprising faculty from BU, experts at USP engaged in research related to quality in medicines, and members of the USP Quality Institute Advisory Group or Steering Committee. Working under the direction of co-mentors, the awarded fellow will refine a research plan, including considerations for Institutional Review Board and other implementation details (e.g., identifying and gathering data).

Co-mentors will commit to the full duration of the fellowship; they will collaborate in the supervision and guidance of the fellow’s research project as well as meaningful outcomes. That is, the fellow is expected to disseminate research methods and/or findings through high-impact, peer-reviewed publications and presentations at national and international research meetings. Research project(s) will be refined and conducted based on mutual interests and competencies of the fellow and co-mentors.

Fellowship Activities

• The fellow will work with mentors to advance evidence for the value of medicines quality. Key activities and training outcomes include:
• Initiate and independently conduct at least one research project on issues relevant to medicines quality, incorporating guidance from mentors as described above
• Develop a comprehensive understanding of the value of quality medical products, its applications to public health, and key evidentiary gaps in the demonstration of that value
• Collaborate with faculty and scientists from BU and USP on research initiatives
• Attend scientific meetings and summarize the process and outcomes of such meetings
• Present on selected medicine quality topics at meetings or in a written format
• Experience learning opportunities with USP (e.g., direct interactions with staff, giving or attending presentations, attendance at select meetings)

Candidate Qualifications

Ideal candidates will demonstrate a strong interest in medicine quality through their professional and educational backgrounds. Candidates should be enthusiastic, self-motivated individuals who have a deep desire to develop their careers at the intersection of academia, industry, and government. Specifically, candidates should possess the following qualifications:

• Advanced degree in a related scientific field (e.g., MD, PhD, or the equivalent)
• Ability to write and communicate clearly and thoughtfully
• Experience and comfort working in a research setting
• Demonstrated capacity to work independently and collaboratively

Location and Duration

The fellow will work full time at Boston University in Boston, Massachusetts, USA. The fellow will be awarded an initial one-year term with a one-year extension upon successful completion of the first year. Success will be defined by pre-specified milestones and deliverables, which the fellow will establish with co-mentors and program directors from BU and USPQI. The start date of the fellowship will be on or before October 1, 2018.

Benefits

• Competitive salary (up to $70,000, commensurate with education and experience)
• Comprehensive benefits including medical, dental, vision, and others
• Funds for travel to professional conferences, at the discretion of fellowship mentors
• Support for research and publications costs

Conditions

This fellowship is supported by the USP Quality Institute and administered by BU. The awardee will be appointed as an academic fellow to an appropriate BU department, depending on educational background and prior training. Upon appointment, BU will require the fellow to complete annual disclosure forms listing financial and other interests that they, their spouses or minor children, or organizations in which they are involved (as a partner, employee, board member, etc.), have a financial interest that may give rise to real or apparent conflicts with the work of the fellowship.

Submitting an Application

Submit items 1-6 of the materials listed on the next page as a single PDF in the order listed via email to Muhammad Zaman or Katie Clifford (contact information below) by July 31, 2018. The PDF filename should follow this format: Applicant Last Name. BU-USPQI Fellowship Application.pdf.

Letters of recommendation should be submitted separately to Muhammad Zaman or Katie Clifford (contact information below) via email from the letter authors. Reference letters must also be received by the application deadline. We will notify applicants to confirm letters have been received.

Required Skills

Application Criteria & Key Dates

Tuesday, July 3, 2018 – Letter of Intent

Applicants are required to submit an email letter of intent (LOI) and strongly encouraged to do so by the date listed above. LOIs sent after the date above, and before the application deadline, will be accepted.

LOIs should include the applicant’s name, highest degree and conferring institution, and contact information (i.e., email address, mailing address, and phone number), as well as a copy of the applicant’s resume or CV. Applicants should indicate their eligibility to work in the United States (i.e., U.S. citizen or permanent resident, holder of a U.S. visa allowing employment, non-U.S. resident/non-U.S. visa holder).

The LOI should be sent via email to Muhammad Zaman or Katie Clifford (contact information below).

Tuesday, July 31, 2018 – Application Deadline

Required Application Elements

1. Cover Page (template sent to you upon receipt of the LOI; see above)
2. Curriculum Vitae (5 page maximum)

3. Personal Statement (500 words maximum) describing professional background, interest in medicines quality, and how the fellowship aligns with long-term career goals.

4. Research Proposal (5 pages maximum, excluding references, in Times 11pt font, 0.5 inch margins) describing a research project to undertake during the fellowship (see “Research” section above). The proposal is intended to gauge the interests, thoughts, and competence of applicants rather than constitute a fully formed research plan. Proposals should include the following:

   • Title, objective, aim(s), methodologic and analytic approaches
   • Data Sources: Data may be accessed from public sources or newly generated. USP resources referenced above can be made available to fellows in support of their research projects. If existing data will be utilized, source(s) should be cited.
   • Challenges or Limitations: The proposal should identify possible challenges or limitations to the feasibility of the research.
   • Milestones: The proposal should identify specific, meaningful milestones that will help to close the evidence gap (as discussed in the “Research” section above) and are feasible to accomplish in each year of the two-year fellowship.
   • Mentorship Plan: The proposal should also indicate how the applicant expects mentorship (as described above) to benefit the proposed research.
5. Quad Chart (template sent to you upon receipt of the LOI; see above) providing a single-page summary of the proposal, should only include information taken directly from the research proposal.
6. Scientific Publications or Other Writing Samples (submit only 2 publications). Applicant should indicate authorship role in the samples provided (i.e., primary drafter or other role). Publications are intended to gauge the research and writing capability of applicants and do not necessarily need to be on the topic of medicines quality or AMR.

7. Letters of Recommendation. Two professional letters of recommendation are required.

Partner Organizations

• Boston University seeks to understand the role between medicine quality and antimicrobial resistance. Preliminary data suggests that poor quality, beyond sub-therapeutic doses, contribute to resistance. With the help of this partnership, we plan on exploring this link rigorously and understanding how, and to what extent, degradation or presence of impurities lead to resistance. This data would be critical in our understanding and developing robust policy to protect vulnerable populations.

• The Quality Institute is an objective, independent institute based at the U.S. Pharmacopeial Convention (USP), a scientific non-profit organization whose mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. The Quality Institute taps into global health, policy, scientific, and technical expertise to assess the benefits, costs, and feasibility of improving medicine quality. The Quality Institute will build a robust evidence base to facilitate evidence-based decisions that can help increase the availability of quality medicines everywhere, helping to build a foundation for a healthier world.

Contact Information

Muhammad Hamid Zaman

Howard Hughes Medical Institute Professor

Boston University

Email: zaman@bu.edu

Katie Clifford, MPH

Manager, Global Health Initiative (Zaman Lab)

Boston University

Email: clifford@bu.edu

References

1. The Review on Antimicrobial Resistance. May 2016. “Tackling Drug-Resistant Infections Globally: Final Report and Recommendations.” Available from: https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf.
2. World Bank. March 2017. “Drug-Resistant Infections: A Threat to Our Economic Future.” Washington, DC: World Bank. Available from: http://documents.worldbank.org/curated/en/323311493396993758/pdf/114679-REVISED-v2-Drug-Resistant- Infections-Final-Report.pdf.
3. World Health Organization. 2017. WHO Global Surveillance and Monitoring System for substandard and falsified medical

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.

Job Location Boston, Massachusetts, United StatesPosition TypeFull-Time/Regular