Abpro Labs

Alumna: Anna Fydrych

Title: Intern- Strategic Market Assessment and Pharmaceutical Demand Analysis for a Specific Biotechnology Platform

Introduction: The former market model in which novelty biotechnologies and pharmaceuticals were standalone entities, is rapidly changing. Within the new market landscape, pharmaceutical giants and biotechnology platforms horizontally integrate to support R&D capacities. Specifically, this integration is examined in Iain Cockburn’s Health Affairs publication, “The changing structure of the Pharmaceutical Industry”, where he discusses the biotechnology sector’s evolving and vital role in the pharmaceutical industry. Abpro Labs is a biotechnology company that has streamlined the major steps to producing recombinant proteins using a high throughput method. By mechanizing the production of this major pharmaceutical drug discovery tool, the process of developing new therapeutics is greatly accelerated. The market model is applicable in this case, as an industrialized gene to protein platform directly improves research efficiency and drives innovation, resulting in a new age of pharmaceutical discovery. In order to support the launch of this high throughput platform, several strategic market positioning analyses are necessary.

Methods: The strategic market assessment was completed in a series of steps including, identifying major players in the market, assessing specific product demand, gathering competitive data, competitive mapping, and segmenting the market accordingly. To further understand the customer process assessment from the pharmaceutical side, an LP analysis on customer data generated a process analysis model.

Results/Outcomes: Completed full market assessment report and produced a customer process analysis model.

Alkermes

Alumnus: Jesse Anderson

Title: New Product Planning Intern

Introduction: Access to medications is an important issue in public health. It affects everyone who requires medications daily to cope with chronic diseases. As part of the New Product Planning team at Alkermes, we constantly analyze market trends to maximize patient access and support services to the patient population we target. We looked at many stakeholders in the healthcare system, including payers, healthcare providers, and patients, to better inform us on issues of access. The goal of this project was to examine and understand the factors affecting the awareness and utilization of support services for this product. 

Methods: I worked directly with a partner organization, which fielded the surveys to our target patient population. My responsibilities on this project included: (1) developed the screener and questionnaire to be administered to patients with this disease; (2) managed the project timeline to ensure timeliness; and (3) analyzed the data to present to internal stakeholders. 

Results/Outcomes: This data helped the team better understand what support services are valuable to the patient. It also informed stakeholders’ decision-making as to what support services were most utilized and worthwhile to offer our patients. Using this information, stakeholders chose and designed these services to fit patient needs.

Alliance for the Prudent Use of Antibiotics

Alumna: Katherine Broecker

Title: Global Public Health Intern

Introduction: Founded in 1981 as a non-profit organization, APUA’s mission is to maximize the effectiveness of antimicrobial treatment by promoting appropriate antimicrobial use and containing drug resistance. Globally, APUA is a respected resource to guide antimicrobial supply, treatment, and policy decisions. APUA provides consultations to industry, governments, and organizations seeking to improve antimicrobial supply, use and management decisions. The APUA local chapters serve as reliable resources for collection and dissemination of information and advocacy for antimicrobial management.

Methods: I provided project support to accomplish APUA’s goals of improving global antibiotics access, use, and containment. Through social media and press releases, I increased awareness of the CDC’s antibiotic stewardship campaigns. I communicated with APUA’s international chapters and partners regarding developments in antibiotic research and policy, and completed deliverables of an unrestricted educational grant with Alere pharmaceuticals.

Results/Outcomes: I organized an international summit meeting of 12 key opinion leaders regarding the use of rapid diagnostic point of care tests and biomarkers such as CRP, developed and analyzed a survey of 150 primary care physicians regarding prescribing habits, submitted a manuscript to the Journal of Family Practice, and developed a PDF of educational materials. I published two newsletters on superbugs and antibiotic resistance genes. On-going outcomes include a four-stage webinar of hospital stewardship programs through an educational grant from BacterioScan and a showing of the documentary “Resistance” with a panel Q&A and sponsors Applegate and Panera at Coolidge Corner Theatre on Sept 25.

American Enterprise Institute

Alumna: Alexandra McPherson, MPH, PharmD Candidate

Title: The Impact of Drug Registration and Regulation on the Prevalence of Counterfeit and Substandard Drugs in 12 Countries- Health Policy Studies (Pharmaceuticals)

Introduction: AEI is a private, non-partisan, not-for-profit institution dedicated to research and education on issues of government, politics, economics, & social welfare. I interned for Dr. Roger Bate in the Health Policy Studies division, where I focused on the global health issue of counterfeit and substandard drugs.

Methods: This practicum involved comprehensive research on drug regulation and registration in 12 countries that have a known issue with counterfeit and substandard drugs – Argentina, Brazil, China, India, Kenya, Nigeria, Peru, Russia, Thailand, Turkey, Uganda, & Vietnam. Fellow BUSPH student Sarah Naoshy and I collaborated to complete the following projects while at AEI: 1) Research reports & summary analyses on 12 countries, 2) Comparison charts, 3) The discussion section of a paper entitled, “Variability of product consistency in developing and mid-income countries: an assessment of raman spectra,” and 4) A working paper entitled, “Drug registration – a necessary, but not sufficient condition for good quality drugs – a preliminary analysis of 12 countries.”

Results/Outcomes: This research has been and will continue to be used as a reference in composing a series of working papers and journal articles. We plan to remain in communication with Dr. Bate and contribute to the next two working papers in the series, including one on regulatory successes and failures, and another on pharmacovigilance.  Ideally, our research will be used from a policy perspective to locate the gaps in drug regulation and registration procedures which enable counterfeit and substandard drugs to thrive in both developed and developing countries.

Alumna: Sarah Naoshy

Title: The Effect of Drug Registration, Regulation and Post-marketing Surveillance Systems on the Quality of Drugs in 12 Countries

Introduction: Comprehensive research was conducted on the drug regulatory structure, drug registration systems, manufacturing practices and the post-marketing surveillance systems of the aforementioned countries. I collaborated with Alex McPherson, another BUSPH student, to complete summary research reports & analyses for all 12 countries, comparison charts of the developed and developing countries and to write the discussion section for a study titled, “Variability of product consistency in developing and mid-income countries: an assessment of raman spectra.”

Methods: This practicum involved comprehensive research on drug regulation and registration in 12 countries that have a known issue with counterfeit and substandard drugs – Argentina, Brazil, China, India, Kenya, Nigeria, Peru, Russia, Thailand, Turkey, Uganda, & Vietnam. Fellow BUSPH student Sarah Naoshy and I collaborated to complete the following projects while at AEI: 1) Research reports & summary analyses on 12 countries, 2) Comparison charts, 3) The discussion section of a paper entitled, “Variability of product consistency in developing and mid-income countries: an assessment of raman spectra,” and 4) A working paper entitled, “Drug registration – a necessary, but not sufficient condition for good quality drugs – a preliminary analysis of 12 countries.”

Results/Outcomes: Coauthored a working paper titled, “Drug Registration – a necessary but not sufficient condition for good quality drugs – a preliminary analysis of 12 countries” that assesses the legislative environment and the registration processes in which drugs are made for people worldwide. Conclusions from the paper highlighted country specific problems in registration, in addition to challenges that all countries struggle with, such as corruption. The research we conducted will be used to contribute to an additional set of working papers for AEI, which will cover drug regulatory structures and post-marketing surveillance systems of these countries.

AmerisourceBergen

Alumna: Catherine Emmons

Title: Data Analytics Intern

Introduction: IntrinsiQ, an AmerisourceBergen Specialty Group, provides oncology information systems, as well as oncology data and analysis to pharmaceutical companies, medical practices, and hospitals within the U.S. The analytics team is responsible for performing research and analyzing data to provide clients with an understanding of particular cancer diagnoses, treatments, and trends.

Methods: The main objective of this practicum was to conduct a series of epidemiological reviews of major cancer diagnoses. Through utilization of the Surveillance, Epidemiology, and End Results (SEER) Program, I constructed a guide to provide a review of the database, its uses and limitations, and instructions on addressing common queries. I identified and summarized clinical, regulatory, and governance news events shaping oncology drug consumption trends. I also conducted extensive research on dosing limits for oncology drugs.

Results/Outcomes: The epidemiological reviews of cancer diagnoses will contribute to annual analytic reports provided to pharmaceutical clients. Becoming familiar with the SEER Program Database and SEER*Stat statistical software allowed for successful development of a detailed instructional guide for data analysts. The review of news events pertaining to particular oncology drugs will contribute to an analysis tool that quantifies the impact of these key events in shaping drug consumption trends in the U.S. The research on dosing limits for oncology drugs will contribute to database operations in constructing data scrubbing algorithms for oncology information systems.

ARIAD Pharmaceuticals, Inc.

Alumna: Alexandra Rogers, MPH

Title: Market Research Intern

Introduction: Lung cancer kills 1.38 million people each year. Anaplastic Lymphoma Kinase Positive, Non-Small Cell Lung Cancer (ALK+ NSCLC) is a rare form of cancer marked by a chromosomal translocation that creates a fusion gene. ARIAD Pharmaceuticals, Inc. has developed a drug, AP26113, which treats this rare form of cancer. In order to understand the marketability of this drug, it is important to determine the incidence of the disease both in North America and globally.

Methods: A literature review was conducted to understand the incidence of ALK+ NSCLC in North America, Japan, and EU countries.

Results/Outcomes: We found that 4.6% of North American patients with NSCLC are ALK+, 5.5% of European Union patients with NSCLC are ALK+, and 3.3% of Japanese patients with NSCLC are ALK+ for a given year. One limitation of this literature review was the fact that each study was included regardless of which method of analysis was used to determine ALK positivity. Immunohistochemistry (IHC), FISH Vysis Assay (FISH), and reverse transcription polymerase chain reaction (RT-PCR) were all used to determine ALK positivity. All were included in our review due to the fact that ALK positivity, determined by any of these methods, will ultimately allow the patient to receive the drug. A patient flow model was created using this ALK+ incidence data as well as data on the incidence of the different stages of the disease. This model allows ARIAD Pharmaceuticals to understand the number of patients that will be treated with AP26113 annually.

Biogen

Alumna: Monica Wang

Title: Intern

Introduction: Psoriasis is a chronic, autoimmune skin and joint disease, characterized by scaling papules and plaques and associated with several comorbid conditions, most notably cardiovascular disease (CVD). Study objectives were to conduct a database study to determine the frequency of comorbid conditions in psoriasis patients compared with matched controls anytime in the database history, and in the 12 months prior to and 12 months post first psoriasis diagnosis, and to analyze specific cardiovascular co-morbidities in psoriasis patients post-diagnosis.

Methods: Subjects were derived from a US Claims Database (Clinformatics, 2004-2013), with psoriasis cases defined as having at least 2 ICD9 codes (696.0, 696.1, 696.2, 696.8). Two controls matched on age, gender, follow-up time, and insurance benefits were selected for each case. Comorbid frequencies, odds ratios, CVD incidence rates, and 95% confidence intervals were calculated.

Results/Outcomes: The mean age of study subjects was ~ 45 years, with 50% male. Mean time in the database was 35 months. The most common comorbid conditions in the twenty-four months surrounding the psoriasis diagnosis were respiratory infections, other skin disorders, lipid disorders, hypertension, and non-traumatic joint disorders. Psoriasis cases were moderately more likely than their matched controls to experience many comorbid conditions, though most differences were less than twofold. Psoriasis cases were 50% more likely than controls to have a heart disease diagnosis anytime in the history of the database. The cumulative incidence of any cardiovascular diagnosis twelve months post the psoriasis diagnosis among those with no CVD history was 9%.

Boston Children’s Hospital

Alumna: Lillian Frohlich

Title: Clinical Research Coordinator – Testicular Torsion Study

Introduction: In my role as a Research Coordinator at Boston Children’s Hospital in the Emergency Department (ED), I assisted with a study addressing the effectiveness of a clinical tool used to diagnose Testicular Torsion (TT) in males. The objective of this study is to identify clinical variables associated with TT and elaborate a scoring system for prediction and diagnosis of torsion applicable for general practitioners. The use of a scoring system to help non-specialists diagnose TT could decrease the time spent with testicular ischemia, which would decrease the likelihood of testicular non-viability and reduce the cost of treatment for patients presenting with acute scrotal pain. The purpose of my practicum was to aid in participant enrollment and to determine the use of urinalysis in the evaluation of males presenting with acute scrotal pain.

Methods: My responsibilities included: 1) enrolling participants into the study; 2) assessing the recruitment rates for the manuscript; 3) conducting a chart review for participants to determine the use of urinalysis, urine culture, ultrasound, STI testing, and Urology consultations.

Results/Outcome: My projected results include: 1) A drafted “Figure 1” including all patients presenting to the ED with testicular pain/swelling, numbers of who was excluded and who was missed, and the proportion of those enrolled who were diagnosed with TT; 2) Assessment of the utilization and results of urinalysis for the population enrolled, stratified by diagnosis.

Alumna: Shruti Sachdeva

Title: Data Analyst Intern

Introduction: The Division of Developmental Medicine at Boston Children’s Hospital aims to focus on children who face developmental and behavioral challenges and to support their families throughout their child’s life span. As a data analyst intern, I learned about ICISS Health (Integrated Clinical Information Sharing System) , a web-based platform that provides remote monitoring, real-time analysis, and tracking of patients’ disease symptoms and response to therapy over time.

Methods: I worked with the team to conduct a chart review and analysis to determine the effect of ICISS on rates of ADHD documentation in a large subspecialty practice 2 years post-implementation. We reviewed medical records for rating scales that were documented at follow-up ADHD visits, and we randomly sampled documents quarterly over 3 time periods: pre-implementation, roll-out, and post-implementation. We assessed change in visit-based documentation rates of parent and teacher ADHD rating scales using statistical process control charts for proportional data (p-charts), stratified by eDMC user vs. non-user status.

Results/Outcome: We reviewed 920 follow-up ADHD visits (~50 per quarter) for 548 patients with ADHD (mean age at first visit=9.9 ± 3.1 years, 77% male, 74% white). Pre-implementation, mean documentation rate for any parent or teacher rating scale was 37. Postimplementation, the mean documentation rate increased to 63%.

Boston Collaborative Drug Surveillance Program

Alumna: Hilary Aroke, MD, MPH

Title: Pharmacoepidemiology Intern

Introduction: There are no universally accepted criteria for phenotypic diagnosis of familial hypercholesterolemia (FH) which affects about 10% of people in the United Kingdom (UK). My objective is to assess the accuracy of the diagnosis of FH in the UK-based Clinical Practice Research Database (CPRD).

Methods: All patients with one or more FH read codes were identified in the CPRD. Codes for physical signs and genetic testing of FH were not available. We used other codes – maximum recorded LDL value; use of any lipid lowering therapy (LLT); personal history of premature MI or stroke; family history of premature CVD; first degree relative with FH, and visit to a lipid clinic – to classify all patients with an FH code by the likelihood of having a true FH diagnosis. We used a scoring system that assigned points to various clinical features.

Results/Outcome: Among 5,209 patients with an FH code, 73.6% had a valid LDL value, 76.3% had received a LLT, 20.2% had a family history of premature CVD, 10.4% had a first degree relative with FH, 10.3% had a visit to a lipid clinic, and fewer than 3% had a history of premature MI or stroke. Based on our scoring system, 8.7% of FH diagnoses were classified as likely, 31.89% as probable, 41.54% as possible, and 17.87% as unlikely. We conclude that the FH codes alone are insufficient for identifying true cases of FH in the CPRD. Other supporting clinical characteristics should be used to provide confidence in the recorded FH diagnosis.

Alumnus: Chandrasekar Gopalakrishnan, M.D., M.P.H., C.P.H.

Title: Prevalence of hypercalcemia of malignancy (HCM) among cancer patients

Introduction: Hypercalcemia of Malignancy (HCM) is a relatively common occurrence in cancer patients. It is a severe condition and can be fatal. Increases in serum calcium are caused by bone resorption. Denosumab, a drug used to treat post-menopausal osteoporosis, works by decreasing bone resorption and thus it is hoped that this drug will reduce HCM. One of our study objectives is to calculate annual prevalence of hypercalcemia among cancer patients in the UK CPRD to estimate the public health burden of this illness.

Methods: Perform data validation through review of patient profiles and also conduct statistical analyses using SAS 9.3 to provide annual prevalence of hypercalcemia in cancer cases in the CPRD during the time period 2003 – 2012, by cancer type.

Results/Outcome: The prevalence rates of HCM in the UK CPRD were marginally higher than those in the US. These differences may be due to a greater proportion of patients with advanced disease in the UK who are treated less aggressively compared to the US. We are currently conducting further analyses to better describe these differences

Boston Medical Center

Alumna: Yinzhu Jin

Title: Research Assistant

Introduction: The prevalence of knee arthritis/pain is high in China, limiting patients’ daily physical activities. However, there is no data supporting this epidemiological problem at a national level. The China Health and Retirement Longitudinal Study (CHARLS) aimed at estimating the prevalence of knee arthritis/pain and the effect of knee arthritis/knee pain on patients’ physical impairments.

Methods: Data was obtained from a national survey among Chinese retired populations. During the study period, exposure status and baseline information were obtained through questionnaires, and outcome measures were conducted through series of physical examinations. One of the physical activity indications was measured by five times chair standing test. Time used to stand up straight from chair was measured as one outcome. Linear regression model was used to estimate the association between exposure and outcome, adjusting for age, sex, BMI, education level, smoking/drinking history, injury history, hip fracture, fall, and Charlson Comorbidity Index.

Results/Outcomes: There were 17708 subjects participated in this study. The self-reported prevalence of knee arthritis was 9.2%, and the prevalence of knee pain was 12.7%. Among these subjects, 12869 completed questionnaires and participated in the five times chair standing test. For knee arthritis patients and non-patients, the adjusted mean time to finish the test was 11.2 seconds, and 10.4 seconds, respectively, with difference of 0.8 seconds (95% CI 0.6, 1.0). Results were similar for knee pain subjects versus non-pain subjects, with difference of 0.7 seconds (95% CI 0.5, 1.0). Knee arthritis/pain significantly affects the basic physical activity of patients.

Boston Medical Center, Infectious Disease Clinical Trials Unit

Alumnus: Oluwadolapo (Dolapo) Dami’​ Lawal

Title: Secondary analysis of the SMF study Intern

Introduction: Tuberculosis remains a major public health problem and diagnostic techniques are often fraught with suboptimal sensitivity. These challenges often lead to delay in detection, disease progression and increased transmission of tuberculosis. Many promising diagnostic techniques such as the Small Membrane Filtration (SMF) have been developed lately. The SMF study, a prospective cross-sectional study, was conducted in Uganda by the Tuberculosis Clinical Diagnostics Research Consortium (TB-CDRC); a multidisciplinary team of clinicians, scientists and support personnel whose objectives are to evaluate the efficacy of investigational diagnostic tests and to further improve the accuracy of TB diagnosis. The SMF study postulated that vacuum concentration of sputum followed by smear microscopy increases the detection of Mycobacterium tuberculosis (M.Tb).

Methods: Using a set of quality indicators, this practicum evaluated the performance and operational efficiency of mycobacteriology laboratories involved in the Small Membrane Filtration (SMF) study with respect to sputum microscopy, culture and GeneXpert results. In my role as an intern, I used SAS 9.3 to conduct quantitative analysis of the SMF data and to produce visual presentations of results to communicate results to the TB-CDRC team and participating laboratories.

Results/Outcomes: Upon completion of the analysis, 29.19%, 27.12%, 25.22% and 25.91% of specimens were mtb positive on any culture, MGIT, LJ and Xpert respectively. Results also showed conformity of quality indicators with expected contamination rates, turnaround time and colony counts.

Boston Medical Center, Department of Neurology

Alumna: Kalan Fasoldt, MPH

Title: Research Intern 

Introduction: Neurocritical care is a relatively new subspecialty which aims at improving the care of patients with life-threatening neurologic illnesses.  Traditionally, critically ill neurologic patients are admitted to general or surgical ICUs, where they are cared for by medical or surgical intensivists without specialized training in neurology.  The neurocritical model allows for a defragmentation of the care of critically ill neurologic patients, by replacing the medical intensivist with a neurointensivist; a clinician cross trained in neurology and critical care.  The purpose of this study is to investigate the impact of a neurocritical care service on the effectiveness and efficiency of care provided to patents with ICH at Boston Medical Center.

Methods:  This study uses a retrospective data review for cohort comparisons.  Two cohorts will be compared of patients with ICH admitted through the emergency department to an ICU at BMC.  The “before” cohort with consist of patients admitted before the first neurointensivist at BMC.  The “after” cohort will consist of patients admitted when ICUs were co-managed by neurointensivists.  I worked to 1. Establish both cohorts by identifying cases using specific inclusion and exclusion criteria and extracting information from electronic medical charts and 2. Create an excel spreadsheet in order to organize data and to aid in analysis of the data.

Results/Outcomes:  Effectiveness outcomes to be compared between the cohorts along with data to compare the frequency of common, preventable ICU complications in ICH patients admitted to a BMC ICU before and after the start of the neurocritical care service.

Boston Medical Center, Department of Obstetrics and Gynecology

Alumna: Meghan Bratton, MPH

Title: HPV Vaccine Study Intern

Introduction: Research shows that about half of girls who start the three shot Human Papillomavirus vaccination do not complete the series, while others fail to initiate. Only 35% of girls have actually completed the series. This research study is being conducted to understand parent’s views on the vaccine to help increase initiation and completion rates.

Methods: Parents were approached in waiting rooms to assess eligibility for participation and to sign the consent form. 20 minute interviews were then administered to parents of girls aged 11-18 at both public and private sites. Questionnaires were tailored to daughter’s completion status as the following: uninitiated, incomplete, complete, and unsure. Three race categories including white, black, and Hispanic were recruited from in order to get a broad range of cultural, religious, economic issues that could encourage or inhibit vaccination against this sexually transmitted disease. The research team met weekly in order to collaborate on qualitative research analysis techniques including coding and thematic analysis.

Results/Outcomes: At this point in the study recruitment is still occurring at all three sites. The knowledge gained thus far will be helpful in reaching target vaccination rates by addressing perceived barriers and educating doctors on how to better communicate and educate parents and daughters on the importance of completing the series.

Alumna: Caroline Finlay

Title: Research Assistant – “Parental attitudes toward initiating and completing HPV vaccination”

Introduction: The Boston Medical Center Department of Obstetrics and Gynecology is conducting a study on parental attitudes toward initiating and completing the HPV vaccination. The goal of the study was to understand why parents do not initiate or complete the HPV vaccine series for their daughters, and to see how these reasons differ in parents of different races, ethnicities, countries of origin, socioeconomic status, and public safety net vs. private practice clinical settings.

Methods: As a research assistant, I approached parents accompanying 11-17 year old daughters to medical visits in one public hospital and three private practice settings. If the parents consented, I performed a qualitative interview with the parents to determine the primary reasons why their daughters had not started or completed the vaccine series. The interviews were then coded using qualitative methods to infer themes among the responses. As a research team, we compared answers across race/ethnicity, socioeconomic status, and practice settings, to determine differences in attitudes, perceptions, parent-provider communication, and primary reasons for not completing vaccination.

Results/Outcomes: The preliminary results found were that the most common reported reason for not vaccinating their daughters was the lack of a physician recommendation. Other reasons included lack of information, feeling that daughters were too young, safety concerns, believing that vaccination was unnecessary due to abstinence, or worry that vaccination could promote unsafe sexual practices. The results of this study will be presented at the Society for Adolescent Health and Medicine 2014 Annual Meeting.

Boston Medical Center, The SPARK (Supporting Parents and Resilient Kids) Center

Alumna: Elizabeth Meuser

Title: Data Analysis Intern

Introduction: On January 12, 2010, an earthquake devastated the country of Haiti. After the earthquake, a needs assessment of the psychosocial impact of the earthquake on Haitian individuals was conducted. The purpose of this study was to identify the prevalence of post- traumatic stress syndrome (PTSD) and depression among Haitian residents after the 2010 earthquake. This study also explores service utilization and perceived need of mental health services post-earthquake.

Methods: Eight months after the 2010 earthquake, Dr. Gemima St. Louis went to Haiti and administered questionnaires to Haitian adults, which included scales to measure PTSD and depression. Questions on perceived need for mental health services were also answered. Data collected from over 400 individuals was entered into SPSS and analyzed.

Results/Outcomes: Mean total PTSD score was 48.2510 ±14.58 and the mean total depression score was 26.45 ±13.24. Both scales were found to be reliable (alpha=0.8942, alpha=0.763, respectively). There was a statistically significant increase of individuals that sough mental health services after the earthquake (p=0.003). Of those that sought mental health services 44% were very dissatisfied with the professional services they sought and 87.1% subjects reported a need for community support services. This study suggests that PTSD and depression after the 2010 earthquake are a problem in Haiti. This assessment demonstrates a need to further evaluate how the earthquake has impacted and will continue to impact the Haitian community so that healthcare providers and public officials can better coordinate mental health services and plan effective interventions to support the community’s recovery.

Boston Medical Center, Tuberculosis Clinical Diagnostics Research Consortium (TB CDRC)

Alumnus: Andrew Cohen

Title: TB-CDRC Data Management Intern

Introduction: The Tuberculosis Clinical Diagnostics Research Consortium (TB CDRC) is an international consortium consisting of clinical staff, scientists and physicians who collect and analyze data to determine the field effectiveness of TB diagnostic tools. My primary study analyzes the feasibility of a TB Lateral Flow Urine LAM Test. The goals of the LAM study in Uganda and South Africa are to determine whether the LAM test maintains the specificity and sensitivity of the current gold standard while decreasing diagnosis time, and to determine whether or not those with compromised immune systems are more likely to succumb to TB once testing positive. As data manager, I coordinate data collection from the study sites, create and input data collection forms, and resolve queries.

Methods: Staff in South Africa and Uganda collected participant information and performed both diagnostic and confirmatory TB tests (including direct AFB smear tests). I organized and entered all of the resulting data from those assessments into Access and then performed preliminary analyses on over 1000 cases. Using SAS 9.3 and Excel, I created summary tables and ran comparisons to determine if there were significant differences in TB outcome based upon CD4 count and LAM result.

Results/Outcomes: The analyses revealed there are no significant differences in TB outcome based on CD4 count when stratified by LAM result. The results of this preliminary analysis will be used to determine what LAM values should require treatment based on patient CD4 counts.

Boston Public Health Commission

Alumna: Pawandeep Kaur

Title: Boston Public Health Commission Intern

Introduction: Boston Healthy Start Initiative (BHSI) aims to reduce disparities in infant mortality and adverse perinatal outcomes by improving women’s health, promoting quality services and strengthening family resilience. BHSI funds 10 sites which include community based health centers, hospitals and a health care agency focused on the homeless which primarily serves residents of the Boston neighborhoods of Dorchester, Mattapan and Roxbury. To achieve the goals of BHSI, Boston Public Health Commission (BPHC) will also work with partner organizations as members of a broad, collective impact Community Action Network (CAN). The purpose of this practicum is to create a report on the first year of CAN’s progress and to provide tools and resources to create continuity between the CAN leadership meetings and membership meetings.

Methods: Practicum activities include: 1) organizing and attending CAN leadership meeting and membership meetings; 2) developing templates for CAN meeting notes and work group gatherings; 3) synthesize meeting notes to create action steps and disseminate work plans; and 4) integrate data from the four different working groups into one cohesive document.

Results/Outcomes: It is anticipated that the report will help identify strategies that mitigate the barriers that working groups likely will encounter while implementing the annual agreed upon mission of the CAN. It will also highlight resources and anticipated time commitment required for each group to effectively complete assigned tasks

Boston University School of Medicine

Alumna: Ellen Diedrichsen

Title: Global Health Group Research Assistant

Introduction: Understanding the global pharmaceutical market is essential for identifying new mechanisms to increase access to essential medications. The availability of large transactional data repositories makes possible comprehensive evaluation of the current state of the global pharmaceutical market, however the information needs to be exhaustively cleaned and critically evaluated to provide accurate and informative results. These descriptive analyses are the first step to understanding the impact of fixed dose combinations (FDCs) on the phar- maceutical market and prices.

Methods: Anti-retroviral (ARV) procurement transactions from 2002 until June 2009 were downloaded from the World Health Organization (WHO) Global Price Reporting Mechanism. Records were cleaned, coded, and validated. For the three most common 2003 WHO treatment regimens, the median price for brand and generic individual components as well as FDCs were calculated.

Results/Outcomes: FDCs were introduced to the market at a price lower than the combination of individual components. The price of individual generic components approached the cost of the FDC, but the brand name components were not consistently affected. From the introduction of the FDCs until 2008, the price of the regimen dropped at least 67% for all regimens. While the market was focused on the three FDCs, the price was driven down. Current treatment trends are moving away from these three regimens towards more costly options. It is unclear whether the same cost savings would be obtained for new regimen FDCs, however options such as a patent pool to introduce new FDCs and reduce treatment costs should be explored.

Boston University School of Public Health, Data Coordinating Center

Alumnus: Armando Aguirre

Title: Research Assistant

Introduction: The Data Coordinating Center (DCC) at Boston University’s School of Public Health supplies a range of data management and programming services to research projects in areas as manifold as aging, infectious disease, clinical trials, and genetics. This practicum’s goal was to provide data management support for two studies being conducted in Russia: ARCH Russia, a cohort study assessing the effects of heavy alcohol consumption upon HIV symptoms in HIV+ individuals, and ARCH Russia ZINC, a randomized trial nested within the cohort study investigating the effects of zinc supplementation on the HIV symptoms in persons HIV+.

Methods: Under the guidance of the director of the DCC, support consisted of (1) conducting frequency checks with SAS on study data for quality control purposes, (2) testing electronic questionnaires for accuracy in skip patterns and question format, (3) creating labels and formats in SAS for study variables, and (4) annotating study questionnaires. Participating in monthly meetings and weekly teleconference sessions also served to inform the direction and scope of my activities.

Results/Outcomes: The four principal deliverables of this practicum included (1) creating a study binder for ARCH Russia, (2) testing two electronic assessments for ARCH Russia ZINC, (3) annotating a number of questionnaires for ARCH Russia ZINC, and (4) assisting in the creation of SAS programs for checking data quality for both trials. Taken together, these deliverables contributed to the DCC’s continued provision of high-quality data management services.

Alumna: Jaclyn Franklin, MPH

Title: Data Coordinating Center Intern

Introduction: The DCC provides data management and analytical support to studies and clinical trials worldwide. In this practicum I assisted with projects including URBAN ARCH (Uganda, Russia, Boston Alcohol Network for Alcohol Research Collaboration on HIV/ AIDS) a consortium that has the goal of understanding how alcohol consumption impacts individuals with HIV; FT. Devens ODS which involves Gulf War Veterans and the effects of various wartime exposures; Med Heart which aims to link HIV-positive homeless individuals with needed services and resources; and the Narcan overdose reversal project, a public health initiative that is aimed at preventing opioid overdose.

Methods: I assisted with maintaining project documentation, verifying collected data, writing SAS programs to call in and check data quality as well as coding to assess correctly completed questionnaires, verifying and correcting individuals’ forms in the Narcan program, questionnaire annotation, and problem solving/ trouble shooting for study systems. I also attended regular study meetings in which members of the project met to discuss the progress of the trials.

Results/Outcomes: All of the trials are ongoing and their current state is confidential. There are many unexpected obstacles that can arise with the collection and management of clinical research. It is important to pay close attention to detail and try to anticipate subjects’ responses (or lack thereof) when designing data collection tools as well as implementing a change in an individuals’ lifestyle.

Boston University School of Public Health, Department of Epidemiology

Alumna: Eghosa Oyegun

Title: Pilot study of a health advocate intervention for smoking cessation among public housing residents

Introduction: Boston’s Public Housing (BPH) houses approximately 10% of Boston’s population, all of whom are low-income, and on Sept. 2012, BPH will be smoke-free. However, low-income smokers have low success in quitting smoking. To improve this I participated in a pilot intervention study, among BPH residents, promoting Tobacco Treatment Advocates (TTAs) trained in patient-centered Motivational Interviewing (MI), where the MI-trained TTAs tailor their counseling to individual subjects’ readiness to change, and help navigate them through the process. My practicum focused on describing study participants’ baseline characteristics, assessing how effectively participants transitioned from recruitment to active study involvement, and elucidating participants’ receptivity to smoking cessation re- source referrals.

Methods: I analyzed study data using SAS statistical Software and Excel, coded follow-up questionnaires using the new QDS questionnaire programming system, and assisted in designing educational Nicotine Replacement Therapy (NRT) pamphlets distributed to BPH residents.

Results/Outcomes: Before the intervention, the most common quit method used was quitting ‘cold turkey’, and the most common quit medication used was the patch. After the intervention, participants were more likely to use professional help to quit smoking. A more effective interven- tion would increase quit rate among BPH residents preventing them from being evicted from their homes when the smoking ban is enforced in 10 months. In time, this TTA intervention can be extended to non-BPH residents. I am 1st author on an abstract of the study results to be presented at the 2012 Society for Research on Nicotine and Tobacco Conference in Texas.

Alumnus: Ian Reynolds

Title: Research Assistant for URBAN ARCH, Ft. Devens ODS project, Med Heart, and Narcan overdose reversal project

Introduction: Cost effectiveness analysis is used to compare patients across conditions and interventions. These comparisons benefit from a “health utility,” cardinal values that correspond to an individual’s preferences for various health states. The Veterans RAND 12 Item Health Survey (VR-12), a modified version of the VR-36 developed from the SF-36, is a health survey with established reliability and validity. The SF-6D is a “health utility” measure for use with SF-12 and SF-36 health surveys. We sought to modify the SF-6D to create a new “health utility,” the VR-6D, that can be used with the VR-12.

Methods: The SF-6D was estimated using a linear equation. Then the instrument was altered to utilize data on items from the VR-12 survey. Survey responses from three cohorts of the Medicare Health Outcomes Survey (including VR-12 items) were used to develop the VR-6D to calculate utility scores from the VR-12. The distributional properties and validity of the VR-6D were evaluated.

Results/Outcomes: The VR-6D was demonstrated to be valid, and comparable to existing utilities for health surveys. It allows one to compare treatments and health plans using costs per utility derived and quality adjusted life years (QALY’s) using VR-12 survey data. The VR-6D allows for cost effectiveness analyses of health care treatments across plans. This metric can be applied to the Medicare Advantage Program and for purposes of resource allocation decisions.

Brigham and Women’s Hospital, Division of Pharmacoepidemiology & Pharmacoeconomics

Alumna: Kelly O’Keefe, MPH

Title: Pathways to Wellness, Integrative Healthcare Intern

Introduction: Pathways to Wellness, a nonprofit organization specializing in complementary alternative therapy, conducted a 3-year study funded by a large managed care organization to assess clinical outcomes and cost-effectiveness of using acupuncture. Over 400 members of the MCO have been referred to ongoing acupuncture treatment for the following conditions: pain, headache or migraine, menstrual or menopausal symptoms, carpal tunnel syndrome, and chemotherapy-related nausea and vomiting. Preliminary evaluations of clinical outcomes and patient satisfaction have already been conducted for Year 1 and Year 2 of the study, and a comprehensive analysis of the entire project is now underway.

Methods: Kelly’s practicum focused on data collection and an integrated assessment of variables from Year 3 with Years 1 and 2. Beginning with the development of a comprehensive database, she utilized medical records and patient surveys to collect pertinent data from all 3 years of the study. With the assistance of clinical staff, she abstracted treatment information in order to evaluate both clinical outcomes and patient satisfaction.

Results/Outcomes: With data collection almost complete, the next step in the project will be overall interpretation, with planned analyses on clinical outcomes, questionnaire validity, cost-effectiveness, quality of life, and patient satisfaction to be performed. Preliminary results show that acupuncture is an efficacious, low cost intervention for these chronic clinical conditions, and hopefully one day soon, the health care community will view this therapy as a valuable non-pharmacological complement to the usual standard of care for these patients.

Brookline-Quezalguaque Sister City Project

Alumna: Julia Kern

Title: Research Assistant

Introduction: In Nicaragua, the prevalence of Chronic Kidney Disease of Unknown origin (CKDu) is estimated to be between 17.9% and 21.1%. CKDu touches 50,000 individuals in late-stage disease worldwide and affects young men below the age of 30. The objective of this practicum was to investigate the community’s knowledge and awareness of CKDu (its symptoms, causes, and available treatments), in addition to engaging with students on sexual health.

Methods: MPH students selected by the Brookline-Sister City Organization designed and implemented interviewer –administered questionnaires to obtain information on nephrotoxic drug use, natural remedies and peritoneal dialysis in relation to CKDu. Literature on etiology and symptoms of CKDu was reviewed to create questionnaires administered to 250 Quezalguaque residents in 25 comarcas. Pharmaceutical-specific questionnaires were given to 15 pharmacies and shops to evaluate nephrotoxic drug availability and distribution. In addition to CKDu research, a three-part sexual health education lecture (charla) was created based on the Peer Health Exchange curriculum. These were provided to 250 primary and secondary school students from selected classrooms in three schools.

Results/Outcomes: Substantial use of nephrotoxic medication among those suffering from CKDu was found. Also, 67% of CKDu participants worked in agriculture and professional occupation seemed to be protective of CKDu, although specific association between agriculture occupation and CKDu disease status is unknown. Among students involved in charlas, awareness of sexually transmitted infections and contraception use ranged from 30% to 89%. A report including findings and appropriate recommendations were provided to the local Quezalguaque administration and to the Brookline Sister City Project.

Brookline Department of Public Health

Alumna: Lina Jew, MPH

Title: Program Associate

Introduction: The Brookline Department of Public Health’s mission is to monitor and improve the health status and quality of persons who live and/or work in Brookline, MA by providing a range of environmental, community, and clinical health services. The Division of Community Health within the department is responsible for overseeing community health initiatives focused on health improvement and disease prevention, such as healthy eating and physical activity and adult immunization. As the Community Health Program Associate, I was responsible for organizing and promoting three major events and programs this fall: Car-free School Day, Food Day, and four community flu clinics.

Methods: Organizing the community events included collaborating with other Divisions within the health department, liaising with community partners such as the Brookline public schools, and recruiting and coordinating volunteers. Promoting the events included activities such as developing educational and promotional posters, drafting press releases for local media and school newsletters, and updating social media.

Results/Outcomes: The community events were all successful. All K-8 Brookline Schools participated in Car-Free School Day and one school had an organized bike parade. For Food Day, a “Shopper’s Guide to Pesticides in Produce” was promoted to educate the community about which foods are better to purchase and consume in organic form. The community flu clinics were busy and well attended. The Division of Community Health is in the process of organizing Brookline on the Move, and events for Climate Week in the new year.

Cameroon Baptist Convention Health Board 

Alumna: Kara Allard, MPH

Title: Project Research Assistant

Introduction: The CBCHB runs 5 hospitals, 24 integrated health centers, 50 primary health centers and a pharmaceutical plant. The CBCHB strives to provide quality healthcare services for its patients. By having a performance measurement tool, administration can see which areas are working well, where there are bottlenecks, and alter practices to improve healthcare delivery. The focus of the project was quality improvement via creating a performance measurement tool. This occurred over a two month period in country with continued work over the following six months. The team analyzed clinical and cross-cutting hospital domains of which I focused on pharmacy and supply chain. Understanding these hospital service practices in a low resource setting allows the team to create a targeted instrument to measure and analyze performance.

Methods: For this project I spent time doing observation, process mapping with a counterpart and creating PowerPoint presentations from those maps, and focus group discussions. We worked with four hospitals, spending a week at each location. I helped create eight process maps, participated in four focus group discussions, and completed over sixty hours of observation. By using process maps and understanding patient flow I was able to work on the beginning stages of instrument development.

Results/Outcomes: The project outcomes include a measurement tool and manual for using the tool describing the process of performance measurement. It will be used to improve the quality of services at CBCHB hospitals. The process mapping, observation, and discussions that shaped the tool will drive the quality improvement goals of CBCHB administration.

Cardno ChemRisk

Alumna: Olga Karlinskaya

Title: Epidemiology Intern

Introduction: Although several studies have reported anatomical differences between male and female hips, total hip prostheses do not vary by gender. Total hip replacement (THR) failure is quantified by surgery revision rate, which several authors have reported to vary significantly between males and females. A medical device manufacturer, under fire for some of its previous hip prosthesis designs, tasked Cardno ChemRisk to ascertain whether its future hip prosthesis designs should vary by gender. I performed a meta-analysis to determine whether a significant difference in revision rate exists between males and females.

Methods: Using strict eligibility criteria, I included all cohort studies in which the exposure was primary THR for any reason, the outcome was revision surgery for any reason, and the study adjusted for confounding by age and type of prosthesis. My systematic review included English and non-English articles identified from PubMEd, Embase, and Scopus. I collected Hazard ratio data on THR revision, stratified by gender. Data were synthesized by random-effects meta-analysis and narrative review.

Results/Outcomes: I identified 12 studies, from 423 articles, to include in the statistical analysis. My findings indicate that the rate of revision surgery in males is 1.20, compared with females (95% CI: 1.08-1.34). Heterogeneity among studies was moderate, quantified by an I2 of 51%. Thus, in this study, males were at a higher risk of revision surgery than their female counterparts. These results indicate that total hip prostheses may need to be structured differently for males and females.

Cedar Associates

Alumnus: Mohammed Abbas-Reza

Title: Budget Impact Model development in the cost evaluation of rituximab in combination with standard therapy versus standard therapy alone

Introduction: Cedar Associates LLC conducts health economic analyses for pharmaceutical and biotech companies, based in Menlo Park, CA. I was involved in the budget impact analysis of Rituxan (rituximab), a therapeutic drug for chronic lymphocytic leukemia manufactured by Genentech. The goal of the budget impact study was to evaluate the cost impact of using Rituxan in combination with standard therapy (fludarabine + cyclophosphamide) versus standard therapy alone, for use of Rituxan as first-line therapy, and as refractory treatment. Such studies are used by health plans in determining if reimbursement of the new therapy is viable purely from a cost point of view.

Methods: Data from two major trials, CLL-8 and REACH (for first-line and refractory treatment respectively), is being used in the analysis. The data was provided by Genentech, who sponsored both trials. As part of the consulting team, I conducted cost calculation and analyses for treatment, adverse event and drug administration costs from raw trial data.

Results/Outcomes: Based on these calculations, the budget impact model will be developed to calculate the differential costs of each treatment arm, for both sets of trial data. Cost-effectiveness analyses alone are not enough to determine whether a cost-effective treat- ment can actually be reimbursed within financial constraints of the health plan. Based on this study, both the CMS and private health plans will be able to evaluate the added cost per member per month (PMPM) as it impacts the bottom line, further enabling the decision-making process.

Clinquest

Alumna: Amanda Wilson

Title: Data collection for public health and safety improvement Intern

Introduction: Clinquest is a Healthcare Product Development Service provider specializing in pharmacovigilance services for investigational and marketed products, medical information, drug development consulting, clinical trial implementation, data management and biostatistics. The Pharmacovigilance Department’s objective is to improve public health and safety in relation to the use of medicines by contributing to the assessment of the risk-benefit profile of medicines and by encouraging safer and more effective use of medicines.

Methods: As a Pharmacovigilance Intern, I aided in the closure of medical information and adverse event cases for three of Clinquest’s clients. I also assisted in the creation of two periodic safety reports that have been submitted to the FDA. My activities at this practicum site will be beneficial to the many people prescribed the drugs of Clinquest’s clients because analysis of the aggregate safety data for each product may lead to necessary label changes and further investigation into potential safety signals that will lead to a greater awareness of adverse events.

Results/Outcomes: While closing cases and working on safety reports, I learned how to process an adverse event and the FDA regulations regarding adverse event reporting. Depending on the seriousness of the case, there are different timelines of submission: 7 days if the event results in death, 15 days if the event is serious and not labeled, and included in an annual report if the event is serious but labeled or nonserious. By meeting with the head of each department at Clinquest I learned about the pharmaceutical industry in depth.

Clinton Health Access Initiative

Alumna: Brennan Scott

Title: CHAI Transition Team Analysis (Developing Operational Systems) Intern

Introduction: Founded in 2002, CHAI currently has offices in 25 countries with a Boston-based headquarters. CHAI facilitates access to low-cost essential medicines and strengthens health systems in low- and middle-income countries. CHAI prides itself on hiring people with initiative and in developing innovative programming. However, it lacks policies and procedures to keep pace with its rapidly evolving pro- grams and grants landscape. It is important to have clear expectations and methods of opening and closing programs and offices so that managers can focus their primary attention on improving health outcomes rather than the operational aspects of public health program- ming. This practicum created tools and a centrally managed process to support country and program teams as they manage the opera- tional issues of major transitions (e.g. record keeping, registration, grant compliance, and risk assessment).

Methods: This practicum involved familiarizing myself with another organization’s office operations materials. I then collaborated with my supervisor and HQ departments to draft and edit master templates of office opening and closing checklists specific to CHAI internal proc- esses. After discussions with two teams currently in the midst of transitions, I customized the applicable master templates to meet the needs of the transitions.

Results/Outcomes: If these checklists are adopted by CHAI in the long-term, a set of standard operating procedures will develop to fill the current void.

Committed Communities Development Trust

Alumna: Pavitri Dwivedi

Title: Program Consultant/Research Intern

Introduction: Committed Communities Development Trust (CCDT) has been working with marginalized populations of Maharashtra state of India since 1990. Their mission is: community action combating hunger, disease, and discrimination with a core focus on children. CCDT’s Home-Based Care (HBC) program works with 12 wards to empower families in becoming independent and self-reliant through interventions and support programs.

Methods: From June to August 2013, I designed and conducted a cross-sectional study to establish a baseline to monitor the impact of HIV disclosure in adolescents of thirty-three HBC families through parent and child’s perspective. I worked directly with the CCDT team to enroll participants, take informed consent, and follow appropriate ethical steps. I used a mixed methods approach, and prepared a questionnaire with quantitative and qualitative questions. The final analysis was done using SAS, NVivo, and Excel.

Results/Outcomes: The survey design included five indicators to assess 1) treatment adherence, 2) blame, shame, and judgment, 3) stigma, fear, and discrimination, 4) disclosure, and 5) daily family interactions. There was a greater variation in stigma and shame perceptions among children and parents. 64% parents compared to 61% children agreed that child’s right to know about disclosure is very important. The right age of disclosure of both child and parent’s status to children varied between 11-15 years. Both parents (45%) and children (42%) reported overall health being good for the children. Overall results indicated a stronger need of emphasizing on educational and financial concerns of families with less focus on HIV/AIDS sessions.

Cross-Cultural Solutions

Alumna: Alex Ireland

Title: Ascertainment of Family Planning Perceptions and Low Male Involvement

Introduction: Stout traditional views, misconceptions, and lack of access to family planning and preventative contraception education contributed to 750,000 teenage pregnancies in Ghana. Increasing education, access, and male involvement is imperative in addressing this salient obstacle. The purpose of the practicum was to ascertain individual and community perceptions of family planning, preventative contraception use, and general lack of male involvement.

Methods: A literature review was conducted to understand family planning programs and lack of male involvement. With Cross Cultural Solutions, a 36-question survey on family planning, preventative contraception use, and male involvement was created and distributed to men and women within the greater Hohoe region. Representing 80 men and 201 women, a total of 281 were completed and collected between March 5, 2014 and March 21, 2014. The data collected will be analyzed and reported to the Reproductive and Child Health Services, Ghana’s Department of Public Health, Cross Cultural Solutions, and the various schools and small businesses in which data was collected.

Results/Outcomes: Of the 281 surveys, preliminary data shows that 88% agreed that family planning is important, 86% wanted to learn more on family planning, and 80% wanted to learn more on preventative contraception methods. Additionally, 74% agreed that family planning involvement amongst men and women should be equal, yet only 14% actually felt that the responsibility was very equal. Stratification among gender and further data analysis is necessary.

DM-STAT, Inc.

Alumna: Kyrena Krekel

Title: Statistical Programming Intern

Introduction: The Prenatal Alcohol in Sudden Infant Death Syndrome (SIDS) and Stillbirth (PASS) Network Safe Passage Study (SPS) will recruit 12,000 maternal-child dyads from the Northern Plains, US, and Cape Town, South Africa, to investigate the association between prenatal alcohol exposure, SIDS and stillbirth. Growth is integral to define outcomes (e.g., small for gestational age, fetal growth restriction) and to diagnose neurodevelopmental disorders in early childhood. The purpose of this investigation was to compare published methodologies for fetal and infant growth using the SPS.

Methods: Longitudinal datasets were created, merging research specific and medical record data. Descriptive statistics and plots were generated by data source, age and race, and were evaluated for distribution, missingness and plausibility. Published methodologies were applied for estimating expected birth weight, accounting for age at delivery and maternal and pregnancy characteristics, as well as postnatal population norms through one year of age, and evaluated descriptively.

Results/Outcomes: Overall the data were of high quality. At least two observations were available on 55% and 91% in utero and during infancy, respectively. Upon review of the plots, most data were within expected ranges (9% outliers). Almost all outliers occurred in the medical chart abstractions, indicating the quality of fetal ultrasound collected for research was better than that of the clinical records. The plotted SPS growth did not reflect what would be expected based on the published norms for infancy. This approach has yet to be applied to the fetal data, yet these findings emphasize the need to develop individualized, population-specific curves for the SPS.

Doctors Without Borders/Médecins Sans Frontières

Alumnus: Joel Buenaventura

Title: US Campaign on Access to Essential Medicines Internship

Introduction: The high cost of existing medicines and the absence of treatments for many diseases are major challenges in providing access to health care, more importantly in the context of delivering emergency aid to people affected by armed conflict, epidemics and natural or man-made disasters. As an international independent medical humanitarian organisation, Médecins Sans Frontières (MSF), or Doctors Without Borders, set up the MSF Access Campaign in 1999 to improve access to existing medical tools (medicines, vaccines, diagnostics) and to stimulate the development of urgently needed better tools for people in countries where MSF works. The Access Campaign Internship aims to provide administrative and research support to the US Manager of the Access Campaign while providing practical learning experience in policy advocacy and international affairs.

Methods: The MSF Access Campaign Internship involves understanding and tracking of current issues relevant to the Access Campaign, with particular focus on the crisis of access to essential medicines in the developing world, including intellectual property rights patents and pharmaceutical research and development, and policy and funding direction of the US Government on global health related activities. Research on other advocacies of the Campaign was also undertaken, such as vaccines, nutrition, malaria, HIV/AIDS and neglected tropical diseases.

Results/Outcomes: Summaries of meeting and budget hearings and analysis reports from assigned research topics were provided to the US Manager of the Access Campaign. This assisted in the preparation of information for the various advocacy meetings in which the MSF Access Campaign, and MSF-USA in general, is involved.

Alumna: Lindsey Frenkel-Rorden, MPH

Title: Pharmaceutical Access Intern

Introduction: Médecins Sans Frontières (MSF)/Doctors Without Borders is an international humanitarian aid organization that provides medical assistance to vulnerable populations in emergencies. As part of their chartered mission to provide quality medical care, MSF strives to improve capacity to treat, as well as improve access to first-rate medicines. MSF has a long history of advocating for the availability and affordability of critical medicines in South Africa. The purpose of this practicum was to examine the current access landscape of key drugs in South Africa as a tool to advocate and push for better access to affordable medicines via IP reform.

Methods: I worked with the MSF Access Campaign on their “Fix the Patents Laws” project, which aims to reform the national patent laws in order to put patients before patent-holders. I supported the campaign by developing evidence to convince stakeholders to test the use of international intellectual property flexibilities to overcome patent barriers on key drugs. I researched the following for 5 key drugs: Current burden of disease, patent landscape, clinical efficacy, national and international medicine pricings, and barriers to access. I liaised with various civil society groups to verify content and obtain campaign buy-in. Research was used to author medicine case studies, including policy recommendations.

Results/Outcomes: At the conclusion of the practicum, the medicine case studies will be used by MSF within their advocacy strategies, as a tool for regional IP training, for internal briefings, and as evidence for potential future litigation.

Fenway Institute

Alumna: Chrysanthe Peteros

Title: Health Policy Research Institute Intern

Introduction: The Health Policy group at The Fenway Institute conducts research on health issues pertinent to the LGBT community, HIV policy, and STDs. Research is shared with policy makers, health care providers, and advocacy groups to guide decision‐making. The practicum involved working with the Director of Health Policy on projects regarding: • LGBT individuals in corrections • Hepatitis C transmission • Interoperability standards • Illicit drug use among LGBT youth • Transgender discrimination • LGBT elder caregiving

Methods: Literature reviews were the primary method of research. Initial reviews involved articles about the use of condoms in prisons and scientific data regarding Hepatitis C transmission. National surveys were used to capture data on hard drug use among LGBT youth, stratified by race and geography. News articles and proposed legislation were utilized to research transgender discrimination. Finally, a journal article regarding caregiving for LGBT elders was drafted based on a study conducted by the Director.

Results/Outcomes: There are significant opportunities to improve LGBT health care. Including sexual orientation data in EHRs would help inform clinical decisions as the LGBT population may have specific needs. This finding was shared with the Office of the National Coordinator for Health IT as comment on their draft of the National Interoperability Standards. As for LGBT elders, the main concerns are experiencing discrimination from caregivers and feeling isolated. Some suggested solutions are mandatory cultural competence training for aides and developing more group, community‐based programs for LGBT elders. The journal article remains in the draft stage with the intent to seek publication.

GfK

Alumnus: Bryan Harris

Title: Cost Analysis of Different Treatment Options for Renal Failure Intern

Introduction: GfK (formerly Bridgehead international) is a strategic consulting firm who works with clients in the pharmaceutical, biotechnology, medical device and diagnostic sectors. Bridgehead provides pricing and reimbursement, market access, due diligence and health economic services to its clients for both developed and emerging markets globally. This practicum involved evaluating the costs of different treatment options for patients with renal failure in order to make an economic argument for the choice of one treatment option over the others.

Methods: This practicum required the systematic review of over 400 articles studying the different costs involved in the various treatment options (one that could be performed at home vs. ones done in a clinic). Then a model to input all of the various costs involved for each treatment will need to be developed in order to calculate a total cost per treatment. Those final costs will then be compared to complete the argument for which treatment option would be the least costly to perform. A manuscript will then be created that will be submitted for publication to articulate this economic argument.

Results/Outcomes: At the time this abstract was written, results had not been calculated yet. However, the projected result of this cost analysis is that the treatment option that could be performed in the home would be less expensive than the other options that are performed in a clinic. This would mean that payers, such as Medicare or other various health insurance providers, should consider coverage of the at-home treatment option.

Alumna: Siyang Liu

Title: Summer Analyst

Introduction: GfK (formerly Bridgehead international) is a strategic consultancy partner for clients in the pharmaceutical, biotechnology, medical device, diagnostics and related financial sectors and they work globally to provide pricing, reimbursement, health economic and market access strategy. During the summer, I worked there on every Thursday from May to August to help their Boston office with internal knowledge management and the company’s newsletter.

Methods: To manage their in-house knowledge and streamline future workflow, I went through their previous projects and pulled out information regarding: 1. Which regulatory agency is responsible for in vitro diagnostics (IVD) approval in each country; 2. Whether a coding system, like the CPT code in the US, exists in each country for IVD; 3. How IVDs are reimbursed for inpatient and outpatient in each country; and 4. What requirements of health technology assessment are in each country and which agency is in charge of that. Additionally I wrote a brief for Bridgehead’s newsletter updating the team and clients on health reform efforts in China.

Results/Outcomes: I created a summary document of all projects that Bridgehead’s Boston office had completed regarding diagnostics in Europe, China and Brazil succinctly summarizing the information in a user-friendly manner. The article about China health reform has been published in Bridgehead’s newsletter and distributed to all Bridgehead’s clients globally.

Global Oncology

Alumna: Caitlin Curnyn, MPH

Title: Global Health Coordinator

Introduction: Cancer is now one of the leading causes of death worldwide, accounting for 8.2 million deaths in 2012. More than 60% of the world’s annual new cases of cancer are found in Africa, Asia, and Central and South America. Global Oncology (GO) was founded in 2012 with the aim of improving cancer care in resource-poor settings. GO is an academic and community-based organization that strives to develop partnerships and launch innovative projects in global oncology.

Methods: My involvement with GO included acting as Global Health Coordinator for the Collaboration and Advising Portal (CAP) project. GO CAP initiated in early 2014 as a way to improve cancer outcomes in Malawi, Nepal, Mexico, and Vietnam. GO CAP connects consulting oncologists in Boston with treating providers abroad, pro bono, through a platform powered by Medting. When a treating provider uploaded a case onto the GO CAP platform I would ensure that all patient information was de-identified and connect them with the appropriate consulting physician based on the type of cancer presented. In addition, I helped create an implementation plan for the GO CAP project and material to reach out to additional providers.

Results/Outcomes: Over the course of my practicum I was able to connect multiple consulting providers based out of Dana Farber and Mass General with treating providers. Consulting providers uploaded helpful commentary related to diagnoses and recommended treatments on difficult cases. Through the GO CAP project cancer patients in resource-sensitive areas were able to receive a higher standard of treatment.

Harvard Clinical Research Institute

Alumna: Jane Pleskunas

Title: Global Health Coordinator

Introduction: Harvard Clinical Research Institute (HCRI) is a joint venture of Harvard Medical School and industry sponsors. HCRI designs and runs clinical trials with top tier professionals from both the academic research and industry. The trial design division at HCRI has proven expertise in study design across all development components for trials of novel drugs, devices, biologics, diagnostics or interventions in the areas of cardiology, central nervous system and pulmonology research. Composed of clinicians, as well as statistical experts, the HCRI trial design group has experience in designing diverse trial types such as prospective randomized, Bayesian adaptive, registry and sequential parallel comparison designs.

Methods: I assisted in the development of statistical plans for HCRI research projects. Additionally, I assisted in the execution of statistical analyses for research projects and aided in the development of manuscripts. Specifically, I performed secondary post hoc analyses on the COGENT clinical trial dataset. COGENT addressed a clinically important question, prospectively, of the efficacy and safety of concomitant administration of clopidogrel and omeprazole in patients with coronary artery disease who received clopidogrel plus aspirin. Bleeding events and cardiovascular outcomes in patients receiving dual antiplatelet therapy with or without omeprazole were counted.

Results/Outcomes: I practiced data management skills including sorting data, creating new variables and merging datasets. I generated summary statistics for variables of interests, as well as the corresponding statistical tests to create a baseline Table 1. Lastly, I started analysis of outcome measures such as survival curves of CVD outcomes (efficacy) and bleeding events (safety).

Harvard Humanitarian Initiative

Alumna: Nga Tong

Title: Research Coordinator Intern

Introduction: While there are organizations that have the capacity to deliver care to HIV/AIDS patients in Nepal, regional context and vulnerable groups present unique challenges to effective antiretroviral therapy (ART). Only 23.7 percent of those in need of ART in Nepal receive the therapy. Children infected and affected by HIV/AIDS are more likely to have significantly lower treatment rates than those without the disease. Children’s homes (long-term care residential facilities for children with HIV) may help provide comprehensive care by addressing the health and development of HIV-infected children in Nepal, while also mitigating and reducing vulnerable orphans’ risk for sex trafficking, human trafficking, and homelessness. The purpose of this feasibility study was to identify barriers to care for this population, which includes 1) availability and affordability of antiretroviral (ARV) drugs and 2) social stigmas that stifle surveillance and treatment uptake.

Methods: This study took place in Nepal during the summer of 2012. We conducted semi-structured interviews based on purposive sampling with managers, directors, and coordinators from various NGOs and government programs related to children’s homes and/or the pharmaceuticals supply chain for ARVs. Transcription and encoding of qualitative data collected from these interviews were analyzed using NVivo research software.

Results/Outcomes: Interview findings are currently undergoing analysis. Once the analysis is completed, the results will be used to provide residential comprehensive care recommendations and guidelines for Tiny Hands International and other similar NGOs who are looking to develop children’s homes in Nepal.

Harvard Pilgrim Healthcare Institute

Alumna: Elizabeth Cavagnaro

Title: Analyst

Introduction: Mini-Sentinel, an FDA pilot project tasked with creating an active post-market drug safety surveillance system, uses a distributed data approach in which multiple Data Partners maintain administrative data in a standardized Common Data Model. This distributed database can be rapidly queried using modular programs, template SAS programs designed to examine common epidemiologic questions and can be customized by adjusting parameter settings. As flexibility and complexity are built into these programs, there is increased potential to introduce bias into a study. Immortal time bias is a particular concern, and an investigation is required to understand how immortal time bias is introduced into a study, its effect on study results, and how it can be avoided.

Methods: We performed a systematic literature review to assess how immortal time bias is produced in pharmacoepidemiology studies and to identify examples of bias in observational studies. We replicated one of these example studies using a modular program and then adjusted program parameters to correct for immortal time bias. We executed these programs on the Mini-Sentinel test database and analyzed results using Microsoft Excel and SAS 9.3. We calculated incidence rates and used crude rate ratios to make comparisons between the biased and unbiased scenarios.

Results/Outcomes: The incidence rates obtained show that failing to account for immortal time bias will underestimate the effect of an exposure on an outcome. We are currently adding a section to the modular program user’s manual to provide FDA and other Mini-Sentinel investigators with advice for avoiding immortal time bias with modular programs.

Heading Home

Alumnus: Justin Maly

Title: Heading Home Graduate Intern

Introduction: Heading Home provides emergency, transitional and permanent housing, and support services, to low-income homeless and formerly homeless families and individuals” within the Boston metro area. Epidemiologist have found homelessness to be an important determinant of health status, with it being shown to be associated with an increased risk of physical illness, chronic disease, and mental health conditions compared to the general public.

Methods: Environmental factors are oftentimes important mechanisms in terms of the disease transmission. The practicum consequently involved conducting site visits at several shelters and housing programs that are managed by Heading Home to evaluate the infection control measures currently in place. A checklist was created and interviews were performed during the process. The practicum also involved communication with Heading Home staff, ranging from case and shelter managers to development coordinators, in regards to specific measures that Heading Home is already taking to improve the health of its clients and the potential for new initiatives. The experience also entailed taking responsibility for Heading Home’s Up & Out program, which is the organization’s highlight volunteer program that couples volunteer groups with clients that are set to take the step of moving from a shelter into permanent housing.

Results/Outcomes: This practicum provided the opportunity to improve the marriage between the fields of public health and social work. It also, on numerous occasions, allowed one to experience the various sides of a non-governmental organization working with health and homelessness, from actual case management and client interaction to management and development.

Health Policy Commission

Alumna: Madeleine Kuhn, MPH

Title: System Performance and Strategic Investment Intern

Introduction: While at the HPC I focused on the Registration of Provider Organizations (RPO) Program project. This program is meant to increase transparency in the healthcare market by mapping out how different healthcare providers interact within the healthcare market. In order to successfully implement this project, my team was tasked with creating a platform to collect specific information regarding who each provider organization owns, negotiates, represents, or otherwise act on behalf of in establishing contracts for when paying for Health Care Services with Carriers or Third Party Administrators.

Methods: In order to implement the RPO project I collaborated in the designing of an internal website for organizing the information collected from provider organizations. Secondly, I participated in creating a registration flowchart to visualize how the specific organizations identified in the regulation would register depending on how they interact with other registering organizations. Lastly, I helped design protocols to layout the steps for each process in the RPO system.

Results/Outcomes: The goal of the internal website was to help the team easily sort each application, flag missing information from each provider and help the team analyze the information to see how provider organizations interact with each other. The flowchart project helped HPC determine how each unique organization would register and what materials they would need to submit to be considered a compliant Provider Organization. The protocols were created to ensure that each process of the system from reviewing an application to answering a Provider Organization’s question were uniform.

mHealth Alliance

Alumna: Osadebamwen Ighile

Title: Information and Communications Technology For Saving One Million Lives (ICT4SOML)/ Project System Analyst

Introduction: The District Health Information System2 (DHIS2) is an online information system used to collate, analyze and distribute information to health program managers for monitoring and management of health services at different levels of the healthcare system. It was developed by Health Information Systems Programme and has been implemented in more than 30 countries worldwide. Despite its implementation in Nigeria, timely reporting rates from community health facilities have remained generally low. This has greatly impaired ability to determine health need and efficient distribution of scarce resources to the community in a timely manner. This study aims to evaluate factors responsible for low reporting rates and provide recommendations for its scale up.

Methods: We conducted a literature review on scaling of an information system and on successful scale up of DHIS2 in 4 countries. Information obtained influenced the conduct of visits and interviews of some stakeholders of health service delivery within two states, Abuja and Nassarawa states of Nigeria.

Results/Outcomes: Three broad categories of challenges to timely reporting of health data were experienced at all levels of the health system: weak governance and regulatory framework; poor funding and technical support; poor training and staffing of health facilities. Recommendations were made and an information system options appraisal table was developed to provide guidance on appropriate tools to adopt to improve reporting.

Management Sciences for Health

Alumna: Jessica Golden, MPH

Title: Strengthening Pharmaceutical Systems: Supply Chain Management and Pharmacovigilance Intern

Introduction: CPM works to improve health worldwide through enhancing access to, and improving the use of, essential medicines and other healthcare products. The Strengthening Pharmaceutical Systems (SPS) program within CPM receives funding from the USAID to work with countries in order to strengthen their existing pharmaceutical systems. I worked with the SPS Ukraine program to address pharmaceutical management issues regarding the management of antituberculosis and antiretroviral therapy-related medicines and commodities; specifically issues regarding supply chain management. I also worked on an assessment of pharmacovigilance practices in Asia.

Methods: I worked with the Ukraine Monitoring and Evaluation Team in Washington, DC to research and identify key relevant supply chain management indicators for tuberculosis and HIV/AIDS medicines. I identified supply chain indicators through a literature review, tracked them using an excel spreadsheet, and then mapped the indicators to a survey of pharmaceutical management practices at tuberculosis and HIV/AIDS facilities in Ukraine. The pharmacovigilance assessment was conducted though a desktop review of 175 documents. This review focused on 14 topics and six countries.

Results/Outcomes: The State Service in Ukraine will send the questionnaire to regional-level TB and HIV/AIDS facilities. The data collected from these surveys will then be analyzed using the indicator analysis plan; the indicators are based on my research. This analysis will provide baseline data of pharmaceutical management practices at regional-level facilities and identify gaps in the system. The pharmacovigilance assessment will be used to identify gaps in the body of knowledge on current status of pharmacovigilance in Asia.

Alumna: Maura Soucy, MPH

Title: Management Sciences for Health Project Intern

Introduction: MSH/CPM is developing practical guidance on managing medicines benefits by providing lessons from successful and unsuccessful country experiences.  I worked to help develop a case study of pharmaceutical management in Costa Rica to inform improved policies and management in Universal Health Coverage schemes.

Methods:  I worked directly with David Lee at MSH and Dr. Albin Chaves Matamorros of the Costa Rican Social Security office to compile and research indicators and data relevant to this case study.  I began with a review of current literature on the subject of pharmaceutical management in Costa Rica under their universal coverage scheme.  The search was to rule out duplicated work and ensure that a similar case study had not already been published.  After ruling this out, I began a review of Dr. Chaves’ publications and PowerPoint presentations to compile a master spreadsheet of data and indicators, laid out chronologically.  I identified gaps in the data and addressed discrepancies in units and conflicting data.  Results/Projected

Results/Outcomes:  Costa Rica is the first country to offer comprehensive drug coverage through a universal coverage scheme successfully.  They have a single payer system that streamlines and consolidates the process, and have achieved coverage of greater than 95% of the population while containing pharmaceutical costs.  A case study that examines the mechanisms that have allowed them to do this successfully will be invaluable to health systems and other countries and international agencies such as the WHO as well.

Massachusetts General Hospital

Alumna: Chuan Hsu

Title: Data Analysis Intern

Introduction: Soft-tissue sarcomas are characterized by the growth of cancer cells in the soft tissue of the body. Although the 5-year survival rate of people with localized soft-tissue sarcomas can be as high as 90%, the risk of distant metastasis is still a major concern. Alternative treatment regimens for patients with higher cancer stage are developing to improve metastasis-free and overall survival as well as quality of life. The purpose of the practicum is to conduct statistical analysis to compare survival rates between two different treatment regimens.

Methods: I am working with one of the physicians in the Department of Radiation Oncology to learn more about this disease through conducting literature review and attending their board meeting. REDCap is the database that the department uses, so I became familiar with the interface and extracted and exported data for data set preparation. SAS 9.3 was also used for data preparation and conducting survival analysis and plotting Kaplan-Miere curves.

Results/Outcomes: Collaborative Institutional Training Initiative courses related to human research were completed. A data set with two treatment regimens and survival data for statistical analysis was prepared. Crude survival analysis was conducted showing there was no difference in the overall survival between the two treatment regimens. Adjusted analysis will be performed once the data on covariates is obtained.

Massachusetts Medical Society

Alumnus: Ryan Marling

Title: Department of Practice Solutions and Policy Research Intern

Introduction: The Massachusetts Medical Society is the state’s professional association for physicians, and is the oldest active physician society in America. Their mission is to be dedicated to educating and advocating for the patients and physicians of Massachusetts.

Methods: Working within the department of Practice Solutions & Research, our goal was to provide value to member practices via practice consulting services, annual research studies, and educational resources on health care topics that are impacting practices in the area and nationwide. Our team of five attains information via surveys of our 25,000-plus member physicians, hosting events with area thought-leaders as keynotes, networking and attending area conferences, reaching out to relevant subject authorities, and manual online research. Our inspiration for research topics stem from our physician helpdesk hotline, on which physicians can call when in need of any sort of guidance in handling a practice related issue. After analyzing the subject of these requests, we get a good idea of what informational resources are in demand.

Results/Outcomes: During my time within the Practice Solutions & Research department I have contributed to multiple informational resources, research publications, practice consulting projects, and a half day conference of 3 speakers on disruptive innovations in healthcare. Our educational resources ranged in topics from considerations before joining an ACO, to practical use of tele-medicine, value-based care delivery, and retail clinic penetration in the state.

Minnesota Department of Public Health

Alumna: Nabeelah Rahmathulla, MBBS, MPH

Title: Epidemiology Student Worker

Introduction: According to the CDC, it is estimated that C. difficile is responsible for 337,000 infections and 14,000 deaths in the United States every year. This bacterial infection, characterized by diarrhea, can entail in serious intestinal conditions, namely pseudomembranous colitis and toxic megacolon. Minnesota, being one of the 10 U.S. surveillance sites for the CDC’s Emerging Infections Program (EIP) C. difficile project, identifies the burden, trends over time, pathogenic strains and numbers associated with health-care, of CDIs. This project also provides infrastructure for studies to identify risk factors and to monitor the efficacy of prevention strategies.

Methods: For my practicum, I was involved with the Recurrent CDI Study, overseen by MDH epidemiologist, Dr. Stacy Holzbauer; a case-to-case comparison of CDIs, designed as a retrospective case-control study. Analyses summarizing characteristics of recurrent CDI cases, risk factors and antibiotics associated with recurrence will be conducted using SAS.

Results/Outcomes: I reviewed medical records on a healthcare database system and extracted data to fill out 74 paper case report forms for the matched controls identified through EIP CDI surveillance. I also provided the researchers with potential analytic questions and data needed for the study. Additionally, I assisted with the ongoing active surveillance, entering data from case report forms and the MDH Access database, into the CDC’s online information system. I entered data from 420 forms (75% of the total number) from January to July 2014 into the database and enabled the team to come up to speed in their C. difficile surveillance efforts.

New England College of Optometry

Alumna: Kerigo Ndirangu

Title: Quality of Glaucoma Care in Massachusetts: Gaps in Service Delivery to an Underserved Population

Introduction: In Massachusetts, doctors of optometry are trained and licensed to diagnose primary open-angle glaucoma (POAG) and often participate in the management of the disease, but the prescriptive authority for this particular eye disease is explicitly held by medical doctors or nurse practitioners. The New England College of Optometry committed to assess how this policy (MGL, Ch. 112, S. 66 B) affects service delivery to a particularly underserved population: Health Safety Net (HSN) Insurance recipients. HSN users face multiple barriers including geographical, temporal and language match constraints. Given that a glaucoma diagnosis requires at least two baseline visits and two follow up visits, the flaws in referrals are a burden on both the patient and the health system.

Methods: Reviewed pertinent literature regarding the natural history and epidemiology of POAG if left untreated to communicate the implications of poor access to treatment. Estimated the prevalence of glaucoma to illustrate the burden of this chronic, progressive disease across the state. Evaluated data from Lynn Community Health Center Eye Clinic to examine factors related to obtaining services or not and determine rate of completed appointments. Drafted a policy memorandum supported by this evidence.

Results/Outcomes: Topical eye medications aimed at lowering intraocular eye pressure are the primary intervention used in the United States to control POAG. Eliminating the mandatory consultation of Ophthalmologists in the management of POAG will promote access. I sought to enhance the evidence base in support of the argument to increase the prescriptive authority of doctors of Optometry.

New York City Department of Health and Mental Hygiene

Alumna: Ka Lai (Kelly) Poon

Title: Summary and Analysis of Tick-Borne Diseases Reported Among NYC Residents 2012-2013 Intern

Introduction: The New York City’s Health Code Article 11 requires the following tick-borne diseases to be reported to NYC Department of Health (NYCDOH) within 24 hours: Babesiosis (BAB), Anaplasmosis (HGA), Ehrlichiosis (HME), Rickettsialpox (RIP), and Rocky Mountain Spotted Fever (RMSF). Patients who are infected with tick-borne diseases often suffer from various unpleasant symptoms and their conditions can become fatal if left untreated. Since these diseases can pose serious threats to public health, it is important for NYCDOH to closely monitor their annual trend and identify risk factors. The main purpose of the internship was to describe factors associated with NYC residents diagnosed with tick-borne diseases in 2012 and 2013. This included clinical presentation, hospitalization, testing methodology and risk factors associated with the infections.

Methods: Data collected by standardized questionnaires was first entered into the Access and Maven databases. Data cleaning was then performed and SAS 9.3 was used to analyze the cleaned data. An annual summary report for each of the five tick-borne diseases was generated, which was essential for disease surveillance and enabled NYCDOH to provide educational materials for the public.

Results/Outcomes: In 2012, 28 cases of BAB, 19 cases of HGA, 11 cases of HME, 12 cases of RIP, and 7 cases of RMSF were reported in NYC. In 2013, 75 cases of BAB, 23 cases of HGA, and 15 cases of HME were reported in NYC and no cases for RIP and RMSF. Overall, most cases resided in Manhattan and traveled outside of NYC before disease onset.

Novartis

Alumna: Nuria Cañigueral Vila

Title: Development Project Manager, Influenza

Introduction: The current standard of prevention for seasonal influenza fails to address significant medical needs of the most vulnerable populations. Evidence shows the lowest vaccine efficacy (<60%) and highest influenza-related hospitalization rates (>40%) in children and the elderly. To address the need for more effective vaccines for these groups, Novartis uses adjuvants to enhance vaccine efficacy. The objective of this practicum was to support cross-functional management of a portfolio of programs focusing on development of adjuvanted influenza vaccines for children and the elderly. Programs included a Phase III pivotal clinical trial and the first license application in the US for a specific product.

Methods: Program management was based on continuous integration of input from different functions (e.g. Clinical, Regulatory, Commercial, Quality) to track execution of activities against objectives and to identify key cross-functional issues requiring further discussion for resolution. Specific tasks included: (1) developing options for business strategy decision-making; (2) organizing and preparing crossfunctional and taskforce meetings; (3) tracking action items with team members; (4) participating in relevant functional meetings; and (5) reporting milestone status through maintenance of program dashboards.

Results/Outcomes: The support provided over 4 months contributed to achievement of several milestones and to key recommendations for this year’s business strategy. This will eventually lead to licensure and launch of superior influenza vaccines for children and the elderly around the globe. Successful development of such vaccines is one step closer to alleviating suffering and enhancing the quality of life of these populations.

Pharmerit

Alumnus: Varun Ektare

Title: Healthcare Consulting Intern

Introduction: I did my internship with Pharmerit, a healthcare consulting company based in Bethesda. I worked mainly on a project for a small start-up pharmaceutical company which is planning to launch an antibiotic into the market in early 2013. The project tasks were focused on ensuring market access and reimbursement for the antibiotic.

Methods: Building and communicating the value story of the product involved preparing the cost-effectiveness model and synthesizing a white paper. The cost-effectiveness model was built in MS Excel and compared the costs and benefits of using the new antibiotic with other products in the same disease category. Various cost inputs such as drug prices, administration costs, cost of adverse events and cost of hospital length of stay were collected for all the drugs in the model. The benefits of the drugs were estimated by calculating the quality of life gains with the help of quality adjusted life years parameter. The white paper spoke about the impact of changing reimbursement system and focus on quality improvement initiatives on the launch of the product. It helped the client to communicate the benefits of the product such as reduced length of stay and reduced resource utilization to a wide audience of stakeholders of payers, patients and physicians.

Results/Outcomes: The cost-effectiveness model showed that the new drug saves cost of treatment and improves the overall patient satisfaction through features such as simplified dosage regimen and reduced hospital length of stay. The white paper builds on the results of the model and communicates the health economic advantages of the product to stakeholders.

Pharmaceutical Society of Taiwan

Alumna: Chun- Wei Hsu

Title: Intern

Introduction: After the commencement of National Health Insurance in Taiwan, the cost of health care has been increasing over time. Three factors are responsible for the increase: aging population, advanced technology, and medicine uses. To solve the financial crisis of National health Insurance, strategies and regulations have been established to address the problem. One way to cut the cost of health care is to cut the use of drugs and even to prevent the disease. Traditionally, pharmacists are only responsible for drug manufacturing and supplement, a study even shows that pharmacy students only see themselves as a drug dispenser. However, pharmacists can do much more. Working with the community pharmacy, pharmacists can reach the goal of identifying potential patients, thus the illness of the pa- tient can be treated earlier and even prevented.

Methods: I searched electronic databases and published literature for studies that examined the effectiveness of the service provided by pharmacists in community pharmacy in the world. The service provided could be divided into 6 different categories: prevention, screening program, disease management, Professional Practice, Epidemics, and Disaster.

Results/Outcomes: I found different services in community pharmacies in different countries, including Australia, New Zealand, United Kingdom, etc. Services include Tobacco cessation program, alcohol screening, asthma disease management, and some educational programs. Most evaluation shows the improvement of certain illness or patients’ perception of the disease. Therefore, it’s highly recommended that the ser- vices be practiced in every country to reduce the use of drugs and thus the cost of health care.

Public Health Foundation of India

Alumnus: Abhishek Sharma

Title: Research Intern/Scholar

Introduction: Insulin is an essential medicine needed for people living with diabetes type 1 and type 2. Access to insulin is poor in low and middle income countries, often due to high prices which result from lack of transparency. India has one of the highest number of people living with diabetes, but a little is known about the access to insulin in India. Our objective is to study the insulin access and private market in the Delhi state in India.

Methods: We employed a modified version of the World Health Organization/Health Action International methodology to obtain the information on the prices of all the insulin products available in a randomly selected sample of 60 private-sector retail pharmacies in the Delhi state. We also conducted key-informant interviews with the insulin wholesalers/suppliers to study insulin price components across the supply chain and understand the market dynamics with regard to domestic and international insulin products.

Results/Outcomes: Analyzing the collected data on prices of the available domestic and international insulin product across the supply system will help us identify policy concerns regarding insulin access. We are currently in process of obtaining the public-sector procurement and the import prices of insulin to perform meaningful price comparisons with the retail and wholesale prices. We aim to put forth recommendations for improving insulin access with regard prices and utilization.

Quintiles Consulting

Alumna: Victoria Park, MPH

Title: Consulting Analyst Intern

Introduction: Quintiles is the world’s leading provider of biopharmaceutical services. The organization helps to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. The Market Intelligence group works closely with sponsors to understand their marketplace and provide effective opportunity assessments, identify and model new product acceptance, strategic positioning, behaviorally based market segments, and product forecasting, and maximize value using linked model revenue/pricing techniques to develop communications platforms and competitive readiness and response analyses.

Methods: As a Consulting Analyst Intern within Decision Modeling Consulting, all required onboarding activities including, but not limited to trainings on company background, BioPharma industry background, IBM SPSS, statistics, Provenance, Microsoft Excel and PowerPoint were completed. The internship involved assisting Market Research Analysts, Senior Analysts, Managers, and Directors with materials development, fielding, data procurement, in-depth interviews (IDIs), tele-depth interviews (TDIs), qualitative and quantitative analysis, and building final reports. In addition, research and analysis was provided for a white paper on personalized medicine focusing on oncological drugs that treat breast cancer, colorectal cancer, lung cancer, and melanoma.

Results/Outcomes: 1) A completed final report with all data findings, analyses, and evaluations delivered to the client via a PowerPoint presentation; 2) A completed report detailing the research and findings for a portion of the white paper; 3) A final PowerPoint presentation delivered at the end of the internship.

Alumnus: Ankur Sharma

Title: Market Intelligence Intern

Introduction: Quintile consulting is a leading pharmaceutical and biotech consulting firm. I interned with the market intelligence group of the consulting arm, the Market Intelligence group works closely with life sciences companies at any stage of their product’s lifecycle and helps clients understand the market place, provides opportunity assessment, identify and model new product acceptance, strategic positioning, behaviorally based market segments and product forecasting.

Methods: One of Quintiles client is preempting the need for a risk management program for one of its products prior to its launch. The client is seeking assistance in designing an optimal service model to address logistical challenges and the needs of key stakeholder groups in a restricted drug distribution/controlled drug distribution model. As I an intern I worked closely with the project team to provide comprehensive secondary background research on risk management programs across key markets including the US, EU and Canada. I also analyzed supply-chain logistics of restricted drug distribution system and stakeholder needs to develop a risk management program in line with regulatory standards (FDA and EMA).

Results/Outcomes: I developed comprehensive synthesis of regulatory requirements for risk management programs and provided background research synthesis including competitive landscape assessment for proposal development. Secondary research bolstered by primary research across prospective markets was used to develop a risk management program for the client.

Sacred Valley Health

Alumna: Erin Ryan

Title: Monitoring and Evaluation Intern

Introduction: SVH is a young organization that runs a community heath worker (CHW) program in rural high-altitude communities in Peru. The program now includes 20 CHWs and works in 15 communities covering 1,567 residents. Over four months in summer 2013 I developed, streamlined and implemented a comprehensive monitoring and evaluation plan for the CHW program. I also had the opportunity to take on various program management tasks.

Methods: In addition to creating a monitoring plan for routine data collection and analysis, I was responsible for baseline data collection in 10 communities for a major program expansion. This involved developing a household survey, training and overseeing data collection teams, logistical planning of surveying and GIS mapping and input and analysis of data. Information collected by the survey included demographic information as well as nutrition, hygiene, reproductive health and perceived barriers to health care indicators. Additionally, I developed a handbook for future Monitoring and Evaluation Coordinators, oversaw social media activities of the organization and provided technical expertise with objective writing and goal setting.

Results/Outcomes: Household surveys and GIS mapping were completed in 10 new communities and a total of 295 households with 887 individuals. The data collected will be used to tailor trainings for CHW to the unique health needs and track health indicators in the communities over years of programming. The full analysis of this data was left to the next M&E Coordinator, as were the monitoring plan and handbook.

Sergio Arouca National School of Public Health

Alumna: Kerri Lipton, MPH

Title: Researcher for the National Assessment on Access to and Use of Medicines

Introduction: Fiocruz is Brazil’s largest public health research institute. Nested within the Fiocruz campus lies ENSP, Brazil’s national school of public health. At ENSP, the Núcleo de Assistência Farmacêutica (NAF), the Center for Pharmaceutical Care, works to promote drug and pharmaceutical care policies through project development. Researchers at ENSP/Fiocruz and other institutions collaborated on the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM), the National Survey on Access, Use and Promotion of Rational Use of Drugs in Brazil. Survey responses were collected from 41, 433 Brazilians across all 5 regions of Brazil.

Methods: While working in the NAF department, I conducted literature reviews to learn more about Brazilian medicines policies pertaining to rational use of antibiotics. Using SPSS, I analyzed survey responses from the respondents who recently used antibiotics to assess compliance with a policy created by the Brazilian Health Surveillance Agency (ANVISA) in 2011 entitled Resolution 20. Resolution 20 states that only qualified prescribers, (i.e. medical professionals) can prescribe antibiotics, and outlines specific rules for pharmacies that distribute these medications.

Results/Outcomes: Although it has been over 3 years since the implementation of Resolution 20, 24.3% of respondents reporting having received antibiotics without a prescription. Compliance with the policy appears weakest in the North and Northeast regions of the country, where 35.1% and 35.7 % (respectively) of respondents reported having received antibiotics without a prescription. Nationally, 30.6% of respondents obtained antibiotics at private pharmacies without a prescription, versus 9.7% of respondents without prescriptions at public pharmacies.

Shire Human Genetics Therapies

Alumna: Lesley Nguyen, MPH

Title: Clinical Trials Study Management Intern

Introduction: Lysosomal Storage Diseases (LSD) are rare inherited disorders that result from dysfunctional lysosomes and affect mostly children. Populations with LSD often lack particular enzymes that are normally responsible for breaking down sugars, lipids, or proteins. This malfunction leads to abnormal accumulation of products within various cells, which translates into developmental/cognitive/movement related difficulties and early death for populations with LSD. Shire HGT focuses a branch of its R&D efforts on developing treatments for diseases in the LSD class, which are Enzyme Replacement Therapies (ERT) for conditions such as Hunter Syndrome, Sanfilippo A/B, and Metachromatic Leukodystrophy (MLD). My purpose in this practicum was to assist Shire HGT’s Clinical Operations department in coordination of six different LSD-related clinical trial studies. Successful management of these studies could lead to FDA approval of Shire’s treatments and ultimately put new drugs on the market.

Methods: My study start-up activities included making IRB submissions and collecting site regulatory documents. To support the progression of studies, I created trackers for drug shipments and vendor invoices. I also made a slide deck summarizing neurodevelopmental assessments and reviewed site Informed Consent Forms. Lastly, I reviewed and restructured the Trial Master File of a completed study.

Results/Projected Outcomes: All study management activities, no matter how seemingly menial, progress the clinical trial. If Shire’s ERTs are proven to be safe and effective in clinical trials, children with life-altering conditions such as Hunter Syndrome or Sanfilippo could live longer, more normal lives with the approved treatment.

The Small Things

Alumna: Alison Anger

Title: No More Orphans Project Intern

Introduction: : The World Health Organization (WHO) has recently recommended use of misoprostol to prevent post-partum hemorrhage for women that cannot achieve a hospital delivery. The No More Orphans (NMO) Project in Nkoaranga, Tanzania is training traditional birth attendants (TBAs) to administer misoprostol immediately after delivery to prevent post-partum hemorrhage (PPH). Misoprostol’s relative safety, ease of use and thermostability makes it ideal for use in regions such as Nkoaranga which lack trained health care providers and consistent access to a cold-chain.

Methods: During my practicum, I conducted literature reviews on best practices, reviewed materials related to PPH and collected demographic data on TBAs serving the Nkoaranga area. I created informational pamphlets and presentations to distribute in community, which I then translated into Swahili. Through the development and administration of pre-post survey, I assessed knowledge and current practices of TBAs. I facilitated procurement of 1 year supply of Misoprostol, conducted training of 43 TBAs on basic female reproductive health, PPH and the safe usage of Misoprostol, developed a sustainable monitoring plan for the continued implementation of the program.

Results/Outcomes: Forty-three traditional birth attendants were trained in basic female reproductive health, PPH and misoprostol use. Follow-up meetings one-month after training provided an opportunity to conduct a refresher training on materials and administration and to evaluate misoprostol use by TBAs. At the time of follow up meetings, no TBAs had administered misoprostol. A second follow-up meeting will be conducted at the end of 6 months to determine misoprostol use by TBAs trained in the program.

Stackpole & Associates

Alumna: Emma Lodato, MPH

Title: Market Research Intern

Introduction: Due to the significant increases in telemedicine, the expansion of US hospitals, and the high costs associated with healthcare, many countries and their hospitals seek to increase their opportunities by offering high quality healthcare at competitive costs. This growth of medical tourism is especially advantageous to developing health markets when educational standards are high and labor costs are low. Currently, medical tourism is a niche market.  To promote the development and use of medical tourism, marketing may be an effective method to increase awareness for select populations. The purpose of this proprietary market research is to identify excess capacity and other opportunities for public and private health care providers and pharmaceuticals to maximize health services delivered to regional and international patients and customers seeking those services.

Methods: This market research utilized macro and micro health indicators as well as an inventory of health care services as the preliminary phase in constructing the foundation for potential marketing strategies. These variables were plotted with ArcGIS mapping software which were utilized to generate maps depicting relevant information.

Results/Outcomes: Results could not be disclosed.

Takeda Pharmaceutical Company

Alumnus: Corey Joseph, MPH

Title: Pharmacovigilance Intern

Introduction: Takeda is a Cambridge-based pharmaceutical company that specializes in the development of chemotherapeutic agents for use in a wide array of malignancies. As an intern within the Pharmacovigilance and Risk Management department I was involved in several projects which can ultimately be categorized by two distinct themes: one, to ensure the safety of clinical trial participants via ad-hoc analyses of safety signals, and two, to further amplify a nascent inter-company initiative to begin conducting normal healthy volunteer studies (NHV) with chemotherapeutic agents in-development.

Methods: Safety signals are unexpected – or expected – adverse events that occur during the course of a clinical trial. Their frequency, intensity and detrimental effects are deterministic of whether a compound can be used as an oncologic in humans. I was responsible for providing background incidence and prevalence rates of the signals in populations similar to the ones being studied in the trial. Facilitation of the push to begin conducting NHVs was achieved through the creation of various documents regarding the methods and regulations taken into consideration when conducting an NHV with a cytotoxic agent.

Results/Outcomes: The prevalence and incidence rates I obtained were used in a number of analyses that initially indicate that the adverse events in question were unrelated to the compound being used. The guidance, slides and documents I created for the NHV initiative will be used to create a white paper and decision tree/algorithm to determine if a compound is a good candidate for an NHV.

Tufts Center for the Study of Drug Development

Alumna: Alayna Tress, MPH

Title: Collaborations of AMC Medical Schools and Pharmaceutical/ Biotech Companies/ Research Assistant

Introduction: Tufts University Center for the Study of Drug Development (CSDD) was asked by the Pharmaceutical Research and Manufacturers of America (PhRMA) to examine the current and expected socioeconomic and scientific impacts of American accredited medical colleges (AMCs) collaborating with pharmaceutical and biotechnology companies.  Past analysis reveals that when such collaborations occur, the industrial companies can save costs during the drug discovery stages of Research and Development. Industry can also rely on the academic partners to contribute their expertise in a particular clinical area.  In return, the academic partner benefits from grant money from industry, and could potentially add more jobs to the respective department in which the collaboration is taking place.

Methods: The technology transfer websites of 150 AMCs were accessed to find technology transfer contract reports. Ideal reports listed the pharmaceutical/biotechnology company, the money granted to the university, and the project assignment. Not every college made this information public, or kept a master report of this information, therefore press releases announcing collaborations were searched via Google News and the press release section of industry websites. A literature review was conducted to examine the socioeconomic and scientific benefits of such collaborations.

Results/Outcomes: Case examples from colleges that had comprehensive databases were selected which highlighted benefits to the college including job creation and increased financial strength to the surrounding community along with the discoveries that the industrial side was able to benefit from. A database was created for PhRMA to review to provide more focus for future projects.

Tufts Medical Center

Alumna: Haechung (Janice) Chung

Title: Intern

Introduction: The Center for the Evaluation of Value and Risk in Health (CEVR) belongs to the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center. CEVR aims to ‘analyze the benefits, risks, and costs of strategies to improve health and health care and to communicate those findings to clinicians and policy makers.’ To meet its mission, CEVR maintains Cost Effectiveness Analysis (CEA) Registry which is an internationally recognized comprehensive database of cost-effectiveness analyses articles published in peer-reviewed journals. The registry is updated annually and the objective of my internship was to support updating CEA registry for studies published in 2013.

Methods: As a summer intern, I reviewed over 80 cost-effectiveness analyses articles published in medical journals. Within the review process, I extracted methods, ratios, and weights used in each cost-utility study. All forms were completed using Microsoft Access. Within the methods form, information such as intervention type, perspective, time horizon, and discount rate was collected. Ratios form collected QALY (quantify health gains) and sensitivity analysis related data. Lastly, weights form collected utility used to derive QALYs. After my own review, I periodically met with either veterans or fellow intern reviewers, who read the same article, to reach a consensus to decide what information should be entered into the database

Results/Outcomes: The CEA registry will now contain consensus articles that I reviewed over the summer. These articles will contribute to enhancing policy makers’ understanding of the value of health care interventions.

United for Health Abyssinia

Alumna: Kim Morgan, MPH

Title: United for Health Abyssinia Intern

Introduction: United for Health Abyssinia (UHA) is a startup organization working to control and treat tuberculosis in Ethiopia. UHA has developed a three step strategic plan to achieve these goals. The plan includes the improvement of hospital infrastructure and capacity to manage tuberculosis, the training of community health workers to detect and help treat tuberculosis patients, and an awareness campaign to lower stigma around the community.

Methods: She worked primarily with one other intern, the Director of Programs and the Program Coordinator to accomplish our tasks. These included: (1) Developing a brand for UHA to strengthen the communication and image of the organization, (2) Conduct a literature review of current global tuberculosis strategies, (3) Create a monthly newsletter to regularly communicate with UHA network, (4) Develop a fundraising plan to support program and development activities, (5) Plan and host a fundraiser event at the end of the summer, (6) Edit and improve the current UHA website to make it more user friendly and inviting, (7) Create and manage online presence through social media networking sites, and (8) Begin to develop a database of potential donors and grant opportunities for future funding prospects.

Results/Outcomes: The communication materials, networking tools, and new technology put in place this summer will continue to be used by UHA to build their network within Boston, the US, and global communities. These resources will allow UHA to continue to focus the majority of their time on project goals and allow the administrative aspects of the organizations to grow simultaneously.

University of California, San Francisco

Alumna: Yu-Hsuan (Teresa) Wang

Title: Research Assistant

Introduction: Approximately 17% of Chinese American preschool children are obese, compared to 12.4% of all children residing in the US. Children of overweight mothers, especially from low-income families, are at a higher risk for obesity. Mobile technology such as tablet computers may be a new and effective way to deliver obesity prevention information. This study aims to implement a family-centered and technology-based intervention to prevent obesity in young Chinese American children from low-income families with overweight mothers. The purpose of this practicum is to work as a clinical data analyst in the study.

Methods: : I performed analysis with the Principle Investigator: 1) Data entry and data cleaning using SPSS. 2) Generated tables containing descriptive statistics of demographics of study participants. 3) Performed Mixed Model analysis to assess the significance of change in each outcome variable over time (Baseline, 3 months, 6 months). 4) Summarized key findings on the effectiveness of the technology-based obesity prevention program.

Results/Outcomes: The three principal deliverables of this practicum included: 1) Using mean differences and standard deviations, I calculated the effect size over time of each outcome variable (BMI, Body Image…), with the result being used for future study sample size planning. 2) I wrote an analytical report of the study in support of manuscript submission in 2015. 3) Preliminary results: Efforts to prevent obesity should start in early childhood and health disparities should be reduced in low income children with ethnic minority backgrounds.

University of Hawaii John A. Burns School of Medicine

Alumna: Lindsey Kohorn

Title: Biostatistics Intern

Introduction: The Hawaii Center for AIDS is a clinical and translational research center at the University of Hawaii John A. Burns School of Medicine. The center specializes in attempting to find new and better ways to treat patients with HIV/AIDS as well as hopefully cure HIV/AIDS in the future.

Methods: This practicum provided an in-depth overview of the biostatistician’s role in an academic program. I was able to assist on a new clinical trial awaiting approval by the IRB, which included writing the statistical analysis plan as well as designing the electronic case report forms on a site called REDCap. I also performed some data analyses on two separate cohort studies using SPSS.

Results/Outcomes: The center will begin recruiting patients for the aforementioned clinical trial in the coming weeks. The two data analyses that I performed have been completed. The first analysis explored the effect of various immunologic parameters on oxidative stress and chronic inflammation. I found that several of these parameters are associated with a decrease in complex I activity, which could contribute to oxidative stress, whereas the Transitional Monocytes are most notably associated with an increase in complex I activity. The second analysis explored soluble CD163 and their effect on neurocognitive function. I found that higher levels of soluble CD163 are associated with a slight decrease in neurocognitive function. Both the clinical trial and the data analyses are expected to contribute to the treatment of patients with HIV.

University of Miami, Project Medishare

Alumna: Panagiotis Kourtesis

Title: Telepathology Whole Slide Scanner Configuration, Validation, Deployment, and Training

Introduction: Cancer diagnosis in Haiti is severely limited to the presence of a trained on-site pathologist. A visiting pathologist can only address a small amount of the undetermined cases per visit. Project Medishare would like pioneer the implementation of a telepathology system that uses a whole-slide scanner to transmit slide scans of suspected cancer biopsies via the Internet to pathologists anywhere in the world. The scanner will also act as an educational tool for the first Haitian cohort of student pathologists in over a decade

Methods: In order to fully grasp the nature of implementing a telepathology system in a resource limited setting, a literature review of was conducted to seek best practices and possible setbacks. The scanner was then configured to the proper settings in order to work in Haiti. Next, the scanner was put through a local technical validation process using some of the College of American Pathologists (CAP) telepathology guidelines. A teaching slide set of known cancer cases were scanned and sent, via the web, to pathologists in the department.

Results/Outcomes: The diagnoses attained from the department pathologists were compared to the actual cytological evidence from the slide set. The concordance was around 94%. The pathologists were debriefed and asked to provide feedback on how to enhance the system to make better diagnoses. The validation process will be repeated once the scanner is deployed to Haiti in order to complete the entire validation of using this scanner technology in resource limited settings.

University of the Western Cape, School of Public Health

Alumnus: Christopher Noble

Title: University of the Western Cape and Chronic Disease Dispensing Unit Facilitator

Introduction: I interned at the University of Western Cape School of Public Health (UWC SOPH).

Methods: I engaged with faculty and researchers to facilitate the relationship between the BUSPH pharmaceutical concentration and the UWC SOPH pharmaceutical area of specialization. I facilitated their Rational Medicine Use and Medicine Supply Management course which included: the preparation of teaching materials, management of daily tasks and logistics, and subsequent gathering of interviews and evaluations for a thorough report for publication and dispersal to increase publicity and engagement with future students and health professionals. I developed a research proposal to be continued upon my return investigating the price and utilization of diabetes medicines through private health insurance schemes to identify areas for improved rational use of diabetes medicines in the Western Cape. I worked with another MPH student to complete their dissertation and will co‐author their final publication on facility utilization of diabetes diagnostic information for informed therapeutic adjustments. I visited hospitals and diabetes health clubs to see what health resources are available for people living with NCDs in the Western Cape.

Results/Outcomes: These trips helped me develop a greater understanding of innovative NCD management models like the Chronic Disease Dispensing Unit, innovative medical‐delivery models, Chronic Disease Support Clubs and the benefits of a National Health Insurance with Single Exit Price controls on medicines to reduce informal mark‐ups. I intend to present these innovative models and systems of pharmaceutical access to continue researching their implications for patients living with chronic diseases in South Africa.

US Agency for International Development- Global Health Fellows Program II

Alumna: Amy Studenic, MPH

Title: Contraceptive Commodities Security and Logistics Intern

Introduction: USAID’s Commodity Security and Logistics supports the USAID | DELIVER Project, which works to strengthen national and international supply chains and increase coordination, commitment and collaboration for commodity financing, procurement and delivery.

Methods: During three months in DC and two months remotely, she worked on projects including: recommending areas for improved performance indicators; drafting technical briefs on current USAID supply chain activities; and conducting an assessment of countries’ collection of logistics data from service delivery points. In order to assess current data collection efforts from service delivery points supported by USAID, Amy performed an initial literature review, drafted an interview guide, and conducted interviews and document reviews with USAID staff and field staff from USAID supported projects. Topics covered in the interviews included: types, methods and frequency of data collection; how data is used at the local and central levels; key challenges; quality and accuracy of data; and feasible options for improving data collection efforts in the future. Amy collected data and information from 15 countries and consolidated her findings into a summary report highlighting current data visibility, key challenges, and recommendations on where USAID should focus its efforts in this area in the future.

Vertex Pharmaceuticals

Alumna: Maithili Jha, MPH

Title: Analytics with Clinical Development-Pharmacovigilance Department Intern

Introduction: Within the pharmaceutical industry, Clinical Trials involve extensive budgets, thorough study design, and complicated timelines.  To make sure that the Clinical group is within time/money/design constraints, operations management tools are used to identify process inefficiencies as well as aid in clinical planning.

Methods: Compiled a budget tracker using 4 milestones from our clinical timelines, analyzing variances in budgets by phase and compound.  I used Ms Project to gather information on clinical timelines: cycle-times, process discrepancies, inefficiencies, and conduct post-mortem analyses of trials.  I applied operations metrics to budget tracking and clinical process to start identifying key performance indicators.  I also used websites like TrialTrove and BioPharm Clinical to do market feasibility, assessing the competitive landscape for secondary indications and future programs.

Results/Outcomes: The budget tracker was used as a platform to incorporate better forecasting tools, as well as reason to further evaluate the assumptions used in creating a budget.  The analysis of the clinical timelines and associated business practices has launched an IT driven data warehouse project. Inefficiencies mainly occur between hand-offs within the trial.  For example, when/how Medical Writing communicates to Biostatistics and the rest of the Study Execution Team that the study protocol is complete and approved.  This project is ongoing since operations management is a relatively new concept for Vertex Pharmaceuticals.

Alumna: Melissa Jordan

Title: Drug Safety Evaluation Intern

Introduction: The project was to design and implement a historical database using reports generated by outside contract organizations for some of the compounds Vertex has investigated since 1989. Vertex has done research on Cystic fibrosis, autoimmune diseases, cancer, IBD, neurological disorders and infectious diseases. The purpose was to pull all pertinent general, safety, and efficacy information on the compounds from the PDF reports containing preclinical trial information into a database where it could be searched and trends could be studied.

Methods: To do this, collaboration was required with LeadScope where I had to reformat their platform, generate a compatible userfriendly template and write a small content loader application to bridge the template with the database. The final step was to go through different reports, pull out the important information, enter it into the template, upload the template and then troubleshoot any issues with the queries. Searching databases, pulling pertinent information from studies and studying trends are all skills used by an epidemiologist.

Results/Outcomes: The outcome of this project was a functioning, searchable database with 27 historical studies worth of information including: compound level, site, efficacy, safety and study design information. This information will eventually be used by the research and development team to streamline all pre-clinical studies, find previously unseen trends, determine dose, establish a safety profile and ultimately help to deliver much needed safe, efficacious drugs to human clinical trials in a more efficient manner. This will eventually help thousands of people across all of Vertex’s disease areas.

Veterans’ Affairs Boston Healthcare System

Alumnus: Sevan Chorluyan, MPH

Title: Health System Administrative Intern

Introduction: Hospitals, including those in the VHA Boston Healthcare System, have been struggling in the past few years with increasing number of backordered medications. In addition to the obvious negative effects backorders have on patient care, they also create logistical communication difficulties. Previously, backorders were ineffectively and sporadically dealt with, resulting in poor communication between purchasers, pharmacists, and physicians. The goal of the project was to create a systematic notification system that allows communication of backorders in an efficient manner to eliminate wasted time and effort.

Methods: Through interviewing different parties I determined that using the VA’s EMR during the ordering of prescriptions was the best method. This was selected because it would act as a reminder at the time of ordering and because of the extreme difficulty of reaching physicians be other forms of electronic communication. I then charted a chain of events that reports the information from the purchasing agents to the clinical coordinator of the pharmacy to the chiefs of the medical services and finally to the physicians. The clinical coordinator now manages an excel sheet that is accessible via the desktop of every computer in the Boston healthcare system giving information on the back-ordered medication and more importantly the available alternatives to the back-ordered medication.

Projected Outcomes: Physicians will less likely prescribe back-ordered medications but instead refer to the desktop excel sheet to choose an alternative medication. This will allow the physician to make this clinical decision when still with the patient.

Alumnus: Stephen McLaughlin

Title: Contraceptive Commodities Security and Logistics Intern

Introduction: The Mental Health Treatment Study (MHTS) is a multi-site demonstration project designed to evaluate the efficacy of supported employment services in helping persons with mental health disorders find and retain jobs. A subset of the MHTS was the Systematic Medication Management (SMM) protocol, which was implemented to create greater coherence in the prescribing patterns of pre- scribers. As an assistant on this project, I performed data analysis for the SMM group.

Methods: Using SAS and Excel, and under the guidance of senior investigators, I performed basic analyses on data sources related to prescriber engagement, perceptions of nurse care coordinator value, and created a chart comparing the Social Security Administration (SSA)’s designation of a beneficiary’s mental health with their results from the Structured Clinical Interview for DSM-IV Disorders (SCID). I also worked with clinicians to identify a patient’s physical health status based on multiple sources.

Results/Outcomes: The results of the SCID to SSA comparison will be used by the SSA to evaluate the efficacy of their policies used to designate a beneficiary as suffering from schizophrenia or an affective disorder. The physical health status will likely be looked at as a predictor of em- ployment outcomes because it is considered as confounder of the relationship between use of employment services and employment out- comes. The prescriber engagement and nurse care coordinator summaries will be used to evaluate the quality of program implementation.

World Health Organization

Alumnus: Joel Buenaventura

Title: Department of Essential Medicines and Pharmaceutical Policies Intern- The Impact of the Economic Recession on the Pharmaceutical Sector in the Baltic Countries

Introduction: The purpose of the study is to investigate the impact of the 2008 economic recession on the pharmaceutical sector of two Baltic countries (i.e. Estonia and Latvia), which was shown to have the most substantial declines in pharmaceutical consumption and explore qualitatively what policies could have caused this decline in order to possibly provide a framework for policy making in times of economic recession.

Methods: Data were gathered through comprehensive literature review in order to identify possible contributory factors that led to the substantial decrease in pharmaceutical consumption in Estonia and Latvia. Country specific quarterly data from IMS Health and Economic Intelligence Unit (EIU) from 2007-2009 were also generated. Teleconference interview with a focal person from Estonia and Latvia was done to validate findings from literature review and clarify other issues.

Results/Projected Outcomes: EIU data showed that the economies of Estonia and Latvia had been contracting earlier, even before the global economic crisis hit other countries. Due to their determination to fulfil the Maastricht Criteria for the adoption of the Euro, they had limited flexibility in terms of policy changes in response to the economic crisis. IMS Health data showed that there was a substantial decline in the pharmaceutical expenditure and consumption and increase in pharmaceutical prices. However, the impact of the decline in pharmaceutical consumption during the economic recession on the health status of these populations remains to be seen.

Alumna: Lindsay Esposito, MPH

Title: Department of Essential Medicines & Health Products; Pharmaceutical Policies Unit Intern

Introduction: Developing countries face the greatest problems in both accessing and properly utilizing essential medicines.  A challenge to achieving these goals in resource-poor settings is a limited knowledge base on what works to improve the selection and use of essential medicines including ensuring affordable prices, increasing sustainable financing, and strengthening reliable supply systems that are relevant to these settings.  I was asked to develop a bibliometric study of existing publications on access to medicines in developing countries.  The objectives were to search the existing evidence base on access to medicines issues in developing countries and to assess the nature of topics studied, areas where gaps of information exist and the general trends in production of research in this area.

Methods: (1) develop a bibliometric search strategy (2) undertake an analysis of results of the bibliometric search (3) produce a preliminary report suitable for submission as part of a grant proposal for the Access to Medicines Research Network.

Results/Projected Outcomes: As anticipated, few developing country corresponding authors were identified. Based on this bibliometric review the dearth of articles written by developing country authors is a challenge if researchers in developing countries are to contribute to ensure universal access to essential medicines and their proper usage.  I prepared the report successfully for the grant submission.  I am currently producing a report for the WHO Research Series as well as writing a paper for submission to a journal.

Alumna: Samantha Straitz

Title: Department of Essential Medicines & Health Products; Policy, Access and Use Unit; Medical Devices Team Intern

Introduction: Health technologies vary widely in availability and complexity and country leaders face difficult decisions when choosing which technologies to fund that best address their population’s priority health needs. In response to World Health Assembly Resolution 67.23, the WHO 2015 Global Survey on Health Technology Assessment (HTA) was administered to all WHO Member States between February 24 and August 31, 2015. The survey evaluated HTA utilization in public sector decision-making, scope and availability of HTA guidelines, institutional capacity supporting HTA, governance of the HTA process and requirements for strengthening HTA capacity at the government and national institute level.

Methods: In June 2015, I wrote and sent a letter to over 100 WHO in-country representatives and Ambassadors of Permanent Missions to the United Nations to ensure completion of the Global Survey and nomination of an in-country health technology focal point. Throughout June-August 2015, I corresponded with these representatives to assist with survey completion. In August 2015, I cleaned all survey response data and submitted this information for analysis and publication.

Results/Projected Outcomes: The WHO Health Systems and Innovation Cluster determined that HTA-related organizations play an advisory role in policy decisions, HTA focuses on safety and clinical effectiveness and two in three countries rely on national HTA organizations/departments/committees to analyze and evaluate health technologies and their impact. Additionally, findings show public health professionals and civil society representatives support national health bodies in initiating HTA and a lack of qualified human resources and in-country training programs pose primary barriers to producing and using HTA.

Alumna: Meredith Wallace

Title: Data Collection Intern, Department of Essential Medicines and Pharmaceutical Policies

Introduction: Ensuring access, availability and quality of essential medications around the globe is a key priority of the World Health Organization (WHO). WHO aims to develop internationally recognized norms, standards, and guidelines for medicines regulation. Between 2009-2011 the Pharmaceutical Country Profile project empowered countries to develop a pharmaceutical profile and make data available at a national level. This preliminary analysis compares regulatory policies and practices across WHO member states by region and World Bank income group.

Methods: Data was collected using the Pharmaceutical Country Profile survey questionnaire, with additional data drawn from the 2010 pilot study and publicly available sources. Fifty-four countries submitted questionnaires in time for inclusion in this analysis, and demo- graphic and health expenditure data on 137 additional countries was included to provide a more comprehensive picture of current practices. This report is an extension of work done by Paul Ashigbie (BUSPH MPH’11) from the 2010 pilot study. Data stored in Access was exported and analyzed in Excel.

Results/Projected Outcomes: Most countries have regulatory structures in place for the pharmaceutical sector. However, the complexity of regulatory systems varies widely across countries studied. While most countries have basic policies and frameworks in place, fewer report regulation of clinical trials. Additionally, it is difficult to assess the extent to which policies are implemented. No significant trends in regulatory practices emerge across regions. Variation within individual countries indicates a national commitment is more important than national wealth in establishing a functioning regulatory system, though several indicators do seem influenced by economic status.

Alumnus: Abdullah Adedotun Yusuf

Title: Department of Essential Medicines and Pharmaceutical Policies Intern

Introduction: The Essential Medicines and Health Products department within the WHO is responsible for a wide range of activities that relate to the access, safety, efficacy, quality and rational use of medicines and health products around the world. As an intern, I worked on the Pharmaceutical Country Profiles (PCP), one of the department’s technical areas. My role was to conduct a quantitative evaluation of the data collection tool that was used in the 2011 round of PCP surveys, with the aim of improving the tool prior to the next round of surveys in 2015. Based on my findings, I created a draft web-based survey to be piloted in a dozen countries in 2014.

Methods: My task involved three separate activities: (1) Determine how many of the 194 participating countries (stratified by region and income level) responded to each of the 500+ questions in the survey (to identify any redundancies in the survey questions). (2) Determine the accuracy of information held at the WHO at the time of the survey on national pharmaceutical sectors of each participating country (represented by survey prefill and change rates). (3) Determine how long it took countries on average to respond to the survey

Results/Projected Outcomes: The overall indication from the exercise was that the survey tool was indeed adequate for its purpose in the generation of Pharmaceutical Country Profiles, and that the WHO had country pharmaceutical sector data that was reasonably accurate at the time of the survey.

Alumna: Miao (Molly) Zhang

Title: The 2011 Pharmaceutical Sector Country Profile Survey Evaluation

Introduction: A comprehensive assessment of the national pharmaceutical sector helps to determine what the gaps are in order to design effective interventions and allows evaluation of the impact of interventions over time. WHO has developed the Pharmaceutical Sector Country Profile (PSCP) to measure key aspects of the pharmaceutical sector and systematically monitor the progress of efforts to improve access to essential medicines. In order to have a comprehensive evaluation upon the 2011 PSCP and to prepare for the 2014 pilot and the 2015 global PSCP, a qualitative evaluation was conducted. It was expected that a web based solution as a substitute for the former paper based questionnaire could be tested through this survey. 

Methods: Research for this report included the review of past reports about the series of PSCP projects, the test of the feasibility of using LimeSurvey to generate the next round PSCP and the collection of respondents’ suggestions and recommendations upon the process and the content of the 2011 PSCP project through both online survey and telephone interviews

Results/Projected Outcomes: Pre-filling was recognized as being helpful and efficient in the validation and completion of the questionnaire; the length of the questionnaire was considered reasonable; the time required for completing the whole questionnaire was complicated by the availability of information, the format of the questions and the different mechanisms used by countries in obtaining the formal endorsement; and the Instruction Manual and Glossary were not all thought to be useful. Detailed suggestions about specific sections and questions were also summarized in the report.

World Health Organization Collaborating Center on Pharmaceutical Policy

Alumnus: Paul Ashigibie

Title: Gender and Pharmaceutical Care Research Intern

Introduction: The World Health Organization Collaborating Center in Pharmaceutical Policy (WHOCCPP) is undertaking a literature re- view (from 1990 to 2010) to summarize published evidence on gender and pharmaceutical care in HIV, TB and Malaria treatment. My practicum duty was to review three databases of articles on medicines use in low and middle income countries to identify and analyze studies that addressed possible gender differences.

Methods: I manually reviewed two article databases: The Holloway and the International Network for Rational Use of Drugs databases. I examined the research design, and statistical analysis used by studies that accounted for gender. I also examined and the thematic areas of medicines use that the studies covered: livelihood assets, structural processes of seeking treatment, and livelihood outcomes. I further classified the study results and objectives according to the following areas of pharmaceutical care: Medicine acceptability, accessibility, adequacy, adherence, affordability and availability.

Results/Projected Outcomes: With 92 articles reviewed, less than half (36) addressed possible gender differences in medicines use. None of these studies evaluated gender differences as its primary objective. Only two of the 36 studies were randomized controlled studies. Twenty eight of the studies addressed gender differences in livelihood outcomes, while 12/36 and 9/36 addressed livelihood assets and transforming structural processes respectively. Twenty one of the studies were on access to medicines, while 15/36 addressed adherence, 11/36 acceptability, 5/36 affordability, 3/36 availability and 2/36 adequacy. From these preliminary results, few rigorous studies examined possible gender differences in the use of animalarial, antiretroviral and antituberculous drugs.

Alumnus: Paul Ashigibie

Title: Global Exchange for Market Intelligence Information (GEMInI) project Intern

Introduction: The Global Exchange for Market Intelligence Information (GEMInI) project of the Boston University Medical School seeks to develop an open access database to capture the trends in donor spending on antimalarials, antiretrovirals and antituberculous agents. I reviewed and updated the list of WHO and FDA registered antimalarials and antiretrovirals to be used for the development of this data- base. This abstract presents the findings on the country of manufacture of these pharmaceuticals.

Methods: I reviewed the monthly publications of WHO prequalified antimalarials and antiretrovirals (from September 2010 to January 2011), for new entries and other changes. I also reviewed the FDA database of antiretrovirals for the same information. For each certified entry, I recorded the manufacturer, product origin, type of formulation, certification date, withdrawal date, pack size and drug strength, etc. on an excel spread sheet.

Results/Projected Outcomes: The WHO prequalification list had a total of 388 antiretroviral products from 16 countries as of January 2011. Out of this, 253 (65%) were produced in India while the USA and the United Kingdom manufactured 18 and 20 respectively (about 5% each). The FDA registered 418 anti-retrovirals from four countries. Out of this, 301 (72%) were manufactured in India, while 112 (27%) were manufactured within the US. The WHO prequalification list had a total of 60 antimalarials from six countries. 25 (42%) of these were produced in India, 14 (23%) from China, 8 (13%) from Morocco and 7 (12%) from the USA. India is the largest producer of internationally certified antimalarials and antiretrovirals.

Zensun USA

Alumna: Erika Alvarez, MPH

Title: Clinical Statistical Intern

Introduction: Zensun, U.S.A. Inc. is a biopharmaceutical company developing a novel treatment for chronic heart failure (CHF). Chronic heart failure is a condition that affects nearly 5 million people in the United States and has no real cure aside from heart transplantation. Zensun, U.S.A. is currently performing Phase III trials in China and has been approved to begin Phase III trials in the United States.

Methods: I assisted in adverse event safety analysis that was to be submitted to the FDA. I generated SAS programs to merge and perform statistical procedures on CDISC SDTM/ADaM databases on 12 Phase I and Phase II clinical trials completed in China, Australia, and the United States. I created individual subject and study summary reports regarding specific adverse events. The proportion of adverse events in the investigational drug group was compared to the placebo group using a Chi-square test.

Results/Outcomes: I practiced clinical trial data analysis skills such as merging datasets and performing statistical procedures. I gained exposure to the major statistical deliverables in the pharmaceutical development process. Through my work, I was able to provide the company with adverse event information required for submission to the FDA.