Current Courses and Descriptions

Our up-to-date course listings can be found below. Some of our courses are open to nondegree students and students enrolled in other degree programs. These courses are noted in the listings below. Please contact us if you have questions or to enroll in a course.

Fall 2017 Courses

MTR/REG 510 Introduction to Clinical and Translational Research
Instructors: Emma Meagher, MD
Time: M/W, 4:00 -5:30 PM
Location: 8030 Maloney
Open to nondegree: Yes

This introductory course lays the foundation for understanding practical aspects of conducting clinical research in an academic environment. The course is divided into two modules: Module 1: Research Methods & Protocol Development and Module 2: Regulatory Environment for Clinical Trials. The first module introduces clinical research, clinical protocols, study designs and biostatistics that underlie such studies. The second module covers ethical considerations in clinical research, study execution and oversight, and the regulatory environment for clinical research. Upon completion, students should have a strong foundation in the fundamentals of clinical research and should be able to apply contemporary research tools to clinically relevant areas of investigation.

MTR 600 Introductory Biostatistics
Instructor: Andy Cucchiara, PhD
Time: T/R, 3:30-5:00PM and W, 2:00-3:30PM
Location: 8030 Maloney
Open to nondegree: No

This course approaches statistics from an applied as well as theoretical point of view. Students learn the correct application and interpretation of basic statistical concepts and techniques. The course covers probability estimation, hypothesis testing, nonparametric tests, tests for categorical data, correlation, and regression. Students will be provided with an understanding of statistical methods, skills in the use of software to apply those methods and the critical thinking to interpret analytic results produced by your effort and/or that of fellow researchers.

MTR 603 Disease Measurement
Instructors: David Mankoff, MD, PhD; Irv Nachamkin, DrPH, MPH; Tracey Polsky, MD, PhD
Time: T/R, 2:00-3:15PM
Location: 8030 Maloney
Open to nondegree: No

Acquire the knowledge to rationally and effectively incorporate disease measurements, including emerging technologies, into the design of translational and clinical research protocols. Gain a basic understanding of measurement methodologies used in clinical medicine. Understand how "normal" values are determined, and how to interpret test results in the context of patients/research subjects. Approach disease measurements (tests) as a mean of answering questions, and to be able to choose appropriate tests to answer the questions being posed. The measurement aspects of the students' research protocol are written and evaluated during this course. This course is separated into lab and imaging sections.

MTR 606 Grantsmanship
Instructor: Rachel Locke, PhD
Time: M, 4:00-6:00PM
Location: 8 Maloney
Open to nondegree: No

Students will learn to write a mentored career development or new investigator NIH grant proposal. More specifically, students will:

  • Understand how grant proposals are reviewed by NIH and which NIH resources are available to investigators
  • Learn how to find and follow the multiple sets of instructions that apply to many NIH proposals
  • Develop a method to assemble, write and track the parts of an application
  • Write an organized and concise Specific Aims page
  • Develop a research proposal that specifically addresses review criteria
  • Gain an improved understanding of how to present your statistical analysis
  • Review classmates’ proposals and receive coaching on how to improve their own proposal
  • Understand how to develop a budget and how budgets are handled in the University system

REG 613 Drug Development Decision Criteria
Instructor: Jeff Barrett, PhD
Time: M/W, 4:00-5:30PM
Location: 9025 Maloney
Open to nondegree: Yes

This course reviews the critical junctures over which innovative and generic drugs are evaluated and the decision criteria used to judge performance and plan next steps. The nature of the collective data under review, the decision paths and the decision makers themselves often change depending on the stage of development. This course covers decision criteria from drug discovery through post marketing and even entertains decision points for generic drugs (pharmaceutical- and bio- equivalence). Metrics for evaluation, company and regulatory expectations and the tools used to facilitate decision (e.g., modeling and simulation techniques to generate “what-if” scenarios) making are all discussed in detail. A key feature of the course are “labs” which involve instructor-led decision analysis role playing. The class will be divided into small teams that review data generated at different stages to examine the thought processes and decision criteria evaluable at different stages of drug development. Labs are constructed from actual case study examples and team performance will be evaluated at the conclusion of the lab session.

REG 622 New Trends in Medicine and Vaccine Discovery
Instructor: Claudine Bruck, PhD
Time: T, 3:30-6:30PM
Location: 9025 Maloney
Open to nondegree: Yes

Modern drug discovery has evolved beyond small molecule drugs to include various biological approaches from proteins to cell and gene therapy, which has enabled progress in a variety of fields, including rare diseases, immuno-oncology, precision medicine, and biomarkers. The goal of this course is for students to understand newer treatment modalities and approaches beyond ‘one size fits all’ small molecule drugs, as well as the technologies that empower them. Students will learn regulatory processes that govern medicine discovery and development and also consider business and societal aspects of medical progress. Students will be able to apply concepts directly to work in the healthcare industry. Students will be taught by prominent experts in the field internal and external to Penn.

Spring 2017 Courses

MTR 604 Scientific and Ethical Conduct
Instructors: Emma Meagher, MD; Tracy Ziolek, MS
Time: M, 8:30-10:00AM
Location: 8030 Maloney
Open to nondegree: No

In this course, students will learn the foundational principles of scientific and ethical conduct of research, complete directed experience in evaluating these principles through IRB membership and ultimately be able to apply them to their own work. By the end of the foundational class sessions, students will understand scientific conduct, ethical considerations including human subjects and animal protections, regulations governing the use of health information, drugs, and devices, good laboratory practices, conflict of interest, and ethics in challenging new research domains. The directed experience will include membership for six months on an Institutional Review Board (IRB) at either the University of Pennsylvania or the Children’s Hospital of Philadelphia. This membership experience will expose students to real issues, considerations, and solutions in human subjects research and study design. ​

MTR 535 Intro to Bioinformatics
Instructors: Casey S. Greene, PhD; Benjamin F. Voight, PhD
Time: M/W/F, 10:00-11:00AM
Location: 10-146 SCTR
Open to nondegree: Yes

This course provides a broad overview of bioinformatics and computational biology for biomedical research. The course is geared towards helping students develop their analytical skills for dealing with data, from single gene to whole genome and transcriptome analysis. Students develop skills in programming, reproducible computational research, and machine learning that will position them to apply certain existing techniques and to provide the vocabulary to collaborate with bioinformatics method developers.

MTR 620 Translational Therapeutics
Instructors: Nalaka Gooneratne, MD, MSc; Tomás Isakowitz, PhD
Time: T/R, 4:00-5:30PM
Location: Maloney 8030
Open to nondegree: Yes

Content is focused on an overview of methodological approaches to the discovery, preclinical evaluation, and clinical development of novel therapeutics including devices, small molecules, biologics, vaccine, cell based therapies, and antibodies. Practical steps needed for real world transfer of academic technology to the patient setting will be emphasized including disclosure, patenting, licensing, business development and marketing.

REG 612 Introduction to Drug Development
Instructor: Jeff Barrett, PhD
Time: M/W, 4:00-5:30PM
Location: Maloney 8030
Open to nondegree: Yes

This introductory course lays the foundation for conducting pharmaceutical research in many ways. It begins with a brief review of the history of drug development and explains the phases of drug development in detail. The decision making process, drug development milestones and compound progression metrics are defined and explained with examples. At the conclusion of this course, students should have a working knowledge of the drug development process, understand the regulatory basis by which new chemical entities are evaluated and ultimately approved and appreciate the time and expense of drug development.

REG 621 Cell & Gene Therapy
Instructors: Mike Milone, MD, PhD
Time: W, 8:30-11:30AM
Location: SPE, 08-100
Open to nondegree: Yes

This course will provide students with a general overview of translational research in the area of gene and cell therapy.  This would include technical considerations, translating preclinical investigation into therapeutics, the execution of gene and cell therapies clinical trials, and key regulatory issues. Entrepreneurial considerations will be discussed as well. By the end of this course, students will understand the basic technologies employed for gene and cell therapy along with approaches and pitfalls to translating these therapies into clinical applications including regulatory and commercial aspects of this emerging area.

Summer 2017 Courses

MTR 601 Scientific Writing I: Review Writing (Summer II session)
Instructor: Rachel Locke, PhD
Time: T/R, 2:00-3:15PM
Location: 9025 Maloney
Open to nondegree: No

This course will lead students through the process of writing a Review Article during their first Summer within the MTR program. Review articles will be authored with the student's primary mentor and will be used to accomplish the following goals:

  1. Attain rapid familiarity with background in their new area of study;
  2. A mechanism for mentor and student to create a productive working/writing relationship;
  3. Help the student identify key gaps in the literature and/or areas of controversy that would benefit from pivotal experiments;
  4. Understand the factors that contribute to variability in research outcomes in their area and;
  5. Introduce the student to other scientists in their new area through an initial publication early in their career.
  6. Mentors will be asked to agree to participate in this process, or identify another senior individual in their group who would perform the function as a condition to have MTR students funded in their program. The course director and members of the curriculum committee will provide guidance and critical reviews throughout the process.

MTR 602 Proposal Development: (Summer II Special Term: July 6 — Sept 19)
Instructor: Anil Vachani, MD
Time: T/R, 3:30-5:00PM
Location: 8030 Maloney
Open to nondegree: No

This course focuses on study design and proposal development as they relate to the studies that probe the mechanism of disease. It discusses concepts such as writing a background section, asking a research question, designing a study, use of biomarkers, writing a research proposal, overview of different study designs and addressing feasibility issues. Development of the thesis proposal starts during this course and concludes with each student submitting and presenting their proposal to the MTR faculty panel for critique and feedback.

MTR 605 Scientific Writing II - Manuscript Writing: (Summer I session)
Instructor: Kachina Allen, PhD
Time: T/R, 2:00-3:15PM
Location: 8030 Maloney
Open to nondegree: No

Students will write a primary data manuscript for publication with their primary lab mentor. Emphasis will be placed on identifying publishable data that was either generated by the student, or which is made available to the student for analysis from the mentor's lab (e.g. perform a new analysis across data from multiple studies, organize and analyze data that is 'laying in wait' for someone to publish it). The student will be expected to learn the role of first author including:

  1. coordination with the senior mentor to write the introduction,
  2. organize data, analyses and figures;
  3. obtain or write methods and results from collaborators;
  4. writing a discussion and;
  5. "getting it out the door".

The authorship for the publication is left to the discretion of the mentor in consultation with the originator of the data and the MTR student. This will both teach the student the value of publishing as an integral part of academic life, and will facilitate their success with subsequent grant applications. The course director will provide guidance and critical review of work throughout the process. Mentors will be asked to agree to participate in this process, or identify another senior individual in their group who would perform the function. Completion of the course and continuation of associated funding is contingent on submission of the manuscript. 

REG 610 Fundamentals of FDA Regulation
Instructor: Monica Ferrante, DPA
Time: R, 4:00-7:00PM
Location: 9025 Maloney
Open to nondegree: Yes

This introductory course provides an overview of Regulatory Affairs in relation to three key areas of development: Drugs, Biologics, and Medical Devices. The course will look at the rules governing prescription and over-the-counter drugs as well as the changes introduced by the influence of genetic engineering and biological product development. The developmental and regulatory path for new devices, as well as the way products are governed once in the marketplace will be explained.  Throughout the course, practical issues facing regulatory specialists as they work with the FDA and other international regulatory bodies to secure and keep product approval will be addressed.

REG 611 Clinical Study Management — Not offered in Summer 2017, next offering will be Summer 2018
Instructors: Emma Meagher, MD; Megan Kasimatis Singleton, JD, MBE
Time: M/W, 5:00-6:30PM
Location: 8030 Maloney
Open to nondegree: Yes

This course will focus on the practical aspects of executing clinical trials in an academic environment in a GCP compliant fashion. Upon course completion students will be able to effectively implement and manage both investigator-initiated and industry-sponsored clinical research studies. Students will be guided through the operational aspects and regulatory processes for the three stages of study management: pre study, study start-up and implementation, ongoing compliance and study close out. Students will learn strategies for navigating the complex regulatory/operational clinical research environment and for successful protocol development and approval, subject recruitment, data management and IRB/FDA interactions. Protection of human research subjects and adherence to good clinical practices guiding research in humans is a critical concept that will be integrated throughout each of the lectures.

Thesis/Capstone and Lab Credits

MTR 607/608 Thesis Credits
Trainees are expected to complete a thesis that involves designing a research project, writing a formal research proposal, performing the study described in it, preparing 1-2 comprehensive scholarly scientific paper(s) reporting the results, and presenting and defending the thesis at a public seminar. The defense portion of the seminar will be a formal oral defense of the thesis with three examiners.

REG 640 Capstone
The capstone project is an intensive learning experience focused on the student’s specific area of interest within Regulatory Affairs and his/her overall career aims. Each MRA student will be mentored by their capstone advisor. The student will develop a detailed project proposal with goals and objectives. The project will be implemented under direction of the advisor, and students will be evaluated at the end of the project.

MTR 999 Laboratory Unit
MTR degree candidates are required to complete two lab rotations of primary, meaningful laboratory research in a translational research setting. Successful completion of each lab rotation results in the awarding of one credit unit. The purpose of the lab rotation is to emphasize the basic components of the translational research experience, to appreciate that the underpinnings of translational research is understanding disease mechanism, and to learn the subtleties of the measurement of disease process and the complexity this brings to the area of human research. The student formulates a lab proposal, conducts the research in the laboratory, collects data, and analyzes it. Each lab rotation is meant to provide experience working in a new environment or learning a new technique.