ITMAT Education Courses

classroom of students

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. If you are interested in enrolling in a course please complete the form at the bottom of this page. Please email us if you have any questions.

Spring 2025 Courses

MTR 6060 Grantsmanship
Instructor: Rachel Locke, PhD
Time: Thur, 9:00 AM - 12:00 PM
Location: 8030 Maloney
Open to nondegree: Yes, with permission of instructor.
Prerequisite: Students are required to be writing a career development award during the term in which they enroll in the course. If you are interested in taking the course, but unsure if you meet the requirements, contact Dr. Rachel Locke.

Students will learn to write a mentored career development award (i.e. NIH K23, K08, Foundation CDA). 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

MTR 6200 Medical Entrepreneurship: Commercializing Translational Science
Instructors: Nalaka Gooneratne, MD, MSCE, & Adam Dakin, MBA
Time: T/R, 3:30-5PM
Location: 311 Towne
Open to nondegree: Yes
Most recent syllabus

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.

MTR 6230 Writing an NIH Grant
Instructor: Karen Teff, PhD
Time: W, January 29 - April 30, 11:00-1:00PM
Location: Online
Open to nondegree: Yes
Audience: Faculty or postdocs who have not written an NIH grant before or need guidance with submitting a revised application. This course is not appropriate for students applying for training applications (Ks and Ts) as the components for these types of mechanisms will not be covered.
Most recent syllabus

This course will provide a comprehensive overview of the NIH structure, submission and review process as well as foundational knowledge for any R01 grant proposal. The course will cover the preparation and writing of the grant application focusing on the required sections of the R01 grant (e.g. biosketch, specific aims, innovation, significance, research strategy and approach) and the expectations/requirements for each of these sections. In addition, an overview of the NIH submission and review cycle, how and when to interact with program directors and scientific review officers, an explanation of the different types of program announcements and how to read them. Identifying the appropriate study section, interpretation of summary statements, how to respond to concerns by reviewers and requirements for revisions will also be discussed. The course is capped at 15 students. Apply by Nov 22, 2024 to be considered. For more information, contact Megan Maxwell, mmaxwell@upenn.edu.

REG 6120 Introduction to Drug Development
Instructor: Eileen Doyle, PharmD
Time: T, 4:00-7:00PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

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 6150 Post-Approval Maintenance of Drugs, Biologics, and Devices
Instructor: Michele Roy, RN, MS
Time: W, 5:00-8:00PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

The FDA regulates prescription drugs, biologics and medical devices for utilization in the United States. The approval of a marketing application is a major accomplishment; however, it comes with significant responsibilities for a sponsor including numerous reporting requirements and activities to maintain a license, as well as a need for lifecycle maintenance activities to stay competitive. The purpose of this course is to provide an overview of post-approval activities required for drugs, biologics and devices, including topics such as understanding pertinent US regulations, general requirements for license maintenance, key periodic reports submitted to regulatory agencies, types of post-approval changes, and reporting categories for post-approval changes and reporting procedures.

REG 6180 Introduction to Vaccine Development
Instructor: Jeff Barrett, MD
Time: W, 4:00-7:00PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

Vaccine development is the process by which new vaccines are discovered, studied in laboratory and preclinical models and investigated clinically in patients to determine if they are safe and efficacious. Assuming the vaccine under investigation passes systematically defined milestones, submission of all documentation to regulatory authorities (e.g., US FDA and equivalent global regulatory authorities) can ensue and, pending a favorable review, market access can be granted. The process is highly regulated and there is significant cost involved for pharmaceutical sponsors to research and develop vaccines with the entire process averaging around 12 years once a product is discovered.  

This introductory course lays the foundation for conducting vaccine research in many ways. It begins with a brief review of the history of vaccine discovery and development and explains the phases of vaccine development in detail. Global Health history and impact of vaccines is described as well as the various stakeholders (e.g., WHO and World Bank) involved which distinguish vaccine from drug development. The decision-making process, vaccine 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 vaccine development process, understand the regulatory basis by which new vaccines are evaluated, ultimately approved, and distributed around the world. 

REG 6190 Research Ethics
Instructor: Melissa Byrn, MBE
Time: R, 6:00-8:00PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

This course will focus on of the connection between biomedical research ethics and aspects of regulatory affairs. Students will apply frameworks for evaluating research ethics questions through the exploration of modern biomedical research topics. Students will cultivate competency in the application, and limitations, of US human subjects’ regulations. This course will prepare students to critically evaluate the ethics of specific research topics and apply ethics-informed decision-making in the regulatory affairs domain.

Contemporary research ethics topics include (but are not limited to) research study recruitment, conflicts of interest, human research protection programs, informed consent, working with vulnerable populations, privacy/confidentiality, and emerging medical technology. The course will implement asynchronous videos and readings and interactive synchronous sessions; assignments include quizzes, discussions (in-class and online), and a generative final project.

REG 6210 Cell & Gene Therapy
Instructor: Mike Milone, MD, PhD
Time: W, 10:15-12:15 PM
Location: In-person, SPE 8-100
Open to nondegree: No
Prerequisite: At least one course in immunology.
Most recent syllabus

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.

REG 6310 The Role of the Clinical Research Nurse: Principles, Procedures, and Purpose
Instructor: Amanda Brock, MSN, MBE
Time: W, 5:30-7:00PM
Location: Online
Open to nondegree:
Prerequisite:

This course will focus on providing the framework for Clinical Research Nurses (CRN) to successfully use the International Association of Clinical Research Nurses Scope and Standards for Clinical Research Nursing and Core Competencies in their practice. Upon completion of the course, students will be able to identify the intersection of foundational clinical nursing skills and the clinical research nursing domains of practice. They will be able to identify strategies to engage with various internal and external stakeholders.

Most recent syllabus

REG 6400 Capstone I
Instructor: Andrew Fesnak, MD, MHCI
Time: M, 4:00-5:00PM
Location: Online
Open to nondegree: No
Most recent syllabus

The Capstone is an intensive project focused on the student’s specific area of interest within Regulatory Affairs. The Capstone is composed of two course units, REG 6400, which consists of scheduled in-person and asynchronous classes focused on the Capstone proposal development and REG 6410 which consists of student-driven completion of the Capstone project. During REG 6400 the student, with the guidance of their Capstone Advisor, the Course Director, and program staff will define objectives and formulate their Capstone proposal and delineate deliverables and milestones. Successful completion of REG 6400 is determined by a finalized proposal approved by the Course Director. The work proposed in the Capstone Project proposal will be the focus of the student’s efforts in REG 6410 Capstone II. Prior to the start of this course students should have a topic idea(s) they are interested in pursuing for their capstone. This topic must be related to their area of interest within Regulatory Affairs.

Summer 2025 Courses

MTR 6040 Scientific and Ethical Conduct
Instructors: Cheilonda Johnson MD,MHS
Time: T/R, 9:30-11:00 AM
Location: 8030 Maloney
Open to nondegree: No
Most recent syllabus

In this course, students will learn the foundational principles of scientific, operational, and ethical conduct of research, complete directed experience in evaluating ethical principles through IRB membership and ultimately be able to apply all principles to their own work. By the end of the foundational class sessions, students will understand scientific conduct, ethical considerations of human subject’s research, good clinical practices (GCP), conflict of interest, and budgetary concepts. The directed experience will include becoming a member of an Institutional Review Board (IRB) (Penn or CHOP) and participating as an active member in 6 meetings.

MTR 6020 Proposal Development (Summer II session)
Instructor: Michael Harhay, PhD, MPH
Time: T/R, 11:00-12:30 PM
Location: 8030 Maloney
Open to nondegree: No
Most recent syllabus

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 MSTR faculty panel, the students research mentor(s), and thesis committee for critique and feedback.

MTR 6050 Scientific Writing II - Manuscript Writing
Instructor: Kachina Allen, PhD
Time: T, 8:00-11:00 AM
Location: Online
Open to nondegree: No
Most recent syllabus

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:

coordination with the senior mentor to write the introduction,
organize data, analyses and figures;
obtain or write methods and results from collaborators;
writing a discussion and;
"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 MSTR 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 6100 Fundamentals of FDA Regulation
Instructor: Christine Lee
Time: Thursday (R), 5:00-8:00 PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

This introductory course provides an overview of Regulatory Affairs in relation to three key areas of development: Drugs, Medical Devices, and Biologics including gene therapy and vaccines. Students will gain insight into the pivotal role of FDA in regulating medical products, as well as explore the therapeutic product development life cycle process from initial concept to market entry. Special emphasis will be placed on formulating regulatory strategies including determining pre-clinical and clinical testing requirements for the three key areas in support of clinical trials and commercialization. Furthermore, the course will dissect different types of FDA enforcement actions and equip students with knowledge to navigate pre- and post- approval compliance challenges effectively. Practical issues encountered by regulatory specialists in collaboration with the FDA will be addressed. Real-world case studies and interactive discussions will provide students with valuable insights into overcoming regulatory hurdles and securing product approvals in a competitive domestic market.

REG 6110 Clinical Trial Management
Instructors: Amy Marshall, MPH; Megan Kasimatis Singleton, JD, MBE
Time: M/W, 4:00-5:30PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

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. This course is divided into three segments. In the first segment, students will be guided through the operational aspects and regulatory processes of clinical trial management across the clinical trial life cycle from pre-study activities through study start-up and implementation, and ongoing compliance through 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. In the second segment of the course, students will learn about specific trial management challenges that may arise based on study type and will learn skills for navigating these challenges for investigator-initiated studies, federally-funded and commercially-sponsored research and research with unique trial management concerns such as conflicts of interest and the use of new technologies. Finally students will have the opportunity to apply the skills they have learned through a final course project which includes identification of a trial management challenge and a proposal for solutions to address that challenge. 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 and course assignments.

REG 6270 Drug Development Decision Criteria
Instructor: Jeff Barrett, PhD
Time: T, 4:00 - 7:00PM
Location: Online
Open to nondegree: Yes

Drug development is a highly regulated process with a great deal of oversight provided by both the global regulatory community and the internal management of the companies themselves. In addition to the regulatory milestones that designate a target molecule’s status, there are scientific hurdles that a drug candidate must traverse in order to gain passage to the next development phase.

The pharmaceutical industry over time has systematically outlined critical junctures at which data, assumptions, models and experience are collated and reviewed by decision makers within the company, and many times in view of external experts, to decide if a compound should progress and also define the best course of action. 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.

Fall 2024 Courses

MTR/REG 5100 Introduction to Clinical and Translational Research
Instructors: Emma Meagher, MD
Time: M/W, 4:00-5:30 PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

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 5350 Intro to Bioinformatics
Instructors: Benjamin F. Voight, PhD; Ophir Shalem, PhD
Time: M/W/F, 1:45 - 2:45 PM
Open to nondegree: Yes
Most recent syllabus

This course provides overview of bioinformatics and computational biology as applied to biomedical research. A primary objective of the course is to enable students to integrate modern bioinformatics tools into their research activities. Course material is aimed to address biological questions using computational approaches and the analysis of data. A basic primer in programming and operating in a UNIX environment will be presented, and students will also be introduced to Python R, and tools for reproducible research. This course emphasizes direct, hands-on experience with applications to current biological research problems. Areas include DNA sequence alignment, genetic variation and analysis, motif discovery, study design for high-throughput sequencing RNA, and gene expression, single gene and whole-genome analysis, machine learning, and topics in systems biology. The relevant principles underlying methods used for analysis in these areas will be introduced and discussed at a level appropriate for biologists without a background in computer science.

MTR 6000 Introductory Biostatistics
Instructors: Roger Vaughan, MS, DrPH
Time: T/R, 8:30-10:00AM
Location: Online
Open to nondegree: No
Syllabus for 2024

The goal of this course is to develop translational scientists who are able to apply the necessary statistical methods to their thesis project, critically assess the application of statistical methods in the literature, and collaborate with biostatisticians. The course will be designed to include weekly seminars to teach introductory biostatistics concepts and group assignments applying the principles through critically assessing the literature.

MTR 6030 Disease Measurement
Instructors: Yong Fan, PhD; Tracey Polsky, MD, PhD,

Course Contributors: David Mankoff, MD, PhD; Charlene Bierl, MD, PhD
Time: T/R,10:30 AM - 12:00 PM
Location: Online
Open to nondegree: No
Syllabus for Fall 2024

Students will 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; and lastly approach disease measurements (tests) as a means of answering questions, and to be able to choose appropriate tests to answer the questions being posed.

MTR 6060 Grantsmanship
Instructor: Rachel Locke, PhD
Time: R, 9:00 AM - 12:00 PM
Location: 8030 Maloney
Open to nondegree: No
Prerequisite: Students are required to be writing a career development award during the term in which they enroll in the course. If you are interested in taking the course, please contact Dr. Rachel Locke to confirm you meet the requirements before requesting permission to register.

Students will learn to write a mentored career development (i.e. NIH K23, K08, Foundation CDA). 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 6120 Introduction to Drug Development
Instructor: Eileen Doyle, PharmD
Time: T, 5:15-8:15 PM
Location: Online
Open to nondegree: Yes
REG 6120 Syllabus

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 6160 Quality Assurance
Instructor: Dawn Lundin, MS
Time: T, 4:00-7:00PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

Quality assurance (QA) plays a critical role in the reliability and reproducibility of product development and, manufacturing. As a component of the Quality Management System, quality assurance includes all activities performed by an organization for the prevention of errors and defects. This course intends to focus on QA principles, standards, and requirements, with regard to the FDA-regulated product development lifecycle. Further, the course aims to offer examples of QA and quality control measures through auditing monitoring and risk management. Application of quality assurance and the interfaces between GLP, GTP, GMP-and Pharmacovigilance regulatory regulated activities during product development and manufacturing will also be addressed.

REG 6250 Manufacturing Novel Therapies & Imaging Agents
Instructor: Andrew Fesnak, MD, MHCI
Time: M, 4:00-5:30 PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

Novel therapeutic and diagnostic agents (eg. CAR T cells, gene therapy for sickle cell disease, radionuclides etc.) have revolutionized modern clinical medicine. Historically, these agents were first developed in academia then transferred to industry for clinical scale manufacturing. Recently, however, some academic centers have developed clinical scale biomanufacturing facilities. Operation of these new facilities requires a unique blend of manufacturing, clinical, basic, regulatory and laboratory sciences. Examples of areas in which academic medical centers have developed in-house manufacturing include cell therapy, gene therapy and novel imaging agents. This course will cover manufacturing approaches, challenges, and controversies in each of these domains.

At the completion of this course students will understand:

The general approach to development, manufacturing, quality control and regulatory compliance in academic manufacturing facilities
Critical steps in the manufacturing cycles of cell therapies, gene therapies and imaging agents
Current challenges in development, manufacturing, and maintaining regulatory compliance in academic manufacturing
Key considerations and relative merits of different positions in the current controversies surround these agents

Each week includes a combination of synchronous and asynchronous work. Synchronous sessions will include instructor led discussions based on pre-recorded lectures or case-based discussions. Asynchronous material includes pre-recorded lectures and discussion board prompts to which students will respond throughout the week.

One unique aspect to this course are the debates. For each debate week, two students will be assigned as debaters and will represent opposing points of view. All students will be provided with required pre-reading and pre-recorded lectures relevant to the debate topic. Ahead of the debate, the debaters will meet with an assigned faculty advisor to help to prepare. Students who are not assigned as debaters for that week will post questions to the discussion board ahead of the debate. The debate will occur during a synchronous session. The debaters will deliver a short introductory statement. This will be followed by QA with the audience. Finally, the debates will deliver a closing statement. These debates are a fun and interactive way for students to engage with controversial and evolving topics in the field. By the end of the course, students will appreciate the academic perspective on core elements of therapeutic and diagnostic agent manufacturing.

REG 6260 Patent Law for Drug Development
Instructor: Joanna Brougher, Esq., MPH
Time: W, 5:00-8:00PM
Location: Online
Open to nondegree: Yes
Most recent syllabus

This course will examine the role and impact of patent law on the behavior of major players in the biotechnology and pharmaceutical industries as they navigate the regulatory process. This course begins with an overview of the current patent laws in the U.S. and how policies and recent changes to those laws affect the research and development of new medicines. This course will also examine the dilemmas created by patents as patent holders seek to bring their technology on to the market. The course will consist of synchronous and asynchronous materials and readings that will conclude with a paper and presentation analyzing a complex issue facing drug innovation and regulatory affairs.

Future Course Offerings

REG 6320 Implementation of the Clinical and Translational Research Protocol
Instructor: TBA
Time: TBA
Location: Online
Open to nondegree: Yes
Most recent syllabus

This course will focus on topics related to successful protocol implementation such as investigational product administration, bio specimen sampling and pharmacokinetics, post administration period monitoring including assessments, clinical monitoring and observation, long-term follow up, and principal investigator oversight. To do this, students will develop a fundamental understanding of product development including phase 1 and first in human studies. Students will be exposed to techniques for creating professional partnerships with clinical research stakeholders including Investigational Drug Service, Radiology, Industry Sponsors, Hospital Administrators, Ancillary Staff, Laboratory Professionals, Principal Investigators, and Basic Scientists. Students will also explore the role of the clinical research nurse in the context of recruitment and retention of participants through managing the patient/family relationship.

REG 6240 Applied Regulatory Processes of Vaccines and Biologics

Summer 2026
Instructors: Narendra Chirmule, Ph.D.
Time: M/W, 4:00-6:00PM, 6-week course
Location: Online
Open to nondegree: Yes
Most recent syllabus

Drug development is at a turning point in human medicine. Over the past three decades, the development of biotherapeutics has revolutionized innovation in medicines. Efficiency and Quality Compliance are critical to achieving innovation and affordability. This course will provide an overview of the multi-dimensional nature of drug development, which involves regulatory, new technologies, statistical, and quality considerations. This 6-week course, which starts with a role-play exercise in developing a drug, will introduce the concepts which include pharmacology, toxicology, product development, clinical trials. All of these topics will be addressed based on regulatory requirements by the FDA. Risk assessment and mitigation will be discussed using discussion boards, case studies, and some invited guests. The content of the course includes seminars, case studies, project reports, and journal article reviews. In addition to the regulatory processes, the course also includes a discussion on soft-skill development such as decision making, scientific eminence, organizational structures, etc.

REG 6220 New Trends in Medicine and Vaccine Discovery

Fall 2026
Instructor: Claudine Bruck, PhD
Time: W, 3:30-6:30PM
Location: 8030 Maloney
Open to nondegree: Yes
Most recent syllabus

The purpose of this course is to provide an overview and points to consider of drug and vaccine discovery, with emphasis on:

Technologies that empower drug and vaccine discovery.
Newer treatment modalities beyond small molecule drugs
Recent areas of progress: new vaccine technologies, rare diseases, immuno-oncology, precision medicine, biomarkers and diagnostics, artificial intelligence
The regulations governing medicine discovery and development
Business aspects, building start-up biotechs from academic research, the importance of intellectual property
Pandemics by new pathogens in the context of drug and vaccine discovery
Societal aspects, from affordability to healthcare company considerations to medicine pricing
How leadership skills impact success in biotechnology

Students will be guided through these topics by a group of experts who will discuss their experience in the field. While learning this content, students will be taught to interrogate and interpret scientific literature as well as present a scientific topic to an audience. At the end of this course, students will have a broad view of the creative, regulatory and business-related aspects of modern medicine discovery and development and be primed to participate in this process.

Thesis/Capstone and Lab Credits

MTR 6070/6080 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 6410 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.
Most recent syllabus

MTR 9999 Laboratory Unit
MSTR 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.

Course Requests & Permits

ITMAT Education programs welcome students interested in taking an ITMAT course but not enrolled in an ITMAT program.

Interested students may submit a course request using the form below. Program staff will contact you via the email listed on this form, and may ask you to submit a permit request through Path@Penn using these steps:

Look up the course you are interested in taking
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Click the small text that pops up and reads "Request Permission for This Course"
Select OK
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Program staff will render a decision on the permit request.

Make sure to complete a separate permit request for each course in which you are interested.