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 contact us if you have any questions.

Due to the impact of COVID-19, all spring 2021 courses will be held remotely.


Spring 2021 Courses

MTR 604 Scientific and Ethical Conduct
Instructors: Emma Meagher, MD
Time: T/R, 8:00-9:30 AM
Location: Online
Open to nondegree: No

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), good laboratory practices (GLP), 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 606 Grantsmanship
Instructor: Rachel Locke, PhD
Time: T, 10:00 AM-12:00 PM
Location: Online
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, 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 620 Medical Entrepreneurship: Commercializing Translational Science
Instructors: Nalaka Gooneratne, MD, MSCE, & Adam Dakin, MBA
Time: T/R, 4:00-5:30PM
Location: Online
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.

MTR 623 Writing an NIH Grant
Instructor: Ragini Verma, PhD
Time: Wednesdays, 11-1:00pm
Location: Online
Open to nondegree: Yes
Audience: Faculty who have not written an NIH grant before or need guidance with submitting a revised application, postdocs, or advanced graduate students.

This course will provide a comprehensive overview of the grant writing process. Participants will be provided detailed information on each aspect of NIH grants: fundamentals of good grant writing, general preparation of grant application (e.g. specific aims, research strategy, budgets, analysis of reviews and strategies of rebuttal and re-application), identifying RFAs, study sections, program officers and Scientific Review Officers (SROs), research strategy and detailed descriptions of the different types of funding mechanisms (R01, R21, Ks). This is a writing course.  This means that you will be drafting, revising, and working one-on-one with your fellow students and the course director to improve your proposal. At the end of the course, participants will have the necessary foundation for a submission consisting of the Specific Aims, Significance, and Innovation.

MTR 535 Intro to Bioinformatics
Instructors: Benjamin F. Voight, PhD; Ophir Shalem, PhD
Time: M/W/F, 10:00-11:00AM
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 and analysis of data that will position them to apply certain existing techniques and to provide the vocabulary to collaborate with bioinformatics method developers.

REG 612 Introduction to Drug Development
Instructor: Eileen Doyle, PharmD
Time: T, 4:00-7:00PM
Location: 8030 Maloney
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 615 Post-Approval Maintenance of Drugs, Biologics, and Devices
Instructor: Ajay Parashar, MDD, MS
Time: R, 5:00-8:00PM 
Location: 8030 Maloney
Open to nondegree: Yes

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 618 Introduction to Vaccine Development 
Instructor: Jeff Barrett, MD
Time: W, 4:00-7:00PM
Location: 9025 Maloney
Open to nondegree: Yes

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 621 Cell & Gene Therapy
Instructor: Mike Milone, MD, PhD
Time: W, 9:00-12:00PM
Location: SPE, 08-100
Open to nondegree: Yes
Prerequisite: At least one course in immunology.

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 640 Capstone I
Instructor: Andrew Fesnak, MD, MHCI
Time: M, 4:00-7:00PM 
Location: 8030 Maloney
Open to nondegree: No

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 640, which is an in-person class focused on the Capstone proposal development and REG 641 which provides credit for successful completion of the Capstone project. Prior to REG 640 the student will select a topic related to their area of interest within Regulatory Affairs and identify an appropriate Capstone Advisor to oversee the project. During REG 640 the student, with the guidance of their Capstone Advisor will define objectives and formulate their Capstone proposal and delineate deliverables and milestones. Successful completion of REEG 640 is determined by a finalized proposal approved by your Capstone Advisor and the Course Director. The work proposed in the Capstone Project proposal will be the focus of the student's efforts in REG 641 Capstone II.


Summer 2021 Courses

MTR 601 Scientific Writing I: Review Writing (Summer II session)
Instructor: Rachel Locke, PhD
Time: T/R, 10:45 AM — 12:15 PM
Location: 8030 Maloney
Open to nondegree: No

This course will lead students through the process of writing a Review Article during their first Summer within the MSTR 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.

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 MSTR 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:
Instructor: Anil Vachani, MD, MS
Time: T/R, 9:00-10:30 AM
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 MSTR faculty panel, the students research mentor(s), and thesis committee for critique and feedback.

MTR 605 Scientific Writing II - Manuscript Writing: (Summer I session)
Instructor: Kachina Allen, PhD
Time: T, 8:00 — 9:30 AM
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 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 610 Fundamentals of FDA Regulation
Instructor: Monica Ferrante, DPA
Time: R, 4:00-7:00PM
Location: 8030 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
Instructors: Amy Marshall, MPH; Megan Kasimatis Singleton, JD, MBE
Time: M/W, 4:00-5:30PM
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.


Fall 2020 Courses

Due to the impact of COVID-19, all fall 2020 courses will be held remotely.

MTR/REG 510 Introduction to Clinical and Translational Research
Instructors: Emma Meagher, MD
Time: M/W, 8:00-9:30 AM
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
Instructors: Roger Vaughan, MS, DrPH
Time: T/R, 8:30-10:00AM
Location: 8030 Maloney
Open to nondegree: No

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 603 Disease Measurement
Instructors: David Mankoff, MD, PhD; Yong Fan, PhD; Tracey Polsky, MD, PhD, Charlene Bierl, 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: T, 10:00-12:00 PM
Location: 9025 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, but unsure if you meet the requirements, contact Dr. Rachel Locke.

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 612 Introduction to Drug Development
Instructor: Eileen Doyle, PharmD
Time: T, 4:00-7:00 PM
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 614 Biopharmaceutical Development, Manufacturing, and Regulatory Affairs
Instructor: Marcia Federici, PhD
Time: W, 4:00-7:00PM
Location: 9025 Maloney
Open to nondegree: Yes

Biopharmaceutical protein products have been successfully used to treat a number of diseases and currently represent a large segment of the product pipeline in most major pharmaceutical companies. More than half of the current top 20 blockbuster drugs are biopharmaceuticals. Drugs like Activase®, Humira®, and Avastin® have revolutionized the drug industry in treating the unmet medical needs of many patients. With innovation at the heart of the biopharmaceutical industry, this course is aimed at developing the student’s understanding of the application of basic research in molecular biology and genetics to the development of novel drugs for treating diseases. The course is designed to provide an overview of biopharmaceutical protein drug development and manufacturing processes with an emphasis on regulatory affairs activities. The class has been developed and is taught by a former VP of biopharmaceutical product development with over 30 years of experience in biotechnology and the biopharmaceutical industry. The course director will provide insights into the unique challenges and opportunities facing the biopharmaceutical industry and how they relate to regulatory affairs. Subject area experts from industry will also participate as guest lecturers.

REG 616 Quality Assurance 
Instructor: Dawn Lundin, MS
Time: T, 4:00-7:00PM
Location: 8030 Maloney
Open to nondegree: Yes

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. 


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
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.
 


Courses Not Currently Offered

Check back for these offerings in 2020-2021!

REG 622:  New Trends in Medicine and Vaccine Discovery
Instructor: Claudine Bruck, PhD
Open to nondegree:  Yes

The purpose of this course is to provide an overview 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: rare diseases, immuno-oncology, precision medicine, biomarkers and diagnostics
  • The regulations governing medicine discovery and development
  • Business aspects, building start-up biotechs from academic research
  • Societal aspects, from affordability to healthcare company considerations to medicine pricing

Course Request Form

ITMAT Education programs (MRA, MSRS, MSTR, and Certificates) welcomes students interested in taking an ITMAT course but not enrolled in an ITMAT program. Complete this form to request registration. After ITMAT students have registered, you will be contacted via the email address you share in this form and be offered a permit. Complete a separate form for each course you are interested in taking.