Master of Science in Regulatory Affairs Curriculum Overview

Students in the MSRA program will enroll as full-time students in both the Henry E. Riggs School of Applied Life Sciences at Keck Graduate Institute (KGI) and the Irell & Manella Graduate School of Biological Sciences at City of Hope (COH) throughout the entire two-year program. Students will complete a total of 60.0 units over the course of two years of study. COH and KGI will grant a joint MSTM degree upon completion of all of the necessary requirements. Of the 60.0 total units, students must complete 30.0 units of core courses, professional development courses and general elective courses and 30.0 units of the Regulatory Affairs Capstone Projects.

First Year - Fall 

SCI 5300 Pharmaceutical Discovery (KGI) 
This course is designed to provide students with an understanding of how pharmaceutical and biotechnology companies discover new drugs. This course will focus on the discovery of small molecule drugs, the process of pharmaceutical drug discovery from selection of targets to discovery of a product candidate, and the characterization of that drug necessary for initiation of clinical trials. 
SCI 5310 Pharmaceutical Development (KGI) 
The course will provide the terminology, timelines and practical examples for successfully understanding the challenges in progressing an idea for a drug from the earliest discovery stages through to product approval and launch. Case studies from industry will be presented detailing companies and products that utilize state-of-the-art discovery technologies and advanced drug delivery systems.
BUS 5000 Introduction to Bioscience Industries (KGI)
The course will introduce students to industry dynamics within the bioscience industries, with a particular emphasis on commercialization dynamics and entrepreneurship. We will examine industry dynamics within different segments of the life science industries, such as therapeutics, diagnostics, and medical devices. Students will learn to evaluate common business models employed by life science firms, and will learn how to employ a variety of analytical tools used to assess the attractiveness of a variety of life science marketplaces. Common tools used for market research, such as survey methods and qualitative interview-based techniques, will be introduced. The course will introduce these topics to students through case studies of bioscience firms. Assessment of learning will be achieved through class participation, reflective essays and business memos, problem sets, and, most importantly, a team-based, client-sponsored market research project.
REG 5000 Intro to US Food and Drug Law (KGI)
This course will provide students with broad general competencies in regulatory affairs for all FDA-regulated product classes (drugs, biologics and devices) throughout the product lifecycle (pre-clinical development, clinical development and post-marketing). Emphasis will be placed on regulatory interactions – submissions, other communications and inspections – for each product class and for each phase of the product lifecycle.
MATH 5020 Clinical Biostatistics (KGI)
This course provides a basic primer in statistical methods commonly used in the design of clinical trials. Topics covered are expected to include data reporting and descriptive statistics, probability, estimation, hypothesis testing (parametric, non-parametric, and categorical), multisample inference, regression and correlation. Sample size and power estimation methods will be developed for various hypothesis testing scenarios.
REG 6120 Medical Device Regulations (KGI)
This course examines the operational, strategic and commercial aspects of the regulatory approval process for new medical devices, biologics, and combination products in the United States. The topics are designed to provide a chronological overview of the requirements needed to seek marketing approval. The goal of this course is to introduce and familiarize students with the terminology, timelines and actual steps followed by Regulatory Affairs professionals employed in the medical device, pharmaceutical, or biotechnology industry. Case studies from the industry will be examined to supplement certain topics and to illustrate the interpretation of regulations.
REG 6110 Drug and Biologic Regulations (KGI)
Drug and Biological medical products are among the most profitable, yet most demanding to commercialize, requiring the major regulatory oversight. This course will provide students with an in-depth understanding of the relationships between scientific discovery, testing and regulatory oversight of drug and biological medical products. It will look at the practical issues and rules governing prescription and over-the-counter drugs, and look at the changes that are being introduced by genetic engineering, generic and biological product development. This course will consider the issues facing regulatory specialists as they work with the FDA and other international regulatory bodies to secure and maintain product approval.

First Year - Spring

SCI 6310 Biotechnology-Based Therapeutics (KGI)
Advances in genomics, proteomics, recombinant protein technology and structural biology have created opportunities and challenges for the biotech and pharmaceutical industries. This course will provide students with a background of the scientific basis of some key aspects of biotechnology-based drug, biologic and vaccine design, discovery and development process. Students will learn about therapeutic and vaccine targets, and how the drugs and vaccines are designed, tested and produced. They will also learn about recently developed biological pharmaceuticals along with many of the current targets of pharmaceutical companies. The mechanism of many of the current biotechnology-based therapeutics will be discussed. In addition, the elements involved in the development of a biotechnology company will be taught. A group project will be required in which each group will provide a short business plan for the development of a new drug. This course will consist of lectures, seminars and student presentations/group discussions. Environmental, ethical, regulatory, patent, economic and social issues related to biotechnology-based therapeutics will also be discussed.
REG 6510 Clinical Trial Design (KGI)
This course will provide students with a more in-depth understanding of clinical trial design, conduct and strategy for therapeutic products. Clinical trial design elements will be examined in the context of their impact on clinical trial outcomes. Emphasis will be placed upon trial designs that reflect the biological nature and mechanism of action of the therapeutic product being tested, rather than a cookbook approach. Design elements related to small molecules, antibodies, therapeutic proteins, therapeutic vaccines, and cell and gene therapies will be discussed. Discussions will include operational issues impacting the execution of clinical trials and why they are critical elements of successful clinical development programs. Students will gain an understanding of the principles for the use of particular biostatical testing procedures and in what context certain methods should be used. There will be an emphasis on clinical development problem-solving as students work on team projects and defend their own clinical development solutions in the context of product profiles, strategy and timelines.
REG 6520 Literature Evaluation (KGI)
This course is a practical application of biostatistics in the context of designing clinical or research protocols and reading research literature. During the first half of the course, students will learn to differentiate among study designs commonly used in medical, biomedical and healthcare research. Based on their knowledge of biostatistics, students will design a research protocol, selecting the appropriate study design, outcome measures and statistical package. During the second half of the course, students will build upon their knowledge of biostatistics and study design to read and critically evaluate current research selected from the literature. Topics include identifying the research question, the study design, bias and confounding, the study population, outcome measures, clinical research ethics and regulation, as well as identifying the testable hypothesis and evaluating the statistical analysis presented by the authors.
REG 6020 Current Issues for FDA Regulated Products (KGI)
The business environment and regulatory framework pertaining to the medical products industry continue to change rapidly, as they are constantly challenged by competition, politics and new technological possibilities. The highly lucrative and competitive nature of this industry requires that professionals have a good working knowledge, background and understanding of the role regulatory strategy plays in effective product development.
ALS 418/419 Quality Assurance/CMC (KGI)
General Elective Courses (KGI/COH) 

Second Year – Fall & Spring

PDEV 5100 Professional Development (KGI)
In two four-hour intensive workshops and a selection of modules, students learn how to build their professional presence, gain insight into the process and timing of finding employment, learn skills that will improve their competitiveness, and develop expertise in showcasing their accomplishments.
PDEV 5220 Healthcare/Life Sciences Industry Ethics (KGI)
This course explores the ethical challenges for commerce in healthcare systems and the biosciences industry as it will be increasingly important for healthcare and bioscience leaders to consider the ethical ramifications of their work. The class will focus more on the practical application of ethical principles through real-world case studies, rather than emphasizing theories.
RES 6250 Regulatory Affairs Capstone Project  (COH)
The goal of this course is to enable students to conduct 2 capstone projects at one of the following centers/programs at COH to acquire hands-on experience in developing new drugs or drugs being optimized in clinic; formulating Investigational New Drug (IND) applications and clinical protocols for FDA review and approval, and performing annual reporting to the FDA, Institutional Review Boards (IRB) and Drug Safety Oversight Board (DSB):