MSKCC Education and Training

Advanced Biostatistics will introduce special methods and topics, relying on the principles taught in Introductory Biostatistics. These include study design, confounding, methods to minimize and adjust for confounding including matching, stratification, regression modeling and propensity scores, predictive modeling, recursive partitioning and Bayesian methods. All of the methods will be presented with examples from continuous, categorical and censored outcomes.

The Science Enrichment Program (SEP) is a ten-month program designed to provide opportunities and intellectual space to selected underrepresented high school students who are science curious and passionate about cancer research. Each participant in the Science Enrichment Program is assigned to an eight-week biomedical or computational lab-based internship at Memorial Sloan Kettering. Students are paired with a mentor who supervises their activities and helps them develop appropriate skills. Over the course of the internship, students complete a self-directed project that provides value to their mentor and/or a principal investigator’s overall research objectives.

Course title: Cancer biology core class for Bridge postbac scholars

Instructor: Alvaro D. Quintanal Villalonga, PhD; quintaa1@mskcc.org

Grading policy: This class is a not for grade class, but scholars will be evaluated with a grade to get a sense of how they performed in this class

Duration: 5 in-person sessions plus 3 recorded lectures

Audience: 17 Bridge postbac scholars

Course topics and learning objectives

The Cancer Biology course will teach scholars how to think about cancer as a disease and as a biological problem. This course leverages the world-class research and clinical expertise at Memorial Sloan Kettering Cancer Center (MSK). This course will feature five in-person sessions as well as several recorded lectures that Bridge scholars are required to view on their own time and ahead of the first lecture.

This course will:

• Provide a review of advanced concepts in cancer biology
• Expose scholars to techniques and experimental design applied to basic-translational cancer research
• Potentiate the ability to perform critic analysis of basic-translational research
• Strengthen capacities to develop a research project

• Cancer as a disease
• Cancer signaling
• Cancer metabolism
• Metastasis

In order to maintain an institutional culture that supports research integrity, Memorial Sloan Kettering offers a biannual Responsible Conduct of Research (RCR) course for research trainees. The course is designed for research trainees and others interested in ethical considerations regarding the responsible conduct of research in the scientific enterprise.

The intent is that this course be thought-provoking and useful, and that it provide participants with a foundation of information that will support their scientific journeys. The future of science depends on attracting the most talented, energetic, and morally strong people to research. It is incumbent on all of us in the research community to learn and work together to create a research environment dedicated to the highest ethical standards as we advance the cause of good science. This course is intended to fulfill mandated requirements for RCR instruction as required by the National Institutes of Health, National Science Foundation, and other sponsoring agencies.

“The scientific research enterprise, like other human activities, is built on a foundation of trust. Scientists trust that the results reported by others are valid. Society trusts that the results of research reflect an honest attempt by scientists to describe the world accurately and without bias. The level of trust that has characterized science and its relationship with society has contributed to a period of unparalleled scientific productivity. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct.”

From: Alberts, B., Shine, K. and White, R. (1995) On Being a Scientist: Responsible Conduct in Research. National Academy of Sciences, National Academies Press: Washington, D.C.

Conducting safe, high-quality clinical research necessitates accounting for on- and off-target drug effects and how drugs reach those targets across a diverse cohort. Principal investigators must apply crucial pharmacotherapeutic concepts when designing clinical cancer research to ensure protocols direct efforts to manage intra- and inter-patient differences in drug exposure and maximize safety.

This course aims to teach the fundamentals of clinical trial design through lectures, discussions, and development of clinical trial protocols. Classroom lectures will cover clinical trial phases, choosing appropriate endpoints, commonly used clinical trial designs in oncology, randomization, interim analyses, and novel trial methods, such as basket trials and master protocols. We will also cover patient reported outcomes, integrative medicine, and imaging studies. Scholars will also learn about using real world data, barriers to accrual, and presenting trials to the DSMB/DSMC. Discussions will incorporate lecture themes. The scholars will choose a clinical trial to develop and then methodically develop their own protocol during the protocol development segment of the course. Protocols will be presented to the class.

One of the main goals of the Master’s in Clinical and Translational Cancer Research is to train researchers to apply their understanding of biomedical science and analytical and critical thinking skills to solve challenging clinical problems. However, these skills are not sufficient to conduct successful clinical cancer research. Clinical scientists must also possess thorough knowledge of the management, regulatory, and compliance practices necessary to implement clinical research projects. This course aims to fulfil these training needs by focusing on the practical aspects of executing clinical trials in a Good Clinical Practice (GCP) and Human Subject Research (HSR) regulatory compliant fashion. Topics include conducting clinical trials in accordance with GCP; regulations established by state, federal, and international regulatory bodies; managing relationships with external academic and industry partners, and the roles and responsibilities of investigators, sponsors, monitors, and auditors. The course will also provide an overview of regulatory affairs in relation to three key areas of therapeutic development: drugs, biologics, and medical devices. Throughout the course, practical issues facing researchers as they work with the FDA and other international regulatory bodies to secure and keep product approval will be addressed. Through expert advice and groups discussions, this course will enhance the foundational knowledge that students gain during the CITI online modules and allow them to provide these lessons to their own research.

Biomarkers are biochemical or molecular indicators of defined states of health, disease, or response to therapy. Biomarkers are used clinically for diagnosis, prognosis, and patient management. Understanding the limitations of biomarker assays is key to appropriate test utilization and interpretation. With increases in novel treatment modalities, the need for companion biomarker assays is growing. This course will enable participants to understand pathways to the development of biomarker assays from the research bench to the clinic, as well as to interpret results, based on understanding assay performance characteristics and limitations.