Translating Novel Scientific Concepts into Innovative Products in Health Care: Focus on Innovation
The course objective is to provide an overview to trainees from various disciplines about the science, methodology, and approach to the translation of science into a product
available for use in health care. The course will follow the science behind drug and device development from discovery to regulatory approval, including clinical trial
designs currently in use in Industry to determine if a product is safe and effective and the opportunities for innovation in the existing processes. The course will review
economic considerations in drug development and approaches to scientific interactions with academic scientists and government regulatory bodies.
Pharmacology and Drug Development (eLearning)
This course covers the drug development process from discovery to post-approval in 5 modules lasting 8 hours. Course topics covered include:
1. How New Drugs are Discovered
2. Preclinical Studies
3. Testing Individual Drugs in Humans
4. Regulatory Review Process
5. Postmarketing Studies & Safety Surveillance
Each module is divided into 2 or more individual lessons which vary in duration (between 15 – 40 minutes) and may be taken at one's own pace. Knowledge checks are included at the end of each lesson allowing self-assessment. Participants are given 2 tries to select the correct answer, after which feedback will be provided. These knowledge checks are not scored. CTEP matriculated students may request elective course credit.
Qualitative Research Methods
The course is intended to enable participants to gain a basic fluency with qualitative research methods. The sessions will consistently interweave the theoretical underpinnings of the method with concrete examples of qualitative research. The nexus between qualitative research and traditions in anthropology, sociology, and history will be explored. Most critically, the utility of qualitative methods in research or clinical practice will be examined. Data entry and analysis will also be addressed.
Clinical Nutrition in Acute and Chronic Illness
This course is designed for students to learn the difference between normal and inflammatory metabolism including acute and chronic inflammatory conditions. They will also understand the implications these different metabolic states have for the nutrition care process. By the end of this course students will be exposed to nutritional assessment skills, and nutritional interventions for acute and chronic disease conditions, and trauma. They will also understand the limitations of research methodologies as they apply to clinical nutrition practice.
Principles of Clinical Research & Design (eLearning)
This course covers the nuts and bolts of clinical research and design, offering step-by-step instruction to develop successful clinical research in 4 modules lasting approximately 7 hours. Course topics covered include:
1. Principles of Clinical Research and Design
2. Randomized Clinical Trials
3. Non-Interventional Studies – Epidemiology
4. Other Non-Interventional Studies
Each module is divided into 2 or more individual lessons which vary in duration (between 15 – 40 minutes) and may be taken at one’s own pace. Knowledge checks are included at the end of each lesson allowing self-assessment. Participants are given 2 tries to select the correct answer, after which feedback will be provided. These knowledge checks are not scored. CTEP matriculated students may request elective course credit.
Immunology I & II
This is a two-part series that will provide a fundamental understanding of immunology. Immunology I will give a comprehensive overview of basic immunology beginning with innate immune responses followed by a study of the main aspects of acquired immunity. Important topics include the following: organization of lymphoid tissues and immune cell migration, cellular and molecular aspects of innate immunity, specific interactions of target cells and T cells that are regulated by the MHC molecule and peptide antigens on the target cell and the antigen specific T cell receptor; generation and molecular structure of B and T cell antigen receptors; signaling through immune receptors; the development of antigen specific T and B cells; and specific roles of some cytokines/lymphokines. The second part of the series is Immunology II, held in the Spring semester, which focuses on aspects of T and B effector cell generation, immune response generation and regulation in the context of infection, autoimmunity, tumor immunity, and transplant.
Logic & Experimental Design
This course will focus on experimental strategies used by biomedical scientists to understand both normal and pathophysiological processes. Lecture topics will cover biochemical, cellular, molecular, immunological, genetic, and bioinformatic approaches. The goal of the course is to equip students with the fundamental knowledge needed to develop independent patient and translational research proposals, and to critically evaluate the work of others.
Statistical Methods for Observational Studies
This course will provide trainees with an overview of statistical methods and issues related to the design and analysis of observational studies. Course objectives are as follows: understand the value of observational study and the background for causal inference; design and write an analysis plan for an observational study; analyze data (using Stata software) with multiple regression analysis to adjust for confounders; review the literature related to large databases to motivate how future studies can be planned; and introduce the concept of meta-analysis for observational studies and their reporting standards.
Advanced Seminars in the Ethics of Clinical Research
This course will introduce students to the ethical dimensions of clinical research. Objectives of the course are as follows: to understand the historic origins of modern research ethics; distinguish the competing ethical obligations of clinical practice and clinical research; appreciate the ethical obligations of the clinical investigator to human subjects; understand the regulation of human subjects research from protocol design to extra-mural oversight; appreciate unique ethical challenges posed by special populations and varying research settings; appreciate ethical challenges posed by different areas of research; consider the difference between regulation and ethics; and how to address novel challenges in clinical research.
In this course students will be instructed on 3D visualization of data and biological concepts using commercial software packages. There will be a strong visual and design theory along with a storytelling focus to the course in parallel to learning the fundamentals of current 3D graphics tools.
BioVisualization II will build upon the concepts presented in the introductory course, BioVisualization I, and present advanced visualization techniques in greater depth and detail. Guest speakers from the design and scientific community will be invited to present lectures and provide demonstrations of visualization technique and theory. BioVisualization I is a prequisite. Exemption of prerequisite is allowable on a case-by-case basis based on student's submission of proposal and approval by faculty, along with likely recommendation to attend selected sessions of BioVisualization I classes as needed.
Introduction to Biomedical 3D Printing
This is a 2-credit course that is open to anyone interested in learning about the applications of 3D printing in biomedical and clinical research. We will engage participants using interactive demos of the 3D printing technologies, materials and equipment. Participants will also learn about the relative strengths and weakness of each of the major 3D printing technologies and the 3D printing workflow. We will use traditional medical imaging data such as CT and MRI, and data acquired from contemporary 3D scanners to enrich participants understanding of the applications of 3D printing.
This course is designed to give students an overview of genomics technologies including microarray and next-generation sequencing and their applications in the biomedical field leading to design, analysis and interpretation of microarray and next-generation sequencing experiments. The course will cover all the latest techniques and theories and will be organized by a combination of lecture and practical sessions.
Physical Principles of Biomedical Imaging
This survey course will cover basic physical, biochemical, computational, and engineering principles underlying current medical imaging techniques, including magnetic resonance imaging, positron emission tomography, radionuclide production and radiochemistry, optical imaging, x-ray computed tomography, and ultrasound. The goal of the course will be to provide students with a broad knowledge of the concepts and implementation strategies of various imaging methods relevant in current research and clinical practice. Practical applications will be used to illustrate the main themes of the course. Tours of the Biomedical Imaging Core Facility and other imaging laboratories will augment the formal course material. At the end of the course students will be able to identify appropriate imaging strategies for clinical research and have a working knowledge of the major techniques available to the investigator.
Nanobiotechnology (BME 6700)
This course covers the basics of biology and the principles and practice of microfabrication techniques. Course lectures are largely from guest faculty with expertise in the presented topic areas. The course focuses on applications in biomedical and biological research. A team design project that stresses interdisciplinary communication and problem solving is one of the course requirements. The course meets twice weekly with 75-minute classes. All lectures are videoconferenced to Weill Cornell Medical College and other cooperating institutions from Cornell University, Ithaca.
Product Engineering and Design in Biomedical Engineering (BME 5500)
This course is a beginning to a cornerstone understanding of engineering, regulatory business, and individual issues for new medical product development. Student background and interests may be highly varied. To accommodate these varied perspectives, the initial focus of the class is on the engineering perspectives of design and development, enabling those undertaking projects (BME 5910) to have timely exposure to key enabling concepts. All lectures are videoconferenced to Weill Cornell Medical College and other cooperating institutions from Cornell University, Ithaca.
A Crash Course on Creativity and Entrepreneurship
This highly experiential course is designed to explore several factors that stimulate and inhibit creativity in individuals, teams, and organizations. Opening your creative mind is essential for successful researchers, clinicians, and administrators. Weekly sessions will focus on different variables related to creativity, such as opportunity identification, reframing problems, connecting and combining ideas, challenging assumptions, and building team dynamics.
Translating Science into Innovation in Healthcare
To provide an overview to faculty scientists and doctoral trainees in health care disciplines about how they can translate their knowledge into innovative opportunities to deliver improved care, better outcomes and lower costs, in part, through the introduction of new businesses and new business models. Beginning with a brief overview of the fundamental economics of global health care today and the growing confrontation between rising expectations and increasingly constrained resources, the course will describe the opportunities and challenges that face us. The course will review how both conventional and unconventional innovation in the field of health care that can influence the coming disruption as a source of opportunity. The course will be offered by a faculty of scientists, physicians, health economists, industry analysts, entrepreneurs, venture capitalists, and executives from payers, service companies and drug firms.
Understanding Team Dynamics
In this course participants will explore the dimensions and inherent benefits of a well-organized, synchronized team and how to develop a systematic and concrete approach to organizing individuals into a highly effective, productive, and cohesive work force.
Drug Development: A Business Approach (Neuroscience 444)
Everyone in biomedical science and medicine will be interacting with biotechnology and pharmaceutical companies, but students are often unprepared to understand these companies as businesses, evaluate them as places to develop our careers, understand how they will impact our science, or appreciate how they will change health care delivery. This seminar course will help educate students about how drugs and medical devices are developed and commercialized. The course will include presentations on drug development, clinical trials, the FDA, patent law, clinical trials, pricing policy, drug sales, financial analysis, and related topics. It will also include presentations on specific biotechnology and pharmaceutical companies including an analysis of present and future performance. Students will be expected to actively participate in 15 meetings over a two year period (there are 10 meetings each year), follow a single company for a year, and formally present a company & evaluate its prospects. The class can be initiated at the beginning of any semester. Offered by John A Wagner, Steve Gross and members of the faculty.
Drug Discovery and Development (3D) Workshop w/ Pfizer
The primary objective of the 3D Workshop is to introduce participants to the complexities and challenges of bringing medications to patients. This computer simulated educational workshop is a competitive program with teams developing compounds with the ultimate goal of achieving regulatory approval. Participation delivers a hands-on education on time, resources, decision-making, and teamwork, which are central to the real-life experiences of drug development. Outcomes are not pre-determined and are dependent upon the choices participants make during the course of the workshop in conjunction with governance and the regulatory environment. Upon completion, participants will have obtained a knowledgeable framework on the role of the pharmaceutical industry in drug discovery and development.
Oncology Drug Discovery & Development (Onc3D) Workshop
The Oncology Drug Discovery & Development (Onc3D) Workshop is a one-day, interactive and competitive workshop aimed at improving your understanding and appreciation of the drug development and approval processes. Teams will role-play a multidisciplinary drug development team at a pharmaceutical company, attempting to bring a new chemical or biological entity from the idea stage all the way to review and approval by the FDA. Each participant will be assigned a specific role (Discovery Scientist, Drug Safety Specialist, Phase I Clinician, Project Manager, etc…), serving as a team's expert in a particular component of the process. Responsibilities for each of the roles will be provided prior to the workshop and participants will be expected to come prepared. Teams will have to work together to be successful. The objective for each team is to obtain approval for the best new oncology drug by the end of the program. Teams will win or lose the competition based on value of their approved drug compared to that achieved by the other teams. Teams will also be judged on the drug pipeline they create. The Onc3D simulation relies on a computer program to generate results from scientific experiments and clinical studies that the teams will plan and conduct. Facilitators from Pfizer Oncology will assist the teams by providing guidance and operating the computer program under the teams' direction.
Decision Analysis in Health Care
This course provides an overview of techniques used by clinicians and health services researchers to understand medical decision making under uncertainty. Participants will learn how to structure decision analysis questions, construct decision trees, and analyze outcomes using probability. Using a combination of lectures and computer labs, the course will cover practical and ethical issues in decision analysis as well as its theoretical basis.
Economic Evaluations in Health Care
This course provides an in-depth exposure to techniques used by health economists and other health services researchers to conduct economic evaluations of health care technologies and programs. Participants learn how to critique economic evaluations using cost-effectiveness and other approaches, and are introduced to tools they can use to apply these techniques in their own research projects.
Fundamentals of Health Economics
This course will provide an introduction to basic economic concepts as they relate to aspects of the US health care system. Topics will include the financing of health care, economic components of the delivery system, and the role of government. These topics will be examined from the view of payers, providers, and regulators, and the interactions of these stakeholders. An introduction to research design and analysis of secondary data will also be covered. Labs for the course will supplement lecture topics and weekly readings.
Study Design and Methods for Comparative Effectiveness Research
This course will cover the conceptual underpinnings and policy context of comparative effectiveness research (CER), highlighting key controversies. It will provide students with an understanding of the analytic methods and data resources used to conduct comparative effectiveness research. Topics that are likely to be discussed include observational studies, risk adjustment, propensity score matching, instrumental variables, systematic reviews, and the use of clinical registries and Medicare claims data. Students will learn why comparative research has come to prominence, what makes good comparative effectiveness research, and how to conduct comparative effectiveness research. Students will learn the main methods used in comparative effectiveness research and the advantages and disadvantages of each. The course will not be a statistics course or how-to course. Course sessions will consist of both lectures from the instructors and experts on selected topics as well as student presentations.
Survey Research and Questionnaire Design
This course will provide an overview of survey research methods for health-related research with patients or other population groups. The course goals are to provide students with an understanding of survey research by hands-on experience designing a survey research project in an area of interest. This will include reviewing the relevant literature, generating hypotheses, and making decisions about measurement, survey design, sampling, recruitment, data collection methods, and statistical analysis.
Global Health: Clinical Skills for Resource-Poor Environments
This elective teaches high-yield skills in preparation for common clinical encounters in resource-poor settings. Geared towards students who plan to serve abroad or who have interest in this area. Hands-on teaching workshops and lab, which span a wide range of disciplines ranging from Infectious Diseases to Mother-child Health to Emergency Medicine and more, will be given by global health faculty and global health practitioners from multiple institutions including: Weill Cornell Medical College, New York-Presbyterian Hospital, Mt. Sinai Medical College, Columbia University College of Physicians and Surgeons, New York University School of Medicine, and more.
Introduction to Global Health
This course will introduce students to thirteen key topics in global health through 1.5-hour weekly seminars. Speakers include global health leaders from academia, policy institutions, and the private sector. The course is intended to be engaging and informative and each seminar is designed to be interactive and discussion-based.
This course provides an overview of the health system: resources, organization, economics, and the delivery of services. The course has two components. Lectures, in-class discussion, and readings will familiarize students with the components of the healthcare system at a "macro" scale. In addition, through field experiences students will be exposed to the processes of healthcare at a "micro" scale. Throughout the semester, students will observe, record, and interpret the daily practice of healthcare in such settings as: inpatient wards, emergency departments, ancillary departments, and outpatient clinics.
Healthcare Information and Information Systems
An introduction to informational, technological, policy, social, and organizational concerns in healthcare informatics.
Informatics for Quality, Safety and Medical Decision Making
This course exposes students to the practical application of health information technology as it is used to improve the quality and safety of healthcare delivery and enhance the decision-making of providers and public health organizations. Students will build upon previous knowledge gained through more basic courses in which they have been introduced to varies types of health information technologies and challenges surrounding their implementation, including unsolved problem such as how to optimize use in real clinical settings. This will be structured as a "flipped classroom" such that students will spend 1-2 hours per week listening to pre-recorded sessions and reading prepatory material. In class sessions will be focused on problem solving and hands-on exercises and discussion.
Obtaining and Using Electronic Clinical Data for Research
This course addresses challenges in the use of electronic clinical data for research purposes, such as electronic health records, clinical data warehouses, electronic prescribing, clinical decision support systems and health information exchange. Students will learn how clinical processes generate data in these different systems, the tasks required to obtain data for research purposes and steps to prepare data for analysis. Examples of research uses of clinical data will be drawn from case studies in the literature. Students will acquire skills in data review, preparation and analysis through hands-on experience with clinical data.
Heart to Heart: Experiential Learning in Community Outreach
The CTSC Heart to Heart Campaign is a multi-institutional service program that reaches out to underserved at-risk communities throughout the metropolitan area by offering free healthcare screenings at local community sites. Volunteer physicians may earn course credit for their participation in these events as part of CTEP's elective course titled, "Heart to Heart: Experiential Learning in Community Outreach." Non-MDs may also enroll for credit; assigned roles are experience dependent, and assignments may be to help with registration or ushering duties.
To qualify you must be an enrolled CTEP student in good standing, MDs must be a U.S. licensed MD (resident, fellow, attending, etc.), non-MDs must be employed at WCMC or one of the partner institutions. Trainees may earn 1 to 2 elective credits based on the number of sessions attended (2 sessions per credit), on the feedback collected from community attendees, and submission of a brief (1-2 page) write-up in a form of a blog post to be published on the Weill Cornell CTSC blog. The write-up should discuss this experience and how it has impacted the trainee's research and/or perspective as a clinician.