Courses

• GMS BT 520: Biology of Cancer
  This course will focus on the cellular and molecular changes that underlie the development and progression of human cancer. We will examine the pathways and processes that involve oncogenes and tumor suppressor genes to understand how they can contribute to cancer. Complex interactions including angiogenesis, tumor immunology, invasion and metastasis will be studied as well. In addition, we will cover targeted approaches to cancer therapy and the latest scientific research including cancer epigenetics, microRNAs and cancer stem cells.
• GMS BT 530: Intro Pharm
  This course description is currently under construction.
• GMS BT 540: Regulatory and Compliance Issues
  This course explains the regulatory requirements for health care products: drugs, biologics, diagnostics, and devices. The focus is on U.S. FDA regulations and their impact on product development and marketing with international requirements. Recommended for students in clinical research concentration.
• GMS BT 550: Clinical Data Management
  Introduces students to the technology, process, and responsibilities of clinical data management. We will examine study setup, case report form (CRF) design, and the data life cycle, including data collection; data validation, coding of adverse events, using standard dictionaries (such as ICD-9 or MedDRA), data review, and database lock. Data Management SOP's will be discussed within this context. An industry-leading clinical data management system (CDMS) will be utilized. We will also explore how new technologies, such as electronic data capture (EDC), affect these processes.
• GMS BT 560: Good Clinical Practices (GCP) in Clinical Research
  Introduces the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed for the clinical trial professional on procedures for ensuring GCP compliance from an industry perspective. Topics include: identifying and selecting qualified investigators, obtaining ethical approval to enroll patients, and initiating sites successfully. Also covers issues related to collecting required regulatory documentation, verifying high quality data, maintaining study materials accountability, and reporting serious adverse events. Group discussions and guest speakers help students learn the practical skills used in the field.
• GMS BT 575: Design and Conduct of Clinical Trials
  This course covers basic principles and current methodologies used in the design and responsible conduct of clinical trials. Topics include statistical design of clinical trials, sample selection; data collection and management; patient recruitment strategies, adverse event reporting and compliance monitoring. Practical exercises will include clinical research protocol and informed consent form writing as well as design of case report forms. [4 cr.]
• GMS BT 580: Legal and Ethical Issues in Clinical Research
  Students examine the development and implementation of regulatory as well as ethical issues involved with conducting clinical trials. Topics include: use of human subjects, privacy and confidentiality, conflicts of interest, use of stem cells in research, federal laws affecting laboratories, and genetic testing of gene and therapy trials. There will also be discussions on landmark legal cases affecting laboratory scientists. 2 cr. summer
• GMS BT 591: Directed Study: Biomedical Externship
  Directed study for degree candidates only. Practical, hands-on experience in laboratory setting. Various credits and fee, as arranged with Director.
• GMS BT 592: Directed Study: Biomedical Externship
  Directed study for degree candidates only. Practical, hands-on experience in laboratory setting. Various credits and fee, as arranged with Director.
• GMS BT 594: Clinical Research Practicum
  Directed study offering direct exposure to the conduct of a clinical trial. Various credits and fee, as arranged with Director.
• GMS BT 595: Clinical Research Practicum
  Directed study offering direct exposure to the conduct of a clinical trial. Various credits and fee, as arranged with Director.
• GMS BY 760: Foundations of Biophysics and Structural Biology
  Prereq: consent of instructor. The course provides thorough grounding in theory and practice of the major, fundamental methods of biophysics and structural biology. The course covers thermodynamics, spectroscopy, electron microscopy, x-ray diffraction and crystallography, and nuclear magnetic resonance from the standpoint of modern molecular and structurally based research. Atkinson. 4 cr, Spring sem.
• GMS BY 771: Biophysics of Macromolecular Assemblies
  Prereq: GMS BI 751 or GMS BI 755, 756, and consent of instructor. Advanced course. Assembly of biomacromolecules, their structure and stabilizing forces; biological function as related to structure, with examples drawn from assemblies of proteins, lipids, lipoprotein systems, and membranes. Shipley. 4 cr, Spring sem.
• GMS BY 871: Biophysics Special Topics/Student Seminar
  A weekly program in which first and second year students present seminars on assigned or selected current topics in biophysics and structural biology. Emphasis is placed on class participation by all students. Atkinson, members of the department. 2 cr, Fall & Spring sem.
• GMS BY 872: Biophysics Special Topics/Student Seminar
  A weekly program in which first and second year students present seminars on assigned or selected current topics in biophysics and structural biology. Emphasis is placed on class participation by all students. Atkinson, members of the department. 2 cr, Fall & Spring sem.
• GMS BY 945: Research Biophysics
  Var cr
• GMS BY 946: Research Biophysics
  Var cr
• GMS CI 631: The Management of Clinical Research
  Prereq: CI 675 and consent of instructor. This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles with an explanation and analysis of selected portions of the Code of Federal Regulations (CFR), applicable to clinical research during the new drug development process. The case study approach is used in this course since the drug development industry translates these regulations into both written and unwritten standards, practices, and guidelines. Each session will use activities to expand the interpretation of the regulations, into an operational and organizational focus, further integrating real-life issues into the classroom. In order to ensure that classroom learning is linked with the students' work experiences, there will be an outside project required which will incorporate the course work with the simulated on-the-job situations, and a final presentation to share the learning with the entire class. Halloran, Roth. 4 cr, Spring sem.
• GMS CI 640: Regulatory and Compliance Issues
  Prereq: consent of instructor. This course explains the regulatory requirements for healthcare products, that is, drugs, biologics, and devices. It is intended for those interested in regulatory affairs or the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provides an in-depth review of pertinent FDA regulations and guidance and links these to the scientific and logistical activities involved in taking a medical product from research to market. Content and preparation of regulatory submissions, including an Investigational New Drug Application (IND), an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologic License Application (BLA), a Pre-Market Approval Application (PMA), and a 510K Pre-Market Notification are described. Aulwes. 4 cr, Fall sem.
• GMS CI 660: Good Clinical Practices in Clinical Research
  Prereq: consent of instructor. This course introduces students to the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed to demonstrate GCP compliance from an industry perspective as well as from an academic perspective. Topics Include: Human protection in clinical trials, institutional review boards, selecting and qualifying investigators, consenting subjects, initiating, monitoring and closing out sites successfully and safety monitoring in clinical trials. Group discussions and exercises help students learn practical skills. Malikova. 4 cr, Summer II sem.

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