Stem Cell Biology


California is at the forefront of stem cell research and the industry continues to offer exciting opportunities in the Bay Area. This introduction to stem cells and their applications is geared towards professionals in the pharmaceutical, biotech, medical device, and healthcare industries. It addresses the basic biology and clinical applications of embryonic and adult stem cell therapies, provides a market overview of stem cell startup companies, and touches on the FDA regulation of biologic products.

Prerequisites :


No prerequisites


Toxicology Basics for Biotechnology


High-throughput efforts by biopharmaceutical companies focusing on the discovery and validation of new targets and identifying agents that affect them will uncover a multitude of new chemical and biological agents that have the potential for clinical benefits. However, before such agents can be tested and used widely in patients, safety and acceptable toxicity to critical organs must be demonstrated.
This course surveys the adverse effects resulting from the interaction of chemical agents with living systems.

Prerequisites :


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
BTEC.X412.(804) 6/15/2018 12:00 AM ONLINE 580 Ronald Tjeerdema View Enroll
BTEC.X412.(805) 9/19/2018 12:00 AM ONLINE 580 Ronald Tjeerdema View Enroll

Viruses, Vaccines and Gene Therapy


The recent outbreaks of Zika and Ebola viruses and an increase in the rates of certain viral infections reflect the profound impact viruses have on human health worldwide. Students in the course study past viral pandemics—influenza, smallpox, and polio—and how they have altered human history. They survey how viruses replicate in human hosts and spread in human populations. Students also learn how recent developments in molecular biology and genetics have been instrumental to the biopharmaceutical industry in developing antiviral drugs and viral vaccines.

Prerequisites :


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
BTEC.X413.(2) 9/10/2018 06:00 PM SANTA CLARA 580 Edward James Rozhon View Enroll

Gene Expression and Pathways


Knowledge of how gene expression is regulated is essential to understanding cellular structure and function, both in normal cells and in the disease state.

Prerequisites :


No prerequisites


Drug Quality Fundamentals: Quality Control of Small Molecule Drugs and Biologics


This introductory course provides an overview of key drug quality concepts and standards for the pharmaceutical and biotechnology industries. Interactive lectures explore quality system and control process best practices in clinical development, drug manufacturing and for commercial products. You'll learn the roles and responsibilities of quality assurance (QA) and quality control (QC) in ensuring the safety, efficacy and quality of drug products. You'll contrast specific quality attributes of large-molecule recombinant biological products with those of small molecule drugs.

Prerequisites :


Offering code Offering title
BTEC.X401 Drug Development Process
REGL.X400 Good Manufacturing Practices
REGL.X403 Regulation of Drugs and Biologics

Molecular Diagnostics


Rapid advancements in molecular diagnostics are drawing the attention of the bioscience industry, regulatory agencies, clinicians, patients and insurers alike. This survey course provides a foundation in the basic science and technologies that underlie the emerging field of molecular diagnostics, and highlights potential impacts on the healthcare landscape.
Interactive lectures explore the intricate relationship between the human genome and diagnostic tests.

Prerequisites :


No prerequisites


Drug Development Process


The development of new drugs is a highly complex, lengthy and expensive process. In this course, you examine this process---from discovery to market and beyond---and see what makes the biopharmaceutical industry unique. Infused with real-world examples, lectures will address drug discovery; preclinical characterization of new drug entities; the phases and purposes of both pharmacological and clinical development; regulatory filings, compliance and oversight; FDA jurisdiction; and strategic issues in drug development.

Prerequisites :


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
BTEC.X401.(4) 9/6/2018 06:00 PM SANTA CLARA 765 Edward James Rozhon View Enroll

Regulation of Drugs and Biologics


Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course will help you understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Through lectures, case studies, and hands-on exercises, you'll gain knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, post-marketing requirements, the impact of regulatory differences between U.S.

Prerequisites :


Offering code Offering title
BTEC.X401 Drug Development Process

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X403.(3) 10/1/2018 06:00 PM SANTA CLARA 825 Sheldon L Mullins View Enroll

Drug Discovery, Introduction


This introductory course provides a framework for understanding the process of drug discovery, from target selection and validation to lead optimization and preclinical studies. Although the fundamental principles of drug discovery are well established, the tools, technologies and methods used in the discovery and development of safe and effective drugs are constantly evolving. Personalized medicine and novel diagnostics involving biomarkers, pharmacogenetics and pharmacogenomics in clinical practice are changing the landscape of drug discovery.

Prerequisites :


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
BTEC.X405.(2) 9/26/2018 06:00 PM SANTA CLARA 765 Chakk Ramesha View Enroll

Good Manufacturing Practices


Familiarity with the Good Manufacturing Practices (GMP) regulations is necessary for employees engaged in the manufacture, regulation, quality assurance, and control of drugs and biologics. Through lectures, discussions, and case studies, you’ll gain an understanding of the FDA GMP and Good Laboratory Practice (GLP) regulations.

Prerequisites :


No prerequisites


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