Degree Programs and Certificate
Program Overview
Explosive advances in new genomic and biomedical sciences are unraveling various disease processes and creating new directions for novel drug research and development. The magnitude of the potential applications of these advances is staggering since more than 100 million Americans suffer from diseases such as heart disease, cancer, Alzheimer's, diabetes, arthritis, clinical depression, stroke, osteoporosis and others, costing society well over $550 billion annually.
.Drug and medical device companies are striving to turn these scientific discoveries into actual products. In recent years, R&D expenditures for PhRMA member companies have ballooned to over $34B while the number of New Chemical Entities (NCEs) approved has inched down. Reasons cited for poor productivity include rapidly rising costs and the increasing complexity of the R&D process in an environment characterized by a tremendous increase in the number of targets identified through advances in genomics.
There is also a need to turn the process of developing new products from an art to a well-understood science. One key bottleneck is the design and execution of clinical trials to prove safety and efficacy of innovative biomedical products while balancing heightened regulatory pressures with an unrelenting drive to control rising costs and improve quality.
It is widely believed that the adoption and use of information technology is critical to companies working to satisfy these demands within the drug-development operating environment. "E-clinical" science, engineering, and technologies can reduce data collection and management inefficiencies, improve development planning and management, and accelerate the filing of drugs with regulatory agencies.
For example, electronic data capture using web-enabled and voice-response technologies can be used to replace paper data capture. Data collection and management activities account for more than 60 percent of the total time within which Phase I-III programs are conducted. Experts estimate that the global pharmaceutical industry could achieve substantial savings and reductions in cycle time by implementing electronic data capture and management technologies.
Additionally, the use of Clinical Trial Management Systems (CTMS) and Project and Portfolio Management (PPM) Systems can streamline and optimize planning, resource management, and trial execution processes akin to automated operations deployed by the process and manufacturing industry. Web-based technologies and collaboration platforms can be used to facilitate interaction between globally dispersed participants in the clinical trials process including sponsors, clinical investigators, CROs, central labs, IRBs and regulatory bodies. Finally, a variety of technology-based approaches can be utilized to optimize the patient recruitment and retention process that has also emerged as a key bottleneck.
The Status of e-Clinical Trials
We need medical scientists, bioengineers, and managers with a comprehensive knowledge of regulatory affairs, dosage formulation, and clinical issues as well as skills such as scientific computing, database and information management, and automation. This background is becoming essential for drug design and pre-clinical and clinical development of traditional and atypical pharmaceuticals as well as novel biomedical devices and combination products. Potential students should also be familiar with the rapid changes in social, regulatory, legal and business aspects in addition to the technical issues mentioned above.