The students will receive an update on molecular biology and immunology needed for understanding the development of biological and advanced medicinal products as well as vaccines. The development, application, and regulatory requirements of these medicinal products will be discussed in detail.
1. Demonstrate an understanding of the scientific, regulatory, ethical and legal issues that are peculiar to biological and advanced therapies.
2. Demonstrate an understanding of the challenges presented in constructing a package of non-clinical data to support the clinical development and marketing of biological and advanced therapies.
3. Recommend a clinical trial plan that is appropriate for the different types of products and technologies represented by biological and advanced therapies.
4. Demonstrate an understanding of the technical and manufacturing issues that are peculiar to biological and advanced therapies.
5. Critically review the non-clinical and clinical scientific knowledge underlying the development of new or prospective biological or advanced therapies.
6. Describe the new technologies now available and those in development; describe the therapeutic opportunities that might arise from the technology.
7. Critically analyse the differences between natural and modified protein constructs.
8. Describe the global need for new and improved vaccines and the barriers to their development.
9. Discuss the history and future prospects for gene therapy, and the technical difficulties developing a gene therapy product.
10. Describe the concept of stem cell therapy, what opportunities it might present, and the ethical issues that are unique to this technology.
11. Describe the particular ethical and regulatory issues of advanced therapies and how The Advanced Therapy Directive is addressing these.
12. Demonstrate the understanding of the basic principles of the development of medical devices. Assess the scientific and regulatory issues relevant to the clinical development of medical device-drug combinations.