Biopharma Lecture series
Regulatory aspects of Drug development - Rare Diseases
A course on understanding the basic concepts of risk-assessment and regulatory aspects of drug development of biological drugs.
by Narendra Chirmule, PhD
- 10 Lessons
- 3 Hours
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Course Description
Drug development is at a turning point in human medicine. Over the past three decades, the development of biotherapeutics has revolutionized innovation in medicines. Efficiency and Quality Compliance are critical to achieving innovation and affordability. This course will provide an overview of the multi-dimensional nature of drug development, which involves regulatory, new technologies, statistical, and quality considerations. This 2-week course will introduce the concepts of drug development, which include, pharmacology, toxicology, product development, clinical trials. All of these topics will be addressed based on regulatory requirements by the FDA. Risk assessment and mitigation will be discussed using a role-play process. The content of the course includes seminars, case studies, project reports, and journal article-reviews.
Course Objectives
Upon completion of the course, the participants should be able to:
1. Identify the basic aspects of drug development, especially as it relates to application in various steps of the process.
2. Evaluate the risks associated with the drug development process.
3. Assess the social impact of the cost of drug development.
4. Apply the tools to develop methodologies in challenges faced during drug development.
5. Develop the ability to understand risk assessment processes.
6. Evaluate complex multi-disciplinary nature of the drug development process, which intersect with several other biological processes.
7. Illustrate a shared understanding of academic and industry requirements.
Each Session will discuss recent case-studies of failures and successes of products. The course will include relevant manuscripts, regulatory guidance documents, and statutory requirements.
A role-play exercise
Narendra Chirmule
Narendra Chirmule
Narendra Chirmule has contributed to the development of vaccines and biopharmaceuticals over the past three decades. The drug development experiences include vaccines for cervical cancer [HPV], shingles [Varicella zoster], childhood diarrhea [Rotavirus]), and biopharmaceuticals for osteoporosis (Prolia), rheumatoid arthritis (Enbrel), platelet loss (NPlate), breast cancer (Ogrivi), biosimilar insulins among many others. He has worked on gene therapy using viral vectors at UPenn in the late 1990s. He has published extensively and presented seminars on subjects of immunology, biologics, and vaccines. He has recently written a book on lessons learned from failures in drug development “Good Genes Gone Bad“.
The subject of his Ph.D. was on the development of a leprosy vaccine, from Cancer Research Institute, Mumbai; post-doctoral studies on the pathogenesis of AIDS from Cornell University Medical College-North Shore Hospital, New York; teaching and research as an assistant professor in gene therapy at the University of Pennsylvania, Philadelphia.