The Regulatory Affairs for Cell and Gene Therapy post-baccalaureate certificate program trains leaders for this growing discipline and prepares them to bring new therapeutics to market. Students learn how to manage everything from pre-clinical IND-enabling studies to product licensure, and into post-approval life cycle management, post-approval change reporting categories, accelerated approval mechanisms, managing agency inspections, ethics, CMC and international market requirements for cell and gene regulatory affairs.
Drexel's program is the only post-baccalaureate certificate in Regulatory Affairs for Cell and Gene Therapy offered by a university. Program courses are taught by Drexel University College of Medicine faculty, as well as adjunct faculty who are currently working in cell and gene therapy, biotech and pharma.
Regulatory affairs for cell and gene therapy (CGT) differs from regulatory affairs for pharmaceutical companies in several key aspects. While both areas involve navigating regulatory requirements and obtaining approvals, CGT presents unique challenges due to the innovative nature of these therapies. Here are some key differences:
- Product Complexity: Cell and gene therapies involve complex, personalized products that often require manipulation of a patient's own cells or genetic material. This complexity differs significantly from traditional pharmaceutical products, which are typically small molecules or biologics. The manufacturing, quality control, and characterization processes for CGT products are distinct and require specialized expertise.
- Development Process: The development pathway for CGT is often more iterative and dynamic compared to traditional pharmaceuticals. CGT products may undergo multiple modifications during the development process to optimize efficacy and safety. Regulatory affairs professionals working in CGT need to navigate this evolving landscape, including addressing changes in the manufacturing process and adjusting regulatory strategies accordingly.
- Clinical Trial Design: Clinical trials for CGT products often involve smaller patient populations due to their personalized nature. Additionally, CGT trials may have unique endpoints and study designs tailored to assess the therapeutic efficacy of these treatments. Regulatory affairs professionals in CGT must have a deep understanding of the specific requirements for designing and conducting trials for these innovative therapies.
- Regulatory Framework: Regulatory authorities worldwide have recognized the need for tailored regulations to accommodate the unique aspects of CGT products. Many countries have established specific regulatory frameworks or expedited pathways to facilitate the development and approval of these therapies. Regulatory affairs professionals in CGT need to stay abreast of these evolving regulations and work closely with regulatory agencies to ensure compliance.
- Safety and Risk Management: Due to the novel nature of CGT products, safety considerations and risk management play a crucial role in regulatory affairs. Assessing and mitigating potential risks associated with the use of genetically modified cells or vectors is a primary concern. Robust pharmacovigilance programs are necessary to monitor the long-term safety and efficacy of these therapies.
Who Should Apply?
We welcome students of all undergraduate backgrounds. This program will prepare students to be a regulatory affairs specialist, manager or director for cell and gene therapy, biomanufacturing, or therapeutic companies.
Creative and Critical Thinking: Students will develop divergent (e.g., generation of novel ideas, thinking out of the box, brainstorming) and convergent thinking (e.g., critical thinking, evaluation of ideas, quantitative and qualitative analysis, scientific reasoning) to generate novel and relevant ideas, strategies, approaches or products.
Ethical Reasoning: Students will assess their own ethical values and the social context of ethical problems, recognize ethical issues in a variety of settings, think about how different ethical perspectives might be applied to an ethical problem, and consider the consequences of alternative actions.
Technology Use: Students will make appropriate use of technologies to communicate, collaborate, solve problems, make decisions, and conduct research, as well as foster creativity and life-long learning.
Student Computer Recommendations
Students and staff are advised to purchase computers listed under "Small Business" or "Business" categories rather than from "Consumer" product lines. Please refer to the specifications listed in the Computer Buying Guide to gain the most longevity from your computer. View computer buying guide.