BIOT 5830 — Regulatory Landscape of Cell and Gene Therapies
2 semester hoursGraduateLectureusually offered: fallBostonOnlineOnlineTraditional
Introduces the current state of regulatory approvals for cell and gene therapies. Focuses on the scientific and technical considerations for approval for such drugs in the United States, in Europe, and in other key global markets. Explores the scientific challenges in the context of regulatory approval of these products, as well as how the process differs from traditional biotherapeutic product approvals. Examines how these regulatory pathways are evolving with a specific emphasis on quality, efficacy, and safety throughout the product life cycle (manufacturing through commercialization).
Offering history
| Term | Sections | Enrolled | Capacity | Full | Open seats/section |
|---|---|---|---|---|---|
| Fall 2024 | 2 | 20 | 45 | 44% | 12.5 |
| Fall 2025 | 2 | 22 | 37 | 59% | 7.5 |
Snapshots from scheduled scrapes — not live seat availability. "Full" can exceed 100% when sections over-enroll.
Meeting times
Share of recent sections by weekday: M 0% · T 0% · W 24% · Th 0% · F 0%
Common patterns: async (76% of sections), W (24% of sections) — in patterns, R means Thursday
Professors
Fall
- Sahar Tavakoli (100% of students) · reviews
Percentages are each professor's average share of the season's enrolled students in recent terms.
Links
Official catalog (BIOT course descriptions) · Student reviews on RateMyHusky · All BIOT courses · Plan it at numap.app