Clinical Trials
103
34 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
1987
Active, not recruiting
34
33.0%
Completed
33
32.0%
Recruiting
1
1.0%
Suspended
1
1.0%
Terminated
26
25.2%
Unknown
4
3.9%
Withdrawn
4
3.9%
- More than 30% of clinical trials globally experience delays due to data quality issues, costing pharmaceutical companies billions and delaying patient access to life-saving therapies. - Ramakrishna Sesham developed enterprise clinical data governance frameworks that connect research systems directly to regulatory requirements, enabling submission-ready outputs immediately after trial completion. - His systems at Spectrum Pharmaceuticals supported FDA approval of ROLONTIS for chemotherapy-induced neutropenia, while his current work at Astellas Pharma manages regulatory submissions for oncology and rare disease programs affecting millions of patients. - The risk-based quality frameworks identify compliance issues during trial design rather than after data collection, significantly compressing drug development timelines.
• The FDA has issued a complete response letter for poziotinib, Spectrum Pharmaceuticals' pan-HER2 inhibitor, rejecting its application for HER2 exon 20 insertion-mutated non-small cell lung cancer treatment. • The rejection follows a 9-4 vote against approval by FDA's Oncologic Drugs Advisory Committee, citing concerns over marginal efficacy, high toxicity rates, and delayed confirmatory trials. • Phase 2 ZENITH20 study showed limited efficacy with 28% objective response rate and five-month median response duration, while 12% of patients discontinued due to adverse effects.
