TABLE 1.
Survey respondents' main area of expertise and years of experience in antibacterial R&D
| Category of respondents | % (no.) of respondents |
|---|---|
| Main area of expertise | |
| Clinical development/medical affairs | 47 (28) |
| Preclinical development | 17 (10) |
| Research | 13 (8) |
| Regulatory affairs | 8 (5) |
| Clinical operations/clinical trial management | 5 (3) |
| Biostatistics | 5 (3) |
| Pharmacometrics | 2 (1) |
| Human pharmacology | 2 (1) |
| Business development | 2 (1) |
| No. of yrs of experience in antibacterial R&D | |
| ≤1 | 2 (1) |
| 2 to 5 | 27 (16) |
| 6 to 10 | 8 (5) |
| >10 | 63 (38) |
| Respondents experience with regulatory environments | |
| FDA | 95 (57) |
| EMA | 93 (56) |
| Othera | 25 (15) |
a
Pharmaceuticals and Medical Devices Agency (PMDA), Japan, n = 8; China Food and Drug Administration (CFDA), n = 6; Therapeutic Goods Administration (TGA), Australia, n = 5; Health Canada, n = 5; Health Sciences Authority, Singapore, n = 2; Africa, n = 2; South America, n = 1; Asia, n = 1; European Union member state regulatory agencies, n = 1.