VitaFlow Drug Development Program WBS.mpp
VitaFlow (VTX-401) Drug Development Program
Vitalis Therapeutics Inc.
C. Tyrrell
1
2022-03-01T08:00:00
2026-10-15T08:00:00
1
480
2400
20
1
1
VitaFlow (VTX-401) drug development program
1
1
1
1
0
0
2022-03-01T08:00:00
2029-11-01T17:00:00
PT22416H0M0S
7
1
2
2
Nonclinical Package
1.1
1.1
2
1
0
0
2022-03-01T08:00:00
2022-12-31T17:00:00
PT2440H0M0S
7
1
3
3
Primary pharmacology
1.1.1
1.1.1
3
0
0
0
2022-03-01T08:00:00
2022-04-09T17:00:00
PT312H0M0S
7
0
4
4
Safety pharmacology
1.1.2
1.1.2
3
0
0
0
2022-04-09T08:00:00
2022-05-11T17:00:00
PT256H0M0S
7
0
5
5
Pharmacokinetics & ADME
1.1.3
1.1.3
3
0
0
0
2022-05-11T08:00:00
2022-06-30T17:00:00
PT400H0M0S
7
0
6
6
GLP repeat-dose toxicology
1.1.4
1.1.4
3
0
0
0
2022-06-30T08:00:00
2022-10-23T17:00:00
PT920H0M0S
7
0
7
7
Genotoxicity
1.1.5
1.1.5
3
0
0
0
2022-10-23T08:00:00
2022-11-17T17:00:00
PT200H0M0S
7
0
8
8
Reproductive toxicology
1.1.6
1.1.6
3
0
0
0
2022-11-17T08:00:00
2022-12-30T17:00:00
PT344H0M0S
7
0
9
9
CMC — Early Development
1.2
1.2
2
1
0
0
2022-03-01T08:00:00
2023-06-30T17:00:00
PT3888H0M0S
7
1
10
10
Route selection & process development
1.2.1
1.2.1
3
0
0
0
2022-03-01T08:00:00
2022-07-28T17:00:00
PT1192H0M0S
7
0
11
11
Formulation development
1.2.2
1.2.2
3
0
0
0
2022-07-28T08:00:00
2022-11-07T17:00:00
PT816H0M0S
7
0
12
12
Analytical method development
1.2.3
1.2.3
3
0
0
0
2022-11-07T08:00:00
2023-03-05T17:00:00
PT944H0M0S
7
0
13
13
Clinical supply, Phase 1–2
1.2.4
1.2.4
3
0
0
0
2023-03-05T08:00:00
2023-05-30T17:00:00
PT688H0M0S
7
0
14
14
Early stability
1.2.5
1.2.5
3
0
0
0
2023-05-30T08:00:00
2023-06-30T17:00:00
PT248H0M0S
7
0
15
15
IND Package
1.3
1.3
2
1
0
0
2022-12-31T08:00:00
2023-06-30T17:00:00
PT1448H0M0S
7
1
16
16
Investigator's Brochure
1.3.1
1.3.1
3
0
0
0
2022-12-31T08:00:00
2023-01-19T17:00:00
PT152H0M0S
7
0
17
17
Module 3 authoring
1.3.2
1.3.2
3
0
0
0
2023-01-19T08:00:00
2023-03-03T17:00:00
PT344H0M0S
7
0
18
18
Module 4 authoring
1.3.3
1.3.3
3
0
0
0
2023-03-03T08:00:00
2023-04-24T17:00:00
PT416H0M0S
7
0
19
19
Module 2 summaries
1.3.4
1.3.4
3
0
0
0
2023-04-24T08:00:00
2023-05-27T17:00:00
PT264H0M0S
7
0
20
20
Publishing & submission
1.3.5
1.3.5
3
0
0
0
2023-05-27T08:00:00
2023-06-15T17:00:00
PT152H0M0S
7
0
21
21
Pre-IND meeting
1.3.6
1.3.6
3
0
0
0
2023-06-15T08:00:00
2023-06-29T17:00:00
PT112H0M0S
7
0
22
22
Phase 1 Clinical
1.4
1.4
2
1
0
0
2023-06-30T08:00:00
2024-05-31T17:00:00
PT2688H0M0S
7
1
23
23
Protocol & start-up
1.4.1
1.4.1
3
0
0
0
2023-06-30T08:00:00
2023-08-05T17:00:00
PT288H0M0S
7
0
24
24
Unit costs & conduct
1.4.2
1.4.2
3
0
0
0
2023-08-05T08:00:00
2024-02-11T17:00:00
PT1520H0M0S
7
0
25
25
Bioanalysis
1.4.3
1.4.3
3
0
0
0
2024-02-11T08:00:00
2024-03-29T17:00:00
PT376H0M0S
7
0
26
26
Data management & statistics
1.4.4
1.4.4
3
0
0
0
2024-03-29T08:00:00
2024-04-30T17:00:00
PT256H0M0S
7
0
27
27
Clinical study report
1.4.5
1.4.5
3
0
0
0
2024-04-30T08:00:00
2024-06-01T17:00:00
PT256H0M0S
7
0
28
28
Phase 2 Clinical
1.5
1.5
2
1
0
0
2024-05-31T08:00:00
2026-06-30T17:00:00
PT6080H0M0S
7
1
29
29
Protocol & start-up
1.5.1
1.5.1
3
0
0
0
2024-05-31T08:00:00
2024-08-01T17:00:00
PT496H0M0S
7
0
30
30
Site activation
1.5.2
1.5.2
3
0
0
0
2024-08-01T08:00:00
2024-10-24T17:00:00
PT672H0M0S
7
0
31
31
Enrolment & conduct
1.5.3
1.5.3
3
0
0
0
2024-10-24T08:00:00
2025-12-26T17:00:00
PT3424H0M0S
7
0
32
32
Investigational supply
1.5.4
1.5.4
3
0
0
0
2025-12-26T08:00:00
2026-03-02T17:00:00
PT528H0M0S
7
0
33
33
Data management & biostatistics
1.5.5
1.5.5
3
0
0
0
2026-03-02T08:00:00
2026-05-13T17:00:00
PT576H0M0S
7
0
34
34
CSR & dose selection
1.5.6
1.5.6
3
0
0
0
2026-05-13T08:00:00
2026-06-30T17:00:00
PT384H0M0S
7
0
35
35
Phase 3 Clinical
1.6
1.6
2
1
0
0
2026-06-30T08:00:00
2028-09-30T17:00:00
PT6584H0M0S
7
1
36
36
Protocol & start-up
1.6.1
1.6.1
3
0
0
0
2026-06-30T08:00:00
2026-08-20T17:00:00
PT408H0M0S
7
0
37
37
Site activation
1.6.2
1.6.2
3
0
0
0
2026-08-20T08:00:00
2026-11-14T17:00:00
PT688H0M0S
7
0
38
38
Enrolment & conduct
1.6.3
1.6.3
3
0
0
0
2026-11-14T08:00:00
2028-02-01T17:00:00
PT3552H0M0S
7
0
39
39
Investigational supply
1.6.4
1.6.4
3
0
0
0
2028-02-01T08:00:00
2028-04-11T17:00:00
PT560H0M0S
7
0
40
40
CV outcomes sub-study
1.6.5
1.6.5
3
0
0
0
2028-04-11T08:00:00
2028-06-04T17:00:00
PT432H0M0S
7
0
41
41
Data management & biostatistics
1.6.6
1.6.6
3
0
0
0
2028-06-04T08:00:00
2028-08-08T17:00:00
PT520H0M0S
7
0
42
42
Safety & pharmacovigilance
1.6.7
1.6.7
3
0
0
0
2028-08-08T08:00:00
2028-09-08T17:00:00
PT248H0M0S
7
0
43
43
Clinical study reports
1.6.8
1.6.8
3
0
0
0
2028-09-08T08:00:00
2028-09-29T17:00:00
PT168H0M0S
7
0
44
44
CMC Scale-Up & Validation
1.7
1.7
2
1
0
0
2024-05-31T08:00:00
2028-09-30T17:00:00
PT12664H0M0S
7
1
45
45
Technology transfer to Aldergate
1.7.1
1.7.1
3
0
0
0
2024-05-31T08:00:00
2025-04-06T17:00:00
PT2480H0M0S
7
0
46
46
Analytical method transfer
1.7.2
1.7.2
3
0
0
0
2025-04-06T08:00:00
2025-09-08T17:00:00
PT1240H0M0S
7
0
47
47
Registration batches
1.7.3
1.7.3
3
0
0
0
2025-09-08T08:00:00
2026-10-26T17:00:00
PT3304H0M0S
7
0
48
48
Process validation (PPQ)
1.7.4
1.7.4
3
0
0
0
2026-10-26T08:00:00
2028-01-16T17:00:00
PT3576H0M0S
7
0
49
49
Stability program
1.7.5
1.7.5
3
0
0
0
2028-01-16T08:00:00
2028-06-19T17:00:00
PT1240H0M0S
7
0
50
50
Device design verification
1.7.6
1.7.6
3
0
0
0
2028-06-19T08:00:00
2028-09-30T17:00:00
PT824H0M0S
7
0
51
51
NDA Preparation & Review
1.8
1.8
2
1
0
0
2028-09-30T08:00:00
2029-10-11T17:00:00
PT3008H0M0S
7
1
52
52
Integrated summaries
1.8.1
1.8.1
3
0
0
0
2028-09-30T08:00:00
2029-01-26T17:00:00
PT944H0M0S
7
0
53
53
Datasets & define.xml
1.8.2
1.8.2
3
0
0
0
2029-01-26T08:00:00
2029-04-09T17:00:00
PT584H0M0S
7
0
54
54
Module authoring & publishing
1.8.3
1.8.3
3
0
0
0
2029-04-09T08:00:00
2029-06-30T17:00:00
PT656H0M0S
7
0
55
55
Review response
1.8.4
1.8.4
3
0
0
0
2029-06-30T08:00:00
2029-09-02T17:00:00
PT512H0M0S
7
0
56
56
Inspection support
1.8.5
1.8.5
3
0
0
0
2029-09-02T08:00:00
2029-10-11T17:00:00
PT312H0M0S
7
0
57
57
Regulatory Affairs
1.9
1.9
2
1
0
0
2022-03-01T08:00:00
2029-10-11T17:00:00
PT22248H0M0S
7
1
58
58
Regulatory strategy & planning
1.9.1
1.9.1
3
0
0
0
2022-03-01T08:00:00
2023-01-24T17:00:00
PT2632H0M0S
7
0
59
59
Agency meetings
1.9.2
1.9.2
3
0
0
0
2023-01-24T08:00:00
2024-05-14T17:00:00
PT3808H0M0S
7
0
60
60
IND maintenance
1.9.3
1.9.3
3
0
0
0
2024-05-14T08:00:00
2025-12-20T17:00:00
PT4680H0M0S
7
0
61
61
Labeling development & negotiation
1.9.4
1.9.4
3
0
0
0
2025-12-20T08:00:00
2027-05-16T17:00:00
PT4096H0M0S
7
0
62
62
Pediatric plan (PREA)
1.9.5
1.9.5
3
0
0
0
2027-05-16T08:00:00
2028-01-27T17:00:00
PT2048H0M0S
7
0
63
63
Regulatory operations & publishing
1.9.6
1.9.6
3
0
0
0
2028-01-27T08:00:00
2029-10-10T17:00:00
PT4976H0M0S
7
0
64
64
Program Management
1.10
1.10
2
1
0
0
2022-03-01T08:00:00
2029-10-11T17:00:00
PT22248H0M0S
7
1
65
65
Governance & gate management
1.10.1
1.10.1
3
0
0
0
2022-03-01T08:00:00
2023-11-21T17:00:00
PT5040H0M0S
7
0
66
66
Planning & schedule control
1.10.2
1.10.2
3
0
0
0
2023-11-21T08:00:00
2025-03-07T17:00:00
PT3776H0M0S
7
0
67
67
Risk & issue management
1.10.3
1.10.3
3
0
0
0
2025-03-07T08:00:00
2026-03-09T17:00:00
PT2936H0M0S
7
0
68
68
Vendor oversight
1.10.4
1.10.4
3
0
0
0
2026-03-09T08:00:00
2027-10-07T17:00:00
PT4616H0M0S
7
0
69
69
Reporting & performance measurement
1.10.5
1.10.5
3
0
0
0
2027-10-07T08:00:00
2028-11-30T17:00:00
PT3360H0M0S
7
0
70
70
Program closure
1.10.6
1.10.6
3
0
0
0
2028-11-30T08:00:00
2029-10-11T17:00:00
PT2520H0M0S
7
0
71
71
Advisors & Other
1.11
1.11
2
1
0
0
2022-03-01T08:00:00
2029-10-11T17:00:00
PT22248H0M0S
7
1
72
72
Regulatory counsel
1.11.1
1.11.1
3
0
0
0
2022-03-01T08:00:00
2023-06-08T17:00:00
PT3712H0M0S
7
0
73
73
Scientific advisory board
1.11.2
1.11.2
3
0
0
0
2023-06-08T08:00:00
2024-04-01T17:00:00
PT2384H0M0S
7
0
74
74
PDUFA user fee
1.11.3
1.11.3
3
0
0
0
2024-04-01T08:00:00
2028-02-24T17:00:00
PT11392H0M0S
7
0
75
75
Insurance & indemnity
1.11.4
1.11.4
3
0
0
0
2028-02-24T08:00:00
2029-02-22T17:00:00
PT2912H0M0S
7
0
76
76
Translation & localization
1.11.5
1.11.5
3
0
0
0
2029-02-22T08:00:00
2029-10-12T17:00:00
PT1856H0M0S
7
0
1
1
C. Tyrrell
1
2
2
Dr. M. Sørensen
1
3
3
Dr. K. Oyelaran
1
4
4
G. Petrossian
1
5
5
Dr. S. Aldridge
1
6
6
Dr. R. Molyneux
1
7
7
T. Nakashima
1
1
3
2
1
2
4
2
1
3
5
2
1
4
6
2
1
5
7
2
1
6
8
2
1
7
10
3
1
8
11
3
1
9
12
3
1
10
13
3
1
11
14
3
1
12
16
4
1
13
17
4
1
14
18
4
1
15
19
4
1
16
20
4
1
17
21
4
1
18
23
5
1
19
24
5
1
20
25
5
1
21
26
5
1
22
27
5
1
23
29
5
1
24
30
5
1
25
31
5
1
26
32
5
1
27
33
5
1
28
34
5
1
29
36
6
1
30
37
6
1
31
38
6
1
32
39
6
1
33
40
6
1
34
41
6
1
35
42
6
1
36
43
6
1
37
45
3
1
38
46
3
1
39
47
3
1
40
48
3
1
41
49
3
1
42
50
3
1
43
52
4
1
44
53
4
1
45
54
4
1
46
55
4
1
47
56
4
1
48
58
4
1
49
59
4
1
50
60
4
1
51
61
4
1
52
62
4
1
53
63
4
1
54
65
7
1
55
66
7
1
56
67
7
1
57
68
7
1
58
69
7
1
59
70
7
1
60
72
7
1
61
73
7
1
62
74
7
1
63
75
7
1
64
76
7
1