Attached files
file | filename |
---|---|
10-Q - FORM 10-Q - BIOCRYST PHARMACEUTICALS INC | gfpf10q_080715.htm |
EX-31.2 - EXHIBIT 31.2 - BIOCRYST PHARMACEUTICALS INC | exh_312.htm |
EX-10.6 - EXHIBIT 10.6 - BIOCRYST PHARMACEUTICALS INC | exh_106.htm |
EX-10.5 - EXHIBIT 10.5 - BIOCRYST PHARMACEUTICALS INC | exh_105.htm |
EX-10.8 - EXHIBIT 10.8 - BIOCRYST PHARMACEUTICALS INC | exh_108.htm |
EX-10.4 - EXHIBIT 10.4 - BIOCRYST PHARMACEUTICALS INC | exh_104.htm |
EX-10.7 - EXHIBIT 10.7 - BIOCRYST PHARMACEUTICALS INC | exh_107.htm |
EX-10.3 - EXHIBIT 10.3 - BIOCRYST PHARMACEUTICALS INC | exh_103.htm |
EX-31.1 - EXHIBIT 31.1 - BIOCRYST PHARMACEUTICALS INC | exh_311.htm |
EX-10.2 - EXHIBIT 10.2 - BIOCRYST PHARMACEUTICALS INC | exh_102.htm |
EX-32.1 - EXHIBIT 32.1 - BIOCRYST PHARMACEUTICALS INC | exh_321.htm |
EX-32.2 - EXHIBIT 32.2 - BIOCRYST PHARMACEUTICALS INC | exh_322.htm |
Exhibit 10.1
Pursuant to 17 CFR 20.24b-2, confidential information has been omitted in places marked “***” and has been filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Application with the Commission.
ATTACHMENT 2
MILESTONE AND DELIVERABLES CHART
May 7, 2015
HHSO100201500007C
WBS
|
Milestone
|
Deliverable
|
Success Criteria
|
Timing
|
Go/No-Go
for initiation
|
CLIN 0001 - MANUFACTURE OF CLINICAL TRIAL MATERIAL
|
|||||
1.2.1
|
Process Improvements Report
|
Report on Process Development
|
Process Developed
|
***
|
|
1.2.2
|
Determination of Sufficient Process for Commercial Scale up
|
Evaluation report
|
BARDA approval of developed process
|
***
|
N/A
|
1.3.1
|
Manufacture ***(Batch ***)
|
***
|
Acceptable quality and yield
|
***
|
N/A
|
1.3.2
|
Manufacture ***(Batch ***)
|
***
|
Acceptable quality and yield
|
***
|
N/A
|
1.4.1
|
Manufacture cGMP BCX4430 (***campaign DS Batch ***)
|
BCX4430 DS
CofA,
|
Acceptable quality and yield
|
***
|
N/A
|
1.4.2
|
Manufacture cGMP BCX4430 (*** campaign DS Batch ***)
|
BCX4430 DS
CofA,
|
Acceptable quality and yield
|
***
|
N/A
|
1.4.3
|
Prepare a Campaign Summary Reports
|
Campaign Reports (DS Batches ***)
|
Completion of DS Campaigns
|
***
|
N/A
|
1.4.4
|
Drug substance stability study
|
Initial Report on stability activities
|
Stability data
|
***
|
|
1.5
|
Drug Product Development
|
DP Process Development Report (WBS 1.5.4)
Pre-formulation and Physicochemical Report (WBS1.5.5)
Extractable/Leachable Report (WBS 1.5.7)
|
Completion of Studies
|
***
|
N/A
|
1.5.8
|
Excipient Compatibility Report for IV Formulation
|
Compatibility Report
|
IV formulation completed
|
***
|
|
1.6.1
|
Manufacture cGMP DP (CTM Batch *** ***)
|
BCX4430 DP
CofA,
|
Acceptable quality and yield
|
***
|
Accepted GMP DS
|
1.6.2
|
Manufacture cGMP DP (CTM Batch *** ***)
|
BCX4430 DP
CofA,
|
Acceptable quality and yield
|
***
|
Accepted GMP DS
|
Pursuant to 17 CFR 20.24b-2, confidential information has been omitted in places marked “***” and has been filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Application with the Commission.
1.6.3
|
Prepare a Campaign Summary Reports
|
Campaign Reports (CTM Batches ***)
|
Completion of DP Campaigns
|
***
|
N/A
|
1.6.4
|
Drug Product stability study
|
Initial Report on stability activities
|
Stability Data
|
***
|
|
1.6.5
|
Comparability Study
|
Comparability Protocol and Report
|
Completion of DS and DP Campaigns
|
***
|
|
1.7.1
|
Manufacture cGMP BCX4340 (*** campaign DS Batch ***)
|
BCX4430 DS
CofA
|
Acceptable DS process
|
***
|
N/A
|
1.7.2
|
Prepare a Campaign Summary Report
|
Campaign Reports (DS Batch***)
|
Completion of DS Campaign
|
***
|
N/A
|
1.7.2
|
Manufacture cGMP DP (CTM Batch *** ***)
|
BCX4430 DP
CofA,
|
Acceptable quality and yield
|
***
|
Accepted GMP DS
|
1.7.4
|
Prepare a Campaign Summary Report
|
Campaign Report (CTM Batches ***)
|
Completion of DS Campaigns
|
***
|
N/A
|
1.7.5
|
Drug Substance and Drug Product stability study
|
Initial report on stability activities
|
Stability Data
|
***
|
Manufacture of 1.7.1 drug substance and 1.7.2 drug product
|
1.7.6
|
Comparability Study
|
Comparability Protocol and Report
|
Comparable DS and DP profiles
|
***
|
N/A
|
CLIN 0002 – COMMERCIAL SCALE UP AND NDA REGISTRATION BATCHES
Go/No Go Criteria to Initiate: WBS 1.2.2 BARDA approval of process developed
|
|||||
2.2
|
Drug Substance Process Scale-up
|
Process Development Report (WBS 2.2.4)
|
Selection of the optimized manufacturing process
|
***
|
*** process
|
2.3.1
|
Manufacture BCX4340 DS (DS Registration Batch ***)
|
BCX4430 Registration
DS
CofA
|
Acceptable quality and yield
|
***
|
*** process
|
2.3.2
|
Manufacture BCX4340 DS (DS Registration Batch ***)
|
BCX4430 Registration DS
CofA,
|
Acceptable quality and yield
|
***
|
*** process
|
2.3.3
|
Manufacture BCX4340 DS (DS Registration Batch ***)
|
BCX4430 Registration DS
CofA,
|
Acceptable quality and yield
|
***
|
*** process
|
2.3.4
|
Prepare a Campaign Summary Report
|
Campaign Reports (DS Batches ***)
|
Completion of DS Campaign
|
***
|
N/A
|
2.4.1
|
Manufacture BCX4430 DP (DP Registration Batch ***)
|
BCX4430 DP
CofA,
|
Acceptable quality and yield
|
***
|
Accepted GMP DS
|
Pursuant to 17 CFR 20.24b-2, confidential information has been omitted in places marked “***” and has been filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Application with the Commission.
2.4.2
|
Manufacture BCX4430 DP (DP Registration Batch ***)
|
BCX4430 DP
CofA,
|
Acceptable quality and yield
|
***
|
Accepted GMP DS
|
2.4.3
|
Manufacture BCX4430 DP (DP Registration Batch ***)
|
BCX4430 DP
CofA,
|
Acceptable quality and yield
|
***
|
Accepted GMP DS
|
2.4.4
|
Prepare a Campaign Summary Report
|
Campaign Report (CTM Registration Batches ***)
|
Completion of DS Campaigns
|
***
|
N/A
|
2.5
|
Drug substance and Drug Product stability study
|
Report on stability activities
|
Stability Data
|
***
|
|
2.6
|
Comparability Study
|
Comparability Protocol and Report
|
Comparable DS and DP profiles
|
***
|
Accepted GMP DS
|
CLIN 0003 – NONCLINICAL NDA-ENABLING TOXICOLOGY - IM
Go/No Go Criteria to Initiate: WBS 1.4.1 Completion of Manufacture cGMP BCX4430 (*** campaign DS Batch ***)
|
|||||
3.1.1
|
Complete GLP *** IM Tox Study - ***
|
Study Report
|
Established NOAEL
|
***
|
Drug Substance confirming to release criteria
|
3.1.2
|
Complete GLP *** IM Tox Study - ***
|
Study Report
|
Established NOAEL
|
***
|
Drug Substance confirming to release criteria
|
3.2.1
|
Conduct *** assessment in *** and ***
|
Study Report
|
No significant findings
|
***
|
N/A
|
3.2.2
|
Conduct *** Dose Range Finding Studies in the ***
|
Study Report
|
No significant findings
|
***
|
N/A
|
3.2.3
|
Conduct Definitive *** toxicology in the ***
|
Study Report
|
No significant findings
|
***
|
N/A
|
3.2.4
|
Conduct *** toxicology ***
|
Study Report
|
No significant findings
|
***
|
N/A
|
3.3.1
|
Conduct Radiolabeled ADME study - ***
|
Study Report
|
Characterize drug disposition
|
***
|
Acceptable Radiolabel Material
|
3.3.2
|
Conduct Radiolabeled ADME – ***
|
Study Report
|
Characterize drug disposition
|
***
|
Acceptable Radiolabel Material
|
CLIN 0004 – IN VITRO EXPERIMENTS – IV
Go/No Go to Initiate: WBS 1.5.8 Completion of Excipient compatibility studies for IV formulation
|
|||||
4.1.
|
Conduct *** Test – IV
|
Study Report
|
No effect on ***
|
***
|
IV formulation WBS 1.5.8
|
4.2.
|
Conduct *** Test – IV
|
Study Report
|
No effect on ***
|
***
|
N/A
|
Pursuant to 17 CFR 20.24b-2, confidential information has been omitted in places marked “***” and has been filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Application with the Commission.
4.3
|
*** IV experiments
|
Study report on all *** assays with recommendation to proceed CLIN0005
|
No toxicology ***
|
***
|
|
CLIN 0005 – NONCLINICAL NDA-ENABLING TOXICOLOGY – IV
Go/No Go to Initiate: WBS 4.3 Completion of *** IV toxicology studies
|
|||||
5.1.1
|
Complete GLP *** IV Tox Study - ***
|
Study Report
|
Established NOAEL
|
***
|
Drug Substance confirming to release criteria
|
5.1.2
|
Complete GLP ***IV Tox Study - ***
|
Study Report
|
Established NOAEL
|
***
|
Drug Substance confirming to release criteria
|
5.2.1
|
Conduct *** assessment in ***
|
Study Report
|
No significant findings
|
***
|
N/A
|
5.2.2
|
Conduct *** Dose Range Finding Studies in the ***
|
Study Report
|
No significant findings
|
***
|
N/A
|
5.2.3
|
Conduct Definitive *** toxicology in the ***
|
Study Report
|
No significant findings
|
***
|
N/A
|
5.2.4
|
Conduct *** toxicology ***
|
Study Report
|
No significant findings
|
***
|
N/A
|