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b. Conduct meeting |
c. Incorporate FDA feedback into CMC, toxicology and clinical development plans (protocols for SAD/MAD Phase I/IA Trial in HV and PoC Phase I/IB Trial in AD subjects) |
4. Assemble IND |
a. SAD/MAD Phase I/IA Trial in HV protocol (General Investigation Plan to include details for the PoC Phase I/IB Trial in AD subjects study) and relevant documents (i.e. SAP, IB, IC, DSUR, SUSAR LL. IND annual report, investigator forms, etc.) |
b. Pharmacology and PK sections, including Written and Tabulated Summaries |
c. cGMP and product quality section, including Overview |
d. cGLP Toxicology and TK sections, including Written and Tabulated Summaries |
e. Module 1 documents (i.e. cover letter, FDA forms, IB, etc.) |
5. Submit IND |
The following Gantt (to be updated prior to contract execution) describes the key clinical, pre-clinical, and CMC activities that will be performed as part of Initial Development Activities as described in the Option Agreement, dated December 14, 2020 between AbbVie and Opsidio (the "Definitive Agreement"). |
[Note: There appears to be a Gantt chart in the original document that shows timeline information for various activities including Cell Line Development, Pre-Clinical Toxicity Testing, Clinical Program, etc. with timeline markers from months 0 to 60] |
II. Elements of Readiness Plan |
Opsidio is using a largely outsourced CRO / CDMO model with consulting expertise in specific functions to execute GxP IND-enabling and Phase I/IA and Phase I/IB Trials. The primary components to the development program are cell line development, cGMP MCB, cGMP manufacturing, cGLP toxicology, assay development, and cGCP... |
A. Quality Plan |
As the execution of key program activities will be outsourced, vendor selection and performance are critical to the success of the program. Opsidio will conduct vendor qualification audits prior to final award of services to ensure compliance with applicable regulations and standards, and ensure chosen vendor has the c... |
B. Project Management |
A project management plan will be developed by Opsidio and agreed by stakeholders ensuring alignment on critical path deliverables, their success criteria and their associated timing. The plan will detail how the program will be executed, monitored and controlled. This will include a communication plan describing progr... |
Opsidio will be overall responsible for the entirety of the program and activities. AbbVie is to be consulted as appropriate and will review and approve the final clinical protocol in accordance with the Definitive Agreement. The following CROs have been identified by Opsidio to execute various activities of the Initia... |
Responsibility Matrix |
Party for execution of activities |
CMC |
1. Cell Line Development: Selexis |
2. MCB Generation: KBI Biopharma/Subcontractor |
3. Upstream Process Development: KBI Biopharma |
4. Downstream Process Development: KBI Biopharma |
5. Formulation: SQ and IV: KBI Biopharma |
6. cGLP Toxicology Lot: KBI Biopharma |
7. cGMP Clinical Lot: KBI Biopharma |
8. Fill/Finish; NOTE: a formal RFP process will happen to select the DP CMO: To be determined in accordance to the Definitive Agreement and operating under cGMP conditions |
9. Analytical Method Development and Product Characterization: KBI Biopharma |
10. Stability |
a. Accelerated: KBI Biopharma |
b. Long term: KBI Biopharma |
11. cGMP Write-up for pIND & IND: BDO/BPTG (BioProcess Technology Group) |
12. QA: BDO/BPTG |
Toxicology |
1. Protocol Development: Charles River Laboratories |
2. Assay development: Charles River Laboratories |
a. Product identification: Charles River Laboratories |
b. TK assay in rat matrix: Charles River Laboratories |
c. TK assay in NHP matrix: Charles River Laboratories |
d. Anti-drug antibody: Charles River Laboratories |
3. Dose Range-finding study: Charles River Laboratories |
4. 13-week cGLP toxicology study: Charles River Laboratories |
5. Toxicokinetic analysis and report: Charles River Laboratories |
6. Human cross-reactivity panel: Charles River Laboratories |
7. cGLP write-up for P-IND & IND: Charles River Laboratories |
8. 6-month cGLP toxicology study: Charles River Laboratories |
a. Supplemental toxicokinetic report: Charles River Laboratories |
b. cGLP write up to file to p-IND & IND: Charles River Laboratories |
9. QA: Opsidio/Advarra |
Pre-IND & IND |
1. Clinical protocol development for SAD/MAD Phase I/IA Trial in HV and PoC Phase I/IB Trial in AD subjects: Opsidio/AbbVie |
2. Write pharmacology section of IND: Opsidio |
3. Pre-IND meeting: Veristat |
a. Prepare and schedule: Opsidio/Veristat |
b. Conduct meeting: Opsidio/Veristat |
c. Incorporate FDA feedback into CMC, tox and clinical development plans (protocols for SAD/MAD Phase I/IA Trial and PoC Phase I/IB Trial in AD subjects): Opsidio |
4. Assemble IND: Veristat |
a. SAD/MAD Phase I/IA Trial in HV protocol (and General Investigational Plan to include details for PoC Phase I/IB Trial in AD subjects) and relevant documents (i.e. SAP, IB, IC, DSUR, investigator forms, etc.): Opsidio/AbbVie to approve protocol |
b. Pharmacology section, including Written and Tabulated Summaries: Opsidio |
c. cGMP and product quality section, including Overview: BDO(BPTG)/KBI Biopharma |
d. cGLP Toxicology section, including Written and Tabulated Summaries: Charles River Laboratories |
e. Module 1 documents (i.e. cover letter, FDA forms, IB, etc.): Opsidio |
5. Submit IND: Veristat |
Clinical |
1. Select clinical CRO and vendors supporting study procedures and assessments for SAD/MAD Phase I/IA Trial in HV: Opsidio |
2. Develop, validate and perform PK, ADA, nAb and SCF165 assays: BioAgylitix |
3. Plan and Execute Phase I/IA Trial: Parexel |
a. Write protocol and file to IND: Opsidio |
b. CRF: Parexel |
c. SAP: Parexel |
d. Database construction: Parexel |
e. Obtain IRB approvals: Parexel |
f. Enrollment: Parexel |
g. Data collection: Parexel |
h. Safety analysis: Parexel |
i. Pharmacovigilance/SAE reporting: Parexel |
j. PK analysis and report: Parexel |
k. PD analysis and report: Parexel |
l. Write and approve CSR, file to IND: Parexel/Opsidio |
m. CQA: Opsidio |
4. Plan and Execute PoC Phase I/IB Trial in AD subjects |
a. Convene DSMB, CAB, SAB on AD: Opsidio (AbbVie to attend; receive summary) |
b. Write protocol and file to IND: Opsidio |
c. Select and vendors supporting study procedures and assessments CRO: Opsidio |
d. CRF: Parexel |
e. SAP: Parexel |
f. Database construction: Parexel |
g. Select clinical sites: Parexel |
h. Obtain IRB approvals: Parexel |
i. Enrollment: Parexel |
j. Data collection: Parexel |
k. Safety analysis: Parexel |
l. Efficacy analysis: Parexel |
m. Pharmacovigilance/SAE reporting: Parexel |
n. PK analysis and report: Parexel |
o. PD analysis and report: Opsidio |
p. Write and approve CSR, file to IND: Parexel/Opsidio |
q. CQA: Opsidio |
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