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QA0013 Deviations |
QA0014 Out of Specification Results Investigation |
QA0015 Corrective Actions and Preventive Actions |
The timetable for later SOPs is presented in the following table: |
Area |
General Management |
Clinical |
CMC |
Vendor Plan |
Vendor Management |
As the execution of key program activities will be outsourced, vendor selection and performance management are critical to the success of the program. Opsidio will conduct vendor qualification audits prior to initiation of work to ensure compliance with applicable regulations and standards, and ensure chosen vendor has... |
Opsidio will utilize an SOP which describes how contract service providers are selected and evaluated for capability and for various quality attributes, how the qualification process is performed, and how ongoing oversight and monitoring occurs. This SOP also addresses contract service provider audits (qualification an... |
Quality Assurance is responsible for performing independent assessments, or audits of the vendors to ensure established quality metrics are achieved, and identified risks are mitigated throughout the vendor performance lifecycle. These quality assurance activities may also be outsourced, if required, due to resources a... |
Opsidio may transfer responsibility of any or all obligations or functions for conducting GxP activities to a vendor unless otherwise mandated by quality policy. Each GxP functional head identifies, evaluates, and determines if a potential vendor has adequate procedures, resources and systems in place for the contracte... |
The Opsidio functional head is responsible for managing on-going vendor quality, compliance, and delivery, and on-going performance may be addressed through quality control procedures, independent auditing, KPIs, or other measurements of progress. Contract manufacturing, clinical research, and preclinical vendors will ... |
Vendor List |
Below is a table of vendors to be used to execute various facets of the development program and anticipated timing of final contract. In all cases, contracting will be finalized early enough to ensure proper sequencing of activities needed to achieve the planned timelines. Depending on final scope requirements and vend... |
Timing of vendor procurement is essential to managing budget and maintaining program timelines. Due to upfront payments upon contract execution and cancellation provisions, several agreements will be negotiated in advance but not executed until the Definitive Agreement. The table below summarizes the key contracts and ... |
Please see the Responsibility Matrix on page 6 of the IDP for detailed task assignments. |
Functional Overview |
Opsidio will have overall responsible for the entirety of the program and activities and will employ a completely outsourced development strategy. AbbVie will be consulted as appropriate and the JGC will approve the final Clinical Study protocol in accordance with the Definitive Agreement. To meet this obligation, Opsi... |
Figure 1. Opsidio Organizational Structure |
[Figure 1 showing organizational structure] |
Figure 2. Program Team Structure |
Successful advancement of the program requires a team-based approach where different expertise is leveraged to achieve agreed upon goals. The Program Leader, Dr. Martin Phillips is responsible for ensuring the needed expertise are available. As shown in Figure 2, all relevant cross-functional Expertise Areas are repres... |
[Figure 2 showing program team structure] |
CMC-Manufacturing and Cell Line Development |
The specific CMC project management activities are described herein. |
The main objectives of our CMC activities are: |
• Commercially viable and stable cell line |
• Commercially viable CMC process |
• Develop high concentration formulation suitable for a single subcutaneous injection or recommended Phase I/IA Trial, Phase I/IB Trial or Phase II Trial dose |
• Sufficient and timely supply to support nonclinical activities |
• Sufficient clinical supply |
Cell line development will be performed by Selexis. GMP manufacturing will be executed by KBI Biopharma under a quality agreement that will provide for the use of KBI Biopharma protocols and SOPs under the supervision of Opsidio/BDO QA, and final approval of release by AbbVie. |
The CMC sub-team as shown in Figure 3 is comprised of the CMC functional leads. If additional resources are needed, BPTG will allocate those resources from the larger BPTG team of >30 consultants, as appropriate. |
Figure 3. CMC Sub-team |
[Figure 3 showing CMC sub-team] |
The CMC sub-team will oversee the day to day activities for Selexis and KBI Biopharma. KBI Biopharma has provided an extensive project team to support Opsidio's anti-SCF248 program (see Figure 4). BPTG will begin the RFP process to identify and select drug product and label package distribution vendors before the end o... |
Figure 4. KBI Biopharma Team |
[Figure 4 showing KBI Biopharma team] |
For detailed CMC support by BPTG/BDO please see the attached service proposal. |
The following four figures provide greater detail and timing of deliverables. |
Figure 5 lists the deliverables as part of the contractual scope of work with Selexis and KBI Biopharma. |
Figure 6 is a matrix of CMC activities, dependencies and assignments referenced to the objectives in the IDP. |
Figure 7 is an integrated Gantt chart showing the inputs and outputs of key activities, dependencies, milestones and cycle times. |
Figure 8 represents the detailed CMC vendor project plan for Opsidio's anti-SCF248 program. These timelines depend on the actual start date. KBI Biopharma and Opsidio will refine the plan, as necessary, to meet Opsidio's project goals as defined in the IDP. The team will identify critical path activities, develop accel... |
Figure 5. Deliverables from Selexis and KBI Biopharma |
[Figure 5 showing deliverables from Selexis and KBI Biopharma] |
Figure 6. CMC Matrix |
[Figure 6 showing CMC matrix] |
The CMC sub-team will meet with CDMOs and independently as needed by project requirements (the frequency is likely to be every 2 weeks). The CMC sub-team will use a secure cloud-based document sharing portal to manage documentation including key contacts and their responsibilities, meeting minutes, action items, report... |
The CMC sub-team will report project status to the JGC at least once per quarter using a format shown in Figure 9. |
Figure 9. Project Status Dashboard |
Period Covered |
ddMMM-ddMMM-yyyy |
Summary |
Scorecard |
N/A |
N/A |
Project Milestones |
Milestone |
• N/A |
EXAMPLE Key Performance Indicators |
Speed |
Quality |
Cost |
Nonclinical: Toxicology |
Lead: CEO |
GLP Toxicology studies, including PK/TK, ADA and exploratory biomarker assays will be performed by Charles River Labs (CRL). Dr. Phillips will oversee the project. For routine toxicology, Opsidio will utilize the staff at CRL. If there are unforeseen adverse findings, we will source appropriate experts. Drs. Phillips a... |
Key dependencies for toxicology: |
• Non-GMP material to initiate assay development from DSP confirmation run (GANTT Line 1.5) |
• GLP Toxicology material to initiate dose finding (GANTT line 1.8) |
• GLP Write-up for IND (3.9/2.2.7) |
Objectives: |
• ICH Compliant 13-week toxicology study in rat and NHP demonstrating acceptable safety and PK to support IND and phase I clinical program (GANTT line 3.5) |
• Demonstrate suitability of SC formulation for clinical use (GANTT line 3.8) |
• Conduct 26-week toxicology study, prior to initiation of Phase I/IB Trial demonstrating acceptable safety to support chronic use for Phase I/IB Trial and beyond (GANTT line 3.11) |
Toxicology Subteam: |
[Toxicology Subteam organizational chart] |
Assay and Biomarker Development |
Lead: CEO |
Co-Lead: CSO |
There are four degrees of assays planned for the Phase I/IA Trial and Phase I/IB Trial, ranging from standard CLIA lab procedures to specialized procedures that are routinely performed in basic research settings but need to be optimized for clinical study applications. Some of these will be used in the GLP toxicology s... |
Type of procedure |
Standard clinical lab procedures |
Specialized lab procedures done routinely in CRO's |
Specialized lab procedures to be developed in CRO |
Specialized procedures to be advanced by Opsidio and transferred to a CRO |
Some planned biomarkers are standard offerings of clinical laboratories. These need no further preparatory work. The next category are assays routinely performed as part of non-clinical and clinical studies, such as PK and ADA assays. These have been quoted by CROs and included in the work plan and budget. Opsidio Proj... |
Opsidio has developed a number of tools to evaluate pharmacologic effects of manipulating the SCF-c-kit axis, and for detection of SCF165, SCF220 and SCF248. Examples are listed in the table above. Opsidio has enough experience with this type of assay that with minimal additional effort, they can be transferred to a cl... |
The fourth category of biomarker are those that will need to be developed for the clinical Phase I/IB Trial, quantitating in human tissue the number of c-kit positive cells and message levels of inflammatory cytokines and products. There are several techniques for these, which are regularly used in Dr. Lukacs' lab. Ops... |
Key dependencies for biomarker development: |
• Non-GMP material to initiate assay development from DSP confirmation run |
Objectives: |
• Develop informative standard and non-standard biomarkers as described in the IDP for GLP toxicology studies, and the clinical Phase I/IA Trial and Phase I/IB Trial. |
• Develop validated PK and ADA assays prior to IND submission |
Assay Development Subteam: |
[Assay Development Subteam organizational chart] |
Regulatory |
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