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REGULATORY (CRO) |
CLIN OPS (CRO) |
CLIN OPS (CRO) |
MEDICAL (OPSIDIO) |
STATS/ DATA MANAGEMENT (CRO) |
Within each functional area, risk management will consist of risk analysis and scenario planning, identification of relevant quality issues or CAPAs, and use of KPIs, to effectively monitor quality and delivery of internal and outsourced activities. Contingency planning, resource and budget management, and on-going eva... |
Interim or final data summaries or reports will be prepared by the respective Opsidio GxP group as outlined in the program management plan for review of milestones and consistent with the communication plan for data reporting and delivery. Ongoing access to data (e.g. clinical safety data summaries) will follow an agre... |
Assessment of the project management plan, KPIs, quality and risk management, will be reviewed by Opsidio management, with a summary of program progress, core issues, and potential program modifications with the JGC. A monthly summary report will summarize core progress and risks across all functional areas, and a comm... |
Quality |
Lead: COO |
Co-Lead: Head of Clinical and Project Management |
Opsidio has engaged two vendors to accomplish the Quality Program. BDO will be responsible for SOP origination, vendor qualification and oversight for all GMP activities, in addition to the overall Quality Program. Advarra will assist Opsidio with the development of relevant SOPs and performing vendor qualification aud... |
As development activities increase, Opsidio may decide to bring on in-house QA when there is enough volume to support a full FTE. A job description has been provided in the Resource Plan. Please refer to the quality plan for Opsidio's quality strategy and related SOPs. |
Objectives: |
• Establish relevant quality metrics for achievement of IDP activities in accordance with applicable regulations |
• Ensure program deliverables are achieved within established quality metrics |
Quality Org Chart |
[Quality organizational chart] |
GMP Quality Assurance will be managed by BDO's BioProcess Technology Group consultants, who will integrate with the BDO SME in upstream and downstream development, formulation, and test methodology and others. The BDO consultant will provide assistance such as: |
• Quality Oversight of CDMOs |
• Review and approval of executed & master batch records |
• Documentation and approval of deviations and investigations |
• Documentation and approval of change controls |
• Review and approval of stability protocols and reports |
• Final Disposition of Products |
Key Opsidio Quality procedures will include: |
• Vendor Qualification |
• External Document Review and Approval |
• Executed Batch Record Review |
• Lot Disposition |
• Change Control |
• Processes such as CAPA and Deviation are in place, however these are usually managed through the vendor, per the Quality Agreement |
For GLP Toxicology, Reg Ops and the CROs used for clinical studies Advarra will perform vendor qualification audits including qualification, process, system and documentation audits. In addition, Advarra will perform mid-project routine or for-cause audits of documentation and data. |
The Advarra QA consultant will provide Quality oversight and assistance for the near-term future, until the Quality function requires a full-time employee, then Opsidio will hire an appropriately qualified Director of QA (job description on page 9 of this document). |
The upcoming audit schedule is in the table below. |
Process |
Cell Line Development |
CMC |
Fill/Finish |
GLP Tox |
Phase I/IA Trial and Phase I/IB Trial |
Reg Ops |
*Remote audit scheduled |
Patent Strategy |
Lead: CEO |
Co-Lead: CSO |
In order to establish better protection of the Humanized 5H10 Antibody, Opsidio will undertake a two-pronged approach to identifying and patenting additional related sequences. The provisional patent application for the Humanized 5H10 Antibody was converted to a full application in September 2020 and will be published ... |
The first approach will be to affinity optimize the Humanized 5H10 Antibody. We have chosen Specifica Bio for this work. Their method is to make substitutions at all of the positions in the combining regions, generating a very fine map of the binding domain. They then test various substitutions and combinations of subs... |
The second approach to broadening patent coverage is to generate fully human antibodies out of Specifica's yeast display library. This library has been selected for manufacturability and lack of immunogenicity. The resulting scFv will first be screened by SPR, and the 48 best candidates sequenced and spliced back into ... |
A provisional patent will be filed on these sequences and SPR data, before March 18, 2021 for the affinity matured 5H10. This is necessary to prevent "copy cats", in addition to enabling PCT acceptance of the new sequences. During the year before the provisional application has to be converted to a full application, th... |
Objective: |
• Develop a fully human antibody against SCF exon 6 |
o Identify and patent related sequences to provide expanded patent protection |
o Qualify and characterize as a suitable back-up antibody |
• Perform affinity maturation on the Humanized 5H10 Antibody |
o Identify and patent related sequences to provide expanded patent protection |
o Qualify and characterize as a suitable back-up antibody |
Finance |
Lead: COO/CFO |
Support: Functional Heads |
Vendor procurement and payments and all budgetary and contracting activities will be managed by the CFO. Routine metric and financial reporting relating to specific functional areas will established with functional heads to ensure budgetary discipline to the program. Establish and maintain forecasted spend against plan... |
Objective: |
• Achieve IDP activities within plan budget and within agreed timelines |
Budget Summary |
The budget summary and the related vendor proposals are based on the activities needed to execute the IDP. |
[Budget summary table] |
Vendor Proposals (in separate file) |
CMC |
• Selexis |
• KBI Biopharma |
• BDO |
Toxicology |
• Charles River Labs |
Assay and Biomarker Development |
• BioAgilytix |
Regulatory |
• Veristat |
Clinical |
• Parexel |
Quality |
• BDO |
• Advarra |
Affinity Maturation and hmAb |
• Specifica |
Schedule 1.150 University Patent Rights |
For so long as the UOFM License Agreement remains in force, the Regents of the University of Michigan's legal rights under the patent laws of the United States or relevant foreign countries for (a) any of the patents or patent applications specifically identified in the table below, and (b) including any divisionals, c... |
Schedule 3.6 Third Party Providers |
1. Advarra, Inc. |
2. BDO USA, LLP's BioProcess Technology Group |
3. BioAgilytix Labs, LLC |
4. Charles River Laboratories, Inc. |
5. KBI Biopharma, Inc. |
6. Parexel International Corporation |
7. Selexis SA |
8. Specifica, Inc. |
9. Veristat, LLC |
Schedule 6.3.1 Phase I/IA Milestone Criteria |
A protocol for the Phase I/IA Trial has been mutually agreed by the Parties and contains the following minimum criteria: |
a. Placebo-controlled, double-blind randomized Clinical Study of a Licensed Antibody in adult healthy volunteers (18-75 years); |
i. Single ascending dose study assessing the safety, tolerability, and pharmacokinetics of single dose of intravenous or subcutaneous of a Licensed Antibody with minimum 50 subjects: |
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