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who has completed at least one full cycle of treatment in accordance with the study protocols for such Clinical Study); and |
(b) a complete set of all Clinical Data that includes such Information generated during the follow up period after enrollment of the last Response-Evaluable Patient enrolled across the Phase I/IA Trial and PoC Phase I/IB Trial is available to Opsidio or other applicable contract research organization engaged by Opsidio... |
As used herein, the Phase I/IA Trial and Phase I/IB Trial shall include the following elements: |
• Phase I/IA Trial with a Licensed Antibody in HV o SAD study portion, with 3 months duration, n=50 o MAD study portion, with 6 months duration, n=60 |
• PoC Phase I/IB Trial 6 months with a Licensed Antibody in subjects with AD (n=72) |
The Data Package will include the final Phase I/IA and Phase I/IB Trials clinical study report and all Clinical Data, pharmacokinetic of the Licensed Antibodies, biomarker, skin biopsy and clinical data, Regulatory Documentation and other Information resulting from the Initial Development Activities conducted on or pri... |
3. Biomarker Reports |
• Immuno-monitoring: o Longitudinal numbers of major leukocyte populations (including eosinophils) in AD patients by differential CBC o Longitudinal numbers of blood T, B, NK cells, and monocytes in AD patients by flow cytometry |
• Target engagement: o Longitudinal numbers of blood ILC2 in HV exposed to Licensed Antibody or PBO (SAD and MAD) o Longitudinal phenotypic data of circulating eosinophils in HV exposed to Licensed Antibody or PBO (SAD and MAD) o Longitudinal quantitation of soluble SCF165 in HV exposed to Licensed Antibody or PBO (SAD... |
• Serology (IgE) o Longitudinal concentration of total IgE in HV |
o Longitudinal concentration of total IgE in AD patients |
• Disease molecular modification: skin biology (only in PoC Study in AD patients) o Longitudinal (BL and PA) expression levels for all analyzed transcripts (depending on method) in AD patients skin biopsies o Longitudinal (BL and PA) cell count for tissue resident ILC2, Eosinophils, and Mast cells in skin biopsies |
Biomarker samples: o Availability of serum / plasma samples from HV exposed to Licensed Antibody or PBO (SAD and MAD) o Availability of serum / plasma samples from AD patients exposed to Licensed Antibody or PBO (PoC) o Availability of WB for RNA samples from HV exposed to Licensed Antibody or PBO (SAD and MAD) o Avail... |
B. Nonclinical and Bioanalytical |
• Bioanalytical method reports and summaries, including validation reports • Standard for Exchange of Nonclinical Data (SEND)-compliant reports and data sets for 26-week toxicity study in non-human primates conducted in accordance with cGLP |
C. CMC Development Reports (Cell line, Formulation, Process) |
Reports for completed activities for cell line development to include: Cell line development including plasmid construction and history of the parental cell line, clonal cell line generation, cell line screening and selection, MCB production and characterization, MCB Certificate of Analysis, Executed batch record for M... |
Definition and justification of critical quality attributes |
Viral clearance study report |
Reports from DS/DP manufacturing process development experiments demonstrating conditions/resins/parameter evaluation leading to the phase I cGMP process |
Reports from manufacture and testing of Non-cGMP batches (including, but not limited to, scale up batches, small scale engineering batches, at scale engineering batches, and cGLP toxicology batches) |
Reports from DS/DP hold-time studies to support at-scale process holds and excursions |
Clinical in use reports to support dose preparation and use in the clinic |
Reports covering reference standard manufacture |
Reports from DS formulation development experiments including studies at stressed storage conditions that led to the selected Phase I/IB Trial DS formulation and container closure (iv and sc formulation as applicable) |
Reports for manufacturing campaign and summaries; to include release data and CofAs for each DS and DP cGMP batch |
Reports for comparability assessment as needed to cover manufacturing/formulation/tox material changes |
D. Analytical Reports |
Reports including identification of impurities as needed (process-related or product-related impurities) |
Reports covering reference standard characterization, qualification and stability |
Report(s) documenting characterization results to include physicochemical, biophysical, and biological tests sufficient to characterize the primary structure, secondary structure, tertiary structure, aggregates, post-translational modifications, purity, product variants, product-related impurities, glycosylation profil... |
Reports and SOPs for establishment of QC test methods, to include: test method SOPs, test method development reports, test method validation reports, method robustness assessment |
Product-specific Host Cell Protein (HCP) method development and qualification reports or coverage assessment of the commercial kit with the parental cell line from CDMO |
Reports and documentation supporting establishment of the cell-based bioassay, including Method development and validation/qualification reports of the cell-based bioassay |
Reports and documentation supporting establishment of the validated, stability-indicating SCF248 inhibition assay for potency measurement, to include: Method development and validation reports of the ATPase method |
Stability study reports |
VII. Budget Summary |
The budget summary is based on the activities needed to execute the Initial Development Activities. |
Schedule 1.107 |
Operational Plan and Budget |
Attached. |
OPSIDIO OPERATIONAL PLAN |
December 7 2020 V 4.0 |
This Operational Plan and Budget provides a summary overview of how the activities in the Initial Development Plan and Budget will be managed and executed. |
Table of Contents |
OVERVIEW: OPERATIONAL PLAN AND BUDGET |
ORGANIZATIONAL CHART |
RESOURCE PLAN |
TEAM PROFILES |
JOB DESCRIPTIONS OF ANTICIPATED HIRES |
PROJECT MANAGEMENT PLAN |
QUALITY PLAN |
SOP LIST |
VENDOR PLAN |
VENDOR MANAGEMENT |
VENDOR LIST |
FUNCTIONAL OVERVIEW |
CMC-MANUFACTURING AND CELL LINE DEVELOPMENT |
NONCLINICAL: TOXICOLOGY |
ASSAY AND BIOMARKER DEVELOPMENT |
REGULATORY |
CLINICAL |
PROJECT MANAGEMENT |
QUALITY |
PATENT STRATEGY |
FINANCE & LEGAL |
BUDGET SUMMARY |
VENDOR PROPOSALS |
Overview: Operational Plan and Budget |
Opsidio's objective is to develop a subcutaneous formulation of a Licensed Antibody, with a commercially viable CMC process, market acceptable safety, tolerability and administration with preliminary clinical efficacy in adult patients with moderate to severe atopic dermatitis to support late stage clinical development... |
Opsidio's Operational Plan and Budget is structured around a core leadership team accountable for the timely, quality execution of development activities by qualified vendors in accordance with the Initial Development Plan and Budget ("IDP") and any amendments should they occur. The resource plan in conjunction with th... |
Opsidio's program development will rely on comprehensive quality management, internal project management, and effective vendor oversight. The primary components to the development program are cell line development, GMP manufacturing, GLP toxicology, assay development, regulatory and GCP clinical operations. |
The core team is led by Martin Phillips, CEO providing overall and scientific/technical leadership and John Oates, COO/CFO providing operational leadership. Functional "Heads" of CMC, Quality, and Clinical and Project Management will provide day to day leadership and management of their respective functions and vendors... |
Organizational Chart |
Below is an organizational chart of the Opsidio development team. Given the size of the program and team, several roles will have some cross functional/collaborative components which may not be fully articulated by the organizational chart. |
Resource Plan |
Below is a table of the core team resources and anticipated start. The FTE calculation and duration are approximate and are an anticipated average. For the initiation of many processes, such as vendor qualification and project kick-off there will be periods of higher FTE utilization, partially offset by periods of lowe... |
Role |
CEO |
COO & CFO |
CSO |
Head of CMC |
Head of Nonclinical and Biomarker development |
Head of Clinical and Project Management |
Project Manager |
Head of Quality Assurance |
Sr Scientist |
Team Profiles |
CEO |
Opsidio's Chief Executive Officer since inception, Martin Phillips, MD is a board-certified hematologist with over 20 years of pharmaceutical and monoclonal antibody development experience. His experience as a physician informs his patient-first focused approach to drug development. As Atterocor/Millendo's first Chief ... |
Responsibilities: |
• Overall leadership and strategy of Opsidio |
• Technical and Scientific aspects of CMC, Nonclinical and IP strategy |
• Clinical development |
• Achievement of the TPP |
COO & CFO |
John Oates serves as Opsidio's Chief Operating Officer and Chief Financial Officer. He brings 20 years of leadership, start-up management and finance expertise to the team. Prior to Opsidio, he served as General Manager, Biotechnology Solutions at United BioSource, an evidence-based pharma services provider. The Biotec... |
Responsibilities: |
• Build operational team and lead resource management |
• Develop and implement operational, quality and financial controls to ensure compliant and timely execution of project activities and related budgets |
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