Sorriso Pharmaceuticals is a Series A funded biotechnology company advancing a pipeline of disease-modifying antibodies for the treatment of inflammatory disease, including Crohn’s disease and ulcerative colitis. The Sorriso platform generates potent antibodies that can be delivered orally and are designed to maintain activity throughout the intestinal system.• Responsible for management of all CMOs (US and Eu) associated with Bulk Drug Substance production, Drug Product production, analytical activities (assay development, release, stability programs, Reference Standard) for BDS and DP, protein characterization, clinical trial material distribution, and other specialized CMC activities.• Participate in corporate infrastructure development e.g. QMS, required for early-stage biotech company.

CnA Consulting Group was founded by two former Life Sciences executives with the goal of providing specialized consulting services to companies in the Life Sciences space. CnA provides consulting services to companies who seek to analyze and refine strategy in the areas of organizational direction, assessment of capital investment need, organizational design, strategy for operational success, operational readiness for commercialization, as well as assisting investors with due diligence activities. The group offers specific experience and expertise in;• Operations Strategic Analysis and Planning• Business Plan Development• Due Diligence, M&A and Integration Strategy• CMC Strategy• Supply Chain and Logistics Assessment and Solution Development• Manufacturing Capability Assessment and Gap Analysis• Real Estate and Facilities Infrastructure Assessment and Gap Analysis• cGMP Facility Design - full program management from site selection through manufacturing of qualification batches• Strategic Program / Project Scope Development• Program and Project Management• Technical Process Analysis• Tech Transfer• Quality and Regulatory Preparedness for PAI / Notified-Body Registration• Supplier Qualifications, Audits, and General Quality Assessments• Compliance Assessment• Regulatory Remediation Program Management

•Project Manager for Shire Regenerative Medicine (SRM) Capital expansion / 2nd Site Campus (Project SHORE). Primary activities included; 2nd site selection activities involving interaction with various geographies and municipalities, internal stakeholders (Finance, Legal, Operations), management and direction of Broker, updates to SRM Senior Management, Shire Leadership Team and approval presentations to Shire Board of Directors. Led Shire team for site selection, lease negotiation and completion, and capital appropriation.•Responsible for; selection and management of Architects, Engineers and Construction Managers for project execution; internal SRM team development; campus program direction development and approval.•Project Manager responsible for development of project schedule, budget and primary companies (Architect, Engineer, Construction Manager) contracting structure.•Key role in multiple Shire / Advanced BioHealing integration teams during acquisition period to ensure 30 day, 60 day and 90 day post-acquisition goals were achieved.•Responsible for development and execution of Manufacturing Strategic Plan involving multiple facilities, development of capital budget, and execution of capital projects. •Responsible for group management activities for Engineering (Operations and Projects), Facilities, Environmental Health & Safety, and space planning personnel.•Participant on numerous diligence teams with responsibility for assessing target merger and acquisition organizations from an operations organizational infrastructure and capital investment perspective. •Represented SRM in multiple agency inspections.

•Responsible for the management and operation of Manufacturing, Development Engineering, Facilities, Supply Chain and EH&S groups.•Responsible for Suneva Medical’s initial product Artefill® dermal filler, a collagen/PMMA dermal filler that requires traditional biologics bulk manufacturing processes and aseptic filling of syringes.•Successes included facility startup completion, media and Artefill® dermal filler process production qualification lots, FDB CA State inspection, KEMA ISO inspection, and FDA Federal inspection.•Responsible for manufacturing success rate of 100% for media and Artefill® dermal fillers.

•Responsible for management of Engineering, EH&S, Facilities and Validation groups. •Improved operations management and activity planning for Facilities and Validation groups and rebuilt Engineering and EH&S groups in order to support company growth in areas of manufacturing facilities, execution of capital expenditure program and maintenance of compliant operations.•Project Management responsibility for ~$21MM manufacturing capital expansion program including negotiation and placement of all primary construction and equipment contracts. •Managed cross-functional matrix project team with involvement from all major Operations groups to design and execute project. •Responsible primarily for budget, schedule, execution and delivery of project involving complex solvent based pharmaceutical manufacturing process.

•CMC Program Lead for third party external collaboration with PDL involving three therapeutic products. •Post negotiation, assumed primary responsibility for execution of purchase and sale agreement for the Biogen Idec NIMO facility to Genentech ($408MM). •Reporting to the CTO, managed FDA PAT program activities and ensured efficient coordination and communication between various stakeholders, consultant(s), and other internal groups (Manufacturing, Engineering, Facilities, QA Compliance, QC, Validation, Legal, etc.).•Improvement of the business processes, efficiency, and effectiveness of the division through trends, metrics, program reviews and evaluations, analyses, option development and investigations. •Responsible for the assessment and impact analysis of various scenarios on current and future divisional planning and operational activities. •Development of corporate manufacturing capacity intelligence database•Responsible for the development of a 5-year strategic electronic systems plan for the division which was a CEO mandated role for each division of the company intended to function as a divisional CIO.•Lead the design, validation and implementation of new divisional electronic systems, remaining consistent with corporate technical standards, governing system policies and data handling procedures. •Engineering I&C Project Lead for the NIMO project reporting directly to the NIMO Project Manager. •Primary responsibility for management (budget, schedule, resources, etc.) of construction manager, design engineer, associated design build subcontractors involved in the I&C field device and control system component design, specification, selection and implementation for the project (~$25MM). •Performed complex multiple site due diligence activities reporting to CFO and Sr. VP Mfg, resulting in IDEC purchase of Oceanside land for the NIMO Project and Oceanside existing site for the NICO Project.