Lead clinical supply chain team ensuring drug substance and drug product availability globally per Clinical program and project plans. Coordinate all clinical supply chain activities including QP release in the EU. Lead company response to BREXIT.

Business: TINAMOU Consulting is an entrepreneurial venture established to perform interim management roles for global pharmaceutical and Health Care related companies; involved in a wide range of assignments covering R&D, Clinical Supply Logistics, IS strategy, software development, outsourcing studies, recruiting world class teams, and process improvement.Projects:*Sr. Business Advisor – Evaluated and select a replacement clinical supply chain management system based upon business processes and rules provided by CSM and R&D IT. Suppliers evaluated were: SAP, Rockwell Automation, Aptuit, Honeywell, and Werum.*Sr. Supply Chain Manager – Orchestrated clinical supply logistics for a 30,000 patient Global Phase III clinical program.*Sr. Supply Chain Manager – For a Japanese pharmaceutical company managing supply logistics for multiple Phase I- Phase III global clinical programs.Invited Lecturer - Invited to speak at a number of US/EU supply chain logistics meetings.*COO/CIO EMR/EHR – Performed the duties of Chief Operating Officer and Chief Information Officer for this east coast based EMR/HER company.

Business: Biotech Company. Mission: to discover, develop and deliver to patients’ novel biologics for the treatment of cancer, autoimmune disorders and infectious diseases.Key Challenges:(i) Managing Global Clinical Supply Logistics for Phase 1-Phase 3 Clinical Programs;(ii) Interface with Clinical, Manufacturing, Quality, Regulatory and Safety to ensure all clinical programs run smoothly; (iii) Interact with pharmaceutical business partners supplying clinical drug product for use in clinical programs: (iv) Source and supply to clinical sites ancillary supplies.Actions and Significant Results:•Orchestrated the shutdown and supply recovery for a global Phase 3 clinical program that did not meet endpoints•Oversee contractors and audit team participant for: manufacturing, packaging, labeling, and logistics of drug product and excipients used in global clinical trials •Managed and ensured global inventory of clinical supplies via third party central and regional depots in the US, Asia, Europe •Identified packaging and labeling suppliers, negotiated contracts and managed scheduling, production and delivery for all clinical programs •Worked in concert with Quality and Regulatory to ensure all product labeling and customs/regulatory documents conformed to local regulatory and customs requirements •Negotiated effective technical, manufacturing and supply agreements in concert with legal affairs•Managed supply preparation and emergency distribution for compassionate use requests•Coordinated and reviewed CRA activities for multiple clinical programs•Managed strategic sourcing relationships in the US, EU and Korea•Analyzed business process and authored/updated work procedures and SOP’s •Responsible for department project plans, forecasts and budgets •Ensure effective work relationships with internal teams, contractors and suppliers•Invited speaker at international venues on ambient and temperature controlled global supply logistics

TINAMOU Consulting is an entrepreneurial venture providing interim management roles for global pharmaceutical and Health Care related companies; involved in a wide range of assignments covering R&D, Clinical Supply Logistics, IS strategy, software development, outsourcing studies, recruiting world class teams, and process improvement.Projects:

Manage multiple global clinical projects (Phases I-IV) in the areas of demand/supply forecasting, packaging, label design, shipment logistics, IVRS setup, vendor (CRO) coordination and collaboration and inventory tracking. Managed the logistics for 2 mega trials conducted in 31 countries that enrolled 30,000 subjects. All clinical supplies, site initiation, and ongoing subject enrollment occurred on schedule complying with all regulatory requirements.

Business: Provider of Clinical Trial Material manufacturing, storage, packaging and labeling, distribution, and return, reconciliation for the pharmaceutical and biotechnology industries. Key Challenges: (i) Grow and Integrate global CTM business units into a seamless client centric organization, (ii) Implementation of Dock to Doc(tor) supply chain management system, iii) Enhanced client portal for controlled access to client proprietary information, (iv) Participated in M&A activities, (v) Increase shareholder value of company for divestiture.Actions and Significant Results:Consolidated IT organization under a single leaderImplemented global storage, manufacturing, and distribution systems; validated and 21 CFR Part 11 compliantEvaluated, negotiated and implemented Rockwell Automation PMX system at USA and UK sitedImplemented Clinical shipment status to sites with delivery to PDAs and cell phones Delivered new website to client community that was robust, secure, and provided timely project status Member of divestiture team that sold company and increased share value in excess of 3x original investment this represented an 80% increase in shareholder value in 10 months

Business: Leading provider of business intelligence data used for territory alignment, sales force compensation and physician targeting for the pharmaceutical industry. NDCHealth processes 90% of all prescriptions generated by pharmacies throughout the US.Key Challenges: (i) Aligning business units and product offerings to better service the demands of clients; (ii) Introducing financial controls that reduced operating expenses while at the same time increasing worker productivity and on-time delivery to clients; (iii) Building a vision and culture to bring disparate business units together; (iv) Identify opportunities to re-use / better use information thereby reducing data acquisition fees.Actions and Significant Results:Stabilized operating expenses reducing the number of consultants and outside service contracts and better defining the roles, responsibilities and expectations of full-time staff. In all, labor pool was trimmed from 700 to fewer than 600 during the first year of tenureExceeded operating income goals for quarter over quarter growth while at the same time increasing revenue 10% over prior yearStreamlined data between main-frame (IBM) and mid-range (NT) environments reducing the effort and time needed to load both environments for end of month closing and data reporting to clientsImproved relationships with customers bringing NDC and its clients closer together with regular meetings and communicationsImplemented balanced scorecard throughout the division with metrics to measure success in achieving goals and objectivesInitiated HIPAA complianceImplemented community outreach programs that funded dental surgery and undergraduate scholarships