Stephen Flanagan Email & Phone Number

Raleigh, North Carolina, Us

PRA Health Science – Merck West Point, PA Monitorand analyze forecasted clinical drug demand across assigned clinical programs • Execute orders for drug manufacturing, purchasing of comparators and delivery of product to the various global production facilities where clinical packaging and labeling of finished clinical supplies will be produced • Create and maintain product data in the dedicated clinical supplies ERP systems where product characteristics are defined (dosage form, container, safety profile, storage conditions, etc.) based on supporting source documentation • Intensive use of the analysis tools available in the GCS ERP system to develop materials requirement plans for bulk dosage form product and components to ensure a sufficient inventory supply of bulk materials to produce finished kits • Key liaison to our Clinical Supply Program Managers (CSPM) whose responsibility it is to help our clinical customers to define a clinical supply design and to our internal GCS Operations group (and our external contractors) who create clinical labels, package bulk dosage form material, assemble them into finished goods, and distribute these to intended destination - Previously Protocol Project Manager • Responsibilities include identifying and managing the supply chain responsible for satisfying the clinical supply demand/supply for a clinical study • Managing the coordination between all internal supply-chain internal groups such as Regulatory Affairs, Clinical Manufacturing, Clinical Packaging, CRO Outsourcing, Global Medical Affairs and Quality Assurance and external CROs • Analysis of study protocol for the development of the most efficient packaging and IVR/IWR design scheme to ensure patient compliance and efficient supply chain logistics for study management • Managed clinical supply user requirements/ functional Specs IVR/IWR system functional specifications

Clifton, Nj, Us

Implementation of a project management organization for this Commercial Contract Packager-Executed a business plan and defined user requirements for quotation and project management IT systems.-Deployed short-term, stand-alone IT systems while defining enhancements and higher level user requirements.-Integrated new systems into a company-wide SAP ERP system.-Improved work-flow for package development and engineering project management.-Launched initiative to enhance production planning and scheduling systems-Participated in program to modernize packaging batch record process and systems-Developed and managed relationships with strategic vendors-Developing new business for company with new and existing customers-Implemented sales strategy to promote the product offerings of the revitalized packaging operation, its enhanced facilities, engineering, and sales services project management capabilities

Consultant: Pharmaceutical IVRS, Pharmaceutical Clinical Supplies Packaging, and Commercial Pharmaceutical Packaging Consulting• Consulted on a clinical labeling project, an IVRS user requirements project, and a commercial pharmaceutical contract packaging acquisition project

Us

San Francisco, CA -Acquired by UBC, Bethesda, MDSales penetration into Eastern US pharmaceutical companies•Responsible for the consultative sales and service required for the design, implementation, and ASP hosting of contract Interactive Voice Response Systems (IVRS), Interactive Web Response Systems (IWRS) and Web-based Electronic Data Capture systems (EDC) used by research pharmaceutical companies to remotely capture source clinical study data into a centralized database during a clinical study of an investigational new drug (IND) product.•Tasked with establishing sales to pharmaceutical customers in the eastern United States and Canada in order to expand beyond Dynarand’s west coast customer base and enhance overall company growth. •Responsible for primary client account management, initial drug study protocol breakdown and analysis, project quotation and costing, and overall client relationship management.

Bangalore, Karnataka, In

Bristol, PA (Acquired by Clintrak Pharmaceutical Services, LLC, Bohemia, NY)Start-up clinical supplies contract packagerJoined a start-up clinical study pharmaceutical contract packager. Successfully secured facility audits by major pharmaceutical customers for this start-up business in a well-established and mature industry in under 10 months.

July 2003 – December 2003Pharmaceutical Trial Systems (PTS), LLC Lafayette Hill, PA(Clinical Trial IVRS Operations Management – CEO of acquisition and turnaround business venture - received venture capital funding commitment - dissolved because seller reversed decision to sell the target company. PTS was an opportunity that originated just as GTS, a similar business plan opportunity described below, was dissolved.)

Clinical Trial IVRS Operations Management – CEO of start-up venture effort - dissolved due to lack of venture capital funding•Worked with VP of Operations and VP of Information Technology to plan and design 21 CFR Part 11 compliant centralized database and integrated phone and Web interfaces to capture and manage clinical test data. Designed all project management functions, developed the database architecture, integrated the IVRS and Web interfaces with the database, and created procedures for product development, testing, and programming. •Developed and implemented business plan for start-up clinical trial IVRS business. Extensively analyzed clinical trial industry including size and growth rate of market, competitors, trends, barriers to entry, and target market. Defined product development and customer requirements. Sought venture capital funding.

Audubon, PA - Management of Clinical Supplies Packaging and Sales(Galen PLC, Northern Ireland, spun-off as Almack)•Managed clinical supplies for major studies, including the protocol specific packaging design, packaging component specifications, clinical label printing and packaging randomization schemes, GMP assembly processes and documentation, distribution strategy, IVRS implementation strategy, production planning timelines, and overall budget.

Allentown, PA - Founded as National Packaging Systems, now Thermo-Fisher Clinical Services - Management of Clinical Trial Supplies and Sales•Helped develop a clinical supplies distribution and production planning system for large global studies for major pharmaceutical companies, which included:­-Planning a global clinical supply that met specific labeling regulations of 12 countries with 15 languages­-Designing a package to optimize the use of an IVRS for patient randomization, drug assignment, and drug inventory management­-Creating a system to handle the European requirements for lot number and expiration date on each blister card­-Designing a global clinical packaging plan for a common drug supply across multiple protocols using multilingual supplies, barcode tracking, point of distribution labeling, expiration date extension labeling, and inventory management for regional distribution centers.