Team

Edward S. Tripp and Associates, Inc.

Management consulting for the Life Sciences industry

Team

With more than 39 years of experience in the Life Sciences industry Ed Tripp can provide consulting services for strategic planning, insight into industry best practice and implementation planning for electronic document management and electronic submissions systems for the Life Science Industry.

Senior Consultant and associate Mauricha Marcussen brings over 15 years experience in Life Sciences including experience at FDA, as a regulatory affairs professional for a large pharmaceutical company as well as a number of key roles for a submission publishing software vendor. Mauricha Marcussen provides domain expertise consulting in regulatory affairs, product labeling and regulatory operations related to electronic global submission processes and requirements for the Life Science Industry.

Senior consultant and associate Ross Raymond has more than 30 years experience in clinical medicine, pharmaceutical clinical research, regulatory affairs strategies and operations, and systems applications. Ross provides expertise in electronic regulatory submission publishing technology, development, implementation and production strategies. He is experienced in the interpretation and application of evolving international regulations and guidance regarding paper and electronic regulatory filings. He provides in-depth knowledge and experience in eSubmission planning and management.

Senior consultant and associate Susan Siegel brings more than 25 years of experience in Safety and Risk Management, Regulatory Affairs and Clinical and Scientific Affairs with Pfizer.

Kathleen Bulgreen is a senior consultant and associate with more than 24 years of pharmaceutical experience. Her expertise includes extensive experience in the preparation and review of safety reports, overseeing and monitoring clinical trials, medical writing, the preparation of submissions documents and product labeling for submission to regulatory agencies

Consultant and associate Angela Heiserman, is a Data Analyst Specialist with expertise in consolidation of complex data and implementation of new functional processes according to client needs. Special expertise in managing complex Microsoft Excel spreadsheets.

Team

Ed Tripp

Implemented an global, multilingual enterprise wide electronic submission system for a major pharmaceutical company. System included a document repository with work flow, electronic signature and functional security model, both paper and electronic publishing capability including eCTD publish, a publishing center, and scanning center.

Developed content template system and process to assure consistency of submission content. Over 300 content templates now in use for Clinical, Non Clinical, CMC and Regulatory Documents. System provides for anonymous web access to templates.

Implemented the first industry integrated system for Structured Product Labeling (SPL) within the e-Submissions system. Features included management of the XML by section within Documentum and a unique life cycle state to manage internal approval and regulatory agency approval. System is capable of rendering the XML content into PDF, Word and Multi part HTML renditions. System provides anonymous web access (in PDF) to all employees for current FDA approved labels.

Managed the integration of documents and data from several acquisitions and the detanglement resulting from the spin off of a major operating division.

Implemented Documentum based repository and system for managing Device Design Control Documents. System successfully passed FDA audit of the system and the content.

Implemented Documentum based system for patent mapping. System included automatic retrieval of desired reference patents, systematic mapping of patent relationships and time line as well as review work flows and annotations.

HL7 Experience

Member HL7 Board of Directors
January 2012 - present

Co-Chair of Regulated Clinical Research Information Management Work Group (RCRIM)
January 2006 - present Co-Chair Domain Experts Steering Division (DESD)
January 2009 – present Member Technical Steering Committee (TSC)
January 2009 – present

PhRMA Experience

Co-Chair Electronic Regulatory Submissions Working Group (ERS)
January 2006 – January 2007 Liaison to Information Management Policy and Coordinating Committee (IMPACC)
January 2005 – January 2008 Member
2000-2008

United Way of Lake County

Member of Board of Directors
Community Services Chair Patents and Publications Awarded 22 U.S. patents in the area of drug packaging and drug delivery

LaFargue, C., & Tripp, E. S. (2007). Improving Time-to-Market with Self-Directed, Cross-Functional Teams in S. Gopalan & N. Taher (Eds.), Empowering Teams (chapter 7). The Icfai University Press.

Mauricha Marcussen - Associate

Provided global business process map consulting to multiple clients for Regulatory Affairs Product Labeling. Process mapping included analysis of Product Inserts (PI), Core Data Sheets (CCDS), Export Labeling, local country labeling, and Summaries of Product Characteristics (SmPC). Performed assessments to identify roles and responsibilities, training approaches and end-user processes, strategic change management considerations, and executive risk mitigation analysis. Collaborated with clients to design an implementation roadmap for global deployment of electronic labeling systems for Structured Product Labeling (SPL) and Product Information Management (PIM).

Managed and provided on-site assessments for integration of electronic submission systems and document management systems for large pharmaceutical and small biotech clients. Assessments included current process analysis, stakeholder interviews, gap analysis, change management and technical infrastructure considerations. Prepared and delivered implementation kickoff meetings and detailed hands-on training for users. Authored and developed detailed, customized SOPs and user manuals for deployment of electronic publishing and document management systems.

Analyzed and recommended best publishing practices for submission and report publishing for multiple clients. Provided detailed analysis of global eCTD content templates for clients. Identified compliant content and gaps between client templates and eCTD requirements. Developed global standards for submission-related document style guides and templates for large pharmaceutical and small biotech clients.

Led multiple simultaneous global paper and electronic submission projects as a Project Manager. Managed the planning, coordination, preparation and submission of regulatory documents to ensure high-quality, on-time completion of dossiers. Prepared project plans for resources, timing of critical information, budgets, risk mitigation, and infrastructure. Delivered hands-on submission and report publishing services and provided trouble-shooting assistance.

Coordinated independent vendor and product evaluations for electronic publishing and document management systems. Developed Request for Proposal documentation and product performance matrices for multiple vendors and clients. Established and evaluated an electronic publishing pilot program to publish nutritional regulatory submissions.

Authored, tested, and executed user acceptance scripts for integration of submission publishing and document management systems on-site for multiple large pharmaceutical clients. Remotely authored, tested, and executed user acceptance and IQ, OQ and PQ scripts for a document management system for a small biotech client

Languages

Fluent in Spanish.

Professional Organizations

Drug Information Association (DIA)

Regulatory Affairs Professional Society (RAPS)

University Faculty

Serve as an Adjunct Professor for undergraduate and adult programs in Business Communications

Microcomputer Business Applications

Ross Raymond – Associate

Recommended, developed, and managed a new business unit providing outsourcing solution for electronic regulatory submission publishing to biopharmaceutical sponsors and CROs.
Served as senior regulatory application consultant/analyst on five major implementation projects for Liquent’s flagship product, Core Dossier.
Recognized with Burroughs Wellcome Co. Senior Management Award for outstanding contribution to Clinical Research’s Neuropharmacology Department. In recognition of technical, motivational, and process management skills during interim analysis of efficacy data of antidepressant trials critical to the continuation of the project.

TECHNICAL COMPETENCIES

Content Creation: MS Office, Visio, Project Manager, Mindjet, SQL Query

Electronic Content Management: Documentum, Open Text, Docubridge

Electronic Submission Publishing: CoreDossier, kPublisher, EZsubs, DocuBridge. Adobe Acrobat 7.0, ISI Toolkit PhARMA ed., Compose
PROFESSIONAL ORGANIZATIONS

Drug Information Association (1984 - Présent)