Pyxa Solutions Overview
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Pyxa Solutions, LLC is a boutique professional services company that specializes in cross-functional R&D services for the pharmaceutical, biotech, and medical device industries. Founded in 2012, the company offers a wide range of consulting services including regulatory strategy, operational excellence, and technology implementation to enhance R&D performance and compliance. With a dynamic team of experts, Pyxa focuses on delivering strategic solutions that drive measurable improvements in cost, quality, and time-to-market.
Pyxa Solutions Overview
- 1. Pyxa Solu*ons, LLC COMPANY OVERVIEW
- 2. A BOUTIQUE PROFESSIONAL SERVICES COMPANY FOCUSED ON R&D DELIVERY WITH A SPECIALTY IN CROSS-FUNCTIONAL R&D SERVICES AND SOLUTIONS FOR THE PHARMACEUTICAL, BIOTECH AND MEDICAL DEVICE INDUSTRIES
- 3. 3 FOUNDATION 9/24/16 TRANSFORM. INNOVATE. DELIVER. PYXA WAS FOUNDED IN 2012, WITH HEADQUARTERS IN THE GREATER PHILADELPHIA AREA
- 4. 4 OVERVIEW Pyxa SoluDons is comprised of a dynamic team of management consultants and R&D subject maTer experts specializing in cross-‐ funcDonal R&D delivery stemming from acDviDes led by Regulatory Affairs 9/24/16 Delivering over 100+ engagements In over 40 companies, Pyxa offers robust professional services in strategic and operaDonal business and technology soluDons for the PharmaceuDcal, Biotech and Medical Device industries Our operaDonal, strategic, consulDng and technology services span across R&D with a focus on all regulatory specialDes within and across the enDre product lifecycle, for both major and emerging markets R&D DELIVERY WITH A SPECIALTY IN CROSS-‐FUNCTIONAL SERVICES
- 5. 5 DRIVING VALUE 9/24/16 We provide regulatory systems and project management exper*se to enable organiza*ons to deliver on their goals and jus*fy investment in end-‐ to-‐end regulatory informa*on management by increasing strategic delivery while reducing commodity tasks We ac*vely help organiza*ons improve their R&D performance through organiza*onal analysis, recommenda*ons, development of improvement plans and implementa*on of robust solu*ons that are scalable and adaptable to the changing regulatory environment We evaluate organiza*ons holis*cally, across all of the departments involved in inpuVng or consuming regulatory data to achieve significant and measurable improvements in cost, quality, compliance and *me-‐to-‐market.
- 6. 9/24/16 6 PRACTICE AREAS OPERATIONS STRATEGY CONSULTING TECHNOLOGY
- 7. 9/24/16 7 PRACTICE AREAS STRATEGY R&D STRATEGIC SERVICES Product Development & Planning Global Labeling & Regulatory Strategy Technical PM (e.g. Labeling, Submissions) Data / Informa*on Governance & Strategy Risk Management and Compliance Informa*on Management
- 8. 9/24/16 8 STRATEGIC SERVICES Product Development & Planning Pre-‐IND/CTA Leading Global R&D Product Strategy Global Dossier Strategy Core submission package Simultaneous & strategic global filings Post-‐Marke*ng IND/CTA & Marke*ng Applica*on Drug Product/Substance InformaDon Maintenance post-‐submission Briefing Document ScienDfic Advice Global Filing Strategies IteraDons New indicaDons Label updates CMC changes New markets RegistraDon Management PromoDonal materials management IB, Protocol, CSRs & Clinical Summaries Pre-‐clinical Reports and Summaries Acquisi*on
- 9. 9/24/16 9 STRATEGIC SERVICES Global Labeling & Regulatory Strategy One Stop Shop for all Global Labeling and Regulatory Strategy Services Efficient Global Labeling Process that enables monitoring, tracking and repor*ng of labels from crea*on of the Company Core Data Sheet through to implementa*on to Local Labels and finally hand-‐ off for Artwork. Labeling Opera*ons Structured Product Labeling (SPL) Management of Drug LisDngs Data and Document MigraDon / Management System Requirements Labeling Strategy Full outsource global labeling support for Label Management Drug Development and Post-‐markeDng Labeling Strategy Compliance Metrics, Tracking, ReporDng, Standards, Templates, Global RegulaDons / Policies Organiza*on Governance, Process, Training, FTE Analysis, OrganizaDon Structure, Design and OpDmizaDon New Legisla*on eXtended EudraVigilance Medicinal Product DicDonary (XEVMPD) IdenDficaDon of Medicinal Products (IDMP)
- 10. 9/24/16 10 STRATEGIC SERVICES Technical PM (e.g. Labeling, Submissions) Pyxa provides technical project and program management to ensure accurate and quality deliverables Providing Technical Project Management Support on a variety of cross-‐func*onal R&D Ini*a*ves Product strategy Label Alignment System implementa*on Standards Process Best Prac*ce Gap Analysis
- 11. 9/24/16 11 STRATEGIC SERVICES Risk Management and Compliance Developing, policies or SOPs within a func*on or cross-‐ func*onally Communica*ng, Implemen*ng and training func*ons on new Regula*ons Founda*onal Risk Management Assessments Developing and implemen*ng compliance and value tracking and repor*ng Pyxa’s broad and diverse range of services enhance compliance and aid in risk management and mi*ga*on Closed-‐loop between change control and regulatory submissions
- 12. 9/24/16 12 STRATEGIC SERVICES Data / Informa*on Governance & Strategy Leverage data to improve processes Transi*on from data to ac*onable insights Create dynamic data models that are easy to sustain Increase compliance through visibility into tangible metrics Improve regulatory intelligence through learning and data sharing Turn sta*c data into ac*onable triggers Reduce costs by elimina*ng data redundancy, commodity tasks & varia*ons Compliance with increased data repor*ng requirements Registra*on, submission, correspondence & commitment tracking Cross-‐func*onal data / informa*on governance and management
- 13. 9/24/16 13 STRATEGIC SERVICES Informa*on Management Business process-‐based applica*on RIM Strategy & Implementa*on Challenge IT complexity Data simplifica*on Connect informa*on flows Shared services for rou*ne ac*vi*es Mul*-‐ func*onal Approach A unique holis*c view of processes, data and requirements A deep understanding of the informa*on flows between Regulatory Affairs and other func*onal areas EVMPD eCTD IDMP
- 14. 9/24/16 14 PRACTICE AREAS OPERATIONS R&D OPERATIONAL SERVICES Submission Management Document Management Publishing Document / Data Migra*on Informa*on Management Systems
- 15. SUBMISSION-‐READY DOCUMENT PREPARATION Ensure compliance with appropriate ICH, eCTD, paper, and regional guidance's PROJECT MANAGEMENT FOR GLOBAL SUBMISSIONS Manage R&D Submission Team and Submission for all major and minor submissions 9/24/16 15 OPERATIONAL SERVICES SUCCESSFUL MANAGEMENT / DELIVERY OF GLOBAL LIFECYCLE SUBMISSIONS GLOBAL SUBMISSION GUIDANCE INTERPRETATION AND DOCUMENT AUTHORING SUPPORT Paper, eCTD and NeeS submission compilaDon, publishing and delivery Submission Management PROVIDE GUIDANCE / MANAGE OUTSOURCING OF STRUCTURED PRODUCT LABELING (SPL) Content of Labeling, Drug LisDngs, Establishment RegistraDons
- 16. 9/24/16 16 OPERATIONAL SERVICES Publishing SUCCESSFUL LEADERSHIP/ PUBLISHING OF GLOBAL SUBMISSIONS DOCUMENT QC AND READINESS CROSS-‐REFERENCING AND HYPERLINKING STRATEGIES CTD GRANULARITY GUIDANCE ICH AND GLOBAL DATA STANDARDS PAPER, ELECTRONIC AND ECTD AND NEES
- 17. 9/24/16 17 OPERATIONAL SERVICES Document Management STRATEGIC DOCUMENT MANAGEMENT FOR ACQUISITIONS, MERGERS, DIVESTMENTS AND LITIGATIONS DOCUMENT STORAGE STRUCTURES AND SUPPORT (ARCHIVING AND DICTIONARY MANAGEMENT) NAMING STANDARDS AND PLACEMENT RULES PROVIDE ASSESSMENT OF TECHNOLOGY SOLUTIONS FOR OPTIMAL DOCUMENT MANAGEMENT LEGACY DOCUMENT MANAGEMENT, (E.G. GAP ANALYSIS, MIGRATION, FORMATTING)
- 18. 9/24/16 18 OPERATIONAL SERVICES Document / Data Migra*on DATA CLASSIFICATION REGISTRATION DATA STANDARDS AND TEMPLATES PROCESS AND TRAINING CONCEPTUAL DATA MODELS
- 19. 9/24/16 19 OPERATIONAL SERVICES Informa*on Management Systems CONTENT MANAGEMENT SYSTEMS Veeva (Vault) Documentum (EMC2) FirstDoc (CSC) SharePoint (Microsoh) GLS (Glemser) PUBLISHING SYSTEMS Insight Publisher (Liquent) eCTDXpress (CSC) Extedo GlobalSubmit Publish DocuBridge (Lorenz) REGISTRATION TRACKING SYSTEMS Insight Manager (Liquent) TRS Tracker (CSC) Trackwise (Sparta Systems) ArisGlobal DrugTrack (Lorenz) Vendor Neutral Product Selection System Implementation, Maintenance and Upgrades User Requirement Specifications (URS), Standards, Process and Training
- 20. 9/24/16 20 PRACTICE AREAS CONSULTING R&D CONSULTING SERVICES Business Strategy and Planning Organiza*onal Transforma*on Acquisi*ons & Post-‐ Merger Integra*on Process Excellence Coaching e-‐Communica*ons and e-‐Learning
- 21. 9/24/16 21 CONSULTING SERVICES Business Strategy and Planning Pyxa’s focus and flexibility provides the founda*onal business planning services essen*al for func*onal or enterprise-‐wide “commitment and alignment” to the same vision, goals, *melines and objec*ves Pyxa’s approach spurs collabora*on and brainstorming across func*ons, and across organiza*ons, encouraging stakeholders to think beyond the “status quo” and put equal emphasis on short term, as well as, long term goals / roadmap Pyxa’s broad range of flexible strategic services aid clients in defining, op*mizing or refining their func*onal strategic plans accoun*ng for market-‐driven pressures, such as globaliza*on Cross-‐Func*onal R&D Delivery
- 22. 9/24/16 22 All organiza*on transforma*on deliverables are designed in alignment with the func*onal and enterprise wide strategic objec*ves to achieve measurable improvements in cost, quality and *me-‐to-‐market Pyxa provides systema*c assessment of the organiza*on, detailed modeling (if needed), and detailed recommenda*ons based on solid analysis and future projec*ons Pyxa’s business transforma*on ini*a*ves include developing business cases, governance models, organiza*onal surveys and assessments, business modeling, skills and gaps assessments and func*onal org design CONSULTING SERVICES Strategic & Cost Effec*ve Organiza*ons Organiza*onal Transforma*on
- 23. 9/24/16 23 Pyxa is sensi*ve to internal poli*cs and mo*va*on, and works collabora*vely across all func*ons of the organiza*on, from Program Management, HR, R&D, Commercial, IT and any others involved in the integra*on effort Pyxa manages all aspects of the integra*on, including but not limited to, the PMO office and Change Management effec*vely integra*ng People, Process and Technology Pyxa offers end-‐to-‐end program management for acquisi*ons and post-‐merger integra*on support Integra*ng People, Process and Technology CONSULTING SERVICES Acquisi*ons & Post-‐ Merger Integra*on
- 24. 9/24/16 24 We develop change management, communica*on, training (class room or e-‐learning) and implementa*on plans and materials to support the successful rollout of the process We assess the “As-‐Is” state in a quick and efficient manner, iden*fying areas of weakness, risks and gaps. We work cross-‐ func*onally to develop the “To-‐Be” state, ensuring alignment and endorsement across the respec*ve func*ons Pyxa offers a streamlined and holis*c approach to cross-‐ func*onal R&D process development and op*miza*on, to enhance opera*ons and ensure compliance Effec*ve and Efficient Opera*ons CONSULTING SERVICES Process Excellence
- 25. 9/24/16 25 We can tailor the use of anima*on, interac*vity, audio, and video to suit your par*cular learning or communica*on needs Through our exper*se in R&D and Ar*culate Storyline, we can create new eLearning content or re-‐purpose your exis*ng content. The content can be run through our Learning Management System (LMS), or through any 3rd party LMS Pyxa specializes in developing cost-‐effec*ve, yet highly engaging, custom content and online courseware and communica*ons Unified Messaging for Streamlined Opera*ons CONSULTING SERVICES e-‐Communica*ons and e-‐Learning
- 26. 9/24/16 26 Coaching CONSULTING SERVICES Pyxa offers a blend of coaching services to aid organiza*ons in developing, enhancing and progressing internal strategic capabili*es for cross-‐func*onal collabora*ons, advancement in leadership abili*es, streamlining opera*ons and more. These services vary from 1:1 support to group workshops and seminars. Business Process Excellence Change Management Leadership Training
- 27. 9/24/16 27 PRACTICE AREAS R&D TECHNOLOGY SERVICES TECHNOLOGY Business Case Strategic Planning Opera*onal Excellence
- 28. 9/24/16 28 TECHNOLOGY SERVICES BUSINESS CASE IT system jus*fica*on for new or replacement systems (ROI) System assessment vs. func*onal and/or regulatory requirements NEW SYSTEM DESIGN AND BUILD CUSTOM VS. OFF-‐THE-‐SHELF SOLUTIONS JUSTIFICATION AND VALUE PROPOSITION FOR TECHNOLOGY NEEDS
- 29. 9/24/16 29 TECHNOLOGY SERVICES STRATEGIC PLANNING Pyxa partners with clients to develop sustainable strategies, technology roadmaps and systems for the management of regulatory-‐focused content throughout the product lifecycle. We bring deep exper*se in business strategy, opera*onal transforma*on and technology to deliver solu*ons that creates measurable business value and jus*fies technology spend. STRATEGIC INNOVATIVE R&D SOLUTIONS DEVELOPMENT AND IMPLEMENTATION INNOVATING TECHNOLOGIES AND BEING EARLIER ADOPTERS LEADING ADVANCEMENTS WITHIN THE INDUSTRY MOBILE INTEGRATION STRATEGY AND DESIGN
- 30. 9/24/16 30 TECHNOLOGY SERVICES OPERATIONAL EXCELLENCE Cross-‐func*onal data governance, analysis & mapping Source system integra*on and roadmap Enterprise architecture and governance Opera*on IT plan development Implementa*on plans Informa*on architecture / requirements assessment CONNECTING INFORMATION FLOWS AND DATA KEEPING PROCESSES AND SYSTEMS SIMPLE IMPLEMENTATION AND OPERATIONAL PLANNING FOR LONG TERM SUCCESS
- 31. 9/24/16 31 WHY PYXA? COLLABORATE & LISTEN PROBLEM SOLVE & PLAN FLEXIBLE INNOVATE Pyxa is managed by a blended team of industry experts and management consultants We listen to our clients needs and collaborate to ensure alignment throughout the engagement We solve complex problems with ac*onable plans. We deliver QUALITY projects ON TIME and ON BUDGET Our flexible approach and experience in iden*fying and implemen*ng solu*ons allows us to respond to a client’s changing needs INDUSTRY EXPERTS We innovate and provide a framework for integra*ng and bridging knowledge across mul*ple technologies and thought leaders