pyxa solutions overview
TRANSCRIPT
Pyxa Solu*ons, LLC COMPANY OVERVIEW
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
FOUNDATION
9/24/16
TRANSFORM. INNOVATE. DELIVER.
PYXA WAS FOUNDED IN 2012, WITH HEADQUARTERS IN THE GREATER PHILADELPHIA AREA
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
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.
9/24/16 6
PRACTICE AREAS
OPERATIONS
STRATEGY
CONSULTING
TECHNOLOGY
9/24/16 7
PRACTICE AREAS STRATEGY
R&D STRA
TEGIC SER
VICE
S
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
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
9/24/16 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)
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
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
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
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
9/24/16 14
PRACTICE AREAS OPERATIONS R&
D OPE
RATIONAL
SER
VICE
S
Submission Management
Document Management
Publishing
Document / Data Migra*on
Informa*on Management Systems
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
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
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)
9/24/16 18
OPERATIONAL SERVICES Document / Data Migra*on
DATA CLASSIFICATION
REGISTRATION DATA
STANDARDS AND TEMPLATES
PROCESS AND TRAINING
CONCEPTUAL DATA MODELS
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
9/24/16 20
PRACTICE AREAS CONSULTING R&
D CO
NSU
LTING SER
VICE
S
Business Strategy and Planning
Organiza*onal Transforma*on
Acquisi*ons & Post-‐Merger Integra*on
Process Excellence
Coaching
e-‐Communica*ons and e-‐Learning
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
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
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
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
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
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
9/24/16 27
PRACTICE AREAS R&D TECH
NOLO
GY
SERV
ICES
TECHNOLOGY
Business Case
Strategic Planning
Opera*onal Excellence
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
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
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
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
