Trends in Regulatory ComplianceTrends in Regulatory ComplianceNovember 8, 2000
Today’s agendaToday’s agenda
Overview of ESPS The state of electronic
submissions ESPS solutions: people, process,
and technology Question & Answer session
ESPS company overviewESPS company overview 191 employees worldwide. Corporate
Headquarters in Fort Washington, PA. Other locations include: La Jolla, CA Raleigh, NC Boston, MA London, UK
Public company since 6/17/99 (Nasdaq: ESPS)
Signed Xerox re-seller & technology agreement in March 2000
ESPS HighlightsESPS Highlights Leader in “Regulatory Publishing” Space (70%+)Leader in “Regulatory Publishing” Space (70%+)
Leader in the emerging multi-billion dollar Leader in the emerging multi-billion dollar knowledge knowledge publishingpublishing space. space.
First mover advantage with knowledge publishing suite of First mover advantage with knowledge publishing suite of products and services with products and services with ExpandedExpanded “Knowledge “Knowledge Publishing Suite”Publishing Suite”
Average revenue growth of 55% (last 3 years)Average revenue growth of 55% (last 3 years)
Strong Financial PositionStrong Financial Position
Cash positive, virtually debt free, Cash positive, virtually debt free,
Strong balance sheet, Strong Cash positionStrong balance sheet, Strong Cash position
Revenue GrowthRevenue Growth
$0.1$0.8 $1.1
$8.6
$17.9
$22.8
$0
$5
$10
$15
$20
$25
1995 1996 1997 1998 1999 2000
$ Millions$ Millions
Fiscal years ended March 31Fiscal years ended March 31
55% average three year growth55% average three year growth
ESPS mission statementESPS mission statement
ESPS, Inc., is the premier provider of knowledge publishing solutions that accelerate the assembly, management, and exchange of diverse, business-critical information for the eWorld.
Knowledge PublishingKnowledge Publishing
Wordicon.exe
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Accicons.exe
My:
Report
SOPs
Proposals
The process of consolidating multiple documents to communicate a concept effectively.
Convey information through publication organization, layout and cross-references.
Knowledge Publishing CycleKnowledge Publishing Cycle content is authored in one of 135 supported native applications
1 source files are collected, organized and rendered to a common PDF format
2
common document level elements are defined and applied across the compiled publication
3 publication is distributed to recipients or approvers via portal, e-mail, or in hard copy
4
TitlePage
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NewEmployeeGuide
Ver 3.5
ESPS Life Sciences customersESPS Life Sciences customers3M 3M (E)(E)
Abbott Abbott (E)(E)Agouron Agouron (E)(E)Alcon Laboratories Alcon Laboratories (MD)(MD)Allergan, Inc. Allergan, Inc. (MD)(MD)Alliance Pharm Alliance Pharm (E)(E)
Alza Alza (B)(B)American Home Products American Home Products
-Wyeth Ayerst (E)-Wyeth Ayerst (E)-Whitehall Robbins (OTC)-Whitehall Robbins (OTC)
Amgen Amgen (B)(B)AstraZeneca AstraZeneca (E)(E)AstraZeneca AstraZeneca (Ag)(Ag)Aventis Aventis (E)(E)
BASF BASF (Ag)(Ag) Baxter Healthcare Baxter Healthcare (MD)(MD)Bayer Bayer (Ag)(Ag)Biogen Biogen (B)(B)
NPS Pharm NPS Pharm (E)(E) Novartis Pharm Novartis Pharm (E)(E)Novartis Animal Health Novartis Animal Health (VM)(VM)NV Organon (NV Organon (E)E)Otsuka (Otsuka (E)E)PRA PRA (CRO)(CRO)Parke-Davis (Parke-Davis (E)E)Pfizer Pfizer (E)(E)Pharmacia (Pharmacia (E)E) PharmaNet PharmaNet (CRO)(CRO)Proctor and Gamble Proctor and Gamble (E)(E)Purdue Pharm Purdue Pharm (E)(E)Quintiles Quintiles (CRO)(CRO)Sankyo USA Sankyo USA (E)(E)Santen Pharm Santen Pharm (E)(E)Schering-Plough (Schering-Plough (E)E)Solvay Pharmaceuticals Solvay Pharmaceuticals (E)(E)TAP Holdings TAP Holdings (E)(E)
Centocor Centocor (E)(E)Chiron Chiron (B)(B)
Chugai Chugai (E)(E)Coulter Pharm Coulter Pharm (E)(E)Covance Covance (CRO)(CRO) DuPont Pharm. DuPont Pharm. (E)(E)DuPont DuPont (Ag)(Ag)Dura Pharm Dura Pharm (E)(E)Elan Elan (E)(E)Genentech Genentech (B)(B)Glaxo -SKB Glaxo -SKB (E)(E)Hoffmann LaRoche Hoffmann LaRoche (E)(E)Immunex Immunex (E)(E)Isis Pharm Isis Pharm (E)(E)
Johnson & JohnsonJohnson & Johnson(( E)E)Ligand Ligand (B)(B)
Molecular Biosystems Molecular Biosystems (B)(B)Mylan Pharmaceuticals Mylan Pharmaceuticals (G)(G)
Highly-Regulated Global IndustriesExternal Requirements
Highly-Regulated Global IndustriesExternal Requirements
Vertical Industries: Regulatory Agencies:
Pharmaceutical: FDA, EMEA, OSHA...Biotech: FDA, EMEA, SEC, HPB...CROs: FDA, EMEA, HPB...Chemical: EPA, OSHA, PMRA, EEA...Utilities: NRC, DOE, FERC, PUC, EPA...Telecom: FCC, PUC, SEC, EPA, OSHA...
Highly-Regulated Global IndustriesHighly-Regulated Global Industries
Plus internal compliance:
• SOPs
• GMPs
• Risk Management Plans
• Process Safety Management
• ISO 9000
• ISO 14000 standards
• And other critical information
The Burden of Compliance:Pharmaceutical
The Burden of Compliance:Pharmaceutical There are 4,000 global pharmaceutical/
medical products companies In the US, companies spent over 22.7
million hours Servicing 111 separate
reporting/record-keeping programs Resulting in 13.7 million annual
responses
The Burden of Compliance: ChemicalThe Burden of Compliance: Chemical Environmental Protection Agency has 324 separate information collection
programs Resulting in over 84.3 million annual
responses And over 119 million burden hours per
year
2525
Global “Paperwork” Compliance CostsGlobal “Paperwork” Compliance Costs
Source: Thomas D. Hopkins, “Regulatory Costs in Profile,” August 1996, 1997 OECD Data and IDC 1998
Compliance Costs
(millions)
45 46 46 47
U.S.Non-U.S.
125125
150150
175175
5050
7575
100100
90 92
9394
48 49
9698
$135billion
$138billion
$139billion
$141billion
$144billion
$147billion
5050
Worldwide Web Users
(millions)
250250
300300
350350
100100
150150
200200
7097
131
173
227
320
19971997 19981998 19991999 20002000 20012001 20022002
Traditional Regulatory Submissions: Publish 3 copies each 500,000+ pages
Final submission fills a tractor trailer truck
Two year development & publishing
timeframe
Project staff of 30 - 40 people Lengthy regulatory agency review cycle
impeded by millions of pages of paper Enter the CoreDossier solution...
The Truckload of Paper DilemmaThe Truckload of Paper Dilemma
InternetInternet
CoreDossierCoreDossier
Electronic Regulatory Submissions:Dramatically changes the internal review
cycle: Develop, review, approve and publish
concurrently Publish electronically to Internet,
corporate intranet, using HTML, XML, PDF, TIFF— and publish direct to paper.
Reduce cycle time and cuts required staff May shorten regulatory agency review cycle
The Truckload of Paper Solution
The State of Electronic Submissions
The State of Electronic Submissions
From FDA CDER…From FDA CDER…
Since November 1997:
45% of all applications had some electronic component
80% have electronic CRTs and/or CRFs
15% are complete submissions
Current regulatory trendsCurrent regulatory trends
One FDA reviewer states: “I electronic submissions”
Your competition is doing more in less time– Producing higher quality deliverables– Achieving simultaneous registration– Providing increased navigability
FDA views the program a great success
More guidances are coming
What is on the horizon?What is on the horizon?CTD and e-CTD November 2000
& May 2001CDER & CBER - joint guidance on advertising and promotional labeling
November 2000
CDER & CBER - joint guidance on eINDs
December 2000
CBER- electronic PMA/510K October 2001
CDER- DMFs and annual reports
September 2002
What is on the horizon?What is on the horizon?
EMEA Product information management EFPIA guidance on electronic submission
of MAAs
CDER Guidance on electronic submission of
investigator information
Why electronic submissions?Why electronic submissions?
Better quality than paper
Better organized information
Easier to process and to find documents
Same technology used for all reviews
Improved reviewer efficiency
Electronic submissions will be required
Starting with the end in mindStarting with the end in mind
“We are taking millions of dollars of information and turning it into a common document – it’s no easy task.”
- Chris Tanner GlaxoWellcome
Submission challengesSubmission challenges
Comply with latest electronic
guidances
Produce identical paper & electronic output
Meet submission deadlines Increase efficiency
““NDA”NDA”
Submission challenges:Submission challenges:
70 Customers…70 Methods…1 NDA70 Customers…70 Methods…1 NDA
Overall benefitsOverall benefits
Fewer resources needed
Quality improvements
Cost savings
Increased publishing capacity for simultaneous agency submissions
Compliant with FDA requirements for electronic submissions
Sample CoreDossier case studiesSample CoreDossier case studies Immunex
12/98 - Installed CoreDossier
3/99 - Shipped BLA to CBER; e-Sub shipped prior to paper
“[ESPS] has been great. Oh, and your software is pretty darn awesome!”
Sample CoreDossier case studiesSample CoreDossier case studies ISIS
3/98 - Used CoreDossier to electronically assemble 10-volume CMC section.
4/98 - Submitted the full 366-volume NDA to the FDA, then prepared an 80-volume MAA to EMEA.
“CoreDossier streamlined the internal review time by approximately four weeks. CoreDossier was one of the reasons that we were able to meet our partner deadlines, achieve our milestones, and receive progress payouts”
Case Study: PfizerCase Study: Pfizer
One recent NDA filing by Pfizer using CoreDossier yielded $600,000 in
specific cost reduction.
Task
Pfizer Legacy System
With ESPS’ CoreDossier
Assemble 3 Core Volumes of a NDA
1.5 Days 5 Minutes
Convert 45 Volume Submission to FDA Standards
10+ Days 1 Hour
ESPS Product Suite
kPublisher and CoreDossierkPublisher and CoreDossier CoreDossier
Typical User is Regulatory Operations/Regulatory Affairs Large, multi-volume, highly structured, often government
defined, relatively infrequent Supports regulatory and pre-market approval publishing
and complex functional requirements (CDER, CBER, DAMOS, CADDY, etc.)
kPublisher Occasional/casual publisher Smaller, single volume, more frequent Simple user interface, low training requirement Designed for larger user community within the enterprise
Provide enterprise-wide web based access to publications
Web-based review and approval of publications No client side technology ( no plug-ins or Acrobat ) Annotation and status based review model Full Text and meta data searching
Ability to organize and manage large collections of publications
Customizable interface by user and role