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ACD Labs
Neuchatel
Open Information Standards forLab Informatics—Allotrope Foundation
Gerhard Noelken, Pfizer
web: www.allotrope.org
mail: [email protected]
Pharmaceutical Sciences PTx
• Analytical Development– Develop analytical test methods
– Stability and clinical release
• Chemical R&D– Develop chemistry to make drug substance (different scales)
– Manufacture API for clinical supplies
• Pharmaceutical Development– Fully characterise and understand unique drug properties
– Convert raw drug to drug product (e.g. tablet)
– Design new forms of drug deliveryControlled-release, Inhaled, Injected, etc.
• Global CMC
• Clinical Supplies• Large scale
trials/• manufacture
PFIZER AT DISCOVERY PARK, SANDWICH
At The Discovery Park site in Sandwich, Kent Pfizer has world-class facilitiesand expert scientists working in an innovative environment
Pfizer’s Pharmaceutical Sciences operations at the site includes the company’s unique pilot plant production and solid and liquid dose manufacturing facilities
Other critical functions at Sandwich include Worldwide Safety and Regulatory; Quality Assurance; Commercial Business Units and Business Support Functions(HR, BT, Finance, Patents etc.)
New Business ChallengesLife science Information Landscape
4
Yesterday Today Tomorrow
Innovation Model Innovation inside Searching for Innovation Heterogeneity of collaborations. Part of wider ecosystems
IT Internal apps & data Struggling with change Security and Trust
Cloud/ Services
Data Mostly inside Partially shared Distributed
Portfolio Internally driven and owned Shared portfolio
Big Life Science
Company
Yesterday Today Tomorrow
Manual data transcriptions
Raw Data
Electronic Raw Data
Import/
Copy Paste/
Attach
Analyzed
Data
Analysis
Programs
Import/
Copy Paste/ Attach
Analyzed Data
Excel
Manually
Enter
Single Point
Data
Reference/Link
to Raw Data
Reference/Link DMID
FileShare
DMID
(produced in Word)
GECR
(Registration)
CSS (Chem
Structure
Search)
Formulation
Instrumentation Formulation Lab
Data Systems
Research Systems
M3 Clinicopia
Search Structure
Read PF#, mol file
PF#
Lookup &
Validation
Read/Update
Drug Pkg
Properties
Excel
Word
PPT
etc..
Embed/
Copy Paste/
Attach
Data
From Std
Windows
Tools
CCT
(Comp Chem
Properties)
Compound
Properties
NuGenesis
SDMS
LabWare
LIMS
(AD)
Approved
DMID
(PDF)
Ref/Link to/Import Stability Data,
CoA, Summary Test Results, SampleIDs
Read/Update
API/DP Physical
Properties
Master GMP Data
Repositories
Supply Chain SystemsPharm Sci
Systems
Formulations
System Architecture
Watson LIMS
Gastro Plus
In vivo
data
RGate
RIF
Research ELN
(CEN)
Read RIF Data
Upload via
BioloaderMed Chem
Data
Blend
Property
Form
Prediction
GDMS
Electronic Raw DataMAPP/
MASS
Read
Form Data
Write Form
updatesForm Sample
Test Request
Instr Initiation
Formulations
ELN
(Symyx)
Expt Work
Formulation
Scientist
Chromatography Electronic Raw and Analyzed Data
Empower
CDSChrom
Electronic
Raw Data
Key
Electronic link
needed
Electronic link
In place or
planned
Manual
Other ELNs
(Form ELN -
WOMS)
Other
Systems
Global Ref.
Data
(now EVS)
Master/Meta Data
Analytical Requests /
Results
Red arrows indicate manual data exchange.Scientist is still the key broker for Data and Information.
We pay scientists to do what?!?!
• we manually compile and write static reports– candidate selection documents
– internal technical reports
– certificates of analysis
– stability reports
– specifications
– release documents
– IQ, OQ, PQ, PM
– IND, NDA, MAA
– et cetera
At work…
• computers give usbutton-click, interactive, drill-down reports
At home…
Imagine a day when...Document
PreparationData
Exchange
Method / Data Transfer
7 symptoms at every company
Document Preparation
Regulatory Compliance
Data Errors
Data Silos
Innovation Constrained
Data Exchange
Data Management
• Costs affect nearly every person, department, and process in every company in our industry
• Downstream effects go well beyond the traditional “analytical laboratory”
Treat the disease…
Symptoms
Disease Pathology
Document Preparation
Data ErrorsData
Exchange
Data Silos
Data Management
Regulatory Compliance
Innovation Constrained
The ‘Framework’ treats the disease…
Automated Documents
Regulatory Compliance
Eliminate Data Errors
Eliminate Data Silos
Innovative Ecosystem
Fast Data Exchange
Better Data Management
How the Framework treats the disease…
• Compatible software
• Class Libraries, SDK, web service
• Lowers barriers to adoption
• Common data formats facilitate data exchange & innovation
• AnIML, HDF, etc
• Eliminates or attenuates cost of 7 symptoms
• Scientists focus on science
• Consistency across all platforms, departments, partners
• Massive data mining & knowledge management opportunities
Real Deliverables Emergent Outcomes
software development starts this summer
Not a ‘Standards Body”;A holistic approach to build upon & promote industry standards & best practices, by providing software that instantiates them
FRAMEWORK Components essential to ecosystem
FREE CORE OPEN-STANDARD
Commercial Instruments &
Software
eLN, LIMS, Archiving, Data Warehouse, Etc..
The Ideal State
Commercial Data Management Solutions
• Vendors create software using framework & standards that allows customers to harmonize data
• Instruments produce data natively in standard representation
• Data management solutions consume and understand data natively in standard representation
10-April-2013
FRAMEWORK Components essential to ecosystem
FREE CORE OPEN-STANDARD
Commercial Instruments &
Software
eLN, LIMS, Archiving, Data Warehouse, Etc..
The Transition
Commercial Data Management Solutions
• Data & metadata live in the framework in ‘standard’ • Interfaces required for existing applications/systems
Co
nve
rsio
n t
oo
ls &
se
rvic
es
Plu
g-in
s
eLN, LIMS, Archiving, Data Warehouse, etc
Legacy Data Legacy
Data Legacy Data 10-April-2013
The development of a collaboration
Spring 2011
• Papers in Am. Pharm. Rev. generate interest*
Summer 2011
• IQ ALG – forms Working Group
• WG develops peer-reviewed technical Project Description
Fall/Winter 2011
• Positive response from instrument companies
• IQ Board sub-team, WG, DBR progress project toward formational meeting
Summer 2012
• Allotrope Foundation formational meeting
Fall/Winter 2012
• Project Definition
• RFP initiated
• Pre-project analyses
Summer 2013
• Software development starts
James M. Roberts, et al., Informatics in the Analytical Laboratory: Vision for a New Decade, American Pharmaceutical Review, September/October 2010James M. Roberts, et al., The Adaptable Laboratory: A Holistic Informatics Architecture, American Pharmaceutical Review, January/February 2011
Current Scope: Analytical Chemistry for Our Industry
• Drug substance, drug product release, stability
• Compound registration
• Development understanding
• Process chemistry monitoring
Functional areas in CMC, Discovery
• Small molecules
• Biopharmaceuticals
Analytical chemistry
• Gene expression, bio-assays, microarray, clinical data
Out of scope of current project
Next steps: 2013 - 2015
Iterative solutions released as we go, not waiting for perfection or completeness
Demonstrate value & tractability
Development starts in 2013
Use specific problem space & PoCs to focus 1st phase of development
Hire established software team to work with SMEs from member companies to build Framework
Intent is something new & vendor independent, not a local fix
RFP responses under review, decision anticipated 2Q 2013
The elephant in the room
• Every company spends lots of money and FTE resource treating or living with the symptoms…
• The moment has arrived for the industry to embrace a pre-competitive approach to treat the underlying disease
10-April-2013
Document Preparation
Regulatory Compliance
Data Errors
Data Silos
Innovation Constrained
Data Exchange
Data Management
10-April-2013
Svetlana Lyapustina, Ph.D.
Senior Science Advisor| Drinker Biddle & Reath LLP
+1-202-230-5179
To join or learn more contact:
“If you want to go fast, go alone. If you want to go far, go together.” – African proverb
Join usAbbvie Amgen Baxter
Boehringer-Ingelheim Bristol-Myers Squibb Eisai
Pfizer GlaxoSmithKline Merck
