slas informatics sig: slas2013 presentation
DESCRIPTION
The Allotrope Foundation led discussion on building an open framework for laboratory data - recommending a holistic approach to build upon & promote industry standards & best practices by providing software that instantiates them.TRANSCRIPT
Confidential Allotrope Foundation Internal Brief 2
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 us button-click, interactive, drill-down reports
At home…
Confidential Allotrope Foundation Internal Brief 3
Imagine a day when...Document
PreparationData
Exchange
Method / Data Transfer
Confidential Allotrope Foundation Internal Brief 4
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”
Confidential Allotrope Foundation Internal Brief 5
Treat the disease…
Symptoms
Disease Pathology
Document Preparation Data Errors Data
Exchange
Data Silos
Data Management
Regulatory Compliance
Innovation Constrained
Confidential Allotrope Foundation Internal Brief 6
The Framework treats the disease…Automated Documents
Regulatory Compliance
Eliminate Data Errors
Eliminate Data Silos
Innovative Ecosystem
Fast Data Exchange
Better Data Management
Confidential Allotrope Foundation Internal Brief 7
How the Framework treats the disease…
•Class Libraries, SDK, web service •Compatible software• Lowers barriers to adoption
• Common data formats facilitate data exchange & innovation
• Eliminates or attenuates cost of 7 symptoms• Scientists focus on
science
• Consistency across all platforms, departments, partners• Massive data mining &
knowledge management opportunities
Not a standards initiative, a holistic approach to instantiate them, imbed in software
Confidential Allotrope Foundation Internal Brief 8
Simplify: one model for all analytical data
supports hundreds of analytical Workflows in CMC, Discovery
Confidential Allotrope Foundation Internal Brief 9
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
Real Deliverables Emergent Outcomes
AGITATION CONCEPTUALIZATION FORMATION PLANNING REALIZATION
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
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
• Software development starts this summer, join us now to help shape the solution
Document Preparation
Regulatory Compliance
Data Errors
Data Silos
Innovation Constrained
Data Exchange
Data Management
Confidential Allotrope Foundation Internal Brief 12
Why become a member of Allotrope Foundation?
• Members of Allotrope Foundation can benefit from the opportunities beyond the use of the final deliverables. – In-depth understanding of the needs relating to the
collection, formatting and transmittal of data;
– “Members Only” solutions, early access to deliverables, including tools for data conversion from proprietary to open formats
• Most importantly, participating in the Foundation will help ensure that the project has sufficient resources and substantive support to succeed.
Confidential Allotrope Foundation Internal Brief 13
Svetlana Lyapustina, Ph.D. Senior Science Advisor| Drinker Biddle & Reath [email protected]@dbr.com
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 us
Confidential Allotrope Foundation Internal Brief 14
References
– James M. Roberts, Mark F. Bean, Steve R. Cole, William K. Young, Helen E. Weston, Informatics in the Analytical Laboratory: Vision for a New Decade, American Pharmaceutical Review, September/October 2010.
– James M. Roberts, Mark F. Bean, Chris Bizon, John C. Hollerton, William K. Young, The Adaptable Laboratory: A Holistic Informatics Architecture, American Pharmaceutical Review, January/February 2011.