Bridging Pharma And IT 2008
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[email protected] m Bridging Pharma and IT Bridging Pharma and IT Making Open Access Instrumentation Open to All Brian Bissett Pfizer Inc. Groton CT Molecular Properties Group
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Transcript of Bridging Pharma And IT 2008
Bridging Pharma and ITBridging Pharma and IT
Making Open Access Instrumentation Open to All
Brian BissettPfizer Inc. Groton CT
Molecular Properties Group
Reality
Despite dramatically increasing expenditures for in-house pharmaceutical research and development (R&D) at major drug companies, few internally discovered, breakthrough products are on the horizon.
The pharmaceutical industry's R&D expenditures doubled over the past decade, but new molecular entity approvals plummeted by more than 50%. Source:
Cutting Edge Information. As a result of the changing landscape in the
pharmaceutical industry, there will continue to be considerable consolidation and restructuring within the industry.Transformational Disruption in the Pharmaceutical Industry - Jeffrey Leiden, M.D., Ph.D. Clarus Ventures
Instrument A
Instrument B Instrument C
Instrument D
Instrument E
Instrument F Instrument G
Instrument H
Common Situation
New Paradigm – Sharing Instrumentation
Instrument A
Instrument B
Instrument C
Instrument D Instrument E
Instrument F
Instrument G
Instrument H
One Solution: Open-Access Laboratories
In an effort to provide chemists with convenient and improved access to analytical instrumentation, many pharmaceutical companies are providing open-access (or walk-up) laboratories, which place the handling and analysis of analytical data in the hands of the chemist. Such a setup allows the chemists themselves to submit their sample to the instrument and run the experiment. The results of the assay are processed, analyzed, and the screens results are mailed to the chemist for interpretation of the data.
Open Source/Access Advantages
Free (i.e. Not out of my budget) Standardized Methods and Protocols Maintenance Free for Chemists No Calibration Worries for Chemists Ease of software license management Easier to scale up capacity Better support Improved performance Convenience – “One stop shopping”
The Problem – Easy Solvent Selection for Screening
If Chemists are expected to learn screen specific software to change the solvents and other system parameters for an assay they may utilize a dozen times a year, they will be resistant to utilize the Open Access resources made available to them, and the initiative will fail for cultural factors.
For Our Purification Process, one of three possible solvents would be utilized:
Trifluoroacetic acid Formic acid Ammonium Hydroxide
HPLC Discovery VP Preparative System“The Offender”
No “User Friendly” means of switching solvents.
Users would need to navigate through a complex menu system prior to beginning an assay.
A manual means of changing solvents required driving relays which were built into the HPLC Unit, but not supported by the HPLC Software.
OP7100 Smart Touch Screen
OP7100 Smart Screen - Rabbit Semiconductor. 16 digital I/O are available.
8 CMOS/TTL-level inputs 8 CMOS/TTL-level outputs.
Memory Flash Memory: 512K (2 x 256K) SRAM Memory: 128K
Meets NEMA 4 water resistance Communication Abilities
Two 3-wire RS-232 One 3-wire RS-232 and One RS-485 One 5-wire RS-232
Programming Language ‘C’ (Package “Dynamic C”)
Added Isolated Digital Input Capability
Should have added a bi-colored LED to indicate the state of each input
RED = VCC (+ 5 VDC) GRN = Ground
Circuit Board Layout - CADSOFT
EAGLE (Easily Applicable Graphical Layout Editor) Layout Editor Schematic Editor Autorouter
Runs under a variety of Platforms Windows Linux Mac
Powerful User (Macro) Language Widely Utilized in both Academia and Industry
Board Layout – Step Two – Parts Arrangement
Parts Arranged Size Defined Symmetrical Airwires still
present.
Board Layout – Step 3 - Routing
Axiom #1AutoroutersPerformPOORLY – butoften Provide aGood StartingPoint.
Board Layout – Step 4 – Fixing the Autorouter’s Mistakes
Add Via’s.Re-route Signal on different Layer.Delete Old Traces.
Look at your Gerber Files!
Gerber is a standard file format used by printed circuit board (PCB) fabrication manufacturers.
Gerber Files contain information necessary for computer controlled machines to fabricate the exact signal trace patterns for printed circuit boards.
Gerber files typically contain features such as land patterns, signal traces, drilled holes, milling and cutting information.
The Gerber Files Generated by any board layout tool (such as EAGLE or CADENCE) can be readily viewed using any number of free Gerber File viewers, some of which are web based.
http://www.circuitpeople.com/ gerbv - A Free/Open Source Gerber Viewer
The advantage of viewing the Gerber Files is that they contain EXACTLY what the boardhouse will deliver.
Board Manufacturing
Surface Mount Components utilized whenever possible.
Allows Cost Effective Population of Board at time of manufacture.
E-TekNet Inc. (http://www.e-teknet.com/) In General, for small jobs, domestic boardhouse
manufacturing is not competitive or cost effective. For Large Jobs (>1000) circuit boards, and jobs
where quality and reliability trump cost issues, consider a board house where circuit boards are actually fabricated in the United States.Ex. Endicott Interconnect http://www.endicottinterconnect.com/
Parts Kitting done by Digi-Keyhttp://www.digikey.com/
Component Placement. It pays to be very Conservative.
When this board was designed two components were 5mm apart, which under ordinary conditions was more than adequate to allow for such conditions as thermal expansion and wave soldering.
During the kitting process for this board, two adjacent components were not available from suppliers.
The vendor found “functionally equivalent” parts to replace a 40 pin IDC connector and a 2 contact screw terminal block situated next to each other on the board.
Sadly, each part was about 2.75 mm longer on each side than the original parts. This resulted in a gap between the components that was 0.5 mm too small.
Watch Those Tolerances! (nothing a little filing can’t fix!)
While annoying, the tech in China was able to file 0.5 mm off the IDC Connector and assemble the board.
Software Flowchart – Dynamic C
Is MethodRunning?
Scan for Solvent Selection
ReadInput 0
ButtonPressed?
Change SolventTo Selection
Selection isDisabled
Start Method
LOW
YES
YES
HIGH
NO
NO
Dynamic C – Special Attributes and Advantages
Comes with many pre-written Libraries to perform most of the arduous tasks.
Graphics Bitmap Converter Multi-Tasking
Function “Chaining” Allows Segments of Code to be Distributed over One or
more Functions. Co Statements
Constructs of Code that can suspend its own execution, allowing other code to execute.
• CoPause• CoBegin• CoResume
“Watchdog” Timer Can be set to reset Program if not “hit”
Additional Resources
Practical Pharmaceutical Laboratory Automation
Hardcover: 464 pages Publisher: CRC Press (May 23, 2003) ISBN: 0849318149
Automated Data Analysis with Excel Softcover: 442 Pages Chapman & Hall (June 2007) ISBN: 1-58488-885-7
Acknowledgements
Dr. Laurence PhilippeAssociate Research Fellow Analytic and Sample Logistics
James BradowScientist - Analytic and Sample Logistics
Polly ChangScientist - Analytic and Sample Logistics
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