Year
|
Milestone
|
Activity
|
Deliverable
|
| 1997 |
Collaboration 1.0 |
Developed software to help scientists organize data, analysis programs, graphics, and text, into one electronic document |
PERSPECTIVE Hypertext Data Analysis Mapping software released |
| 1999 |
Real Time PK and PD Data Assembly Services initiated |
Identified critical information required to deliver timely and accurate analysis-ready datasets for M&S efforts |
Formal policies and procedures for receiving treatment codes and working with clinical trial data during study execution before database lock |
| 2001 |
Installed NONMEM Grid Engine |
Moved from desktop installations to fully automated grid engine for managing computations |
Savings in time required to manage modeling and simulation activities on the grid |
| 2002 |
NONMEM moves to the cloud |
Developed validated web interface for NONMEM to facilitate model development for academic institutions |
First generation PANDA software released |
| 2003 |
Pharma of the Future initiative begins |
Investigated the Factory of the Future program and its implications for Pharma R&D |
Standardized the M&S workflow |
| 2004 |
Cognigen becomes a laboratory |
Implemented research and training initiatives to reduce flow times, improve quality and consistency of work products |
Definition of systematic, process, and informatic needs of M&S activities |
| 2005 |
M&S process formalization |
Identified the primary tasks, defined the critical inputs, and standardized the outputs |
Company-wide standards for M&S project execution. |
| 2006 |
Refined Data Assembly process workflow |
Defined the tasks, procedures, and interactions for building an analysis-ready dataset |
“Guide to NONMEM® Dataset Creation” training manual published for Cognigen data programmers |
| 2006 |
Knowledge Portals implemented |
|
Secure, virtual private networks establish for client communications and data transfers |
| 2007 |
Data assembly process improvement |
Implemented continuous process improvement techniques and forensic tools to identify root causes of rework in data assembly |
Reduce time required to deliver high quality analysis-ready datasets with less errors |
| 2008 |
Graph Library established |
Analyzed commonly-used graphs to identify critical elements required to produce graphs more efficiently |
Provide the right graphs at the right time, with the right information, to tell the story of the data analysis effort |
| 2009 |
Focus on Integrated Project Teams |
Investigated strategies to more fully engage interdisciplinary teams in model definition and use of M&S results |
Use of conceptual schemas as a blueprint for model development |
| 2010 |
Forensic Pharmacometrics |
Developed a systematic approach to independent peer review of model efforts and reports |
Pre-submission reviews of regulatory documentation and reports |
| 2011 |
PANDA grows up |
Redeveloped PANDA to provide a model development platform for global teams |
First enterprise license for KIWI software sold to global pharmaceutical company |
| 2012 |
Progressive Reporting Strategy |
Investigated knowledge threads across M&S project execution life-cycle |
Canonical document library: project justification and resource allocation, analysis plans, and technical reports |
| 2012 |
Scientific Workflows |
Refined workflow structure and requirements for common analysis activities |
Formalized workflow definitions for logistic regression and time to event analyses |
| 2013 |
Cognigen move to new headquarters |
Upgraded computer systems, automated off-site backup storage, installed green technology to reduce computer cooling costs |
Fully validated, secure IT infrastructure and business continuance strategy |
| 2014 |
The Paradox of Scientific Excellence |
Investigated enterprise barriers to innovation and the source of silo-thinking |
Model-based framework for fostering interdisciplinary collaboration |
| 2014 |
Data Assembly Automation Initiative |
Created code library and programming templates and developed enhanced data definition documentation |
Data assembly process formalization and automation modules |
| 2015+ |
The Pursuit of Excellence in model-driven R&D begins |
Investigating strategies for using mechanistic models as a basis for accelerating scientific innovations to improve R&D productivity |
Wait and see… |
