Making PK/PD as easy as ABC.
You have a fabulous pharmacometrics team. They’re smart, talented, experienced, and know PK/PD inside and out. But that doesn’t mean they don’t need a little help every once in a while. What we can do is work with your team, and lend a hand with specific aspects of the development process. Basically, we’ll do the dirty work so you don’t have to.
As part of Cognigen’s Forensic Pharmacometrics services, we will review your submission package and provide the feedback that will arm you with knowledge, credibility, and confidence—knowledge to achieve critical milestones successfully, credibility to withstand regulatory scrutiny, and confidence that you will avoid costly surprises down the road. We will systematically review data elements, verify analysis variables, review code, verify data integrity, check assumptions, and ensure the dataset has been built correctly. We will also review documentation for accuracy, completeness, and coherence of the scientific strategy.
At Cognigen, not only do we excel in data assembly for population-based analyses, but we’re the only company in the world with a definitive niche in the field. Our experience in data assembly is unique and extensive. In fact, between 2001 and 2007, we wrote 40,950 data programs and we are still programming strong.
Regulatory Submissions and Scientific Writing
Cognigen can prepare the pharmacology sections of documents — including IND, CSR, EOP2a briefing book, SAP, FTR, CTD, and NDA — to support your important regulatory milestones. We’ve developed taxonomies that not only guide the writing of these documents, but make sure you’re addressing all the critical components that will be used throughout the lifecycle of drug development. Our goal is to minimize or eliminate the questions posed by regulatory reviews, while balancing the cost and time it takes to develop any of these documents. Our analysis plans and reports also help anyone — from a new team or employee to a licensing company to a regulator agency — understand what was done any why, which reduces the need for rework.
Pharmacometric Enterprise Support
The Pharma of the Future (PoF) initiative at Cognigen is focused on the identification and application of people, process, and technology enhancements in support of model-based drug discovery and development. The purpose of early PoF initiatives has been to examine and improve the essential functional elements required to successfully generate timely and relevant modeling and simulation results. The goals of these efforts are to reduce costs, increase productivity, and raise the standard of quality and effectiveness of M&S work products. Examples of early work include:
- Formalization of the M&S process, including provisioning and execution workflows
- Improving the requirement specification process
- Implementing a centralized interdisciplinary team communication system
- Developing strategies for addressing informatic deficiencies
- Creating tools for documenting and communicating the modeling process
- Workshops to identify the strategic gaps, operational gaps, and readiness reviews of implementing model-based drug development at pharma companies
The value of the tools and processes that have come out of the PoF program has been successfully demonstrated during the execution of M&S projects for both large and small pharma and biotech companies.