clients / case studies / non-profit

Critical Path Institute

Goal

To help C-Path with its goal of bringing FDA scientists, industry and academia together to improve the path for innovative new treatments for major neuro-degenerative diseases

Solution

The creation of new tools and methods of data collection, analysis and collaboration to accelerate the development and approval of new treatments

Results

Introduction

C-Path is an independent non-profit institute that serves as a "trusted third party" enabling scientists from the FDA, academia and industry – including some major pharmaceutical companies --- to work together for the public good.

A part of their mission is to improve and modernize the path for innovative new drugs, diagnostic tests and devices to reach patients in need who are suffering from major neuro-degenerative diseases such as Parkinson’s or Alzheimer’s. Its aim is to do this by sharing data and building relationships between industry, the FDA, and academia, with the goal being to more rapidly bring effective new treatments to the public.

To help C-Path achieve this goal, Ephibian is working with C-Path in multiple initiatives, including their Coalition Against Major Diseases (“CAMD”) and their Predictive Safety Testing Consortium (“PSTC”) initiatives.

What are we working on?

Ephibian is currently:

• Translating data collected from the medical products industry, FDA scientists and representatives from patient groups into a standardized format
• Implementing automated data validation/error checking mechanisms
• Capturing the standardized data into a consolidated database
• Integrating research from multiple sources (including major Pharmaceutical companies) regarding research data for various diseases including Alzheimer’s and Parkinson’s
• Making the consolidated data securely available to contributors and the FDA
• Providing data that is secure, centralized and accessible that can be submitted to the FDA for qualification for use in drug development
• Facilitating data sharing and communication between industry and the FDA “earlier in the process”, in a mutually agreeable format
• Leveraging industry standards such as C-DISC’s SDTM and SEND for submission into the C-Path repository and export to the FDA
• Providing custom query tools
• Integrating 3rd party analysis tools
• Providing custom reporting tools
• Delivering Collaboration Tools
• Incorporating Security Mechanisms
• Accounting for Intellectual Property concerns regarding data that has not been authorized to share

What will the result be?

The provision and presentation of this data will:

• Become an unprecedented collaborative database/knowledge base of clinical trial data from multiple, major contributors
• Allow contributors to leverage knowledge of one another’s trials, to bring effective products to market more effectively and rapidly
• Incorporate the FDA into the process earlier and more thoroughly, thus streamlining the approval process --- its goal being to shorten and improve the drug approval process
• Communicate between industry, academia and the FDA in a predefined, standards-consistent manner --- once again, so that the drug-approval process can be made more efficient and timely