Non-Clinical Road-map and Impacts on Implementation

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Overview

Vision

This working group 6 at FDA/PhUSE CSS meeting aims to improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and then establishing an innovative framework for addressing them in a collaborative manner. This is a hands-on working session in which the group will jointly identify, discuss, and prioritize topics to be considered for further work during the year. Additionally, the group will create a framework for supporting nonclinical data standardization efforts, discuss specific implementation considerations for SEND (see more on this effort on the SEND Implementation page), and identify key needs for data mining and decision support. There are no formal presentations or speakers, although there will be facilitators from both FDA and industry for the discussions.

Ongoing Commitment

The expectation is that this workgroup will continue to collaborate throughout the year. The workgroup will refine and further develop the concepts and frameworks defined during this working session based on the identified priorities. At the meeting we will be addressing how this collaboration will occur, with possibilities as monthly teleconferences, semi-annualsemiannual face to face meetings, and use of wiki spaces. We look forward to your participation in this meeting and the workgroups going forward. We are confident that we can truly improve nonclinical assessment and regulatory science by approaching our needs and challenges in innovative and collaborative ways.

Overview & Scope

Welcome to the Wiki for the FDA/PhUSE Computational Sciences Nonclinical Working Group. Below you can find an overview, scope, and objectives for the upcomming meeting.

Overview

This working group 6 at FDA/PhUSE CSS meeting aims to improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and then establishing an innovative framework for addressing them in a collaborative manner. This is a hands-on working session in which the group will jointly identify, discuss, and prioritize topics to be considered for further work during the year. Additionally, the group will create a framework for supporting nonclinical data standardization efforts, discuss specific implementation considerations for SEND, and identify key needs for data mining and decision support. There are no formal presentations or speakers, although there will be facilitators from both FDA and industry for the discussions.

Scope

Up to this point, one of the major efforts in nonclinical regulatory informatics has centered on the development and testing of the SEND standard (http://www.cdisc.org/send).http://www.cdisc.org/send). The production of the SEND 3.0 Implementation Guide in 2011 was a major step forward for the electronic submission and exchange of standardized data and enablement of data warehousing efforts that better support scientific review and regulatory science initiatives. However, it is recognized that data standards are simply enablers to support the broader goals of better exploring and exploiting diverse study data and metadata in order to answer important scientific, review and regulatory science questions.

Technology solutions are needed to allow users from the industry and regulatory agencies to derive full value from the data they have at hand. Additionally, it is vitally important to recognize that these data resources can be further enriched with metadata, documents, external resources and other contextually relevant information. In many cases, valuable study data types continue to reside in ‘locked in formats’ or lack standardized representations limiting broader use beyond the narrow scope of a single study.

In order to fully use these data, combine them in proper context with other data, and enrich the collective knowledge base, it is necessary to rapidly develop standardization, extraction and exchange techniques. Likewise, as data and content resources become more readily accessible, new tools and techniques need to be developed or refined to better search, analyze and interpret them. The range of needs and challenges that come out of these related areas in the regulatory pharmacology and toxicology field can be daunting but many of the challenges are shared among key stakeholders (the FDA and sponsors, or sponsors and CROs, and solution providers). This opens up novel opportunities for partnerships in bringing new insights to the problems on hand and developing or sharing solutions that can harness powerful and innovative technologies.

Objectives

Objective 1

During the first day of this meeting, the group will be tasked with identifying and prioritizing needs and challenges for nonclinical data users, determine the overlap among stakeholders, and then develop the framework(s) for how to develop and pilot solutions that address the top priority needs. The expected output of this session is an outline and key points for a white paper to be written and published after the meeting delineating the framework(s) to be followed by the workgroup.

Objective 2

During the second day of the meeting, the group will focus on specific implementation considerations for SEND. The aim will be to develop a collaborative space to support implementers of the standard where resources, gaps, issues, challenges, and possible solutions are shared. There will be a similar white paper, ‘roadmap’, or similar output for this session that will describe the approach and schedule for the framework/space to be setup.


Draft Agenda for 2012 CSS

Agenda for FDA PhUSE Working Group #6

Day 1: Session 1 (1.5h)

  1. Introduction and Statement of Objectives
    1. FDA's statements of vision and objectives for the meeting and workgroup
    2. Overview/vision/expectations for meeting and post-meeting engagement
  2. Review of Needs and Challenges
    1. Discuss needs/questions list
      1. Clarify list items for understanding, relevance and feasibility
      2. Maintain parking lot for those issues we won’t be discussion but are worthy idea for additional workgroups/forums.
    2. Discuss benefits of innovation for all stakeholders in the priority areas
    3. Prioritize initial focus areas/topics and needs

Day 1: Session 2 (1.5h)

  1. Development of Roadmap Framework - How do we go about addressing the identified issues?
    1. Detail questions about framework - How will this effort be organized into a sustainable working model among diverse stakeholders moving forward?
    2. Discuss possible approaches to establishing sustainable efforts to address top priorities
    3. Discuss execution plans, roles and responsibilities, and deliverable targets
  2. Poster Discussion

Day 2: Session 3

  1. Recap of day 1. Check in on deliverables.
  2. Thinking outside the box: Repurposing innovative IT solutions?
    1. Examples of innovative and repurposed solutions
    2. Presentation on metadata
  3. Discussion on approaches to use it for nonclinical questions.

Day 2 Session 4

  1. SEND Implementation Roadmap
    1. Define scope of discussion
    2. Lessons Learned during the development, testing, and implementation of SEND
    3. Identify needs and challenges of the implementation of SEND
    4. Determine framework for addressing needs and challenges
    5. Establish path forward (Define approach, timelines, commitments…)
  2. Wrap-up. Prepare to report-out.

Prework request

Pre-Meeting Request: NonClinical Development and Review Needs and Challenges

FDA, Sponsors, CROs, or others, doing work applicable for drug development are asked to define specific data needs or challenges based on their scientific expertise, data analysis/interpretation experiences or submission experiences. This is a critical activity to ensure we have collected a full list of needs as well as to identify where there are overlaps among participants. We have provided some guidance on how to identify problems of interest and the information you should include when submitting your challenges and needs.

  • This request should be forwarded on to anyone who may have needs or challenges that fit this request.
  • The needs and challenges spread sheet should be returned to Tim Kropp (timothy.kropp@fda.hhs.gov) by 6 Mar 2012. Any questions can also be directed to Tim.
  • The data challenges should be related to drug safety evaluation and have some impact on the FDA’s regulatory work (either from a submission & review standpoint or from a regulatory science standpoint).
  • Data challenges will be prioritized based on scientific innovation, feasibility and applicability to the review and approval of medicines or devices.
  • Top priority needs and challenges will be discussed and prioritized for work during the FDA PhUSE meeting (March 19th and 20th, 2012). The expectation is that selected needs and challenges will be framed into specific projects with milestones and deliverables during the upcoming year.
  • Please submit the following information using the spreadsheet template (Please contact timothy.kropp@fda.hhs.gov for the NeedsChallengesTemplate.xls file). Please note that the examples are for illustrative purposes only, they may be further modified or removed. The examples should be removed for your template additiona. If you have a similar need or challenge to the ones listed, please enter your own row.
    • The data need or challenge:
      • Describe the Business Problem and Current State
      • Describe Use Case Scenarios (as applicable)
    • What would be the benefit of innovation in this area?
      • Describe the Purpose, its Importance, and Benefits
      • Does it have an impact on drug development, regulatory review, approval…
    • What would be a optimal/acceptable solution? How could success be measured? (optional)
      • Define deliverables, measurable outcomes…
    • What has been done already? (optional)
      • Describe current methods, activities or published approaches…
      • Are there other groups working on this challenge?

Leadership

(hold for core group and workstream leads)



Conference Calls and Minutes

WG6 DDMONYYY





Last revision by DanBoisvert,03/16/2012