WG6 Tcon2 Meeting minutes 05082012

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PhUSE Standards Roadmap Tcon #2 - May 8th, 2012

Attendees: Gitte, Jerger, Bob, Lynda, Alain, Tim

Action Items Wrap-up:

Posted prior meeting minutes; Sent recurring Invite for Tcon; Established a consistant Tcon phone number; Connect Pro account set-up
Member-built roadmap pieces; Viewed Therapeutic Area Standard Roadmap; Feedback from your company about their priorities of standardization?
Discussion -
-Gitte: A noted concern was raised from members in one company about pharmacology data, saying that systems are already up. There was a feeling that studies are unique and defy standardization. i.e. Anesthetized animal, a GI dose for exposure. How is this captured? In vivo, ex vivo may cause difficulties.
- Balance necessary between data captured and catching study conditions (design) for appropriate context.
- Can a general standard be suggested for pharmacology studies?
- Can a system for trial design be bolstered? There was a recognition that standards for study design currently leave gaps. These study design gaps are a challenge to accurately capturing studies in a standardized format.
- Idea for a case study: Need to get a fixed set of study designs to identify their gaps.
- Discussion that pharmacology may not be a first element of safety signal, but will still help to support the robust development of drugs.
Lynda: Her group expressed an interest in genetox (in general). - Idea was to look at the established predictive tools for genetox to see if there is anything to gain in standardization.


Tim Kropp: Grasping “Data Accessibility”
* Data Usability
**User accesses data in most efficient way possible
***Access – looking at it with multiple tools, proper training, etc.
***Data Storage – tabs on it, accessible to the tools.
*Later discussion was held about the “concept of data” where raw, operational, or submission data all have different forms and uses. The needs for each type of data should guide the rules that govern it. Discussion Tab will be opened to explore the “concept of data”
**Data seen in context – for interpretation (granular vs. total submission), i.e. data gained with a particular drug lot,
**Efforts started with data standardization
- To get it in and warehouse it, we developed tools. It is not the endpoint, but enables our access.
- To prioritize data standardization, but expand thoughts on how to better access data (storage, context solutions).
-Standardization is time consuming. How can we get prime data for best meta-data evaluation?

    • Concept of Data:

Data comes in different forms: Raw data, captured data (GLP), operational, data in a repository for analysis. These are different than submission data for regulatory purposes. Submission data is a final from some perspectives, and seen as elemental building blocks to a reviewer.
***Explore how need from data defines the rules around the data.

A.I. – This concept can use a String in our discussion tab.

**Solutions for data accessibility may be software, possibly evolve standardization efforts. Considering novel approaches. Some studies are easily standardized (genetox), but other elements may need more consideration (meta).

View of Wiki: Progress in the past two weeks
Does Tim’s perspective give us ideas of where we can expand our list? Yes.
A.I. -Bob will populate Wiki Discussion Tab with Bulleted points for Storage and Data Context for further expansion.
A.I. Members should freely add to these Discussion Strings on wiki.

Discussion – How does the Therapeutic Area Data Standards Roadmap affect our ideas of the nonclinical roadmap?
Ongoing discussion *Difficulties in being prescriptive about specific pharmacology studies (example) for submission.
*Clinical Therapeutic Area Roadmap – Defined by clinicians in ongoing effort. Retrofitting the terminology to nonclinical pharmacology studies would be a challenge. Can one indication between nonclinical and clinical (Case study) be an exercise to explore this?
Jerger suggests an invitation to Eslie Dennis as a translational researcher (Clinical Path Initiative) to address how nonclinical and clinical areas may find overlap.
A.I. Jerger contact Eslie Dennis for future discussion.

  • Organic Agenda Setting - Can it be seeded on Wiki and built during the two weeks prior to the Tcon?

**General acceptance by the group

Call for participation *Draft a welcome email to future participants (borrowed from Endpoint Pred. group)

		**A.I. Bob, Alain, Gitte: Drafting Welcome letter. Bob will forward a (very) rough draft.

***Elements: Welcome, Wiki link, Outlook meeting invite, Tcon details, Connect Pro Link...
*Recruiting: Ask someone you know to participate
**discussions during the Tcon, Jerger said he may recruit a database specialist to the group. Lynda may have an interested person who is currently probing the Wiki. Bob has extended an invitation also and is awaiting response.

Last revision by Dorsamr,05/9/2012