Pistoia Alliance Debates: SEND, the CDISC Standard for Exchange of Nonclinical Data, 17th March 2016
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Tuesday 28 June 2022 SEND, the CDISC Standard for Exchange of Nonclinical Data A Pistoia Alliance Debates webinar Chaired by Veit Ulshöfer Partner logo if required
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Transcript of Pistoia Alliance Debates: SEND, the CDISC Standard for Exchange of Nonclinical Data, 17th March 2016
2 May 2023
SEND, the CDISC Standard for Exchange of Nonclinical DataA Pistoia Alliance Debates webinar
Chaired by Veit Ulshöfer
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This webinar is being recorded
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Veit Ulshöfer is the Global Head of Research and Bioinformatics at Merck KGaA, with more than 20 years of experience in discovery and early development informatics. He has been on the board of directors of the Pistoia Alliance between 2012 and 2015 and is a passionate about the idea of pre-competitive collaboration and data exchange.
William Houser is a Senior Research Scientist with 25+ years of experience with the toxicology group at Bristol-Myers Squibb. He has been responsible for their SEND implementation and for the IT portfolio for the regulatory toxicology group and is now more focused on SEND than ever before. His passion for enabling the exchange of nonclinical data is evident: • To further the SEND standard he is leading the development of SEND for Genetic Toxicology data and serves
on the CDISC SEND extended leadership team. • To supporting the industry’s adoption of SEND, he is on the leadership team for the nonclinical PhUSE/FDA
Computational Sciences Consortium working group. • To accelerate the development of better medicines for patients he is serving as a member of the Toxicology
Data Sharing workstream of BioCelerate.
Lou Ann Kramer is the VP of Regulatory Submissions at Instem, working in the areas of SEND-related products, services, and consulting for clients around the globe. Prior to this, she worked for thirty years at a major pharmaceutical sponsor company in Indiana where she held roles in IT, R&D operations, and early phase clinical. For the last decade she led the team responsible for producing all nonclinical submissions for global regulatory authorities. Lou Ann is a founding member of the CDISC SEND team and has been the CDISC leader for the team since 2005. She is a member of the CDISC Technical Leadership Committee. Lou Ann is also active on PhUSE teams, is co-leading a PhUSE project, and is a member of the PhUSE nonclinical core working group.
Susan DeHaven is Director, Applications & Information Management, Disposition, Safety and Animal Research, Sanofi US, and co-leads the nonclinical PhUSE/FDA Computational Sciences Consortium working group, doing collaborative projects addressing data challenges in computational science. Susan co-leads the Nonclinical Study Data Reviewer’s Guide template development project for PhUSE, which is currently the subject of an FDA Federal Register Notice for Intent to Review. With degrees in Chemistry, Biology and Organizational Leadership, she’s worked in the Pharma industry for 26 years in Reproductive Toxicology, Nonclinical Drug Safety and Information Systems. Susan leads the SEND implementation project at Sanofi and is also a member of the CDISC/SEND team.
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INTERACTIVE QUESTION #1
A1: US FDAA2: Japan PMDAA3: Europe EMEAA4: I don’t know
Which health authorities will require SEND datasets in submissions next year?
Regulatory MandateWhy SEND is important
William Houser, Bristol-Myers Squibb
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Photo by: Andrei NiemimäkiCreative Commons Attribution-ShareAlike 2.0 Generic (CC BY-SA 2.0)
Photo by: Orin ZebestCreative CommonsAttribution-ShareAlike 2.0 Generic (CC BY-SA 2.0)
“Please”
Guidance Compared toBinding Guidance Do it!
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Regulatory Mandate• FDA http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm
• FDA Binding Guidance Documents • December 2014: “Guidance for Industry ‐ Providing Regulatory Submissions in
Electronic Format ‐ Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act”
• December 2014: Guidance for Industry: “Providing Regulatory Submissions In Electronic Format — Standardized Study Data”
• FDA Non-Binding Guidance Document • Study Data Technical Conformance Guide
• Timing of SEND Submissions• Single-dose and repeat-dose and carcinogenicity studies that start on or after 17
Dec 2016 in support of NDAs/ANDAs/certain BLAs
• Single-dose and repeat-dose and carcinogenicity studies that start on or after 17 Dec 2017 in support of INDs
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Regulatory Mandate
• PMDA http://www.pmda.go.jp/english/review-services/reviews/advanced-efforts/0002.html#r=s&r=s
– Beginning to support SDTM for clinical studies Oct 1, 2016
– The timeline for SEND has not yet been determined.
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INTERACTIVE QUESTION #2
How familiar are you with the SEND standard?A1: Not at allA2: Somewhat familiarA3: Very familiarA4: SEND level : Expert!
What is SEND?The Basics
Lou Ann Kramer, CDISC/SEND Team LeaderInstem
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What is SEND?
• CDISC– Clinical Data Interchange Standards Consortium– Global open standards development organization– Standards include: CDASH, SDTM, ADaM, and others
• SDTM– Study Data Tabulation Model (SDTM) > SDTM IG is implementation for clinical studies
• SEND– Standard for Exchange of Nonclinical Data– Shared model, SDTM > SEND IG is implementation for nonclinical studies– Nonclinical vs. Preclinical– SEND Team is 100+ members from Pharma, CRO, Product Vendor, FDA
representation
• PhUSE– Pharmaceutical User’s Software Exchange– SEND Implementation wiki – PhUSE
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SEND 3.0 Production Standard
– FDA / CDER Preferred Standard since mid-2011
– Supports:• Single dose general toxicology• Repeat dose general toxicology• Carcinogenicity
– Consists of domains: • Study Design• Animal details• Dose Administration• In-life Results & Observations• Post mortem (organ measurements, gross and microscopic
observations)
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Coming Up in 2016Nonclinical standards in final stages of development
SEND 3.1• Updated domain: Microscopic Observations• New domains: Respiratory (RE), Cardiovascular (CV)• Revisions to improve representation of timing• Corrections and clarifications
DART (Developmental and Reproductive Toxicology) v1.0• New implementation of SEND for Embryo-Fetal Development
studies
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In Development• DART Multi-generational • DART Fertility• CNS Safety Pharm• Dermal / Ocular• Genetic Toxicology
Immunohistochemistry
Anti Drug Antibodies
Nonclinical Efficacy Pharmacology
Discovery Pharmacology
Immunotoxicity
Pharmacodynamic Biomarkers
future???
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Where is SEND defined?
SEND Implementation Guidewww.cdisc.org/SEND
SEND Controlled Terminologywww.cdisc.org/terminology
Data Definition File Specificationhttp://www.cdisc.org/define-xml
SEND Implementation Wikihttp://www.phusewiki.org/wiki/index.php?title=SEND_Implementation_Wiki
Benefits of SENDThe Vision
Susan DeHavenSanofi USPhUSE Nonclinical Working Group
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Benefits Boost Value
• SEND boosts long term value of data• More Exchangable: Data Exchange Mechanism Opportunities
• Common format to repeatedly share data with research consortiums• One format for CROs to provide for many Sponsors’ needs• Support smooth data flow through department processes/applications
• More Reusable: warehousing for cross-study data mining efficiency• Consistent data presentation within and across drug projects • Diagnostic analysis of collected data content• Predictive analysis using knowledge to predict future outcomes
with: Reliable Content
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REDUCECOST
RESPOND FASTER
MAKE BETTER DECISIONS
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• SEND helps realize innovations into consumable data solutions
Structured representation with standard
ontology
“Wearable” data recording
technology
Innovative Solutions Standardized Data
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SEND is more than required,it’s also “nice to have”
• Are we past the tipping point?– exponential data volume growth– secondary use of data growing in priority– increased reduction of animal use
• SEND can enable more access, more usability of data – old and new
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