January 19, 2017

IDMP: It’s all about the patient: enhancing patient safety through improved R&D information exchange

A Pistoia Alliance Debates Webinar

Chaired by Andrew Marr and Gerhard Noelken

This webinar is being recorded

Poll Question 1:What’s your level of familiarity/ involvement with IDMP?

A. I know very little about IDMP

B. I have a basic understanding of IDMP

C. I contribute to IDMP work in my organization

D. I lead IDMP work in my organization

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The Panel

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Frits Stulp, Managing Director at Iperion Life Science Consultancy IDMP SME and trusted client program advisor for several IDMP initiatives Project manager in IT projects for Reg. Compliance, Business Intelligence related to

IDMP/XEVMPD

Andrew Marr, Managing Director, Marr Consultancy Leading consultant for IDMP Member of the expert groups for the ISO implementation guides for Products and Substance Member of the SPOR Implementation Working Group (IDMP implementation for EU)

Martin Romacker, Principal Scientist, Roche Principal Scientist in Data and Information Architecture and Terminologies at Roche

Innovation Center Basel Focusing on the definition and application of Data Standards to facilitate data federation

and answering of complex scientific queries.

Sergio Rotstein, Director Business Technologies, Pfizer Director in the Research Business Technology organization at Pfizer Responsible for the infrastructure and methodology needed to enable the use of biological

entities as therapeutic agents across Pfizer R&D

January 19, 2017 IDMP

Edsel David, Global Information Systems Lead at Astellas Specializing in knowledge management, eDiscovery, records and content management,

business process improvement, collaboration, training and compliance Founding or leading member of DIA EDM SAIC, DIA EDM Reference Model, PhRMA ERS

Working Group, IRISS, AIIM

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IDMP 5

Agenda

• Welcome by Gerhard Noelken (Pistoia Alliance)

• IDMP and Substancesby Andrew Marr (Marr Consultancy)

• Implementation of the IDMP Regulations at Astellasby Frits Stulp (Iperion) and Edsel David (Astellas)

• Ontology Mapping project by Martin Romacker (Roche)

• HELM project by Sergio Rotstein (Pfizer)

5January 19, 2017

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IDMP and SubstancesDr Andrew P MarrManaging DirectorMarr Consultancy Ltd

Pistoia Alliance19 January 2017

IDMP Background and Timelines Substances/Specified Substances Substances as Ingredients of Products

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Outline

IDMP = Identification of Medicinal Products Initially an ICH initiative to support improved pharmacovigilance Collaboration with Standards Development Organisations –

primarily ISO and HL7◦ Broadened scope beyond pharmacovigilance and into wider support for

regulatory activities and healthcare 5 standards issued in 2012

◦ 3 currently under revision 4 ISO Implementation Guides to be issued

◦ 2 issued (of which one requires a further edition - Substances)◦ 2 nearing publication

Regional guidance will be needed for each specific implementation

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IDMP

Primarily EU and FDA◦ EU - Use of IDMP standards is defined by Regulation

(EU) No 520/12012 (art. 25 & 26) Focus is only on use for Pharmacovigilance

◦ FDA already using much IDMP-like information (as Structured Product Labelling – SPL) Plans not yet in place to fully align

◦ Other regulators’ plans not yet defined

Implementation in EU is therefore the driver

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Regulators Driving Developments

© EMA 2016 10

Why do we need standardisation?

…improve signal detection and speed of response for authorised products, thus improving protection of public health in EU

…allow substances and products to be identified across countries enabling faster identification and withdrawal

…improve the link between the Supply Chain and the regulatory dossier since inspectors will have better records available to support their findings on Manufacturing sites

…allow substances and products to be identified across countries enabling faster response to address shortages

…facilitate process efficiencies in regulatory activities e.g. submission of regulatory application forms and Variations

…support cross-border electronic prescriptions of medicines in EU enabling patients to obtain the right products when outside their home country based on

standardised data

…support the mechanism for controlling authenticity of medicines

Pharmacovigilance

Batch recalls

Falsified medicines

Shortages

ePrescription

Inspections

Regulatory activities

Introduction to SPOR data services

Standardised data will…

EMA/NCAs implementing IDMP as part of a Master Data Management initiative – SPOR◦ S = Substances◦ P = Products◦ O = Organisations◦ R = Referentials (i.e. controlled vocabularies)

Organisations and Referentials are current focus Products and Substances ramping up

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EU – Master Data Management

2Q 2017 – implementation of Organisations and Referentials◦ Vocabularies/data to be used in a variety of updated business processes (from end-

2017) Go-live of Products will be 12 months after EU guidance is issued (mid-2019?)

◦ Mandatory after a further 6 months (end-2019?) Substance will need to be in place before Products

◦ Substance IDs needed for Product record

Several dependencies before dates can be firmed up◦ Finalisation of ISO guidance◦ Drafting and consultation on EU guidance◦ Infrastructure availability◦ Etc.

More information in Backup slide

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Timing - Key Points

Codification of data about products◦ Globally where achievable

Mapped where necessary Codification of data about substances

◦ Globally by default

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IDMP requires Codification of Data

Identifiers and Terminologies

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Medicinal Product + Identifiers(MPID)

Pharmaceutical Product +Identifiers(PhPID)

Substance/Specified Substance+ Identifiers

(SID & SSID)

TerminologyConcepts

Packaging

Measurement Units

Dose Forms

Routes of Administration

Presentation Units

By Jurisdiction

AcrossJurisdictions

AcrossJurisdictions

AcrossJurisdictions

Package+ Identifiers(PCID)

Batch + Identifiers(BAID)

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Medicinal Product – High Level Model

MedicinalProduct

Manufacturer/Establishment

Marketing Authorisation

Packaged Medicinal Product

Pharmaceutical Product

Ingredients

Clinical Particulars

Medicinal Product – Mainly administrative data

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MedicinalProduct

Manufacturer/Establishment

Marketing Authorisation

Packaged Medicinal Product

Pharmaceutical Product

Ingredients

Clinical Particulars

Marketing Authorisation – Mainly administrative data

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MedicinalProduct

Manufacturer/Establishment

Marketing Authorisation

Packaged Medicinal Product

Pharmaceutical Product

Ingredients

Clinical Particulars

Packaged Medicinal Product – Product as manufactured

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MedicinalProduct

Manufacturer/Establishment

Marketing Authorisation

Packaged Medicinal Product

Pharmaceutical Product

Ingredients

Clinical Particulars

Manufacturer/Establishment – Where manufactured

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MedicinalProduct

Manufacturer/Establishment

Marketing Authorisation

Packaged Medicinal Product

Pharmaceutical Product

Ingredients

Clinical Particulars

Pharmaceutical Product – Product as administered

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MedicinalProduct

Manufacturer/Establishment

Marketing Authorisation

Packaged Medicinal Product

Pharmaceutical Product

Ingredients

Clinical Particulars

Ingredients – in the Pharmaceutical Product and in the Packaged Medicinal Product

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MedicinalProduct

Manufacturer/Establishment

Marketing Authorisation

Packaged Medicinal Product

Pharmaceutical Product

Ingredients

Clinical Particulars

Clinical Particulars – Key prescribing information (from the SmPC)

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MedicinalProduct

Manufacturer/Establishment

Marketing Authorisation

Packaged Medicinal Product

Pharmaceutical Product

Ingredients

Clinical Particulars

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Substances – High level categorisation

Herbals Homeopathics Plasma-derived Vaccines* Allergens* Advanced Therapies*

* Due to be included in next (final) version of ISO Implementation Guide (ISO TS/19844) – due 1Q 2018

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Structurally Diverse Substances

Specified Substances Each substance may be described in more detail as a Specified

Substance◦ Group 1: Constituents

Including material containing multiple substances (e.g. Flavours, Colorants, growth media) Physical form and physical properties (e.g. crystalline/amorphous, polymorphic form,

micronised)◦ Group 2: Limited manufacturing information

e.g. Synthetic, extractive, recombinant e.g. Manufacturer (more detailed for biologically-derived substances e.g. herbals, plasma-derived, vaccines

etc. where extraction/deactivation processes have significant impact on substance profile/safety)

◦ Group 3: Grade and source of grade e.g. Grade and source (pharmacopoeial, in-house)

◦ Group 4: Detailed manufacturing information, constituents and specifications Akin to CTD Module 3 level of Drug Substance information (Out of scope of current implementation)

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Data will vary from substance type to substance type Plan is to assign identifiers at start of clinical trials

◦ IND/CTA◦ Data to grow with time◦ Stay with substance ID throughout its lifecycle

Let’s take a look at an example (note: not quite up to date with some recent changes to the model)

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Data Requirement

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Structural Representation of Brentuximab Vedotin

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Example of a Protein (1)Element Name Value Data

FormatNote #

Element Group: SubstanceSubstance Type Protein CD  Substance ID JKHGYD6453 (Artificial ID) II  

Element Group: Substance NameSubstance Name Brentuximab Vedotin ST  Substance Name Type Official CD  Language en CD  

Element Group: Official NameOfficial Name Type USAN, INN CD  Official Name Status Current CD  Official Name Domain Drug CD  Official Name Jurisdiction US, EU CD  

Element Group: Reference SourcePublic Domain Yes BL  Reference Source Type Recommended INN list CD  Reference Source Class Official Name Source CD  Reference Source Citation INN, WHO Drug Information, Vol. 25, No. 1, 2011 Recommended

INN: List 65ST 1)

Reference Source URL http://www.who.int/medicines/publications/druginformation/innlists/RL65.pdf?ua=1

ST 1)

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Example of a Protein (2)Element Name Value Data

FormatNote #

Element Group: Substance Name (Repeat)Substance Name Brentuximab Vedotin (genetical recombination) ST  Substance Name Type Official CD  Language en CD  

Element Group: Official NameOfficial Name Type JP CD  Official Name Status Current CD  Official Name Domain Drug CD  Official Name Jurisdiction JP CD  

Element Group: Reference SourcePublic Domain Yes BL  Reference Source Type JP CD  Reference Source Class Official Name Source CD  Reference Source Citation JP, monograph ST  

Element Group: CodesCode 914088-09-8 ST  Code System CAS Registry CD  Code System ID 0049 II  Code System Status Active CD  

Element Group: Codes (Repeat)Code 7XL5ISS668 ST  Code System FDA Substance Registration System (UNII) CD  Code System ID 0050 II  Code System Status Active CD  

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Example of a Protein (3)Element Name Value Data

FormatNote #

Element Group: StructureStructural representation type

Representative CD  

Structural Representation Attachment

Brentuximab Vedotin structure.pdf\

(see next slide)

ED 2)

Element Group: Structure (Repeat)Structural representation type

Representative CD  

Structural Representation Attachment

Brentuximab Vedotin disulphide linkage.pdf

(see next slide)

ED 2)

 

Element Group: GeneGene Sequence Origin Mouse-Human Chimeric CD  Gene Name Heavy Chain: Mus musculus VH(IGHV1-84*02 -(IGHD)-

IGHJ3*01) [8.8.10] (1-117) - Homo sapiens IGHG1*01 CH3 K130>del (118-446)

CD or ST 3)

 

Gene ID ID ghdftwu123 CD  

Gene Name Light Chain: Mus musculus V-KAPPA(IGKV3-4*01 -IGKJ1*01) [10.3.9] (1'-111') - Homo sapiens IGKC*01(112'-218')

CD or ST 3)

 Gene ID ID glertwu456 CD  

Structural Representations

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Example of a Protein (3a)

Note: HELM notation can be a suitable format for transmitting definitive information on selected proteins and peptides

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Example of a Protein (4)

Element Name Value Data Forma

t

Note #

Element Group: Substance ClassificationSubstance Classification Type

Monoclonal Antibody CD  

Substance Class Subtype

IgG1 CD  

Element Group: TargetTarget Organism Human CD  Target Organism Type

Human Receptor CD  

Target ID 943 (From NLM Gene) CD or ST

 

Target Name TNFRSF8 tumour necrosis factor receptor superfamily, member 8 [Homo sapiens (human)] receptor

CD  

Interaction Type Toxin Delivery CD  

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Example of a Protein (5)Element Name Value Data Format Note #

Element Group: Protein Number of moieties 1 INT  Sequence Type Complete CD  Number Of Subunits 4 INT  

Element Group: Protein SubunitSubunit 1 INT  Sequence QIQLQQSGPEVVKPGASVKISCKASGYTFTDYYITWVKQKPGQGLEWIGWI

YPGSGNTKYNEKFKGKATLTVDTSSSTAFMQLSSLTSEDTAVYFCANYGNYWFAYWGQGTQVTVSAASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK

ST  

Length 446 INT  Element Group: Protein Subunit (Repeat)

Subunit 2 INT  Sequence QIQLQQSGPEVVKPGASVKISCKASGYTFTDYYITWVKQKPGQGLEWIGWI

YPGSGNTKYNEKFKGKATLTVDTSSSTAFMQLSSLTSEDTAVYFCANYGNYWFAYWGQGTQVTVSAASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK

ST  

Length 446 INT  

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Example of a Protein (6)Element Name Value Data

FormatNote #

Element Group: Protein Subunit (Repeat)Subunit 3 INT  Sequence DIVLTQSPASLAVSLGQRATISCKASQSVDFDGDSYMNWYQQKP

GQPPKVLIYAASNLESGIPARFSGSGSGTDFTLNIHPVEEEDAATYYCQQSNEDPWTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

ST  

Length 218 INT  Element Group: Protein Subunit (Repeat)

Subunit 4 INT  Sequence DIVLTQSPASLAVSLGQRATISCKASQSVDFDGDSYMNWYQQKP

GQPPKVLIYAASNLESGIPARFSGSGSGTDFTLNIHPVEEEDAATYYCQQSNEDPWTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

ST  

Length 218 INT  Element Group: Protein (Part of Group)

Disulfide Linkage 1_22-1_96; 1_144-1_200; 1_220-3_218;1_226-2_226; 1_229-2_229; 1_261-1_321; 1_367-1_425; 2_22-2_96; 2_144-2_200; 2_220-4_218; 2_261-2_321; 2_367-2_425; 3_23-3_92; 3_138-3_198; 4_23-4_92; 4_138-4_1 98

ST  

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Example of a Protein (7)Element Name Value Data

FormatNote #

Element Group: GlycosylationGlycosylation Type Mammalian CD  N-Glycosylation 1_297; 2_297 ST  

Element Group: Protein subunit (Part of Group)N-Terminal Modification Pyroglutamic acid (pE) ST  N-Terminal Modification ID SZB83O1W42 (UNII) II  

C-Terminal Modification Lysine (K) ST  C-Terminal Modification ID K3Z4F929H6 (UNII) II  

Element Group: Modification (N-Terminal Modification)Modification Type Structural Modification CD  Residue Modified Glutamine ST  Residue Site 1_1; 2-1 ST  

Element Group: Structural ModificationStructural Modification Type Amino Acid Substitution CD  

Element Group: Molecular FragmentRole N-Terminal Pyroglu Formation CD  Molecular Fragment ID SZB83O1W42 (UNII) CD  Molecular Fragment Name Pyroglutamic acid (pE) CD  

Element Group: Modification (Repeat)(C-Terminal Modification)Modification Type Structural Modification CD  Residue Modified Lysine (K) ST  Residue Site 1-447; 2-447 ST  

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Example of a Protein (8)Element Name Value Data Format Note #

Element Group: Structural Modification Structural Modification Type Amino Acid Removal CD 4)

Element Group: Molecular FragmentRole C-Terminal Lysine removal CD  Molecular Fragment ID K3Z4F929H6 (UNII) CD  

Molecular Fragment Name Lysine (K) CD  Amount Type Percent removed CD  

Element Group: AmountHigh Limit 90 PQ  Low Limit 70 PQ  Non-numeric value Incomplete CD  

Element Group: Modification (Repeat)Modification Type Structural modification CD  Residue Modified Cysteine ST  Residue Site Variable ST 6)

Element Group: Structural Modification (Repeat)Structural Modification Type Amino Acid Substitution CD 5)

Element Group: Molecular FragmentRole Toxin Conjugation CD  Molecular Fragment ID 6603L01WUR (UNII) CD  Molecular Fragment Name Cysteine-VC-MMAE CD 7)

Amount Type Average Mole Ratio Toxin to Antibody CD  Element Group: Amount

Average 4.5 PQ  High Limit 3 PQ  Low Limit 5 PQ  

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Example of a Protein (9)Element Name Value Data

Format

Note #

Element Group: StructureStructural Representation Molecular Fragment

Full CD  

Molecular

Fragment

Attachment

See image below

 

ED  

Migration of data by FDA from old SRS to new G-SRS – on-going (go-live soon)

EU regulators to be responsible for substances in currently authorised products◦ Check/augment FDA to be fully ISO compliant◦ Add additional substances out of scope of migrated FDA data

Sponsor/MAH to be responsible for provision of data for new substances◦ Process to be defined – company or regulator responsibility to add data? ◦ Degree of training required may be of concern

Shared responsibility for Specified Substances◦ Regulators can do some (e.g. SSG3 – grades)◦ Regulator may be able to do some SSG2 – manufacturers

But MAHs will need to do some (or check) Will have to be done in advance of go-live for Products (currently mid-

2019)

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Tentative Plans from Regulators

Poll Question 2:Information exchange on substances between Regulatory and R&D in your company is based on:

A. Unstructured Paper + pdf based reports

B. Electronic documents enriched by extraction tools

C. Regulatory info mgmt system w formalin/output definitions

D. Fully structured info based on standard data formats

Implementation of the IDMP Regulations at Astellas

Edsel Calliste-David, Global Information Systems LeadFrits Stulp, IDMP Program Manager Managing Director at

January, 2017

WHY IS IDMP COMPLIANCE NEEDED? 44

Pharmaceutical product

Patient

MPID (S)SID PhPID PCID

Individual Case Safety Report

(ICSR)

In case of adverse event

IDMP codes

Compliance drivers:1. To allow continued compliant drug safety reporting2. To ensure continued Astellas product presence on the market

E2B (R3) 1

Dossier ManufacturingPackaged Product Pharmacy

¹ Electronic Transmission of ICSR

THE IDMP ELEVATOR PITCH

Increased patient safety• IDMP allows for improved signal detection and product control and comparison, for both

health authorities and marketing authorization holders

Improved internal product management• Unified and harmonized product definitions and identifiers improve communication and

product understanding between countries/affiliates, departments and with other companies

Ensure compliance• With related consequences to perceptions of public and regulators

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The first item has driven the decision to initiate the IDMP Program within Astellas (December 2013)

COMMISSION REGULATION (EC) No 658/2007 Article 16:

IDMP AT ASTELLAS 46

Astellas maintained the target date of IDMP legislation: July 1st, 2016Target Date

Analysis was done in 2012/2013 (EU, US, JP), leading to a global blueprintAnalysis

Initial Iteration 1 solution and process delivered in July 2016Delivery

Program approved at C-level in December 2013 and started in 2014Program approval

Data gathering / transformation ongoing, along with life cycle management of IDMP data (product by product)

Currently

SIMPLIFIED IDMP OVERVIEW AT ASTELLAS 47

CVM

AIDA

< IDMP APPLICATION >

Health Authorities

EAGLEREGISTER

• Clinical Particulars• SmPCs⁵ / PLs⁶

• Controlled Vocabularies• MedDRA⁷ / EDQM⁸ / GSRS⁹

• Medicinal Product Information

• IDMP Product Record Submissions

- RegOps²- Affiliates- RAMs³

- RegOps- Other dep.

• Data Enrichment• IDMP Submissions

- RegOps- RAMs

- RegOps- Affiliates- RAMs- GPV⁴

² Regulatory Operation ⁴ Global Pharmacovigilance ⁶ Package Leaflet ⁸ European Directorate for the Quality of Medicines³ Regulatory Affairs Managers ⁵ Summary of Product Characteristics ⁷ Medical Dictionary for Regulatory Activities Global Substance Registration System⁹

PROGRAM COMPONENTS 48

Adaptations of the RIMS10 system to support IDMP data managementRIMS

Introduction of a Structured Authoring tool to collect and manage Clinical ParticularsStructured Authoring

Introduction of an “IDMP application” capable of: Consolidating IDMP data from relevant sources; Enriching with missing IDMP information; Submitting to authorities

“IDMP application”

Introduction of a tool capable of assigning and managing IDMP related Controlled Vocabularies

CV Management

Update / introduction of required process descriptions and related instructionsUpdates process

Gathering of all required (Iteration 1) dataData

gathering

1

2

3

4

CVM

AIDA

< IDMP APPLICATION >

EAGLEREGISTER

1 2 3

4

10 Regulatory Information Management System

2. EAGLE: STRUCTURED AUTHORING OF CLINICAL PARTICULARS

One global structured authoring based system with Product Information (PI) (e.g. SmPC, PI, PL, CCDS11) for all products

• Securing oversight & availability of all approved PI

• Allowing comparison of approved PI

• Document lifecycle of all PI documents submitted to and approved by authorities

Utilized IDMP as a strong driver to capture PI documents in the global system

• With focus on generating the clinical particulars as required!

• Leading to Global Labelling System

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SPC

Select ClinicalParticular(s)

Assign Codes, via dialog and code list2

Structured Authoring Tool

1

CVM

AIDA

< IDMP APPLICATION >

EAGLEREGISTER

11 Company Core Data Sheet

3. CV MANAGEMENT MODULE

Counter part system of EMA’s RMS 12

A tool developed in-house to not only facilitate IDMP requirements but have a centralized repository to support other business areas with CVs. This tool supports:• Audit trail (in compliance with GxP, GAMP513 and 21 CFR14 Part 11)• Upload, review and comparison of new CV versions• Release and versioning for different sources• Use of multiple approved versions (e.g. MedDRA)• Cross reference of codes to enable IDMP submissions

The tool is currently setup to enable loading data from multiple sources;• Loading data through API15

• In development (upon release of CV details)• CV’s Automatic or Manual Load• Automatic or Manual Load, incl. versions

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CVM

AIDA

< IDMP APPLICATION >

EAGLEREGISTER

12 Referentials Management Services 14 Code of Federal Regulations13 Good Automated Manufacturing Practice 15 Application Programming Interface

AIDA, ASTELLAS IDMP DATA APPLICATION

• Collection of data from source systems

• Verification of correctness & completeness of source data against the agreed source data rules

• Feedback to source systems on data issues

• Creation of IDMP submission

• Version control of IDMP submission

• Validation of IDMP submission

• Package and submit IDMP (XML/ZIP)

• Manage responses (acknowledgements, rejections, approvals)

• Distribute IDMP identifiers• CV’s are used verify collected source data

• CV management is a separate component in the IDMP solution

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CVM

AIDA

< IDMP APPLICATION >

EAGLEREGISTER

IDMP ROADMAP AT ASTELLAS 52

Next stepsResults

Agile compliance to iteration 1

• Early insight into upcoming IDMP process

• Time to adopt IDMP process in organization

• Training people• Adapting systems• Implement solutions• Improved data quality

Investigational products

• EMA IDMP Iteration 2• Consistency across

submissions for IMPs16

Global approach and consistency

• Using the same systems and processes for US and Japan

EMA IDMP requirements

• Organizational & Referential information and systems

• Final guidance on Iteration 1• Iteration 4 & alignment with

Falsified Medicine

Relation to Global Labeling

• Global Labeling project• EMA IDMP Iteration 3• SPL v7 17

2014 2016

16 Investigational Medicinal Products17 Structured Product Labeling

THANK YOU FOR YOUR ATTENTION 53

Edsel Calliste-David

Global Information Systems Lead

Astellas

224-205-5762

Edsel.Calliste-David@astellas.com

www.astellas.com (Global site)

https://www.linkedin.com/in/edsel-david-38a8b19

Frits Stulp

Managing Director Consultancy

Iperion Life Sciences Consultancy

+31(0)652727351

  Frits.Stulp@iperion.nl

 www.iperion.nl

http://www.linkedin.com/pub/frits-stulp/1/aa7/b7b

IPERION CONSULTANCY HAS BEEN WORKING IN THE INDUSTRY SINCE 2012 ON ALL ASPECTS OF IDMP 54

IDMP expertise Assessments Strategy Roadmap Solution development Solution implementation Program oversight Technologies & services

Related experience XEVMPD solutions & maintenance Regulatory information management & systems (Master) data management System and solution validation Structured content authoring Pharmacovigilance and quality systems

The team’s IDMP client facing experience to-date (among others): Top 10 pharma (1 year) Large pharma (4 years) Large pharma (2 years) Speciality pharma (2 years) Small & orphan drug (1 year)

How might the Pistoia Alliance help?

• Expertise• Interest group on IDMP• Consortium based projects

Martin Romacker – RocheSergio Rotstein - Pfizer

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Ontologies Mapping Project

Pistoia Webinar IDMP: enhancing patient safety through improved R&D

information exchange19th January 2017

Martin Romacker on behalf of the Project Team

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Ontologies Mapping – Business Case

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• Increasing variety of data• Increasing number of data providers (e.g. CROs)• Increasing need for data integration (e.g. IMDP)• Lack of defined and universally applied Data Standards• Ontologies are the “smart glue” for data integration to

semantically enable knowledge managementBUT…• Many varying ontologies overlap in the same data

domain e.g. disease and phenotype, multiple standards• Need better practice, tools and services to manage

ontologies and how they map to each other=> The Ontologies Mapping Project

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Project Phase 1&2: Timeline and Deliverables

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1) Ontologies domain selected

as “test case”

2Q 3Q2015

4Q

4) Evaluate & select existingOntologies Mapping tool(s) 5)

Requirements for an Ontologies Mapping service

6) Understand the demand for anOntologies Mapping service

1Q 2Q2016

4Q3Q

2) Guidelines for minimal standards & best practices

3) Requirements for Ontologies Mapping tool

Funded by GSK, Merck & Co, Novartis, Roche and BIOVIA 3DS

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Further Achievements

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• Conformity with the FAIR principles– Findable and Accessible (public wiki)– Interoperable and Re-usable (aligned to OBO etc.)

• Endorsed by external groups:– Interoperable Services at ELIXIR, Molecular Archival Resources at

EMBL-EBI, Ontologies Mapping Project Community of Interest

• Promotion at conferences/workshops:-– EMBL-EBI March 2016, ISMB July 2016, ECCB September 2016,

Industry Semantic Forum at Roche September 2016, OM October 2016 and ISWC October 2016

• Ontology Alignment Evaluation Initiative– Sponsoring of a competition for the best ontologies matching

algorithm (International Workshop on Ontology Matching)

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Ontologies Mapping – Phase 3

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• Requirements for Ontologies Mapping Service– Build and maintain mappings for public ontologies– Build and maintain mappings of internal to public ontologies– Publishing of service requirements (feedback)– Scope: various ontologies in the disease and phenotype domain

• Provider for Ontologies Mapping Service (OMS)– Ongoing discussion with an outstanding academic institution with a

strong track in ontologies management– Evaluate quality and feasibility for sustainable OMS– Preparation of standardized SLA documents for OMS

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Value for IDMP

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• Ontologies Mapping Service for Referentials– Mapping internal vocabularies to IDMP referentials– Usage of mappings between public ontologies for data

integration processes

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Some Links

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• http://www.pistoiaalliance.org/projects/ontologies-mapping/• http://www.pistoiaalliance.org/ontologies-mapping-plans-partic

ipate-oaei-2016/• https://pistoiaalliance.atlassian.net/wiki/display/PUB/Ontologie

s+Mapping+Resources – Guidelines for Best Practices– RFI and– Ontologies Mapping Service Requirements

• Please join us sponsoring Phase 3Roche has already committed

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Acknowledgements

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Funders• BIOVIA 3DS• GSK• Merck & Co• Novartis• RochePistoia Operations• Richard Holland• John Wise• Carmen Nitsche• Nick Lynch

Project team• Ian Harrow (Pistoia Project Manager)• Martin Romacker (Roche)• Andrea Splendiani (Novartis)• Stefan Negru (Merck & Co)• Peter Woollard (GSK)• Scott Markel (BIOVIA)• Martin Koch (Osthus)• Heiner Oberkampf (Osthus)• Yasmin Alam-Faruque (Eagle Genomics)• Erfan Younesi (Bayer)• James Malone (FactBio)

Community of Interest

Pistoia Alliance HELM ProjectSetting the Standard for Biomolecular Data Exchange

19th January 2017

Sergio H. Rotstein, Ph.D.

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Introduction• Key factor for IDMP: Ability to supply a rigorous, unequivocal representation of molecular

structures• For small molecules and simple sequences, informatics technology and standards are

reasonably mature• HELM is the standard and corresponding toolkit that was created to enable the

representation and management of biomolecules of greater complexity (though it can, of course, be used for simple sequences too)

N

NH

O

O

O

N

NH

O

O

O

Small Molecules SequencesBiomolecules

• Oligonucleotides• Peptides• Proteins• Antibodies• Bioconjugates• Etc.

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The HELM Ecosystem

R&D Organizations

Software Vendors

Content ProvidersService Providers

Regulatory Agencies

• BMS• GSK• Ionis• Merck

• Novartis• Pfizer• Roche

• ACD/Labs• Arxspan• Biochemfusion• BioMax• Biovia

• ChemAxon• NextMove• PerkinElmer• Scilligence

• EBI (ChEMBL)• NCBI (PubChem)

• quattro

• FDA• ISO 11238 HELM

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Current Goal: Maximize “Adoptability”

• Removal of barriers to adoption– Biomolecular ambiguity representation– Improved architecture

• Easier to integrate into adopter’s existing infrastructure– Creation of a web-based HELM editor

– Enables integration into web-only portfolios

• Interested? – www.OpenHelm.org– info@openhelm.org

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AcknowledgementsPfizer Team• Peter Henstock• David Klatte• Christine Lawrence• Frank Loganzo• Hongli Li• Sergio Rotstein• Simone Sciabola• Rob Stanton• Nathan Tumey• Simon Xi• Tianhong Zhang

Leadership• Sergio Rotstein (Pfizer) – Project Lead• Claire Bellamy (Pistoia Alliance) – Project ManagerActive Team• Dennis Hanssen (Roche)• Stefan Klostermann (Roche)• Roland Knispel (ChemAxon)• Jeff Milton (Ionis)• Sven Neumeyer (Novartis)• Matthias Nolte (BMS)• Yohann Potier (Novartis)• Eric Swayze (Ionis)• Markus Weisser (quattro)• Tianhong Zhang (Pfizer)Steering Committee• Margret Assfalg (Roche)• Ramesh Durvasula (BMS) • Leah O'Brien (GSK)• Sergio Rotstein (Pfizer) • Eric Swayze (Ionis)• Chris Waller (Merck)• John Wise (Pistoia Alliance)• Quan Yang (Novartis)

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Audience Q&APlease use the Question function in GoToWebinar

Ontology Mapping

The next Pistoia Alliance Discussion Webinar:

Moderator:  tbd. Date: February 23, 2017

check http://www.pistoiaalliance.org/events/ for the latest information

info@pistoiaalliance.org @pistoiaalliance www.pistoiaalliance.org

Thank you all, you have been a great audience !!Hope to see you soon in a Pistoia Interest group on IDMP.

General IDMP webpage◦ http://

www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp&mid=WC0b01ac058078fbe2

Webinar held 4 August 2016◦ http://

www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/07/event_detail_001307.jsp&mid=WC0b01ac058004d5c3

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EMA Links

Back-up slides Andrew Marr

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GSRS and Substance Identification - Possibilities

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GSRS