Embed Size (px)
Citation preview
Elemental Impurities
Data Sharing Initiative
Business Development Manager
Dr. Crina Heghes
Overview
• Lhasa Limited –who are we and what we do!
• Background• ICH Q3D
• Elemental Impurities Data Sharing Initiative• Consortium aims and objectives
• Get Involved!
Who is Lhasa Limited?
Established in 1983
Not-for-profit organisation
Educational Charity
Controlled by our members; no shareholders
~350 Member organisations
Currently more that 140 employeesHQ in Leeds, UK
Account Managers in the US
Software development teams in Newcastle, UK and
Poland
Overview of Lhasa’s members by sector
Academic
Agrochemical
Biotech Pharma
Chemical
Consultant/CRO
Cosmetic
Flavours and FragrancesFood and
NutritionGenerics
Medical DevicesMultiple
Personal Products
Petrochemicals
Pharma
Government / Regulator
Speciality Chemicals
Tobacco Veterinary
Lhasa Limited – what we do
Focus
• Toxicity
• Metabolism
• Degradation
• Purge
Data & Knowledge
Sharing• consortia databases
• agreed best practise
Publications• papers
• presentations
• educational lectures
Software• databases
• decision-support tools
Universities
IndustryRegulators
Research collaborationsData sharing
Sponsorship
Free tools• KNIME nodes
• Carc-db database
• web content
Lhasa Limited – Product Suite
Purge Factor
calculation tool
Statistical/
machine
learning
DatabaseExpert system
Derek Nexus
Toxicity
Meteor Nexus
Xenobiotic metabolism
Zeneth
Chemical degradation
Vitic Nexus
Toxicity
Sarah Nexus
Mutagenicity
ICH Q3D Background
• Changing regulatory guidance has led to the need to build
knowledge of EI levels in excipients
http://www.ich.org/products/guidelines/quality/article/quality-
guidelines.html
ICH Q3D Background
• Q3D :-
• Section 5 - Information for this risk assessment includes but is not
limited to: data generated by the applicant, information supplied by
drug substance and/or excipient manufacturers and/or data
available in published literature.
• Section 5.5 - The data that support this risk assessment can come
from a number of sources that include, but are not limited to:
• Prior knowledge;
• Published literature;
• Data generated from similar processes;
• Supplier information or data;
• Testing of the components of the drug product;
• Testing of the drug product.
Elemental Impurities Data Sharing Initiative
A proactive action from the pharma industry
Facilitate more scientifically driven elemental impurities risk
assessments under ICH Q3D, and reduce unnecessary
testing as part of the elemental impurities risk assessment
efforts.
• The data shared is analytical data generated to establish
the levels of trace metals within batches of excipients
• Aims to save time and provide further evidence when
partners are setting the limits for the elemental impurities
in the API
• Lhasa acts as the ‘honest broker’ and hosts the data
within a custom version of Vitic and facilitates the data
sharing group
Elemental Impurities Data Sharing Initiative
Elemental Impurities Data Sharing Consortium
What the Consortium do?
✓ Discuss and agree upon the scientific direction of the project
✓ Contribute expertise and knowledge
✓ Monitor the data provided by the member organisations and
ensure it meets predefined quality standards
✓ Recommend priorities for work on the project
• Vision = data is accessible to industry and regulators and can be
used to make it very clear why specific excipients are regarded as
low (negligible) or higher risk in a particular formulation at a given
daily intake.
• It should be easy to understand from the data and the Risk
Assessment why controls are required or not.
How is the database used by industry?
How is the database used by industry?
• Provides a better assessment of which materials represent a more
significant risk than others
• Indicate where the risk is real and where it is negligible
• Reduce the amount of testing that is needed
• Can be used as key supportive information in conjunction with some
product specific test data for a risk assessment
• Various case studies have been presented in a Lhasa vICGMhttps://www.lhasalimited.org/publications/?custom_in_RelatedEvent=4032&o
rderby=Name
• Published in Journal of Pharmaceutical Sciences, (2018)
https://doi.org/10.1016/j.xphs.2018.04.009
Conclusions
• The feasibility of sharing excipient elemental impurity data has
been successfully demonstrated.
• Pooling and publishing data;
• Can help improve the ease with which risk assessments
can be completed
• Will give a better picture of which materials represent a
more significant risk than others
➢ Indicate where the risk is real & where it is negligible
• Reduce the amount of testing that is needed to be done
moving forward to support implementation
Get involved!
New consortium members (pharmaceutical organisations and
excipient suppliers) are actively being sought to expand the
database.
Get involved!
• Lhasa Limited acts as an honest broker and expertly curates the
data from participating organisations.
• Member organizations participating in the data sharing initiative
will join with the intent of regularly (e.g. annually) providing EI
data on non-proprietary excipients.
• Member organizations will contribute excipient elemental
impurities data to Lhasa utilizing a defined template.
https://www.lhasalimited.org/data-sharing-submission.htm
Data Donation Process
Get involved!
• All data is stored in a restricted area which can only be
accessed by named individuals (Data Scientists).
• Any data that requires blinding will be done by Lhasa and the
blinding process will stay within this restricted area.
• Once Lhasa has received the data, it will be added to the
specific Vitic Nexus Database.
• This will then be released to members via the online system.
Get involved!
Companies willing to join the initiative can directly contact Lhasa
Limited at [email protected]
Acknowledgements
The Elemental Impurities Database Consortium steering group is chaired by
Helmut Rockstroh (Hoffmann-La Roche) and consists of the following
representatives:
Laurence Harris (Pfizer), Carlos Lee (Pfizer), Joerg Bund (Hoffmann-La Roche),
Valerie Chiva (Sanofi), Christopher Day (AstraZeneca), Andrew Teasdale
(AstraZeneca), Fiona King (GlaxoSmithKline), Laura Rutter (GlaxoSmithKline),
Wilfried Keurentjes (MSD), Frans Maris (MSD), Peter Jacobs (MSD), Nancy
Lewen (Bristol Myers-Squibb), Mark Schweitzer (Novartis), Radu Horga
(Apotex), Lance Smallshaw (UCB), Juan Gil (B.Braun), Elaine Shannon
(Takeda), Agnieska Ceszlak (ZF Polpharma), Danny Eykholt (Qualiphar) and
Enid Gatimu (Abbvie).
Grace Kocks (Lhasa Limited) maintains and manages the Vitic Elemental
Impurities Database, Carol Marchant (Lhasa Limited) provides scientific
direction, Will Nye (Lhasa Limited) provides training and technical support.
Lhasa Limited
Granary Wharf House, 2 Canal Wharf
Leeds, LS11 5PS
Registered Charity (290866)
Company Registration Number 01765239
+44(0)113 394 6020
www.lhasalimited.org
Questions?
