Transcript John Wise presentation

RSC - Chemical Information and
Computer Applications Group
Measurement, Information and Innovation:
Digital Disruption in the Chemical Sciences
Tuesday 20th October 2015, RSC, Burlington House, Piccadilly, London
John Wise, Executive Director Business Development, Pistoia Alliance
Challenges in a Changing Landscape
The Challenge for Pharma
Drug Efficacy
is not the same as
Drug Effectiveness
The terms “efficacy” and “effectiveness” have very different
meanings.
Efficacy refers to the extent to which a drug does more good than
harm in clinical trials where patients are carefully selected and
monitored
Effectiveness refers to the extent to which a drug does more good
than harm in real life where patients are not so narrowly selected and
often not closely monitored.
Hans-Georg Eichler, M.D., M.Sc.
Senior Medical Officer at the European Medicines Agency in London, United Kingdom
The Tale of Health Care Reform - DIA Global Forum December 2010 p20
© Pistoia Alliance
[Today] “Pharma is developing drugs that bring incremental benefits, but at a
premium price. This has given rise to the debate between the providers and
payers—what is the value of the extra benefit?”
3
© Pistoia Alliance
Escaping the sword of Damocles:
Toward a new future for pharmaceutical R&D (McKinsey)
How Much Does Pharmaceutical Innovation Cost?
A Look At 100 Companies
Blue Line – The number of NMEs / BLAs per company in 10 years
Brown Line – Average cost to develop each NME / BLA over 10 years
Number of NMEs and the average R&D costs / NME
12
12,000
10,000
Number of NMEs
10
8,000
8
6,000
6
4,000
4
2
0
2,000
0
Blue Arrow – Member of the Pistoia Alliance
4
http://www.forbes.com/sites/matthewherper/2013/08/11/the-cost-of-inventing-a-new-drug-98-companies-ranked/
Avergae cost / NME in Millions USD
14
A rapidly evolving ecosystem
Yesterday
Today
Tomorrow
Big Life
Science
Company
Yesterday
Today
Tomorrow
Innovation
Model
Innovation inside
Searching for Innovation
Heterogeneity of collaborations. Part
of the wider ecosystem
IT
Internal apps & data
Struggling with change
Security and Trust
Cloud/Services
Data
Mostly inside
Inside  Outside
Distributed
Portfolio
Internally driven and owned
Partially shared
Shared portfolio
Strategic Alliance in Life Sciences
“Currently there is a lack of
adequate alliance setup and
first-hand experience of
alliance management which
will most likely only serve to
inhibit the industry’s ability to
capture the full value of
strategic alliances.
To realise the true potential of
strategic alliances an increase
in the number of alliance
engagements as well as a high
commitment – be it financial
or not – is required.”
Racing to define pharmaceutical R&D external innovation models
Liangsu Wang, Andrew Plump, Michael Ringel
Drug Discovery Today, March 2015
Racing to define pharmaceutical R&D external innovation models
Liangsu Wang, Andrew Plump, Michael Ringel
Drug Discovery Today, March 2015
The Pistoia Alliance
Pistoia Alliance
Lowering the barriers to innovation in life science
R&D
by improving inter-operability of business
processes
© Pistoia Alliance
through pre-competitive collaboration
Current Pistoia Alliance members
11
© Pistoia Alliance
25th Nov 2014
IP3 encourages open innovation
•
Collection of all PA
project ideas
•
Highlights PA active
and funding portfolios
•
Discussion around
ideas
•
Progress updates and
status reports
•
Fully open to
everyone
•
Please contribute!
https://main.qmarkets.org/live/pistoia/
12
Develop new insights and new contacts via the
Pistoia Alliance webinar programme
13
Current Pistoia Alliance projects
– Chemists need to be aware of the potential hazards of their
experiments.
– However, such information is not always to hand where chemists
need it most - at the bench.
– Ontologies are critical to manage life sciences data.
– Within each domain we often find multiple ontologies being applied
– a better understanding of the ontologies that are used, and ways to
interchange between these ontologies.
– Identify industry associations, alliances, and initiatives, and identify
the domain and scope of each.
– Create pictures and tools to allow the industry to identify who it
should contact for its needs.
– Enable alliances to identify their partners and competitors and how
best to support each other and collaborate towards the common goal
of improving science.
Recent Pistoia Alliance successes
•
Controlled Substance Compliance Services
(CSCS)
– Big pharma and compound vendors alike benefit from
standardised commercial tools to interpret regulations
•
•
•
•
Sequence Services – establishing secure, cloud-based
implementations of gene sequence analysis
Sequence Squeeze - developed a number of new, faster,
better compression algorithms for NGS data
tranSMART - established an independent foundation to
maintain and support the code, community and continuity of
this popular translational research tool
Hierarchical Editing Language for Macromolecule
(HELM)
– Exchangeable and consistent notation allows for easier
sharing and representation of complex molecules, such
as antibodies
– Won the Bio-IT Best Practices Award 2014
Pistoia Alliance HELM Project
Setting the Standard for Biomolecular Data Exchange
Pistoia Alliance Project Leader: Sergio H. Rotstein, Ph.D.
Pistoia Alliance Project Manager: Claire Bellamy, MBA
What is a “Biomolecule”
ASOs
siRNAs
Peptides
Therapeutic
Proteins
Antibodies
ADCs
Vaccines
© Pistoia Alliance
Biomolecule: Anything that is not a small molecule
Stuck in the middle…
Small Molecule Tools
Sequence-Based Tools
HN
O
Sequences
O
N
O
HN
O
O
N
O
Biomolecules
© Pistoia Alliance
Small
Molecules
G
A
P
Pistoia HELM Project Goal
Transition HELM technology from Pfizer
proprietary to Open Source
© Pistoia Alliance
• Provide an industry-wide standard for data exchange
within and between organizations
• Reduce software development costs and time by
minimizing the need for companies to develop similar
functionality
Open Source HELM
HELM Editor
API
https://github.com/PistoiaHELM
Code for
• HELM Toolkit
• HELM Editor
• HELM Antibody Editor
Permissive MIT licence
© Pistoia Alliance
HELM Notation Toolkit
HELM Evolution
OpenHELM
Released
2012
2013
Pistoia
project
conceived
Pistoia
project
started
UNIVERSITY OF
CAMBRIDGE
Andreas Bender Group
Inline Search
HELM Prototype
HAbE
Released
2014
Exchangeable
HELM
2015
ChEMBL20
with HELM
© Pistoia Alliance
Paper
published
21
How do you take the HELM?
Biomolecule Data
Exchange Mechanism
Level of Adoption
22
© Pistoia Alliance
Foundation for your biomolecule
informatics infrastructure
• Registration
• Visualization
• Analysis and design
• Workflows
The HELM Ecosystem
• Pharma / Biotech / Institutes
– BMS, GSK, Lundbeck, Merck,
Novartis, Pfizer, Roche
• Software vendors
– ACD/Labs, Arxspan, Biochemfusion,
BioMax, Biovia, ChemAxon,
NextMove, Scilligence
• Content / Service Providers
• Active discussions on-going with
others
© Pistoia Alliance
– EBI (ChEMBL), eMolecules, quattro
research,
HELM Phase 2 - Ambiguity
Systems need to handle molecules that are not
always fully defined
24
© Pistoia Alliance
• A design for the representation of ambiguity has
been drafted
• RFP Issued and bid selected
• Development work starting soon
IDMP
The implementation guide for ISO 11238: Health
Informatics - Identification of medicinal products will
include HELM as an acceptable format.
25
© Pistoia Alliance
Working with the FDA to include HELM as a format within
GInAS.
• GInAS (Global Ingredient Archival System) will provide
a common global identifier for all substances used in
medicinal products or active substances under clinical
investigation
HELM Team Members
Active Team Members:
• Roland Knispel (ChemAxon)
• Matthias Nolte (BMS)
• Jan Holst Jensen (Chembiofusion)
• Thomas Gan (Merck)
• Stefan Klostermann (Roche)
• Sven Neumeyer (Novartis)
• Yohann Potier (Novartis)
• Tianhong Zhang (Pfizer)
Steering Committee Members:
• John Wise (Pistoia Alliance)
• Margret Assfalg (Roche)
• Leah O'Brien (GSK)
• Ramesh Durvasula (BMS)
• Sergio Rotstein (Pfizer)
• Alex Drijver (ChemAxon)
• Chris Waller (Merck)
• Quan Yang (Novartis)
Pfizer Team
•
Peter Henstock
•
David Klatte
•
Christine Lawrence
•
Frank Loganzo
•
Hongli Li
•
Sergio Rotstein
•
Simone Sciabola
•
Rob Stanton
•
Nathan Tumey
•
Simon Xi
•
Tianhong Zhang
© Pistoia Alliance
The Pistoia Alliance HELM Project Team, especially:
• Sergio Rotstein (Pfizer) – Domain Lead
• Claire Bellamy (Pistoia Alliance) – Project Manager