March 2013
Day two of the 1st Test in Dunedin, NZ
England collapse to 167 all out.
New Zealand 131-0.
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Re-thinking the
R&D Paradigm to
Drive Change,
Innovation and
Progress across
the Drug Discovery
and Development
Realm
“If we want things to stay as
they are, things will have to
change. D’you understand?”
John Wise
Executive Director, Pistoia Alliance
Programme Coordinator, PRISME Forum
http://pistoiaalliance.org
Beyond The Shadow of a Drought: The Need for a
New Mindset in Pharma R&D - Oliver Wyman
http://www.oliverwyman.com/4638.htm#.URpXYirKeMo
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“…standing on the shoulders of giants”
Sir James Whyte Black
OM FRS
Nobel Prize for Medicine 1988
1924 – 2010
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Challenges in a Changing Landscape
• 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.
[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?”
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
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Figure 3 | R&D productivity model: parametric sensitivity analysis. This parametric sensitivity analysis is created from an R&D model that calculates the capitalized cost per
launch based on assumptions for the model’s parameters (the probability of technical success (p(Ts)), cost and cycle time, all by phase). When baseline values for each of the
parameters are applied, the model calculates a capitalized cost per launch of Us$1,778 million. This forms the spine of the sensitivity analysis (tornado diagram). At the top of the
graph are the parameters that have the greatest effect on the cost per launch, with positive effect in blue (for example, reducing cost) and negative effect in red. Parameters
shown lower on the graph have a smaller effect on cost per launch.
“How to improve R&D productivity: the pharmaceutical industry’s grand challenge” - Steven M. Paul et al.
MARCH 2010 | VOLUME 9 www.nature.com/reviews/drugdisc
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http://c1776742.cdn.cloudfiles.rackspacecloud.com/downloads/pdfs/GartnerMagicQuadrant.pdf
Isambard Kingdom Brunel, (1805-1859)
http://www.brunel.ac.uk/about/history/ikb/greateastern
The 'Great Eastern', or 'Leviathan', launched 1858. Larger than any previous ship - not equalled
in size for another 50 years. Paddle and screw propulsion & designed to carry 4,000 passengers.
Made only nine Atlantic crossings before her conversion to a cable-laying ship.
Length 692 feet. Displacement 32,000 tons. Total IHP 8,300.
The Great Eastern later went on to lay the first cable to India in 1870.
http://en.wikipedia.org/wiki/Submarine_communications_cable
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1858 cable – 0.1 words per minute
1866 cable – 8 words per minute
1900s – 120 words per minute
2001 – VSNL Transatlantic – 5.1 Tbits
~ 1 * 10^9 words per minute
http://en.wikipedia.org/wiki/Transatlantic_telegraph_cable
1.
2.
3.
4.
5.
6.
7.
8.
Polyethylene
"Mylar" tape
Stranded metal (steel) wires
Aluminum water barrier
Polycarbonate
Copper or aluminum tube
Petroleum jelly
Optical fibers
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Wave Division Multiplexing
The Information Ecosystem - Dream or Reality?
Scientific Strategy
R&D Decision
Support
Project managers
Research Teams
Resource, process
management
Scientific Analysis
Regulatory Strategy
Risk Management /
Signal Detection
Virtual
Pharma
Public / Private
Partnerships
Regulators
Web Interface
Standards-based, Scalable, Analytical Processing,
Workflow and Knowledge Management
Ecosystem Semantic Interface
Co-Development
Partners
Product X-licensing
in vitro
in silico
in vivo
in patient
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The Pistoia Alliance
John Wise
Executive Director, Pistoia Alliance
Programme Coordinator, PRISME Forum
http://pistoiaalliance.org
The Pistoia Mission
Lowering the barriers to
innovation
by improving inter-operability of
R&D business processes
through pre competitive
collaboration
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Pistoia Alliance Membership
Board
Other Members
Q1 2013
Cloud-based Sequence Services
• 10 Companies or Consortia responded to the Phase 2 RFP
• 3 Consortia were selected to implement the Phase 2 Specification
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Sequence Squeeze Results & Winner
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Financial Times
25-Feb-13
Current portfolio of Pistoia Alliance projects
• AppStore
– to encourage innovation in the information eco-system through
the encouragement, creation and discussion of life science R&D
Apps
• Controlled Substance Compliance Service
– to enable pharma to maintain compliance in whatever geography
they or their externalised research partners are operating,
• HELM
(Hierarchical Editing Language for Macromolecules)
– a standard approach for a computer-based way of managing large
molecules such as Peptides, Antibodies, Therapeutic Proteins and
Vaccines.
• tranSMART
– to enable scientists to mine and analyse translation research data
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09:00 – Michael Braxenthaler & Yike Guo
Michael Braxenthaler, PhD
President of the Pistoia Alliance
Global Head Strategic Alliances, Pharma Research and
Early Development Informatics - Roche.
Yike Guo, PhD
Professor of Computing Science, Imperial College
London.
Chief Innovation Officer, IDBS Ltd
Building a tranSMART-based data integration and
analysis platform for translational research in a broad
public-private partnership approach
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09:30 – Harsukh Parmar
Harsukh Parmar, MD
Head of Translational and Experimental Medicine –
Inflammation, Roche
Vice President and Global Head of Early Clinical
Development in the Respiratory and Inflammation
Therapeutic Area, AstraZeneca
MD from the University of Aberdeen, Scotland
Postgraduate research at Westminster and Charing
Cross Hospitals.
Extensive publications.
At the interface of Evolution, Revolution and Innovation in
Pharma R&D
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10:30 – Stevan W Djuric
Stevan W Djuric, PhD
Senior Director at AbbVie Inc.
Rhone-Poulenc Rorer
Searle/Monsanto/Pharmacia/Pfizer
PhD University of Leeds
Enabling chemistry technologies: Accelerators of Drug
Discovery
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11:00 - Peter Hamley
Peter Hamley, PhD
Global Head, Parallel Synthesis & Natural Products at
Sanofi-Aventis
AstraZeneca
PhD Cambridge, University
BSc Imperial College, University of London
Cycle time and attrition improvements through chemistry
innovation at Sanofi
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11:30 – Alastair Lawson
Alastair Lawson
Head of Antibody Biology at UCB Celltech
Head of UCB's A2HiTä technology, in which
biologically-derived information is being used to
power small molecule design.
Antibodies as tools in small molecule drug discovery
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13:30 – Matthias Gottwald
Matthias Gottwald, PhD
Vice President Research Policy and Collaborations,
Bayer Pharma AG
Microbiologist
Partnering along the value chain – finding the right model
for different needs
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14:00 – Matt Pando
Matt Pando, PhD
Chief Scientific Office, VP R&D and Member of
Executive Committee at Diaxonhit
Navigating the technological currents in an evolving R&D
environment
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14:30 – Suvit Thaisrivongs
Suvit Thaisrivongs, PhD
Vice President, Discovery Chemistry, Pfizer
Undergraduate degree from Harvard College
Graduate degree from California Institute of
Technology
Post-graduate work at the ETH, Swiss Federal
Institute.
Selective covalent inhibition in contemporary medicinal
chemistry design: Covalent-reversible inhibitors of
Bruton’s Tyrosine Kinase
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15:00 – Shane Olwill
Shane Olwill, PhD
Senior Director Pharmacology and Oncology, Pieris
Director of Research and Development, Fusion
Antibodies
Dublin Institute of Technology
University of Ulster
Multispecific therapeutic proteins: cutting edge
approaches for addressing unmet medical needs
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16:00 – William W. Johnson, PhD
Bill Johnson, PhD
VP Global Operations at SOLVO Biotechnology
GlaxoSmithKline
OSI Pharmaceuticals
Schering-Plough Research Institute
Roles of Transporters in ADMETox
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16:30 – Daniel Zicha, PhD
Daniel Zicha, PhD
Head of Light Microscopy, Cancer Research UK,
London Research Institute
Institute of Medical Genetics, Czech Academy of
Sciences
Potential of interference microscopy in cancer diagnosis
and treatment
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