Maximizing Emerging Technology’s Potential Chris L. Waller, Ph.D. October 2011 1 Outline • Industry Drivers for Change – Vertical Disintegration and Selective Sourcing • The Pistoia Alliance – A Pre-competitive Technology Development Experiment • eHealth – A Transformative Opportunity for Pharma Driven by Emerging Technologies • Pharma 2.0 – The Emerging Research Alliance Network Model and The Importance of Technology Partners R&D: Long, Expensive, and Risky Target Selection Chemical Selection Clinical Trials Launch Discovery (2-10 years) Pre-clinical Testing Laboratory and animal testing Phase 1 20-80 healthy volunteers - safety and dosage Phase 2 100-300 patient volunteers efficacy & safety Phase 3 3,000-5,000 patient volunteers used to monitor adverse reactions to long-term use FDA Review/ Approval Years 0 2 4 6 8 10 Cost = $1.3B/new drug 12 14 16 Productivity is Decreasing Source: Tufts Center for the Study of Drug development, PhRMA Industry Driver: Externalization PHARMA CHEM CRO SYNTHESIZE REGISTER DESIGN DISTRIBUTE ASSAY DISTRIBUTE REPORT PHARMA CHEM SYNTHESIZE BIO CRO Selectively Integrated Model DESIGN DATA CRO Fully Internal Model PHARMA Cost pressures, disruptive technologies, and other forces often drive business processes to be externalized. BIO ASSAY REGISTER REPORT DATA Opportunities Academia Co-PIs, Institutions Biotech Partnerships, JBVs Pharma Alliances, Acquisitions 6 Opportunities Academia Biotech Tech. Transfer, Start-ups Pharma Tech. Transfer, Acquisitions 7 Pistoia Alliance: Description and Purpose Mission To streamline pre-competitive workflow elements of pharmaceutical research and development by specifying common business terms, relationships and processes Goal • Develop taxonomies and vocabularies, application interface specifications, data dictionaries, data models, etc. • Establish standards that will be embraced by producers and consumers of pre-competitive workflows Pistoia Alliance: Membership as of: August 26, 2009 >65 Individuals from 18 member organizations Technology Trends Supporting eHealth SOA EMR SaaS Digital Workflow PaaS Digitization of Health Information Cloud computing Smart Apps EHR IaaS PHR Health Outcomes Registries Semantic Web Digital Paper Holographic Storagec Health Xchanges Webservices Personal Wellness Plans E-mail Mobile IP Personal Agents Internet of Thingsc GPS Unified Communications XMPP 4G, LTE IPv6, IPSec Self Monitoring Device Mobile Payments Health devices Convergence Ultra WideBand Search VOIP Smartphones Telehealth Portals Personal Assist Devices Mobile Broadcast 3D UI Ambient Social Networks Quantum wiMax Networking Communities Remote Monitoring Cryptography Telemedicine Rapid Diagnostic Kits RFID RxAuthentication Nano Photonics Low Power Senors Nanofibers Imaging sensors Biometric Senors Behavior Sensors Senor Nets(atom+, Optical Diagnostics Zigbee, Blue Lite) Digitization of Health Communication Decreasing Costs of Sensors DNA Sequencing Microfuidics Decreasing Cost of DNA Sequencing BioPhotonics DTC Genetic Testing Biomarker Microarrays OpenSource (Hadoop, Crossbow) Increased Computational Analytics Capabilities PreImplantationGenetic Diagnosis Personal Genome Record Dx-Rx Kits Molecular Imaging Predictive Models Real-time analytics BioMedical Modeling Utility Computing Grid Computing Now Solution/Service/Product 2011 Social Mining 2012 2015 2020+ Technologies 10 eHealth Focused Portfolio Patient-centric 1a Health & Wellness Consumer Electronics 2a Care provision augmentation 1b Health & Wellness SelfManagement Services 2b Clinical Decision Support Aids New Product and Services Keas Well Being / Nokia / iPhone Provider-centric Business Diversification beyond Pharma PACeR Clinical Data Flow and Uses 3a Uses of Clinical Data for R&D 3b Adverse Event Reporting Utility DAER/ASTER Maccabi 3c Health Economics Analytics Business Innovation within Pharma eHealth Strategic Priority Areas for 2010 need to be developed and validated in concert with the BUs, RUs, Divisions, and the Leadership Team 11 The Evolving Pfizer R&D Ecosystem Evolving paradigm for the discovery of medicines (Collaborative) A vision that points towards open innovation and collaborations Open research model to collectively share scientific expertise Enhance speed of drug discovery beyond individual resource capabilities (Speed) Limited research budgets and capabilities driving greater shared resources Goal to see all partners succeed by accelerating the SCIENCE Synergize Pfizer’s strengths with Research Partners (Knowledge) Pair Pfizer’s design, cutting edge tools, synthetic excellence with research partners (academics, not-forprofits, venture capitalists, or biotechs) to develop break through science, novel targets, and indications of unmet medical need Current example of academic and not-for-profits partners (Discover and Publish) Drive to publish in top journal with science receiving high visibility and interest Body clock mouse study suggests new drug potential Mon, Aug 23 2010 By Kate Kelland LONDON (Reuters) - Scientists have used experimental drugs being developed by Pfizer to reset and restart the body clock of mice in a lab and say their work may offer clues on a range of human disorders, from a few months ago we entered into a collaboration jetlag to bipolar disorder. with the giant pharmaceutical industry Pfizer to test some of their leading molecules for potential relevance to HD. Contacts: Travis Wager (travis.t.wager@pfizer.com) Paul Galatsis (paul.galatsis@pfizer.com) Emerging Technology Watch List Horizon 1 Mobility Digital Platforms Enterprise Federated Infrastructure Integration Services Collaboration and Interconnectivity Disruptive Business Innovation Horizon 2 Horizon 3