Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Drug design wikipedia , lookup
Neuropsychopharmacology wikipedia , lookup
Pharmacognosy wikipedia , lookup
Pharmaceutical marketing wikipedia , lookup
Pharmacokinetics wikipedia , lookup
Prescription costs wikipedia , lookup
Drug discovery wikipedia , lookup
Pfizer’s Centers for Therapeutic Innovation December 16, 2011 Today’s Agenda Share rationale/context for creation of CTI Provide an overview of the CTI model and progress to-date Discuss unique attributes of the academic-industry collaborative model For External Presentation Purposes Only; Not for Distribution •2 A bit of background on me… Chief Operating Officer, Centers for Therapeutic Innovation Responsible for business affairs of CTI, including alliance management Background on the commercial side of the biotech industry –R&D strategy and commercial development – MedImmune –Product management and marketing - Genentech 3 Context for Creation of CTI For External Presentation Purposes Only; Not for Distribution •4 Background Context for CTI: Challenges to Pharmaceutical Industry and Academic Centers Slow progression of pipeline Cost of drug development Cost of drug discovery •Industry Productivity Pressure from: Investors Payors Physicians Legislators Regulators Patients Focused on Translational Medicine PIs challenged to translate discoveries VC funding retreat to the clinic while Academia maintaining Public funding pressures "control" CTI New partnership to deliver on the promise of innovative discoveries to treat diseases of high unmet medical need with differentiated new medicines 5 Pharma R&D Productivity For External Presentation Purposes Only; Not for Distribution •6 Allocation of the 252 drugs approved by the FDA from 1998 - 2007 Kneller, Nature Reviews DD, 2010 Academia/Biotech •7 Past Approaches to External Partnerships Standard licenses and sponsored research agreements Pharma concern re: controlling all aspects of products, especially intellectual property – Attempts to limit publication/presentation of results – Loss of patent rights due to premature disclosure Less emphasis on understanding disease biology & mechanisms of action – Not Invented Here syndrome – Perception that non-pharma research less reliable – Led to “Valley of Death” for many academic discoveries For External Presentation Purposes Only; Not for Distribution •8 CTI – How It Works For External Presentation Purposes Only; Not for Distribution •9 Centers for Therapeutic Innovation CTI VISION Accelerate the translation of innovative discoveries from bench to the clinic CTI STRATEGY OPEN INNOVATION model that deploys Pfizer R&D resources where breakthrough science is happening CTI APPROACH A new entrepreneurial partnerships at Academic Medical centers focused on translational medicine 10 Core Elements of the CTI Model New type of partnership Focused on biologics From discovery to end of Clinical Phase I Focus on mechanisms across all disease areas Enable translational medicine Deploying people and technology Access to IND-enabling activities Equal and fair IP Financial incentives 11 CTI: Scientific Approach Scientific Approach Partner with PIs to enable development of preclinical discovery into the clinic (Phase I) Focus on protein therapeutics Parallel development of Translational Medicine approach – understanding patient heterogeneity and patient stratification Focus on Mechanisms - across all disease areas Oncology, Infectious Disease, CV, Metabolic diseases, Neuroscience, Autoimmune and Respiratory Disease 12 CTI Head In collaboration Semi-Autonomous Labs Partnership Model Encourages Collaboration Antibody Engineering Protein Group CTI Biology Processes Academic PI #1 Clinical Phage Generation Protein Purification Assay Development Translational Medicine Humanization Protein Bioanalytics Cell Signaling Bioinformatics Affinity Maturation Partnerlines Post Doc Post Doc Academic PI #2 Post Doc Toxicology PK / PD Pharmaceutical Sciences Joint Decision-Making Global Resource Access Joint Steering Committee Headquarters Collaborative decision making Go / No-go decision points and timelines Pursue alternative funding sources Declaration of POM achievement Post Doc Boston, MA Leadership and drug discovery expertise Resource allocation 13 Shared AMC Governance of the Open Innovation Model New targets and associated IP PI identifies post-docs Projects selected Discovery Research at CTI Center •Project Selected •Co-development Processes PI recruits clinical collaborator Early clinical studies conducted at AMC Evaluate program for continued inclusion Candidate Drug Selection Go / No-go for IND submission and clinical study design IND Endorsement •3–4 years $$ $$$$ •POM (+/-) POC •4 years •2–3 years Pfizer $$$ $$$ Partner lines support Regulatory Support •Decision Point •Milestone Investment Program support including clinical and translational sciences •Milestone Payment •JSC Go / No-go decision to exercise license option •Flexible Fund 14 Incentives for Collaboration with CTI •Incentives Access to proprietary Pfizer libraries Enable PI to translate the mechanism from discovery into the clinic Broad IP and publishing rights Significant financial awards 15 CTI Value Creation for Pfizer and Academic Partners Diversified Monetization Scenarios Academic Partner Assets Returned CTI POM Pfizer Assets Exclusively Developed by Pfizer to POC Assets Developed in Partnership with Third Parties Assets Out-licensed 16 Centers for Therapeutic Innovation – CTI Network CTI-Boston CTI-New York CTI-California 17 The Next Evolution of Model? Motion Picture Industry A TimeWarner Co. film produced by New Line Cinema in association with Castle Rock Entertainment Pharmaceutical Industry A CTI molecule developed by Pfizer [funded by JDRF/Pfizer] Discovered by Children’s Boston and CTI •18 Attributes of the Collaborative Model For External Presentation Purposes Only; Not for Distribution •1 Key Attributes Project Selection Process Project Team Structure Funding Approach 20 How CTI Solicits & Selects Proposals Scientifically Rigorous, but Light on Bureacracy 1 •CTI Conducts a Call for Proposals – Annually on Each Campus 2 •PIs Submit a 3-page, Non-confidential Pre-proposal for Consideration 3 •CTI Convenes a Local Joint Steering Committee to Select Finalists 4 •Finalist PIs Author a Full Proposal, Working Together with a CTI Scientist 5 •Joint Steering Committee Reviews Full Proposal and Selects Projects for Funding 21 Drill Down: The Proposal Process Key elements increase chances of success for academic project concepts to become future pipeline candidates: – Managing contamination risk – pre/full proposals – Building trust – confidentiality and limited review audience – Combining areas of expertise – co-authorship of full proposals 22 What We Look for: Key Attributes of Successful Programs • Essentials Targetable with a biologic Principally monoclonal antibodies, peptides, proteins Novel mechanism addressing key areas of unmet medical need Strong link of pathway to disease • Differentiators Ability to elucidate path to proof-of-mechanism in humans Focus on translating basic biological research into the clinic Connection of basic scientific researcher and clinical investigator Understanding of the Clinical Differentiation opportunity via Patient Stratification, Molecular Signatures, Genetic associations, Biomarkers Range of projects stages from ideas/validated pathways to pre existing mAbs 23 Project Team Structure Academic PI #1 Post Doc CTI Head Antibody Engineering Phage Generation Humanization Affinity Maturation Protein Group Protein Purification Protein Bioanalytics CTI Biology Assay Development Cell Signaling Pfizer Project Leader Academic PI Post Doc Core Team Clinical Translational Medicine Bioinformatics Partner Lines Toxicology PK / PD Pharmaceutical Sciences Pfizer Project Manager Enabling Function Reps Tox, PKPD CTI: A New Partnership Model with Leading AMCs True integration and partnership Joint governance Combining the best of capabilities within both academia and industry Aiming to translate novel discoveries into the clinic Focused on developing important medications for patients 25 This webinar is sponsored by Merrill DataSite – The Secure Virtual Data Room Solution for the Life Sciences Industry