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JOԍ9U+!'zru"_zbc>6ykt=p4l?= Y҂ Qj9X]^z݆?-h>>9iHzj. ;Y,6d0ń8g첢64:g+WW\[Y%A}=$'D#Lfmx. :uMb>s+ESu0h`ç?GIջ1"+a}優d;e"jL~];a0BrCcG>6yxN'[qatz{&#< ^^UȐe `h FVIl HT YK-TOY:hONGsMz\A3xp{8DtdE]nyDFxPdmEzKMxa^NIlLc; HHؑ>sZ|H^9,n}q7%{tl6dTfv#z<ˤ\kV^$(ZiA\MzT2\.=6)?39-[K6rĵz?NV?+uK7xnQᡒHL&?SOb1`w zOny7\|_$4!Q1Wư^(=jϑ 7aɪa2C4xl*:+[{gS ݃4=b99m#rB:U2EZM};pU>TUWQ{BIEfhfvIhԷSj~kt jXyvvϔx[͟<E'X!&]'L@uCuN)+;[uT)"{3[&b.krbvZRNFR̤bL|KJS%""^ }|*ItɍIm]*&lU3WE3Xa`2&1|+[E6D_",4^QcEDt&""f (p (0EDDяQ1TɝsDD`QD&Yk]Rq:p!N3c!""| (Q00] úw X.r QHq Q1"""" 1XDDDD!(`,"""cEDDDb BQ1"""" 1XDDDD!(`,"""cEDDDb BQ1"""" 1XDDDD!(`,"""cEDDDb B['(` `Eaw LIENDB`1( g/ 0LDTimes New Roman(0(B 0 @ .  @n?" dd@  @@`` o%@Mf bW4AA!."@%&'() d1238:<>CE45ABDFGHIJKLMob$#{+P6y$$$$b$5^:ڶ<<&"(y 0AA@*uʚ;2Nʚ;g44d4d@B 0,ppp@ <4!d!dlpC 00 <4ddddlpC 00  <4BdBdlhG 0g46d6d@B 0p@ pp80___PPT10 pp?  %O <rLondon IDEAS Pharmacogenetics Workshop 19th December 2005 tDr Paul Martin - Integrating pharmacogenetics into societyn% " 7Paul Martin, Graham Lewis, Andrew Smart, Andrew WebsterAcknowledgementsWellcome Trust Biomedical Ethics Programme funded project: The Clinical and Commercial Development of Pharmacogenetics Initial findings published in Webster A., Martin, PA., Lewis G., and Smart A. (2004) Integrating pharmacogenetics into society: in search of a model? Nature Reviews Genetics. 5(9) p663-669 Full report of findings will be published in February z0 Z;=w"""" "DA4Mapping the development of PGx Summary findings of empirical social science project: How is pharmacogenetics being developed by industry? What are the drivers and barriers facing clinical adoption? How is it being regulated? What are the implications of current development trajectories? <6ZZZ6The shaping of technology Innovation is not a linear process in translating science into technology Need the creation of a social and technical infrastructure New medical technologies shaped by industry, regulators, clinicians, policymakers, patients Early stages of innovation Creation of range of different designs and applications (options) Search for  workable solutions TJ;wcJ;wc?2Technical options for PGxJIdentified 12 discrete options under 6 headings related to key processes of drug discovery, development, marketing, purchasing, use Options are at different stages of realisation Some will not be adopted, even if they  work Two analytical divisions New v licensed drugs Safety v efficacy 0P2.0P20P2'0P2P0.'=0D7,Analysing the commercial development of PGx ZMapped the PGx industry (300+ claimed interest) Identified core universe and leading companies Mapped pattern of collaborations to identify who is investing in PGx Identified main commercial options Analysed each option Level of interest and investment Potential commercial benefits and main barriers ELSIs raised Interviews with company managersBZ^Z!Z^!G:PGx core company universeM@PGx tests in use or development / In use In development Drug metabolism 14 1 Anti-viral drug resistance 5 3 Cancer 6 6 Other conditions 4 11 Total 29 21 00E8 Large firm collaborations in PGxGlaxo SmithKline 16 Pfizer (inc. Pharmacia) 15 Bristol-Myers Squibb 8 AstraZeneca 8 Roche (inc. Roche Diagnostics) 7 Bayer 7 Aventis (inc. RPR) 6         $$!( ( ,,NA4The use of PGx in new drug discovery and developmentISupport within pharmaceutical industry for use of PGx to improve established internal processes (e.g. target selection, trial design) Will not result in stratification or segmentation More limited investment in applications that will lead to patient stratification and market segmentation Emphasis on efficacy rather than safety`Z2ZjZ(Z2i(OB*The use of PGx with already licensed drugs+* Limited interest/ investment by pharma Lack of a commercial incentive - reduced sales? Products are diagnostic tests, not drugs Significant level of interest/ investment by biotechs, diagnostic firms Creation of new market for genetic testing? Potential cost savings to drug purchasers Divergent interests  will not be driven by pharma  market failure?'ZYZIZVZLZ'YHVK>1The clinical adoption of PGx Pilot study of four licensed case study drugs (clozapine, warfarin, 6-MP/ azathioprine, isoniazid) Review of clinical literature and semi-structured interviews with prescribers Focus on drivers and barriers to clinical adoption of PGx testingB5The problem of adoption Drivers Improved decision-making, treatment and patient experience Reduce costs Barriers Complexity Evidence Utility in practice FinancenH 0H 0C6!The emerging regulatory framework"" <FDA now playing pro-active role Principles of framework established, but key details to be worked out Exact use of PGx data Assessment of diagnostics Pharmacovigilance and  off-label use Testing for already licensed drugs Orphan genotypes Ethical issues re genetic testing unresolved BfZZ.Zf.Summary New drugs Industry - investment by pharma Clinical  success of Herceptin, Glivec Regulation - permissive environment Licensed drugs Industry  investment by small firms Clinical  significant barriers (evidence, practice) Regulation  uncertainty re genetics, diagnosticsv l- 6 $% The development of public policyThe need for a  comprehensive framework Realistic expectations Create evidence base (licensed drugs/ generics) Development of genetic testing infrastructure Greater training and education re PGx Resolve ethics of genetic testing Support for SMEs developing PGx tests Regulatory policies re generics, diagnostics etc. Improved PV and oversight of licensed drugs *)ZGZ)G/PQRSTUVW^_`abcdef ` ` ̙33` 333MMM` ff3333f` f` f` 3>?" dd@,|?" dd@   " @ ` n?" dd@   @@``PR    @ ` ` p>> $(    6U P  T Click to edit Master title style! !  0\   RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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