Re-Imagining Drug Safety Powered by Genomics, Information Integration, and Emerging Technologies

Size: px

Start display at page:

Download "Re-Imagining Drug Safety Powered by Genomics, Information Integration, and Emerging Technologies"

Meagan Byrd
5 years ago
Views:

1 Re-Imagiig Drug Safety Powered by Geomics, Iformatio Itegratio, ad Emergig Techologies Abstract Scietific advacemets, emergig techologies, ad extesive iformatio have created ew opportuities for moderizig drug safety. Simulateously, the pharmacovigilace regulatory ladscape is shiftig to esure improved safety for patiets. This is the time to reimagie the drug safety sector to trasform it ito a advaced, proactive ad patiet-cetric practice.

2 Itroductio The global healthcare eviromet is udergoig trasformatio across the care delivery eco-system to provide more affordable ad quality healthcare. Ehacemets i the healthcare ecosystem have cotributed to loger life spas, but at the same time, there is a icrease i chroic diseases which require lifelog disease maagemet. This has several implicatios o drug safety, which eeds to be esured both i the log term view (iterferig with a multitude of disease coditios ad other drugs) as well as i a short term view (providig immediate relief from diseases ad cotrollig its spread). Pharmaceutical orgaizatios are leadig the way to make persoalized medicie a reality ad icreasigly movig towards demostratig health outcomes. They are also udergoig costat chage to esure ehaced safety that is aliged with the shiftig drug safety regulatory ladscape. Chagig Cotext for Drug Safety Today there is icreased awareess about health due to growig adoptio of digital techologies. Adoptio of techology i the healthcare ecosystem is also icreasig, especially the implemetatio of Electroic Medical Records (EMR). EMR systems facilitate care delivery ad moitorig, reduce medical errors, ad track health outcomes. These systems brig ease ad effectiveess i sharig patiet health iformatio. The key questio for drug safety is how itegratio with EMR ca facilitate active surveillace ad prevet adverse evets. Geomics has greatly ehaced our uderstadig of biology ad presets a huge opportuity to devise geetic diagostics ad therapies. The challege is how to ehace drug safety through persoalized safety aalysis ad adverse evet predictio for patiet-subgroups. Utilizig Geomics for Drug Safety Today geomics, alog with various tools of moder biology, allows examiatio of livig systems at uprecedeted levels of detail leadig to greater uderstadig of biology. This uderstadig is further used to develop drugs that are iheretly safer. There is also a icreasig realizatio that aimal models are ot effective i assessig toxicity. This is

3 icreasigly evidet whe predictig the impact of drugs o the Cetral Nervous System (CNS). Therefore, i-silico modelig of humas is essetial; ad i order to build good models, oe eeds the ability to examie huma fuctios with great detail. Toxicogeomics aswers how umbers ad levels of proteis beig produced i huma cells get affected whe toxic side effects occur due to drug cosumptio. Toxicogeomics combies toxicology ad geomics alog with various 'omics' approaches such as trascriptomics (study of the complete set of RNAs), metabolomics (study of the uique chemical figerprits that specific cellular processes leave behid), ad proteomics (study of proteis particularly their structures) amog others. There are a umber of ways i which toxicogeomics ca help to make safer drugs. Small geetic differeces that each idividual carries ca affect how he or she respods to a treatmet. The study of this relatioship betwee geetic variatio ad respose to a drug is the subject of pharmacogeomics. It also icludes the use of geomic-based approaches for discoverig ew drugs or repurposig old drugs for ew idicatios. Itegratig Iformatio ad Isights Biological ad Chemical Iformatio Though there are multiple iformatio sources for safety aalysis, there is o sigle platform for all the available biological ad chemical kowhow. The ext-geeratio drug safety program eeds to be able to search ad itegrate isights from structured iformatio o gees, proteis, biological fuctio, drugs, toxicity profiles, ad diseases. There is a equally critical eed to iclude relevat isights from large amouts of ustructured iformatio such as joural publicatios, articles, ad patets. Cliical Iformatio Huma trials are the primary source of cliical iformatio but these represet limited scearios with miimal iformatio whe compared to iformatio available post drug lauch. With the icreasig adoptio of IT i the healthcare delivery ecosystem, EMR data is beig evisaged to brig may beefits by effectively utilizig patiet data. Drug safety systems eed to start itegratig this data for safety aalysis. Icreasigly there has bee a surge i adoptig Electroic Data Capture (EDC) systems to icrease ad capture patiet data

4 electroically durig cliical studies. Opportuities to itegrate EDC with EMR systems for cliical isights are beig explored, ad this approach eeds to be exteded to post-marketig cliical studies. Advaced Aalytics The ability to search ad combie all relevat iformatio ad isights would provide a uique opportuity to perform advaced safety aalytics durig the trials as well as postmarketig. This requires good algorithms to combie iformatio from differet sources with the appropriate cofidece levels to draw ifereces. Data Miig Pharmacology, Pharmacokietics & Toxicology Studies Database Spotaeously Reported ADR Database Aalytics Ÿ Measuremet of Disproportioality Ÿ Clusterig & Segmetatio Ÿ Lik Aalysis Ÿ Deviatio detectio Ÿ Predictive Modelig Active Surveillace EMR Systems Database Pharmacy & Medical Health Claims Database Pre-& post-marketig Cliical Studies Database Pharmacogeomics Studies Database Ÿ Detectio, stregtheig & validatio of safety sigals Ÿ Idetificatio of specific patiet populatio at risk Datasets from Iteret Search Egies Datasets from Iteret Search Egies Aalytics use cases for drug safety Adoptig Emergig Techologies Emergig techologies are shiftig architectural paradigms. Adoptio of these techologies blurs the boudaries across systems ad provides tremedous opportuities to leverage the power of iformatio itegratio as ever before. This also eables utilizatio of distributed resources to meet the computatioal eeds of safety related processes. Primarily, the focus of drug safety is o pharmacovigilace (case processig activities) which operates i a trasactio orieted fashio. With the chagig approach to drug safety due to geomics ad the possibility of itegratig various ewer isights (geerated from vast amout of cotiually flowig iformatio), the etire architectural ladscape of drug

5 safety eeds a relook. The guidig priciples of the moder drug safety architecture would require the ability to itegrate ad aalyze safety isights quickly; eable stakeholders to access relevat iformatio ad perform aalysis, ad esure that proactive measures ca be plaed effectively to address patiet safety. Represetative, ext-geeratio drug safety architecture with seamless flow ad itegratio of iformatio ad isights Keepig Pace with Regulatory Expectatios The drug safety regulatory ladscape is costatly udergoig chages to esure ehaced patiet safety. Uderstadig regulatory expectatios ad future directio is critical to reimagie the ladscape, icludig beefit risk assessmet ad pharmacovigilace legislatios. Itegrate Iquire Idetify Improve Target Idetificatio Lead Optimizatio Biological & Chemical Iformatio Cadidate Evaluatio I-Silico Modelig (Quatitative, Math & Statistical Methods) IND Phase I-II Trials Phase III Trials Isights from Safety Studies (Scietific & Cliical Studies) Cliical Assessmet & Statistical Evaluatios Toxicogeomics Studies Pharmecogeomic Studies Post authorizatio Safety Studies Advaced Aalytics (Pharmacoepidemiology & Sigal Detectio) NDA Cliical Iformatio Risk Predictio Risk Mgmt. Plaig Risk Maagemet Post Lauch Iform Beefit Risk Assessmet & Goverace Stakeholder Commuicatios & Regulatory Iteractios TCS 5I Model o Drug Safety *The boudaries are idicative

6 TCS 5I Model of drug safety Itegrate, Iquire, Idetify, Improve ad Iform represets differet compoets of safety i the etire life cycle of a drug. The future drug safety fuctio is expected to combie various perspectives: Itegrate: costatly itegrate iformatio ad isights eeded for drug safety ad be a custodia of all safety related kowledge Iquire: collaboratig with R&D for capturig safety related isights ad executig safety studies throughout the life cycle of the drugs Idetify: perform advace aalytics to predict ad idetify safety cocers early Improve: proactively address safety cocers via risk maagemet practices Iform: devise safety commuicatio strategy (icludig safety educatio to the stakeholders such as physicias, patiets ad care givers) ad perform regulatory iteractios Coclusio There is a strog eed to develop ext-geeratio drug safety platforms based o thorough drug safety domai isights combied with cuttig-edge techology leadership capabilities ad a patiet-cetric itegrated drug safety visio. Developig a trasformatio roadmap ad appropriate chage maagemet models, keepig i mid the curret state of techology maturity i drug safety, ca eable easier adoptio of ewer platforms.

7 About The Authors Debashis Ghosh Debashis Ghosh is Presidet - Maufacturig, Life Scieces ad Eergy Busiess Group, ad also Head TCS North Idia Operatios. He is curretly resposible for the strategic, fiacial ad busiess performace of the Maufacturig, Life Scieces ad Eergy Busiess Group. Amit Saxea Amit is Master of Egieerig from Idia Istitute of Sciece, Bagalore. He has bee i the IT idustry for more tha 14 years cotributig to automatio ad trasformatio strategies i various idustry verticals. About TCS' Life Scieces Busiess Uit With over two decades of experiece i the life scieces domai, TCS offers a comprehesive portfolio i IT, Cosultig, KPO, Ifrastructure ad Egieerig services as well as ew-age busiess solutios icludig mobility ad big data caterig to compaies i the pharma, biotech, medical devices, ad diagostics idustries. Our offerigs help cliets accelerate drug discovery, advace cliical trial efficiecies, accetuate maufacturig productivity, ad amplify sales ad marketig effectiveess. We draw o our experiece of havig worked with 12 of the top 15 global pharmaceutical compaies ad 8 of the top 10 medical device maufacturers. Our commitmet towards developig ext-geeratio iovative solutios ad facilitatig cuttig-edge research - through our Life Scieces Iovatio Lab, research collaboratios, multiple ceters of excellece ad Co-Iovatio TM Network (COIN ) - have made us a preferred parter for the world's leadig life scieces compaies. Cotact Visit TCS Life Scieces Busiess uit page for more iformatio lshcip.pmo@tcs.com Dr. Rajgopal Sriivasa Dr. Sriivasa heads the Bio-IT divisio of the Life Scieces R&D at Iovatios Lab, Hyderabad. His curret research is focused o iterpretatio of geomic variatio i collaboratio with researchers at the Uiversity of Califoria at Berkeley ad Sa Fracisco. Subscribe to TCS White Papers TCS.com RSS: Feedburer: Ail Lele Ail Lele is Head, Pharmaceutical Aalytics Services i the Life Scieces Busiess Uit, TCS. His expertise icludes pharmaceutical strategic aalytics, decisio support cosultig ad pharmaceutical marketig strategy. About Tata Cosultacy Services Ltd (TCS) Tata Cosultacy Services is a IT services, cosultig ad busiess solutios orgaizatio that delivers real results to global busiess, esurig a level of certaity o other firm ca match. TCS offers a cosultig-led, itegrated portfolio of IT ad IT-eabled, ifrastructure, egieerig ad assurace services. This is TM delivered through its uique Global Network Delivery Model, recogized as the bechmark of excellece i software developmet. A part of the Tata Group, Idia s largest idustrial coglomerate, TCS has a global footprit ad is listed o the Natioal Stock Exchage ad Bombay Stock Exchage i Idia. For more iformatio, visit us at All cotet / iformatio preset here is the exclusive property of Tata Cosultacy Services Limited (TCS). The cotet / iformatio cotaied here is correct at the time of publishig. No material from here may be copied, modified, reproduced, republished, uploaded, trasmitted, posted or distributed i ay form without prior writte permissio from TCS. Uauthorized use of the cotet / iformatio appearig here may violate copyright, trademark ad other applicable laws, ad could result i crimial or civil pealties. Copyright 2016 Tata Cosultacy Services Limited TCS Desig Services I M I 12 I 16

Framework to Assess Applicability of 3D Printing in Manufacturing

Egieerig ad Idustrial Services Framework to Assess Applicability of 3D Pritig i Maufacturig Abstract 3D pritig has bee hailed as a game chager i the maufacturig sector, with major imprits across multiple