1. How to Detect Safety Reports in Social Media forProcessing in Oracle Argus?Brad GallienNovember Research Group

2. SummaryA quick look into the presentationCurrent Regulatory FrameworkApproaches to Monitoring Social MediaIntegrating Social Media into YourBusiness ProcessWhats Next 3. 3Problem Statement Lets start at the beginning Identifiable reporter Identifiable patient Medical product An adverse event or fatal outcome suspected to be cause by the product Is this an AE?From a tweet: My mom just got taken to hospital after passingout #tylenolsux It sure feels like one Reporter: child of patient, with a twitter account Patient: mom of twitter user Product: Tylenol Event: Initial hospitalization following syncope 4. 4Why Does It Matter? The infamous WOMMA study Nielson Buzzmetrics randomly sampled 500 healthcare messages Only 1 message had all four criteria Woo hoo! We are safe! So what do we have to worry about??? Current daily volume of tweets: 500 million Current daily volume of Facebook posts: at leastthat many, more counting comments Proliferation of sponsored and unsponsored health blogs(e.g. patientslikeme.com, adverseevents.com, etc.) 5. 5What Are the Regulators Saying? EMA: Guideline on good Pharmacovigilance Practices, Module IV VI.B.1.1.4. Information on suspected adverse reactions from the internet ordigital media Marketing authorization holders should regularly screen internet or digitalmedia under their management or responsibility, for potential reports ofsuspected adverse reactions If a marketing authorization holder becomes aware of a report of suspectedadverse reaction described in any non-company sponsored digital medium, thereport should be assessed to determine whether it qualifies for reporting. Unsolicited cases of suspected adverse reactions from the internet or digitalmedia should be handled as spontaneous reports. The same reporting timeframes as for spontaneous reports should be applied 6. 6More Regulatory Opinions CIOMS Section IId (p.55) of Current challenges in pharmacovigilance: pragmaticapproaches, (report of CIOMS Working Group V) states8: A procedure should be in place to ensure daily screening by a designatedperson(s) of the website(s) in order to identify potential safety case reports The working group does not believe it necessary for regulators or companiesroutinely to surf the internet beyond their own sites for individualspontaneous reports. 7. 7And More FDA Has published guidance on advertising Has yet to weigh in on adverse events But has suggested a safe harbor for sponsored sites that include anapproved link to FDA or company AE reporting site WEBAE project (Public/Private) The WEBAE project (Web Adverse Events) aims to build on these trends andform a specialist public private consortium that undertakes research into theappropriate policy and technology solutions that enable the leverage of suchweb based media mining and crowd-sourcing technologies inpharmacovigilance to strengthen the protection of public health. The ABPI (Association of the British Pharmaceutical Industry) has agood overview article http://www.abpi.org.uk/our-work/library/guidelines/Documents/ABPIGuidance on PV and Digital Media.pdf 8. 8The Perfect Big Data Storm What is big data and why does everyone keep talking about it? The broad area of concern is deriving knowledge out of unstructured data(like tweets, blog posts, publications, etc.) It is big because it typically encompasses the entire set of stuffaccessible on the knowledge It is data IF you can make sense out of it How can this technology help? The suite of big data technology can search a social media feed like Twitter,Facebook, and health blogs and use technology to identify potential adverseevents based on computer intelligence 9. 9How Does It Work? Big Data uses a few core technologies in order to deduce that astring of text might pertain to an adverse event: NLP (Natural Language Processing): In order for a computer to understandtext, it needs to know how we humans talk. Computer scientists have spentdecades developing this basic framework (driven from the field of voiceactivated computing). And just as they figured it out, we invented a newlanguage: tweeting Semantic search: This component of the technology is used when askingquestions of text. A library of triples consisting of a subject , a predicate,and an object (aspirin relieves pain, viagra is known to cause visioncoloration). The triples support the NLP processing. Ontologies: In this context, we forget the meta, and focus on the physical.Ontologies for the basis for describing things that we are looking for in thedata. The idea here is to build a universe of synonyms to help find an objectof interest. Examples include MedDRA, SNOMED, WHO-DRL, etc. but thetechnology also allows you to build custom ontologies based on human inputand computer learning 10. 10Who Is Doing it? There are several companies now that are applying thistechnology to adverse event detection IMS: Nexxus AE Tracker. Part of their library of Nexxus tools, AE Trackeridentifies potentially reportable adverse events Epidemico: MedWatcher for Enterprise. A spin off from MIT, Harvard MedicalSchool and Boston Childrens Hospital offers a subscription service tocompanies Is the technology enough? No. Both companies include manual curation of the result sets. This refinesthe results as well as feeds their custom ontologies. What are they finding? The example on the Epidemico site shows approximately 300,000mentions that the algorithms tagged with 4500 potential AEs (this is forxanax over a 3 month period) 11. 11Yikes! What Do I Need to Do? Clearly the volume of potential adverse events is staggering, butthe actionable adverse events are probably MUCH lower(remember the WOMMA study) Many companies are approaching these in an experimentalfashion Purely exploratory Post-marketing surveillance studies The regulatory agencies have not mandated this, but considerliterature sources and how they have evolved In my opinion, it is inevitable that there will be some movementtowards standard monitoring of these information feeds 12. 12Some Practical Considerations Give it a try! There are companies out there that can assist you asyour explore this emerging area Consider your operational response Be sure that you have SOPs in place for sponsored sites (patient registries,etc.) Consider products that would benefit from added surveillance (productsunder a REM for example) Stay engaged These are potentially reportable adverse events You need a staging area for them outside your global PV system Affiliate module, ARISg IRT, PRIMO, etc. Develop a set of criteria for following up on these 13. 13References and Links Innovative Medicines Initiative (WEBAE):http://www.imi.europa.eu/sites/default/files/uploads/documents/9th_Call/Calll_9_Text.pdf ABPI Document: http://www.abpi.org.uk/our-work/library/guidelines/Documents/ABPI Guidance on PV and DigitalMedia.pdf Bart Colbert article: http://www.telerx.com/blog/collecting-adverse-events-with-social-media/ Bloomberg Law: http://www.bna.com/pharma-challenges-adverse-event-reporting-and-social-media/ Eye For Pharma: http://social.eyeforpharma.com/patients/patients-social-media-and-adverse-event-reporting John Mack article: http://www.news.pharma-mkting.com/pmn93-article04.pdf 14. 14Continuing the Conversation How are companies here handling this? Are any companies doing this? How concerned are you about the potential wave of work? 15. 15Speaker BioBrad Gallien is a Vice President of Product Development at November Research Group, aprofessional services company focused on the implementation and support ofpharmacovigilance systems. He is responsible for product development at NovemberResearch Group.Brad has been focused on the pharmacovigilance business for over 15 years, leadingproduct development and implementation of global pharmacovigilance systems. This focushas provided him with a broad understanding of industry best practices and trends.Brad joined November Research Group in October 2005, after three years at OracleCorporation as Director of Life Sciences Strategy and the Product Manager for Oracle AERS.Prior to Oracle, he was Vice President of NetForce, following nine years in clinical researchand development at Syntex.Brad has a BA in Biology from UC Berkeley and MS in Zoology from University of Hawaii.Contact InfoEmail: brad.gallien@novemberresearch.comPhone: +1 415-279-9107