Innovations and Expertise in Risk Evaluation and Mitigation Strategy (REMS) Program Design and Implementation. July 2010

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1 Innovations and Expertise in Risk Evaluation and Mitigation Strategy (REMS) Program Design and Implementation July 2010

2 About BioTrak Leader and innovator in REMS program design and implementation Industry best practice methodologies for REMS Assessments Consulting experience, industry best practices, novel technology tools, REMS educational videos, REMSadvisor.com PharmaTrak Research, PharmaTrak Viewer, Treatmentsurvey.com Optimization methodologies for ETASU implementation system design REMS Design Optimization (RDO) Program State-of-the-art electronic data capture options through technology alliance BioTrak-assisTek alliance Novel technology tools for communication of REMS elements TouchPRO MobilePRO eqm 2

3 About BioTrak Two Core Consulting Areas: PharmaTrak Research drug safety risk management consulting services:» REMS Consulting: Development and implementation of Risk Evaluation and Mitigation Strategy (REMS) programs, including those with Elements to Assure Safe Use (ETASU).» REMS Assessments» Risk analysis tools and predictive market models.» Advanced analytics and statistical support.» Registries: Development and implementation of custom registry solutions for patients, health care providers and pharmacists BioTrak Custom Consulting services:» Observational research studies» Labeling comprehension studies 3» Product usability studies

4 BioTrak Fact Sheet Founded in 1999 to provide commercial support and new product planning consulting services to the pharmaceutical and medical device industry Team of 10 including researchers, pharmacists, regulatory, biostatistics experts, and support staff based in Carlsbad, California Leadership from the pharmaceutical industry Conducted over 270 total research studies and over 45 web-based questionnaire survey studies with patients, health care providers, and pharmacists Recent and relevant REMS and pharmaceutical risk management consulting experience Considered a leader and innovator in REMS assessments Key partnerships with ParagonRx (REMS assessments) and assistek (ETASU novel technology solutions) Complete offering for optional GCP program: SOPs and policies covering ethics, privacy, security, part 11 compliance, and Good Clinical Practice (GCP) and well as data server safeguards 4

5 REMS Consulting Experience 5

6 Leadership in REMS Program Design and Implementation Establishing industry best practices in REMS Assessments:» Design of efficient and successful REMS assessment protocols - Expertise in questionnaire development - Expertise in web-based survey design and secure hosting (since 2002) - Expertise in statistical analysis and sample size recommendations - Robust survey validation process including literacy review options and pretesting» Proven methods for cost-effectively recruiting prescribers and patients for Rx assessments and observational studies. Includes access to large physician and patient ailment panels as needed.» Proprietary web survey portal providing easy but well controlled online survey access at Real-time assessment reporting dashboard PharmaTrak Viewer» Bilingual, HIPAA compliant call support» Producer of a three-part videos series on REMS assessments at: 6

7 Leadership in REMS Program Design and Implementation Centralized assessment portal for easy stakeholder and client access Unique client specific dashboard for real-time assessment reporting Q3. Pharmacy dispensed Med Y Guide N 27% 73% Proprietary web coding and database system verifies survey code authorization, and directs to appropriate survey 40% Q2. HCP distributed Med Guide 60% Y 14% Q1. Med Guide Received N 86% 0% 50% 100% 7

8 Multi-Modal Recruitment Capabilities Prescribers Pharmacy Claims Databases Consumer Health Panels Pharmacy Intercept Patient Advocacy Groups/Foundations Opt-in Patient Databases Online Forums Targeted Advertisement 8

9 Leadership in REMS Program Design and Implementation Innovative solutions for ETASU program and implementation system design:» REMS Design Optimization Process (RDO); a unique, high value modeling technique providing critical insights into the expected commercial impact of a ETASU design: Model outputs predict likely: Potential to mitigate risk Stakeholder acceptance Intent to prescribe product and expected patient utilization metrics Market share impact» Novel technologies tools for ETASU implementation system data capture and communication of REMS elements: TouchPRO, MobilePRO, eqm, other Commitment to REMS education and consulting:» January 25, Launched REMSadvisor.com, the first dedicated REMS information website - (official go live date planned for February 2, 2010) 9

10 REMS Consulting Experience Disease Area Sample Product Type of Research Study Methodology Antiviral Patients New Rx Medication Cardiovascular Patients and Prescribers New Rx Medication REMS Assessment for measuring understanding of the serious medication risks REMS Assessment for measuring ]understanding of medication risks, appropriate use, and medication guide distribution compliance Cardiovascular Prescribers New Indication of Existing Rx Medication REMS Assessment for measuring ]understanding of medication risks, appropriate use, and medication guide distribution compliance CNS Patients and Physicians New Rx Medication CNS Patients New Rx Medication Epilepsy Patients New Rx Medication Epilepsy Patients Existing Rx Medication Epilepsy Patients Existing Rx Medication Gastroenterology Patients New Rx Medication Gastroenterology Patients New Rx Medication Metabolic Patients New Rx Medication Pain Patients Existing Rx Medication Surgical/Other Patients and Physicians New Rx Medication Transplantation Patients and Prescribers New Rx Medication Transplantation Patients and Prescribers Existing Rx Medications REMS Assessment for measuring ]understanding of medication risks, appropriate use, and medication guide distribution compliance REMS Assessment for measuring understanding of serious risks and medication guide distribution compliance REMS Assessment for measuring understanding of serious risks and medication guide distribution compliance REMS Assessment for measuring understanding of serious risks and medication guide distribution compliance REMS Assessment for measuring understanding of serious risks and medication guide distribution compliance REMS Assessment for measuring understanding of serious risks and medication guide distribution compliance REMS Assessment for measuring understanding of serious risks and medication guide distribution compliance REMS Assessment for measuring understanding of the serious medication risks REMS Assessment for measuring understanding of serious risks and medication guide distribution compliance REMS Assessment for measuring ]understanding of medication risks, appropriate use, and medication guide distribution compliance REMS Assessment for measuring ]understanding of medication risks, appropriate use, and medication guide distribution compliance Elements to Assure Safe Use Program, Shared REMS. REMS assessment design and implementation for patients and health care providers to measure REMS performance 10

11 Other Pharmaceutical Observational Research and Labeling Comprehension Study Experience Observational Research and Labeling Comprehension Study Experience Disease Area Sample Product Type of Research Study Methodology Allergy Patients and Parent Caregivers Injectable Drug/Device combination Observational study pre-market assessment of usability and attitudes towards a new drug delivery device One-on-one interviews Asthma Patients and Parent Caregivers Inhaled Drug/Device combination Observational study and pre-market assessment on probable use patterns and attitudes towards new inhaler technology Web-based Survey Dermatology Patients Injectable Aesthetic Observational study and pre-testing of a patient package insert for readability and comprehension One-on-one interviews Diabetes Patients Injectable Drug/Device combination Observational periapproval study on product usability and comprehension of patient package insert One-on-one interviews Patients and Parent Caregivers Rectally administered Drug/Device combination Observational periapproval study on product usability and comprehension of patient package insert One-on-one interviews Epilepsy Pharmacists Rectally administered Drug/Device combination Observational periapproval study on dose preparation and understanding of instructional materials One-on-one interviews Patients and Parent Caregivers Rectally administered Drug/Device combination Phase IV Patient Registry to measure pharmacy dispensing performance and patient understanding Survey Gastro-esophageal Reflux (GERD) Patients Orally administered Drug capsule Pre-Market Product Evaluation for new oral GERD medication including swallow test One-on-one interviews Pain Patients Inhaled medication Observational periapproval study on product usability and comprehension of patient package insert One-on-one interviews 11

12 Elements to Assure Safe Use Program Design and Implementation Capabilities 12

13 BioTrak REMS Management Process - 1 Phase III/Pre-NDA Periapproval Launch Post-market Benefit-Risk Assessment & Strategy Design Program Prepare & Negotiate Regulatory Documents Implement & Operate Assess Effectiveness Optimize & Redesign Characterize toxicities and safety concerns Identify risks associated with care delivery Itemize risks; determine which may require intervention beyond labeling (i.e., REMS) Define strategic options for risk mitigation Labeling, Appropriate Use Program, REMS Select risk mitigation strategy, e.g., REMS and/or non-rems As appropriate; create developmentstage risk management plan Develop plan with BOTH clinical and market inputs REMS Design Optimization (RDO) Pre-assessments Create REMS elements Effective risk communications Novel communication tools Elements to Assure Safe Use Implementation systems Assessment protocols Create REMS document and supporting materials Develop assessment protocol Plan contingencies Document implementation details to support negotiations Rapid response process to edit REMS Begin implementation readiness planning 13

14 BioTrak REMS Management Process - 2 Phase III/Pre-NDA Periapproval Launch Post-market Benefit-Risk Assessment & Strategy Design Program Prepare & Negotiate Regulatory Documents Implement & Operate Assess Effectiveness Optimize & Redesign ETASU implementation Specifications Operational interface considerations Reporting capabilities System development Integrate communication and training elements, agreements Validation and usability testing Beta testing Other tool integration (IVRS, wireless) HCP Communication Plans and Medication Guide Programs Implement assessment protocol(s) For REMS elements For ETASU For REMS performance Define and produce reports of REMS effectiveness For REMS elements For ETASU For REMS performance Define measures, metrics, and reporting for internal REMS Effectiveness Management process Root cause analysis Re-design program Re-design REMS promotion Re-define internal communications & commitments Rapid response to changes in REMS elements content, design, and promotion 14

15 BioTrak s REMS Design Optimization (RDO) Process for ETASU Key Business Question: Which REMS ETASU program design do we adopt? How will it effectively mitigate risk? What impact will it have on the potential market? Answer REMS Design Optimization: Identify the REMS ETASU program design and options with best predicted probable market outcome Decision Tree Analysis (DTA) Market Simulation Models Primary research with Stakeholders Market outcome predictions The Process Build the Decision Tree Design 2-3 REMS ETASU program concepts Develop a branch for each ETASU program design Represent ETASU design tradeoffs or variations using branches within the decision tree Construct Supporting Models Impact on risk mitigation Usability and acceptability Intent to use Intent to prescribe Prescribing intensity Link model metrics and tradeoffs to Decision Tree Populate Prediction Models for each REMS ETASU Design Populate models using quantitative research with intended stakeholder groups Optimization of ETASU Program Design from a Commercial and Risk Mitigation Perspective Select tradeoff options observe impact on market prediction Adopt best probable outcome Examine DTA Policy Suggestion Review best probable outcome for all options Policy suggestion illustrates best probable outcome Perform Monte Carlo Simulation or Build Conjoint Simulator Model Generate a probabilistic (riskadjusted) market predictions for each REMS program branch Results populate Decision Tree 15

16 Integrated REMS ETASU Solutions BioTrak-assiTek REMS ETASU Technology In March 2009, BioTrak formed a technology partnership with assistek to offer state-of-the-art solutions for REMS ETASU programs. REMS Program Design, Implementation & Assessment Expertise BioTrak REMS-related consulting experience: ETASU design, Med Guides, HCP Communication plans REMS assessment best practices Commercial planning expertise Market research expertise Analytics/STATS Performance reporting Innovation Toolbox assistek Over 100 Electronic data capture programs Databases and novel registration technology solutions Wireless and internet based health questionnaires and data collection Multimedia communication tools and devices, touch screens 16

17 BioTrak-assisTek Alliance Electronic Data Capture Solutions assistek has extensive experience with web, touch screen tablet, and recently mobile phone design and deployment for electronic questionnaire and data capture. Mobile/cell phones Site Sponsor Data Collection Options Touch screen tablets Electronic Questionnaire Link (e-ql) (web-based) Electronic Questionnaire Data (e-qd) (web-based) Source Data Delivery (required by regulations).assistek Data Repository Electronic Questionnaire Management (e-qm) (web-based) Sponsor Data Delivery System (ASCII, SAS or customized) (technology based on customer needs) 17

18 BioTrak assistek Alliance Novel Technology Solutions TOUCHPRO Implemented to collect data from patients, physicians, nurses, in 26 countries for 15 years. Most broad and in depth experience using this technology in pharmaceutical studies. Multimedia device with internet capability Almost 100 assistek studies with this device, high customer satisfaction Effectively engages patients and prescribers Novel approach to communicate REMS elements One touch wireless access to registry portal Windows XP software Customized web browser screens will make registry interface easy to follow and read Proven robust platform Can run locally to reduce costs 18 MOBILEPRO Selected for multiple PRO and clinical studies to remotely capture patient survey data. Load video and MP3 files for audio-visual communication of key risk messages and training modules. Fast, convenient registration, verification, and questionnaire administration for patients at point-ofservice or point-of-prescription. Multimedia device with internet capability Effectively engages patients and prescribers One touch wireless access to registry portal Novel approach to communicate REMS elements Windows XP software Customized web browser screens

19 Example of ETASU Implentation System Capability Through BioTrak-assiTek Whslr Pharm MD Patient E N R O L L I N T E R F A C E Manufacturer DATABASES Enrollment Longitudinal Pt Medication Record MD Attestation & Training Documentation Pt Education & Agreement Documentation Pharmacist training and attestation Supply chain tracking D A T A I N T E R F A C E WEB TOUCHPRO CALL CTR Volof EUs shipped Enrolled MD Written Rx w DEA # MD EDUCATES, COUNSELS, MONITORS & REASSESSES Whslr Pharm RPH VERIFIES MD & PT ENROLLED, ATTEST, EDUC & AGREEMENT PT AGREES & COMMU- NICATES Enrolled Patient Dispense tabs with instructions Vol of EUs received Vol of EUs shipped Vol of EUs received Vol. of units dispensed Vol. of units refilled OPERATING REPORTS Enrollment Usage PERFORMANCE REPORTS Gaps in bulk vs. dispensed/refills Noncompliance events Alerts SUPPLY CHAIN REPORTS FDA 19

20 Compliance and Quality Assurance 20

21 Compliance Statement Ethics policy, training, and designated Ethics Officer Good Clinical Practice (GCP) and Part 11 compliance procedures and training program Privacy and Security compliance procedures and training program and designated Officer 100% of staff NIH certified in human subjects research and privacy Data management safeguards Secure server - Physical and IP security measures (i.e. intrusion detection, encryption security, locked restricted access room) Remote (offsite) backup and disaster recovery plan Offer SSH that is user name/password authenticated SSL on all data collecting websites In compliance with all federal, state and local laws no history of non-compliance 21

22 BioTrak-assisTek Alliance REMS ETASU System Validation and Quality Assurance The BioTrak-assisTek ETASU alliance has strong processes for implementation system validation (audited many times with compliments from Top 10 pharma). System Development Life Cycle NewSoftwareVersionasneeded 1 P r o je c t KickOff 2 P r o je c t M a n a g e - m e n t 3 * T r a n s la tio n (If a p p lic a b le ) 4 R e q u ir e - m e n ts 5 D e s ig n 6 T e s tin gp r e p (eachversion ) 7 D e v e lo p m e n t (eachversion ) 8 * T e s tin gd e v ic e M a n a g e m e n t (eachversion ) 9 T e s tin g (eachversion ) 1 0 * U s e ra c c e p ta n c e T e s tin g (if a p p lic a b le ) 1 1 F in a l V a lid a tio n * S y s te m s D e c is io n s F o rm L e g e n d SDLCPhases SDLCDeliverables E s tim a te P ro je c t H o u rs P ro je c t S c h e d u le V a lid a tio n P la n P ro je c t B in d e r A s s is t T ra n s la to rs re v ie w tra n s la tio n s fro ms p o n s o r a n dre v is e asnecessary R e q u ire m e n ts / R e q u ire m e n ts A d d e n d u m T ra c e a b ility M a trix P a rt 1 D e s ig n S tra te g y Design / D e s ig n A d d e n d u m T ra c e a b ility M a trix P a rt 2 * D a ta T ra n s m is s io n V e rific a tio n * M C F /Im a g e a n ds ite C o n fig u ra tio n C h e c k lis t c re a tio n T e s t S tra te g y T e s tin g R e s o u rc e A lo c a tio n (if a p p lic a b le ) T e s t P la n T ra c e a b ility M a trix P a rt 3 C la rific a tio n L is t FixIssuesIfNeeded S o u rc ec o d e V e rific a tio n (firs t v e rs io n o n ly ) V e rs io n C o n tro l DevelopCode P e e rc o d e R e v ie w R e c o rd s U n it T e s t R e c o rd s * M C F /Im a g e a n ds ite C o n fig u ra tio n C h e c k lis t v e rific a tio na n d a p p ro v a l(if a p p lic a b le ) C o d es e t to R E A DO N L Y inv S S C o n fig u reo n e d e v ic ew / n e w versionof s o ftw a re M C F /Im a g e QualityCheck IssueReports (asneeded ) In te rn a l R e q u e s t fo r d e v ic e s C o n fig u re m u ltip le devicesw / n e wv e rs io n o f s o ftw a re S ig no u t to T e s tin g TestPlanExecution Tracktest c a s e so n d e v ic e sv ia labels (if a p p lic a b le ) Is s u e R e p o rts (a s n e e d e d ) T ra n s fe r d e v ic e sto S y s te m s E n g in e e rin g fo ra n a ly s is, (if a p p lic a b le ) Is s u e S u m m a ry L o g * T ra n s la to rs R e v ie w tra n s la tio n s o nd e v ic e * T ra n s la tio n Is s u e R e p o rts * T ra n s la tio n Is s u e S u m m a ry L o g U s e ra c c e p ta n c e T e s tin gd a tae n try S h e e t (if a p p lic a b le ) IssueReports (if a p p lic a b le ) UATApprovalForm V a lid a tio n S u m m a ry C o d el o c k a fte r V a lid a tio n S u m m a ry s ig n e d A l d o c u m e n ts inproject b in d e r w ith in1 0 d a y s Alphatesting 22

23 Contact Larry Risen President BioTrak Market Intelligence, Inc Balfour Court - Suite 201 Carlsbad, CA t f

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