BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 13.3//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:By Conny Berlin and Rachael DiSantostefano\nIn our 1-hour webin ar on the \;12 of \;July 2017 (4:30pm CET\, 3:30pm BST\, 10:30am E ST) \;we will have a presentation by Conny Berlin who \;is the ind ustry project leader of the public-private IMI PREFER project and Rachael DiSantostefano\, a task co-leader on the IMI PREFER project.  \;\n\n\n Abstract\nThe main objective of the IMI PREFER project is to strengthen pa tient-centric decision making throughout the life cycle of medicinal produ cts by developing evidence-based recommendations to guide industry\, Regul atory Authorities\, HTA bodies\, reimbursement agencies\, academia\, and h ealth care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.\ nWhile over the last years all stakeholders gained experience individually how to engage patients for decision making this project aims to bring all stakeholders together taking a structured approach to determine their nee ds\, expectations\, and concerns regarding the use of patient-preference i nformation and methodologies for patient-preference elicitation. \;\nM ethodologies for patient value elicitation are available and have been use d frequently in market research\, in health economics and outcomes researc h to substantiate real-life evidence. Further structured research has been done in projects like IMI PROTECT but there is no systematic use of these methodologies in the regulatory licensing processes yet. \;\nThe pres entation will address \;\n\n Objective of PREFER\n Changing envi ronment\n Patient preference study example\n PREFER participants\n PREFER project approach &\; status \n\nAbout the Presenters\nConny Be rlin\, Global Head Quantitative Safety &\; Epidemiology\, \;\nNovar tis International AG \;\n \n\n\nConny Berlin leads the Quantitative Sa fety &\; Epidemiology group at Novartis International AG. She holds a d egree in mathematics from the University of Rostock\, Germany and has more than 25 years of experience within the pharmaceutical industry.\nConny Be rlin has a profound knowledge of quantitative methodology as applied to cl inical and observational data and to spontaneous reports to respond to saf ety and benefit-risk questions during drug development and post-approval. \nConny Berlin is a member of the company&rsquo\;s internal Medical Safety Review Board and of the Real World Evidence Leadership Team.\nShe is well experienced in managing projects\, leading and coordinating interdiscipli nary teams. Conny Berlin is the industry project leader of the public-priv ate IMI PREFER project.\n \;Relevant references \;\n\n Esther W . de Bekker-Grob\, Conny Berlin et al. Giving Patients&rsquo\; Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public&ndash\;Private Project. Patient: Editorial\n Participant of the CIOMS working group X on "Evidence Synthesis and Meta-Analysis for Drug Safety"\; report publis hed in 2016\n Berlin C\, Blanch C et al. Are all quantitative postmarke ting signal detection methods equal? Performance characteristics of logist ic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiology and Drug Safety. 2011: 622-630\n\n \;\nRachael DiSantostefano\, \; PhD\, MS is a Director\, Benefit-Risk in Epidemiology at Janssen R&\;D\ n\n\n\nRachael L. DiSantostefano \;has nearly 25 years of pharmaceutic al research experience across the quantitative disciplines of epidemiology \, biostatistics\, and health outcomes.  \;She is currently responsibl e for guiding clinical teams in structured benefit-risk assessment\, inclu ding the use of both qualitative and quantitative methods.  \; \;S he received her PhD in Health Policy and her Master&rsquo\;s degree in Bio statistics at the University of North Carolina Gillings School of Global P ublic Health.  \;Prior to joining Janssen in 2015\, she was an epidemi ologist at another pharmaceutical company for 10 years\, where she evaluat ed medication safety and contributed to benefit-risk assessment in regulat ory submissions and at FDA Advisory Committee meetings. \; She is curr ently active as a task co-leader on the IMI PREFER project and an active m ember of the Benefit-Risk Assessment Communication and Evaluation Special Interest Group (BRACE-SIG) within the International Society for Pharmacoep idemiology.\nTo access the recording\, please visit the Video-on-Demand Li brary. DTEND:20170712T163000Z DTSTAMP:20260310T005832Z DTSTART:20170712T153000Z LOCATION: SEQUENCE:0 SUMMARY:Patient Preferences in Benefit-Risk Assessments during the Drug Lif e Cycle: PREFER – an IMI Project UID:RFCALITEM639087011128551089 X-ALT-DESC;FMTTYPE=text/html:

By Conny Berlin and Rachael DiSantostefano

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In our 1-hour webinar on the \;12 of \;July 2017 (4: 30pm CET\, 3:30pm BST\, 10:30am EST) \;we will have a presentation by Conny Berlin who \;is the industry project leader of the public-privat e IMI PREFER project and Rachael DiSantostefano\, a task co-leader on the IMI PREFER project.  \;
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Abstract

\n< p>The main objective of the IMI PREFER project is to strengthen patient-ce ntric decision making throughout the life cycle of medicinal products by d eveloping evidence-based recommendations to guide industry\, Regulatory Au thorities\, HTA bodies\, reimbursement agencies\, academia\, and health ca re professionals on how and when patient-preference studies should be perf ormed and the results used to support and inform decision making.

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While over the last years all stakeholders gained experience individually how to engage patients for decision making this project aims to bring all stakeholders together taking a structured approach to determine their need s\, expectations\, and concerns regarding the use of patient-preference in formation and methodologies for patient-preference elicitation. \;

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Methodologies for patient value elicitation are available and have be en used frequently in market research\, in health economics and outcomes r esearch to substantiate real-life evidence. Further structured research ha s been done in projects like IMI PROTECT but there is no systematic use of these methodologies in the regulatory licensing processes yet. \;

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The presentation will address \;

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About the Presenters

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Conny Berlin\, Global Head Quantitative Safety &\; Epidemiolog y\, \;
\nNovartis International AG \;

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\n Conny Berlin
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Conny Berlin leads the Quantitative Safety &\; Epidemiology group at Novartis International AG. She holds a degree in mathematics from the Uni versity of Rostock\, Germany and has more than 25 years of experience with in the pharmaceutical industry.

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Conny Berlin has a profound knowle dge of quantitative methodology as applied to clinical and observational d ata and to spontaneous reports to respond to safety and benefit-risk quest ions during drug development and post-approval.

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Conny Berlin is a member of the company&rsquo\;s internal Medical Safety Review Board and o f the Real World Evidence Leadership Team.

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She is well experienced in managing projects\, leading and coordinating interdisciplinary teams. Conny Berlin is the industry project leader of the public-private IMI PREF ER project.

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 \;Relevant references \;

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 \;

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Rachael DiSantostefa no\, \;PhD\, MS is a Director\, Benefit-Risk in Epide miology at Janssen R&\;D
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\nDiSantostefano_Rachael-201 3_p57 medium
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Rachael L. DiSantostefano \;has nearly 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology\, biostatistics\, and health outcomes.  \;She is curre ntly responsible for guiding clinical teams in structured benefit-risk ass essment\, including the use of both qualitative and quantitative methods.  \; \;She received her PhD in Health Policy and her Master&rsquo\; s degree in Biostatistics at the University of North Carolina Gillings Sch ool of Global Public Health.  \;Prior to joining Janssen in 2015\, she was an epidemiologist at another pharmaceutical company for 10 years\, wh ere she evaluated medication safety and contributed to benefit-risk assess ment in regulatory submissions and at FDA Advisory Committee meetings.&nbs p\; She is currently active as a task co-leader on the IMI PREFER project and an active member of the Benefit-Risk Assessment Communication and Eval uation Special Interest Group (BRACE-SIG) within the International Society for Pharmacoepidemiology.

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To access the recording\, pleas e visit the Video-on-Demand Library.

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