In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm GMT, 10:30am EST) we had a presentation by Conny Berlin who is the industry project leader of the public-private IMI PREFER project and by Rachael L. DiSantostefano member of IMI PREFER. They talked about:
Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle: PREFER – an IMI Project
by Conny Berlin and Rachael L. DiSantostefano
The replay of the webinar including the Q&A is now available here:
The main objective of the IMI PREFER project is to strengthen patient-centric decision making throughout the life cycle of medicinal products by developing evidence-based recommendations to guide industry, Regulatory Authorities, HTA bodies, reimbursement agencies, academia, and health care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.
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 needs, expectations, and concerns regarding the use of patient-preference information and methodologies for patient-preference elicitation.
Methodologies for patient value elicitation are available and have been used frequently in market research, in health economics and outcomes research 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.
The presentation will address
- Objective of PREFER
- Changing environment
- Patient preference study example
- PREFER participants
- PREFER project approach & status
About the presenters:
Conny Berlin, Global Head Quantitative Safety & Epidemiology
Novartis International AG
Conny Berlin leads the Quantitative Safety & Epidemiology group at Novartis International AG. She holds a degree in mathematics from the University of Rostock, Germany and has more than 25 years of experience within the pharmaceutical industry.
Conny Berlin has a profound knowledge of quantitative methodology as applied to clinical and observational data and to spontaneous reports to respond to safety and benefit-risk questions during drug development and post-approval.
Conny Berlin is a member of the company’s internal Medical Safety Review Board and of the Real World Evidence Leadership Team.
She is well experienced in managing projects, leading and coordinating interdisciplinary teams. Conny Berlin is the industry project leader of the public-private IMI PREFER project.
Rachael L. DiSantostefano, PhD, MS
Rachael L. DiSantostefano is a Director, Benefit-Risk in Epidemiology at Janssen R&D. She has nearly 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes. She is currently responsible for guiding clinical teams in structured benefit-risk assessment, including the use of both qualitative and quantitative methods. She received her PhD in Health Policy and her Master’s degree in Biostatistics at the University of North Carolina Gillings School of Global Public Health. Prior to joining Janssen in 2015, she was an epidemiologist at another pharmaceutical company for 10 years, where she evaluated medication safety and contributed to benefit-risk assessment in regulatory submissions and at FDA Advisory Committee meetings. 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 Evaluation Special Interest Group (BRACE-SIG) within the International Society for Pharmacoepidemiology.
- Esther W. de Bekker-Grob, Conny Berlin et al. Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project. Patient: Editorial
- Participant of the CIOMS working group X on “Evidence Synthesis and Meta-Analysis for Drug Safety”; report published in 2016
- Berlin C, Blanch C et al. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiology and Drug Safety. 2011: 622-63
- DiSantostefano RL, Berlin JA, Chuang-Stein C, Quartey G, Eichenbaum G, Levitan B. Selecting and Integrating Data Sources in Benefit-Risk Assessment: Considerations and Future Directions. Statistics in Biopharmaceutical Research. 2016; 8:4, 394-403.
- Bibeau K, DiSantostefano RL. Medication Guide Reading Behaviors and Attitudes Among Subjects with Migraine, Asthma, or COPD. Ther. Innov. Regul. Sci. e-publication December 18, 2014.