Cambridge Healthtech Institute’s Third Annual
Managing Post-Marketing Studies and Registries:
Overcoming Operational Challenges
February 4-5, 2014 | Hyatt Regency Miami | Miami, FL
Non-interventional studies are an integral part of clinical development programs and product development plans. Product benefit risk profile, comparative effectiveness data, and health economic evidences obtained from non-interventional studies are essential for multiple stakeholders, including regulatory agencies, payers, health care management organizations, formulary inclusion decision makers, healthcare professionals, as well as patients. CHI’s 3rd Annual “Managing Post-Marketing Studies and Registries” is designed to facilitate knowledge exchange around all aspects of observational research, from design of non-interventional studies and their management to application of the obtained data to business and stakeholder decisions.
CHI’s 3rdAnnual “Non Interventional Post-Marketing Studies and Registries: Overcoming Operational Challenges” is taking place February 4-5, 2014 at the Hyatt Regency Miami in Miami, FL. The gathering will once again be co-located with the Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted over 600 leaders in clinical operations and research in February 2013.
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Mon February 3 See all Short Courses
TUESDAY, FEBRUARY 4
7:00 am Registration and Morning Coffee
8:00 Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
8:05 Chairperson’s Opening Remarks
Kenneth Getz, Director, Sponsored Programs, Tufts CSDD; Chairman, CISCRP
8:15 Plenary Keynote Introduction
Nancy Mulligan, Senior Director, Operations, Patient & Physician Services,
United BioSource Corporation
8:20 Plenary Keynotes and Panel
What Does a Trial Mean in the Era of Real-Time Measurement?
Jamie Heywood, Co-Founder and Chairman, PatientsLikeMe
The Silent Partners and Their Role in Clinical Research: Improving Trial Design and Management by Understanding the Real “Customer”
Christine Pierre, President, The Society for Clinical Research Sites (SCRS)
PANEL: Perspectives from a Cast of Characters Needed for Any Successful Study Execution
9:45 Grand Opening Coffee Break in the Exhibit Hall
10:45 Chairperson’s Remarks
Adam Wilcox, Ph.D., Director, Medical Informatics, Intermountain Healthcare
10:55 KEYNOTE PRESENTATION: Will HealthCare Settings Become the Major Data Source in Non-Interventional Research?
Charles Barr, M.D., Head, Evidence Science & Innovation, Group Medical Director, US Medical Affairs, Genentech, Inc.
11:20 Using Large Existing Data System to Conduct Post-Approval Safety Studies (PASS)
Sean Zhao, M.D., Ph.D., former Pharmaceutical Executive in Global Safety Organization
Strategically planned PASS using one or multiple large existing data systems may be the best approach. The presentation will be focused on strategy, design, common methodology as well as key practical considerations of using large existing data system to conduct PASS.
11:45 Leveraging Existing Patient Databases To Build Out Post-Market Registries
Christian Reich, M.D., Global Head, Discovery Informatics, AstraZeneca
12:10 pm Optimizing Site Selection and Management for Observational Research
Kathleen Mandziuk, MPH, RN, Senior Scientific Affairs Director, PRA Late Phase Services
Identification, recruitment, activation and long-term management of clinical sites is one of the most challenging aspects of observational research. This presentation will outline a few of the major challenges and multidisciplinary strategies to address each. Several case studies will be presented to depict “real-life” examples, implementation strategies and results.
12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:15 End of Morning Session
1:25 Chairperson’s Remarks
1:35 Development of Post-Marketing Pharmacoepidemiology Study Assessing Long-Term Drug Safety
Fei Xue, M.D., Observational Research Director, Center for Observational Research (CfOR), Amgen, Inc.
The presentation will describe the experience and considerations in developing a prospective, multi-national, multi-year database study to assess the drug safety with input from FDA commensurate to mechanism of action, biological plausability, clinical trial evidence, and/or findings from studies of similar agents.
2:00 Operational Excellence in Phase IV Research
Barbara Isquith Arone, MS, Senior Director, Service Operation, Real-World Late Phase, Quintiles
In this presentation we will focus on the operational aspects of effective registries. Discussion will include creating and managing effective advisory boards, study design and planning with the end in mind, site recruitment and retention, strategies to reach quality data and successful planning for the analysis of registry data.
2:25 A Step-By-Step Path to Collect Data from Electronic Health Records Systems
Lee Walke, Senior Director, Biometrics, Mapi Real World Evidence
Which eCRF elements are best suited for extraction from EHR systems – and which are not? This presentation will describe a system that presents a hybrid approach, in which late phase EDC is used for some elements of the case report form, while an integrated EHR module collects the rest.
2:50 Panel Discussion: Meeting the Evidentiary Needs of Multiple Stakeholders by Better Non-Interventional StudiesModerator: Sean Zhao, M.D., Ph.D., former Pharmaceutical Executive in Global Safety Organization
Product benefit risk profile, comparative effectiveness data, health economic evidences obtained from non-interventional studies are essential for multiple stakeholders, including regulatory agencies, payers, health care management organizations, formulary inclusion decision makers, health care professionals, as well as patients. The panel discussion will be focused on the following topics and related questions:
- What are key considerations and approaches to balance scientific and commercial values of non-interventional studies;
- What are common utilization of non-interventional studies in supporting clinical development program;
- How can evidences generated from non-interventional studies be used in discussions with regulatory agencies during product development and post marketing in support of establishing product benefit risk profile, continual safety monitoring, and risk management and mitigation activities, as well as fulfilling regulatory post marketing safety requirement (PMRs and FUMs) ;
- What are key strategic considerations in planning global non-interventional studies to fulfill regulatory, clinical practice, health economic needs and to meet evidentiary requirements of payers
Panelists: Speakers of the Session
3:05 Refreshment Break in the Exhibit Hall
4:05 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day's sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
CLICK HERE to view the current topics and moderators
5:15 Welcome Reception in the Exhibit Hall
6:15 End of Day
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