DAY ONE | THURSDAY, APRIL 23
8:00 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 ICEBREAKER: SHARING PERSPECTIVES ON RISK BASED MONITORING IMPLEMENTATION
The rising emphasis of risk based monitoring presents new challenges for many clinical quality professionals as teams work to ensure clinical protocols evolve alongside industry standards and regulatory compliance. As a result, many clinical quality teams are taking on new responsibilities during the development of pharmaceutical trials. This interactive ice breaker session will provide an opportunity for all participants to meet with peers and engage in discussion on how risk based monitoring has impacted the day to day responsibilities for clinical quality professionals and what the implementation of those changes has looked like at different organizations.
MULT-PART MODULE: MITIGATING RISK OF MONITOR VARIABILITY AND HARMONIZING INTERPRETATIONS THROUGHOUT CLINICAL TRIALS
Differences in monitoring interpretations of clinical studies have introduced a new set of challenges for quality teams that seek to standardize risk models across clinical trials. Variances in clinical training, professional background and site standards of care can all influence how a monitor will interpret a clinical finding. While audits can reveal such differences of interpretation after the clinical trial is completed, planning and controlling for this variability in the preclinical phase can help avoid inconsistencies before they occur. As a strategy for controlling this kind of disparity, harmonized monitor interpretations are being built into monitor contracting as an aspect of a clinical team’s overall risk mitigation strategy.
- Overview of common monitor deviations and root causes
- Training clinical staff to harmonize monitor interpretations
- Building clearly defined interpretations into clinical contracting
9:30 MODULE ONE: CASE STUDY: CRO PERSPECTIVE ON UNIFORM MONITOR INTERPRETATIONS
Bill Dirkes, Senior Director, Global Quality, Internal Audit, PPD
10:15 MODULE TWO: CASE STUDY: MANUFACTUERER EFFORTS TO HARMONIZE INTERPRETATIONS
Deborah Guattery, Director, Clinical Quality Lead, PFIZER
Pending Final Confirmation
11:00 CASE STUDY: UTILIZING AUDIT FINDINGS TO STRENGTHEN DEVELOPMENT OF RISK BASED CLINICAL PROTOCOLS
As the FDA indicates a renewed focus on risk based monitoring for clinical studies, it is critical to maintain adequate auditing practices as an essential part of the preclinical trial process. While risk monitoring aims to predict possible deviations and adverse events, auditing can also provide a detailed account of what actually occurred during the protocol deviation. Auditing and risk assessment teams often work independently, but delegates will learn how these two approaches can complement one another to strengthen the clinical study over all.
- Building severity-based risk monitoring practices
- Using audit findings to develop clinical risk checklists
- Avoiding overreliance on risk monitoring systems
Patrice Horwath, Director of Clinical Operations, RALEXAR THERAPEUTICS
11:45 LUNCHEON FOR SPEAKERS, SPONSORS AND ATTENDEES
1:00 PANEL: DEVELOPMENT OF DATA DRIVEN RISK ASSESSMENT MODELS WITH STANDARDIZED CONTROLS
Risk monitoring and mitigation is now an essential aspect of a clinical quality professional’s responsibilities, but many teams lack the resources and experience to develop data driven risk assessment models that can be applied across different studies. Rather than relying on “I think” mitigation plans, clinical quality teams require an understanding of the full scope of resources available for developing these protocols. For insight into what strategies are being employed throughout the industry, panelists with experience working in CROs, as well as industry sponsors will convene to discuss the various strategies for the development of concrete plans for risk mitigation.
Irina Kulinets, MICROVENTION
Phillip Doyle, EXELIXIS
Deborah Guattery, PFIZER
1:45 PANEL: PRIORITIZING QUALITY TEAM COOPERATION DURING DEVELOPMENT OF RISK BASED CLINICAL PROTOCOL
Risk monitoring is now being accounted for within every phase of a clinical trial, however, different branches within an organization’s quality team often address this task independently. While clinical quality teams share the aligned goal of a successful clinical trial, gaps in communication protocol and monitoring oversight cause complications that could delay a product’s development. Following an overview of the many important roles within a quality team, delegates will hear the perspectives from a variety of clinical professionals that prioritize cooperation between pharmacovigilance, clinical scientists, and quality assurance professionals to ensure success in implementing risk mitigation practices into the clinical trial process.
- Overview of roles within clinical quality assurance
- Establishing question protocols and open communication
- Establishing oversight across multiple clinical studies
Michael Torok, ASTELLAS PHARMA
Klaus Goodwin, RADIUS HEALTH, INC.
2:30 ENSURING COMPLIANCE AND RISK MITIGATION FOR LATE PHASE CLINICAL STUDIES
While clinical trials often incorporate risk mitigation strategies into the early stages of pharmaceutical development, controlling for these risks in later phase studies presents a separate challenge. The rate of technological development and changes in regulatory requirements have made it difficult for quality teams to ensure compliance in risk monitoring practices over the next decade, and leaving space for noncompliance at such a late stage presents a nonviable option for pharmaceutical sponsors. For an overview of full-cycle quality by design, clinical quality professionals will benefit from seeing practical examples of how risk mitigation can be built in to clinical protocols for late stage studies.
Rachel Ruggieri, Clinical Quality Operations Lead, Oncology, MERCK
Liza Brienza, Director, Inspection Management, MERCK
3:15 COFFEE AND NETWORKING BREAK
4:00 MITIGATING CLINICAL RISKS DURING THE INTEGRATION OF ACQUIRED QUALITY SYSTEMS
As more pharmaceutical organizations engage in mergers and consolidations, many clinical quality teams have struggled to integrate external quality systems or implement established procedures within an acquired entity. The interruption in procedural continuity has introduced unique risks into the clinical trial process as quality professionals are met with resistance to the adoption of new protocols. Delegates attending this session gain insight on mitigating risk for clinical studies within newly acquired entities and how those acquired entities can work to implement the clinical quality management system of a parent organization.
Bill Dirkes, Senior Director, Global Quality, Internal Audit, PPD
4:45 PANEL: AVAILABLE RISK ASSESSMENT RESOURCES FOR THE DEVELOPMENT OF CLINICAL TRIALS
While many clinical quality teams work to implement new systems of risk mitigation, companies with established risk monitoring procedures are updating existing systems that do not account for the associated risks of electronic data gathering and emerging clinical technologies. Given the wide variety of clinical studies conducted by pharmaceutical organizations, quality professionals have struggled to find resources that best meet the challenges specific to the updates a team requires. For a complete picture of available resources to help achieve a team’s risk mitigation objectives, attendees will learn strategies for assessing a team’s specific needs and where to find the appropriate support.
TL Clarkgerman, SAREPTA THERAPEUTICS
Stefan Samuelson, SAREPTA THERAPEUTICS
Ryan O’Mara, SAREPTA THERAPEUTICS
Michael Fitzpatrick, SAREPTA THERAPEUTICS
5:30 END OF DAY ONE CONFERENCE