DIA 2019 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-522-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session addresses the concern of inconsistent real world evidence in drug safety by presenting 1) epidemiological approaches for assessing inconsistent findings in observational studies, 2) lessons learned from observational studies in a distributed research network and 3) challenges using methods that synthesize findings from observational studies.

Learning Objectives

Identify possible study factors contributing to heterogeneity of real world evidence using claims databases; Discuss lessons learned from observational studies in a distributed research network regarding heterogeneity of RWE; Describe methods for synthesizing findings from observational studies and their limitations.

Chair

Michael Blum, MD, MPH

Speaker

Epidemiological Approaches for Assessing Inconsistent Findings in Observational Studies
Huei-Ting Tsai, PhD, MS

Minimizing Heterogeneity in Distributed Research Networks: Examples from the Canadian Network for Observational Drug Effect Studies
Adrian Levy, PhD, MSc

Challenges with Methods Used to Synthesize Findings from Observational Studies
Alicia Gilsenan

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-538-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss proactively planning and pilot-testing high-quality safety monitoring programs in the pre-marketing phase to ensure timely implementation of monitoring programs and post-marketing safety studies.

Learning Objectives

Describe the role of real world data in active safety monitoring, strengths, and limitations of real world data, and basic pharmacoepidemiological study design considerations; Recognize analytic and logistical considerations in planning and testing a safety monitoring program based on use case examples and translate lessons learned to your own pharmacovigilance team.

Chair

Jeremy Rassen, DrSc, MS

Speaker

Academia Perspective
Noelle Cocoros, DrSc, MPH

Industry Perspective
Kimberly Brodovicz, DrPH

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-570-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how to complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organizational science which addresses human factors and transparency to enhance organizational learning and continuous improvement. This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future.

Learning Objectives

Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.

Chair

Brian Edwards, DrMed

Speaker

Applying CAUSAL Analysis System Theory to the TGN1412 First-In-Human Clinical Trial
Brian Edwards, DrMed

Innovation in First-in-Human Safety
Howard Greenberg, DrMed, MD, MBA, MS

Investigators from the Warfarin-Stimulated Frail Hospitalized Patients Project
Nichola Crust, MSc

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-573-L04-P; CME 1.25; IACET 1.25; RN 1.25

Following the initial success of an unprecedented collaboration between nineteen sponsors to address major pharmacovigilance challenges with regulators, this session will provide lessons learned and an update on an increasing scope of collaborative work. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 3:15-4:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Identify expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space; Discuss strategies to address pharmacovigilance challenges in the long-term.

Chair

Jose Vega, MD

Speaker

The European IV Iron PASS Consortium: Experiences from Coordinating a Multi-Company, Multi-Registry PASS
Michael Forstner, PhD

Regulator Observations and Feedback
Gerald J. Dal Pan

Advancing Safety Analytics
Paul Chang, MD

Intelligent Automation in Pharmacovigilance
Songlin Xue, MD, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-579-L04-P; CME 1.25; IACET 1.25; RN 1.25

Expectations for quality and compliance in pharmacovigilance process and systems continues to rise Having a comprehensive quality system, including a robust CAPA process, is now essential for both good quality management and to drive continuous improvement. CAPA is also a focus of inspection by many key regulatory authorities. Meanwhile, the global expansion pharmacovigilance and evolving safety requirements continue to add complexity, increasing the challenge of executing consistently in a compliant manner. This is exemplified in the challenges presented by assuring proper distribution of safety report to the right person at the right time as well as in the management of Reference Safety Information (RSI) and Investigator's Brochures (IBs) according to the EU requirements.

This session will explore these hot topics in pharmacovigilance quality and compliance and provide insight on current expectations.

Learning Objectives

Describe the trending of PV audit findings and how to detect systemic issues before the proliferation of conflicting or redundant CAPA and constructing CAPA hygiene; Discuss how to develop a CAPA at the right level of detail, with reasonable timelines and root cause classifications; Identify the changing landscape related to Reference Safety Information (RSI) and perspectives on navigating RSI complexities in light of new EU requirements; Discuss approaches for consideration in context of global

Chair

Matthew Krumrai

Speaker

CAPAs, CAPAs Everywhere: How Effective are They and How Can they be Improved?
Kelly Traverso

Optimizing Global Safety Reporting in Clinical Trials Using Local Laws
Steven Beales

Global Clinical Trials and the Complexities of Reference Safety Information (RSI)
Andrea Best, DO, MPH

Component Type: Session
Level: Basic

Round table discussion tied to session #136: Interpretation of New Pharmacovigilance Regulations: Key Insights (Monday, June 24, 2:15-3:15PM). Seating is limited. To include special guests from the session: Ajay Singh, Jane Carroll.

Chair

Jeremy Jokinen, PhD, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

Immuno-oncology (IO) agents are emerging as essential tools to treat a wide range of solid tumors and their indications for use continue to expand. However, the antitumor immune activity of these agents can also be a threat to healthy tissue, resulting in novel presentations of adverse reactions, sometimes with highly undesirable outcomes. Early recognition and intervention can have a dramatic effect outcomes, particularly for very rare events that are progressive. However, presentation can mimic other less serious conditions that do not require early intervention. Thus, these immune-mediated phenomena have become the focus of intense exploration.

This session will provide a very brief conceptual overview of these agents, followed by two presentations. the first presentation will include methodological considerations for identifying potential predictors, such as transcriptomic biomarkers or specific interleukins, etc., that might aid prevention, facilitate early detection, or predict mortality. The second presentation will provide regulatory considerations in ensuring that benefits of these products outweigh their risks. Both presentations will include examples to illustrate key points. The session will conclude with an opportunity for Q&A.

Learning Objectives

Outline basic mechanistic aspects related to the efficacy and safety of immuno-oncology agents; Describe methodological considerations when identifying utility of markers that can help in the prevention or early diagnosis of IO-associated adverse events; Discuss considerations in benefit-risk assessment and communication for these agents.

Chair

William Gregory, PhD

Speaker

Checkpoint Inhibitor-Associated Myocarditis: Prevention or Early Detection?
Tarek Hammad, MD, PhD, MS, MSc, FISPE

Regulatory Challenges in Benefit/Risk Assessment and Labeling of Immuno-Oncology Agents
Meredith K. Chuk, MD, MHS

Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to the session #154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Meredith Smith, Marc Boutin, Herve Le Louet, Theresa Mullin, Kerry-Leeson-Beevers.

Chair

Judith Zander, MD

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-19-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

The development of immuno-oncology products has spanned decades, culminating in approvals for the use of immune modulating cytokines, monoclonal antibodies, fusion proteins, genetically modified T cells, cancer vaccines and oncolytic vectors, for the treatment of cancer. Currently there are hundreds of immuno-oncology products in clinical trials.

This session will provide an overview of immuno-oncology products, highlighting the relevant preclinical safety regulations and potential safety concerns ascribed to different categories of products. Preclinical development challenges, such as, selecting the relevant pharmacology and toxicology models, distinguishing pharmacologic from toxicologic responses, and justifying first in human dose, will be discussed. Case examples highlighting the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology drugs will also be presented.

Learning Objectives

Describe immuno-oncology products, including the potential safety concerns ascribed to different immunotherapeutic modalities; Identify the regulatory requirements (and/or challenges) associated with preclinical safety evaluation for different modalities of immuno-oncology drugs; Discuss the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology products through case study presentations.

Chair

Laurie Iciek, PhD

Speaker

New Challenges for Developing HER2-Targeted Cancer Immunotherapeutics
Karin Staflin, PhD

Strategies for Preclinical Safety Assessment of Immune-Oncology Biologics
Simone Nicholson, PhD

Challenges in Predicting Animal-to-Human Safety for Immune-Stimulatory Agents from Toxicology Studies
Theresa Sweeney, PhD

Component Type: Session
Level: Basic

Round table discussion tied to session #202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration (Tuesday, June 25, 8:00-9:15AM). Seating is limited. To include special guests from the session: Songlin Xue, Michael Forstner, Jose Vega, Paul Chang.

Chair

Jill Notte

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-637-L04-P; CME 1.25; IACET 1.25; RN 1.25

Statistical attention to safety data is often times left to routine, basic calculations and tabulations. Absent statistical input, the data run the risk of being presented in ways that are unintuitive, uninformative, or in the worst case, deceptive. Speakers in this session will present examples where statisticians are collaborating with clinical colleagues and data scientists to more effectively analyze and clinically interpret safety data.

Learning Objectives

Recognize the importance of statistical engagement in the assessment of clinical trial safety data; Apply appropriate statistical methods in the analysis of safety data; Identify the need to work collaboratively with clinicians and data scientists.

Chair

Mat Soukup, PhD

Speaker

Improving Analyses and Displays for Clinical Trial Safety Data
Mary Nilsson, MS

ASA/DIA Safety WG Presents: Finding Safety Signals During Clinical Development with R Shiny
Susan Duke, MSc

FDA Perspective
Matthew Guerra, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-682-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will inform attendees about the 3S project. Funded by the Bill and Melinda Gates the WHO are working with low and middle income countries with a high disease burden in specific areas that are subject to new treatments to increase their pharmacovigilance capabilities. MHRA are collaborating in the project to ensure regulatory pharmacovigilance capacity is increased to collect, analyse and act on safety data.

Learning Objectives

Describe the rationale for 3S; Discuss how industry is key to the success of PV in low and middle income countries; Identify the need for robust regulatory frameworks for PV.

Chair

Mick Foy

Speaker

Smart Safety Surveillance (TripleS)- Pharmacovigilance Strengthening in Low- to Middle-Income Countries (LMIC)
Raj Long, MEd, MSc

Panelist
Andrea Best, DO, MPH

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-646-L04-P; CME 1.25; IACET 1.25; RN 1.25

Both regulators and sponsors are increasingly using structured frameworks to assess the benefit-risk profile of medicinal products. Such frameworks can accommodate a variety of data sources and can be supplemented by an array of graphical presentations. As experience with using structured benefit-risk assessment (SBRA) frameworks in both the pre- and post-market context accrues, a number of important questions remain, including: 1) What has been learned by FDA and EMA in regard to using a structured benefit-risk assessment framework for new drug application assessments? 2) How are these regulatory authorities continuing to train and support their reviewers in conducting such assessments? 3) What are the challenges involved in incorporating real world data into structured benefit-risk assessment analyses? 4) What are good practices in terms of evaluating the impact of different types of uncertainty on the quality of the benefit-risk assessment decision?

Learning Objectives

Describe the FDA’s and EMA’s experiences to date in implementing structured approaches to benefit-risk assessment, including the use of the Effects Tables and other tools; Discuss the key considerations in evaluating the impact of uncertainty on the quality of the benefit-risk assessment decision; Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

FDA's Experience to Date Using the Structured Benefit-Risk Assessment Framework to Support Regulatory Decision-Making
Graham Thompson

Use of Real World Evidence in Personalized Benefit-Risk Assessment: Closing the Knowledge Gap
Tarek Hammad, MD, PhD, MS, MSc, FISPE

EMA Perspective
Douwe Postmus, PhD, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-664-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will describe the process of conceptualizing, implementing, and evaluating digital risk minimization tools, using several real world examples. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 4:15-5:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the process of developing a digital risk minimization tool; Outline considerations for the effective implementation and evaluation of a digital risk minimization tool.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

Leveraging Digital for Effective Risk Minimization Tools: Operational and Policy Considerations
Simon Ingate, PhD, MBA

One Company's Perspective on Implementing Digital Risk Minimization Tools Globally
Sarah A. Frise, PhD, MS

Applying the Diffusion of Innovaton Theory Framework to the Implementation of Innovative Digital Risk Minimization Measures
Carmit Strauss, PharmD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-678-L04-P; CME 1.00; IACET 1.00; RN 1.00

Drug scheduling is implemented by regulatory agencies to mitigate the risk of drug abuse. Learn about the pivotal clinical studies required to evaluate the abuse and dependence potential of CNS-active drugs and the evolving regulatory requirements.

Learning Objectives

Describe the most recent FDA recommendations for the clinical evaluation of abuse and physical dependence of CNS-active drugs; Discuss how this data is used to determine drug scheduling and the implications of controlled substances;Evaluate the best strategies to design robust abuse/dependence potential clinical trials.

Chair

Beatrice Setnik, PhD

Speaker

Panelist
Jack Henningfield, PhD

Panelist
Beatrice Setnik, PhD

Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to session #229: An Industry Collaboration on Pharmacovigilance Analytics (Tuesday, June 25, 10:30-11:30AM). Seating is limited.

Chair

Jill Notte

Component Type: Session
Level: Basic

Join DIA Clinical Safety and Pharmacovigilance Community for a round table discussion tied to the session #282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions (Tuesday, June 25, 4:15-5:30PM). Seating is limited.

Chair

Judith Jones

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-732-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore the state-of-the-science in regard to patient involvement in benefit-risk communication for medicinal products. Interactive audience engagement will occur throughout the session to stimulate dialogue on implications for advancing the science and practice in this area. Questions will include: • What steps are regulators taking to involve patients in benefit-risk communication? • What new tools are being developed to educate patients about the benefits and risks of drugs, and how effective are they? • What are the current challenges and barriers that impede greater patient involvement in benefit-risk communication of medicinal products? How can they be addressed? • What are promising avenues for further advancing the science of patient involvement in benefit-risk communication?

Learning Objectives

Describe the state-of-the-science in terms of patient involvement in benefit-risk communication of pharmaceutical products; Discuss challenges and solutions for enhancing patient involvement in benefit-risk communication and for improving how such information is provided to them; Identify pragmatic scientific approaches for enhancing patient involvement in benefit-risk communication and the role of new types of interactive digital educational tools for patients.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

Trends in the Use of Interactive Digital Tools to Educate Patients Regarding Safe and Appropriate Use of Drugs: What Has Been Learned to Date?
Meredith Y. Smith, PhD, MPA

Patient Engagement in Pharmacovigilance and Benefit-Risk Communication: Update from EMA
Tânia Teixeira, PharmD

Involving Patients in Benefit-Risk Communication: What are the Opportunities? What are the Challenges?
Marc M. Boutin, JD

Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to session #255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance (Tuesday, June 25, 2:00-3:15PM). Seating is limited. To include special guests from the session: Bruce Donzanti.

Chair

Jill Notte

Component Type: Session
Level: Basic

Round table discussion tied to session #327: Digital Risk Minimization: The “Next Generation” Risk Management Tools (Wednesday, June 26, 10:30-11:45AM). Seating is limited. To include special guest from the session: Carmit Strauss, Simon Ingate, Meredith Smith.

Chair

Karen Ward, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-718-L04-P; CME 1.25; IACET 1.25; RN 1.25

With the advent of biosimilars on a global scale and thus the introduction of multi-source biological products, the importance of accurate pharmacovigilance and unique product traceability cannot be understated. Not only do these efforts support detection of adverse drug reactions, they give confidence to providers and patients in the safe and appropriate use of these medicines. Various approaches have been taken in attempts to facilitate unique product traceability and improve risk minimization.

This session will focus on some of these approaches and their effectiveness and will highlight the role of National Regulatory Authorities and evolving technology infrastructure to improve traceability and enable global harmonization in these approaches.

Learning Objectives

Describe the current state of pharmacovigilance efforts for biological products in various regions; Identify different approaches to unique product traceability and determine their effectiveness; Discuss how to help to identify opportunities for global harmonization to facilitate unique product identification.

Chair

Brad Jordan, PhD

Speaker

Analysis of Biosimilars Approved in EU and US: Insights into Risk Minimization Strategies
Kalindi Hapani, MPharm

Biosimilars: Should They Have a ‘Similar’ System to the Originator?
Brian Edwards, DrMed

FDA Perspective
Lubna Merchant, PharmD, MS

Biologic and Biosimilar Nomenclature: How Important is Distinguishability and International Harmonization?
Philip J Schneider, MS, RPh

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-724-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA currently uses a structured, qualitative framework for benefit-risk assessment of human drugs and biologics. This session will cover FDA’s efforts to enhance this qualitative framework and explore more advanced benefit-risk assessment methods.

Learning Objectives

Describe FDA’s approach to benefit-risk assessment under PDUFA V and VI; Discuss efforts to continue enhancing FDA’s methodological approach to benefit-risk assessment; Summarize findings from analysis of BRFs in 2017 novel drug approvals.

Chair

Graham Thompson

Speaker

Implementation of a Structured Benefit-Risk Framework into FDA's Human Drug Review
Leila Grace Lackey, MHS, PhD

CBER’s Experience with Benefit-Risk
Hong Yang, PhD

Planning and Assessing Benefit-Risk Quantitatively in the Next Decade
Susan Duke, MSc

Best Practices for Quantitative Benefit-Risk Assessments
Tommi Tervonen