DIA 2016 Annual Meeting

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-523-L01-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000186; RN 1.25

This forum will provide an overview of traditional small molecule drug development, and highlight special considerations, opportunities, requirements, and risks for specialized programs, such as oncology, vaccines, biologics, or breakthrough therapies.

Learning Objectives

Explain how oncology, vaccine, and biologic drug development are similar to, or different from, a traditional small molecule program; Compare and contrast oncology, vaccine, and biologic drug development with respect to project leadership and project management strategies, approaches, and resource investment decisions; Discuss the impact of breakthrough therapy designation on each of these.

Chair

Eva M. Finney, PhD, PMP

Speaker

Panelist
Susan Uptain, PhD

Panelist
David Robinson, PhD

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-554-L01-P; CME 1.25; IACET 1.25; RN 1.25

In this session, representatives from large pharmaceutical companies will present and discuss the science, current methodologies and achievements in their advanced clinical programs in the area of immuno-oncology. They will address what makes the difference to standard and targeted therapies, what has been learned by studying the interaction of the tumor and the immune system, and the predictors for patient response.

Part 2 is scheduled for Monday, June 27, 10:45AM-12:00PM.

Learning Objectives

Describe the most recent advances in cancer immunotherapy; Discuss the interaction of the tumor and the immune system; Identify predictors for patient response.

Chair

Holger G. Adelmann

Speaker

Overview of Immuno-Oncology
Ashok K. Gupta

Molecular Predictors of Response to Immuno-Oncology Therapeutics
Brandon Higgs, PhD

Opportunities and Challenges for the Use of Biomarkers in Anti-PD1/PD-L1 Immunotherapy
Ti Cai, PhD

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

As clinical care moves toward increasingly patient-centric models, research must also account for the participant’s perspective in order to maximize clinical trial recruitment, enrollment, adherence, and completion. Quality indicators that capture information about participant preferences and challenges can be used to inform clinical trial feasibility. Leveraging mobile technologies, in particular, can potentially empower a participant population, while emphasizing participant understanding of the commitment involved and, simultaneously, easing burdens on sites and study staff. This session will explore mobile applications, including eConsent, and at-home clinical trials, as potential tools—even providing the capacity to conduct remote trials—to spur participation through increased participant engagement, convenience, and satisfaction.

Learning Objectives

Identify emerging technologies and methods for both achieving efficiencies and optimizing effectiveness in clinical trial design; Evaluate quality metrics related to participant satisfaction and challenges associated with study implementation; Assess technologies and methods for their impact on clinical trial feasibility from a participant-focused perspective; Describe how to create an integrated plan, leveraging available technologies and methods, to improve the success of clinical trials.

Chair

Linda M Coleman, Esq, JD

Speaker

Mobile Clinical Trial Technologies: Use Cases and GCP Compliance Considerations
Philip J. Coran, Esq

Mobile Technology in Research: A Compliance and Ethics Review Perspective
Linda M Coleman, Esq, JD

Mobile Health Applications and eConsent: A Sponsor’s Perspective
Kevin Hudziak, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

Innovative tools/methods acceptable to drug developers and regulators require focused development strategies for necessary evidence. This session presents case studies illustrating what has been learned to achieve success based on real examples.

Learning Objectives

Discuss the importance of consortia in advancing biomarkers, modeling, and simulation tools that inform drug development; Describe through a lessons learned approach on reaching consensus on the science (e.g. data sharing, governance procedures); Identify and help scientists understand the competencies and expectations involved in development of novel tools and methodologies.

Chair

Martha Ann Brumfield, PhD

Speaker

FDA Perspective
ShaAvhree Y. Buckman-Garner, MD, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-547-L01-P; CME 1.25; IACET 1.25; RN 1.25

Disease interception focuses on the development of medicines that stop or delay disease progression for patients at risk or asymptomatic within the disease continuum. Learn as regulators and payers share perspectives in this new drug development space.

Learning Objectives

Discuss the regulatory and implementation challenges to innovation in disease interception; Propose solutions to regulatory challenges to innovation for disease interception therapies; Assess the benefit and risk framework and value of disease interception therapies.

Chair

Karin Van Baelen, PharmD

Speaker

FDA Perspective
Ellis Unger, MD

EU Perspective
Hans-Georg Eichler

Payer Perspective
Sean R. Tunis, MD, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

Horizon scanning is a method for identifying and monitoring interventions and innovations that have potential to impact clinical care, patient outcomes and the broader health care system. Dedicated horizon scanning programs focused on American and international markets function as publicly available tools useful for setting research agendas; planning regulatory and coverage/payment decisions; and providing early alerts to patients, clinicians, and health technology assessors. In this forum, representatives from American- and European-based horizon scanning efforts will demonstrate how both hits (early captured innovations with major impacts) and misses (e.g., non-identified interventions, non-impactful interventions), and the broader horizon scanning system methodology can provide a useful view of emerging technologies and the future health care landscape.

Learning Objectives

Identify horizon scanning resources and findings; Describe uses for horizon scanning findings by research funders, technology assessment organizations and coverage/payer groups; Describe the use of horizon scanning for understanding the larger landscape of innovation in a variety of clinical areas.

Chair

Christian Cuevas, PhD

Speaker

Horizon Scanning Systems: Comparison of US and International Systems
Diane Robertson

Panelist
Elise Berliner, PhD

Panelist
Christian Cuevas, PhD

Component Type: Session
Level: Intermediate
CE: CME 0.50; IACET 0.50; RN 0.50

Design thinking is a customer-centric approach designers use to solve complex problems. A design mindset is focused on solutions, starting with the perspective of the end-user-and their needs. This session will provide a brief introduction to design thinking, describe its benefits and potential applications to clinical development, and provide a brief example of how one company applied the methodology. The session will be followed by an Engage and Exchange session where participants will apply design thinking concepts hands on.

Learning Objectives

Recognize the basics of design thinking; Describe the case for applying the design thinking methodology in clinical development; Identify areas in which design thinking could be applied in clinical development to enhance trial success and the participant experience.

Chair

Patricia Leuchten

Component Type: Workshop
Level: Intermediate

In this fast-paced, highly interactive session, we will:

• Provide participants with a basic overview and vocabulary for human-centered design methodology through a brief didactic presentation;

• Through brief case studies, communicate examples of how human-centered design methods have been utilized by clinical development R&D organizations via a pharmaceutical industry consortia and by individual pharmaceutical companies to progress challenges and initiatives;

• Stage an interactive dialogue amongst participants on challenges and considerations specific to clinical development when integrating design thinking methods into areas of opportunity for improved efficiency and quality outcomes.

Participants will be challenged to rapidly learn the basic concepts of human-centered design, integrate their subject matter expertise to identify potential challenges and past analogous experiences, and develop creative solutions to using human-centered design as a catalyst for improving how industry solves common challenges in clinical development. Having achieved the above objectives, participants will leave with take-away materials to facilitate immediate integration of design thinking methods into their respective projects and initiatives.

This session is coordinated with “Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials” (Wednesday, 10:30-11:00 am, Track 11).

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Identify areas where human-centric design approaches have or could be leveraged within clinical research to progress challenges and initiatives; Explain strategies for avoiding or overcoming common challenges to introducing design thinking methods into research organizations; Build a network of like-minded professionals who are interested and/or active in using design thinking in their projects and initiatives within clinical research and development.

Chair

Dennis Salotti, MBA, MS

Speaker

Facilitator
Steven B. Whittaker

Facilitator
JoAnn Muir