DIA 2017 Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-565-L04-P; CME 1.50; IACET 1.50; RN 1.50

Though the Randomized Controlled Trial (RCT) has been the trusted standard for generating high-quality evidence of medical product safety and efficacy, the need for more rapid and cost effective understanding of product effectiveness and safety in the real-world has given rise to the vision that draws on real-world evidence as well as that derived from more traditional clinical research applications.

In this DIAmond session, prominent thinkers on scientific evidence for support of biomedical decision-making will discuss our readiness to tap Real World Evidence (RWE) for safety and efficacy questions and then consider its uses for regulatory purposes. The benefits and challenges of using RWE to generate evidence of sufficient quality for decision making, following the concept of using fit-for-purpose research tools, will be examined.

This DIAmond session will stimulate new insights on our readiness for the next steps in the evolution of evidence generation using RWE.

Learning Objectives

Discuss current uses of RWE in the medical product life cycle; Describe potential uses of RWE to improve the speed and cost effectiveness determining safety and effectiveness of medical products in real world use; Compare and contrast the strengths of RCT and RWE data as evidence for medical and regulatory decision making.

Chair

Iris Loew-Friedrich, DrMed

Speaker

Panelist
Nancy A. Dreyer, PhD, MPH

Panelist
Robert J. Temple, MD

Panelist
Alison Cave, PhD

Panelist
Brian D. Bradbury, PhD, MA

Panelist
Stephanie Devaney, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-568-L04-P; CME 1.50; IACET 1.50; RN 1.50

As awareness and theory around patient engagement in the medical product life cycle have matured, stakeholders are now focusing on best practices and implementation of patient centric strategies. In this session, patient, industry, and regulatory stakeholders will share their perspectives on today’s meaning of effective engagement and what the future state of patient engagement will look like. Panelists will discuss what they believe should be the outcomes of their investments of effort and how we can engage patients to identify the outcomes that matter most. The idea of “return on engagement” will be explored: how do we measure what matters? How do we turn insights into regulatory utilities? And how do we capture the return – to drug and device development – on this investment in patient engagement?

Join Patient Engagement Community for a follow up Round Table discussion at 12:30pm in the Community Corner.

Learning Objectives

Describe the meaning of effective patient engagement and where it should take place during the medical product life cycle; Discuss approaches to involving patients in the determination of meaningful outcomes throughout the life cycle of medical therapies; Identify potential measures that could demonstrate the return on meaningful engagement for patient, regulatory, and industry stakeholders. Explore patient engagement in today’s policy environment and in the context of global harmonization.

Chair

Debra Lappin, JD

Speaker

Panelist
Anne C. Beal, MD, MPH

Panelist
Juan Garcia-Burgos, MD

Panelist
K. Kimberly McCleary

Panelist
Paul Kluetz, MD

Panelist
Ronald Joseph Bartek, MA

Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-563-L04-P; CME 1.50; IACET 1.50; RN 1.50

Recent political and media attention has focused on the cost of medicines, with U.S. politicians and some consumer organizations demanding lower prices, as well as more transparency around pricing that all too frequently seems opaque. At the same time, U.S. health care is transitioning to focus more on paying for the value of care provided, rather than on the volume of goods and services, including for drugs. This DIAmond session will provide context on how drug pricing, reimbursement, and purchasing decisions are evolving in the US. Topics to be explored include how U.S. biopharmaceutical prices are determined in contrast to other countries; the roles of different players, such as pharmacy benefit managers, in the system; and how payers and manufacturers are embracing new value-based arrangements to make more efficient and effective use of the dollars spent on biopharmaceuticals.

Learning Objectives

Discuss the decision making process for drug pricing, reimbursement, and access to medicines; Define value and its impact on health care spending

Chair

Sudip Parikh, PhD

Speaker

Panelist
Sloane Salzburg, MS

Panelist
Shawn Davis

Panelist
Joel Beetsch, PhD

Panelist
Phillip J. Lerner, MD, MPH

Component Type: Session
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

In this DIAmond session, innovative thinkers project the impact of some of the most radical emerging technologies on the future of biomedical research. From real-time patient monitoring through mHealth technology to digitally enabled precision medicine to “research as a care option” supported by advanced analytics, the expert panel will explore radical changes that will improve the biopharmaceutical development process of the future and the radical technologies that will make them possible.

Learning Objectives

Discuss the potential impact of one or more emerging new technologies on the development process and outcomes for biopharmaceutical products; Describe ways in which today's biopharmaceutical development process will be different in five years and what the impact will be for industry as well as the patient/consumer.

Chair

Craig H. Lipset, MBA

Speaker

Panelist
Jeffry G. James, MBA

Panelist
Alicia Staley, MBA, MS

Panelist
Julian M. Jenkins

Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-564-L04-P; CME 1.50; IACET 1.50; RN 1.50

The availability of safe, effective therapies is critical to meet the needs of pediatric patients. FDA’s 2016 status report on the BPCA and PREA concluded that progress has been made in obtaining pediatric studies and new labeling but significant challenges remain in studies for neonate, infants, pediatric cancer, and international coordination of pediatric trials.

This DIAmond panel will discuss recent progress in global pediatric research and regulatory science and new developments in pediatric research networks such as the Pediatric Trials Consortium (C-Path Institute) and the International Neonatal Consortium.

Learning Objectives

Discuss recent legislative and regulatory developments in the US and EU related to pediatric studies and labeling and their expected impact on availability of safe and effective therapies for children; Identify regulatory and research approaches to address challenges that limit the availability of innovative medicines for infants, neonates, and children.

Chair

Ronald Portman, MD

Speaker

Panelist
Susan McCune, MD

Panelist
Mark Turner

Panelist
Robert M. Ward, MD

Panelist
Christoph Male, MD

Panelist
Marie-Helene Pinheiro, PharmD

Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-567-L04-P; CME 1.50; IACET 1.50; RN 1.50

As we seek to ensure that the right medicines are available for the right patients at the right time, the representation of appropriate population groups in clinical trials is increasingly important. In this DIAmond session, a multi-stakeholder panel takes a 360 degree view of the issue of diversity in today’s clinical trials. What constitutes a diverse, representative population for a clinical trial? Does the focus on personalized medicine have an impact on the context of diversity? What is the status of including more diverse populations in clinical trials, and is progress consistent for racial/ethnic minority, female, and elderly populations? What is the outlook for current efforts and initiatives to address these issues?

Learning Objectives

Describe the current status of clinical trials in the US in terms of appropriate diversity among study participants; Discuss the factors that determine appropriate diversity within clinical study populations; Identify and discuss at least two current initiatives that address the need to diversify the make-up of clinical study populations.

Chair

Joe V. Selby

Speaker

Panelist
John Whyte, MD, MPH

Panelist
Sam S. Oh, PhD, MPH

Panelist
Karen Brooks, PhD

Panelist
Nikos Dedes

Panelist
Regina Greer-Smith, MPH