DIA 2017 is located at:
2301 South Martin Luther King Jr. Drive
Monday, June 19
Drug repurposing includes approved drug indication expansion, drug-like compound repositioning, and drug reformulation strategies to help get medicines to patients faster. Because repositioning leverages sunk costs for compounds that have failed to reach market, and approved drugs can be reformulated or repurposed to treat a different disorder, the cost and often time to get the new therapy to market is reduced. Will “repurposing" disrupt the current market? How can academia, industry, and health authorities collaborate to advance drug repurposing efforts? What is needed to overcome economic, patent, and regulatory hurdles to get repurposed drugs to patients faster? These questions and others will be addressed during this DIAmond session by an esteemed panel of representatives from NIH NCATS, Cures Within Reach, industry, and academia.
As awareness and theory around patient engagement in the medical product life cycle have matured, stakeholders are now focusing on implementation of patient-centric practices. 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? And can we build a future state in which achieving what matters most to the patient is the measure of our success?
The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision-Making8:00-9:30AM
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.
Among the questions to be explored: How is RWE being used now and for what purposes? Is there a broader application of RWE that would satisfy regulatory needs, and if so, under what circumstances? What efforts to use RWE to generate evidence of sufficient quality for purpose are ongoing now and how can/will they be connected or bridged to achieve the ultimate goal? As concerns the enhancement of RCTs, in what circumstances might non-interventional RWE acceptably support regulatory decision making and when would some combination of RCT tools and RWE be appropriate?
This DIAmond session will stimulate new insights on our readiness for the next steps in the evolution of evidence generation using RWE.
Tuesday, June 20
There is growing interest from global stakeholders — biopharma, regulators, and patients — to analyze digital health information either posted online by patients or captured by pharma through patient/HCP requests. This information represents a large repository of safety and patient experience insights that could supplement data from existing sources. Panelists in this DIAmond session will address how digital health information can be analyzed to support medical affairs, pharmacovigilance and commercialization efforts. Topics addressed include an overview of techniques, use cases, compliance with regulatory guidelines, and patient privacy.
In this DIAmond session, innovative thinkers project the impact of some of the most radical emerging technologies on the future of biomedical research. From autonomous protocol development driven by artificial intelligence 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.
This session was developed in collaboration with Research America.
Recent political and media attention has focused on the cost of medicines, with US 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.Want more on Value and Access? See our Value and Access Track and Preconference Short Course, The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment.
Wednesday, June 21
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?
Join senior leadership from international regulatory authorities to hear the latest on multi- and bilateral initiatives that avoid duplication and increase mutual reliance, their strategic governance, and their impact on industry.
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..
Thursday, June 22
The FDA Forum will focus on inter-center collaboration between CDER, CDRH, CBER, and the Office of Combination Products. The recently established Oncology Center of Excellence will be highlighted as a new area of collaboration. FDA representatives will share how they collaborate to provide advice regarding products in development, review marketing applications, and help accelerate medical product approvals.Check out the Exchange and Engage session, Strategies for Communicating with FDA.
In this forum, EMA and FDA leadership will engage in a round table discussion on areas covered by the EMA/FDA confidentiality arrangements and discuss how both agencies contribute to global development and supervision of medicines. Experts from both Agencies who are at the forefront of EMA/FDA collaboration will explore topics such as innovation support to industry, use of real-world data, development of medicines in rare diseases, and data transparency.
The audience will be invited to submit questions. Please come prepared with your questions for the EMA/FDA Question Time panel. You may submit questions and topics of interest in advance to AnnualMeetingProgram@DIAglobal.org, and include “EMA/FDA Question Time” in the subject line.