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 have matured, stakeholders are now focusing on implementation of patient focused development of therapies. This DIAmond Session will provide a platform for patient, industry, and regulatory stakeholders to share their perspectives on the meaning of effective engagement, what they expect to give in a collaborative engagement relationship, and what they believe should be the outcomes of their investment of effort. Panelists will explore the idea of “return on engagement”: Should it be measured? Can it be successfully measured, and if so, how?
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 in the real-world has given rise to the vision of drawing and repurposing data from real-world sources for research applications. In this DIAmond Session, prominent thinkers on scientific evidence to support biomedical decision-making will discuss our readiness to tap Real World Evidence (RWE): What types of RWE can be generated, and do they meet the highest evidentiary standards? What are the challenges to applying RWE, and who is currently addressing them? What benefits can we expect from a seamless blending of RCT and RWE in meeting the needs of patients?
Tuesday, June 20
There is growing interest from global stakeholders — biopharma, regulators, and patients — in exploring the use of social media (“social listening”) to supplement established approaches for pharmacovigilance. Health information posted online by patients is often publicly available, and represents an untapped source of postmarketing safety data that could supplement data from existing sources. Panelists in this DIAmond Session will address challenges associated with gathering and analyzing this information. Topics addressed include compliance with regulatory guidelines, data mining, patient privacy, and data mapping to standard adverse drug reactions across numerous languages.
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.
Wednesday, June 21
Recent political and media attention has focused on the cost of medicines with many demanding more transparency around on the flow of dollars in the system. This DIAmond Session will provide context on how drug pricing, reimbursement, and access decisions are made in the US. Questions such as “Who is involved?” and “What is the role of each player in the process?” will be addressed. Panelists from industry and payer groups will evaluate how the concept of value has impacted health care spending, and describe where we are today with value-based health care decision-making.
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.
Thursday, June 22
The availability of therapies that are known to be safe and effective for pediatric patients is critical to meeting the needs of this vulnerable population. The development of medical therapies for children and especially for neonates faces unique challenges, however, and has given rise to a number of pediatric research networks, some spanning multiple regions. This DIAmond Session will host a panel to provide a global update on the status of pediatric therapeutic research and discuss new developments aimed at benefitting this special population.
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.
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.