Our DIAmond sessions provide you with rare opportunities to listen to and engage with a variety of key stakeholders participating in open conversations on controversial topics such as the opioid crisis,the future of PharmaTech, global perspectives on patient engagement, international regulatory convergence, and a forum with the FDA. DIAmond Sessions in Development for DIA 2018 are Underway!
Here's a Preview of our Current DIAmond Sessions. More to Come!
Analyzing Innovation’s Progress in the Gottlieb EraSession Chair: Nancy Bradish Myers, Esq, JD, President and Founder, Catalyst Healthcare Consulting, Inc.
FDA Commissioner Scott Gottlieb has advanced an ambitious plan to modernize drug development and FDA’s approach to regulation. He has taken bold new approaches to streamline clinical trials, engage in efficient, risk-based regulation, and advance innovation. Gottlieb is focused on transformative innovations that hold the promise of both significantly impacting disease and reducing overall health care costs. How is the agency’s approach impacting innovation? Is it making a difference? Are further changes needed? Where are the key opportunities for collaboration between FDA and industry? This DIAmond Session will bring together top regulatory thought leaders from FDA, industry, and the venture capital world, for an interactive, forward-looking discussion of FDA’s modernization plan and its impact on development of innovative therapies.
EMA/ FDA Question TimeSession Chairs: Representative Invited, Principal Scientific Administrator, International Affairs, European Medicines Agency (EMA), United Kingdom; Representative Invited, Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
EMA and FDA leadership come together at a round table discussion on areas covered by the EMA/ FDA confidentiality arrangements and how both agencies contribute to global development and supervision of medicines. Experts from both Agencies who are at the forefront of EMA/FDA cooperation will explore topics such as innovation support to industry, development of medicines for special populations, challenges on quality of medicines, and data transparency. You are invited to submit questions both on the topics explored and of general interest. Please come prepared with your questions for the EMA/FDA Question Time panel. You may submit questions in advance to AnnualMeetingProgram@DIAhome.org.
Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable EvidenceSession Chair: Gregory W. Daniel, PhD, MPH, RPh, Deputy Director and Clinical Professor, Duke-Margolis Center for Health Policy
The last several years have seen increasing effort to better understand when and how real-world data and evidence could better support a wide range of regulatory decisions. And while sponsors, researchers, policymakers, and regulatory agencies continue to develop RWE frameworks to achieve that express aim, guiding principles are emerging related to the selection of adequate real-world data sources and appropriate study designs within specific regulatory contexts: How do specific characteristics related to disease area, data source, or analytical method affect questions around maintaining randomization? When can well-done observational studies suffice for generating actionable evidence? Are we nearing truly proof-of-concept pilot opportunities? This session will highlight progress to date on addressing these key questions and furthering the regulatory acceptability of RWE.
Precision Medicine, Gene Editing, and Gene Therapy: Current Status and Regulatory Challenges of Integrating Genetic Medicine into Clinical CareSession Chair: Tshaka Cunningham, PhD, Associate Director, Scientific Collaboration, DIA
This DIAmond session will discuss the scientific, regulatory, and ethical/access issues surrounding these emerging technologies as they progress through the development process and become more integrated into clinical practice. Collectively, these rapidly emerging disruptive technologies are poised to dramatically change the practice of medicine and transform patient care and disease monitoring and prevention in the future. There will be a diverse group of speakers in this session representing the various stakeholders in these areas represented including scientists, government regulators, pharmaceutical companies, and HMO executives, as well as patient advocates and experts on value and access. A particular focus of this session will be a discussion of the anticipated changes in the global regulatory landscape for gene-based therapeutics and diagnostics as the technology in the space continues to evolve at a rapid pace.
Value-Based Contracting, Fee-for-Performance, Outcomes-Based Agreements: Where Do We Stand Globally?Session Chair: Michael Rosenblatt, MD, Chief Medical Officer, Flagship Pioneering
Today's contracting models are not sustainable. We need a better understanding of which outcomes will meet the evolving criteria. Join the debate and discuss appropriate ways forward for precision medicine or orphan products – are we currently looking in the wrong direction? This DIAmond session will bring clarity by discussing solutions and their implementation across different healthcare systems. Learn what has been successfully applied globally on the key aspects of VBC (data collection, finding suitable metrics, and trust building between partners).