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.
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Monday, June 25
11:00AM-12:30PM
Analyzing Innovations Progress in the Gottlieb Era
Session 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 healthcare 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.
3:00-4:30PM International Regulatory Convergence
Session Chair: Agnès Saint-Raymond, MD, Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA), European Union
We intend to show how international regulatory authorities cooperate to ensure global coordination of research activities, convergence on regulatory requirements for the approval of antibacterial agents, support to discussions on new business models for antibacterial agents, on alternative therapeutics approaches to antibiotics, and on prevention of resistance across regions, including antimicrobial stewardship following the One Health approach.
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Tuesday, June 26
8:00-9:30AM Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence
Session 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. While sponsors, researchers, policy-makers, 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 use key takeaways from stakeholder case studies to highlight progress to date on addressing these key questions and furthering the regulatory acceptability of RWE.
10:30AM-12:00PM Global Perspectives on Patient EngagementSession Chair: Mathieu Boudes, PhD, PARADIGM Coordinator, European Patients' Forum, France
In Europe and North America, patient engagement in drug development is now expected, though not perfect. In this session, a panel of patient, industry, and regulator stakeholders will discuss the thinking and initiatives in other global regions to give patients a voice. We will look beyond Europe and North America to explore the thinking and efforts in other regions to engage patients in the medical product lifecycle. What efforts are underway or emerging to give patients a voice? What cultural, societal, and economic factors drive current thoughts and practices? Who are the influencers who are encouraging change? A diverse panel representing patient groups, regulators and industry from regions such as Asia and Latin America will talk about current experience, hopes, and aspirations for patient engagement worldwide.
2:00-3:30PM Future of PharmaTechSession Chair: Patrick Brady, PharmD, Regulatory Policy and Intelligence, Bayer
What is PharmaTech? How is the pharmaceutical and biotech industry evolving with new technologies, such as artifical intelligence (AI) and block chain? How will the business model be impacted? Are there lessons learned from other industries? This DIAmond session will examine how innovative technologies in drug development are impacting the pharmaceutical and biotech industry.
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Wednesday, June 27
8:00-9:30AM Value-Based Assessment and Contracting: What Needs to be Done to Make it a Best Practice?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).
10:30AM-12:00PM 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.
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Thursday, June 28
9:00-10:30AM
EMA/FDA Question TimeSession Chair: Tânia Teixeira, PharmD, EMA Liaison Official at FDA, European Medicines Agency (EMA), European Union
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.
The audience is 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, and include “EMA/ FDA Question Time” in the subject line.
10:45AM-12:00PM FDA Town HallSession Chair: Sudip Parikh, PhD, Senior Vice President and Managing Director, DIA Americas, DIA
This forum will include discussions and updates from FDA leadership on regulatory issues and the audience will be invited to submit questions of general interest.