DIA 2020 Virtual Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-541-L04-P; CME 1.00; IACET 1.00; RN 1.00

The introduction of innovation into healthcare systems requires decision making based on an increasingly complex and diverse evidence. This international panel of regulators and HTAs will discuss perspectives for “universal clinical evidence”.

Learning Objectives

Contrast principles for different types of decision making to facilitate introduction of innovative medicines;Translate evidence requirements for different types of decision making(regulatory, HTA, payers and reimbursement); Apply the understanding of multi-dimensional decisions on universal evidence generation plan value versus.

Chair

Michael Berntgen, PhD

Speaker

Perspectives From a Regulator
Michael Berntgen, PhD

Planning for Evidence for HTA
Michelle Mujoomdar, PhD

Panelist
Guido Rasi, MD

Panelist
Pierre Sabourin, MBA

Panelist
Peter W. Marks, MD, PhD

Panelist
Niklas Hedberg, MPharm

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-569-L04-P; CME 1.00; IACET 1.00; RN 1.00

Health Technology Assessment (HTA) is defined as a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of an intervention or health technology. In anticipation of COVID-19 vaccine, a panel composed of the relevant stakeholders will have an open dialogue about the role of HTA in informing public health policy-making, with particular focus on vaccination, and enforcing such policies at an individual country and global levels. Potential learnings from previous pandemics, such as H1N1, will be reviewed. Ethical and economic challenges will be debated to offer a consensus position that takes into account societal benefits, economic, logistical and legal considerations.

Learning Objectives

Debate the ethical, logistical, and legal implications if a mandated vaccine program were to be instituted and what would inform such a decision; Discuss the role and opportunity of HTA to inform and recommend a decision.

Chair

Richard Hiraiwa Stanford, PharmD, MS

Speaker

Panelist
Richard Hiraiwa Stanford, PharmD, MS

Panelist
Phil Ball, PhD

Panelist
Andrew H. Briggs, PhD, MSc

Component Type: Forum
Level: Basic
CE: ACPE 0.50 Knowledge UAN: 0286-0000-20-760-L04-P; CME 0.50; IACET 0.50; RN 0.50

The Covid-19 pandemic has shed light on what the access to medicines movement has known for more than 20 years - the profit-driven models used to research and develop medicines have led to a system that has failed almost everyone, everywhere. People all over the globe from all backgrounds, ethnicities, levels of status and wealth have been impacted, and will continue to be. Alternative needs-driven, people-centered models already exist and the role of public funds and universities is critical to their success. We are living in a unique global moment with a common enemy that we will need to face - strongly and together in solidarity - or we will inevitably experience further pandemics in our lifetimes, including the greater challenge of facing a pandemic in the form of antimicrobial resistance. All of us are vulnerable, although unequally. More urgently than ever the global need for collaboration and solidarity is being felt by people who had never before paid attention to these issues. Almost everyone, everywhere is waiting for drugs and vaccines that can change lives, history and the current narrative. And an urgent question needs to be answered: who will eventually get access to them and in what order?

Learning Objectives

Discuss ways the current biomedical R&D model we use to make medicines has failed people; Describe the critical role public funds and universities play in the development of life-saving medicines, vaccines etc; Identify what alternative models already exist and what action can be taken and what campaigns, actions and opportunities exist.

Chair

Merith Basey, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-711-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will focus on an overview of strategies and recommendations – by the Duke-Margolis Center for Health Policy, faculty and researchers, and leaders from across the health care and health policy landscape – for collectively addressing the COVID-19 pandemic. Primary areas of focus include the development, scale, and distribution of diagnostics, therapeutics, track and tracing strategies, and vaccines. During this interactive discussion, Dr. McClellan will highlight national initiatives, discuss a road map for reopening and preliminary indicators of impact, and describe short-term efforts over the next six months as well as health and health care changes in the long-term.

Learning Objectives

Describe the roles of vaccines, diagnostics, track and trace practices, and therapeutics in a comprehensive approach to reducing the health and economic impact of the COVID-19 pandemic; Discuss reduction of the COVID-19 disease burden by strategic alignment of regulatory approval and access pathways, increased effectiveness and capacity of clinical trials, management of access to avoid shortages, and real-world data collection to develop evidence on outcomes.

Chair

Mark B. McClellan, MD, PhD

Speaker

Moderator
Sissi Pham, PharmD

Component Type: Forum
Level: Intermediate

Reimbursement of drugs through value-based payment may benefit from patient data that is not available through clinical trials. This session will explore how early-stage evidence generation might bridge clinical endpoints and clinical endpoints.

Learning Objectives

Identify long-term patient outcomes that would benefit from additional early-stage data; Describe the impact of misalignment in clinical validity and clinical utility on evaluation of outcomes in value-based reimbursement; Discuss approaches to incorporate clinical utility measures into the regulatory process, with Alzheimer’s disease as a case study.

Chair

Monika Schneider, PhD

Speaker

Payer Perspective
Lisa Mostovoy, PharmD

Industry Perspective
Phyllis Barkman Ferrell, MBA

Public Payer Perspective
Shari M. Ling, MD

Component Type: Forum
Level: Intermediate

Population-based reimbursement for antibiotics will potentially support appropriate use while rewarding their societal benefit, but valuation will be key to success. This session will examine factors contributing to value in a subscription model.

Learning Objectives

Discuss positive externalities that impact a medical product’s value; Describe challenges to reimbursement based on population health benefits; Assess clinical outcome measures that could contribute to value determinations over time.

Chair

Monika Schneider, PhD

Speaker

Panelist
Christine Årdal, PhD, MBA

Panelist
Kevin Ronneberg, MD

To be determined
Patrick Holmes, MS