DIA 2016 Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-614-L04-P; CME 1.50; IACET 1.50; RN 1.50

The importance of engaging patients in medical product development is a message that has reached the industry. Acting on that message to adopt and sustain meaningful practice requires organizational cultures that value and place high priority on patient focus. In this session, sponsor companies and patient organizations will share their experiences with building internal cultures that encourage the collective group and individuals to incorporate patient engagement into their everyday work. A diverse panel will discuss reframing the challenges of cultural change to achieve the best outcomes for patients in the health care process.

Learning Objectives

Explain the role of organizational culture in enabling meaningful patient engagement practices; Assess key motivators for organizations to adopt a patient-focused culture; Describe effective approaches to incorporating patient focus throughout the organization; Discuss ways to meet challenges that may prevent a fully patient-focused culture.

Chair

Kim McCleary

Speaker

Panelist
Lode Dewulf

Panelist
Andrea Stern Ferris

Panelist
Andrew J. Garvey

Panelist
Mary Stober Murray, MBA

Panelist
Durhane Wong-Rieger, PhD, MA

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-609-L04-P; CME 1.50; IACET 1.50; RN 1.50

“Alone we can do so little; together we can do so much.” Harnessing the power of collaboration truly has the ability to alter the healthcare landscape as we know it today. What is the next generation of collaborations and what will be unique about them? What will change in our organizations in the future, and how will they be different from today? Is collaborative R&D going to become a reality for our industry? What roles will FDA and other stakeholders play? This forum will bring together a diverse panel representing some of the industry’s most influential and powerful organizations for a candid and innovative conversation about what is needed to shake up the current ecosystem and truly transform patient health. Submit your questions in advance for the panelists to annualmeetingprogram@diaglobal.org; subject line: Next Gen Collaborations.

Learning Objectives

Review the role of collaborations to date in better aligning biopharmaceutical R&D with needs and constraints of an evolving health ecosystem; Discuss the impact of coming landscape changes on the industry of tomorrow and needs that new collaborations must address; Describe the stakeholders and innovative elements of the new and transformational collaborations that are emerging.

Chair

Dalvir Gill, PhD

Speaker

Panelist
Margaret A. Anderson, MA

Panelist
Christopher P. Austin, MD

Panelist
Jonathan P. Jarow, PhD

Panelist
C. David Nicholson, PhD

Panelist
Drew Schiller

Component Type: Forum
Level: Intermediate
CE: CME 1.75; IACET 1.75; RN 1.75

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.

Part 1 of this session will see the heads of three regulatory agencies provide updates on the challenges facing them as global regulators, both domestic and within the framework of international cooperative initiatives.

In Part 2, the panel will be joined by additional heads of regulatory authorities with leading roles in the International Coalition of Medicines Regulatory Authorities (ICMRA) and will provide an overview of the developing role of ICMRA and initiatives aimed at facilitating interactions, coordination, and convergence. It will also address ICMRA's current status of strategic collaboration in areas such as pharmacovigilance, crisis management and supply chain integrity (GMP and traceability).

The combined panel will look at existing initiatives to avoid duplication and increase mutual reliance between regulators, the need for strategic governance of these initiatives and their impact on industry and other stakeholder.

Learning Objectives

Identify the current framework of bilateral and multilateral international cooperation initiatives; Describe how international regulatory authorities cooperate and collaborate, and the public health, economic, and political drivers for that cooperation; Describe how international regulatory agencies seek to set the strategic direction and priorities for the various regulatory initiatives.

Chair

Emer Cooke, MBA

Speaker

Panelist
Emer Cooke, MBA

Panelist
Robert M. Califf, MD

Panelist
Tatsuya Kondo, MD, PhD

Panelist
Anil Arora

Panelist
Lorraine Nolan, PhD

Panelist
Jonathan Mogford

Panelist
John Skerritt, PhD

Panelist
Jarbas Barbosa, MD, PhD

Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

Just how BIG will Big Data be? Understanding how innovators plan to use it to disrupt drug development and advance new health care offerings across delivery systems will be HUGE for everyone involved in innovation.

Come hear from top thought-leaders about what innovations are in the pipeline that will both generate and harness BIG DATA. Learn how innovators will use Big Data to disrupt the health care system. This dynamic forward-focused session will bring together industry, technology innovators, academia, and government agencies to paint a colorful picture of how they will drive advances in health care founded on big data platforms.

Learning Objectives

Discuss how big data will impact innovation in health care; Describe the way academia, industry, government agencies, and technology innovators are advancing health care utilizing big data.

Chair

Nancy Bradish Myers, JD

Speaker

Panelist
Luciana Borio, MD

Panelist
Kara N. Dennis

Panelist
Michael J Doherty

Panelist
Brad Hirsch, MD

Panelist
Sally A. Howard, JD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-610-L04-P; CME 1.50; IACET 1.50; RN 1.50

Europe and the US are experimenting with ways to develop therapies based on their actual ‘real world’ performance. This session will discuss the benefits and challenges of outcomes-based health care, as well as the remaining barriers to implementation.

Learning Objectives

Describe the concept of outcomes-based health care; Define real world evidence, Adaptive Pathways, and Precision Medicine; Identify how we can use health data to improve the efficiency of clinical trials and research (better targeting, smaller trials, flexible models); Recognize the links between failures rates, trial sizes, and investments into new therapies.

Chair

Duane Schulthess, MBA

Speaker

European Approaches to Outcomes-Based Health Care
Hans-Georg Eichler

Engineering Outcomes: Driven Biomedical Innovation
Gigi Hirsch, MD

Big Data for Better Outcomes: Innovative Medicines Initiative - IMI Taking the Lead
Richard Bergström, MS

Measuring Outcomes and Performance
Steve Rosenberg

Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

As demand increases for better management of health care costs while still providing the highest levels of care, the landscape is evolving into one assessed on value. All stakeholders – providers, payers, manufacturers, and ultimately patients – are interested in the impact this movement toward value has, including who is making or influencing access decisions and what information and evidence is being used to define value. In this session, you will hear perspectives from multiple stakeholders to better understand the challenges and implications brought by this new focus towards value, and uncover ideas of collaboration to realize smarter health care spending.

Learning Objectives

Review the global landscape of value-based health care decision making; Discuss the challenges facing health care stakeholders as they work to understand this new “value” assessment and what that means for future decisions and patient access; Identify evidence considerations for pharmaceutical research and development plans; Share ideas on stakeholder collaboration for optimal results.

Chair

Jennifer Snow, MPH

Speaker

Panelist
Ben Heywood, MBA

Panelist
Sarah Garner

Panelist
Richard J. Willke, PhD

Panelist
Newell McElwee

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-611-L04-P; CME 1.50; IACET 1.50; RN 1.50

This forum will provide an opportunity for EMA and FDA leadership to explore at a roundtable discussion 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, patient involvement in the development, evaluation and post-authorization of medicines, and mutual reliance on GMP inspections.

The audience will be invited to submit questions of general interest. 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.

Learning Objectives

Summarize key issues discussed by EMA and FDA; Identify regulatory hot topics; Discuss the areas covered under the bilateral cooperation between EMA and FDA aimed at bringing new medicines to patients throughout the world while assuring consistent standards of quality, efficacy, and safety; Identify how to engage both agencies in the development of a medicine at the same time.

Chair

Sabine Haubenreisser
Sandra L. Kweder, MD, FACP

Speaker

Panelist
Emer Cooke, MBA

Panelist
Dara Corrigan, JD

Panelist
John K. Jenkins, MD

Panelist
Jordi Llinares Garcia

Panelist
Anabela Marcal, PharmD

Panelist
Heidi C. Marchand, PharmD

Panelist
Peter W. Marks

Panelist
Isabelle Moulon, MD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-612-L04-P; CME 1.50; IACET 1.50; RN 1.50

From stating study objectives, participant criteria, endpoints and methods for data collection to establishing safety, the protocol is a key document for all stakeholders to ensure a successful clinical trial. The protocol defines the study design and provides the foundation for data collection that is used to evaluate clinically and statistically meaningful results of a study. It defines to a great extent what will be known about a drug or medical intervention, and is thus highly relevant to diverse stakeholders. During this session, the requirements and considerations for developing a successful and executable clinical trial protocol will be presented from the perspectives of sponsors, research sites, and patient representatives. The unique viewpoints will serve as the basis for a moderated discussion that analyzes the current process for protocol development, while suggesting approaches to more fully incorporate the patient voice into protocol design and implementation.

Learning Objectives

Discuss the requirements and considerations for developing a clinical trial protocol from the combined perspectives of the statistician, the clinical operations director, the patients, the medical officers and the regulators; Describe a process for protocol writing that is holistic rather than atomistic and involves collaborative as opposed to separate contributions; Identify ways to more fully and impactfully incorporate patient input into protocol design and implementation.

Chair

Richard Murray, DrMed, MD, FACP

Speaker

Panelist
Michael Krams

Panelist
Andy Lee, MA

Panelist
Christine Pierre, RN

Panelist
Steven Taylor, MBA