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Sunday, June 26

8:30am EDT

#26: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Payers play an important role in both national and global health care systems: their decision-making signals to manufacturers their likelihood to support the R&D required for innovative, new medicines. Only a small number of innovative medicines are approved annually. The large proportion of new drug candidates fail during the development, and the average R&D cost per approved new molecular entity is increasing. Providers and payers can be thought of as agents acting on behalf of patients and their covered beneficiaries. Payers are critical in expressing the willingness of health care systems to provide funds to support innovation. Manufacturers must understand, monitor, and anticipate the evolving payer environment to increase the likelihood of regulatory and commercial success for new products. Key tools such as pharmacoeconomic evaluation of cost-effectiveness and budget impact, as well as important processes such as health technology assessment are used in many developed countries. Understanding their varying role in different jurisdictions is critical for pricing and market access negotiations.

This tutorial, which is hosted with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), will introduce participants to the basic economics of drug development, pricing, contracting, and market access. It will address commonly used economic concepts, such as demand, supply, willingness to pay, monopoly, intellectual property, and value. Practical observations will be made on the similarities and differences in how health care systems approach these pricing and access practices and decisions, with an emphasis on the implications for stakeholder incentives. Examples will be used to illustrate key concepts as well as both routine and special cases.

Who should attend?

This tutorial is designed for industry professionals and academics with an interest to learn more about the economic perspective on drug development, incentives for innovation, and how different countries grapple with these difficult health sector resource allocation decisions.

Learning Objectives

• Explain what makes innovative medicines unique economic inputs into population health including how the patent system relates to the financing of global R&D;
• Describe in what way prices for innovative medicines are established, how this differs by system, as well as the evolving impact of pharmacoeconomics and health technology assessment;
• Discuss how the complex global network of public and private payers judge the value of innovative medicines.

avatar for Louis Garrison

Louis Garrison

Professor, Pharmaceutical Outcomes Research and Policy Program, University of Washington
Dr. Garrison is Professor in the Pharmaceutical Outcomes Research and Policy Program in the School of Pharmacy, and Adjunct Professor in the Departments of Global Health and Health Services at the University of Washington, where he joined the faculty in 2004. He also co-directs the... Read More →
avatar for Jack Mycka

Jack Mycka

Global President and CEO, Medical Marketing Economics LLC (MME)
As MME’s Global President & CEO, Jack provides critical global support for strategic marketing and pricing decisions to clients in the biotech and pharmaceutical industries. As a recognized expert consultant since 2001, he has successfully completed engagements encompassing many... Read More →

Sunday June 26, 2016 8:30am - 12:00pm EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm EDT

#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-510-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (Consultations with PMDA and Clinical Trial Notifications), the integration of Japanese drug development with East Asian and global drug development, accelerated approval pathways (sakigake; regenerative medicine), orphan drug regulation and J-NDA review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

Who should attend?

This tutorial is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

• Explain the major elements of the Japanese regulatory system;
• Describe the regulatory procedures during development, registration, and post-approval;
• Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.

avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel, United States
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →

Sunday June 26, 2016 1:00pm - 4:30pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 08: Reg Affairs, Tutorial
Wednesday, June 29

2:00pm EDT

#336: Effect of International Reference Pricing on Planning for Global New Product Launches
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-597-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000184; RN 1.25

As more countries adopt cost containment strategies, it becomes increasing difficult to plan and execute successful, global launches of new drugs. This session will provide an overview of how to plan a successful launch given these challenges.

Learning Objectives

Identify the variables which influence the price of new drugs; Explain how international reference pricing affects optimal launch sequence; Recognize the other considerations (e.g., country scope, intellectual property, clinical plan) when planning a successful launch.


Matthew Steven Curin, PharmD


What Every Project Manager Should Know about HTA and Pricing
Claire Corry, MS

Mapping the Global Launch Sequence in a Partnership
Nathan J. Murray

Practical Application of Global Launch Best Practices
Matthew Steven Curin, PharmD

avatar for Matthew Curin

Matthew Curin

Executive Director, Program Management, Epizyme
Matt has been working in the pharmaceutical industry for almost 20 years, spending the first 8 years in clinical manufacturing before moving into project management in 2007. Since then, Matt has provided project, program, and portfolio management leadership in clinical development... Read More →

avatar for Claire Corry

Claire Corry

Director, Global Project and Alliance Management, Merck & Co., Inc.
Claire Corry currently is a Director in Global Project and Alliance Management at Merck and has been working in project and portfolio management roles for 15 years. Claire has a wealth of knowledge across all phases of drug development, working with both small molecules and biologics... Read More →
avatar for Nathan Murray

Nathan Murray

Global PRA Advisor, Autoimmune, Eli Lilly and Company
Currently lead a cross-functional (and multinational) team in the development of global price, reimbursement and access (PRA) strategy for both pre-launch and commercialized products. Primarily responsible for achieving acceptable access and reimbursement levels for patients and for... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Session

4:00pm EDT

#370: Pricing, Patient Access, and What’s Next for Today’s Biopharma and Devices
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-573-L04-P; CME 1.25; IACET 1.25; RN 1.25

Industry leaders, public payers, policy makers and issue experts provide insights into today’s heated debate about drug pricing, patient access and the policy battles ahead. This forum will offer engaging presentations, moderated discussion, and participant Q&A.

Learning Objectives

Identify key issues affecting the treatment pricing and patient access landscape; Describe how to apply potential models for determining a treatment’s value; Discuss ways to integrate new ideas for communicating a product’s rationale for patients, treaters and payers.


Jane Horvath, MHA


Matt Salo

Michael Gray, MBA

John Hoffman, MBA

avatar for Jane Horvath

Jane Horvath

Market Access Lead, 3D Communications
Jane Horvath, MHSA, leads 3D's Market Access and Value Communications team. Jane brings nearly 25 years of experience in health policy and reimbursement. She was Merck’s Executive Director of Health Policy and Reimbursement for a decade, Deputy Director of the RWJF project at Johns... Read More →

avatar for Michael Gray

Michael Gray

Vice President and Chief Operating Officer, The Resource Group, Ascension
Michael has executive oversight and thought leadership responsibility for the ongoing development, implementation, and management of The Resource Group’s Strategic Direction. He spent seven years as President and CEO of Mercy Resource Management Inc., with responsibilities for Corporate... Read More →
avatar for John Hoffman

John Hoffman

Senior Director, Health Policy, Advocacy and Quality, Johnson & Johnson
As the Senior Director, Health Policy, Advocacy & Quality for the Strategic Customer Group at J&J North American Pharmaceuticals, John's responsibilities include ensuring unencumbered access to all J&J NA Pharma products for patients and physicians. The Strategic Customer Group develops... Read More →
avatar for Matt Salo

Matt Salo

Executive Director, National Association of Medicaid Directors
Matt Salo was named Executive Director of the National Association of Medicaid Directors in February 2011. The association represents all 56 of the nation’s state and territorial Medicaid Directors, and provides them with a strong unified voice in national discussions as well as... Read More →

Wednesday June 29, 2016 4:00pm - 5:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA