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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

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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.


Speakers
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
 
Monday, June 27
 

10:45am EDT

#130: Take Two Aspirin and Text Me in the Morning: Technology Suited for 20,000 Virtual Patients on the PCORI Aspirin Trial
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-535-L04-P; CME 1.25; IACET 1.25; RN 1.25

The ADAPTABLE study, started in 2015, is the largest virtual study ever done in the clinical research industry. Speakers will review the lessons learned from establishing a technology process suited for 20,000 remote patients on this study.

Learning Objectives

Demonstrate a working knowledge of implementing remote consenting; Discuss updates on recent guidance documents and regulatory approvals for virtual data collection.

Chair

Anthony Costello

Speaker

ADAPTABLE: A 20,000 Patient Study Leveraging Health Systems, EHR, and Patients to Transform Clinical Research
Adrian Hernandez

REACHnet’s Recruitment for the ADAPTABLE Virtual Trial Using Technology at the Point-of-Care
Elizabeth Nauman



Chair
AC

Anthony Costello

Chief Executive Officer, Mytrus, Inc.
Anthony Costello: Co-Founder and CEO of Mytrus has co-founded many clinical & hi-tech start-up companies in N. CA. He was selected as PharmaVoice Top 100 Most Inspiring People in Clinical Research, served as Chairman of the Board for the Society for Clinical Data Management, on founding... Read More →

Speakers
AH

Adrian Hernandez

Co-Private Investigator, PCORnet Coordinating Center, Professor of Medicine, Duke Clinical Research Institute (DCRI)
Dr. Hernandez is a cardiologist with extensive experience in clinical research ranging from clinical trials to outcomes and health services research. He is the Faculty Associate Director of the Duke Clinical Research Institute and Director of the Health Services and Outcomes Research... Read More →
avatar for Elizabeth Nauman

Elizabeth Nauman

Research Director, Research Action for Health Network (REACHnet), Louisiana Public Health Institute (LPHI)
As REACHnet's Research Director, Dr. Nauman works with a multi-institutional team to develop and optimize the informatics and technology infrastructures as well as stakeholder engagement to support efficient pragmatic clinical research. She leads the development of the network’s... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session

10:45am EDT

#139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-568-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interdisciplinary session will explain how, with increased patient engagement, both regulatory and health technology assessment agencies need to be able to assess and report on how patient input is being utilized and how it is informing the decision process.

Learning Objectives

Discuss how health technology assessment agencies and regulators engage with patients so that the assessment and decision making is utilizing patients’ viewpoints; Identify the challenges that agencies face to ensure that the patient’s viewpoints are embedded into their decision processes; Assess the types of parameters agencies are using to measure the impact patient engagement is having on their processes and decision making.

Chair

Neil McAuslane, PhD, MSc

Speaker

FDA Perspective
Theresa M. Mullin, PhD

Empowering Patients as Organizational Change Agents
Durhane Wong-Rieger, PhD, MA

HTA Perspective
Victoria Thomas, MSc



Chair
avatar for Neil McAuslane

Neil McAuslane

Director, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →

Speakers
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... Read More →
avatar for Victoria Thomas

Victoria Thomas

Head of Public Involvement, Public Involvement Programme, National Institute For Health and Care Excellence (NICE)
Victoria Thomas has run the Public Involvement Programme at NICE since 2009, and has been with the Programme since 2001. Following a degree in Art History, Victoria has worked exclusively in the public and voluntary sector, specialising in healthcare quality improvement activities... Read More →
avatar for Durhane Wong-Rieger

Durhane Wong-Rieger

President and Chief Executive Officer, Canadian Organization For Rare Disorders (CORD)
Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:15pm EDT

#147: Interpreting Meaningful Change on PRO Instruments: Methods in Action
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

One aspect of patient-reported outcome (PRO) instrument development that continues to perplex the field is the interpretation of change scores. How much change must be observed on a PRO instrument to be able to say that a patient has experienced a treatment benefit? This session will provide a brief background on commonly-used and novel methods for assigning meaning to PRO score changes, and then attendees will participate in one of three activities where these methods are demonstrated. The goal of the methods demonstrated in each of these three activities is to identify a threshold at which changes on the PRO instrument are deemed meaningful. The first activity will be a mock exit interview where a participant is probed about their experience during a clinical trial and the meaning behind their observed PRO scores. The second activity will be a mock bookmarking exercise where a participant rates hypothetical vignettes as better, worse, or the same as their own condition using items from a PRO instrument. The third activity will be a group exercise on synthesizing results from multiple methods into one responder definition (i.e., the triangulation process). The session attendees will reconvene at the end of these exercises to discuss the value and challenges of each method.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Recognize the value of and challenges with different methods for informing the interpretation of change on PRO instruments by engaging in mock exercises demonstrating these methods in practice.

Chair

Cheryl D. Coon, PhD

Speaker

Facilitator
Scott Komo, DrPH



Chair
avatar for Cheryl Coon

Cheryl Coon

Principal, Outcometrix
Cheryl D. Coon, PhD is a psychometrician with over a decade of experience in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments. During her years in the field, she has been involved in all stages of instrument... Read More →

Speakers
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →


Monday June 27, 2016 12:15pm - 1:15pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 22: Engage and Exchange, Workshop

1:45pm EDT

#150: Quintiles Innovation Theater: Evidence Optimization: Fueling Smarter Clinical Development and Value Generation
Limited Capacity filling up

Component Type: Session
Level: Intermediate

Drug development challenges drive the need to translate scientific and therapeutic advances to better outcomes. Maximizing real-world and clinical evidence can shorten cycle times from pipeline to patient. This presentation highlights innovative approaches by integrating evidence alongside scientific expertise, technology and global delivery to:
Design and deliver smarter trials
Accelerate study start-up
Make earlier, more informed decisions
Execute with efficiency
Generate better value from evidence.

Chair

Quintiles Transnational


Chair
avatar for QuintilesIMS

QuintilesIMS

Quintiles Transnational

Monday June 27, 2016 1:45pm - 2:15pm EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am EDT

#219: Regulatory Science Considerations Applying to Novel Combinations of Biologics and Bifunctional Biologics Development
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-552-L01-P; CME 1.25; IACET 1.25; RN 1.25

This session will focus on specific aspects of the regulatory development of novel combination biologics, as well as bifunctionals. Specific considerations for each of these modalities for different clinical stages and therapy areas will also be addressed, and a comparison/contrast of development requirements for each will be provided.

Learning Objectives

Describe the regulatory requirements for development of combinations of novel biologicals and bifunctional biologics.

Chair

Owen Fields, PhD

Speaker

Unique Challenges in the Regulation of Bispecific Antibodies
Raj G Nair, MD

Unique Preclinical and Clinical Aspects of Bifunctional Development
Rakesh Dixit, PhD

Q and A Panel
Badrul Chowdhury, MD, PhD



Chair
avatar for Owen Fields

Owen Fields

Vice President, Inflammatory and Immunology, WW Safety and Regulatory, Pfizer Inc
I received my Ph.D. in molecular and cellular biology from Berkeley. Following this I worked in food biotechnology regulation at the US FDA. I then moved to regulatory strategy at Wyeth where I worked in autoimmune disease, tissue repair, and other areas. After the merger with Pfizer... Read More →

Speakers
avatar for Badrul Chowdhury

Badrul Chowdhury

Director, Division of Pulmonary, Allergy, and Rheumatology Products, OND, CDER, FDA
Dr. Badrul A. Chowdhury is the Director of the Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research, US Food and Drug Administration. Dr. Chowdhury is trained and board certified in Internal Medicine, and in Allergy and Immunology, and... Read More →
avatar for Rakesh Dixit

Rakesh Dixit

Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune
RN

Raj Nair

Medical Officer, DPARP, OND, CDER, FDA
I am a medical officer within the Division of Pulmonary Allergy, and Rheumatology since 2013. I was previously an assistant professor in Rheumatology at Georgetown University with an interest in use of musculoskeletal ultrasound in diagnosis and management of patients with rheumatic... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm EDT

#246: Valuing the Signal and the Noise in Health Care Horizon Scanning
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

Horizon scanning is a method for identifying and monitoring interventions and innovations that have potential to impact clinical care, patient outcomes and the broader health care system. Dedicated horizon scanning programs focused on American and international markets function as publicly available tools useful for setting research agendas; planning regulatory and coverage/payment decisions; and providing early alerts to patients, clinicians, and health technology assessors. In this forum, representatives from American- and European-based horizon scanning efforts will demonstrate how both hits (early captured innovations with major impacts) and misses (e.g., non-identified interventions, non-impactful interventions), and the broader horizon scanning system methodology can provide a useful view of emerging technologies and the future health care landscape.

Learning Objectives

Identify horizon scanning resources and findings; Describe uses for horizon scanning findings by research funders, technology assessment organizations and coverage/payer groups; Describe the use of horizon scanning for understanding the larger landscape of innovation in a variety of clinical areas.

Chair

Christian Cuevas, PhD

Speaker

Horizon Scanning Systems: Comparison of US and International Systems
Diane Robertson

Panelist
Elise Berliner, PhD

Panelist
Christian Cuevas, PhD



Chair
avatar for Christian Cuevas

Christian Cuevas

Senior Clinical Analyst, Health Technology Assessment Group, ECRI Institute
Clinical Analyst at ECRI Institute I worked on the Horizon Scanning program following the clinical development of close to 200 emerging oncology interventions and determining their potential to have an impact on the healthcare system. Postdoctoral Fellow at University Pennsylvania... Read More →

Speakers
EB

Elise Berliner

Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
Dr. Berliner is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment Program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions... Read More →
avatar for Diane Robertson

Diane Robertson

Director, Health Technology Assessment, ECRI Institute
Served as ECRI Institute's project manager for the AHRQ Healthcare Horizon Scanning Program for 5 years. More than 30 years (including 22 with ECRI Institute’s Health Technology Assessment program) leading projects, health technology research and analysis, writing, and publishing... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER-Glob Health Econ, Forum
 
Wednesday, June 29
 

8:00am EDT

#302: Europe and the US: Making Outcomes-Based Health Care Possible
Limited Capacity seats available

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



Chair
avatar for Duane Schulthess

Duane Schulthess

Managing Director, Vital Transformation
Duane is the Managing Director of Vital Transformation which consults to national health authorities, blue chip multi-national organisations, governments, and stakeholder groups on healthcare policy and technology. He and his firm have developed many unique techniques and methods... Read More →

Speakers
avatar for Richard Bergström

Richard Bergström

Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
Richard Bergström has been the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since April 2011. Previously he served for nine years as the Director-General of LIF, the Swedish Association of the Pharmaceutical Industry, following... Read More →
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at... Read More →
avatar for Gigi Hirsch

Gigi Hirsch

Executive Director, Massachusetts Institute of Technology (MIT) Center For Biomedical Innovation
Her current efforts are leading the New Drug Development Paradigms initiative (NEWDIGS), a “think and do tank” that is re-engineering pharmaceutical innovation to deliver new, better, affordable therapeutics to the right patients, faster. Within the broad strategic framework of... Read More →
avatar for Steve Rosenberg

Steve Rosenberg

Senior Vice President and General Manager, Health Sciences Global Business Unit, Oracle Health Sciences
Steve Rosenberg, Senior Vice President and General Manager of Oracle Health Sciences Global Business Unit, has over 30 years of experience leading development, services, support, and consulting, in addition to significant industry experience in life sciences and healthcare. Some of... Read More →


Wednesday June 29, 2016 8:00am - 9:30am EDT
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

8:00am EDT

#303: Value-Based Health Care Decision Making: The Quest for Smarter Spending
Limited Capacity seats available

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



Chair
avatar for Jennifer Snow

Jennifer Snow

Director, Health Policy, Xcenda
Jennifer Snow, MPH, is a Director of Health Policy and keeps clients and stakeholders informed on the latest legislative and regulatory updates and their commercial impact. Her team analyzes the healthcare environment and provides strategic guidance on how to best navigate challenges... Read More →

Speakers
avatar for Sarah Garner

Sarah Garner

Associate Director – Science Policy and Research, National Institute for Health and Care Excellence (NICE)
Professor Sarah Garner is a pharmacist specialising in the interface between Health Technology Assessment (HTA) and regulation. Sarah is the Associate Director for Scientific Policy and Research at NICE and an honorary professor at UCL and Manchester University. She leads Work Packages... Read More →
avatar for Ben Heywood

Ben Heywood

President and Co-Founder, PatientsLikeMe
As President and Director of PatientsLikeMe, Benjamin Heywood is responsible for setting the company vision to improve healthcare and accelerate research, while directing its business growth strategy. Inspired by his brother Stephen’s battle with ALS, Heywood co-founded the company... Read More →
avatar for Newell McElwee

Newell McElwee

Assistant Vice President, Center for Observational and Real-world Evidence, Merck & Co., Inc.
Newell McElwee, PharmD, MSPH, is Executive Director of U.S. Outcomes Research, Merck & Co., Inc. Dr. McElwee serves an active role on many committees including the Steering Committee for the AHRQ Centers for Education, Research, & Training, the Advisory Board for the Institute for... Read More →
avatar for Richard Willke

Richard Willke

Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Dick became ISPOR’s first Chief Science Officer in 2016, where he develops, leads, and supports strategic initiatives related to research, scientific, and content priorities. Prior to ISPOR he worked for 25 years at Pfizer and its legacy companies, where he retired as a vice president... Read More →


Wednesday June 29, 2016 8:00am - 9:30am EDT
Ballroom A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

10:30am EDT

#322: Real-World Evidence in Drug Development: Creating the Right Environment for Enhanced Pre-Launch Evidence
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-571-L01-P; CME 1.00; IACET 1.00; RN 1.00

Ideally, health technology assessment and other decisions at launch are informed by an understanding of the (added) value of treatments for patients. In this session, we will explore the barriers and enablers for using real-world data in generating effectiveness evidence in R&D.

Learning Objectives

Identify the positive and negative incentives for generating effectiveness evidence in the current environment; Distinguish different study designs and forms of evidence synthesis using real-world data that can provide input to decision makers; Identify potential solutions for addressing current challenges for generating effectiveness evidence in the pre-launch environment.

Chair

Pieter Stolk, PharmD, PhD

Speaker

The Environment for Enhanced Pre-Launch Evidence: An EU Perspective
Chris Chinn, MSc

The Environment for Enhanced Pre-Launch Evidence: A US Perspective
Gregory Daniel



Chair
PS

Pieter Stolk

Project Manager, University Medical Centre Utrecht
Pieter Stolk, PhD, was trained as a pharmacist with a PhD from Utrecht University. Pieter is interested in all aspects of medicines regulation and policy (with a focus on marketing authorisation and HTA of medicines). He has been involved in several EU public private partnerships... Read More →

Speakers
CC

Chris Chinn

Head of Real World Data Strategy and Partnerships, Sanofi
Chris graduated from Oxford University with a degree in Biochemistry. He qualified as a chartered accountant with Ernst & Young in London and completed a MSc in Health Economics at City University, London. He has led health outcomes research teams at Eli Lilly and GSK, and in his... Read More →
avatar for Gregory Daniel

Gregory Daniel

Deputy Director and Clinical Professor, Duke-Margolis Center For Health Policy
Gregory Daniel, PhD, MPH is the Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy and a Clinical Professor in Duke's Fuqua School of Business. He directs the DC-based office of the Center leading its pharmaceutical and medical device policy portfolio, and... Read More →
avatar for Gregory Daniel

Gregory Daniel

Deputy Director and Clinical Professor, Duke-Margolis Center For Health Policy
Gregory Daniel, PhD, MPH is the Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy and a Clinical Professor in Duke's Fuqua School of Business. He directs the DC-based office of the Center leading its pharmaceutical and medical device policy portfolio, and... Read More →
PS

Pieter Stolk

Program Manager, Escher, the Lygature Platform For Regulatory Innovation
Pieter Stolk, PhD, was trained as a pharmacist with a PhD from Utrecht University. Pieter is interested in all aspects of medicines regulation and policy (with a focus on marketing authorisation and HTA of medicines). He has been involved in several EU public private partnerships... Read More →


Wednesday June 29, 2016 10:30am - 11:30am EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER/Glob Health Econ, Session

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.

Chair

Matthew Steven Curin, PharmD

Speaker

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



Chair
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 →

Speakers
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

2:00pm EDT

#348: Interpreting Meaningful Change on PROs: When to Talk, When to Use Cumulative Distribution Functions, and When to ROC
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-572-L01-P; CME 1.25; IACET 1.25; RN 1.25

Methods to interpret the meaning of change in patient-reported outcome (PRO) scores often do not directly include perspectives of potential stakeholders. In this session, we will discuss how common and novel methods to define meaningful change can enhance insight into treatment benefit.

Learning Objectives

Distinguish when to use different methods to identify meaningful individual-level change and group-level differences on a patient-reported outcome; Recognize issues related to assessment frequency and missing data that impact the ability to assess treatment benefit.

Chair

Marian M Strazzeri, MS

Speaker

Panelist
Scott Komo, DrPH

Panelist
Cheryl D. Coon, PhD



Chair
avatar for Marian Strazzeri

Marian Strazzeri

Mathematical Statistician, OB, OTS, CDER, FDA
Marian Strazzeri currently works on clinical outcome assessments (COAs) and data standards within the Office of Biostatistics (OB) at FDA/CDER. Before joining FDA in her current capacity, she worked as a survey statistician at the National Center for Health Statistics (NCHS) in the... Read More →

Speakers
avatar for Cheryl Coon

Cheryl Coon

Principal, Outcometrix
Cheryl D. Coon, PhD is a psychometrician with over a decade of experience in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments. During her years in the field, she has been involved in all stages of instrument... Read More →
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER-Glob Health Econ, Forum