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Value-Based Evidence [clear filter]
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
 
Tuesday, June 28
 

2:00pm EDT

#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-547-L01-P; CME 1.25; IACET 1.25; RN 1.25

Disease interception focuses on the development of medicines that stop or delay disease progression for patients at risk or asymptomatic within the disease continuum. Learn as regulators and payers share perspectives in this new drug development space.

Learning Objectives

Discuss the regulatory and implementation challenges to innovation in disease interception; Propose solutions to regulatory challenges to innovation for disease interception therapies; Assess the benefit and risk framework and value of disease interception therapies.

Chair

Karin Van Baelen, PharmD

Speaker

FDA Perspective
Ellis Unger, MD

EU Perspective
Hans-Georg Eichler

Payer Perspective
Sean R. Tunis, MD, MSc



Chair
avatar for Karin Van Baelen

Karin Van Baelen

Head, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karin is leading the Global Regulatory Affairs organization at Janssen. She facilitates the relationship between the Janssen pharmaceutical companies and global health authorities, influencing and interpreting global regulatory requirements and enabling our companies to meet those... Read More →

Speakers
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 Sean Tunis

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMTP)
Sean Tunis, MD, MSc, is Founder and Senior Strategic Advisor of the Center for Medical Technology Policy, an independent, non-profit organization that provides a neutral platform for multi-stakeholder collaborations that promote high value innovation by improving the quality, relevance... Read More →
avatar for Ellis Unger

Ellis Unger

Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum
 
Wednesday, June 29
 

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

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

4:00pm EDT

#363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-550-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patients with unmet medical needs want early access to medicines. Regulators need to feel confident that the the benefit-risk balance of a medicine they are licensing is positive. Regulators from the EU, Japan, and the US will discuss how access to medicines can be speeded up and the use of postmarketing data to reduce the uncertainties.

Learning Objectives

Recognize the concepts and current progress with speeding up access to medicines in different regions.

Chair

Stella C.F. Blackburn

Speaker

Sooner or Later? Cost and Benefit of Utilizing Rolling Reviews in US and Japan
Toshiyoshi Tominaga

EU Adaptive Pathways Process
Hans-Georg Eichler

Expedited Reviews and Using Postmarketing Data to Supplement Clinical Trials
Gerald J. Dal Pan, MD



Chair
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →

Speakers
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 Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session