How are comparative effectiveness research and HTA applicable to the biopharmaceutical industry?

Understanding Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) inthe Biopharmaceutical Industry

June 23 from 1:00PM – 4:30PM in Boston

Health care reform has amplified interest in Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA). CER/HTA may sound threatening without a realistic context for what it is, how it has evolved, what it is intended to do and its limitations. A brief introduction and overview of CER/HTA will be presented through lecture, interactive discussions and case study. This tutorial will present a perspective of CER/HTA in the context of clinical trials and health care policy and provide timely insights for today’s biopharmaceutical professionals.


Instructor(s):
Nancie E. Celini, DrPH,MPH
Chief Learning Consultant
CAB Inc., United States

Vadim Tantsyura, DrPH,MA,MS
Director, Data Management
Cincinnati Children's Hospital Medical Center, United States


What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

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Comparative Effectiveness Research Series ~ online training

Purchase two of the following online courses in one transaction and save 10%. Purchase all three in one transaction and save 20%. Discount will be reflected in the final step of the checkout process. Strategies for Comparative Effectiveness Research for Regulatory, Compliance, and Legal Professionals in Life Sciences Promotion April 23 | 11:00AM-12:30PM ET In 90 minutes, you will get a combination of background instruction into the principals of CER, current and future impact on the broader regulatory industry, along with implications for future communications, marketing, monitoring, and resource planning. Real-world examples will be used to help explain changing implications of new sources of data and outcomes measures, detailing the transition to newer CER based advertising and promotional material and how to effectively incorporate these into developing corporate sales and marketing, value research, and product attribute messaging. Faculty: Danny A. Benau, PhD, Director, Biomedical Writing Programs, University of the Sciences Darshan Kulkarni, JD, PharmD, MS, Principal Attorney, The Kulkarni Law Firm Andrew M. Peterson, PharmD, PhD, Dean, Mayes College, University of the Sciences   Overview | Register Online Essentials for Comparative Effectiveness Research for Medical Affairs and Health care Professionals June 5 | 1:00-2:30PM ET Understand changes to today’s practices, when and why they are being transitioned to the newer CER format, and methods to effectively include these changes into future studies, payor and patient interactions and value focused research. Faculty: Danny A. Benau, PhD, Director, Biomedical Writing Programs, University of the Sciences Stephanie Michelle Knight, Associate Director, Pfizer Inc. Andrew M. Peterson, PharmD, PhD, Dean, Mayes College, University of the Sciences   Overview | Register Online Implication of Comparative Effectiveness Research for Clinical Research Organizations September 18 | 11:00AM-12:30PM ET This 90-minute online offering will allow you to quickly understand current practices, when and why they are being transitioned to the newer CER format, and methods to effectively include these changes into your future investigations. Faculty: Danny A. Benau, PhD, Director, Biomedical Writing Programs, University of the Sciences Darshan Kulkarni, JD, PharmD, MS, Principal Attorney, The Kulkarni Law Firm   Overview | Register Online   Newly Released Webinar: Preparing for the Physician Payment Sunshine Implementation: Research, Marketing & Education April 29 | 1:00-2:30 PM ET All transfers of value to covered recipients must be tracked by covered manufacturers starting August 1. This 90-minute webinar will provide a high-level overview of the basic requirements of the final rule for implementing the Physicians Payment Sunshine Act, before turning to many of the gray areas where manufacturers are struggling to understand what they need to track and report. This webinar will focus on the requirements for research-related activities, indirect payments, and the determination of value for many educational efforts. Industry experts will help you go beyond a cursory understanding of the rule to help their organizations determine how they will ensure compliance and avoid the costly fines.   Overview | Register Online April 9, 11, 16 & 18 12:00-1:30PM ET April 10 12:00-1:30PM ET April 25-26 10:00-11:30AM ET

Building a National Data Infrastructure to Advance Patient-Centered Comparative Effectiveness Research

We hope you'll mark your calendar for an important PCORI roundtable discussion: Building a National Data Infrastructure to Advance Patient-Centered Comparative Effectiveness Research. When: Tuesday, April 23, 2013, 9:00-11:00 a.m. ET (Light breakfast available at 8:00 a.m.) Where: The National Press Club in Washington, D.C. RSVP: Friday, April 19, 2013, by 5:00 p.m. ET (If registration reaches the venue's capacity, registration will close before this time.)   Comparative clinical effectiveness research (CER) can play a significant role in improving the volume and quality of information available to patients, caregivers, clinicians and other healthcare stakeholders. A data-rich national infrastructure to support high-quality, efficient CER will benefit all Americans. The right infrastructure has the potential to transform research and foster a learning healthcare system that uses meaningful evidence drawn from clinical practice to improve patient outcomes. On Tuesday, April 23, PCORI will host a roundtable discussion on how to create a national data infrastructure to support high-quality patient-centered CER. The roundtable will bring together representatives from government, industry, payers, health systems, and the research and patient communities to discuss the challenges and opportunities in creating such a research infrastructure and where PCORI's investments can provide unique value. Audience members will be able to pose questions to roundtable participants toward the end of the event. A webcast will be available for those who can't attend in person. Individuals who wish to attend in person should register for the event through the PCORI website. The event agenda will be updated as roundtable participants are confirmed. ###

Health Economic Outcomes/Comparative Effectiveness Research/Health Technology Assessment Track at DIA's 49th Annual Meeting

TRACK 13: HEALTH ECONOMICS AND OUTCOMES (HEO)/COMPARATIVE EFFECTIVENESS RESEARCH (CER)/HEALTH TECHNOLOGY ASSESSMENT (HTA) Learning Objectives:  Describe current issues in measuring and communicating the medical need, health impact, and economic value associated with medical products How can clinical trial design impact reimbursement potential?

How are comparative effectiveness research and HTA applicable to the biopharmaceutical industry?

What are the pharma, safety, and patient perspectives on big data methodology?

2012 US Payer Landscape survey looks at CER and EBM use in coverage decision making.

What are benefits and outcomes of collaborations between payers and pharmaceutical companies?

How can we utilize EMRs as an  innovative methodology for evaluating Therapeutic Effectiveness?

What are different ways for incorporating patient-centered approaches in model development?

What are pros/cons of using observational methods to support comparative effectiveness research?

How can information sharing  be facilitated across Sponsors, Regulatory and HTA Agencies?

How do Public and Private Payers translate CER into Medical Payment Policy?

PCORI approves 25 awards, totaling $40.7 million over three years, to fund patient-centered CER

December 18, 2012

The Patient-Centered Outcomes Research Institute (PCORI) has approved its first primary research projects. PCORI today announced the approval of 25 awards, totaling $40.7 million over three years, to fund patient-centered comparative clinical effectiveness research projects under the first four areas of its National Priorities for Research and Research Agenda.

All proposals were approved by PCORI's Board of Governors pending a business and programmatic review by PCORI staff and completion of a formal award contract.   The approved research projects, based at institutions in 17 states, resulted from PCORI's first cycle of primary research funding announcements issued May 22. PCORI received nearly 500 applications. The approved projects were selected through a competitive, multi-stage review process that incorporated patients, caregivers and other stakeholders in the evaluation of proposals. Applications were evaluated on scientific merit, engagement of patients and other stakeholders, methodological rigor and fit within PCORI's research priorities and research agenda.   The projects approved for funding include those that will study ways to improve care for people with such health problems as bacterial and viral infections, cardiovascular disease and stroke, certain cancers, chronic kidney disease, chronic pain, depression and other serious mental illness, and pediatric diabetes, as well cross-cutting proposals investigating how to improve care for people with multiple conditions. Other projects seek ways to improve patient-clinician communication, reduce selected health disparities, and improve the way healthcare systems operate.   Information on all of today's awards, including the project name, primary investigator, and research institution, is provided on the PCORI website, www.pcori.org.   For more information about PCORI funding opportunities visit www.pcori.org/funding-opportunities.   #####

About PCORI The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.