Brookings: Experts - Gregory W. Daniel

Innovative Technologies and Nonprescription Medications: Addressing Undertreated Diseases and Conditions through Technology Enabled Self-Care

Thu, 09 May 2013 09:00:00 -0400

Event Information

May 9, 2013
9:00 AM - 4:00 PM EDT

The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On May 9, the Engelberg Center for Health Care Reform convened an expert workshop “Innovative Technologies and Nonprescription Medications: Addressing Undertreated Diseases and Conditions through Technology Enabled Self-Care.”

Recognizing the public health impact of undertreatment of common diseases and conditions, the U.S. Food and Drug Administration is exploring how a regulatory expansion of the nonprescription drug class might increase access to important medications and treatments. This initiative is referred to as Nonprescription Safe Use Regulatory Expansion (NSURE).

At this meeting, a wide range of experts and stakeholders explored the use of technologies as a condition to the safe use of medications within a nonprescription setting, discussed perspectives on the role of technology to support the safe and effective use of nonprescription products, and explored the integration of innovative technologies into the health care delivery system.

Event Materials

Promoting the Effective Use of a Common Data Model

Wed, 08 May 2013 09:00:00 -0400

Event Information

May 8, 2013
9:00 AM - 12:15 PM EDT

The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

The passage of the Food and Drug Administration Amendments Act of 2007 mandated that the U.S. Food and Drug Administration (FDA) develop a system for postmarket risk identification and analysis. In response, FDA launched the Sentinel Initiative. FDA’s Mini-Sentinel pilot has made significant strides toward developing a national system for generating post-market safety evidence, and has succeeded in developing an effective distributed research network through a claims-based common data model. As the Sentinel Initiative enters the final year of the Mini-Sentinel pilot, FDA has identified the need to reduce the burden of data collection on the data owners and secondary data users as an area for further exploration.

On May 8, the Engelberg Center for Health Care Reform at Brookings convened an expert workshop, “Promoting the Effective Use of a Common Data Model,” to discuss the opportunities and challenges of adopting a common data model to support a broad range of stakeholder research and data needs. This strategic discussion focused on the potential of using a common data model as a tool to reduce the burden of data collection and the duplication of effort in order to support a stronger national capacity for health research and analysis. Representatives from the FDA, Sentinel data-partners, state all-payer claims databases, and federal agencies discussed their research and data needs, the utility of a common data model or several common data models to meet those needs, and the possibility of utilizing the Mini-Sentinel common data model as a base for broader adoption and expansion.

Event Materials

Accessing and Communicating Device Information: UDI as a Tool for Improved Patient and Provider Connectivity

Mon, 18 Mar 2013 09:00:00 -0400

Event Information

March 18, 2013
9:00 AM - 3:45 PM EDT

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue NW
Washington, DC 20036

Accessing and Communicating Device Information: UDI as a Tool for Improved Patient and Provider Connectivity

On Monday, March 18, 2013, the Engelberg Center for Health Care Reform at Brookings convened a diverse group of patient groups, providers, academic researchers, and other relevant stakeholders to discuss unique device identification (UDI) as a tool for improving the flow of important device information between and among patients and providers.

At the initial UDI Implementation Work Group meeting and throughout ongoing conversations with the Work Group and other experts, stakeholders emphasized the importance of facilitating seamless communication of device safety information, easy access to important device information for patients and providers, and improved communication regarding devices between patients and providers. Although enabling each of these capabilities will likely require the adoption of UDI by an array of stakeholders (e.g., health care systems capturing UDIs in electronic health records), participants emphasized that patients and providers will likely benefit most from and, therefore, should have an important role in the development of the UDI system. However, participants also recognized that the task of realizing the vision of an effective UDI system is not trivial and will require broad stakeholder input and focus. This workshop provided an opportunity for stakeholders to consider what will likely be the most pressing challenges and workable strategies for achieving these enhanced capabilities.

Event Materials

Highlights from the Fifth Annual Sentinel Initiative Public Workshop

Thu, 07 Mar 2013 14:30:00 -0500

Event Information

March 7, 2013
2:30 PM - 3:30 PM EST

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On March 7, the Engelberg Center for Health Care Reform at Brookings hosted a roundtable webinar, “Highlights from the Fifth Annual Sentinel Initiative Public Workshop.” This webinar featured presentations from Dr. Patrick Archdeacon, a medical officer in the Office of Medical Policy at the U.S. Food and Drug Administration, and Dr. Richard Platt, professor and chair of the Department of Population Medicine at Harvard Medical School and executive director of the Harvard Pilgrim Health Care Institute.

This webinar provided an opportunity for stakeholders to revisit the discussions from the Fifth Annual Sentinel Initiative Public Workshop, which included an update on the status of Mini-Sentinel activities and the progress and future directions of the Sentinel Initiative.

Audio

Highlights from the Fifth Annual Sentinel Initiative Public Workshop

Event Materials

Presentation

Improved Access to Device Information:What a UDI System Can Do for Patients and Consumers

Tue, 26 Feb 2013 12:00:00 -0500

Event Information

February 26, 2013
12:00 PM - 1:30 PM EST

Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On February 26, 2013, the Engelberg Center for Health Care Reform at Brookings hosted a webinar entitled “Improved Access to Device Information: What a Unique Device Identification (UDI) System Can Do for Patients and Consumers.” Successful UDI implementation offers a number of potential benefits for patients and consumers, including faster detection of safety concerns associated with specific devices, more efficient communication between providers and patients regarding important medical device information, and independent patient access to information regarding their devices. However, the value of UDI implementation will not be fully achieved without broad stakeholder support and adoption. Patients and consumers have a large stake in this effort and can help shape UDI implementation efforts in important ways. This webinar explored the value of UDI for patients and consumers as well as the potential role they can play in shaping and driving UDI implementation.

Audio

Improved Access to Device Information:What a UDI System Can Do for Patients and Consumers

Event Materials

The State of Drug Safety Surveillance in the U.S.: Much Improved, More to Come

Gregory W. Daniel — Fri, 08 Feb 2013 13:30:00 -0500

When a new drug is approved in the United States, it is virtually impossible to know all of the risks that a population may encounter when using that product. Even though the U.S. Food and Drug Administration (FDA) requires drug manufacturers to meet rigorous standards demonstrating the drug’s safety and effectiveness for its intended use, once approved, drugs can be used by many more patients than were studied in clinical trials. This may include patients with unique clinical conditions, differing health status, ethnicity, age, or other characteristics which were not well-represented before the drug’s approval. Further, the drugs themselves can be used in different ways and in different settings than were studied. Until recently, FDA did not have the necessary tools and data access to rapidly and consistently track the risks of serious side effects of regulated drugs after approval. Recognizing this challenge, FDA has developed a pilot system to make the best use of available electronic health data using a new data and research network capable of evaluating the safety of medical products in the U.S.

Authorized by the Food and Drug Administration Amendments Act (FDAAA) of 2007, this pilot is known as Mini-Sentinel, and is part of FDA’s larger Sentinel Initiative. Sentinel was envisioned as a national electronic system to track the safety of regulated medical products, through the use of existing health insurance claims and electronic clinical data that are generated as part of routine care. In the four years since its inception, Mini-Sentinel has made tremendous progress toward developing this system. Mini-Sentinel is comprised of insurance claims and clinical data from 18 participating data-partners, including some of the largest private health plans in the United States. In order to best protect patient privacy, the data from each partner is maintained behind each individual health plan fire-wall. This “distributed data” approach allows a single coordinating center to distribute FDA safety questions in the form of “queries,” to each of the participating data partners to be run against their own data. Aggregated summary results are then sent back to the coordinating center for final analysis. This process allows FDA to access data that can help in addressing safety questions in near real-time.

Through Mini-Sentinel, FDA has the capability to better understand the safety outcomes using electronic health care data of approximately 169 million covered lives. This accumulation of data represents the capture of 382 million person-years of observation time and billions of prescription dispensings.[1] Examples of the types of safety questions that have already been addressed by Mini-Sentinel include the following:

Safety concerns with drugs used to treat high blood pressure and the incidence of angioedema;
Safety concerns with a new diabetes treatment and the incidence of heart attacks; and
Impact of FDA regulatory actions (i.e. drug label changes) intended to mitigate serious risks of drugs.

The Mini-Sentinel pilot has demonstrated substantial progress and has proven to be a very useful tool for FDA, largely due to the strong partnerships developed between FDA, collaborating academic institutions, and private health plans. However, in order to ensure continued progress and long-term sustainability, it will be critical for progress to continue in several key areas.

First, continued methods development and data understanding will be necessary to ensure FDA has access to the most innovative tools. The field of pharmacoepidemiology and drug safety surveillance is still young and the continued development of better study designs and analytic tools to quantify risks of serious adverse events, while accounting for many confounding factors that are inherent on observational data, will be critical. Further, as health reforms impact that way health care is delivered and financed (e.g., development of accountable care organizations and increased use of bundled payments), the electronic health data will change. It will be important to focus efforts on understanding how these changes will impact data used for safety evaluations.

Second, it is clear that Sentinel’s contributions may extend well beyond FDA’s medical product assessments. The tools and infrastructure that have been developed by FDA over the last four years could be used as a platform to establish a national resource for a more evidence-based learning health care system. This system will enable a better understanding of not only the risks, but also benefits and best uses, of drugs in the post-market settings.

FDA has initiated steps to ensure the long-term sustainability and impact of Sentinel infrastructure and tools. Within the next few years, FDA has proposed that Sentinel be transitioned into three main components: the Sentinel Operations Center, the Nation Resource Data Infrastructure, and the Methodological Resource for Medical Product Surveillance using Electronic Healthcare Databases. FDA has indicated that while the Sentinel Operations Center will continue to serve as FDA’s portal to the distributed database, the Nation Resource Data Infrastructure could potentially be used by other groups to support broader evidence generation. Potential groups with interest in improving our understanding of the impact of medical products and who could benefit from this framework include the National Institutes of Health, the Regan-Udall Foundation, the Patient Centered Outcomes Research Institute, and other possible stakeholder groups, such as the private industry.

Collectively, these components will ensure that FDA continues to have the tools to engage in medical product surveillance, while ensuring the long-term sustainability of the system. In just four years, the Sentinel Initiative has laid the groundwork to transform how FDA, and the nation, benefits from electronic health care data. This network continues to foster a community of stakeholders committed the evidence generation, which will ultimately contribute to a learning health care system.

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New Advances in Medical Records Reflects the Realities of the U.S. Healthcare System

For more information on these issues, including discussion by leaders from Sentinel stakeholders, please visit the Sentinel Initiative Public Workshop event page. There you will find archived video, presentations, and further reading.

[1] http://mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx

Video

New Advances in Medical Records Reflects the Realities of the U.S. Healthcare System

Authors

Gregory W. Daniel

Sentinel Initiative Public Workshop

Thu, 31 Jan 2013 09:00:00 -0500

Event Information

January 31, 2013
9:00 AM - 4:00 PM EST

Marriott Wardman Park
2660 Woodley Road, NW
Washington, DC 20008

On January 31, the Engelberg Center for Health Care Reform hosted the fifth annual Sentinel Initiative public workshop, at the Washington Marriott Wardman Park in Washington, DC. This public workshop brought together the members of various stakeholder communities for a productive discussion on the continuing development of active medical product surveillance, including:

The State of Mini-Sentinel Activities
Selected Mini-Sentinel Protocol-Driven Evaluations
Collaborations Supporting Active Surveillance Research
Planned Expansion of Prospective Surveillance Programs
Opportunities to Expand the Public Health Impact of the Sentinel Initiative
Stakeholder Feedback on Mini-Sentinel as a Tool for Evaluating Drug Safety Issues that Require Regulatory Action

Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, provided the morning keynote address. Both Dr. Woodcock and Dr. Karen Midthun, the Director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration participated in a panel seeking input on the ongoing progress as well as the future of the Sentinel Initiative.

Event Video:

Video

Moving Forward with the Sentinel Initiative

Event Materials

UDI Expert Workshop #2: Identifying Steps for Implementation and Integration of UDI within Electronic Data Infrastructure of Care Delivery Sites

Thu, 13 Dec 2012 09:00:00 -0500

Event Information

December 13, 2012
9:00 AM - 4:00 PM EST

Saul/Zilkha Rooms
Brookings Institution
1775 Massachusetts Avenue NW
Washington, DC 20036

Identifying Steps for Implementation and Integration of UDI within Electronic Data Infrastructure of Care Delivery Sites

On Thursday, December 13, 2012, the Engelberg Center for Health Care Reform at the Brookings Institution convened a diverse group of providers, vendors, medical device manufacturers, academic researchers, and other relevant stakeholders with important roles throughout the medical device lifecycle to discuss workable strategies for meaningfully integrating unique device identifiers (UDIs) into and across administrative and clinical data systems within health care delivery sites.

At the initial UDI Implementation Work Group meeting, stakeholders emphasized the importance of integrating UDI into the electronic data infrastructure at health care delivery sites to enable an array of benefits, including streamlining the supply chain, providing access to device information to inform provider decision-making, and creating enhanced mechanisms for device safety surveillance and effectiveness evaluation. Despite these potential benefits, achieving this goal is not trivial and will require broad stakeholder input and focus. This workshop provided an opportunity for stakeholders to consider what incentives could be used to drive incorporation of UDI into administrative and clinical data systems within health care delivery sites, potential obstacles that will need to be anticipated, and paths forward for integrating UDI recording into and across these systems without disrupting workflow.

Event Materials

Developing a Taxonomy of Surveillance Methods for Medical Product Safety

Fri, 07 Dec 2012 14:00:00 -0500

Event Information

December 7, 2012
2:00 PM - 3:00 PM EST

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On December 7, 2012, the Engelberg Center for Health Care Reform at Brookings held a webinar on “Developing a Taxonomy of Surveillance Methods for Medical Product Safety.” This webinar explored how the classification of surveillance methods allows for researchers to determine the most suitable methodology for monitoring medical product safety scenarios. This classification has helped to provide clear and practical guidance for methods selection in active medical product surveillance. Dr. Joshua Gagne highlighted progress in categorizing medical product safety scenarios and developing structured decision tables for methods selection. Dr. Meghan Baker provided an overview of a methods framework for vaccine-specific safety monitoring.

Audio

Developing a Taxonomy of Surveillance Methods for Medical Product Safety

Event Materials

Taxonomy Webinar Presentation

Biomedical Innovation in a Challenging Fiscal Environment

Gregory W. Daniel — Fri, 30 Nov 2012 15:24:00 -0500

The U.S. biomedical “innovation ecosystem”—encompassing the universe of stakeholders and activities directed toward understanding disease areas and developing novel treatments for them—is in a period of stress. As noted in the September release of a report by the President’s Council of Advisors on Science and Technology (PCAST), significant scientific advances over the last 25 years have moved us toward a better understanding of the biologic underpinnings of some of the most debilitating diseases that affect the U.S. population. While novel treatment options for many of these disease areas have been developed over this time period, recent history has demonstrated that advances in basic research have not consistently translated into substantial progress in the production of novel treatments and cures. The rate at which new biomedical products are entering the market has remained relatively constant over the last few decades, while the cost and time associated with the development of new products appears to have steadily increased. Seeing the advances in novel treatments that have been made during this time may lead many to believe that increased funding for early stage research and development can relieve the stress on the innovation ecosystem. In today’s economy, however, this notion may well prove unachievable as additional public funds are unlikely to be available and private investment is constricted. These trends point toward the need for novel strategies to improve productivity in biomedical innovation and efficiently move medical products from scientific discovery to clinical practice.

Consequently, it is more important than ever to identify ways that current levels of investment could have greater impact rather than simply increasing the level of spending. In other words, we need to be able to do more with less. While capital is needed for basic research and translation of bench-top findings to clinical science, we must create efficiencies in the development process and generate more robust, meaningful clinical evidence on the developing targets in order to make research and development investments go further and continue attracting greater investment. This is especially true for investments needed to support smaller startup companies, which often struggle to raise funds needed to move promising initial results from Phase 2 clinical trials into the larger and more expensive Phase 3 trials despite promising results. Identifying such hurdles and smartly deploying available resources to overcome them could result in increased efficiency of clinical development. It is important to note that pursuing efficiencies should not be taken to mean that the evidentiary or safety standards for moving a product to market ought to be lessened or changed; rather, efficiency in clinical development will help address challenges by allowing us to learn how products perform in a faster, less expensive manner.

In order to harness data and resources efficiently, it will be important for industry to continue exploring pre-competitive collaborations to better understand the nature of diseases and how to treat them. Ultimately, such arrangements provide greater benefit to those involved than any potential loss of competitive advantage associated with collaborating. By forming creative partnerships in which multiple competing companies come together to share data and explore tough questions, industry can not only make better use of the basic science tools at their collective disposal but also better integrate patient outcomes and post-market evidence into a more concerted industry-wide assessment of where innovative products are needed. In this way, data from across the drug discovery, development, and use spectrum can be fully utilized. A primary example of companies coming together in the pre-competitive space is the recently announced TransCelerate BioPharma, a group effort between 10 leading pharmaceutical companies to accelerate drug development and improve clinical trials.

Improvements in the research and clinical development of innovative medical products can also be supported by a learning health care system that is able to generate and harness more and better evidence to inform health care decision making post product approval. Given the current economic environment, it will be important for stakeholders to continue their work in establishing such a system and augmenting the impact that they can have on improving the biomedical landscape. With a true learning health care system, one that leverages the billions of pieces of information from the totality of electronic health care data generated during routine care (e.g., administrative claims, electronic health records, patient-reported data), we will benefit from a strong data environment that supports more efficient outcomes research, benefit/risk assessment, and health care decision-making. This would allow continual learning from patients’ experiences as they encounter the health care system to understand what treatments work best and for whom. A better understanding of what medical interventions can have substantial impact on improving quality of care and patient outcomes, including those of most importance to patients themselves, could then bring increased clarity to the ecosystem on what approaches are most promising and what areas are most in need of further innovation.

Finally, addressing the challenges to improving biomedical innovation must include a push to recognize and strengthen the aspects of translational and regulatory sciences that make them unique and indispensable in the product development process. Understanding the evidentiary requirements of each field will be paramount, especially as new methodologies, clinical trial designs, and types of evidence continue to force these fields to be nimble and rigorous in their analytics while maintaining a commitment to patient safety. It will be especially important for the fields of translational and regulatory science to engage academia and industry to recruit and train new generations of scientists capable of advancing their respective disciplines. In short, strengthening the ways in which basic, translational, and regulatory sciences inform and bolster one another will be key to ensuring a robust and efficient product pipeline.

For more information on these issues, including discussion by senior thought leaders from across the biomedical innovation ecosystem, please visit the Brookings event pages for “New Policy Directions for Biomedical Innovation ” and the “Annual State of Biomedical Innovation Conference.” There you will find archived webcasts, background documents, and further reading.

Authors

Gregory W. Daniel

Image Source: © Jessica Rinaldi / Reuters

The Value of Unique Device Identification (UDI) for Health Care Systems and Providers

Mon, 05 Nov 2012 14:00:00 -0500

Event Information

November 5, 2012
2:00 PM - 3:30 PM EST

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On November 5, 2012, the Engelberg Center for Health Care Reform at Brookings hosted a webinar on “The Value of Unique Device Identification (UDI) for Health Care Systems and Providers.”

Experts have highlighted a variety of enhanced capabilities that could arise from UDI adoption and implementation. For example, UDI implementation offers health care systems and providers the opportunity to streamline internal supply chains, conduct more effective recall management, and improve access to device information. This webinar explored the operational, financial, and clinical value of UDI implementation for health care systems and providers.

Audio

The Value of Unique Device Identification (UDI) for Health Care Systems and Providers

Event Materials

UDI Webinar 1 Presentation

Brookings Roundtable on Active Medical Product Surveillance: Findings from a Mini-Sentinel Medical Product Assessment

Tue, 16 Oct 2012 13:00:00 -0400

Event Information

October 16, 2012
1:00 PM - 2:00 PM EDT

Online
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On October 16, 2012, the Engelberg Center for Health Care Reform at Brookings held a webinar on “Findings from a Mini-Sentinel Medical Product Assessment.” Mini-Sentinel investigators have recently completed an assessment that examined a possible association between use of certain antihypertensive medications and angioedema events. This protocol-based assessment compared the incidence of angioedema with drugs that target the renin-angiotensin-aldosterone system using beta blockers as comparators. While not intended to provide a definitive conclusion on the association, the results will help to interpret the larger context of what is known about the drugs from various sources. The assessment also enabled Mini-Sentinel investigators to build general strategies to assess suspected associations of selected medical products and adverse events.

Audio

Brookings Roundtable on Active Medical Product Surveillance: Findings from a Mini-Sentinel Medical Product Assessment

Event Materials

MiniSentinel Medical Product Assessment

Participants

Panelists

Gregory W. Daniel

Managing Director for Evidence Development & Innovation, Engelberg Center for Health Care Reform
Fellow, Economic Studies

UDI Expert Workshop #1: Exploring the Opportunities and Challenges Associated with Capturing UDIs in Claims

Mon, 15 Oct 2012 09:00:00 -0400

Event Information

October 15, 2012
9:00 AM - 4:00 PM EDT

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue, N.W.
Washington, DC 20036

Exploring the Opportunities and Challenges Associated with Capturing UDIs in Claims

On October 15, 2012, the Engelberg Center for Health Care Reform at the Brookings Institution convened a diverse group of experts, including payers, providers, academics, medical device manufacturers, and other relevant stakeholders, for a productive discussion on capturing unique device identifiers (UDIs) in administrative health care claims.

Electronic health care claims data have increasingly played an important role in a range of activities related to drugs and other health care services, including active drug safety surveillance, evaluation of patterns of care and effectiveness, and identification of opportunities for improvements in the quality of care that patients receive. During the initial meeting of the UDI Implementation Work Group, participants emphasized that if UDIs were captured in claims, similar activities may become more feasible for medical devices. However, overcoming the technical and motivational challenges associated with incorporating UDIs into claims is not trivial. Broad stakeholder input will be required and this expert workshop was designed as an initial forum for discussion. Specifically, this workshop provided an opportunity for stakeholders to consider the potential benefits of capturing UDIs in claims, associated technical challenges, and appropriate policies to support consistent UDI reporting in claims.

Event Materials

Unique Device Identification (UDI) Implementation Work Group Kick-Off

Mon, 16 Jul 2012 09:30:00 -0400

Event Information

July 16, 2012
9:30 AM - 4:00 PM EDT

The Stein Room
The Brookings Institution
1775 Massachusetts Ave., N.W.
Washington, DC 20036

On July 16, 2012, the Engelberg Center convened a small work group of experts representing key stakeholder groups, including device manufacturers, payers, electronic health record vendors, academics, clinicians, and others with a vested interest in UDI implementation. This Work Group convened for an initial in-person meeting at Brookings where the group delved into the major use cases that should be the focus of initial UDI implementation efforts, explored major challenges to implementation, and identified those that could benefit from greater attention during subsequent expert workshops.

Recently, the U.S. Food and Drug and Administration (FDA) released its Proposed Rule outlining a system of unique device identifiers (UDIs). The Engelberg Center for Health Care Reform at Brookings is beginning work to support the implementation and full adoption of UDIs across the medical device lifecycle. Initiated in cooperation with FDA and Chickasaw Nation Industries, Inc. as part of the Medical Device Epidemiology Network (MDEpiNet) program, this work will help identify, prioritize, and explore the most pressing issues pertaining to UDI implementation.

Event Materials

Participants

Panelists

Gregory W. Daniel

Managing Director for Evidence Development & Innovation, Engelberg Center for Health Care Reform
Fellow, Economic Studies

Mark B. McClellan

Director, Engelberg Center for Health Care Reform
Senior Fellow, Economic Studies
Leonard D. Schaeffer Chair in Health Policy Studies

Progress from the Patient-Centered Outcomes Research Institute

Thu, 12 Jul 2012 11:00:00 -0400

Event Information

July 12, 2012
11:00 AM - 12:00 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On July 12, The Engelberg Center for Health Care Reform at Brookings hosted a webinar on progress from the Patient-Centered Outcomes Research Institute (PCORI).

Established by the Affordable Care Act of 2010, PCORI was launched to promote evidence-based information to help people make informed health care decisions and to improve health care delivery and outcomes. PCORI leadership and staff have worked to develop the framework, standards, and methods necessary for providing patients and providers with beneficial information.

Dr. Anne Beal and Dr. Sharon-Lise Normand provided an overview of the progress made at PCORI, including a discussion of the National Priorities and Research Agenda, research funding and pilot projects, and methodological standards.

Audio

Progress from the Patient-Centered Outcomes Research Institute

Event Materials

PCORI Webinar

Participants

Panelists

Mark B. McClellan

Director, Engelberg Center for Health Care Reform
Senior Fellow, Economic Studies
Leonard D. Schaeffer Chair in Health Policy Studies

Anne Beal

Sharon-Lise Normand

Gregory W. Daniel

Managing Director for Evidence Development & Innovation, Engelberg Center for Health Care Reform
Fellow, Economic Studies

State of Biomedical Innovation Conference

Wed, 27 Jun 2012 09:00:00 -0400

Event Information

June 27, 2012
9:00 AM - 12:30 PM EDT

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue, N.W.
Washington, DC 20036

On June 27, the Engelberg Center for Health Care Reform at Brookings hosted the State of Biomedical Innovation Conference in Washington, DC. Designed to bring together diverse stakeholders and senior thought leaders from across the biomedical enterprise, this event engaged participants in discussion on the health of biomedical innovation in the United States, obstacles to innovation, policy options for overcoming those obstacles, and key metrics that can be used to evaluate whether the U.S. biomedical enterprise is effectively delivering new and innovative medical products to the patients who need them.

Panelists included distinguished experts, industry leaders, policymakers, and regulators. After each panel, participants took audience questions.

Video

Event Materials

Brookings Roundtable on Active Medical Product Surveillance European Medicines Agency’s Postmarket Drug Safety Activities: Overview of PROTECT

Wed, 20 Jun 2012 11:30:00 -0400

Event Information

June 20, 2012
11:30 AM - 12:30 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

Coordinated by the European Medicines Agency, the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project was launched to strengthen the monitoring of the benefit-risk of medical products in Europe. A methodological framework for the project is currently being developed through public and private partnerships. This framework focuses on data collection and the early detection and assessment of adverse events. Dr. Xavier Kurz, Principal Scientific Administrator at the Post-Authorisation, Pharmacovigilance, and Risk Management Sector of the European Medicines Agency, provided an overview of this project. Dr. Kurz discussed PROTECT’s governance, innovative tools, methods that are currently being or have recently been developed, and the project’s future direction.

Audio

Webinar Audio

Event Materials

PROTECT slides final

Participants

Panelists

Mark B. McClellan

Director, Engelberg Center for Health Care Reform
Senior Fellow, Economic Studies
Leonard D. Schaeffer Chair in Health Policy Studies

Xavier Kurz

Principal Scientific Administrator

Facilitating Antibacterial Drug Development

Wed, 09 May 2012 08:30:00 -0400

Event Information

May 9, 2012
8:30 AM - 2:30 PM EDT

Saul/Zilkha Rooms
Brookings Institution
1775 Massachusetts Avenue NW
Washington, DC 20036

As the prevalence of drug-resistant bacteria continues to rise, there is a pressing need for new drugs to combat infections by these organisms. However, research and development in this area has slowed, creating a public health concern that we lack the drugs necessary to treat multi-drug resistant infections. Challenges to promoting antibacterial drug development may be scientific, methodological, regulatory, or economic in nature.

On Wednesday, May 9, 2012, the Engelberg Center for Health Care Reform convened an expert workshop, "Facilitating Antibacterial Drug Development,” that explored solutions to methodological and regulatory challenges that could make the development process more efficient. This meeting brought together diverse multi-stakeholder experts—including medical product developers, health care professionals, researchers, patient advocates, representatives of the U.S. Food and Drug Administration, and other groups—to explore the following issues:

Existing paradigms for antibacterial drug development;
Novel approaches to further antibacterial drug development, including use of pharmacokinetics and pharmacodynamics, Bayesian methods, innovative clinical trial designs, new data sources, alternate clinical endpoints, and new regulatory tools; and
Short- and long-term opportunities to advance the antibacterial drug development enterprise through collaboration among stakeholders, improved regulatory science, and other means.

For more information on FDA’s Antibacterial Drug Development Task Force, click here.

Event Materials

Participants

Panelists

Expert Workshop: Prescribing Information for Healthcare Professionals

Fri, 20 Apr 2012 09:00:00 -0400

Event Information

April 20, 2012
9:00 AM - 2:00 PM EDT

Saul Zilkha
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On April 20, the Engelberg Center convened an expert workshop to discuss prescribing information for health care professionals.

This workshop brought together a diverse set of stakeholders who discussed the following issues:

How the prescribing information (PI) is currently accessed and utilized;
If the current PI format is meeting the needs of prescribers and other health care professionals and if all PIs should be standardized in this format;
How PIs could be encouraged as the primary resource for prescription drug information; and
The content that is most useful for prescribers and other health care providers in the Patient Counseling Information (PCI) section of the PI.

Transcript

Discussion Guide (.pdf)

Event Materials

Participants

Panelists

Janet Woodcock

U.S. Food and Drug Administration

Amy L. Ebel

GlaxoSmithKline

Brian Pinto

The Johns Hopkins Hospital

John Graykoski

Mayo Clinic Health System

Nancy Beth Barr

MedStar Franklin Square Medical Center

Jessica K. Lee

Kerr Drug

Lorraine M. Reiser

Clarion University of Pennsylvania

Robyn F. Chatman

Trinity Family Medicine

Edward J. Fotsch

PDR Network

Rachel Sherman

U.S. Food and Drug Administration – Introduction

Amy L. Ebel

GlaxoSmithKline – Introduction

Derjung Mimi Tarn

David Geffen School of Medicine at UCLA

Joan Davenport

University of Maryland School of Nursing

Sandra F. Ryan

Take Care Health Systems

Heather Free

BioScrip Specialty Pharmacy

Developing the Capabilities for Device Surveillance through the Medical Device Epidemiology Network

Mon, 09 Apr 2012 03:30:00 -0400

Event Information

April 9, 2012
3:30 AM - 4:30 PM EDT

Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On April 9, the Engelberg Center for Health Care Reform hosted a roundtable, “Developing the Capabilities for Device Surveillance through the Medical Device Epidemiology Network.” The Medical Device Epidemiology Network (MDEpiNet) was launched by FDA to develop the infrastructure and methodological approaches for conducting robust analytic studies that will improve FDA’s understanding of medical device performance.

The roundtable featured presentations from Danica Marinac-Dabic, Director, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; Mary Beth Ritchey, Associate Division Director, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA; Benjamin (Ben) Eloff, Senior Scientific Program Manager, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA; Frederic (Fred) Resnic, Director, Cardiac Catheterization Laboratory, Brigham and Women’s Hospital and Assistant Professor of Medicine, Harvard Medical School; and Art Sedrakyan, Associate Professor of Public Health, Director, Patient-Centered Comparative Research Program, Weill Cornell Medical College. The presentations included a discussion about MDEpiNet’s role as part of a comprehensive postmarket national medical product surveillance strategy, an update on the current status of MDEpiNet, an overview of its methods and infrastructure work streams, and a discussion about its future direction.