FDA Town Hall Meeting is a multi-part session held yearly at the Transcatheter Cardiovascular Therapeutics (TCT) conference. At this year's conference, the first portion, titled The Year in Review: A Year in Transition, was introduced by Martin B. Leon, MD, and Bram D. Zuckerman, MD. The Town Hall Meeting is meant to be dynamic and inclusive of key forces from the regulatory environment, clinical scientists, and representatives from industry.
The multi-part session, On Deck: Next Generation Biologics, was part of a larger session at the Transcatheter Cardiovascular Therapeutics (TCT) conference, called Strategies for Cardiovascular Repair: Stem Cells and Beyond. The first portion on extracellular matrices and related products was presented by Karen Christman, PhD, associate professor of bioengineering at the University of California San Diego. Dr Christman discussed the use biomaterials for treating the extracellular matrix of the heart after MI.
A multi-part session titled Stroke in Atrial Fibrillation: A Preventable Condition was begun by Michael D. Ezekowitz, MB, ChB, DPhil, of the Lankenau Institute for Medical Research. In his presentation titled All Novel Agents are Preferred to Warfarin, he discussed the benefits of novel anticoagulant agents.
Atrial Fibrillation, the Epidemic of Our Time was the first portion of a multi-part session titled Pharmacological and Interventional Options for Stroke Prevention in Atrial Fibrillation. The introduction, titled Multifaceted Approaches to Atrial Fibrillation: From Drugs to Ablation to Left Atrial Appendage Closure, was delivered by Vivek Y. Reddy, MD, professor of medicine in cardiology at Mount Sinai Medical Center.
The first part of the session titled Innovation in Transition: Models, Global Trends, Regulatory Challenges, and Funding Opportunities started with a presentation from John B. Simpson, MD, PhD, chief executive officer at Avinger, Inc, called Individual-Based Innovation. Dr Simpson briefly described the lumivascular approach to treatment of cardiovascular disease, which is image-guided atherectomy.
This multi-part presentation was begun with Then and Now: The Evolution of Translational Science, Clinical Evidence-Based Medicine, and Socioeconomic Considerations, delivered by Elazer R. Edelman, MD, PhD, physician at Brigham and Women's Hospital and professor at Harvard Medical School and MIT. He began by discussing the history of innovation in biomedical research and then outlining a current problem in US innovation.
The first presentation in this multi-part session, Current Status of Lipid Lowering Therapy in CAD, PAD, and CKD, was delivered by Rita Redberg, MD, professor of medicine and director women's cardiovascular services, University of California, San Francisco. According to Dr Redberg, a heart-healthy diet, regular physical activity, weight management, medications, and smoking cessation are mainstays of prevention.
The multi-part session at the Transcatheter Cardiovascular Therapeutics (TCT) conference was moderated by Roxana Mehran, MD, professor of medicine at Icahn School of Medicine at Mount Sinai in New York, NY. Dr Mehran began by emphasizing the importance of clinical research in interventional cardiology. She then described the session's speakers as premier investigators.
For Douglas Long, MBA, vice president, industry relations, IMS Health, Inc, keeping up-to-date on the trends and forecasts of the evolving managed care arena is crucial to remaining competitive.
Michael Fischer, MD, associate professor of medicine, Harvard Medical School, associate physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, said that the complexity of the healthcare system is part of the challenge of managing adherence.
Dual eligibles-the class of Americans that qualify for both Medicaid and Medicare coverage-are mostly older adults with low incomes and tend to be the sickest beneficiaries covered by either Medicaid or Medicare.
Almost all pharmacy and therapeutic committees have a unique process for evidence-based formulary decision making, said Steven Pearson, MD, founder & president, Institute for Clinical and Economic Review.
The dynamic landscape of healthcare and managed care pharmacy will be deeply impacted by new and emerging specialty medications. The ever-spiraling costs of specialty medications have led many experts to question whether these treatments translate into true improvements in health outcomes or patients' quality of life.
Not surprisingly, Thomas Merrill, lead researcher, Center for Accountable Care Intelligence, Leavitt Partners, LLC, said that cost is a major work flow challenge associated with Accountable Care Organizations.
In this interview, Curtis Triplitt, PharmD, associate professor and assistant dean of research, Texas Tech University Health Sciences Center, Permian Basin, explains why diabetes should be treated with a patient-centered approach.
Jeff Goldsmith, PhD, healthcare futurist and analyst, says that the Affordable Care Act (ACA) has significantly impacted healthcare policy, in both negative and positive ways.
The patient-centered medical home (PCMH) has many key goals and components. When paneled, the majority of AMCP 2013 Nexus attendees agreed that the PCMH is best described as a practice model that organizes primary care practice operations and incentives to deliver patient-centered, coordinated, comprehensive care with the goal of improved quality and efficiency.
Since 2010, the growth and proliferation of accountable care organizations (ACOs) has increased, and the rise of this collaborative care model is not without reason. Lack of consumer engagement, lack of competition, and misaligned incentives have made care less affordable.
Richard Stefanacci, DO, chief medical officer, The Access Group, said that it is necessary for retail pharmacists to break out of their silo. Dr Stefanacci noted that retail pharmacists are being utilized within practices and stepping out of their normal roles.
Suzanne Tschida, PharmD, vice president, specialty benefits & outcomes, OptumRx, said that at UnitedHealth Group a tiering system is used for the management of specialty medications with a cost-share or copay structure.
The gold standard for measuring treatment outcomes in multiple sclerosis (MS) is the randomized clinical trial (RCT). However, RCTs are often short-sighted and biased in their execution. Dr Maria Sormani, PhD, Biostatistics Unit, Department of Health Sciences, University of Genoa, Genoa, Italy, addressed this problem in a lecture on immunomodulatory treatment of MS.
In this video, Fred Lublin, MD, Saunders Family professor of neurology, director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, discussed the results of his poster presentation, Natalizumab Reduces the Disabling Amplitude of Multiple Sclerosis Relapses and Improves Post-relapse Residual Disability.
Clinical trials and treatment in multiple sclerosis (MS) place an unwelcome economic burden upon countries with MS prevalence. With rising costs and a growing interest in MS clinical trials from emerging countries, new studies are needed to evaluate the significance of these factors.
Fatigue and cognitive impairment are 2 of the most common health problems associated with multiple sclerosis (MS). Recent MS studies evaluate the nature of these 2 conditions not just as side effects of MS, but as chronic conditions with varying degrees of severity based on objective assessment and self-perception.
Barry Singer, MD, director, MS Center for Innovations in Care, St. Louis, MO, said that the Affordable Care Act could cause challenges in terms of coverage.
New disease-modifying drugs in multiple sclerosis (MS) show potential for improving quality-of-life (QoL) of patients with multiple sclerosis. The clinical benefits of dimethyl fumarate and PR-fampridine were discussed at a Biogen Idec-sponsored satellite symposium at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Daniel Kantor, MD, medical director, Neurologique, immediate past president, Florida Society of Neurology, said that after an initial diagnosis of multiple sclerosis (MS) is made, providers must compare risks versus benefits when choosing which agent to treat with.
Recent discussions of risk gene variation and pharmacogenitc studies were highlighted at a parallel session during the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Genome-Wide Association Studies (GWAS) have identified over 100 common risk variants in just over a quarter of observed heritability.
Predictors of long-term disability and treatment failure in multiple sclerosis were discussed at a platform presentation during the 29th Congress European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In the first presentation discussed here, Marzia Romeo, MD, San Raffaele Hospital, Milan, Italy, shared findings from an observational study examining the viability of early prediction of long-term treatment failure in relapsing remitting multiple sclerosis (RRMS) patients treated with disease-modifying treatments (DMT).
At a satellite symposium during the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference, presenters focused upon the usage of disease-modifying treatments (DMT) in relapsing-remitting multiple sclerosis (RRMS).
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