Heart Valve Replacement: A Full-Team Approach for Operational Success

When considering the growing need for well executed and conclusive trials within the valve replacement and repair arena, fully engaging the entire trial team is essential to achieving the required operational oversight. This is especially important when you consider that the TAVR (transcatheter aortic valve replacement) market is expected to approach $4 billion by 2020 ^{1, 2} — and that demand for transcatheter mitral valve replacement devices is expected to grow to four times³ the TAVR market.

This webinar will take a deconstructed look at clinical trial requirements for valve replacements, defining a full-team approach, explaining its importance, and defining the factors that are critical to success in this field of research. Among them:

• The team’s experience: globally, by region, and by country.
• Regional regulatory requirements: accounting for differences between the FDA and European regulators.
• Patient considerations (patients are, after all, important members of the research team).
• Front-line experience: sites, investigators, nurses, and staff.
• Project manager proficiency in clinical monitoring and data handling.
• The valve study life cycle: applying the full team’s experience to planning milestones and other major decision points.

Takeaways from this webinar will help researchers at every point in the clinical trial process.

1. Osnabrugge, R., et al. Disease prevalence and number of candidates for transcatheter aortic valve replacement. J Am Coll Cardiol. 2013:62(11):1002-1012.
2. Global transcatheter aortic valve replacement market to generate close to USD 4 billion by 2020, says Technavio. Press release. February 3, 2016
3. Stuart, M. Percutaneous mitral valve therapy: the next decade. START-UP, February 2012, Vol 17, No. 2. Elsevier Business Intelligence.

Speakers

Joanne Emmett, Vice President, Medical Device & Diagnostics, Premier Research

Joanne Emmett has been part of the clinical research industry for 20+ years with a keen focus on operational design and delivery. Ms. Emmett started her career in academia within transplant research and proceeded on to cardiovascular research involving valve and imaging trials. Once joining the CRO business space in 1995, she was engaged as a CRA, LCRA and Project Manager working on trials in CNS, Oncology, Respiratory, Cardiovascular Device and several diagnostic programs. Ms. Emmett took her front-line delivery experience to the next level and moved into oversight and department leadership specializing in Clinical and Project Management Delivery, spending time at PRA and joining Premier Research in early 2011.

Since then, Ms. Emmett, has been responsible for the operational delivery structures and planning for both clinical and project management. She has focused on the key needs and standards within therapeutic and medical device and ensuring core process designations for staffing and oversight, including the unique regulatory and scientific avenues required for medical device.

Ms. Emmett has been engaged over her career with ACRP, chairing the Poster Committee in 2006 and moving onto Chair the Annual ACRP meeting in 2007. She also spent time with development and implementation of the Post Graduate Clinical Research Program at Humber College in Toronto. Ms. Emmett has her PMP designation, Management and Business Administration Certificate from the American Management and Business Administration Institute, CCRA from ACRP, Post Graduate Clinical Research Certification and BSc from the University of Western Ontario in London, Canada.

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Janet Kube, Director, Project Management, Premier Research

Janet Kube oversees Premier Research’s project managers and directors, supporting global collaboration, monitoring activity and metrics reporting, and acting as senior customer liaison to ensure adherence to time, cost, and quality performance targets.

Mrs. Kube has more than 20 years of experience in clinical drug development and medical device licensing in the CRO field, operating in Western, Central, and Eastern Europe; the United States; Australia; and New Zealand. After spending several years as a clinical research associate, she managed complex oncology and central nervous system studies before moving into the medical device field, where she currently specializes and has overall responsibility for trials and customers in the cardiovascular field.

Before joining the drug development industry, Mrs. Kube worked as a registered pediatric nurse and an operating room nurse, focusing on orthopedic, emergency, and plastic surgery. She is a former member of Interplast, an international organization of plastic surgeons. In this role, she traveled to developing countries to perform reconstructive surgeries.

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