It is paramount that new medical therapies be shown to be safe for patients. Monitoring safety is accomplished in a variety of ways depending on the therapy and its potential adverse impact. There are many therapies that have been shown to have adverse cardiovascular implications and fortunately, innovative tests and tools are available that are effective in monitoring the safety of new biologics, drugs and devices in development. The goal of this webinar is to discuss the application of cardiovascular imaging when monitoring safety in the development of new medical therapies.

This webinar will provide:

  • A clinical overview of monitoring cardiovascular safety through imaging across various drug classes and therapies
  • Practical and regulatory considerations
  • A description of imaging-based endpoints for safety monitoring
  • Comparisons between established, routine endpoints versus advanced endpoints
  • Considerations in choosing the appropriate imaging endpoints

Speakers

Tim Crowe, Director, Cardiovascular Imaging Services, Bioclinica

As Director, Cardiovascular Imaging, Tim provides technical and operations imaging support and input to the CV therapeutic areas. His background suits him well to ensure quality and scientific integrity is maintained for all project deliverables. Prior to joining Bioclinica, Tim supported a renowned academic research group at the Cleveland Clinic, leading their new business activities with a focus on the cardiovascular imaging sector of clinical trials. His experience in cardiovascular imaging stretches over the last 25 years and has included directing a prominent atherosclerosis imaging core laboratory which supported research in dyslipidemia, coronary intervention, intravascular ultrasound, cardiac transplantation, valve disease, hypertension and AAA, devices to name a few. He has co-authored over 60 publications, numerous abstracts, presented at major scientific sessions and provided imaging and clinical research training for clinical trial meetings internationally.

Bruce Lloyd, MD, Associate Medical Director and Director of Clinical Cardiology Services, Bioclinica

Bruce K. Lloyd, MD is Bioclinica’s Associate Medical Director and Director of Clinical Cardiology Services. Dr. Lloyd is responsible for the day to day operation of Bioclinica’s cardiovascular services. This involves answering clinical questions, supervising the cardiovascular technicians, and coordinating ECG interpretation services. He also provides clinical review and oversight for Quality Control processes.

Dr. Lloyd received a Doctor of Medicine degree from the Cornell University Medical College in 1972 and his initial training in Internal Medicine was completed at the Johns Hopkins Hospital. He completed his training in both Internal Medicine and Cardiovascular Diseases at the National Naval Medical Center in Bethesda, Maryland. Following completion of his training, Dr. Lloyd remained on the staff at the National Naval Medical Center. In 1984 he became the Chief of Cardiology at the National Naval Medical Center and was appointed as the Senior Cardiovascular Advisor to the Surgeon General. In 1985, Dr. Lloyd was selected as the Consulting Cardiologist for the White House serving under both President Ronald Reagan and President George H.W. Bush and was a consultant for the US Congress.

During his work at the National Naval Medical Center, Dr. Lloyd was the attending physician for one of the landmark cases involving drug interactions and its effect on the QT interval. He is one of the authors of the article ‘Toursade de Pointes Occurring in Association with Terfenadine Use’ reporting this significant drug interaction.

Since moving to Georgetown University, Dr. Lloyd has held multiple positions within the hospital. He has continued to teach and provide clinical care to a wide variety of patients. He has been a visiting professor at numerous locations including four different hospitals in the Russian Federation. He has received multiple awards for his teaching excellence.

Blaine Horvath, Medical Affairs Advisor, Bioclinica

Mr. Horvath has been with Bioclinica for over 18 years, making significant contributions to imaging protocol design and review methodology for clinical trials across several therapeutic areas including cardiovascular, oncology and neuroscience. He brings with him over 20 years of experience as a Radiologic Technologist during which he managed the daily operations of several radiology departments and developed MRI protocols for research purposes.

Blaine Horvath, Medical Affairs Advisor, Bioclinica

Mr. Horvath has been with Bioclinica for over 18 years, making significant contributions to imaging protocol design and review methodology for clinical trials across several therapeutic areas including cardiovascular, oncology and neuroscience. He brings with him over 20 years of experience as a Radiologic Technologist during which he managed the daily operations of several radiology departments and developed MRI protocols for research purposes.

Who Should Attend?

  • Clinical Trial Study/Protocol Managers
  • Clinical Project Management
  • Medical Monitors
  • Imaging Leads
  • Regulatory Groups
  • Directors & Associate Directors of Operations
  • R&D Directors

Xtalks Partners

Bioclinica

Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention solutions, and a post-approval research division.

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