Gopal Muppirala, President & CEO, has nearly three decades of commercial experience in the pharmaceutical and healthcare industry in the US and International regions. Gopal worked for Glaxo, GlaxoWellcome, and GlaxoSmithKline for over twenty years, as well as for Bayer. His experience began in sales, and has covered a variety of commercial operations roles including marketing at the local and global levels, market research, new product development, and administration/management. Gopal, as the Global Commercial Director, led the transformation of a neurology product from a small contributor ($200MM) to the organization to a blockbuster with over $2B in sales, including the development of a key line extension, for which he holds a patent, and new indications. In addition, Gopal developed the step-by-step process for managing a global brand from discovery/development to commercialization for the GlaxoWellcome organization. Gopal is also the President of Compass Consulting International, based in Morrisville, NC, a provider of strategy consultancy services to the pharmaceutical industry. As the co-founder and CEO of Phoenix Cardiac, Inc., Gopal has transitioned the company from initial concept to a full development program, including meeting key regulatory milestones, while maximizing the limited resources available.
Jai Raman, M.D., FRACS, Ph.D.
Dr. Jai Raman, inventor of the BACE Device is a highly skilled cardiac and thoracic surgeon known for his efforts to develop new and innovative surgical procedures, especially for the treatment of heart failure. Currently he is a Professor of Surgery and Director of Adult Cardiac Surgery at Rush University Medical Center in Chicago. Dr. Raman helped develop ventricular containment (or the wrap procedure), which uses an innovative mesh bag to stop the heart from enlarging in patients with heart failure. He performed the first eight of these procedures in the world. In addition, Dr. Raman developed the geometric endo-ventricular repair procedure–a new technique to reconstruct badly scarred heart chambers to restore the shape and size of the heart’s ventricles. Dr. Raman is also an expert in the surgical treatment of atrial fibrillation. He has created new surgical instruments to perform intra-operative radiofrequency ablation to eliminate the tissue that causes abnormal heart rhythms. His work to develop new techniques to repair mitral and tricuspid valves and adapting minimal access techniques has been particularly successful. These procedures have spared many patients from requiring early total heart valve replacement. He specializes in “redo” valve surgery through small incisions. Dr. Raman is actively participating in a number of research initiatives. He has convened a multi-center international clinical trials group. His clinical research interests include renal bio-markers in cardiac surgery, kidney protection in heart surgery, arterial grafting and less invasive valve and arrhythmia surgery. In total, Dr. Raman has performed nearly 2,500 heart surgeries and more than 700 thoracic operations. His surgical expertise encompasses a wide range of cardiac and thoracic procedures, with particular skill in complex, high-risk cardiac surgeries.
Krishna Talluri, M.D.
Dr. Talluri is a practicing physician with more than 2 decades of global clinical development experience, including roles as a principal investigator for several trials in different therapeutic areas. She most recently led product development teams at Johnson & Johnson and Talecris Biotherapeutics that include a cross-functional group of clinical development, medical affairs, biostatistics, commercial, and regulatory personnel. Dr. Talluri’s insight into clinical development comes not just from her work with the pharmaceutical and biological companies but also from her experience working in CROs, from Pre–clinical to Phase I through Phase IV trials, covering the entire spectrum of bringing a product to market. She has worked in clinical pharmacology and has a thorough understanding of the payer payee relationships through her work in managed care outcomes. She has several publications to her credit in leading medical journals. In addition to her experience in the pharmaceutical and biotech industries, Dr. Talluri has practiced general medicine and emergency medicine in India and the Caribbean, and Psychiatry in the US. She completed her residency in Psychiatry at Duke University Medical Center.
Cynthia Pritchard, Ph.D.
Dr. Pritchard has 30 years in the medical device/diagnostic/biologics industry, and has brought more than 30 Class II and Class III products from research into development through clinical trials and manufacturing to market launch. She served in positions of increasing responsibility at Syva (Roche), Serono, Becton Dickinson, Gene-Trak Systems (Abbott), Cardiovascular Diagnostics (Pharmanetics) and Aldagen (Cytomedix)], integrating various assay chemistries with instrumentation and developing cell therapy products. She has a strong Regulatory and Quality Assurance background, with extensive experience in FDA/ICH/ISO regulations, clinical project management, design control, and documentation, and has written over 40 successful submissions to CDRH and CBER divisions of the FDA and to European regulatory agencies. Dr. Pritchard obtained a BS in microbiology at the University of South Florida, a PhD in virology/molecular biology at Virginia Tech, and was a Damon Runyon Postdoctoral Fellow in biochemistry at Harvard Medical School.
Karl Leinsing, MSME PE
Karl Leinsing has over 20 years experience with design and project management of medical devices and automation. His areas of expertise include full life cycle product development, product conception, polymer selection, thorough computer aided design and analysis, molding and manufacturing, project organization, technical presentations and leadership, and cross-functional teamwork. Karl currently holds 19 patents (several patents pending), 5 design awards, and was listed as one of 100 notable people in the Medical Device Industry by MD&DI. Karl has a Masters of Science Degree in Mechanical Engineering from North Carolina A&T State University and a Bachelor of Science Degree in Mechanical Engineering from the University of New Hampshire. He is a licensed professional engineer in New Hampshire and has lectured Medical Device and Manufacturing (MD&M) Seminars on The Science of Successful Product Design.