Dr. Phil Febbo is Chief Medical Officer at Illumina, responsible for developing and executing medical strategy to drive genomic testing into healthcare practice. Before joining Illumina, Dr. Febbo served as CMO of Genomic Health where he was accountable for the development of evidence supporting GHI’s proprietary tests, engaging with the payer community to drive reimbursement. Prior to his years at Genomic Health, Dr. Febbo was a Professor of Medicine and Urology at the University of California, San Francisco, where his laboratory focused on using genomics to understand clinical behavior of prostate cancer, and his clinical practice focused on genitourinary oncology.
Dr. James is the Chief Medical Officer for Johnson & Johnson Medical Devices. In the role, he is responsible for overseeing patient monitoring and safety surveillance practices. He also serves on the Board of Directors of the Medical Device Innovation Consortium, a public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle.
Dr. Davide Manissero is Chief Medical Officer at QIAGEN. He joined the industry after training in paediatrics and tropical medicine and working in global public health for WHO and ECDC. His industry experience includes development and introduction of novel antibiotics and ID diagnostics extending to both molecular and immunodiagnostics. His academic interest extends to infectious diseases, antibiotic development and the understanding of antimicrobial resistance.
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Professor Ian T. Meredith AM is executive vice president and global chief medical officer at Boston Scientific. In this role, he is responsible for leading clinical science and medical affairs across Boston Scientific and providing global leadership of the company’s clinical trial strategy. Prior to joining Boston Scientific, Professor Meredith served as professor and director of MonashHeart, and executive director of the Monash Cardiovascular Research Centre at Monash University in Melbourne, Australia. Professor Meredith has over 25 years of experience as a clinical and interventional cardiologist and also served as director of the Cardiac Catheterization Laboratories and Interventional Cardiology. Professor Meredith has been a member of the Board of the National Heart Foundation (Australia) and a member of the Cardiac Society of Australia and New Zealand National Board.
Tara Blair is a manager within Medtronic’s Commercial Operations group and has been with the company for 11 years. In her role, she is responsible for leveraging technology to offer innovative solutions that help teams and customers be more successful. Tara went from product to digital marketer when she decided to bring together her creativity and love of technology. Tara holds her Master’s in Business Administration, has 17 years industry experience and resides in RI with her husband and three children.
Roxanne Bonner is the program management, change management and implementation lead for IT solutions used by the Quality and Regulatory functions. She has extensive experience in project management, design control, quality control, change control, risk management, design history and nucleic acid technologies.
Brenda is currently senior manager clinical systems operations at Edwards Lifesciences. During her career, she has worked on both the employee and consultant side in a variety of industries and utilized a variety of programming platforms and tools. Since moving into the Medical Device industry in 2003, Brenda also held positions at Boston Scientific and American Medical Systems in which she was responsible for data management, performing study builds, and clinical systems operations. She graduated from DeVry Chicago with a BS in Computer Information Systems.
James is Head of Regulatory Operations at GE Healthcare. He has 19 years experience in the industry, including 9 years at a major innovator, as well as stints in outsourcing, consulting, Generic Pharma and now Nuclear Medicine. Recent extensive experience of system and process design, migration, training and system ownership for a full Veeva RIM implementation (Registrations, Submissions and Submissions Archive)
Lori Holder is the Director of Global Regulatory Operations at Alcon Laboratories, Inc., a leading manufacturer of ophthalmic medical devices located in Fort Worth Texas. She has over 25 years of experience in the medical device industry through positions at Guidant Corporation, Sulzer Orthopedics, Sulzer Intermedics, and Cyberonics, Inc. She has held positions of increasing responsibility in clinical research, quality assurance, and regulatory affairs, and currently is the head of Alcon’s Regulatory Operations group. Lori has earned her Regulatory Affairs Certification (RAC) and has a B.S. in Biomedical Engineering from Texas A&M University.
Jennifer Kerr is the President of Cook Research Incorporated (a Cook Medical Company), in the Purdue Research Park, West Lafayette, Indiana. Jennifer’s role includes executive oversight of product development, testing, clinical studies, medical/scientific writing, and regulatory submissions for medical devices. She is Cook’s Global Leader for Clinical Affairs which is responsible for the design, oversight, and management of pre-market and post-market clinical projects. She also collaborates with experts on Good Clinical Practice (GCP) including the international standard ISO 14155 (Clinical standard for conducting medical device studies).
Larry leads Baxter Healthcare’s Global Regulatory Affairs (GRA) Global Strategy and Delivery (GSD) organization, designed to create an aligned and unified approach to regulatory support across the GRA organization. His primary focus is on simplifying regulatory processes and providing strategic support to business partners to further enable efficiency and effectiveness on a global scale, while delivering with excellence through speed, courage, collaboration and simplicity across the Baxter portfolio. Prior to Baxter, Larry served in senior leader roles within Johnson and Johnson and Sanofi-Aventis spanning local, regional, and global functional areas, within and linked to Regulatory Affairs.
Ayaz Malik has spent the majority of his career in building, transforming and enabling marketing and communications teams with a focus on healthcare/medical devices. His passion in the last decade has increasingly turned to marketing in the digital era and the evolving roles within a highly matrixed organization – especially those of the marketer and communicator, as they work to remain relevant and capable in the face of rapidly evolving technologies that enable a company’s content creation, curation, management, delivery and measurement today. Ayaz’s peers describe him as a polymath and seek him out for his ability to connect-the-dots across multiple and complex business challenge, and to lead collaboration efforts that result in relevant, compelling and actionable solutions.
Mike Baca is a graduate of the United States Military Academy at West Point. Following his active duty commitment, Mike went into business, working with companies such as Johnson & Johnson, Medtronic, and Stryker. Over a 36 year career in Medical Devices, Mike focused on the Quality arena. He retired in 2017 after serving as the Vice President of Quality/Regulatory/Clinical for the Instruments Division of Stryker. He founded White Rook Consulting, LLC in 2018 where he is President and Principal.