Vice President, Regulatory Affairs and Quality Angiodynamics Gary completed his PhD at Cranfield University in Biotechnology prior to working in several start-up companies in a research perspective. A gradual transition to regulatory and quality was finalized by a position within a leading notified body as an auditor and reviewer. He returned to Industry in regulatory leadership roles culminating in his position as a Sr. VP Regulatory and Quality for Angiodynamics.
AngioDynamics is a leading provider of innovative medical devices used by interventional radiologists, nephrologists and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease. Its diverse product line includes market-leading radiofrequency ablation and NanoKnife® systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. AngioDynamics has distinguished itself through the company’s consistent ability to successfully develop and bring to market new technologies and products.
LISA GRANEY, RAC
Vice President, Global Regulatory & Clinical Affairs LifeNet Health Lisa has over 25 years’ experience in regulatory, clinical affairs and quality assurance in medical devices, in vitro diagnostics, and biologics. Prior to joining LifeNet Health, she was Vice President of Regulatory Affairs for Johnson and Johnson’s DePuy Synthes Trauma/CMF division, where she led the upgrade of the advertising and promotion program in 2011 and trained many in the art of finessing the message into compliance. Prior to this she developed the claims support process at Bausch & Lomb, and has worked in large and small companies serving diverse customers from anesthesiologists to MRI technicians to consumers. She has taught advertising and promotion best practices in the US and EU, and is a member of the Regulatory Affairs Professional Society and the Society of Women Engineers.
LifeNet Health is a non-profit global leader in regenerative medicine and the world’s largest provider of allograft bio-implants and organs for transplantation. Its mission is Saving Lives. Restoring Health. Giving Hope. It is the world’s most trusted provider of transplant solutions, from organ procurement to new innovations to bio-implant technologies and cellular therapies – a leader in the field of regenerative medicine, while always honoring the donors and healthcare professionals that affect the healing process.
Principal Consultant GxP Compass LLC
Robert has over 22 years’ experience in FDA, ISO, EMA and ICH regulated industries in corporate compliance, regulatory affairs, Six Sigma, quality assurance and process engineering within the domestic and international markets of Asia, Europe and North America. His educational background is a Juris Doctor from the Pontifical Catholic University of Puerto Rico, an MBA from the University of Massachusetts-Lowell and a Master in Chemical and Life Sciences from the University of Maryland-College Park. He was admitted to practice law in the District of Columbia and is a registered professional engineer in North Carolina. An ASQ fellow, he possesses five different ASQ certifications and is a US RAC by RAPS.
GxP Compass is an international organization focused in regulatory affairs, quality assurance, commercial compliance and performance excellence within the pharmaceutical, biologics and medical device industries. GxPC services are designed to assist clients in all stages of product lifecycle from design concept to launch and commercialization. That includes GLP, GCP and GMP systems implementation based on the discipline of Six Sigma and global regulatory compliance with US FDA, notified bodies, and ministries of health across the globe.
Vice President, Global Regulatory Strategy AbbVie
Andrew has 30 years in the pharmaceutical industry, providing leadership for regulatory affairs. He previously was a senior executive with global responsibilities for 14 years at Cangene (Toronto) and CBL (Baltimore). Prior to that he held several regulatory positions in small biotech companies. He has led the development of many innovative products and therapies and also successfully licensed a biosimilar product in the US in 2008. Post 9/11, he spent 11 years working on the development of medical countermeasures to bioterrorism and worked with CDC, NIH and BARDA to install multiple biodefense products into the US Strategic National Stockpile (SNS) as well as in other global stockpiles . He is presently working on exciting challenges related to the Humira, and Viekira Pak franchises, as well as a comprehensive pipeline of Oncology products at AbbVie.
AbbVie’s 28,000 employees are scientists, researchers, communicators, manufacturing specialists and regulatory experts located around the globe. They come up with new approaches to addressing today’s health issues—from life-threatening illness to chronic conditions. AbbVie targets specific difficult-to-cure diseases where they can leverage their core R&D expertise to advance science, creating solutions that go beyond treating the illness to have a positive impact on patients’ lives, on societies and on science itself. They focus on discovering, developing and delivering drugs in therapeutic areas where they have proven expertise, including immunology, oncology, neuroscience, virology and general medicine.