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LifeSciences BC McCarthy Spotlight Speaking Series on “Exporting to the U.S. and trends at the FDA”
November 17, 2016 @ 4:30 PM - 7:30 PM
LifeSciences BC is pleased to feature Novateur Ventures Inc. and LivaNova Canada Corp. at our McCarthy Spotlight Speaking Event on “Exporting to the U.S. and interesting trends to be aware of at the FDA” on Thursday, November 17, 2016.
- Interesting and current trends to be aware of at the FDA
- Exporting to the U.S. from a medical device perspectives
- How U.S. election outcomes might impact on how the FDA makes decisions
Novateur provides innovation for life science, virtually, anywhere & anytime. In the life science industry most products, drugs or devices, fail not because they have an inherent flaw, but because they are not properly developed due to lack of experience, planning, and resources. Novateur’s mission is to change that — one client at a time.
Dr. Thomas Stephens has more than 25 years of experience in pharmaceutical development and he contributed to multiple INDs and CTAs in the USA, Europe, Australia, South Africa, India and Mexico. Dr. Stephens has several years of experience in Lilly global regulatory affairs as Chief Operating Officer and Senior Regulatory Scientist within USA regulatory affairs in therapeutic areas of diabetes, obesity and endocrine therapeutics, including pulmonary insulin, growth hormone, basal insulin, leptin and beta3 adrenergic receptor agonist. Dr. Stephens previously worked as Clinical Research Advisor / Asset Manager and Chief Regulatory Officer of the Chorus Division and he has managed seventeen Phase I-II development programs in a range of therapeutic areas (migraine treatment and prevention, chronic pain, depression, cognition, anti-thrombotics, postmenopausal symptoms, type 2 diabetes, osteoporosis, osteoarthritis, rheumatoid arthritis, transplant rejection and obesity). Dr. Stephens was responsible for developing initial global regulatory capability through contract resources and development of a global internet-based network for coordinating development. The Chorus Group is an autonomous division of Eli Lilly and Company; Dr. Stephens with two other founders developed business processes, defined and developed roles and SOPs for Chorus. Dr. Stephens also spent several years in pre-clinical through Phase II project management (therapeutic areas including cancer, cognition, antiviral, anti-thrombotic, lupus, rheumatoid arthritis, and sepsis) in the LRL Project Management group. He has also led discovery research programs in diabetes and obesity therapeutics including research on leptin, thiazolidinediones and amylin. Prior to work in drug and device development, Dr. Stephens was a supervisor of research and quality assurance for an in-vitro diagnostics company as well as general manager for another. Dr. Stephens received his PhD degree in Biochemistry with minor in Biomathematics from Indiana University School of Medicine and he has RAC (US) professional certification.
Dr. Carol Stephens has 28 years of experience in drug development and support with focus on regulatory planning, negotiation, execution, and compliance. She has worked on 6 successful new NDAs and BLAs and 4 supplements for new indications as well as INDs. Dr. Stephens worked for 25 years at Eli Lilly and Company where she focused on CNS, cardiovascular, endocrine, and oncology drugs, in vitro diagnostics, and drug-device combinations. In Regulatory Affairs at Lilly, she supported products from early clinical phases through submission, approval and market growth. Her experience includes regulatory strategies for obtaining product approvals and negotiations with regulatory authorities backed up by her expertise in US and international regulations, guidances, and agency precedents. Dr. Stephens has broad experience in using desired physician’s prescribing label claims as driver of the development process. In addition to roles within Regulatory Affairs, Dr. Stephens has served as a manager of clinical trials, alliance manager of partnerships with US and international biotechs, and project manager of drug and device development. Dr. Stephens received her PhD in Communications from the University of Wisconsin, and she has a number of publications in the pharmaceutical industry.
LivaNova believes that partnership leads to progress. That’s why LivaNova brought together Sorin and Cyberonics to create a premier global medical technology company. United in passion, focus, and commitment, they develop and deliver innovative solutions today for better health tomorrow.
The story of a life transformed—the story of a life renewed.
That’s why they chose the name LivaNova.
We looked for a name that embodied their goal of impacting people’s lives for the better. Uniting a derivation of “life” with the Latin word for “new,” LivaNova speaks to the essence of our core mission: extending and enhancing life.
As LivaNova, they remain committed to the highest quality of service and care that we offered as Sorin and Cyberonics, in order to deliver health innovation that matters.
Jennifer Arntorp serves as Director of Operations for the Vancouver plant of LivaNova Canada Corp. LivaNova PLC was formed in 2015 by bringing together Sorin and Cyberonics to create a premier global medical technology company to deliver health innovation that matters. In her current role, Jennifer is responsible for the Vancouver plant with over 300 employees. She oversees the manufacturing, quality and engineering of tissue heart valves for distribution worldwide. Jennifer has over 20 years of experience in the Medical Device Industry with a primary focus on Class III Medical Devices. Her background includes research & development, engineering, information technology and operations leadership roles. Jennifer holds a Bachelor of Applied Science in Mechanical Engineering from The University of British Columbia.
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