Dr. Joseph Kozikowski will present on operational excellence at Thermo Fisher Scientific Company-Wide FDA and Global Medical Device Conference.
NATICK, MA – October 1, 2011 – Clinivation, Inc. announced today that clinivation Founder and CEO Joseph Kozikowski, M.D. will present at Thermo Fisher Scientific Global Headquarters.
As an authority on the development and commercialization of advanced medical technology, and having led thousands of new submissions, renewals, refilings, novated submissions for major multinationals worldwide, Dr. Kozikowski will share his perspectives in a presentation entitled “Your First One Million Approvals: Your Journey to Excellence in Global Market Clearance Operations.”
The presentation will address important industry best practices, and will include:
- How the approval cycle workflow, commonly represented as a sequential flow process, does not, in actuality, scale in proportion to the number of people assigned, as can be readily observed by workflow break downs in large regulatory affairs organizations;
- How the approval cycle workflow is, in fact, a multi-node process, wherein the burden of information exchange rises in proportion to the square of the number of people assigned, which explains the paradox of why simply adding more people makes the workflow break down faster;
- How the answer to this “Information Logistics Problem” lies in minimizing the number of nodes by putting an information system in the middle of all the people;
- How submission cloning can leverage harmonized regulatory regimes and products with similar technical characteristics and indications for geometric increases in productivity;
- How a Market Clearance Compliance Maturity Model can be used for organizational transformation to address the challenges and requirements of SarbOx Section 406; and
- How Global Regulatory Affairs can be a center of value creation by advancing revenue flow with market clearance efficiencies, which, for a $525MM new revenue opportunity (a recent acquisition) equates to ~$2MM in revenue and ~$4MM in enterprise value per business day gained.
The audience will include Thermo Fisher Scientific regulatory affairs, quality, information technology, business analyst, legal, and other executives. The presentation will be held in conjunction with the Thermo Fisher Scientific Company-Wide FDA and Global Medical Device Conference on October 13, 2011 at the Learning Center, Thermo Fisher Scientific Global Headquarters, Waltham, MA.
Following the presentation, Dr. Kozikowski will be available for discussions and meetings to discuss the topics in greater depth.
Quotes & Commentary:
“It is an honor to have been invited to present, and I thank the Thermo Fisher Scientific executive leadership for their efforts in arranging this opportunity for international learning,” said clinivation Founder and CEO Joseph Kozikowski, M.D.
About Thermo Fisher Scientific:
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $12 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.
