FDA officials, Captain Brenda Stodart (CDER Director of Small Business and Industry Assistance Program), and Elias Mallis (CDRH Director Division of Industry and Consumer Education), share all the resources they have available for industry access every day. These resources include FDA web training, conferences and workshops, education series, and incredible links to pertinent information you need. Find out how you can best take advantage of learning directly from FDA during this interview with Elias and Brenda.
The words “cyberattack or “cyber threat” are increasingly in the news headlines and recently, the spotlight was on a major pharmaceutical company besieged by a ransomware attack. The truth is, it could happen to anyone. We spoke to Jerry Bessette, Associate Director, Navigant Consulting Inc., and former FBI Chief of Cyber Operations Section II, to learn how prepared the medical device and pharmaceutical industries are to combat cybersecurity risk.
Imagine this: the next big cure—the next blockbuster drug for your company that can tackle untreated serious health conditions for patients around the world—is just sitting in a research publication, collecting dust, waiting to be discovered. Jason Barkeloo, Chairman and Founder of Opentherapeutics will shares shocking information that will be upsetting to know people we love could have been cured, and exciting to feel a renewed sense of rigor for the pharmaceutical pipeline that has only been trickling over the past 15 years.
In today’s world, we are facing unprecedented dynamics as 5 generations of employees are present in the workplace. Dr. Linda Gravett is an industrial psychologist who has 20 years of experience in researching the impact of generational differences in the workplace, and will share with us: who the generations are, what motivates each of them, misconceptions that exist about them, and what concerns they have about each other.
Michael Johnson, Vice President of Business Development at Eli Lilly, explored the inside story of mergers and acquisitions with participants. Xavier Health Director Marla Phillips asked Michael: Do mergers and acquisitions ever really benefit the organization in the end, or do they just create churn and change that doesn’t improve the bottom line in the end?
Xavier University has launched the Center for Artificial Intelligence to help FDA and industry advance its predictive capabilities…and even move towards prescriptive capabilities. Rob Studt and Ryan Schoenfeld will share with you how Janssen (a J&J company) have built their own internal capabilities to identify patterns in clinical trial data and end points, and are moving into applications in quality operations. The use of artificial intelligence arms us with information and signals that lie within our data and documents, but typically goes undetected until a failure occurs. Move your organization from one that is reactive to one that is predictive. Then take that learning to prescribe your actions in order to set your organization up for success before you even start.
Aligning with an external organization through contract operations, supplier relationships, mergers and acquisitions goes beyond FDA regulated industries – and has existed for decades. Michael Taylor, co-founder and CEO of Schellingpoint, will share insight from multiple industries that he has gained through the Schellingpoint Alignment Optimization process, which is a sophisticated methodology based on the Nobel Prize winning algorithms of Thomas P. Schelling. Through the Alignment Optimization process, Michael has identified trends of obstacles and successful practices that gives us a greater chance to achieve “Right First Time” in our FDA regulated industries.
Jessica Zeller, J.D., is the newest FDA ombudsmen in a position that was created for the first time in the Office of Regulatory Affairs. In this position, Jessica serves as an impartial voice to bring FDA and external parties toward a common understanding (often referring to herself as a translator). This newest position is instrumental in bridging gaps that might have existed for decades, as the Office of Regulatory Affairs houses all of the investigators across the country.