Ep. 2: Medical Regulations and the Byzantine Journey for Patients to Access Life-Saving Drugs w/ Simone Azevedo & Henk Schuring

Niklas talks with Simone Azevedo, CEO and Co-Founder of Xingu Health, and Henk Schuring, Chief Regulatory and Commercialization officer at Prilenia Therapeutics.We talk about the right of patients to access medical drugs not approved by the U.S. Food and Drug Administration (FDA).Why would patients want to take non-approved medical drugs?Patients of rare diseases often have few options. So they turn to drugs in clinical trial stage, even though their safety & efficacy isn't proven.Henk & Simone draw from a wealth of experience from patients, doctors and industry across multiple therapeutic areas to draw a vivid picture of the status quo.We learn about the Byzantine requirements for patients to access these drugs, the bureaucracy and logistical difficulties, as well as supply issues.Niklas is critical of the regulatory requirements for drug approvals, and we discuss alternatives such as medical tourism and more international regulatory cooperation.We invite you to join us to build the healthcare system of the future together on Roatan, Honduras, a beautiful Caribbean island on September 23-25, 2022: https://infinitafund.com/events/event-one-83cse-nbr6bNiklas on Twitter: https://twitter.com/NiklasAnzingerInfinita Fund Website: https://infinitafund.com/Discord: https://discord.gg/Z4H6UjbubK This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.infinitacitytimes.com