BEGIN:VCALENDAR PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN VERSION:2.0 BEGIN:VEVENT DESCRIPTION:Join us at the MassBioHub in Cambridge\, Massachusetts (USA) o n March 12\, 2025 for this \;exclusive complimentary event \;and expert panel discussion showcasing the impact of unified trial design and regulatory strategies on derisking and accelerating clinical development .\n\nRegistration: From 11:30 am\n\nPanel discussion:12:00\n\nPost discus sion lunch: 12:45-13:30\n\nSecure faster development and regulatory pathw ays\n\nBiotech organizations face a series of high-stakes decisions as th ey design their clinical development programs. These decisions include tr ade-offs between factors such as speed and cost\, as well as delivery and regulatory risk. In this balancing act\, too often\, companies default t o traditional study designs and endpoints\, often missing opportunities f or innovative approaches that could reduce patient numbers or secure a fa ster regulatory pathway.\n\nLearn from our regulatory and statistical exp erts\n\nThis panel-led session\, brought to you by \;MMS \;and fe aturing Aiden Flynn\, SVP Statistical Consulting\, Amanda Beaster\, Direc tor Regulatory Strategy\, and Ben Dudley\, Chief Commercial Officer\, wil l examine real-life design optimization case studies\, including using po werful statistical simulation software like KerusCloud. The presenters wi ll explore innovative strategies including Real-world-data (RWD) augmenta tion\, innovative trial designs\, model-informed drug development\, the r ole of statistical simulation in optimizing the probability of success\, and best-practices for Regulatory risk management when pursuing non-stand ard designs. At the conclusion of the \;panel discussion\, there will be the opportunity for the audience to ask the experts their most pressi ng questions in an interactive Q&\;A.\n DTEND:20250312T013000 DTSTAMP:20260514T153515Z DTSTART:20250312T113000 LOCATION:MassBio\, 700\, Technology Square\, Middlesex County\, 02139\, SEQUENCE:0 SUMMARY:Join us at the MassBioHub in Cambridge\, Massachusetts (USA) on Ma rch 12\, 2025 for this \;exclusive complimentary event \;and expe rt panel dis... UID:3aa37911-5c29-43cf-9c4d-ea056fa383f4 END:VEVENT END:VCALENDAR