Title: Leveraging Data to Shape the Future of Clinical Development
Date: 14-15 Oct 2022
Venue: Irvine, CA
After 2 years of hiatus, the OCLBASA is excited to get back to hosting the in-person Orange County Biostatistics Symposium. The symposium is currently scheduled for 14-15 Oct 2022 with Day 1 including keynote and invited speakers' sessions and Day 2 including invited speaker sessions and a workshop.
Since we had to cancel the 2020 Symposium close to the date of the event due to global pandemic and many people had registered to the event that time, I am happy to announce that all these registrations will be honored, and these registered attendees can attend the 2022 Symposium free of charge. We have sent an email to all previously registered attendees to confirm their attendance. We are open for the new registrations at this time.
This 2-day symposium is a great opportunity to hear from leading statistical and clinical experts from industry and FDA on the experience and practice of leveraging data in decision making for clinical development in drug and devices. The symposium focuses on topics such as real-world data backed clinical development, new FDA initiatives such as 21st century cures act, master protocols and innovative trial design, real-world data analytics and machine learning, regulatory submission data preparation, etc. Day 2 includes a workshop on Master Protocols and additional invited topic presentations.
Who should attend:
Statisticians, Statistical Analysts/Programmers, Clinical Research Professionals, Clinical Trial personnel, Regulatory Affairs associates, academic researchers, students or anyone who is interested in learning more about drug development and regulatory aspects.
Key speakers:
Prasun Mishra, Agilent Technology, AAPM; Donald Berry, MD Anderson Cancer Center
Agenda:
Day 1: 8 AM – 12 Noon – Keynote session and panel discussions; 1-5 PM – Invited and contributed topics in clinical/statistics and data science/analytics
Day 1: 5:30 - 7 PM Evening Reception
Day 2: 9 AM – 1 PM – Workshop on Master Protocols; 1:30 - 4:30 PM – Invited and contributed topics in clinical/statistics and data science/analytics
Topics of presentations:
Track 1: Clinical and Statistics
- Clinical development in rare diseases and unmet medical needs
- Innovative designs in clinical development – adaptive design and master protocols
- Translation research from bench to bedside
- Real-world data backed clinical development
- New FDA initiatives such as 21st Century Cures act
- Accelerated approval pathways
- Usage of synthetic control
Track 2: Data Science and Analytics
- Data visualization techniques
- Data science using AI and machine learning
- Data mining through real-world data in rare diseases
- Regulatory submission data preparation
Parking:
Details of the parking and instructions to enter the facility will be posted week in advance of the Symposium date. Please visit the below website then.
https://community.amstat.org/oclb/home
Cancellation and refunds:
Registration fee is non-refundable
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Gajanan Bhat, PhD
Chair, Section on Biopharmaceutical Statistics, OCLBASA
Senior Vice President, Clinical Science, Spectrum Pharmaceuticals
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