Upcoming Events



UPDATE: RESCHEDULED 2020 Orange County Biostatistics Symposium

Date:  Friday/Saturday, 16-17 October 2020

Title:  Leveraging Data to Shape the Future of Clinical Development

Venue: Allergan Auditorium, 2525 Dupont Drive, Irvine, CA

 

This 2-day symposium is a great opportunity to hear from leading statistical and clinical experts from the industry and the FDA on the experience and practice of leveraging data in decision making for clinical development in drugs and devices. The symposium focuses on topics such as real-world data-backed clinical development, new FDA initiatives such as the 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 Bayesian mini-symposium and focuses on academic-industry collaboration in new methodology, research efforts and provides an opportunity for new graduates to learn industry transition from academics.

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:
Lisa LaVange, Former FDA/UNC; Rob Scott, Abbvie; Donald Berry, MD Anderson Cancer Center, Ivan Chan, Abbvie; Dan Jeske, UCR, Susan Jerian, Oncord

For the program brochure, please click here, Program Brochure

Program Overview:

Day 1: Keynote Session

7:30 – 8:30AM – Registration / Breakfast

8:30 AM – 12:00N – Keynote Session and Panel Discussion

  • Keynote address 1 – Innovative designs in clinical development – adaptive design and master protocols by Lisa LaVange, Professor, UNC/Former Director of statistics, CDER/FDA
  • Keynote speaker 2 – Future of clinical development from a clinician by Rob Scott, Chief Medical Officer, Abbvie
  • Panel Discussion – Innovative Designs and Regulatory pathways Moderated by Gajanan Bhat, Spectrum Pharmaceuticals

12:00 – 1:00 PM – Lunch/Round Table Discussions

1:00 – 5:00 PM Invited and Contributed Sessions

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 the 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

 5 - 6:30 PM – Reception and Networking

Day 2:

8:00 – 8:30 AM - Light breakfast

8:30 – 10:30 AM – Industry-academic collaboration – Welcome by Xinping Cui

  • Keynote Speaker: Ivan Chan, Abbvie, Future of Statistics in Pharmaceutical Development – Innovative Trial Designs, Bayesian Paradigm, and Precision Medicine
  • Invited speakers

 

10:30 – 12:30 AM – Bayesian mini-symposium in honor of James Press

  • Keynote Speaker: Donald Berry, UT MD Anderson Cancer Center, Bayesian Statistics Enables a Revolution in Medical Research: Patient-focused Clinical Trials for the 21st Century
  • Invited speakers
12:30 – 2:00 PM – Lunch/Panel discussion: The Life of An Industry Statistician or Statisticians at Work moderated by Xinping Cui, Professor, and Head of Department of  Statistics UC Riverside

Abstracts submission: Closed for submission

Parking:
Details of the parking and instructions to enter the facility will be posted by end of Feb 2020. Please visit the website then.

Registration Fees: Please register early as the space is limited.

Please visit eventbee website by clicking below link
 


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