Agenda

Day 1 Apr 24, 2017

7:30 AM — 6:00 PM

Registration

8:30 AM — 12:00 PM

Course 1: New Graphical Methods for Clinical Trials

8:30 AM — 12:00 PM

Course 2: Assessing Biosimilarity and Interchangeability - Issues and Recent Development

1:00 PM — 1:30 PM

Welcome and Opening Remarks

1:30 PM — 2:30 PM

Keynote Address(es)

2:30 PM — 3:45 PM

Session 1: The 21st Century Cures Act and PDUFA VI: Highlights and Impact

3:45 PM — 4:05 PM

Refreshments and Networking Break

4:05 PM — 5:20 PM

Session 2: Prescription Opioid Abuse Epidemic: Regulatory Actions and Quantitative Evaluation

5:30 PM — 6:30 PM

DIA Statistics Community - Open Meeting

Day 2 Apr 25, 2017

7:30 AM — 8:30 AM

Continental Breakfast

7:30 AM — 7:00 PM

Registration

8:30 AM — 8:35 AM

Welcome to Day 2

8:35 AM — 10:05 AM

Session 3: Alternative Data Sources: Analytical Challenges and Opportunities for Statisticians to Take the Lead

10:05 AM — 10:30 AM

Refreshments and Networking Break

10:30 AM — 12:00 PM

Session 4: Synthesis of Real-World Evidence and Randomized Controlled Trials

12:00 PM — 1:30 PM

Luncheon and Round Table Discussions

1:30 PM — 3:00 PM

Session 5: Statistical Innovation in Antimicrobial Drug Development

3:00 PM — 3:30 PM

Refreshments and Networking Break

3:30 PM — 5:00 PM

Session 6: Bridging Statistics and Pharmacometrics: Informing Drug Development Decisions Through Model-Based Approaches

5:00 PM — 6:00 PM

Networking Reception & Poster Session

Day 3 Apr 26, 2017

7:30 AM — 8:30 AM

Continental Breakfast

7:30 AM — 3:00 PM

Registration

8:30 AM — 8:35 AM

Welcome to Day 3

8:35 AM — 10:05 AM

Session 7: Statistical Challenges and Opportunities in Drug Development with Immunotherapy Oncology Studies

10:05 AM — 10:30 AM

Refreshments and Networking Break

10:30 AM — 12:00 PM

Session 8: Novel Statistical Methods in Oncology Studies

12:00 PM — 1:30 PM

Luncheon

1:30 PM — 2:45 PM

Session 9: 21st Century Communication for Medical Product Development: Getting Better and Better

2:45 PM — 4:00 PM

Session 10: Town Hall

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DIA/FDA Statistics Forum

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