American Statistical Association
New York City
Metropolitan Area Chapter

THE INAUGURAL STATISTICAL INNOVATION COMMUNITY SUMMIT

November 9, 2023
8:00 AM - 5:00 PM (EDT)


The New York Metro Area Chapter of the American Statistical Association

In Collaboration With

Regeneron Pharmaceuticals, Inc.

Is Pleased to Invite You to a One-Day Hybrid Workshop On

Exploring the Opportunities and Challenges of Statistical Innovation
in the
Pharmaceutical Industry and Health Agencies


Scope

This one-day summit will focus on the role of statistical research innovation in pharmaceutical and regulatory agencies.
It involves statisticians from pharma, academia, and FDA discussing the steps for successful implementation of statistical innovation.


Preliminary Agenda


Date & Time
Thursday, November 9, 2023
8:00 AM to 5:00 PM (EDT)

In-Person
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591

Conference room to be announced.

A photo ID is required to enter the building.

Directions
https://www.mapquest.com/us/new-york/regeneron-pharmaceuticals-1312999

Parking
On-site parking available.
There will be signs directing you to the parking area.
Parking Map

Area Hotels
(Note: Workshop hotel discounts are not available.)
Westchester Marriott
Sheraton Tarrytown Hotel
Courtyard by Marriott Tarrytown

Virtual
Link will be emailed to virtual participants prior to the event.

This event is not being recorded.

Registration
This event is free of charge but advance registration is required.
Capacity for both in-person and virtual is limited, so you are encouraged to register early.
Only those that are registered will be admitted to the event.
You will receive an email confirming registration within 2-3 days after registering.
A waitlist will open once capacity is reached.

Important Notes & Reminders
(October 2, 2023)
The chapter is currently working on registration confirmations.
If you selected 'In-person' on your registration form, you will not be provided the virtual link.
If you choose to modify your registration from, contact the chapter.
If you have questions about the registration process, contact the chapter.
Only registered attendees will be admitted to the event (this includes both in-person and virtual).
Registration closes Thursday, November 2, 2023, 5:00 PM (EDT).

Online Registration Form
https://www.nycasa.org/NYCASA-StatInnovationSummit-Nov-09-2023-RegistrationForm.html

Registration Deadline
Thursday, November 2, 2023, 5:00 PM (EDT)

Event Flyer
https://www.nycasa.org/NYCASA-StatInnovationSummit-Nov-09-2023-EventFlyer.pdf

For Questions
Contact the ASA NYC Metro Area Chapter


INAUGURAL STATISTICAL INNOVATION COMMUNITY SUMMIT

WORKSHOP AGENDA
Subject to Change

THURSDAY, NOVEMBER 9, 2023
8:00 AM - 8:45 AM

Registration & Breakfast
8:45 AM - 9:00 AM

Opening Remarks
9:00 AM - 11:30 AM

Keynote Session

Maximizing the Impact of Innovative Statistical Methods in Partnership with Health Agencies

Keynote Speakers

John Scott
CBER, FDA
(Virtual)
Statistical Innovation in Regulatory Science: Review and Research

Jose Pinheiro
Janssen R&D, Johnson & Johnson
Regulatory Qualification of a Statistical Methodology: the MCPMod Pioneering Experience with EMA and FDA

Ying Yuan
University of Texas MD Anderson Cancer Center

Neal Thomas
Independent Consultant
Dose-finding with Emax Modeling: Experience with FDA Methodology Qualification
11:30 AM - 12:30 PM

Lunch & Networking
12:30 PM - 1:45 PM

Session I

Statistical Innovation in Action

Speakers/Discussants

Haoda Fu (Eli Lilly)
Binbing Yu (AstraZeneca)
Inna Perevozskaya (GlaxoSmithKline)
Jian Zhu (Servier)
Li Wang (AbbVie)
Jiawen Zhu (Genetech)
1:45 PM - 2:00 PM

Break
2:00 PM - 3:15 PM

Session II

Integrating Statistical Innovation in Healthcare Organizations

Speakers/Discussants

Ron Yu (Gilead Sciences)
Kentaro Takeda (Astellas)
Jose Pinheiro (Janssen R&D, Johnson & Johnson)
May Mo (Amgen)
Yongming Qu (Eli Lilly)
Demissie Alemayehu (Pfizer)
David Ohlssen (Novartis)
3:15 PM - 3:30 PM

Break
3:30 PM - 3:45 PM

Session III

Strengthening the Statistical Innovation Community

Additional details to follow.
4:45 PM - 5:00 PM

Closing Remarks

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