Regulatory Reboot

Agenda

8:00 a.m.

Breakfast and Networking

Registration and Networking Breakfast

9:00 a.m.

Welcome Remarks

Opening Remarks

9:10 a.m.

Drug Development Essentials for the FDA Regulatory Lawyer

Torrey Cope
‍Coleen Klasmeier
Kelly Cho

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10:00 a.m.

Key Risk Considerations for Promotional and
Non-Promotional Communications

Torrey Cope
‍Coleen Klasmeier

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11:00 a.m.

Break

11:15 a.m.

Market Access: Anti-Kickback Statute Considerations and Hot Topics

Torrey Cope
‍Meena Datta

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12:15 p.m.

Lunch

1:15 p.m.

Statutory Exclusivities

Sean Griffin
‍Emily Marden
‍Sean Royall

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2:15 p.m.

Analyzing Business Purpose Under the Anti-Kickback Statute

Meena Datta
‍Jaime Jones

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3:15 p.m.

Break

3:30 p.m.

In-House Counsel Panel

MODERATOR: Coleen Klasmeier
Jeffrey Chasnow, Pfizer
‍Carissa Davis, Novo Nordisk Inc.
Erica Jackson, Ginkgo Bioworks
‍Michael Hulka, Eli Lilly and Company
Keren Tenebaum, Vifor Pharma

4:30 p.m.

Cocktail Reception

8:00 a.m.

Breakfast and Networking

Registration and Networking Breakfast

8:30 a.m.

Former FDA Lawyers Panel

MODERATOR: Becky Wood
Chris Fanelli
Jim Johnson
Coleen Klasmeier
Jeff Senger

9:30 a.m.

Ethics That Matter to You: Issues and CaseStudies for Lawyers in the Life Sciences Industry

Carlo Felizardo
Coleen Klasmeier
Jeff Senger

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10:30 a.m.

Break

10:45 a.m.

Securities Disclosure Considerations for FDA-Regulated Companies

Sonia Gupta Barros
Torrey Cope
Hille Sheppard

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Download
Annual Survey

11:45 a.m.

Lunch

1:00 p.m.

Supply Chain Essentials – DSCSA & GMP

Jim Johnson
Diane McEnroe

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2:00 p.m.

Drug Development Part 2 – Dispute Resolution at FDA

Torrey Cope
Sean Griffin
Coleen Klasmeier
Kelly Cho

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3:00 p.m.

Assuring Compliance Across All Systems Using a Quality Approach

Jim Johnson
Chris Fanelli

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Speakers

Guest Speakers

Jeffrey Chasnow

CHIEF REGULATORY
COUNSEL

Pfizer

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Carissa Davis

CHIEF COUNSEL, CLINICAL & COMMERCIAL LAW

Novo Nordisk Inc.

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Erica Jackson

ASSOCIATE GENERAL COUNSEL

Ginkgo Bioworks

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‍Michael Hulka

VICE PRESIDENT AND DEPUTY GENERAL COUNSEL

Eli Lilly and Company

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Keren Tenenbaum

GENERAL COUNSEL

Vifor Pharma

View Bio

Sidley Speakers

Sonia Gupta Barros

PARTNER

View Bio

Kelly Cho

MANAGING ASSOCIATE

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Torrey Cope

PARTNER

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Meena Datta

PARTNER

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Christopher Fanelli

PARTNER

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Carlo Felizardo

Managing Associate

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Sean Griffin

PARTNER

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Jim Johnson

Partner

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Jaime Jones

PARTNER

View Bio

Coleen Klasmeier

PARTNER

View Bio

Lei Li

Partner

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Emily Marden

COUNSEL

View Bio

Diane McEnroe

PARTNER

View Bio

Sean Royall

PARTNER

View Bio

Jeff Senger

PARTNER

View Bio

Hille Sheppard

PARTNER

View Bio

Josefine Sommer

SENIOR MANAGING ASSOCIATE

View Bio

Eva von Mühlenen

Advisor

View Bio

Becky Wood

Partner

View Bio

Chen Yang

SENIOR COUNSEL

View Bio

Regulatory Reboot:

Agenda

8:00 a.m.

Breakfast and Networking

9:00 a.m.

Welcome Remarks

9:10 a.m.

Drug Development Essentials for the FDA Regulatory Lawyer

10:00 a.m.

Key Risk Considerations for Promotional and Non-Promotional Communications

11:00 a.m.

Break

11:15 a.m.

Market Access: Anti-Kickback Statute Considerations and Hot Topics

12:15 p.m.

Lunch

1:15 p.m.

Statutory Exclusivities

2:15 p.m.

Analyzing Business Purpose Under the Anti-Kickback Statute

3:15 p.m.

Break

3:30 p.m.

In-House Counsel Panel

4:30 p.m.

Cocktail Reception

8:00 a.m.

Breakfast and Networking

8:30 a.m.

Former FDA Lawyers Panel

9:30 a.m.

Ethics That Matter to You: Issues and CaseStudies for Lawyers in the Life Sciences Industry

10:30 a.m.

Break

10:45 a.m.

Securities Disclosure Considerations for FDA-Regulated Companies

11:45 a.m.

Lunch

1:00 p.m.

Supply Chain Essentials – DSCSA & GMP

2:00 p.m.

Drug Development Part 2 – Dispute Resolution at FDA

3:00 p.m.

Assuring Compliance Across All Systems Using a Quality Approach

Speakers

Guest Speakers

Jeffrey Chasnow

Carissa Davis

Erica Jackson

‍Michael Hulka

Keren Tenenbaum

Sidley Speakers

Sonia Gupta Barros

Kelly Cho

Torrey Cope

Meena Datta

Christopher Fanelli

Carlo Felizardo

Sean Griffin

Jim Johnson

Jaime Jones

Coleen Klasmeier

Lei Li

Emily Marden

Diane McEnroe

Sean Royall

Jeff Senger

Hille Sheppard

Josefine Sommer

Eva von Mühlenen

Becky Wood

Chen Yang

On-Demand Sessions

China Hot Topics

New Medical Device Rules And Artificial Intelligence Proposal in the European Union

Resources

Global Life Sciences

Food, Drug and Medical Device Compliance and Enforcement

Healthcare

Food, Drug and Medical Device Regulatory

Key Risk Considerations for Promotional and
Non-Promotional Communications