4th Annual Summit on Controlled Substances - DS

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June 14 – 15, 2021 (EDT) • Virtual Conference

4th Annual Summit on

CONTROLLED SUBSTANCES REGULATION, LITIGATION, AND ENFORCEMENT

Attend this one-of-a-kind forum, in a unique, virtual format. Hear from leading stakeholders, discuss your most pressing challenges, and walk away with tailored strategies for solutions as the opioid crisis enters its next stage.

JUNE 14, 2021 – WORKSHOP A: Controlled Substances Bootcamp: An Introduction to Key Agencies, Regulation, and Scheduling June 15, 2021 — WORKSHOP B: Compliance Think Tank: Building and Enhancing an Effective Controlled Substances Compliance Program

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Richard Hartunian Partner, Manatt, Phelps & Phillips, LLP (Former U.S. Attorney – Northern District of New York U.S. Department of Justice)

Lynn Mehler Partner, Hogan Lovells (Former Senior Counsel, FDA Office of the Chief Counsel)

Government Insights from:

Workshops:

Sponsored by:

Distinguished Co-Chairs:

DEA: Claire M. Brennan Section Chief, Liaison Section, Diversion Control Division U.S. Drug Enforcement Administration

Scott A. Brinks Section Chief, Regulatory Drafting & Policy Support Section, Diversion Control Division U.S. Drug Enforcement Administration

Gustav Eyler Director, Consumer Protection Branch U.S. Department of Justice

Ross Goldstein Senior Litigation Counsel U.S. Department of Justice

Scott Dahlquist Trial Attorney, Consumer Protection Branch U.S. Department of Justice

Elliot M. Schachner Assistant U.S. Attorney U.S. Attorney’s Office, Eastern District of New York

DOJ:

AmericanConference.com/ControlledSubstances • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

WHO ATTENDS ACI invites you to connect with government officials and industry stakeholders

By Industry:

By Job Function:

from throughout the controlled substances supply chain to examine the latest legal and regulatory developments affecting this class of drugs and gain key insights for addressing the fallout from this next stage of the opioid crisis.

Attend from the comfort of your home office and learn how to best conform business practices to meet industry and regulatory demands, bolster compliance programs, mitigate risk, and reduce liability.

Our faculty will provide a forward-thinking analysis of the existing regulations, proposed reforms, as well as best practices and real-world guidance for ensuring compliance.

Explore the new administration’s agenda for controlled substances including its plans for addressing the latest chapter of the opioid crisis, decriminalizing cannabis, and identifying new addictive substances.

Analyze and understand the DEA’s newly released two-part framework on handling suspicious orders and discover how to enhance your compliance program.

Our esteemed, top-notch speaking faculty consists of current and former officials from DEA and FDA, representatives from State Attorneys General and U.S. Attorney Offices, as well as high-level in-house executives, and top outside counsel.

Do not miss the exclusive opportunity this conference presents.

Register today for the 4th Annual Controlled Substances Regulation, Litigation and Enforcement Conference by calling 1-888-224-2480, or visiting us online at AmericanConference.com/ControlledSubstances We look forward to seeing you virtually this June!

2 | #ControlledSubstances

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40%

34%

29%

32%

Manufacturer/ Distributor

Law Firm

Compliance/ DEA Compliance

Regulatory

15%

Government

28% Legal

10%

Industry Consultant

6%

Diversion

6%

Healthcare

DISTINGUISHED FACULTY CO-CHAIRS: Richard Hartunian Partner Manatt, Phelps & Phillips, LLP (Former U.S. Attorney – Northern District of New York U.S. Department of Justice) Lynn Mehler Partner Hogan Lovells (Former Senior Counsel, FDA Office of the Chief Counsel) GOVERNMENT: Claire M. Brennan Section Chief, Liaison Section Diversion Control Division U.S. Drug Enforcement Administration Scott A. Brinks Section Chief, Regulatory Drafting & Policy Support Section, Diversion Control Division U.S. Drug Enforcement Administration Dominic Chiapperino, Ph.D. Director, Controlled Substance Staff, Center for Drug Evaluation and Research U.S. Food and Drug Administration Scott Dahlquist Trial Attorney, Consumer Protection Branch U.S. Department of Justice Gustav Eyler Director, Consumer Protection Branch U.S. Department of Justice

REGISTER NOW

Ross Goldstein Senior Litigation Counsel U.S. Department of Justice

John A. Gilbert, Jr. Director Hyman, Phelps, & McNamara

Elliot M. Schachner Assistant U.S. Attorney U.S. Attorney’s Office, Eastern District of New York

Todd Harrison Partner Venable LLP

Brandon J. Zanotti State’s Attorney Williamson County, Illinois COUNSEL, CONSULTANTS, AND ASSOCIATION REPRESENTATIVES

Seth Mailhot Partner Husch Blackwell LLP Raj D. Pai Partner Sidley Austin LLP

Daniel Blaney-Koen Senior Legislative Attorney, Advocacy Resource Center American Medical Association

Jason R. Parish Shareholder Buchanan Ingersoll & Rooney PC

Susan E. Briones Partner Lewis Brisbois

Edward D. Rickert Partner Quarles & Brady LLP

Amy B. Cadwallader, PhD Director of Science and Drug Policy American Medical Association

Nicole Russell Director, Government Affairs National Council for Prescription Drug Programs, Inc. (NCPDP)

Ronald W. Chapman II Shareholder, Chairperson of White-Collar Defense & Government Investigations Chapman Law Group Shannon F. Cox Counsel King & Spalding LLP Tom Firestone Partner Baker & McKenzie LLP

Jack Teitelman President Titan Group Kenneth Weinstein Managing Principal Analysis Group Joel White Executive Director Health Innovation Alliance

AmericanConference.com/ControlledSubstances • 888 224 2480

“

This conference was spot on with the issues we are facing everyday.

Amy D’Anna Novartis Institutes for Biomedical Research

It was great to hear from current and former industry leaders and experts from DEA, US AG offices, FDA, etc. Hearing about the current events and upcoming trends/ expectations was valuable.

Jaime McDermott Kroger Health

As the Director of Compliance for IPC, I was extremely pleased with last year’s speakers and the insight they provided into the latest controlled substance regulations.

Brian Rucker Independent Pharmacy Cooperative

” Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Take advantage of the

All Access Pass

Join Us Virtually this June!

to attend Pre-and-Post Conference Workshops and Main Conference at one low price.

PRECONFERENCE

See page 9 for details.

MONDAY, JUNE 14, 2021 (EDT) Workshop A

9:00 AM

CONTROLLED SUBSTANCES BOOTCAMP: An Introduction to Key Agencies, Regulation, and Scheduling microphone-alt Tom Firestone, Partner, Baker & McKenzie LLP Seth A. Mailhot, Partner, Husch Blackwell LLP

What to Expect at Our New Virtual Conference Enjoy an Easy to Use, Dynamic Online Platform Immerse Yourself in Live Presentations and Panel Discussions

Get the background information you need to seamlessly follow and engage in the more in-depth discussions that will take place during the main conference.

• An introduction to the DEA and FDA: agency missions and organizational structures relative to controlled substance regulation • Understanding the intersection between FDA and the DEA jurisdiction over controlled substances • Defining a “controlled substance • Understanding drug scheduling and the potential for abuse, safety, addictive potential and whether it has any legitimate medical applications • Considering the process to obtain approval from the DEA for schedule I-V controlled substances

Engage with Attendees and Speakers in an Interactive Format Meet 1-on-1 with Your Fellow Attendees

• Understanding abuse-deterrence, its current status, and its effect on the approval process • Working effectively with the DEA and FDA • Exploring the interplay between state licensing and federal regulations as they impact the discovery, development and marketing of controlled substances.

• Responding to DEA enforcement actions 12:00 PM

4 | #ControlledSubstances

End of Workshop

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MAIN CONFERENCE DAY ONE

MONDAY, JUNE 14, 2021 (EDT)

3:00 PM

1:1 Networking

1:00 PM

Co-Chairs’ Opening Remarks microphone-alt Richard Hartunian, Partner, Manatt, Phelps & Phillips, LLP

(Former U.S. Attorney – Northern District of New York U.S. Department of Justice) Lynn Mehler, Partner, Hogan Lovells, (Former Senior Counsel, FDA Office of the Chief Counsel)

Takeaways from the Latest Chapter of the National Prescription Opioid Litigation microphone-alt Susan E. Briones, Partner, Lewis Brisbois Jason R. Parish, Shareholder, Buchanan Ingersoll & Rooney PC

1:15 PM

Examining the Biden Administration’s Stance on Controlled Substances microphone-alt Joel White, Executive Director, Health Innovation Alliance Nicole Russell, Director, Government Affairs, National Council for Prescription Drug Programs (NCPDP) This opening session will look at what the new administration’s agenda for controlled substances including addressing the opioid crisis, decriminalizing cannabis, and identifying what is on the horizon for the next four years.

• Understanding the continuing establishment and status of the opioid task force to address the opioid crisis • Exploring the regulation of other controlled substances in the U.S. » Examining the state versus federal policies for cannabis • Analyzing the recent controversy over the prescribing of buprenorphine • Understanding the impact of the MDL settlement on this Administration’s controlled substances policies 2:00 PM

Conversation with the DEA: Federal Enforcement Initiatives microphone-alt Claire M. Brennan, Section Chief, Liaison Section, Diversion Control Division, U.S. Drug Enforcement Administration

Scott A. Brinks, Section Chief, Regulatory Drafting & Policy Support Section, Diversion Control Division, U.S. Drug Enforcement Administration Edward D. Rickert, Partner, Quarles & Brady LLP MODERATOR:

Richard Hartunian, Partner, Manatt, Phelps & Phillips, LLP (Former U.S. Attorney – Northern District of New York U.S. Department of Justice)

REGISTER NOW

3:15 PM

• Examining the latest settlements and dispositions in the national prescription opioid litigation » Identifying parties which have settled, which parties remain • Evaluating new allegations and causes of action tied to the outcome of the national litigation. » Opioid baby litigation • Debating whether the question of who bears responsibility for the opioid crisis has ever been answered • Understanding how the various state litigations tie into the MDL • Understanding how COVID-19 has affected the litigation trajectory • Examining compliance measurement requirements under any existing and anticipated settlements 4:15 PM

Examining the Complexities of the Supply Chain and Distribution Methods microphone-alt Shannon F. Cox, Counsel, King & Spalding LLP Jack Teitelman, President, Titan Group • Navigating the government bureaucracy affecting the supply chain • Identifying the impact COVID-19 has played on worldwide distribution impact • Developing best practices towards creating a comprehensive compliance program for distribution of controlled substances • Analyzing the evolving state and federal regulations and concepts for bolstering distribution compliance programs 5:00 PM

Co-Chairs’ Closing Remarks & Conference Adjourns to Day Two

AmericanConference.com/ControlledSubstances • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

MAIN CONFERENCE DAY TWO

TUESDAY, JUNE 15, 2021 (EDT)

9:30 AM 8:00 AM

Co-Chairs’ Opening Remarks microphone-alt Richard Hartunian, Partner, Manatt, Phelps & Phillips, LLP

(Former U.S. Attorney – Northern District of New York U.S. Department of Justice) Lynn Mehler, Partner, Hogan Lovells, (Former Senior Counsel, FDA Office of the Chief Counsel)

A Conversation with the DOJ microphone-alt Gustav Eyler, Director, Consumer Protection Branch, U.S. Department of Justice Scott Dahlquist, Trial Attorney, Consumer Protection Branch, U.S. Department of Justice Elliot M. Schachner, Assistant U.S. Attorney, U.S. Attorney’s Office, Eastern District of New York 10:45 AM

8:05 AM

The Cannabis Conundrum: Marijuana, Hemp, and the Legal Status of Products Containing Cannabidiol (CBD) microphone-alt Ross Goldstein, Senior Litigation Counsel, U.S. Department of Justice Dominic Chiapperino, Ph.D., Director, Controlled Substance Staff, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Todd Harrison, Partner, Venable LLP Seth Mailhot, Partner, Husch Blackwell LLP MODERATOR:

Raj D. Pai, Partner, Sidley Austin LLP Reviewing the status of hemp, marijuana, and other cannabinoids under current federal law: • Considering the evolving development of state cannabis laws

Morning Break

11:00 AM

NEW OBJECTS OF ADDICTION: Recognizing Dangerous Patterns for New Drugs of Concern microphone-alt Daniel Blaney-Koen, Senior Legislative Attorney, Advocacy Resource Center, American Medical Association

Amy B. Cadwallader, PhD, Director of Science and Drug Policy, American Medical Association The nation’s drug overdose epidemic has become one driven by overdose and death from illicitly manufactured fentanyl, fentanyl analogs, methamphetamine and cocaine. Death due to causes related to heroin and cocaine remain far too high. Despite hundreds of new laws, the epidemic continues to worsen. The COVID-19 pandemic, moreover, brought even greater challenges and has resulted in even greater acceleration of drug overdose and death. This presentation will discuss effective policy interventions that would have a meaningful impact on prevention, treatment and reducing harms from overdose.

• Complying with state storage and record keeping laws • Determining what are the ramification and prospects are • Assessing state level enforcement and labelling challenges

11:45 AM

HOT BUTTON: Legal Perspectives and Analytical Trends on Controlled Substances Act issues microphone-alt Kenneth Weinstein, Managing Principal, Analysis Group John A. Gilbert, Jr., Director, Hyman, Phelps, & McNamara

6 | #ControlledSubstances

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Take advantage of the

All Access Pass

to attend Pre-and-Post Conference Workshops and Main Conference at one low price.

12:30 PM

1:1 Networking 12:40 PM

Lunch

1:30 PM

State Regulation of Controlled Substances microphone-alt Brandon J. Zanotti, State's Attorney, Williamson County, Illinois MODERATOR:

Lynn Mehler, Partner, Hogan Lovells, (Former Senior Counsel, FDA Office of the Chief Counsel) • Defining state licensing and trends • Understanding state implemented opioid taxes • Identifying state of reporting requirements for controlled substances 2:15 PM

Closing Remarks & End of Conference

POSTCONFERENCE

See page 9 for details.

TUESDAY, JUNE 15, 2021 (EDT) Workshop B 2:30 PM

Compliance Think Tank: Building and Enhancing an Effective Controlled Substances Compliance Program microphone-alt Ronald W. Chapman II, Shareholder, Chairperson of White Collar Defense & Government Investigations, Chapman Law Group

In this compliance think tank, our controlled substance thought leaders will help you design a comprehensive handbook detailing the latest regulatory developments influencing risk management to maintain compliance and avoid unforeseen fines and/or federal charges.

Topics to be discussed include: • Examining your existing controlled substances compliance program and identifying any gaps in relation to new regulation • Conducting internal audits of your facility and controlled substance inventory to ensure preparedness • Understanding your data and expected trends • Knowing what to do when you discover noticeable volume changes • Utilizing your data to prophylactically identify highest risks

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• Developing monitoring protocols and strengthening internal controls • Completing an appropriate biennial inventory of all Schedule II-IV controlled substances • Improving theft and loss reporting requirements • Ensuring proper whistleblower policies for your program 5:00 PM

REGISTER NOW

AmericanConference.com/ControlledSubstances • 888 224 2480

End of Workshop

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

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