Conference Program
Flip through our 2021 conference brochure and discover what’s new this year.

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Day 1 - Monday, June 14, 2021

WORKSHOP A — Controlled Substances Bootcamp: An Introduction to Key Agencies, Regulation, and Scheduling

Jun 14, 2021 9:00am – 12:00pm

Speakers

Tom Firestone
Partner
Baker & McKenzie LLP

Seth A. Mailhot
Partner
Husch Blackwell LLP (Washington, DC)

1:00
Co-Chairs’ Opening Remarks
1:15
Examining the Biden Administration’s Stance on Controlled Substances
2:00
Conversation with the DEA: Federal Enforcement Initiatives
3:00
1:1 Networking
3:15
Takeaways from the Latest Chapter of the National Prescription Opioid Litigation
4:15
Examining the Complexities of the Supply Chain and Distribution Methods
5:00
Co-Chair Closing Remarks Conference Adjourns to Day Two

Day 2 - Tuesday, June 15, 2021

8:00
Co-Chairs’ Opening Remarks
8:05
The Cannabis Conundrum: Marijuana, Hemp, and the Legal Status of Products Containing Cannabidiol (CBD)
9:30
A Conversation with the DOJ
10:45
Morning Break
11:00
NEW OBJECTS OF ADDICTION: Recognizing Dangerous Patterns for New Drugs of Concern
11:45
HOT BUTTON: Legal Perspective and Analytical Trends on Controlled Substances Act issues
12:30
1:1 Networking
12:40
Lunch
1:30
State regulation of Controlled Substances
2:15
Closing Remarks End of Conference

Post-Conference Workshop

WORKSHOP B — Compliance Think Tank: Building and Enhancing an Effective Controlled Substances Compliance Program

Jun 15, 2021 2:30pm – 5:00pm

Speakers

Ronald W. Chapman II
Shareholder
Chairperson of White Collar Defense & Government Investigations

Chapman Law Group

Day 1 - Monday, June 14, 2021

1:00
Co-Chairs’ Opening Remarks

Richard S. 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)

1:15
Examining the Biden Administration’s Stance on Controlled Substances

Joel White
Executive Director
Health Innovation Alliance

Nicole Russell
Director, Government Affairs
National Council for Prescription Drug Programs, Inc. (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
Conversation with the DEA: Federal Enforcement Initiatives

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

3:00
1:1 Networking
3:15
Takeaways from the Latest Chapter of the National Prescription Opioid Litigation

Susan E. Briones
Partner
Lewis Brisbois

Jason R. Parish
Shareholder
Buchanan Ingersoll & Rooney PC

  • 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
Examining the Complexities of the Supply Chain and Distribution Methods

Shannon F. Cox
Counsel
King & Spalding LLP

Jack Teitelman
Founder & CEO
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
Co-Chair Closing Remarks Conference Adjourns to Day Two

Day 2 - Tuesday, June 15, 2021

8:00
Co-Chairs’ Opening Remarks
8:05
The Cannabis Conundrum: Marijuana, Hemp, and the Legal Status of Products Containing Cannabidiol (CBD)

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

Dominic Chiapperino, Ph.D.
Director, Controlled Substance Staff
Center for Drug Evaluation and Research

Food and Drug Administration

Todd A. Harrison
Partner
Venable LLP (Washington, DC)

Seth A. Mailhot
Partner
Husch Blackwell LLP (Washington, DC)

Moderator:

Raj D. Pai
Partner
SIDLEY AUSTIN LLP (Washington, D.C.)

Reviewing the status of hemp, marijuana, and other cannabinoids under current federal law:

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

9:30
A Conversation with the DOJ

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

Scott B. 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
Morning Break
11:00
NEW OBJECTS OF ADDICTION: Recognizing Dangerous Patterns for New Drugs of Concern

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

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

  • Understanding how Covid-19 has loosened restrictions on prescribing for monitoring or allowing controlled substances to subscribe via telemedicine.
  •  Determining how to measure addiction propensity and severity
  • Identifying the next “opioid” and preventing the next crisis
  • Looking head to what’s on the horizon for the DEA
          • Determining if there is a connection between illicit drugs of abuse and their legal drug counterparts

11:45
HOT BUTTON: Legal Perspective and Analytical Trends on Controlled Substances Act issues

Kenneth A. Weinstein
Managing Principal
Analysis Group

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

  • Understanding Drug Enforcement Administration regulatory developments
  • Tracking recent enforcement actions
  • Identifying key implications of newly proposed rule on suspicious orders
  • Reviewing recent controlled substance distributions trends and impact of the pandemic

12:30
1:1 Networking
12:40
Lunch
1:30
State regulation of Controlled Substances

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
Closing Remarks End of Conference

WORKSHOP A — Controlled Substances Bootcamp: An Introduction to Key Agencies, Regulation, and Scheduling

Jun 14, 2021 9:00am – 12:00pm

Tom Firestone
Partner
Baker & McKenzie LLP

Seth A. Mailhot
Partner
Husch Blackwell LLP (Washington, DC)

What is it about?

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
  • 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

WORKSHOP B — Compliance Think Tank: Building and Enhancing an Effective Controlled Substances Compliance Program

Jun 15, 2021 2:30pm – 5:00pm

Ronald W. Chapman II
Shareholder
Chairperson of White Collar Defense & Government Investigations

Chapman Law Group

What is it about?

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
  • 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