5th Annual Summit on Controlled Substances - WEB

Featuring Exclusive Keynotes from DOJ, DEA, and FDA on Regulation and Enforcement Initiatives

In-Person & Livestream

5th Annual Summit on

CONTROLLED SUBSTANCES REGULATION, LITIGATION, AND ENFORCEMENT July 12–13, 2022 • Washington Marriott Georgetown, Washington, DC

EARN CLE CREDITS

Reconnect in-person with industry peers, key stakeholders from the controlled substances supply chain, and government officials to examine the latest regulatory and legal developments and trends impacting the industry.

DISTINGUISHED CO-CHAIRS: Uttam Dhillon Chair, Regulatory Defense, Compliance & White-Collar Practice Group Michael Best & Friedrich LLP (Former Acting Administrator, U.S. Drug Enforcement Administration) Dayle Elieson Principal Dayle Elieson PLLC (Former Chief Counsel, U.S. Drug Enforcement Administration)

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GOVERNMENT INSIGHTS FROM: Jay Baez Legislative Director New York State Senate Dominic Chiapperino, Ph.D. Director, Controlled Substances Staff U.S. Food and Drug Administration Scott Dahlquist Trial Attorney, Consumer Protection Branch U.S. Department of Justice Monica Hanna Special Counsel New York State Office of the Attorney General Dwayne Jeffcoat DEA Diversion Investigator U.S. Drug Enforcement Administration

Amanda Liskamm Principal Deputy Director, Consumer Protection Branch U.S. Department of Justice Lindsay Saxe Griffin Assistant United States Attorney Affirmative Civil Enforcement Coordinator United States Attorney’s Office Middle District of Florida Elliot M. Schachner Assistant U.S. Attorney U.S. Attorney’s Office Eastern District of New York Eric Triana Deputy Assistant Administrator, Office of Diversion Control Operations U.S. Drug Enforcement Administration Joshua Vinciguerra, JD Director, Bureau of Narcotic Enforcement New York State Department of Health

Pre-Conference Workshop on July 11th, 2022: COMPLIANCE THINK TANK

Establishing and Structuring an Effective Controlled Substances Compliance Program

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American Conference Institute (ACI) invites you to join our 5th Annual Summit on Controlled Substances: Regulation, Litigation, and Enforcement Be part of the only conference that presents strategies and solutions for every link of the controlled substances supply chain.

Connect with government officials and key industry stakeholders from throughout the controlled substances supply chain to examine the latest legal and regulatory developments impacting the industry.

Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster compliance programs, mitigate risk, and reduce liability.

DISTINGUISHED FACULTY CO-CHAIRS Uttam Dhillon Chair, Regulatory Defense, Compliance & White-Collar Practice Group Michael Best & Friedrich LLP (Former Acting Administrator, U.S. Drug Enforcement Administration) Dayle Elieson Principal Dayle Elieson PLLC (Former Chief Counsel, U.S. Drug Enforcement Administration) GOVERNMENT Jay Baez Legislative Director New York State Senate Dominic Chiapperino, Ph.D. Director, Controlled Substances Staff U.S. Food and Drug Administration Scott B. Dahlquist Trial Attorney, Consumer Protection Branch U.S. Department of Justice Monica Hanna Special Counsel New York State Office of the Attorney General Dwayne Jeffcoat DEA Diversion Investigator U.S. Drug Enforcement Administration

Amanda Liskamm Principal Deputy Director, Consumer Protection Branch U.S. Department of Justice Lindsay Saxe Griffin Assistant United States Attorney Affirmative Civil Enforcement Coordinator United States Attorney’s Office Middle District of Florida Elliot M. Schachner Assistant U.S. Attorney U.S. Attorney’s Office Eastern District of New York Eric Triana Deputy Assistant Administrator, Office of Diversion Control Operations U.S. Drug Enforcement Administration Joshua Vinciguerra, JD Director, Bureau of Narcotic Enforcement New York State Department of Health

IN-HOUSE LEADERSHIP, IN-HOUSE COUNSEL, AND LAW FIRMS Jason Bologna Shareholder Buchanan Ingersoll & Rooney PC Nathan Beaver Partner Foley and Lardner LLP Michele Buenafe Partner Morgan, Lewis & Bockius LLP Charrai Byrd, PharmD, MBA, RPh Pharmacy Operations Manager – Controlled Substances NewYork-Presbyterian Hospital Ronald Chapman II Shareholder Chapman Law Firm Kimberly Chew Senior Counsel, Coleader of Psychedelics and Emerging Therapies Practice Group Husch Blackwell LLP Roger Cohen Life Sciences Partner Goodwin Procter LLP Corey Cox Senior Counsel Columbia Care Shannon Cox Counsel King & Spalding LLP Hunter G. DeKoninck Practice Group Attorney Quarles & Brady LLP Delia Ann Deschaine Partner Epstein Becker Green

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Tom Firestone Partner Stroock & Stroock & Lavan LLP Todd Harrison Partner Venable LLP Jonathan A. Havens Partner & Co-Chair, Cannabis Law; Co-Chair, Food, Beverage & Agribusiness Saul Ewing Arnstein & Lehr LLP Derrelle Janey Managing Partner The Janey Law Firm PC Michael Labson Partner Covington & Burling LLP Andrew O’Connor Partner Ropes & Gray LLP Karla L. Palmer Director Hyman, Phelps & McNamara PC Quinn Shean Strategic Advisor Tusk Venture Partners Jack Teitelman President TITAN GROUP Jackie von Salm, PhD Co-Founder & Chief Scientific Officer Psilera Inc. Will Woodlee Partner Kleinfeld, Kaplan & Becker LLP

Take advantage of the All Access Pass and attend both Conference Workshops and Main Conference at one low price.

See page 9 for details.

PRE-CONFERENCE WORKSHOP MONDAY, JULY 11, 2022

1:30 PM – 5:00 PM | COMPLIANCE THINK TANK

Building an Effective Controlled Substances Compliance Program microphone-alt Karla L. Palmer, Director, Hyman, Phelps & McNamara PC Delia Ann Deschaine, Partner, Epstein Becker Green At this practical, industry-driven working group, our speakers will discuss how companies along the supply chain are using a tiered approach based on the appropriate risk level. This compliance think tank will provide you with the opportunity to upgrade your best practices, discover how your approach compares with your peers, and reevaluate your risk ranking, while managing the costs of a robust controlled substances compliance program. Topics include: • Designing a comprehensive compliance handbook » Detailing the latest regulatory developments influencing risk management to maintain compliance and avoid unforeseen fines and/or federal charges • Examining your existing controlled substances compliance program and identifying gaps • Identifying best practices for conducting internal audits of your facility and controlled substance inventory to ensure preparedness • Understanding your data and mapping your trends • Responding to noticeable volume changes • 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 • Exploring DEA compliance in a post-COVID world Workshop is offered in-person only.

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Accreditation will be sought in those jurisdictions requested by the registrants CREDITS which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

EARN CLE

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

For more information on ACI’s CLE process visit: www.americanconference.com/accreditation/cle/

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Main Conference Day 1 TUESDAY, JULY 12, 2022

8:00 AM | Breakfast and Registration 9:00 AM

Co-Chairs’ Opening Remarks microphone-alt Uttam Dhillon, Chair, Regulatory Defense, Compliance

& White-Collar Practice Group,Michael Best & Friedrich LLP (Former Acting Administrator, U.S. Drug Enforcement Administration) Dayle Elieson, Principal, Dayle Elieson PLLC (Former Chief Counsel, U.S. Drug Enforcement Administration)

9:05 AM

DOJ KEYNOTE ADDRESS microphone-alt Amanda Liskamm, Principal Deputy Director, Consumer Protection Branch, U.S. Department of Justice

» The impact of harm-reduction initiatives in various states The rollout and impact of programs in New York, Rhode Island, and Philadelphia » How the National Harm Reduction Coalition is aiding in the fight against the U.S. Drug Overdose crisis 11:00 AM

Exploring the Shifting Landscape of Opioid-Related Litigation microphone-alt Jay Baez, Legislative Director, New York State Senate Monica Hanna, Special Counsel, NY State Office of the AG MODERATOR:

Derrelle Janey, Managing Partner, The Janey Law Firm During this comprehensive assessment of the opioid MDLs, session leaders will review the status of sweeping settlements of the more than 3,000 lawsuits filed by cities and counties across the country, and forecast the outcomes of the pending cases. Points of discussion will include:

9:35 AM | Morning Coffee Break

• Addressing the impact of the MDLs and their impact on the controlled substances supply chain and communities across the country

10:00 AM | T OWN HALL: THE CURRENT STATE OF THE U.S. DRUG OVERDOSE CRISIS

• Understanding how the Opioid Settlement Board will assist in funds distribution and its recommendations on how states should receive the funds

Analyzing the Implications of Recent State and Federal Controlled Substances Initiatives on the U.S. Drug Overdose Epidemic microphone-alt Scott Dahlquist, Trial Attorney, Consumer Protection Branch,

» How funds are being distributed to communities across the country » How funds are being used to rebuild communities through harmreduction measures

U.S. Department of Justice

12:00 PM | Networking Luncheon

Joshua Vinciguerra, JD, Director, Bureau of Narcotic Enforcement, New York State Department of Health

1:15 PM | SCOTUS WATCH

MODERATOR:

Uttam Dhillon, Chair, Regulatory Defense, Compliance & White-Collar Practice Group, Michael Best & Friedrich LLP (Former Acting Administrator, U.S. Drug Enforcement Administration)

Critical Takeaways from Ruan v. United States and the Potential Implications for the Prescribing of Controlled Substances microphone-alt Ronald W. Chapman II, Shareholder, Chapman Law Firm

When the Controlled Substances Act (CSA) was enacted in 1971, approximately 7,000 people had died from overdose deaths. In 2021 alone, the CDC estimated that more than 100,000 people have died in the U.S. from drug overdose deaths, a marked increase likely driven by the global pandemic. In response, the DOJ and DEA have broadened the scope for establishing liability by bad actors under the CSA. In this opening Town Hall, key controlled substances stakeholders will provide you with insights into the current political and legislative landscape. Topics of discussion will include:

This panel discussion highlights the Supreme Court case Xiulu Ruan v.

United States of America. At issue before the Court is whether physicians can be convicted for unlawful distribution of controlled substances if they believe prescribing such drugs are under professional norms.

• Addressing the alarming spike in U.S. drug overdose deaths » The path to today’s massive overdose crisis » Analyzing the correlation between the increase in overdose deaths and the COVID-19 pandemic • Examining how current controlled substances and sentencing laws are becoming more stringent in light of this spike » Understanding pending legislation focused on the overdose crisis • Identifying barriers to evidence-based care for substance-use disorders » Developing collaborative, evidence-based solutions to improve outcomes » Identifying Best Practices for stakeholders looking to collaborate with policymakers to help end the U.S. overdose epidemic • Reviewing the CDC’s February 2022 draft revision to its 2016 Opioid prescribing guideline • Taking stock of the state of harm-reduction services and community prevention programs » Community-based prevention programs, including Syringe Service Programs (SSPs)

• Addressing what constitutes the “standard of care” and “usual course of professional practice” under the Controlled Substances Act (CSA)

During this panel, we will explore the various facets of this case, including: • Analyzing the government’s brief in Ruan v. United States

• Assessing when acting in “good faith” can be used as a defense for practitioners charged with unlawfully distributing narcotics under the CSA • Examining the consolidated case, Kahn v. United States

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

4 | #ControlledSubstances twitter: @ACI_Pharma linkedin: ACI: Pharmaceutical/Biotech/Life Sciences

1:45 PM

Exploring the Regulatory and Enforcement Arena of Marijuana microphone-alt Corey Cox, Senior Counsel, Columbia Care Will Woodlee, Partner, Kleinfeld, Kaplan & Becker LLP Jonathan A. Havens, Partner & Co-Chair, Cannabis Law; Co-Chair, Food, Beverage & Agribusiness, Saul Ewing Arnstein & Lehr LLP MODERATOR:

Tom Firestone, Partner, Stroock & Stroock & Lavan LLP During this panel, we will review current marijuana and medical marijuana legislation in the U.S. Panel leaders will focus on navigating security and compliance measures in an industry filled with new possibilities, but rife with stringent regulatory restrictions. Topics will include: • Assessing the landscape of marijuana as a schedule I controlled substance in 2022 • Reviewing current marijuana laws, including legislation focused on adult-use marijuana and the current landscape of legalization • Addressing the latest regulatory updates from the federal government • Considering DEA’s authorization of increased legal production • Navigating DEA compliance of marijuana 2:45 PM | Afternoon Break

• A look at the DEA’s ‘One Pill Can Kill’ campaign • How pharmacies are responding to the alarming trends • Exploring Fentanyl and its impact on the Controlled Substances industry • Identifying community access to resources like Narcan nasal spray and Fentanyl test strips • How young social media users are being solicited by drug dealers selling fake pills on popular platforms » Identifying ways that dealers are advertising Fentanyl-laced pills using emojis » Snapchat’s enforcement strategies and the path forward for social media • Exploring legislation that is harsher on ‘street dealers’ • Identifying best practices for urgent and critical community education and exploring: » How are kids in school being educated about deadly fake pills? » How are community leaders responding to the crisis?

5:00 PM | Conference Adjourns to Day 2

WHO ATTENDS

By Industry:

By Job Function:

3:15 PM

Considering Psychedelics as a Viable Therapeutic microphone-alt Todd Harrison, Partner, Venable LLP Michael Labson, Partner, Covington & Burling LLP Jackie von Salm, PhD, Co-Founder & Chief Scientific Officer, Psilera Inc. MODERATOR:

Kimberly Chew, Senior Counsel, Husch Blackwell LLP Recent studies are pointing to the promise for psychedelic drugs like LSD and psilocybin to help alleviate depression, anxiety and addiction. This panel will explore the legal status of psychedelic drugs under federal law, as we explore the DEA’s 2022 production goals for psychedelics and the status of psychedelics as a Schedule I controlled substance. Topics include: • Reviewing the legal status of psilocybin, MDMA, ibogaine and DMT • Understanding the basics of psychedelic therapy and navigating risks • Exploring Psilocybin designation as a breakthrough therapy 4:15 PM | FENTANYL & FAKE PILLS

Fighting Fentanyl and Fake Pills in the U.S. microphone-alt Dwayne Jeffcoat, DEA Diversion Investigator, U.S. Drug Enforcement Administration

Amanda Liskamm, Principal Deputy Director, Consumer Protection Branch, U.S. Department of Justice

40%

Manufacturer/ Distributor

29%

Law Firm

15%

34%

Compliance/ DEA Compliance

32%

Regulatory

Government

10%

28%

6%

6%

Industry Consultant

Healthcare

Legal

Diversion

MODERATOR:

Dayle Elieson, Conference Co-Chair, Principal, Dayle Elieson PLLC The record number of counterfeit pills containing fentanyl seized by DEA is chilling. During this panel, we will explore the DEA-led “One Pill Can Kill” campaign designed to educate the public of the deadly dangers of fake prescription pills. We will also address the trends fueling the US fentanyl and fake pill crisis. Topics include:

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Main Conference Day 2 WEDNESDAY, JULY 13, 2022

8:00 AM | Breakfast and Registration 8:55 AM

Co-Chairs’ Opening Remarks and Recap of Day One microphone-alt Uttam Dhillon, Chair, Regulatory Defense, Compliance & WhiteCollar Practice Group, Michael Best & Friedrich LLP (Former Acting Administrator, U.S. Drug Enforcement Administration)

Dayle Elieson, Principal, Dayle Elieson PLLC (Former Chief Counsel, U.S. Drug Enforcement Administration)

While drug diversion investigations historically focused on the role of individuals, future enforcement will focus on an organization’s role in preventing drug diversion and related liability. During this panel, we will explore the power of data analytics and other novel technologies to better understand patient risk with controlled substances. Topics we will explore include: • Exploring the data provided by Prescription Drug Monitoring Programs (PDMPs) » Using Data Analytics to identify heavy over prescribers • Addressing the need for data sharing and interoperability between states • Ensuring compliance with your state’s current requirements • Examining ways that PDMPs can impact the future of healthcare overall • Identifying the most successful, creative diversion techniques that can save money and bolster compliance 11:45 AM | Networking Luncheon

9:00 AM

1:00 PM

DEA KEYNOTE ADDRESS

FDA KEYNOTE ADDRESS

microphone-alt Eric Triana, Deputy Assistant Administrator, DEA Office of Diversion Control Operations

9:30 AM | SOM COMPLIANCE

Adjusting Your Compliance Program in View of New DEA Regulations microphone-alt Michele Buenafe, Partner, Morgan, Lewis, Bockius LLP Hunter DeKoninck, Attorney, Quarles & Brady LLP Federal and state agencies are increasing investigation into the players of the pharmaceutical supply chain, paying close attention to the validity and fluctuation of ordering practices to combat the diversion of controlled substances. In order to avoid entanglements with the government for failing to report suspicious orders, session leaders will provide a forwardthinking analysis of the existing regulations, proposed reformations, and real-world guidance that can be proximately executed. Topics will include: • Adapting your Suspicious Monitoring program to respond to state and federal authorities • Identifying suitable due diligence and “know your customer” actions • Understanding the strategy and operation of a suspicious order monitoring and reporting system • Executing support for ongoing employee training 10:15 AM | Morning Coffee Break 10:45 AM | TECHNOLOGIES TRANSFORMING AND PREVENTING CONTROLLED SUBSTANCES DIVERSION

Harnessing the Power of Data Analytics, AI, and Prescription Drug Monitoring Programs (PDMPs) to Measure Patient Risk

microphone-alt Dominic Chiapperino Ph.D., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

1:30 PM | TELEHEALTH AND TELEMEDICINE

Opportunities and Barriers: Examining the Embrace of Telehealth and Telemedicine and Resulting Impacts on the Prescription of Controlled Substances microphone-alt Nathan Beaver, Partner, Foley & Lardner LLP Roger Cohen, Life Sciences Partner, Goodwin Procter LLP Quinn Shean, Strategic Advisor, Tusk Venture Partners State Policy Advisor, American Telemedicine Association In a post-pandemic world, and with the growing demand for telemedicine, several changes have been made to telehealth policies to make telemedicine more accessible. During this panel, we will address ways that telehealth and telemedicine are impacting the controlled substances industry. Topics of discussion will include: • How e-Prescribing has impacted the opioid epidemic » How telemedicine is being used to treat opioid-use disorders • Reviewing the state and federal regulatory landscape of telehealth policy • Appreciating how the federal government is loosening restrictions on telehealth • Understanding electronic prescribing of controlled substances (EPCS) mandates • Discerning remote patient monitoring (RPM) and RPM tools can shape healthcare at large • Exploring the SUPPORT Act, enacted Jan. 1, 2022, which requires every controlled substance prescription to be transmitted electronically

microphone-alt Shannon Cox, Counsel, King & Spalding Charrai Byrd, PharmD, MBA, RPh, Controlled Substances Pharmacy Operations Manager, NewYork-Presbyterian Hospital Elliot Schachner, Assistant U.S. Attorney, U.S. Attorney’s Office Eastern District of New York MODERATOR:

Jack Teitelman, President, TITAN GROUP

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

6 | #ControlledSubstances twitter: @ACI_Pharma linkedin: ACI: Pharmaceutical/Biotech/Life Sciences

2:30 PM | Networking Break 3:00 PM | FCA BEST PRACTICES AND COMPLIANCE

Controlled Substances and the False Claims Act: Reducing Legal Risk Amid the Expanding Reach of the FCA microphone-alt Andrew O’Connor, Partner, Ropes & Gray LLP Jason Bologna, Shareholder, Buchanan Ingersoll & Rooney PC MODERATOR:

Lindsay Saxe Griffin, Assistant United States Attorney, Affirmative Civil Enforcement Coordinator, United States Attorney’s Office, Middle District of Florida In 2021, the DOJ targeted the opioid epidemic, Medicare Advantage program (Medicare Part C) fraud and abuse, kickbacks, including a $2.8 billion resolution with one opioid manufacturer. Even amidst the challenges associated with the pandemic, DOJ demonstrated that enforcement activity has not faltered, rather persisted. This panel discussion will explore the record-shattering year for FCA recoveries in the controlled substances arena. Topics include:

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• Evaluating the reason for the spike in False Claims Acts (FCA) recoveries

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• Implementing effective and comprehensive FCA compliance measures • Identifying compliance strategies to avoid FCA litigation • Outlining best practices to maintain FCA compliance 4:00 PM | Conference Concludes

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Planning Ahead for Live Conferences: C5’s All Secure Safety Plan

As American Conference Institute and our partners plan for in-person events, we are committed to building and enhancing the planning and preparation with a view to offering our guests a safe place for live conference delivery. In addition, to ensure your safety, our event staff is fully vaccinated.

All our events will adhere to official government and local authority guidance in addition to venue or location-specific regulations, and will follow the commitments below.

Attendance Screening All attendees will need to assert that at the time that they first attend the conference and for the 14 days prior: y Have not experienced any COVID-19 symptoms now or within the last 14 days. y Have not had close contact with any person with or suspected of having COVID-19 within the last 14 days. y Have not had a positive COVID-19 test within the last 14 days. y Have not been advised by any health authority, government agency or regulatory body, within the last 14 days, to self-isolate due to possible exposure to COVID-19.

Link to COVID-19 symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/ symptoms.html We are closely monitoring industry best practices and will be evaluating further additional measures pertaining to vaccinations and on-site screening based on the advice of health authorities.

Safety and Physical Distancing y Physical distancing protocols such as limiting attendance, directional signage and markers throughout the conference. y A conference room layout with planned seating for appropriate physical distancing. y We continue to work closely with our venue partners to ensure the safety of our attendees. Please check back frequently as we monitor and evolve our plan in the weeks ahead.

Enhanced Communication y Advance communication to all attendees on what to expect and prepare for at the conference: from registration to conference materials to room layout to food and beverage options and more. y Education and training for the team to ensure we provide a safe and secure conference experience. y Distribution of local health-resource information in advance of the event. y Ongoing communication and advance planning with the venue regarding enhanced cleaning and sanitizing measures, response strategies and other onsite protocols.

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