Past Events

Discussion of the Current Washington Landscape and Potential Effects for Healthcare and Life Sciences Companies

WHEN:  Tuesday, January 8, 2019 
WHERE:  Le Meridien 333 Battery Street, San Francisco, CA

Speakers:

What is it about?

The 2018 midterm election results ushered in a dividend government in Washington, DC.  Healthcare was one of the key issues for many voters, which will make it a priority for both Chambers of Congress.  Prescription drug prices, 340B program reform, addressing innovation in the regulatory process, removing regulatory barriers and strengthening the Affordable Care Act are among topics facing Congress and the Administration.

Please join us for a discussion of how the healthcare and life science industries could be impacted by legislative and oversight agendas, the outlook for regulations and the possibility of cooperation between Capitol Hill and 1600 Pennsylvania Ave.

For more information, please email Amanda Richardson at arichardson@cooley.com  or call +1 617 937 2460.

CBI’s 2018 PAP Legal Update:
Address Compliance Risks to Ensure Sustainable Patient Programs

WHEN:  Tuesday, September 25, 2018
WHERE:  Westin Arlington Gateway – 801 N Glebe Road Arlington, VA

Speakers:

What is it about?

CBI’s 3rd Annual PAP Legal Update Forum brings together industry thought leaders, government stakeholders, non-profit organizations and advocacy groups to discuss the most pressing compliance challenges.

Event details and registration

CBI’s Drug Pricing Transparency Congress

WHEN:  Thursday, September 27, 2018 • 7:30 am – 5:00 pm
WHERE:  The Bellevue Hotel – 200 South Broad Street, Philadelphia, PA

Speakers:

What is it about?

State drug pricing regulations remain in the headlines as state legislatures continue to introduce and pass laws aimed at transparency and reporting obligations leaving a myriad of legal and compliance complexities. Over the past year, states including Oregon, California, Nevada, Maryland, New York, Massachusetts and Vermont  have introduced and/or enacted different laws and enforcement initiatives mandating the disclosure of drug pricing increases, introducing restrictions limiting Medicaid drug spending, requiring disclosure of company metrics and expenses, and other related pricing ballot initiatives.

Event details and registration

Let’s Talk Compliance Series:
How Do We Ensure The Success of Our Compliance Efforts?

WHEN:  Wednesday, October 3, 2018 • 5:30 pm – 7:00 pm
WHERE:  Local Kitchen & Wine Merchant – 330 1st Street  San Francisco, CA

Speakers:

What is it about?

Cooley’s Let’s Talk Compliance Series is a private, invitation only series that allows life sciences companies with newly launched compliance functions to discuss strategies and better practices for ensuring its success. This multi-part series will cover trending compliance topics in a conversational and relaxed atmosphere.This session will focus on patient assistance programs and will include a discussion of the legal parameters, recent enforcement activity and compliance tips for ensuring that your compliance is ready for success.

Future Let’s Talk Compliance Series topics will include:

  • Patient advocacy interactions
  • Federal and state “sunshine” laws
  • Drug pricing and pricing transparency

For more information, please email Amanda Richardson  or call +1 617 937 2460.

19th Annual Pharmaceutical and Medical Device Compliance Congress

WHEN: Wednesday, November 7, 2018 – Friday, November 9, 2018
WHERE: Mandarin Oriental – Maryland Avenue SW, Washington, DC

Speakers:

What is it about?

Cooley is sponsoring the 19th Annual Pharmaceutical and Medical Device Compliance Congress. Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance professionals and legal counsel from 50+ of the largest research-based pharmaceutical manufacturers.

Event details and registration

CBI’s 2017 PAP Legal Update: Navigate Legal Challenges to Build Sustainable Patient Programs

WHEN: September 25-26, 2017
WHERE: The Westin Arlington Gateway – 801 North Glebe Road, Arlington, VA 22203

Speaker

What is it about?

CBI’s 2017 PAP Legal Update will provide critical insight into key legal issues, including recent advisory opinions from the OIG, sustainable funding models, and opportunities for industry collaboration in the face of an increased need for risk mitigation.

  • Prepare for the future with a detailed analysis of recent OIG Advisory Opinions
  • Learn about how changes in healthcare reform may affect PAPs moving forward
  • Enhance your strategies for patient assistance for Medicare Part D patients
  • Analyze opportunities for improved communication and collaboration between PAP foundations and manufacturers
  • Examine the relationship between programs for uninsured and underinsured to enhance prospects for patient access
  • Hear from industry and legal experts on advancing programs despite legal uncertainty
  • Discuss best practices and case studies with stakeholders across the PAP space

Event details and registration

18th Annual Pharmaceutical and Medical Device Compliance Congress

WHEN: November 6 – 8, 2017
WHERE: Mandarin Oriental, Washington DC – 1330 Maryland Ave SW, Washington DC 20024

Speakers

What is it about?

The purpose of the Pharmaceutical Compliance Forum is to discuss education and other industry practices regarding compliance with the ultimate aim of promoting effective pharmaceutical corporate compliance and ethics programs in accordance with the Federal Organization Sentencing Guidelines and the OIG Compliance Guidance for Pharmaceutical Manufacturers.

Event details and registration

The Future of New York Healthcare: Where Are We and What Happens Next?

WHEN: June 14, 2017 at 5:30pm EST
WHERE: Cooley LLP, 1114 Avenue of the Americas, 46th Floor

Moderator

Speakers

  • Amanda Parsons, MD
    Vice President, Community & Population Health
    Montefiore Health System
  • Dan McCarthy
    President & Chief Operating Officer
    Healthfirst
  • Joseph Conte
    Executive Director
    Staten Island Performing Provider System
  • Mario Schlosser
    CEO and Co-Founder
    Oscar

For more information or to register, please click here.

Regulatory Roundtable Immersion Series – Session #13: State of the Healthcare Union: A Review of 2016 Key Events, A Look Into The 2017 Healthcare Agenda and Practical Tips for Living in Current Times

WHEN: April 25, 2017 at 5:30pm PST
WHERE: Cooley LLP, 3175 Hanover Street, Palo Alto, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide insight, real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

For more information, please email Leah Lowery at llowery@cooley.com.

FDLI’s Introduction to U.S. Biologics and Biosimilars Law and Regulation

Regulation of Biological/Drug Development

WHEN: March 15, 2017 at 1:00pm EST
WHERE: Arnold & Porter Kaye Scholer, 601 Massachusetts Ave NW, Washington, DC 20001

Speakers

For more information or to register, please click here.

ACI’s 17th Annual Conference on Fraud and Abuse in the Sale and Marketing of Drugs, Devices, and Medical Technology

Pricing Considerations for the Compliance Agenda in an Evolving Environment

WHEN: March 6, 2017 at 4:30pm EST
WHERE: Omni Parker House, 60 School Street, Boston, MA 02108

Speakers

  • Wendy Goldstein
    Partner
    Cooley LLP (New York, NY)

  • David Ralston
    Senior Director, Associate General Counsel, Business Conduct
    Gilead Sciences

What is it about?

  • Update on industry activity
  • Better practices to manage pricing, reimbursement support, copay mitigation, and charitable foundation relationships
  • Trends in state law pricing transparency
  • Developing a relevant oversight agenda for your organization on key relationships that impact pricing

For more information or to register, please click here.

Regulatory Roundtable Immersion Series – Session # 12: What to Expect in Health Policy Under the 115th Congress and New Presidential Administration

WHEN: February 1, 2017 at 6:00pm PST
WHERE: Cooley LLP, 3175 Hanover Street, Palo Alto, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide insight, real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

NYCHBL’s Privacy Please: How Healthcare is Managing Cyber Risk

WHEN: December 13, 2016 at 5:30pm EST
WHERE: Cooley LLP, Grace Building, 1114 Avenue of the Americas, New York, NY 10036

Moderator

Speakers

  • Asaf Evenhaim
    CEO
    Crossix

  • Edward Glynn
    Principal
    Ernst & Young

  • Andy Roth
    Partner
    Cooley LLP (New York, NY)

  • Brian Smith-Sweeney
    CISO
    Columbia University Medical Center

What is it about?

  • What is keeping healthcare CEOs up at night? The threat of cyber attacks. Cybersecurity is one of the most critical issues facing healthcare executives across the ecosystem. From HIPAA breaches to medical identity theft to safeguarding intellectual property, protection from cyber attacks has become an urgent imperative. On October 27, Cooley will host a panel discussion on cybersecurity that will cover the current legal, regulatory, business, and technological environment, and explore options for effective management for senior management and boards of directors.

Please register here.

ACI’s 16th Annual Drug Pricing Master Course

Developing a Culture of Pricing Compliance – Strategies for Avoiding OIG and DOJ Scrutiny of Drug Pricing Practices

WHEN: November 2, 2016 at 3:45pm EST
WHERE: Park Lane Hotel, 36 Central Park S, New York, New York 10019

Speakers

  • William Davis
    Member
    Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Washington, DC)

  • Wendy Goldstein
    Partner
    Cooley LLP (New York, NY)

What is it about?

  • Understanding the current environment for compliance and enforcement related to pricing issues
  • Identifying compliance guidance for pricing issues
  • Anatomy of a government False Claims Act and Anti-Kickback investigations
  • Identifying the roles of CMS, OIG and DOJ relative to pricing, rebates and enforcement
  • Acknowledging the OIG’s direct pricing authority to determine and force WAMP (widely available market price) as an alternative to ASP
  • Comprehending the OIG’s indirect impact on pricing
  • Coupons
  • Part D rebates and administrative fees
  • Assessing potential anti-kickback violations with treatment of payment support programs for price reporting
  • Bolstering compliance programs and internal practices to minimize the risk of investigations
  • Analyzing enforcement trends
    • False claims act cases
    • Bundling cases
  • Responding to government investigations
  • Assessing the collateral consequences of investigations

Please register here. 

The Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress

R&D Compliance: Introduction, Panel Discussion and Q&A

WHEN: October 20, 2016 at 10:30am EST
WHERE: Mandarin Oriental, 1330 Maryland Avenue SW, Washington, D.C.

Moderator

  • Daniel A. Kracov
    Partner and Head, FDA and Healthcare Practice
    Arnold & Porter (Washington, D.C.)

Speakers

  • Natasha Leskovsek 
    Partner
    Cooley LLP (Washington, D.C.)

  • Sue Seferian
    Global R&D Health Care Compliance Office
    Johnson & Johnson (New Brunswick, NJ)

  • Michelle Shwery
    Senior Advisor, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN
    Eli Lilly and Company (Indianapolis, IN)

What is it about?

  • The Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance professionals and legal counsel from more than 50 of the largest research-based pharmaceutical manufacturers.

Learn more about the event here.

CLSA’s Inaugural Corporate Counsel Committee Meeting Featuring Cooley’s Regulatory Roundtable Immersion Series – Session #11

WHEN: October 19, 2016 at 5:30pm PST
WHERE: Cooley LLP, 3175 Hanover Street, Palo Alto, CA

Speakers

What is it about?

  • Cooley is sponsoring CLSA’s inaugural Corporate Counsel Committee meeting on October 19 and will feature Regulatory Immersion Roundtable Series, session# 11 led by Cooley partners Wendy Goldstein and Natasha Leskovsek.
  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization. All CLSA members interested in joining the committee are invited to attend.

Regulatory Roundtable Immersion Series – Session #10: Who Dun It? Conducting Effective Internal Compliance Investigations

WHEN: August 9, 2016 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

What is it about?

  • Cooley’s Regulatory Roundtable Immersion Series is an invitation-only series for senior company executives and investors.  It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

Regulatory Roundtable Immersion Series – Session #9: Now Hear This – Promotional Compliance Considerations in an Evolving Environment

WHEN: April 19, 2016 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

Seton Hall’s Life Sciences Compliance Program – West Coast Immersion

WHEN: March 21, 2016 – March 23, 2016
WHERE: The Marker San Francisco, 501 Geary Street, San Francisco, CA

Speakers

What is it about?

  • This three-day educational program immerses attendees in the statutes, regulations, and other guidance that comprise the body of law known as “fraud and abuse law,” as well as other healthcare-related laws and regulations, to help the audience understand the legal underpinnings of the life sciences compliance education programs they develop and enforce. Click here for more information.

Regulatory Roundtable Immersion Series – Session #8: To Infinity and Beyond: A Discussion of the Hot Topics Inside the Beltway and how they could Impact your Company

WHEN: February 24, 2016 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

Regulatory Roundtable Immersion Series – Session #7: Do Not Enter: Privacy & Security for Life Sciences Companies

WHEN: January 19, 2016 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

 

Regulatory Roundtable Immersion Series – Session #6: Knock, Knock: Government Investigations & Inquiries

WHEN: November 10, 2015  at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

Regulatory Roundtable Immersion Series – Session #5: How To Get Paid: Coverage, Reimbursement & Pricing

WHEN: October 7, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

  • Kathleen Peterson
    Special Counsel
    Cooley LLP (Washington, DC)

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

Regulatory Roundtable Immersion Series – Session #4: SPF 50: Federal and State Sunshine Laws

WHEN: September 2, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

Regulatory Roundtable Immersion Series – Session #3: Sleepless Nights: Which Health Care Laws (Should) Keep You Up At Night?

WHEN: June 22, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

Regulatory Roundtable Immersion Series – Session #2: House of Card: How To Build An Effective Corporate Compliance Program For Your Organization

WHEN: May 14, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.

Regulatory Roundtable Immersion Series – Session #1: Board Talk: How To Address Health Care Compliance With The Board Of Directors

WHEN: April 14, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA

Speakers

What is it about?

  • Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.