Day 3 - ET (Eastern Time, GMT-05:00)
- Update DOJ and OIG on free testing
- Implications for wider diagnostic testing
- Anti-kickback risks
- Implications of recent OIG opinion on one-time genetic test or treatment approval
- David King - Executive Director, Head of US Compliance, Alexion Pharmaceuticals
- Andrea Kocharyan - Vice President, Legal Development & Compliance, Legal & Intellectual Property, uniQure
- Craig Bleifer - Partner, McGuireWoods
- What are your guardrails and parameters around social media posts? What does your social media policy cover?
- How do you distinguish between Corporate, Medical, and Commercial social media initiatives?
- How do you define, utilize, and compensate DOLs and influencers?
- How do you monitor social media? Do you use a 3rd party for monitoring?
- Jill Atstupenas - Director, Compliance, Syndax Pharmaceuticals, Inc.
- Sharon Delshad - Director, Legal Affairs, Corporate and Compliance Counsel, Travere Therapeutics
- Kaushal Rana - Brand Counsel, Takeda Pharmaceuticals
- Noah Goldstein - Counsel, Life Sciences Legal, Regulatory, and Compliance, Porzio, Bromberg & Newman, P.C.
- How to prepare and write compelling presentations: discover the secrets of brilliant presenting
- How to grab and maintain attention: make sure your audience is hearing what you want them to hear
- How to look and sound impressive: learn the tricks that the best presenters use
- Alyssa Zeff - VP and Head, the bswift Engagement Agency
- Navigate the roles of Compliance, finance, and investor relations
- Uncover relevant risk areas and overcome key challenges that could arise during joint ventures and M&A
- Assess the impact of CIAs during M&A
- Key considerations including DOJ Guidance
- Integration phase – Experience post-acquisition impact on employee and Compliance framework
- How to prepare for being acquired and to acquire another company
- Gregory Moss - Chief Corporate Strategy, Legal Officer and Chief Compliance Officer, Evommune Inc.
- Tim Moore - Vice President, Head of Legal & Compliance, Secretary, Corium
- Dissecting practical approaches of successful campaigns
- How to cultivate a culture of Compliance: from creating open lines of communication to overcoming information barriers
- Practical campaign insight: what components were most beneficial in building awareness?
- How do you become ‘the voice’ of Ethics and Integrity in your organization?
- Masha Goodman-Khan - Senior Director of Compliance & Legal Operations, Vericel Corporation
- Molly Joyce - Vice President, Ethics and Compliance Officer, Global Internal Investigations, Training & Communications, AbbVie
- Loren Becher - Senior Director, Ethics & Compliance Programs and Operations, Emergent BioSolutions
- Sujata Dayal - Independent Board Director, Emergent BioSolutions
The Trump Administration has dramatically shifted the focus of US enforcement activity.
Ethics and Compliance teams in pharmaceuticals are asking themselves whether they should also shift focus. Should they focus more on the risks they may be exposed to in relation to drug cartels and transnational crime organizations; or on forced labor that may exist in their supply chain?
Meanwhile anti-corruption laws around the world - including the FCPA - remain in place and an effective compliance program is still essential.
This session will highlight how compliance teams are adapting to the need to remain agile and the need to add new areas of risk to their focus, rather than simplify shifting.
It will provide practice insights on how effective compliance teams are using their limited resources to cover a broader range of activities.
- Alex Lav - Director, Risk & Compliance, Dow Jones
- Feedback on audits and lessons learned for the industry to be aware of and apply
- Vision and CMS focus going forward
- Data insight: how do regulators and investigators use the data? How can companies ensure they know what is in the data and what should they expect regulators to know about their data?
- Amy Bedsaul - Open Payments Communications, Centers for Medicare & Medicaid Services (CMS)
- Veronika Peleshchuk Fradlin - Director of Division of Transparency Projects (DTP), Centers for Medicare and Medicaid Services (CMS)
- Gain practical insights from real-world CMS audit experiences
- Discover valuable lessons and strategies for improvement
- Learn actionable steps compliance professionals can take to prepare effectively for upcoming audits
- Nikki Reeves - Partner, FDA & Life Sciences, King & Spalding LLP
- Sara Kimball - Assistant General Counsel, Corporate Functions, Legal Affairs, Daiichi Sankyo, Inc.
- Margaret Feltz - Chief Compliance Officer, Purdue Pharma.L.P.
- Impact of recent legislative and administrative developments on drug pricing, reimbursement, and access
- US consensus framework: a model for healthcare compliance
- Rebate rule redux and the impact of Loper Bright
- Implications of Pharmacy Benefit Manager (PBM) reform for manufacturers
- 340B Drug Pricing Program developments
- James Stansel - Executive Vice President, General Counsel and Corporate Secretary, PhRMA
- Gain insight into the current priorities at the FDA’s Office of Prescription Drug Promotion
- Regulator insight into the monitoring activities undertaken by organizations
- Catherine Gray - Director, Office of Prescription Drug Promotion, US Food and Drug Administration (FDA)