Day Three - EST (Eastern Standard Time, GMT-5)
Day Three - EST (Eastern Standard Time, GMT-5)
- Encourage stakeholder responsibility and accountability within organizational leadership, including how to work with the board
- Promote and support ongoing education to enhance knowledge of the evolving legal and regulatory landscape to the organization
- Position compliance training as a tool to enable productivity and empower actions
- Terra Buckley - Vice President, Head of Compliance Advisory Services, MedPro Systems
- Daryl Kreml - Vice President & Chief Compliance Officer, Sage Therapeutics
- Christie Camelio - SVP, Chief Compliance & Risk Officer, EQRx
- DOJ Updates
- Monaco Memo
- Craig Bleifer - Partner, Akin Gump Strauss Hauer & Feld LLP
Expanding your company footprint to outside of the US is a major milestone but, it can come with unchartered territory and unknown risk. Benchmark with, and hear stories from, colleagues on how to navigate foreign rules and regulations to ensure that your business is remaining compliant during each approval phase.
- Ann Beasley - Chief Compliance Officer, Zai Lab
- Jim Gibney - Executive Director, Global Compliance Operations, Regeneron Pharmaceuticals
- Justin Farrell - Executive Director & Assistant General Counsel, Regeneron Pharmaceuticals Inc.
Switching of roles and companies is not uncommon in the specialty compliance world, as people often shift from large pharmaceutical giants to smaller pre-commercial entities or vice versa. The transition from one company to another can be daunting, as each business operates differently, based on their size, function and leadership. Hear real life examples on the differences and similarities between various company sizes and discuss how you can best adapt with each transition to ensure that your overall career goals are being reached.
- Joseph Philipose - SVP, Chief Ethics and Compliance Officer, Emergent BioSolutions
- Cheryl Chamallas - Vice President, Head of US Compliance, Argenx
- Brando Twilley - Senior Legal Counsel, Ipsen Biopharmaceuticals, Inc.
As the specialty pharmaceutical and medical device industries continue to integrate, there has been an increase of cross combination products.
- Consider the challenges associated with the crossing of these industries
- Explore the different types of cross combination products, including devices that are literally administered or used, and understand the importance of drug companies being knowledgeable about their products
- Learn how to think about risks in terms of these products
- Eva Temkin - Partner, FDA and Life Sciences, King & Spalding
- Jessica Greenbaum - Counsel, King & Spalding
Kick-start your afternoon with a personal development summit, hearing real-life experiences of colleagues’ successes, challenges, and individual experiences with their role in compliance.
- Strategize to overcome biases and strive to create a more diverse and inclusive culture within the life sciences industry
- Discuss the idea of raising awareness through representation and allowing employees to bring their most authentic versions of self to work
- Understand the difference that is made when a company makes DEI a part of their mission, value and everyday activity, rather than a stand-alone initiative
- Dr. JoQuese Satterwhite, MBA - Chief of Staff, Senior Director, Global Compliance Governance & Risk, Medtronic
- Caroline Mailloux - Senior Director, Diversity, Equity & Inclusion, Sarepta Therapeutics, Inc
- Daneal Espada-Johnson - Senior Manager, Diversity Outreach, Sumitomo Pharma America Holdings Inc.
- Christine Del Regno - Global Diversity, Equity and Inclusion Leader, Thermo Fischer Scientific
Social media presents great room for opportunity but also grave room for danger. Benchmark with colleagues on some of the more apparent social media complexities, such as influencer marketing and off label promotion, as well the gray areas of social media. Hear real life examples regarding which channels, and specific areas per platform, are important to monitor and how to avoid common mistakes to remain compliant.
- Nereyda Garcia - VP, Head, Ethics & Compliance USBU, Takeda Pharmaceuticals
- Latarsha Stewart - Vice President, Head of Compliance U.S., Servier Pharmaceuticals
As the industry continues to explore channels beyond traditional face to face interaction, there has been a steady integration of both conventional and digital means of communication. This growing digital sophistication has resulted in increased HCP expectations for engagements to be both more tailored and engaging. Take a deep dive into what exactly omni channel engagement means for compliance, why it is valuable to the different stakeholder groups and how your organization can achieve this model.
- Tim Moore - Associate General Counsel, Corium, LLC
- Recognize the importance of environmental, social and governance practices in corporate responsibility
- Analyze the impact of ESG responsibility and prepare an actionable plan to execute across the business
- Brainstorm approaches to fulfill the components of ESG with consideration of compliance
- Understand how the role of ethics and integrity fits into the mission of ESG priorities
- Brian Conner - SVP, Chief Compliance and Risk Officer, Strongbridge Biopharma plc
Close out the conference by learning by getting the answers to the questions you need most. Use this opportunity as an open forum to benchmark with colleagues to clarify outstanding questions and ensure excellence within your compliance programs.