FOR THE LIFE SCIENCES INDUSTRY

11:15  CRO AND SPONSOR FOCUS GROUP

Clinical Trials: The Latest on Managing Unique, Evolving Bribery Risk Factors for Sponsors and CROs

• Ensuring partners in global clinical trials are developing processes to determine the legitimacy of and need for clinical trials

• What CROs are doing to prevent improper payments, and reduce bribery risks when interacting with government officials, and seeking clinical trial and marketing approvals

• Sponsor obligations to assess and monitor CRO anti-corruption compliance: How much due diligence and oversight can be done while remaining at arm’s length during the clinical trial?

• How to go about bridging the legal/technical divide when launching a trial

• Bridging the commercial/medical affairs divide

» Executing health economics and outcomes studies that can evaluate the impact of a drug’s use on variables such as medical costs and patient quality of life

• Knowing where the money is going: Effective monitoring and auditing plans for foreign clinical trials

» Mitigating bribery risks when engaging local doctors

• Explore different types of data and stage-gate approaches that can be used to assist with decision-making for allocating resources

• Establishing effective due diligence processes and oversight over all third parties involved in your clinical research plans

Susan Lipsitz

Vice President, Associate General Counsel, and Chief Compliance Officer

IQVIA

Angelique Lee

Vice President, Chief Compliance & Ethics Officer

Jazz Pharmaceuticals

12:00  COMPLIANCE PROGRAM BENCHMARKING

Life Science-Specific Considerations for Measuring the Effectiveness of Compliance Programs: Real-World Takeaways for Pressure-Testing Your Program Amid the Latest DOJ Guidance and Enforcement Posture

Amid the newly revised DOD Corporate Enforcement Policy, it is critical that life sciences companies ensure that their compliance programs are fully developed, implemented and pressure-tested to confirm that they are functioning effectively and detecting issues when they arise.

• DOJ’s focus on the development of a compliance culture: Perspectives on designing and operationalizing a compliance culture that passes DOJ muster

• Assessing your compliance controls in an era of remote and hybrid work

• Where does FCPA compliance intersect with data privacy compliance requirements?

• How to evaluate your training and controls by means other than audits

• Ensuring that your program is aligned on paper and in practice

Arunabha Bhoumik

Executive Director, Assistant General Counsel, Head, General Litigation and Government Investigations

Regeneron Pharmaceuticals, Inc.

Terri Segura

Vice President, Global Compliance Investigations

Zimmer Biomet

For The Life Sciences Industry

1:00  Networking Luncheon

2:15  APAC MARKET-HYPOTEHTICALS AND AUDIENCE POLLING

China and The Region's Fast-Changing Life Sciences Business Landscape: The Top 5 Most Vexing Questions and Practical Tips for Navigating Grey Areas

The life sciences market in Asia Pacific remains strategically important with its predicted growth and market size. However, the business environment in markets such as China, Japan and Korea will continue to shift due to geopolitical tensions, macroeconomic and policy changes. To help build or maintain a successful life sciences business in the region, what compliance questions should multinationals be aware of about the realities of operating in Asia, and navigating known and unknown risk factors?

• We examine the structural rapid transformation taking place in the healthcare systems of China and in the rest of Asia, and critical compliance implications for life science companies such as pricing, reimbursement and market access issues

• A view from the ground – we discuss the latest legal developments and the most critical or common compliance risks faced by multinational Life Sciences companies operating in Asia

• Navigating WeChat and WhatsApp communication landmines: Document sharing, data retention

• Data protection and blocking statutes in China: Balancing these laws with DOJ and SEC expectations for FCPA compliance

• What go-to-market considerations are most important in crafting a winning strategy in response to rapid health reforms taking place in Asia?

• How multinationals are evolving their programs in response to global trade tensions relating to China

Ashley Watson

General Counsel, Medical Devices Johnson & Johnson

David Ralston

Senior Vice President Deputy General Counsel

Taysha Gene Therapies

Yuet Ming Tham

Global Co-Head, White Collar, Litigation & Investigations

Sidley Austin LLP (Hong Kong/Singapore)