Agenda - Day One: Thursday, September 4 | PCC West | Pharmaceutical Compliance Congress

7:45am - 8:45am

Registration & Light Refreshments

8:45am - 9:00am

Informa Connect Welcome and Chair’s Opening Remarks

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Regulatory & Enforcement

9:00am - 9:45am

Policy Shifts Under the New Administration – Implications for Life Sciences

Explore recent executive orders implemented by the new administration and resulting shifts in the regulatory and enforcement landscapes
Examine impact on the pharma/biotech/MedTech industry and discuss how compliance programs are reacting

9:45am - 10:30am

Enforcement Panel – Explore Emerging Trends and Current High-Risk Areas

Discuss recent settlements, current enforcement priorities, and shifts in focus areas under the new administration
Explore insights into current high-risk activities, such as speaker programs, co-marketing events, etc. and the practical implications for bio/pharmaceutical companies

Meena Datta - Partner, Sidley Austin LLP

10:30am - 11:00am

Networking & Refreshment Break

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Executive Leadership Spotlight

11:00am - 11:45am

Chief Compliance Officer Panel

Hear directly from CCOs on their current key priorities, challenging risk areas and navigating today’s regulatory environment
Discuss measures that compliance teams should be implementing to withstand evolving regulatory scrutiny
Explore real-world examples of ways of working between legal and compliance functions, and how to navigate complex regulatory challenges and the complexities of internal inquiries and legal risk mitigation

Jeff Rosenbaum - Co-Founder and Partner, Dovetail Consulting Group
Robert Ladd - Senior Vice President, Chief Ethics & Compliance Officer, Gilead Sciences
Michael Hercz - General Counsel and Chief Compliance Officer, Sentynl Therapeutics Inc.
Ryan Macpherson - Vice President and Chief Compliance Officer, Dexcom, Inc.

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Mergers & Acquisitions

11:45am - 12:30pm

Mastering Mergers & Acquisitions Compliance – Examining Due Diligence Strategies

Learn how to strategically prepare your compliance program for rigorous due diligence, enhancing your company's valuation and attractiveness
Discover the critical compliance due diligence items that provide essential insights into target companies, minimizing risk and ensuring successful integration
Explore best practices for building robust, acquisition-ready compliance programs that strengthen operational integrity and drive long-term value

Craig Bleifer - Partner, McGuireWoods LLP
Fabiana Lacerca-Allen, JD, LLM - Chief Compliance Officer, Cipla USA

12:30pm - 1:30pm

Interactive Networking Luncheon

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Guardrails for Patient Support Programs & Patient Interactions

1:30pm - 2:15pm

Patient Support Programs in the Digital Age – Navigating Data Privacy & Compliance Risks

Establish robust protocols for handling patient data within tech-enabled patient support programs, ensuring compliance with evolving privacy regulations (CCPA, HIPAA)
Develop strategies to mitigate risks associated with AI-driven patient support, including potential biases, off-label promotion, and the spread of inaccurate medical information
Implement effective monitoring and auditing procedures for AI-powered patient support programs to safeguard against regulatory scrutiny and data breaches

2:15pm - 3:00pm

Strategies for Compliantly Navigating Patient, Parent, and Caregiver Interactions

Develop compliant strategies for interacting with diverse patient groups, including parents/guardians of pediatric patients and caregivers of elderly patients, understanding their unique needs and potential compliance risks
Establish clear guidelines for navigating complex interactions, ensuring empathy and compliance while addressing the sensitivities of patient advocacy and caregiver support

Ryan Bonistalli - Executive Director, Compliance, Ultragenyx

3:00pm - 3:30pm

Networking & Refreshment Break

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Data Utilization & Governance

3:30pm - 4:15pm

Master Data-Driven Compliance – Enhancing Monitoring and Competitive Analysis

Integrate internal and external data (such as Open Payments) to identify risks and outliers
Discuss utilizing data to inform risk assessments and tailor monitoring programs, ensuring resources are focused on high-risk areas
Utilizing benchmarking to inform internal policies and procedures related to healthcare provider (HCP) engagement and ensure consistency with industry best practices
Explore how to evaluate data value versus risk of keeping certain data, and learn which data insights drive the most impactful compliance decisions

Stephen Chien - Vice President, Global Compliance Operations, Gilead

4:15pm - 5:00pm

Data Governance & Privacy – Building a Resilient Compliance Framework

Establish robust data governance frameworks to ensure data integrity, security, and compliance with evolving privacy regulations (EU’s General Data Protection Regulation (GDPR), California Consumer Privacy Act (CCPA), Health Insurance Portability and Accountability Act (HIPAA))
Develop strategies for conducting effective data privacy risk assessments, identifying vulnerabilities and implementing mitigation measures
Implement best practices for data lifecycle management, including data collection, storage, access controls, and secure data disposal
Navigate the complexities of cross-border data transfers and ensure compliance with international data privacy standards
Secure buy-in across all levels by engaging executives and operations teams in data governance and privacy initiatives

Amanda Foster - Senior Director Corporate Compliance – Market Access and Privacy, United Therapeutics

5:00pm - 6:00pm

Close of Day One and Networking Reception

Day One: Thursday, September 4Thursday, September 4, 2025