Agenda
Day 1
June 4, 2025
8:00 am
Registration and Breakfast
8:45 am
9:15 am
- Understanding the evolving regulatory landscape, including privacy and security laws, and restrictions on data transfers to China and other “countries of concern”
- Highlighting key operational and compliance risks from geopolitical instability
- Setting the stage for actionable strategies to safeguard operations and innovation
10:15 am
Emerging Challenges in Life Sciences Biosecurity: DOJ Rule on Sensitive Data Transfers to Countries of Concern
Susan WiseChief Privacy Officer, Head of Privacy and Data ProtectionBiogen
David PeloquinPartnerRopes & Gray LLP
- Understanding the Biden Executive Order and DOJ Final Rule on sensitive data transfers to China and “countries of concern”
- Understanding the relevant implications for life sciences companies, and practical operational steps for compliance
11:15 am
Extended Networking Break
11:45 am
Kirk NahraCo-Chair, Artificial Intelligence PracticeWilmer Cutler Pickering Hale and Dorr LLP
Corey M. DennisChief Privacy Officer & Assistant General CounselLegend Biotech
- Understanding applicability and limitations of HIPAA
- Understanding new state laws filling gaps where HIPAA does not apply
- Understanding evolving legislative landscape, ensuring compliance, and managing risk
12:45 pm
Networking Lunch
1:45 pm
Elizabeth H. JohnsonPartner, Privacy & Data Security PracticeWyrick Robbins Yates & Ponton LLP
- Developing security strategies that align with biosecurity and data privacy regulations
- Addressing security risks in cross-border research, clinical trials, and CRO collaborations
- Proactively protecting proprietary technologies in a high-risk regulatory environment
2:45 pm
Dr. Natallia KarniyevichAttorneyBird & Bird (Germany)
- Conducting comprehensive risk assessments to identify vulnerabilities in supply chains
- Implementing reshoring and diversification strategies with real-world case studies
- Adapting to laws restricting supplier relationships with flagged regions and entities
- Mitigating disruptions caused by geopolitical pressures and regulatory requirements
3:45 pm
Tom HineyPrivacy CounselBlueprint Medicines
Eric SoloweyVice President and Assistant General CounselParexel
Robert StilesAssistant General Counsel – Data Privacy OfficerPerceptive, Inc.
- Managing privacy compliance in clinical trials
- ICF consent
- Secondary research
- Balancing compliance costs with maintaining R&D efficiency and trial continuity
- Proposed BIOSECURE Act and potential to be reintroduced
4:30 pm