Agenda
Day 1
June 4, 2025
Registration and Breakfast
Federica De SantisCounselGoodwin Procter LLP
Emily MilanInformation Security OfficerLegend Biotech
Corey M. DennisChief Privacy Officer & Assistant General CounselLegend Biotech
- 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
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
Sara BerksonVice President, Chief Privacy OfficerVertex Pharmaceuticals
- 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
- Overview of April 2025 guidance and potential enforcement priorities
- Strategies for Addressing within Life Sciences organizations
Extended Networking Break
Kirk NahraCo-Chair, Artificial Intelligence PracticeWilmer Cutler Pickering Hale and Dorr LLP
Joanna HalperinPrivacy Officer & Chief Privacy CounselMemorial Sloan Kettering Cancer Center
- 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
Networking Lunch
Elizabeth H. JohnsonPartner, Privacy & Data Security PracticeWyrick Robbins Yates & Ponton LLP
Tarique N. CollinsChief Legal OfficerClick Therapeutics, Inc.
Devon AckermanGlobal Head, Digital Forensics and Incident ResponseCybereason
- Developing security strategies that align with regulations
- Addressing security risks and minimizing breach impacts in your organization and with partners
- Proactively protecting data and proprietary technologies in a high-risk regulatory environment
Dr. Natallia KarniyevichAttorneyBird & Bird (Germany)
Corey M. DennisChief Privacy Officer & Assistant General CounselLegend Biotech
- Understanding key cybersecurity obligations for healthcare and life sciences organizations, including under the new EU NIS2 and CER Directives
- Practical insights into operationalizing EU cybersecurity requirements and improving data governance across global operations, including for medical device manufacturers, pharmaceutical companies, and digital health providers
- Strategies for developing a practical and harmonized approach based on evolving EU and global regulations
Tom HineyPrivacy CounselBlueprint Medicines
Eric SoloweyVice President and Assistant General CounselParexel
Robert StilesVP, Assistant General Counsel, Data Privacy OfficerPerceptive Informatics, LLC
- 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