LIFE SCIENCES AI SUMMIT
AI is transforming the life sciences industry at an unprecedented pace, accelerating drug discovery, optimizing clinical trials, and enhancing disease diagnosis. This technology can connect groundbreaking innovations with real-world healthcare delivery, enriching patient experiences.
However, the integration of AI brings legal, regulatory, and ethical challenges unique to the life sciences:
ĉ Navigate legal complexities in market expansion and product development
ĉ Understand liabilities in drug discovery and medical devices
ĉ Clarify inventorship and proprietary rights in AI-generated outcomes
ĉ Ensure compliance with regulatory standards for modernized clinical trials
ĉ Address data privacy concerns in AI-driven operations
To help you harness the potential of AI while navigating its unique challenges, the American Conference Institute (ACI) invites you to our 2nd Annual Life Sciences AI Summit
Join us on February 20–21, 2025, at the New York Bar Association in New York City and gain invaluable insights and expertise to navigate the complex legal and regulatory landscape of AI in life sciences. Don't miss this opportunity to stay ahead in this fast-evolving field!
Introducing ACI’s Life Sciences AI Advisory Board
American Conference Institute’s Life Sciences AI Advisory board was created as part of ACI’s ongoing effort to provide industry leading content from a world-renowned speaker faculty. This ‘inner circle’ counsels ACI on the impact of legal, regulatory, and compliance trends and emerging concerns in this rapidly evolving arena.
Jeremy Bond
Leader of Digital & Device Patents, US Patent Analytics Sanofi
Betsy Greytok
Vice President & Associate General Counsel, Foundational Models IBM
Charlene Cho
Director and Corporate Counsel, Digital and Technology Law
Thermo Fisher Scientific
Rekha Hanu
Senior IP Strategy Counsel, Patient Care Solutions
GE Healthcare
Emeritus Member:
Danny Tobey M.D., J.D.
Global Co-Chair and Chair
Lucy Muzzy
VP, Compliance –M&A/Business Development Government Agreements; Artificial Intelligence Pfizer
Alejandra Parra-Orlandoni COO
Pasteur Labs & ISI
Rosemarie Purcell Director, Global Regulatory Policy & Innovation Takeda
Lora Spencer
Principal Global Litigation & Investigations Counsel Medtronic
Sheea Sybblis
Vice President, Human Pharma Business Law Boehringer Ingelheim
Zheng Yang
Worldwide Head, AI/ML Strategy and Solutions
Healthcare and Life Sciences
Amazon Web Services
Distinguished Faculty
Co-Chairs:
Nick Mercker
AVP, Assistant General Counsel –Chief Privacy Officer and Head of Privacy, Cyber and AI Legal Eli Lilly and Company
Lora Spencer
Principal Global Litigation & Investigations Counsel Medtronic
Sheea Sybblis
Vice President, Human Pharma Business Law
Boehringer Ingelheim
Faculty:
Melissa K. Bianchi
Partner
Hogan Lovells US LLP
James A. Boiani Shareholder
Epstein Becker & Green PC
Charlene Cho
Director and Corporate Counsel, Digital and Technology Law Thermo Fisher Scientific
Patrice Ettinger
Vice President, Chief Privacy Officer Regeneron
Daniel Fisher
Director, Digital & Data Merck
Kevin Fumai
Assistant General Counsel Oracle
Betsy Greytok
Associate General Counsel, Foundation Models IBM Corporation
Benjamin C. Hsing Partner
Venable LLP
Brenda K. Leong
Managing Partner Luminos Law
Donna Meuth
Associate General Counsel
Intellectual Property Eisai
Sharick Naqi
Principal IP Counsel, IP Lead, AI & Digital Novartis
John Nappi
Assistant General Counsel PhRMA
Huong Nguyen
Former GC and Compliance Officer
Kevin Noonan Partner
McDonnell Boehnen Hulbert & Berghoff LLP
Rosemarie Purcell Director, Global Regulatory Policy & Innovation Takeda
David V. Sanker
Founding Partner SankerIP
Hans Sauer
Deputy General Counsel, VP for IP Biotechnology Industry Organization (BIO)
Mark Sentenac Partner
King & Spalding LLP
Jackie Stanley
Senior Compliance Counsel, Responsible AI/Digital Health Pfizer
Timothy M. Swan Partner
BakerHostetler
Elham Tabassi
Associate Director for Emerging Technologies National Institute of Standards and Technology (NIST)
Julia Weisberg
Vice President, Drug Development, Regulatory Law Bristol Myers Squibb
Zheng Yang
Worldwide Head, AI/ML Strategy and Solutions Healthcare and Life Sciences Amazon Web Services
RuiHui (Rachel) Yu Partner
Sullivan & Cromwell LLP
EARN CLE CREDITS
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.
ACI certifies this activity has been approved for CLE credit by the State Bar of California.
ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.
For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE
PRE-CONFERENCE WORKSHOP
February 19, 2025
WORKSHOP A 9:00 am–12:30 pm (Registration opens at 8:30 am)
Mastering AI & ML for the Life Sciences: Essential Strategies for Counsel and Executives
This interactive workshop will provide legal, regulatory and compliance professionals in the life sciences with a solid understanding of the technology driving AI, ML and deep learning. Industry thought leaders will provide an in-depth analysis of key concepts, challenges, regulations, and practical insights, enabling participants to adeptly navigate the confluence of these technologies and the life sciences. Topics of discussion will include:
• Generative AI v. Traditional AI
Zheng Yang
Worldwide Head, AI/ML Strategy and Solutions
Healthcare and Life Sciences
Amazon Web Services
» Defining basic distinctions, characteristics, and foundational tech that separate generative AI from traditional AI
» Understanding how generative AI revolutionizing areas like drug discovery, bioinformatics, and personalized treatments is relative to traditional AI in the life sciences
• Fundamentals of AI and ML
» Defining what Artificial Intelligence (AI) and Machine Learning (ML) are
» Differentiating between AI and traditional programming
» Understanding supervised, unsupervised, and reinforcement learning
» Exploring Natural Language process, neural networks, and deep learning
• AI Applications in Life Sciences
» Exploring real-world applications of AI and ML in the life sciences
» Understanding AI capabilities for drug discovery, clinical trials optimization, disease diagnosis, medical imaging, personalized medicine, and more
• The AI Lifecycle: Data, Algorithms, and Model Training
» Developing data collection and preprocessing:
Quality, bias, privacy, and security considerations
» Selecting appropriate algorithms and models for specific tasks
» Harmonizing the training process
Supervised learning, validation, and testing
• Challenges and Risks in AI and ML
» Anticipating bias and fairness issues in AI algorithms and their impact on decisions
» Integrating ethical considerations when using AI in medical decision-making
» Meeting regulatory and legal challenges
FDA regulations, GDPR compliance, intellectual property, and liability
• Business and Compliance Considerations
» Identifying business opportunities and ROI through AI adoption to be more effective
» Ensuring compliance with relevant regulations, including FDA guidance and GDPR
» Managing risks associated with AI implementation and usage
» Fine-tuning transparency – what does it mean, and to whom
PRE-CONFERENCE WORKSHOP
February 19, 2025
WORKSHOP B 1:30–12:30 pm (Registration opens at 1:00 pm)
AI & IP Masterclass: Navigating Complex IP Challenges in the Life Sciences
In the age of AI, protecting your IP in the life sciences is more critical—and complex—than ever. This interactive working group explores the unique challenges AI introduces to IP rights, providing strategies for safeguarding innovation. Topics of discussion will include:
• IP Challenges in AI for Life Sciences
» Exploring common and complex IP concerns and challenges specific to AI in the life sciences
» Examining case studies highlighting real-world IP disputes relative to AI and lessons learned
• Trademarks, Copyrights, and Branding in AI
» Establishing how trademarks and copyrights intersect with AI technologies in the life sciences
Donna Meuth
Associate General Counsel
Intellectual Property Eisai
Kevin Noonan Partner
McDonnell Boehnen Hulbert & Berghoff LLP
David V. Sanker
Founding Partner SankerIP
» Understanding the role of copyrights in AI algorithms and the thorny questions this presents for the life sciences industry
• Patenting AI in Life Sciences
» Developing strategies for drafting robust patent applications for AI inventions in the life sciences
• Trade Secrets and AI
» Safeguarding proprietary AI algorithms and data as trade secrets
» Best practices for maintaining secrecy and competitive advantage
• Data Privacy and IP
» Understanding the interplay between data privacy regulations (e.g., GDPR) and IP considerations
» Ensuring compliance while protecting data-driven innovations
• Ethical Considerations
» Examining ethical considerations related to AI and IP in life sciences
» Maintaining transparency and fairness in innovation
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DAY ONE February 20, 2025
• Navigating
• Exploring EMA alignment with the EU AI Act and its regulations for AI in the life sciences
• Examining case studies showing how companies navigate FDA and EMA directives
• Comparing key differences and similarities between FDA and EMA AI regulations
11:15 AI Litigation and Enforcement Risks throughout the Life Sciences Product Lifecycle: From Pre-Commercialization to Post-Market
This session focuses on the potential litigation challenges arising throughout the lifecycle of AI-driven products in the life sciences sector. By examining legal risks from R&D to postmarket, attendees will gain actionable insights into litigation strategies and how to mitigate risks in real-time. Topics of discussion will include:
• Clarifying product liability in cases of AI errors during commercialization, and how fault is determined under current legal frameworks
• Managing data privacy litigation risks, particularly concerning patient data misuse during AI-powered clinical trials
Mark Sentenac Partner King & Spalding LLP
Jackie Stanley
Senior Compliance Counsel, Responsible AI/Digital Health Pfizer
• Navigating post-commercialization legal risks, including real-time performance monitoring, algorithm failures, and regulatory non-compliance
• Exploring recent case law surrounding AI-generated content and proprietary algorithms, including practical litigation strategies for life
and Regulatory Sandboxes: Testing Innovation in Life Sciences
This session explores how regulatory sandboxes create a safe space to test AI applications in life sciences while ensuring legal compliance. Session leaders will detail how sandboxes foster innovation, manage risks, and align with global regulations. Topics of discussion will include:
• Using regulatory sandboxes to test AI in a compliant setting
• Navigating global regulations for AI in life sciences
• Managing AI bias and ethical issues during testing
• Strengthening partnerships and cross-border compliance
• Addressing legal challenges including antitrust risks in AI-driven innovations
Charlene Cho Director and Corporate Counsel, Digital and Technology Law
Thermo Fisher Scientific Kevin Fumai
Assistant General Counsel
Oracle
This session considers the unique capabilities of generative AI in life sciences, particularly in drug discovery, personalized medicine, and synthetic biology. Topics of discussion will include:
• Understanding how generative AI is being used to create novel compounds, optimize molecular structures, and reduce the time needed for R&D
• Using generative AI to develop individualized treatment plans and predict patient responses to therapies
Lora Spencer Principal Global Litigation & Investigations Counsel Medtronic
RuiHui (Rachel) Yu Partner
Sullivan & Cromwell LLP
• Addressing the legal and regulatory hurdles specific to generative AI in these areas, and how companies are managing these complexities in line with FDA and EMA guidelines
• Examining the ethical concerns around using AI to create synthetic biology, potential risks of generating novel compounds, and ensuring patient safety
3:15 Afternoon Networking Break
3:30 IP Protections for AI-Driven Innovations: Navigating Ownership and Inventorship Challenges in the Life Sciences
As AI becomes integral to innovation in the life sciences, it creates complexities in IP law. Understanding how to protect AI-driven discoveries while navigating uncertainties of inventorship and ownership is mission critical for staying ahead in this rapidly evolving landscape. Topics of discussion will include:
• Evaluating patentability and the boundaries of IP protection for AI-generated innovations
• Determining ownership rights when AI contributes to the inventive process
• Addressing joint ownership scenarios and the impact on licensing agreements
• Mitigating infringement risks when AI uses existing IP for training
Sharick Naqi
Principal IP Counsel, IP Lead, AI & Digital Novartis
Hans Sauer
Deputy General Counsel, VP for IP Biotechnology Industry Organization (BIO)
John Nappi Assistant General Counsel PhRMA
Benjamin C. Hsing Partner Venable LLP
• Distinguishing between proprietary data used for AI training and AI-generated datasets, assessing copyright and data ownership risks
4:30 Revolutionizing Clinical Trials with AI: Driving Innovation from Design to Submission
This session will explore cutting-edge applications of AI to optimize trial design, improve data management, and navigate the regulatory landscape. Topics of discussion will include:
• Using AI to enhance trial design, boost recruitment with synthetic data, and address biases for more diverse and fair trial population
• Implementing FDA guidance on Clinical Decision Support Software while ensuring data management consistency and reducing errors
Rosemarie Purcell Director, Global Regulatory Policy & Innovation Takeda
Julia Weisberg
Vice President, Drug Development, Regulatory Law Bristol Myers Squibb
• Exploring the legal and ethical challenges of AI in patient engagement, from recruitment through participation
• Leveraging AI-driven post-trial analysis for more efficient regulatory submissions and accuracy in reporting
• Understanding the FDA and EMA’s evolving regulations on AI tools, including new rules for AI in clinical trials
5:30 Closing Remarks Cocktail Reception - Conference Adjourns to Day Two
7:30
8:15 Opening Remarks and Recap of Day One from the Chairs Lora Spencer Principal Global Litigation & Investigations Counsel
8:30
9:00
Nick Mercker AVP, Assistant General Counsel –Chief Privacy Officer and Head of Privacy, Cyber and AI Legal Eli Lilly and Company
This session will explore how to create and manage AI collaborations that not only advance research but also translate into real-world clinical outcomes. Topics of discussion will include:
Building seamless AI partnerships that bridge research and clinical use, driving real-world innovation in diagnostics, drug discovery, and personalized care. Topics of discussion will include:
• Mastering collaboration challenges such as data sharing, model deployment, and regulatory compliance
• Avoiding common pitfalls like misaligned goals, data privacy issues, and technical barriers
• Crafting agreements that prioritize patient safety, data security, and ethical AI practices
• Ensuring post-partnership success by integrating AI solutions into clinical workflows
» Addressing technical challenges like system compatibility
10:30 Navigating Data Privacy Challenges and AI in the Life Sciences: A Global Roadmap for the Digital Age
This panel will guide attendees through the evolving landscape of privacy laws, including GDPR and HIPAA, and offer practical solutions to balance the innovation of AI-driven technologies with the critical need to protect sensitive patient data. Topics of discussion will include:
• Balancing risks and rewards of using large datasets in AI-driven life sciences
» Ensuring data security and privacy
Daniel Fisher Director, Digital & Data Merck
• Navigating GDPR and HIPAA compliance for healthcare organizations leveraging AI, addressing breach notifications, data rights, and the role of Data Protection Officers
• Aligning HIPAA’s Privacy and Security Rules with evolving AI technologies and ensuring data protection through anonymization and encryption techniques
• Mitigating bias and ensuring ethical AI use in data-driven applications, harmonizing AI ethics with patient consent and safeguarding sensitive data
• Safeguarding patient data while staying compliant with global data privacy laws
» Strategizing for cross-border data transfers
11:30 KEYNOTE WITH NIST: Shaping AI Standards in the Life Sciences
Explore how AI standards are being crafted to ensure safety and transparency in life sciences. Learn what steps organizations should take to stay aligned with these evolving standards.
Elham Tabassi
Associate Director for Emerging Technologies National Institute of Standards and Technology (NIST)
12:00 Networking Luncheon
1:30 Maximizing AI's Potential in Marketing and Promoting Drugs and Devices
AI’s role in the marketing and promotion of drugs and devices cannot be understated. This session will outline the multifaceted applications of AI in promoting life sciences products, while also highlighting the legal intricacies and considerations vital for ensuring compliance and mitigating potential risks. Topics of discussion will include:
• Assessing the role of AI in drug and medical device marketing strategies
Moderator: Brenda K. Leong Managing Partner Luminos Law
• Unpacking FDA’s Draft Guidance on marketing submission recommendations for a Predetermined Change Control Plan (PCCP) for Artificial intelligence/Machine Learning-Enabled Device Software Functions (April 2023)
• Strategizing for minimizing potential legal risks in AI-empowered marketing campaigns
Global Sponsorship Opportunities
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Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com
SPOTLIGHT ON HEALTHCARE
2:30 Revolutionizing Healthcare: AI's Transformative Role in Digital Health Technologies and Software Medicines
This session will explore how AI innovations are driving the development of software-based treatments while aligning with evolving regulatory frameworks – topics of discussion will include:
• Examining how AI-powered patient monitoring is transforming remote healthcare
• Understanding AI's impact on wearables, predictive analytics, and personalized patient care
• Addressing concerns about AI in patient data management and navigating regulatory requirements
• Decoding FDA’s evolving stance on AI-integrated software as a medical device (SaMD)
• Considering the ethical and regulatory implications of AI’s advancing diagnostic capabilities
3:30 AI in Action: Enhancing Clinical Decision-Making with AI
AI has transformed clinical decision-making, but it also introduces significant risks, including data privacy concerns, regulatory challenges, and potential bias in treatment decisions. This session explores both the benefits and dangers of AI-powered healthcare. Topics of discussion will include:
Patrice Ettinger Vice President, Chief Privacy Officer
Regeneron
Melissa K. Bianchi Partner
Hogan Lovells US LLP
James A. Boiani
Shareholder
Epstein Becker & Green PC
Betsy Greytok
Associate General Counsel, Foundation Models
IBM Corporation
• Improving clinical decision-making with AI, enhancing speed, accuracy, and data-driven treatment options
• Navigating FDA guidelines and implementing post-market surveillance for continuous AI system updates
• Transforming medical imaging and precision medicine, enabling personalized treatments and reducing errors
• Addressing data privacy concerns while ensuring robust datasets for effective AI model training
• Overcoming barriers to AI integration in healthcare systems while ensuring regulatory compliance and patient outcomes
4:30 Addressing AI Bias in the Life Sciences: Promoting Fairness and Accountability
As AI becomes more embedded in life sciences, ensuring fairness, equity, and accountability is essential to prevent bias and promote ethical applications. Topics of discussion will include:
• Tackling AI bias in drug development, clinical trials, and diagnostics
• Addressing bias sources from data collection to algorithm design to ensure fair outcomes
• Evaluating the impact of the EU AI Act on fairness, transparency, and accountability
• Exploring tools to diversify data and enhance model transparency for fairer AI decisions
• Balancing ethical considerations and real-world challenges where AI decisions confront traditional norms
5:15
Huong Nguyen Former GC and Compliance Officer
Sheea Sybblis
Vice President, Human Pharma Business Law
Boehringer Ingelheim
Timothy M. Swan Partner
BakerHostetler
Closing Remarks from the Chairs
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