Inaugural Life Sciences AI Summit - WEB by C5Group

CO M PL I M EN TA RY WEB I N A R

EARN CLE CREDITS

What the Executive Order Signals for Life Sciences AI November 30th 1–2pm ET More Info inside!

ACI’s Inaugural

LIFE SCIENCES AI SUMMIT The Legal, Regulatory, and Compliance Event for Safe and Responsible AI Innovation in the Biopharma and Medical Device/Diagnostic Industries February 21 – 22, 2024 | New York City Bar Association, New York, NY Special Address from the USPTO Matthew Sked

Senior Legal Policy Advisor USPTO

2024 Conference Chairs Lucy Muzzy

VP & Lead Counsel, Compliance – Artificial Intelligence; Digital Health & Medicines; M&A/Business Development Pfizer Inc.

Associate Sponsors

Matthew Smith

Senior Corporate Counsel Amazon Web Services Legal

Day 1 Cocktail Reception Sponsor

AmericanConference.com/LifeSciencesAI • 888 224 2480

Danny Tobey M.D., J.D. Chair, AI & Data Analytics DLA Piper

Day 2 Cocktail Reception Sponsor

a C5 Group Company Business Information in a Global Context

is transforming the life sciences industry at an unprecedented pace. From accelerating drug discovery and drug development to improving clinical trials to enhancing disease diagnosis, and supercharging manufacturing productivity, there has never been a technology - which still in its infancy – that has had such an iconoclastic impact on the life sciences industry. This technology also has the unique potential to bridge the gap between life sciences innovations and healthcare delivery, ultimately promising greater meaning to the patient. However, the use of AI in the life sciences also comes with a wide range of legal, regulatory, and ethical challenges, including: • The opportunities and perils of using generative AI in market expansion and product development • Potential and inevitable liabilities that arise from leveraging AI in drug discovery and the development of medical devices and diagnostics • Concerns related to the determination of inventorship and proprietary rights in AI-generated outcomes • Adherence to regulatory standards when modernizing clinical trials through AI applications • Intricate data privacy concerns that emerge with the incorporation of AI in life sciences operations All these controversies must be addressed to ensure the responsible, safe, and effective use of these technologies.

WHO SHOULD AT TEND In-house counsel and business executives responsible for oversight and management roles related to AI implementation, like: • General counsel • Chief legal officer • Chief executive officer • Chief technology officer • Chief information officer • Chief scientific officer • Corporate counsel for data privacy and security • Regulatory or compliance counsel • Legal directors overseeing AI initiatives • Legal specialists in IP and patents • Heads of R&D • Business development executives • Strategy and product managers

Outside counsel with practices in the life sciences related to: • Intellectual property • Regulatory Compliance • Technology and cybersecurity • AI, privacy and data analytics • Corporate and commercial

To help you understand the transformative impact of AI and its unique challenges to the life sciences industry – as well as its still untapped potential – American Conference Institute (ACI) is pleased to present our Inaugural Life Sciences AI Summit. Join us at the New York City Bar Association in New York City on February 21–22, 2024 to receive the knowledge and insights that you need to understand and navigate the complex legal and regulatory landscape of AI in life sciences.

• Product liability and personal injury • Compliance risk management • Antitrust and competition • ESG

Our Email List  Join to Stay Connected SIGN UP TO RECEIVE EXCLUSIVE DISCOUNTS, OFFERS AND PROGRAM UPDATES

AmericanConference.com/join-our-email-list/

2 | #ACIConferences #LifeSciencesAI #LSAI LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

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

Rekha Hanu Senior IP Strategy Counsel, Patient Care Solutions GE Healthcare

Lucy Muzzy VP & Lead Counsel, Compliance – Artificial Intelligence; Digital Health & Medicines; M&A/Business Development Pfizer Inc.

Alejandra Parra-Orlandoni VP, Ethical Innovation & Privacy, Global Portfolio Division Takeda

Lora Spencer Principal Global Litigation & Investigations Counsel Medtronic

Sheea Sybblis Associate General Counsel & Practice Group Leader Genentech

Zheng Yang Worldwide Head, AI/ML Strategy and Solutions Healthcare and Life Sciences Amazon Web Services

AmericanConference.com/LifeSciencesAI • 888 224 2480

a C5 Group Company Business Information in a Global Context

ESTEEMED FACULT Y 2024 CHAIRS

Lucy Muzzy VP & Lead Counsel, Compliance – Artificial Intelligence; Digital Health & Medicines; M&A/Business Development Pfizer Inc.

Matthew Smith Senior Corporate Counsel Amazon Web Services Legal

Danny Tobey M.D., J.D. Chair, AI & Data Analytics DLA Piper

SPEAKERS

Daniel J. Barsky Partner Holland & Knight Maureen Bennett Partner Jones Day James Boiani Shareholder Epstein Becker & Green, P.C. Jeremy Bond Leader of Digital & Device Patents, US Patent Analytics Sanofi Charlene Cho Senior Counsel Thermo Fisher Scientific Miranda Cole Partner Norton Rose Fullbright, LLP Charles T. Collins-Chase Partner Finnegan Corey M. Dennis Senior Director, Counsel – Information Security & Privacy Eli Lilly and Company Philip Desjardins Partner Arnold & Porter

(Former Associate Director for Policy, FDA Center for Devices and Radiological Health)

Rama G. Elluru Senior Director Special Competitive Studies Project – SCSP

Rekha Hanu Senior IP Strategy Counsel, Patient Care Solutions GE Healthcare

Daniel Fisher Director, Digital & Data Merck

Benjamin Hsing Partner Venable LLP

Emily Gardel Associate Director, Patent Attorney II Dyno Therapeutics

Donielle Johnson Former VP Global Regulatory Affairs Bausch + Lomb

Bill Geary Co-Founder and Partner Flare Capital Partners

Michael P. Kahn Partner Akin Gump Strauss Hauer & Feld LLP

Avi Gessler Partner Debevoise & Plimpton LLP Erin Geygan Senior Counsel Privacy (MedTech), Data Protection Legal Global Legal Organization Johnson & Johnson Aleksander J. Goranin Partner Duane Morris LLP Anna Gressel Counsel Paul, Weiss, Rifkind, Wharton & Garrison LLP Betsy Greytok Vice President & Associate General Counsel, Foundational Models IBM

Alexander Korenberg Partner Kilburn & Strode LLP Alejandra Parra-Orlandoni VP, Ethical Innovation & Privacy, Global Portfolio Division Takeda

Kelliann H. Payne Partner Hogan Lovells US LLP Corey Salsberg Vice President, Global Head IP Affairs Novartis Hans Sauer Deputy General Counsel, VP for IP Biotechnology Industry Organization (BIO) Sarah C. Schlotter Patent Attorney Wolf, Greenfield & Sacks, P.C. Mark Sendak, MD, MPP Clinical Data Scientist Duke Institute for Health Innovation Matthew Sked Senior Legal Policy Advisor USPTO

Chris Mammen Partner Womble Bond Dickinson (US) LLP

Lora Spencer Principal Global Litigation & Investigations Counsel Medtronic

Nick Merker Associate Vice President Assistant General Counsel, AI, Information Security and Privacy Eli Lilly and Company

Michele Suggs Adeleye Vice President, Assistant General Counsel, Digital Implementation Pfizer

Christine Moundas Partner Ropes & Gray LLP

Sam Tyner-Monroe, Ph.D Managing Director of Responsible AI DLA Piper Rahan Uddin Senior Corporate Counsel, Director, Americas Customer and Partner Solutions Microsoft Luis Vilarin Vice President, Associate General Counsel, Patient, Data & Privacy Law Bristol Myers Squibb Zheng Yang Worldwide Head, AI/ML Strategy and Solutions, Healthcare and Life Sciences Amazon Web Services Eva F. Yin Partner Wilson Sonsini Goodrich & Rosati RuiHui (Rachel) Yu Partner Sullivan & Cromwell LLP

Sheea Sybblis Associate General Counsel & Practice Group Leader Genentech

4 | #ACIConferences #LifeSciencesAI #LSAI LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

PRE-CONFERENCE WORKSHOPS Tuesday, February 20

9:00 – 12:30 PM

and ML Tech Boot Camp: A Guide to Understanding Artificial A AI Intelligence and Related Technologies for Life Sciences Counsel and Executives

Zheng Yang, Worldwide Head, AI/ML Strategy and Solutions, Healthcare and Life Sciences, Amazon Web Services Anna Gressel, Counsel, Paul Weiss 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:

» Defining basic distinctions, characteristics, and foundational tech that separate generative AI from traditional AI » Understanding how generative AI is revolutionizing areas like drug discovery, bioinformatics, and personalized treatments 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

IP Working Group: Understanding Unique IP Challenges for the B AI Life Sciences Industry in the Age of AI microphone-alt Charles T. Collins-Chase, Partner, Finnegan

microphone-alt Alejandra Parra-Orlandoni, VP, Ethical Innovation & Privacy, Global Portfolio Division, Takeda

• Generative AI v. Traditional AI

1:30 – 5:00 PM

• The AI Lifecycle: Data, Algorithms, and Model Training » Developing data collection and preprocessing: ç Quality, bias, privacy, and security considerations » Selecting appropriate algorithms and models for specific tasks » Harmonizing the training process ç 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

Alexander Korenberg, Partner, Kilburn & Strode LLP Sarah C. Schlotter, Patent Attorney, Wolf, Greenfield & Sacks, P.C. Harnessing the power of AI can lead to novel discoveries and innovations in the life sciences, creating complex scenarios for patentability, IP rights, and ownership. As algorithms and machine-driven processes influence drug development, diagnostics, and personalized treatments, there’s an urgent need to understanding the distinct IP challenges that arise, ensuring that IP is both protected and preserved. Topics of discussion will include: • IP Challenges in AI for Life Sciences

• Trade Secrets and AI

» Exploring common and complex IP concerns and challenges specific to AI in the life sciences

» Safeguarding proprietary AI algorithms and data as trade secrets

» Examining case studies highlighting real-world IP disputes relative to AI and lessons learned

» Best practices for maintaining secrecy and competitive advantage

• Trademarks, Copyrights, and Branding in AI

• Data Privacy and IP

» Establishing how trademarks and copyrights intersect with AI technologies in the life sciences

» Understanding the interplay between data privacy regulations (e.g., GDPR) and IP considerations

» Understanding the role of copyrights in AI algorithms and the thorny questions this presents for the life sciences industry

» Ensuring compliance while protecting data-driven innovations

• Patenting AI in Life Sciences » Developing strategies for drafting robust patent applications for AI inventions in the life sciences

» Meeting regulatory and legal challenges

• Ethical Considerations » Examining ethical considerations related to AI and IP in life sciences » Maintaining transparency and fairness in innovation

ç 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

Media Partner

» Fine-tuning transparency – what does it mean, and to whom

AmericanConference.com/LifeSciencesAI • 888 224 2480

a C5 Group Company Business Information in a Global Context

10:15

CONFERENCE DAY ONE Wednesday, February 21 7:00

Part II: Navigating FDA and EMA Directives: Shaping AI’s Role in the Life Sciences microphone-alt James Boiani, Shareholder, Epstein Becker & Green, P.C. Philip Desjardins, Partner, Arnold & Porter (Former Associate Director for Policy, FDA Center for Devices and Radiological Health)

Breakfast and Registration

Donielle Johnson, Former VP Global Regulatory Affairs, Bausch + Lomb

8:00

Opening Remarks from the Chairs microphone-alt Lucy Muzzy, VP & Lead Counsel, Compliance – Artificial Intelligence; Digital Health & Medicines; M&A/Business Development , Pfizer Inc.

Matthew Smith, Senior Corporate Counsel, Amazon Web Services Legal Danny Tobey M.D., J.D., Chair, AI & Data Analytics, DLA Piper

Hannah Rosenfeld, Digital Health Specialist, FDA • Understanding the importance of the FDA and EMA in guiding AI’s trajectory in the life sciences • FDA’s regulatory framework for AI » Examining FDA’s approach to AI-based medical devices and AI algorithms ç Predetermined Change Control Plans (PCCPs) » Reviewing FDA’s guidance on clinical decision support software » Understanding how FDA view and categorizes AI-driven medical solutions • Appreciating EMA’s position on AI:

8:15

Fireside Chat: How Can Policy Clear the Way for Transforming the Life Sciences Through Technology? microphone-alt Bill Geary, Co-Founder and Partner, Flare Capital Partners Danny Tobey M.D., J.D., Chair, AI & Data Analytics, DLA Piper

TRAVERSING AI’S LEGISLATIVE AND REGULATORY LANDSCAPE IN THE LIFE SCIENCES 9:15

Part I: Key Legislative Enactments and Proposals Impacting AI in the Life Sciences in the US and EU microphone-alt Miranda Cole, Partner, Norton Rose Fullbright, LLP Alexander Korenberg, Partner, Kilburn & Strode LLP Matthew Smith, Senior Corporate Counsel, Amazon Web Services Legal • Comparing and highlighting major contrasts and parallels between the US and EU legislative approaches towards AI in the life sciences • Exploring recent and anticipated legislative developments related to AI in the life sciences » US Legislation in focus: ç The Algorithmic Accountability Act of 2022 and the implications for the life sciences ç Proposed legislative measures concerning AI biases and their impact on decision-making » EU’s AI Act: ç Analyzing the potential influence on life sciences, from drug discovery to patient care ç Proposed provisions specifically targeting health-related AI applications • Legislative preparedness » Strategies for life sciences companies and their counsel to ensure compliance and proactive adaptation

» Exploring EMA’s stance on integrating AI into drug development and patient care » Clarifying EMA’s criteria for AI-driven medical applications and their alignment with EU’s AI Act • Identifying areas of alignment and disparity between FDA and EMA directives • Offering insights on effective strategies for regulatory compliance and proactive engagement with these agencies 11:15

Morning Networking Break

11:30

Generative AI in the Life Sciences: An Analysis of Opportunities, Challenges, and Risks for Market Expansion and New Products microphone-alt Daniel J. Barsky, Partner, Holland & Knight Emily Gardel, Associate Director, Patent Attorney II, Dyno Therapeutics Lucy Muzzy, VP & Lead Counsel, Compliance – Artificial Intelligence; Digital Health & Medicines; M&A/Business Development , Pfizer Inc. Michael P. Kahn, Partner, Akin Gump Strauss Hauer & Feld LLP Generative AI creates new data models or simulations based on existing data, enabling the generation of novel drug compounds or biological structures. Traditional AI, on the other hand, primarily analyzes and interprets existing data, such as predicting drug interactions or diagnosing conditions based on provided inputs. This panel will shed light on the world of generative AI, outlining its transformative capabilities and the associated legal, ethical, and business implications in the life sciences. • Understanding how generative AI differs from traditional AI models and its specific applications in the life sciences • Identifying market expansion opportunities » Spotting the areas within the life sciences that stand to benefit the most from generative AI innovations ç Drug discovery and design ç Medical imaging ç Synthetic biology ç Disease modeling

6 | #ACIConferences #LifeSciencesAI #LSAI LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

ç Personalized medicine ç Natural language generation for clinical data

ç Data augmentation in genomics

3:45

From Design to Outcome: Revolutionizing Clinical Trials with AI microphone-alt Maureen Bennett, Partner, Jones Day

• Addressing legal and ethical impediments

Luis Vilarin, Vice President, Associate General Counsel, Patient, Data & Privacy Law, Bristol Myers Squibb

» Preparing for the potential IP challenges 12:30

Networking Luncheon

Charlene Cho, Director and Corporate Counsel, Digital and Technology, Thermo Fisher Scientific

1:30

The Power of AI in Drug Discovery and Medical Device/Diagnostic Advancement: Preparing for Potential Legal Liabilities microphone-alt Lora Spencer, Principal Global Litigation & Investigations Counsel, Medtronic Benjamin Hsing, Partner, Venable LLP • Understanding how AI is revolutionizing drug discovery and the advancement of medical devices/diagnostics • Identifying the areas where legal liabilities will arise in AI-driven drug and device development » Innovation and IP

» Accountability and transparency

» Quality control and assurance

» Regulatory approvals

» Data integrity and privacy • Best practices for life sciences companies to minimize legal risks and remain compliant

• Safeguarding how AI enhances clinical trial design, patient recruitment, and outcome prediction » Addressing potential biases and ethical considerations in AI-driven recruitment strategies • Incorporating the FDA’s guidance on Clinical Decision Support Software and its impact on trial optimization » Understanding FDA’s stance on Clinical Decision Support Software and the impact on clinical trials • Underscoring how AI can ensure data consistency, mitigate data errors, and streamline data collection • Contemplating the legal and ethical aspects of AI-driven patient engagement strategies • Considering the legal implications of AI-generated post-trial analyses and their acceptability in regulatory submissions 4:45

AI for All: Ensuring Equity, Equality, and Fairness in AI Applications in the Life Sciences microphone-alt Avi Gesser, Partner, Debevoise & Plimpton LLP

2:30

IP Protections and AI Inventions in the Life Sciences: Exploring Complexities in Inventorship and Ownership microphone-alt Chris Mammen, Partner, Womble Bond Dickinson (US) LLP Rama G. Elluru, Senior Director, Special Competitive Studies Project – SCSP Corey Salsberg, Vice President, Global Head IP Affairs, Novartis Hans Sauer, Deputy General Counsel, VP for IP, Biotechnology Industry Organization (BIO) • Untangling AI’s impact on intellectual property in the life sciences industry » Assessing the patentability of AI-driven innovations and understanding the limits of IP protection for these inventions • Evaluating IP protections when AI is utilized as part of the inventive/creative process » Determining ownership rights when AI contributes to or independently creates solutions » Exploring joint ownership scenarios and their licensing ramifications

Betsy Greytok, Vice President & Associate General Counsel, Foundational Models, IBM • Delving into the challenge of AI bias in the life sciences » Evaluating sources of bias in AI from data collection to algorithmic design » Addressing AI bias in: ç Drug development ç Clinical trials

• Taking stock of the EU’s proposed AI Act and its relevance to fairness and accountability » Understanding the key components of the proposed Act • Reviewing ethical considerations related to AI in life sciences » Examining real-world dilemmas where AI’s decisions challenge traditional ethics • Discussing fairness, transparency, and accountability in AI-driven decisions • Exploring tools and techniques to enhance fairness in AI models, from diversifying data sources to clarifying model reasoning

• Assessing infringement risks of existing IP when used for AI training, selection, or generation

5:45

• Comparing the complexities of AI-generated inventions, data ownership, and copyright infringement

Closing Remarks from Chairs Conference Adjourns to Day Two

» Distinguishing between proprietary data used for training and AI-generated datasets » Understanding the scope and risks when AI reproduces or builds upon copyrighted materials » Evaluating fair use defenses » Anticipating and mitigating liabilities arising from AI-induced copyright breaches 3:30

ç AI-powered diagnosis

Cocktail Reception Sponsored by

Afternoon Networking Break

AmericanConference.com/LifeSciencesAI • 888 224 2480

a C5 Group Company Business Information in a Global Context

CONFERENCE DAY TWO

• Addressing GDPR’s implications for healthcare organizations utilizing AI-powered systems » Exploring data rights, breach notifications, and the role of Data Protection Officers

Thursday, February 22

• Strategizing for ensuring data protection while complying with HIPAA requirements

8:00

• Securing data anonymization

Breakfast

8:45

Opening Remarks and Recap of Day One from the Chairs microphone-alt Lucy Muzzy, VP & Lead Counsel, Compliance – Artificial Intelligence; Digital Health & Medicines; M&A/Business Development , Pfizer Inc.

Matthew Smith, Senior Corporate Counsel, Amazon Web Services Legal Danny Tobey M.D., J.D., Chair, AI & Data Analytics, DLA Piper

» Understanding how HIPAA’s Privacy and Security Rules interact with evolving AI tech in the life sciences » Evaluating techniques and technologies to anonymize sensitive data • Harmonizing AI ethics and bias mitigation • Preserving patient data, protection, and consent 11:00

USPTO KEYNOTE microphone-alt Matthew Sked, Senior Legal Policy Advisor, USPTO 11:30

9:00

Assessing the Full Spectrum of AI Litigation in Life Sciences: Evaluating Potential and Inevitable Legal Risks from Pre-Commercialization to Post-Commercialization

Formulating Strategic AI Partnerships in the Life Sciences microphone-alt Jeremy Bond, Leader of Digital & Device Patents, US Patent Analytics, Sanofi Sheea Sybblis, Associate General Counsel & Practice Group Leader, Genentech

microphone-alt Anna Gressel, Counsel, Paul Weiss

RuiHui (Rachel) Yu, Partner, Sullivan & Cromwell LLP

Aleksander J. Goranin, Partner, Duane Morris LLP As AI integrates into every facet of the life sciences, from pre-commercialization R&D efforts to post-commercialization patient care, the legal landscape grows equally complex. This session will prepare you for the potential legal challenges awaiting life sciences companies. Topics of discussion will include: • Reconciling who is at fault when AI errors occur from a product liability standpoint

• Considering AI partnerships, collaboration models, and business strategies that bridge the gap between research and clinical implementation • Grasping the nuances of AI collaborations, from data sharing to model deployment » Identifying common pitfalls and challenges in AI partnerships » Recognizing and resolving potential disconnects in goals and expectations

• Navigating the blurred lines of AI-generated content and proprietary algorithms

• Creating collaborative agreements that prioritize safety, data security, and ethical AI applications

• Mitigating risks in an age of heightened sensitivity to patient data misuse

• Evaluating strategies for integration of AI solutions post-collaboration

• Bulletproofing agreements and collaborations centered on AI

• Addressing technical challenges arising from integrating different AI systems

• Preparing for the unseen antitrust pitfalls of AI’s predictive capabilities in pricing and treatment paradigms

12:15

10:00

1:30

Navigating Data Privacy Challenges and AI in the Life Sciences: A Legal Roadmap for the Digital Age microphone-alt Corey M. Dennis, Senior Director, Counsel – Information Security & Privacy, Eli Lilly and Company Erin Geygan, Senior Counsel Privacy (MedTech), Data Protection Legal, Global Legal Organization, Johnson & Johnson Christine Moundas, Partner, Ropes & Gray LLP Daniel Fisher, Director, Digital & Data, Merck • Understanding the intersection of AI and the life sciences, focusing on data privacy and security » Assessing the inherent risks and rewards associated with using vast datasets in AI-driven innovations

Networking Luncheon

AI Testing on the Front Lines: How to Examine Medical AI microphone-alt Mark Sendak, MD, MPP, Clinical Data Scientist, Duke Institute for Health Innovation Sam Tyner-Monroe, Ph.D, Managing Director of Responsible AI, DLA Piper Nick Merker, Associate Vice President, Assistant General Counsel, AI, Information Security and Privacy, Eli Lilly and Company Nearly every proposed regulation and law emphasizes the importance of testing artificial intelligence, but what does AI testing mean in the context of the life sciences and healthcare? What is the benchmark for patient and HCP-facing AI? How do the expectations of FDA, HHS, NIST, and other regulators differ? And how does all of this apply to multipurpose generative AI? Learn from the leading practitioners in the field at the intersection of law and data science.

8 | #ACIConferences #LifeSciencesAI #LSAI LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

SPOTLIGHT ON WHERE AI IN LIFE SCIENCES AND HEALTHCARE INTERSECT 2:30

AI’s Role in Digital Health Technologies and Software Medicines microphone-alt Rekha Hanu, Senior IP Strategy Counsel, Patient Care Solutions, GE Healthcare Kelliann H. Payne, Partner, Hogan Lovells US LLP Michele Suggs Adeleye, Vice President, Assistant General Counsel, Digital Implementation, Pfizer • Examining how AI-powered patient monitoring is revolutionizing remote healthcare

hands-helping BECOME A SPONSOR With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world. 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

» Understanding AI’s capacity in wearables, predictive analytics, and personalized patient care • Addressing concerns about AI in patient data management and regulatory requirements • Understanding AI and ML in software as a medical device (SaMD) » Decoding FDA’s evolving stance on AI-integrated SaMDs • Considering the ethical and regulatory implications of AI’s ever-improving diagnostic capabilities 3:30

Afternoon Networking Break

3:45

AI in Action: Enhancing Clinical Decision-Making with AI microphone-alt Rahan Uddin, Senior Corporate Counsel, Director, Americas Customer and Partner Solutions, Microsoft

Eva F. Yin, Partner, Wilson Sonsini • Exploring how AI assists healthcare providers in making informed treatment decisions • Addressing FDA’s oversight of clinical decision support software and its implications for patient care » Evaluating the post-market surveillance and modifications of AI-powered clinical decision support (CDS) tools

Continuing Legal Education Credits 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. Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/accreditation/cle/

• Controlling disease diagnosis and medical imaging » Harnessing Ai in enhancing the accuracy, speed, and consistency of medical imaging interpretation • Defining the challenges and opportunities of implementing AI in radiology and pathology » Discussing the transformative impact of AI on precision medicine and targeted treatments • Balancing data privacy concerns with the need for comprehensive datasets to train and refine these types of AI models 4:45

Closing Remarks from Chairs Conference Adjourns to Cocktail Reception Sponsored by

AmericanConference.com/LifeSciencesAI • 888 224 2480

C5 celebrates 40 years of excellence! We are thrilled to have provided exceptional conference experiences globally with our outstanding team, speakers, sponsors, partners, and attendees. To mark this milestone, we're launching a new logo which represents our commitment to innovation, growth, and excellence, represented by the five Cs of C5: Current, Connected, Customer-Centric, Conscientious, and Committed. Looking back on 40 years, we are grateful for our achievements—hosting global conferences, uniting industry leaders, and supporting business growth. However, we are not done yet! We are committed to pushing boundaries and creating impactful experiences and we're excited for the next 40 years of success. a C5 Group Company Business Information in a Global Context

REL ATED E VENT S

COMPLIMENTARY WEBINAR

What the Executive Order Signals for Life Sciences AI

ACI’s

HatchWaxman

2nd Annual Forum on IP, Funding and Tech Strategies for

Novel Therapeutic Modalities

SERIES

19th Annual

N O V E M B E R 3 0 T H | 1–2 P M E T

PARAGRAPH IV DISPUTES

March 19 – 20, 2024 • Boston, MA

Join our 2024 chairs as they they discuss the implications for the industry arising from President Biden’s landmark October 30 Executive Order on AI. Learn more at AmericanConference.com/LifeSciencesAI/Webinar

April 24 – 25, 2024 • New York, NY

building VENUE:

WORRY FREE Registration

New York City Bar Association 42 West 44th Street, New York, NY 10036

3 Ways to Register

GUARANTEE

Register and pay to lock in your early rate and be eligible for a full refund until February 6. If you are unable to attend for any reason, you will have the following options: y A full credit note for you, or a colleague to attend another event. y A full refund. All cancellations and changes must be submitted to CustomerService@AmericanConference.com by February 6.

 ONLINE: AmericanConference.com/LifeSciencesAI

SAVE $300

Book with confidence!

 EMAIL:

CustomerService@AmericanConference.com

SAVE $200

REGISTRATION CODE:

PRICING

B00-757-757L24.WEB

Conference

$2,095

$2,295

$2,495

Bringing a Team?*

Workshop A: Overcoming Life Sciences IP Challenges

$600

Workshop B: Understanding AL and ML Technology

$600

All program participants will receive an online link to access the conference materials as part of their registration fee. Additional copies of the Conference Materials available for $199 per copy. To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/. Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/

3–4

10% Conference Discount

5–6

15% Conference Discount

20% Conference Discount

Call 888-224-2480

 PHONE: 1-888-224-2480

CONFERENCE CODE:

757L24-NYC

Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service. *Team/group registrations must be from the same organization/firm and register together in one transaction.