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Legal and Business Issues at the Intersection of Life Sciences and Artificial Intelligence

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Join Morrison Foerster for a five-part webinar series exploring the cutting-edge legal and business issues at the intersection of Life Sciences and AI.

Please join Morrison Foerster for a five-part webinar series exploring the cutting-edge legal and business issues at the intersection of Life Sciences and AI.This series will feature experts in law, business strategy, and biotechnology, who will help to illuminate the evolving landscape at the intersection of Life Sciences and AI. This series is designed for entrepreneurs, investors, executives, and students eager to grasp the complex legal frameworks, intellectual property and regulatory challenges, and market opportunities shaping the future of healthcare and biotech industries. As you seek to pioneer new technologies, gain actionable insights to navigate the legal pathways and strategic considerations essential for success in this rapidly advancing field. Register now to secure your spot in this pivotal discussion.The course begins Wednesday, May 8, 2024, from 4:00 – 5:00 p.m. (Eastern) and runs through Wednesday, June 5, 2024.Topics covered will include:<ul><li>May 8: Current State of the Venture Market at the Intersection of Life Sciences and AI, with Jim Krenn and <a href="https://www.linkedin.com/in/john-p-casey-jr/" target="_blank">John Casey</a> (Venture Partner, Pillar VC)</li><li>May 15: The Patent Landscape of AI in Life Sciences: Trends, Strategies, and Case Studies. with Josh Crawford and Anna Yuan</li><li>May 22: Contracting at the Intersection of AI and Life Sciences – Top Pitfalls to Avoid and Key Must-Haves to Include When Contracting in the U.S., UK, and Europe with Charlotte Walker-Osborn and Stephanie Sharron</li><li>May 29: Healthcare and Life Sciences Enforcement in the AI Age, with Nate Mendell and Brigid Bondoc</li><li>June 5: Privacy and Data Security Considerations for AI in Health Technologies, with Melissa Crespo and Marian A. Waldmann Agarwal</li></ul>Upon registering for this course, you will receive a unique Zoom link that provides access to all five sessions. Please use this same link to join each session. You will receive a reminder email containing your personal link before each session. You may attend all sessions during the five-week program, or only those of interest to you.Certificates will be awarded to individuals attending all five sessions!<hr>

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Jim Krenn is a corporate partner and co-chair of the firm’s Emerging Companies + Venture Capital Group. Jim has extensive experience representing private and public companies and investors in significant business transactions from formation through liquidity. His practice focuses on mergers and acquisitions, venture capital financings, and emerging company counseling. His clients span a broad range of industries, with a concentration in life science and technology companies.Jim advises clients on private and public acquisitions on both the buy-side and sell-side across numerous transaction structures, including equity purchases, asset purchases, mergers, acquisitions, divestitures, cross-border transactions, and auctions. He has represented buyers and sellers in acquisitions and divestitures ranging from the low millions to over $1 billion.Jim counsels emerging and established life sciences and technology companies in equity financings and general corporate matters, and angel, corporate, and venture capital investors in investments in such companies. He has represented clients in hundreds of venture capital financings ranging from seed rounds to $100 million-plus later-stage rounds.In addition, Jim represents public companies in public offerings, other capital markets transactions, and SEC reporting and compliance matters, and advises boards of directors on corporate governance issues.Jim is member of the firm’s Life Sciences + Healthcare Group leadership team and Artificial Intelligence steering committee and serves on the Board of Directors of the San Diego Entrepreneurs Exchange.<h4 dir="ltr">Mergers and Acquisitions</h4><ul dir="ltr"><li dir="ltr">ACEA Biosciences, a medical instruments company, in its sale to Agilent Technologies (NYSE: A) for $250 million.</li><li>Adicet Bio (Nasdaq: ACET), a biopharmaceutical company, in its merger with a wholly owned subsidiary of resTORbio (Nasdaq: TORC) to create a combined publicly traded biotechnology company.</li><li>Alaska Energy & Resources Company, a parent company of a regulated electric utility in Alaska, in its $170 million sale to Avista (NYSE: AVA).</li><li>Astute Medical, a medical diagnostic company, in its $90 million sale to bioMérieux (EPA: BIM).</li><li>B. Riley Financial (Nasdaq: RILY), a diversified financial services company, in its $53 million private placement and merger with investment banking firm B. Riley & Co.</li><li>Biotix, a private equity-backed developer and manufacturer of laboratory consumables and liquid handling solutions, in its sale to Mettler-Toledo (NYSE: MTD).</li><li>California Cryobank, a private equity-backed leader in reproductive tissue donor services and stem cell banking, in multiple acquisitions.</li><li>Clean Energy Fuels (Nasdaq: CLNE), a provider of natural gas as an alternative fuel for vehicle fleets, in its sale for up to $180 million of components of its renewable natural gas business to BP (NYSE: BP).</li><li>Cogent (Nasdaq: COGT), a biometric identification solutions provider, in its $943 million sale to 3M (NYSE: MMM).</li><li>Deere & Company (NYSE: DE), an agricultural, construction, and forestry machinery corporation, in its planned acquisition of the precision planting unit of Monsanto (NYSE: MON).</li><li>Dosatron International, a distributor of water-powered dosing pumps and systems, in connection with its sale to Ingersoll Rand (NYSE:IR).</li><li>Gillco, a leading specialty ingredient provider, in its sale to Azelis (BR: AZE).</li><li>Mentor (NYSE: MNT), a leading supplier of medical products for the global aesthetic market, in its $1.12 billion sale to Johnson & Johnson (NYSE: JNJ).</li><li>Mitchell International, a developer of smart technology solutions, in its acquisition of Cogent Works.</li><li>MyChem, a provider of ultra-pure nucleotides, in connection with its sale to Maravai (NASDAQ: MRVI) for $240 million at closing with potential additional consideration.</li><li>Protomer Technologies, a biotechnology company, in its sale to Eli Lilly and Company (NYSE: LLY) with a potential value of over $1 billion with successful achievement of future development and commercial milestones.</li><li>Rakuten Medical, a biotechnology and medical device company, in its acquisition of Medlight SA and its acquisition of key assets and manufacturing technology from Li-Cor Biosciences.</li><li>Safebuilt Insurance Services, a managing general agent and insurance technology company, in its sale to Integrated Specialty Coverages.</li><li>Sequlite Genomics, a DNA sequencing firm, in connection with its sale to Fapon Biotech, a diagnostic technology company.</li><li>Tendo, a digital health software company, in its acquisition of MDsave, a healthcare marketplace company.</li><li>Wavestream, a provider of high-power solid-state amplifiers, in its $137 million sale to Spacenet, a subsidiary of Gilat Satellite Networks (Nasdaq: GILT).</li></ul><h4 dir="ltr">﻿Venture Financings</h4><ul><li dir="ltr">9amHealth, a provider of virtual diabetes care, in its $4 million Series Seed financing and $16 million Series A financing.</li><li>ACEA Biosciences, a developer of cell analysis instrumentation technologies, in its $30 million Series E Preferred Stock financing.</li><li>Adicet Bio, a biopharmaceutical company, in its Series A financing of up to $51 million, and $80 million Series B financing.</li><li>Astute Medical, a medical diagnostic company focused on high-risk medical conditions and diseases, in over $200 million of equity and debt financings.</li><li>Bidra as an investor in multiple equity financings.</li><li>Biolumic, an agtech company, in its $13.5 million Series B financing.</li><li>California Cryobank, a private equity-backed leader in reproductive tissue donor services and stem cell banking, in multiple equity and debt financings.</li><li>Carlsmed, a medical device and artificial intelligence company, in its $10 million Series A financing, $30 million Series B financing and $52.5 million Series C financing.</li><li>Crinetics as a strategic investor in Radionetics Oncology’s $52.5 million Series A financing.</li><li>Forward Ventures as an investor in multiple equity financings, convertible debt financings, and M&A transactions.</li><li>Foxen, a provider of financial technology solutions for the real estate industry, in its $44 million Series A financing.</li><li>Greenoaks Capital Partners and its affiliates as investors in multiple equity financings, debt financings, and secondary transactions.</li><li>GroupSolver, an artificial intelligence market research platform, in multiple preferred stock financings.</li><li>Hume.ai, an artificial intelligence company, in multiple preferred stock financings.</li><li>Oak Investment Partners as an investor in multiple preferred stock financings.</li><li>OrbiMed as an investor in multiple equity financings, debt financings, and M&A transactions.</li><li>Petuum, an artificial intelligence and machine learning software infrastructure provider, in its $93 million Series B financing.</li><li>Pi Health, an AI-enabled health technology and clinical research company, in its spin-out from BeiGene, Ltd. and $35 million Series A financing.</li><li>RA Capital as an investor in multiple equity financings.</li><li>Rakuten Medical, a biotechnology and medical device company, in over $730 million of debt and equity financings.</li><li>Softbank affiliates as investors in multiple equity financings.</li><li>Solarflare Communications, a software and hardware company, in over $200 million of equity and debt financings.</li><li>VoloAgri, an agriculture technology company focused on seed genetics, in over $150 million of equity financings.</li><li>Western Digital Capital as an investor in multiple preferred stock financings.</li></ul>

Jim Krenn

Co-Chair of Emerging Companies + Venture Capital Practice

Josh Crawford's practice focuses on domestic patent prosecution, international patent portfolio management, patent infringement and validity determinations, inter partes review proceedings, and IP litigation support.Josh has experience drafting and prosecuting patents in numerous technology areas, including network security, cloud computing, machine learning, computer vision, medical devices, laboratory and assay equipment, microfluidics devices, bioinformatics, user interfaces, and consumer electronics.In addition to patent prosecution, Josh’s practice includes preparing petitions and responses in inter partes review proceedings, as well as preparing invalidity and non-infringement positions in district court litigations.  In adversarial proceedings, Josh has worked on matters concerning network security systems, GPS technology, medical devices, and integrated circuit technologies.Josh received his J.D. with highest honors from The George Washington University Law School, where he was elected to the Order of the Coif and received the Presidential Merit Scholarship and Bobby Burchfield Scholarship. During law school, he worked at Morrison & Foerster as a summer associate and as a law clerk.Before law school, Josh received his B.S. in physics with high honors from the University of Maryland. During his undergraduate studies, he worked with the Joint Quantum Institute performing optics research, including designing and constructing an optical cavity for use in cavity quantum electrodynamics experiments.Josh is licensed to practice law in the District of Columbia and Virginia and is registered to practice before the USPTO.

Joshua Crawford

Of Counsel

Anna Yuan’s practice focuses on patent prosecution, IP due diligence, post-grant proceedings, and IP litigation support. She has been recognized as one of the “Ones to Watch” in America by Best Lawyer and a Rising Star in Intellectual Property by Americas Women in Business Law. Anna is the co-founder and co-chair of the firm’s Life Sciences + AI patent practice. She leverages her experience in software development and product design gained as a product manager at Microsoft to build valuable patent portfolios covering highly complex technologies to maximize their commercial value. Anna’s practice spans a wide array of technologies, including artificial intelligence, autonomous driving, blockchain, robotics, electronic devices, data analytics, virtual reality, wireless communications, network security, medical devices, diagnostics, health care, and genomics. She has developed and managed clients’ core portfolios in the United States, China, Canada, Europe, Japan, Korea, Mexico, and Australia. Anna’s clients include emerging companies, multinational corporations, and universities.Anna received her J.D. from Harvard Law School. During law school, she served as an executive editor of the Harvard International Law Journal and co-founded the Harvard China Law Association. She was also active in clinical and pro bono programs such as the Cyberlaw Clinic based at the Harvard Berkman Center for Internet and Society, and the Harvard Mediation Program.She received her B.S. summa cum laude in computer engineering from Louisiana State University, with minors in computer science and mathematics. Prior to attending law school, Anna worked as a program manager at Microsoft in the Windows Division. At Microsoft, she led projects relating to software user interface design, software reliability, and software privacy compliance. She has also worked as a facilities engineer at Chevron and as a software developer at Halliburton.She is admitted to practice in California and is registered to practice before the United States Patent and Trademark Office. Anna is a fluent Chinese speaker and regularly counsels Chinese clients in Silicon Valley and abroad.

Anna Yuan

Charlotte Walker-Osborn is a partner based in the London office of Morrison Foerster and a member of the Technology Transactions Group. She co-leads the European and London Technology & Commercial Practices.Charlotte advises suppliers, customers and governments across the spectrum of non-contentious technology, cybersecurity and telecommunications law. She has nearly 25 years' experience advising organizations in relation to artificial intelligence, Internet of Things, cybersecurity and cyber resilience, outsourcing, information and data privacy law, digitalization, smart cities, ethics in technology, connected and autonomous vehicles and systems, robotics, cloud computing, systems development and licensing, m-commerce and e-commerce, due diligence, transitional services arrangements, hardware and services agreements, additive manufacturing, software and hardware leasing, open source and intellectual property rights, ESG, and new product launches and related risk assessments. Charlotte regularly helps clients with advice around implementing new laws relevant to their business globally, shaping their business models, drafting their global and local sales and procurement templates, and with their strategic negotiations both on the supply and customer sides. She regularly helps clients train their own legal teams in these areas too. Charlotte’s practice is global in nature. She has helped businesses with their projects in more than 75 countries. She has particularly strong industry expertise across the technology, telecoms, social media, life sciences, industrials, automotive and consumer sectors.Charlotte has helped governments in various countries draft and/or shape legislation in the fields of national security, cybersecurity, Internet of Things and artificial intelligence.Charlotte has been recognized both personally as well as when part of a team (when leading client mandates) across numerous law and technology industry awards in relation to legal work, innovation in law, and for thought-leadership, including at the British Legal Awards, the Global Sourcing Advisory Awards and the European Outsourcing Advisory Awards. Charlotte has been a partner for more than 15 years. Before joining Morrison Foerster, she launched, grew and led an international law-firm’s TMT sector, started and led their artificial intelligence practice and their technology sector globally and was a global board member. She was also a member of the TMT board, representing the law service line, at a global professional services firm. Charlotte is a top ranked tech-lawyer in Chambers UK (ranked for 11 years) and a recognized lawyer in The Legal 500 . In the words of her clients: “Charlotte Walker-Osborn is an astute, knowledgeable and dependable lawyer. She hasn’t just raised the bar; she has built a whole new benchmark for upcoming lawyers. She is highly recommended for complex and cross-border commercial contract negotiations.” (Chambers UK 2023).Charlotte is passionate about diversity, equality and inclusion and regularly speaks on these subjects.Charlotte is qualified as a solicitor in England & Wales where she is admitted to practice law. She speaks French.<h4>Representative Experience</h4><ul><li>Helping a US headquartered supplier of technology and telecommunications equipment and services negotiate and put in place a global deal worth more than $1billion with one of their top ten customers</li><li>Supporting a global pharmaceutical company in putting in place its collaboration with a life-sciences focused AI technology company for use of AI to accelerate drug discovery</li><li>Advising a global semi-conductor and technology business in relation to numerous strategic technology outsourcings, including its SOC contract with a leading cyber-security supplier for its Security Operations Centre for its newly launched Internet of Things business</li><li>Helping a global life-sciences company put in place their ethics and governance approach to use of AI across their entire business</li><li>Leading a deal for a technology company helping them with all the legal work relating to the build and deployment of an international smart ticketing transit hub utilizing near field communication and an underlying cloud-based transit hub. This complex deal involved putting in place several contracts at once to build the new business line and culminated in helping negotiate a number of mandates with their customers and a collaboration with a leading global US tech/telecoms company. This Internet of Things deal won “Highly Commended” at the British Legal Awards and was nominated for 4 other awards</li><li>Advising a Japanese headquartered automotive company in relation to the launch of its connected car/IoT offering in 56 countries (in two phases), leading a team advising on technology, IP, data and data privacy, consumer, cyber resilience and insurance aspects</li><li>Leading the legal stream of work, working with technology consultants, supporting the United Nations High Commissioner for Refugees (the UN Refugee Agency UNHCR) put in place its contract for the procurement, development, hosting and support and maintenance of a new global system for its refugee data</li><li>Advising a premiership football club in relation to its worldwide digital offerings and digitalization project</li><li>Assisting a Japanese headquartered technology business with the launch of its additive manufacturing business, including its approach to risk and writing its European sales templates – a project which was nominated for a British Legal Award for TMT deal of the year</li><li>Advising a leading consumer brand in relation to its first generation outsourcing of its networks, end user computing and digitalization with a deal value of around $500 million </li><li>Assisting a US and UK listed company with the complex contractual, technology, due diligence and transitional services aspects relating to a high-profile business separation</li><li>Advising a leading UK broadband supplier client in relation to its long-term strategic collaboration with a full fibre platform company for the roll-out of full fibre throughout the UK</li><li>Advising a UK government body in relation to the procurement of several long-term contracts relating to smart cities, both initially and then at re-tender stage several years later</li><li>Advising a US headquartered company in relation to the technology, IP, cyber-resilience and data law aspects across hardware, software, cloud and services to run its newly-acquired smart factories </li></ul>

Charlotte Walker-Osborn

Co-head of Technology and Commercial for Europe and London

Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and Privacy + Data Security practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. He represents companies, financial institutions, boards, and executives through all phases of investigation and litigation involving allegations of corporate healthcare fraud, securities and other financial fraud, public corruption, criminal intellectual property theft, data breach or disclosure, and international money laundering. Nate leverages his two decades of service in the U.S. Department of Justice to offer clients an invaluable insider perspective on white collar defense, internal investigations, cyber breaches, and government enforcement actions.Prior to joining Morrison Foerster, Nate served as First Assistant U.S. Attorney and Senior Litigation Counsel advising the U.S. Attorney. As Acting U.S. Attorney, Nate led over 135 prosecutors and reported directly to the Attorney General. Before serving as First Assistant, Nate was Chief of the Narcotics and Money Laundering Unit, where he led more than a dozen prosecutors investigating and prosecuting money laundering cases across the United States, Colombia, Europe, and the Middle East. He also contributed to the creation of the District Court’s RISE Program and was an Assistant U.S. Attorney in the Southern District of Florida.Nate earned his B.A., cum laude, from Amherst College and earned his J.D. from Harvard Law School where he served as the Editor in Chief of the Harvard Latino Law Review.<h4>Representative Experience</h4><h5>Defense Experience</h5><ul><li>Representation of a multinational holding company in a DOJ investigation arising from the client’s investment into a telehealth company under investigation for the unlawful prescription of controlled substances involving potential violations of the Controlled Substances Act (CSA) and the False Claims Act (FCA).</li><li>Advising a pharmaceutical company seeking to mitigate Anti-Kickback Statute (AKS) risk in supporting commercially insured patients in the transition to a new biosimilar therapy. While providing support to commercially insured patients and carving out federally insured patients is not prohibited, such arrangements can draw government scrutiny if they are intended to induce or “pull through” federally insured patients to use medical services or products. We are helping formulate practical parameters for a program that will assist commercially insured patients, meet business goals, and comply with applicable laws and regulations. </li><li>Advising pharmaceutical company whose trade secrets and confidential information were used as the basis for a patent application filed by a competitor and former employees.</li><li>Advising a commercial bank on the acquisition of a medical records company under investigation by DOJ for alleged violations of the FCA.</li><li>Advising an investment management company on the acquisition of a medical device manufacturer under investigation by the DOJ for alleged violations of the FCA.</li><li>Provided training to an online market place regarding the legal framework of the AKS, recent enforcement trends, and compliance best practices.</li></ul><h5>Government Experience</h5><ul><li>Violations of the AKS against a variety of major pharmaceutical companies, which culminated in settlements involving nearly $1,000,000,000 in fines and restitution to resolve the improper use of “patient assistance programs” to subsidize patient co-pays.</li><li>Violations of the CSA against the founder and chief executive officer of a publicly‑traded pharmaceutical company related to the opioids epidemic.</li><li>FCA matters involving improper inducements, insurance pull-through schemes, and improper billing and coding practices.</li><li>Fraud and tax fraud charges against a professor suspected of stealing trade secrets and intellectual property from U.S. interests for a foreign government.</li><li>Conspiracy to obtain unauthorized access to computers and to commit wire fraud and securities fraud charges against a Russian businessman.</li><li>Charges of mail fraud, money laundering, bribery, conspiracy to commit mail and wire fraud, and racketeering conspiracy against coaches, administrators, and parents who fraudulently obtained test scores and college admissions for students related to the Varsity Blues scandal.</li><li>Six-week mail and wire fraud trial against an American businessman involved in a multi-million dollar Ponzi scheme.</li></ul>

Nathaniel R. Mendell

Partner

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.As a member of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Melissa Crespo helps clients navigate a wide range of challenging privacy compliance and data security matters with a focus on the health information and the health care sector. She regularly helps clients develop and implement privacy compliance programs and advises companies on managing risk in connection with cutting-edge technologies and data initiatives.Melissa has particular experience in advising clients on compliance with the Health Insurance Portability and Accountability Act (HIPAA) and other laws governing the collection and use of medical and health information.Melissa regularly counsels clients responding to data breaches and security incidents. She has successfully defended clients in numerous regulatory inquiries regarding data security practices, including investigations by the Federal Trade Commission, the U.S. Department of Health and Human Services, state attorneys general, and foreign regulators following data security incidents.Melissa also advises multinational companies on the privacy and data security aspects of their M&A transactions and has experience drafting and negotiating tailored privacy and data security contract provisions.In 2019, 2020, and 2021, The Legal 500 US recognized Melissa as a “Rising Star” in the area of cyber law, data privacy, and data protection. In 2016, she was shortlisted for the “Future Leader – Gender Diversity” award at the inaugural Chambers USA Diversity Awards. Melissa was a 2015 recipient of the Burton Award for Legal Achievement, which honors excellence in legal writing.Melissa earned her J.D., cum laude, from Howard University School of Law.

Melissa Crespo

Marian Waldmann Agarwal is a partner in the Privacy + Data Security Group at Morrison Foerster. She also co-leads the firm’s Artificial Intelligence Group and is a member of the global Environmental, Social, and Governance (ESG) Responsible Tech Committee. Marian’s unique blend of business and legal skills, honed through her background in information systems and business management, is a key asset in her role. Her in-house experience as a secondee to two different companies has provided her with firsthand knowledge of the internal business needs required for company initiatives to succeed. Marian has been instrumental in advising global clients on the developing field of AI. Clients seek her guidance due to her extensive understanding of, and experience with, the ethical use of AI and the developing legal compliance requirements, including data privacy and regulatory provisions, in connection with the design and implementation of innovative AI tools. Her work extends to helping clients identify and mitigate the potential risks associated with AI technologies.Marian counsels clients across a range of industries, including technology, finance, consumer goods and services, healthcare, insurance, media, and hospitality. She assists in designing and building their privacy programs, advising on compliance with U.S. and foreign privacy and data protection laws, such as the California Consumer Privacy Act (CCPA) and the EU’s General Data Protection Regulation (GDPR). Her work includes drafting internal policies, procedures, and guidelines for legal and non-legal audiences that incorporate privacy best practices and legal requirements in daily operations. One of Marian’s core strengths is her ability to comprehensively assess and improve privacy programs, and ensure they remain compliant with evolving privacy laws and regulations. She also drafts and negotiates contracts to protect clients’ data in key commercial agreements, advises on cross-border data transfer issues, and assists with completing multijurisdictional surveys of privacy obligations.In addition, Marian uses her privacy, data security, and AI implementation skills to provide pro bono counseling services to a variety of non-profit clients.Marian received her J.D. from University of Pennsylvania Law School in 2004 and her B.S. and M.B.A. from the State University of New York at Buffalo in 1999. Prior to attending law school, she worked as an application specialist for a small software company.

Marian A. Waldmann Agarwal

Stephanie assists companies with technology and life sciences transactions, representing both private and public companies, from emerging growth through the Fortune 50. In particular, Stephanie focuses on helping companies that leverage data through technology in structuring their business and commercial transactions.Stephanie has over two decades of experience working with clients on the complex technology, intellectual property, and data rights issues across technology and business sectors, including, among others: artificial intelligence (including machine learning and other data analytics approaches), cloud services, life sciences and healthcare, the Internet of Things (IoT), fintech, digital transactions, autonomous systems, cybersecurity solutions, semiconductors, edtech and cleantech. Additionally, Stephanie advises on the commercial technology and intellectual property aspects of mergers, acquisitions, asset spin-off transactions, and private equity investments. Stephanie serves on the Responsible AI Venture Council, part of the recently launched Lucas Institute for Venture Ethics at Santa Clara University’s Markkula Center for Applied Ethics. Stephanie is also a member of the firm’s global ESG + Sustainability steering committee as well as the firm’s FinTech steering committee, where she helps to lead and collaborate with attorneys across multiple practices. Stephanie is also a sought-after speaker and thought leader on the issues at the intersection of technology and law, including regarding AI, Life Sciences and FinTech.Since 2016, Stephanie has taught as a guest lecturer in the Technology Transactions course in Cornell Law School’s Technology and Entrepreneurship LLM program at CornellTech. She also was adjunct faculty at Cornell Law School for a Legal Issues in FinTech course.

Legal and Business Issues at the Intersection of Life Sciences and Artificial Intelligence

08 May 2024 - 05 Jun 2024