Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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On June 1, 2023, the Supreme Court issued a decision in <a href="https://www.supremecourt.gov/opinions/22pdf/21-1326_6jfl.pdf" target="_blank">United States ex rel. Schutte v. SuperValu, Inc.</a>, clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA). The Court held that a defendant that submits a false claim does so knowingly when it subjectively believes the claim is false at the time of submission. We have been tracking this decision in our <a href="https://www.mofo.com/resources/insights/230410-true-facts-about-false-claims?utm_source=publication&utm_medium=email" target="_blank">FCANewsletter</a> and our <a href="https://govcon.mofo.com/topics/supreme-court-weighs-in-on-the-role-of-subjective-intent-under-the-false-claims-act" target="_blank">Government Contracts Insights</a> as it changes the law of several circuits, which had held that an FCA defendant has not knowingly presented a false claim if its claim was consistent with an “objectively reasonable interpretation” of the relevant law, regardless of what the defendant believed about the claim.Read the <a href="https://www.mofo.com/resources/insights/230606-look-to-defendants-subjective-beliefs" target="_blank">full client alert</a>.

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Joe Palmore co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Chambers USA describes him as “an outstanding oral advocate,” who is “calm, focused, effective and doesn’t back down,” and has “complete command of the facts.” Joe “writes great briefs” (Chambers USA), with one client recounting that “the Court mirrored the language he thoughtfully chose in its ultimate order” (Legal 500).

Joseph R. Palmore

Joseph R. Palmore is co-chair of the firm's Appellate and Supreme Court Practice Group and Managing Partner for the Washington, D.C. office. Before joining Morrison Foerster, Joe was an Assistant to the Solicitor General at the United States Department of Justice and the Deputy General Counsel of the Federal Communications Commission (FCC).

Joseph Palmore

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J. Alex Ward is co-chair of Morrison Foerster’s Government Contracts and Public Procurement group. 

J. Ward

Alex is co-chair of Morrison Foerster’s Government Contracts and Public Procurement practice. His practice covers a full range of government contracts matters, including bid protests, claims, investigations, corporate transactions, and counseling.

J. Alex Ward

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Adam L. Braverman is a partner in Morrison Foerster’s Investigations + White Collar Defense practice. Adam formerly served as an Associate Deputy Attorney General for the U.S. Department of Justice (DOJ) and as the U.S. Attorney for the Southern District of California. 

Adam L. Braverman

Adam L. Braverman is a partner in Morrison Foerster’s Investigations + White Collar Defense group. He represents companies and their executives in internal and government investigations, white collar criminal defense matters, and parallel civil litigation related to allegations of bribery, government procurement fraud, COVID-19 and CARES Act fraud, anti-money laundering violations, and matters involving organized crime.

Adam Braverman

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United States Supreme Court: Look to Defendant's Subjective Beliefs to Decide Whether It "Knowingly" Submitted False Claim

New DCMA Defective Pricing Pilot Team Will Possess Audit Resolution Authority

On June 1, 2023, the Supreme Court issued a decision in United States ex rel. Schutte v. SuperValu, Inc., clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA).

United States Supreme Court: Look to Defendant's Subjective Beliefs to Decide Whether It "Knowingly" Submitted False Claim

On May 3, 2023, New York Governor Kathy Hochul signed into <a href="https://www.nysenate.gov/legislation/bills/2023/A3007" target="_blank">law</a> an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions” at least 30 days before closing. This new law will require healthcare entities, such as management service organizations, physician practices, and other similar entities, to submit notice and supporting documentation to DOH when engaging in mergers, acquisitions, and other transactions in New York. Here are four key points from the new law:1. How does the enacted legislation differ from the initial proposal? The original proposed legislation gave DOH broad authority to both review and approve material transactions and allowed DOH to define what transactions are material. See our previous blog post <a href="https://lifesciences.mofo.com/topics/states-extend-scope-of-regulatory-oversight-of-health-care-entities" target="_blank">here.</a> The enacted legislation pulls back on this authority and does not grant DOH the ability to approve transactions and also excludes “de minimis” transactions from review. De minimis transactions in this context are those that result in a healthcare entity increasing its total gross in-state revenues by less than $25 million.[1]2. Definition of “Material Transactions.” The law defines “material transactions” as any of the following:(1) a merger with a healthcare entity(2) an acquisition of one or more healthcare entities, including, but not limited to, the assignment, sale, or other conveyance of assets, voting securities, membership or partnership interest, or the transfer of control(3) an affiliation agreement or contract formed between a healthcare entity and another person(4) the formation of a partnership, joint venture, accountable care organization, parent organization, or management services organization for the purpose of administering contracts with health plans, third-party administrators, pharmacy benefit managers, or healthcare providers as prescribed by the commissioner by regulation.[2]3. Exclusions from Review. In addition to de minimis transactions mentioned above, the law excludes the following transactions from review: clinical affiliations of healthcare entities formed with the intent to facilitate collaboration between the entities (i.e., collaboration on clinical trials), transactions already subject to the Certificate of Need (CON) process, or an insurance entity approval process under the New York Public Health or Insurance Laws.4. Notice Requirements. The notice and review process will be further defined in regulations promulgated by DOH. Written notices must have information including, but not limited to, name and address of the transaction parties, copies of the definitive agreements, locations impacted by the transactions, closing date, and description of the purpose of the transaction, including anticipated impacts on cost, quality, and access in the impacted markets.[3] Upon receipt of a transaction notice, DOH will submit the notice to various bureaus of the Office of the New York Attorney General and post a summary of the proposed transaction on its website with an opportunity for public comment. 5. Noncompliance Consequences. DOH may impose a civil penalty of $2,000 for each day that a transaction is out of compliance. This penalty may be increased up to $5,000 for subsequent violations that pose a “serious threat to the health and safety” of individuals.[4] Each day that the violation continues is a separate violation and the penalty may extend until and unless a notice is filed.ConclusionAlthough the law is less onerous than what had been originally proposed, it does impose obligations on a broad array of entities, including management services organizations, in an attempt to monitor investments and other activities in the healthcare industry. [1] NY Pub. Health L. § 4550(4)(b).[2] NY Pub. Health L. § 4550(4)(a).[3] NY Pub. Health L. § 4552(1).[4] NY Pub. Health L. § 4552(4); NY Pub. Health L. § 12.

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On May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions” at least 30 days before closing. This new law will require healthcare entities, such as management service organizations, physician practices, and other similar entities, to submit notice and supporting documentation to DOH when engaging in mergers, acquisitions, and other transactions in New York. 

New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways

On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) <a href="https://www.federalregister.gov/public-inspection/2023-09985/using-artificial-intelligence-and-machine-learning-in-the-development-of-drug-and-biological" target="_blank">announced</a> the publication of a new discussion paper titled “<a href="https://www.fda.gov/media/167973/download" target="_blank">Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products</a>.” The discussion paper aims to facilitate a discussion with stakeholders on the use of artificial intelligence and machine learning (AI/ML) in drug development, including the development of medical devices intended for use with drugs. The discussion paper covers three main topics: the landscape of current and potential uses of AI/ML; considerations for the use of AI/ML; and next steps and stakeholder engagement.Here are five key takeaways:1. FDA Acknowledges that AI/ML Applications Exist for Each Stage of Drug Development. AI/ML may have applications for use in all stages of drug development, from drug discovery to pharmaceutical manufacturing. AI/ML has been applied to real‑world data (RWD) and data from digital health technologies (DHTs) to support drug development.  The first section of the discussion paper summarizes the different ways in which AI/ML can be used in drug discovery, clinical and nonclinical research, postmarketing surveillance, and advanced pharmaceutical manufacturing. 2. FDA Is Growing Its Own Experience with AI/ML for Drug Development. In recent years, the FDA has seen a growth in drug and biological product submissions that reference AI/ML. In response, FDA has taken a number of actions, including establishment of the CDER AI Steering Committee, the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program, and the Model‑Informed Drug Development (MIDD) Pilot Program. For postmarket safety surveillance, the CDER Sentinel System, CBER Biologics Effectiveness and Safety (BEST) system, and CDRH National Evaluation System for health Technology (NEST) efforts, are exploring AI/ML approaches to improve existing systems.3. FDA Understands Development of Standards and Practices for Use of AI/ML Is Critical. The U.S. government and international community have expressed an increased commitment to facilitating AI innovation and adoption. Regulators and standards organizations have developed and issued standards to facilitate the advancement of ethical AI. For example, in August 2019, the National Institute for Standards and Technology (NIST) released the “U.S. Leadership in AI: A Plan for Federal Engagement in Developing Technical Standards and Related Tools.” In addition, in October 2021, the FDA, Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly published 10 guiding principles to inform the development of Good Machine Learning Practices (GMLP) for medical devices using AI/ML.4. FDA Has Identified Key Questions on AI/ML in Drug Development. The FDA aims to initiate a discussion with stakeholders on the following three key areas and provides specific questions to solicit feedback.Human-Led Governance, Accountability, and Transparency<ul><li>In what specific use cases or applications of AI/ML in drug development are there the greatest need for additional regulatory clarity?</li><li>In your experience, what are the main barriers and facilitators of transparency with AI/ML used during the drug development process (and in what context)?</li><li>How are pre-specification activities managed, and changes captured and monitored, to ensure the safe and effective use of AI/ML in drug development?</li></ul>Quality, Reliability, and Representativeness of Data<ul><li>What additional data considerations exist for AI/ML in the drug development process?</li><li>What are some of the key practices utilized by stakeholders to help ensure data privacy and security?</li><li>What processes are developers using for bias identification and management?</li></ul>Model Development, Performance, Monitoring, and Validation<ul><li>What practices and documentation are being used to inform and record data source selection and inclusion or exclusion criteria?</li><li>In what context of use are stakeholders addressing explainability, and how have you balanced considerations of performance and explainability?</li><li>What are some examples of current tools, processes, approaches, and best practices being used by stakeholders for: selecting model types and algorithms for a given use, determining when to use specific approaches for validating models and measuring performance in a given context, evaluating transparency and explainability, and increasing model transparency, etc.?</li></ul>5. FDA Wants Your Feedback. The FDA is soliciting feedback on the opportunities and challenges in using AI/ML in drug and medical device development. The FDA includes a series of questions for feedback in the discussion paper, and a workshop with stakeholders is planned to provide an opportunity for further engagement. <a href="https://www.regulations.gov/docket/FDA-2023-N-0743" target="_blank">Comments must be submitted by August 9, 2023 (Docket No. FDA-2023-N-0743). </a>