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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In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

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While the traditional process of discovering a new drug is long and expensive, artificial intelligence drug development platforms can help reduce time and money by efficiently analyzing vast data sets within the drug discovery process. Researchers can use such AI platforms for identifying new biological targets associated with a particular disease, screening known compounds for new applications and designing new therapeutic compounds, among other applications.In this article, originally published in Law360, we explain the top 10 considerations for AI transactions involving use in drug discovery, which are:<ol><li>Consider the nature of the services being provided.</li><li>Be mindful of IP ownership.</li><li>Consider quality and privacy issues for training data.</li><li>Consider exclusivity.</li><li>Account for infringement risk.</li><li>Be reasonable with royalties.</li><li>Evaluate confidentiality and competitive use.</li><li>Plan for uncertainty.</li><li>Scrutinize contractual risk allocation.</li><li>Beware of an evolving regulatory landscape.</li></ol>For more detail on each of the considerations, read the <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltc9412c34b10121da/64499b26d57e320df0d8163a/230425-considerations-licensing-ai-drug-discovery.pdf">full article</a>.

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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 Sharron

Stephanie Sharron is partner in the Palo Alto office and a member of the firm’s Technology Transactions Group. Clients turn to Ms. Sharron for advice on how to leverage data through technology and the related issues that apply to their business models in light of the rapid changes in business, technology and law.

Stephanie Lynn Sharron

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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10 Considerations When Licensing AI for Drug Discovery

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While the traditional process of discovering a new drug is long and expensive, artificial intelligence drug development platforms can help reduce time and money by efficiently analyzing vast data sets within the drug discovery process.

10 Considerations When Licensing AI for Drug Discovery

On April 3, 2023, FDA released the draft guidance titled “<a href="https://www.fda.gov/media/166704/download" target="_blank">Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions</a>” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine learning device software function (ML-DSF) while continuing to provide reasonable assurance of device safety and effectiveness. FDA is accepting <a href="https://www.regulations.gov/docket/FDA-2022-D-2628" target="_blank">comments</a> on the draft guidance until July 3, 2023.Background:Historically, changes to an approved or cleared medical device that could significantly affect the safety or effectiveness of the device or that constitute a major change or modification in the intended use of the device required submission of a new 510(k). This framework is at odds with the use of artificial intelligence and machine learning in medical devices, which enable and encourage continuous improvements and modifications to the device based on information gathered during use. FDA has been engaged in the process of developing a regulatory approach tailored to AI/ML-enabled devices that allows for safe and rapid modifications in response to new data while ensuring safety and effectiveness.The idea of using a “predetermined change control plan” (PCCP) was first mentioned by FDA in its 2019 discussion paper entitled “<a href="https://www.fda.gov/media/122535/download" target="_blank">Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)</a>” and has been widely discussed in the industry. In FDA’s <a href="https://www.fda.gov/media/145022/download" target="_blank">Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan</a> published in January 2021, FDA committed to publishing PCCP guidance. In addition, <a href="https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf" target="_blank">Section 3308 of the Consolidated Appropriations Act</a>, also referred to as the Food and Drug Omnibus Reform Act (FDORA), added section 515C to the Food, Drug and Cosmetic Act, granting FDA authority to approve a PCCP “submitted in an application . . . that describes planned changes that may be made to the device . . . if the device remains safe and effective without any change.” In addition to FDA’s discussion of AI/ML-enabled devices, the White House released a <a href="https://www.whitehouse.gov/ostp/ai-bill-of-rights/" target="_blank">Blueprint for an AI Bill of Rights</a> on October 4, 2022, which discusses principles regarding the design, use, and deployment of automated systems.The draft guidance is applicable to ML-DSFs that the manufacturer “intends to modify over time” including those “for which modifications to the ML model are implemented automatically . . . as well as for ML-DSFs for which modifications to the ML model are implemented manually.”[1] The term “PCCP,” as used in the guidance, “refers to a plan that includes device modifications that would otherwise require a premarket approval supplement, De Novo submission, or a new premarket notification.”[2] Proactively pre-specifying and seeking market authorization for intended modifications to an ML-DSF in a PCCP removes the need to submit additional marketing submissions for each future modification that is delineated and implemented in accordance with the PCCP. Modifications to an ML-DSF that “could significantly affect, or that could affect, the safety or effectiveness of the device”[3] require premarket authorization, unless those modifications are covered by a PCCP. In addition, the modifications cannot change the intended use of the device or the benefit-risk profile.Elements of a PCCP:A PCCP is to be composed of three elements: (i) a Description of Modifications; (ii) a Modification Protocol; and (iii) an Impact Assessment.1. Description of ModificationsA PCCP must contain a detailed description of the specific, planned device modifications. The description of modifications includes three sub-elements: (i) an enumerated list of individual proposed device modifications; (ii) a specific rationale for the change to each part of the ML-DSF; and (iii) reference to the labeling changes associated with each modification. FDA recommends that a PCCP include specific modifications that can be verified and validated. These modifications should be “presented at a level of detail that permits understanding of the specific modifications that will be made to the ML-DSF.”[4] The Description of Modifications should clearly indicate whether the planned modifications will be implemented automatically or manually. FDA recognizes this is an evolving area and is proposing to consider PCCPs for ML-DSFs where modifications are implemented automatically to the extent FDA can “properly review them for substantial equivalence to the predicate or a reasonable assurance of safety and effectiveness.”[5] FDA reiterates that this subset of ML-DSFs is complex and will consider the benefit-risk assessment when reviewing PCCPs with automatically implemented modifications.Not all modifications may be appropriate for inclusion within a PCCP. Types of modifications that are acceptable for inclusion in a PCCP include:<ol><li>Modifications related to quantitative measures of ML-DSF performance specifications (e.g., improvements to analytical performance resulting from re-training the ML model using new data within the intended use population from the same type and range of input signal);</li><li>Modifications related to device inputs to the ML-DSF (e.g., expanding the algorithm to include new sources of the same type of signal); and</li><li>Limited modifications related to the device’s use and performance (e.g., for use within a specific subpopulation).</li></ol>FDA expects that modifications included in a PCCP should maintain the device within both the device’s intended use and indications for use.2. Modification ProtocolThe Modification Protocol describes the methodology used to develop, validate, and implement those modifications in a way that ensures the continued safety and effectiveness of the devices across relevant patient populations. FDA states that the draft guidance is consistent with the principles in the <a href="https://www.whitehouse.gov/ostp/ai-bill-of-rights/">Blueprint for an AI Bill of Rights</a>. The Modification Protocol should have four primary content elements, each with their own requirements:1. Data Management Practices – The Modification Protocol should include an outline of how data to support the proposed modifications will be collected, annotated, stored, retained, controlled, and used. The Modification Protocol should also clarify the relationship between the Modification Protocol data and data that is used to train and test both the initial and following versions of the ML-DSF. This is called the “data sequestration strategy” by FDA to ensure that training data sets and testing data sets are separated. Training data and testing data are sequestered to prevent overfitting and misquotes of test performance.The Modification Protocol should also include a description of the control methods used to prevent data or performance information leaking into the modification development process. In essence, the Modification Protocol should provide information that describes the protocols put in place to prevent access to performance testing data during the training and tuning process.Examples of the types of information to be included in a Modification Protocol describing data management practices are provided in Appendix A of the draft guidance.2. Re-training Practices – The Modification Protocol should include information about re-training practices, including the objective of re-training, a description of the ML model, the device components that may be modified, and triggers for re-training.3. Performance Evaluation – The Modification Protocol should discuss how the performance of the ML-DSF will be evaluated, including the triggers for evaluation, performance metrics to be computed, the statistical analysis plans that will be used to test performance for each modification, and confirmation that failures will be recorded and screened from implementation.4. Update Procedures – The Modification Protocol must include a description of how the devices will be updated to implement the modifications. This includes confirmation that either the verification and validation plans have not changed or that any changes are justified. Differences in performance and testing methods will be communicated to users. The PCCP should include a description of any labeling changes that will result, and the available labeling must include adequate directions for use and reflect information about the currently available versions of the ML-DSF, including information on site-specific modifications. Labeling should not reflect information on modifications that have not yet been implemented in the current version, as it could cause confusion and would be deemed misbranded. Examples of the types of information that should be submitted describing update procedures are also provided in Appendix A of the draft guidance.The PCCP should also clearly delineate which parts of the Modification Protocol are applicable to each modification. For a PCCP with multiple modifications, this may be achieved through a traceability table. The draft guidance includes a sample traceability table that provides an example of how a manufacturer can depict the traceability between the Description of Modifications and the Modification Protocol.3. Impact AssessmentThe draft guidance refers to the Impact Assessment as an assessment of the benefits and risks of the planned modifications and risk mitigations. There are five elements of an Impact Assessment:<ol><li>Comparison of the modified device to the unmodified version of the device;</li><li>Benefits-risk assessment for each individual modification;</li><li>Continued assurance of the safety and effectiveness of the device;</li><li>Impact of one modification on the implementation of another; and</li><li>Collective impact of implementing all modifications.</li></ol>Modifications to an authorized PCCP will generally constitute changes to the ML-DSF that require a new marketing submission for the device, including a modified PCCP. This is because modifications described in the PCCP include device changes that would typically require a PMA supplement, De Novo submission, or 510(k) premarket notification. FDA expects that the modified PCCP will need to be reviewed as part of the premarket review of the modified device because the modification will generally significantly affect the safety or effectiveness of the device. Where modifications to the PCCP are the only significant modifications since the prior device and PCCP authorization, FDA intends to focus review on the proposed PCCP.The draft guidance includes a decision tree[6] for determining whether a modification is within the scope of an authorized PCCP or if a new submission is required:<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt4f5734e3eb37046b/6449a8834205ff10fc2438e4/230426-fda-ai_image.png?format=auto&amp;quality=60" alt="FDA "/></div>Referencing a PCCP in a Submission:FDA considers the PCCP to be part of the technological characteristics of the device. For devices subject to 510(k) requirements, the determination of substantial equivalence where the predicate device was authorized with a PCCP will be determined based on a comparison to the version of the predicate device cleared or approved prior to changes made under the PCCP.Example Scenarios of ML-DSFs That Employ PCCPs:Appendix B to the draft guidance provides examples that “illustrate different ML-DSF scenarios where a PCCP could be employed.”[7] For example, a particular ML-DSF analyzes images of skin lesions by identifying and characterizing features to aid in diagnosis. This ML-DSF was validated with a specific camera and is intended for use by a primary healthcare provider. The device was authorized with a PCCP. The pre-specified modification was for extension for use on additional general-purpose computing platforms, like smartphones and tablets. The general-purpose computing platform must include a 2D-camera that meets the minimum specifications in the PCCP, and the updated device must achieve a minimum performance defined in the Modification Protocol. In a scenario where the manufacturer implements a modification that was already specified in the PCCP and in conformance with the PCCP, the modification would not require a new marketing submission. On the other hand, if the manufacturer wanted to deploy a modified ML model that uses images captured by a thermographic camera, which was not specified in the PCCP, then a new marketing submission would be required because the modification could significantly affect the safety or effectiveness of the device and was not included in the PCCP.Appendix B also provides examples for patient monitoring software, ventilator settings software, an image acquisition assistance device, and feeding tube placement radiograph analysis software, with various hypothetical modification scenarios for each.Takeaways:This draft guidance is a significant step forward in FDA’s ability to effectively regulate AI/ML-enabled medical devices. The PCCP approach has the potential to save manufacturers from continuous submissions and to reduce the uncertainty around what support is required before making changes to devices with AI/ML components. However, as the draft guidance details, there are extensive requirements that manufacturers will need to satisfy in order to utilize the PCCP process. Depending on feedback from stakeholders, the final version of the guidance may be different from the current draft version.Device manufacturers developing ML-DSFs or incorporating them into their medical devices should consider submitting comments to the draft guidance. FDA recommends that the public submit comments to the draft guidance (<a href="https://www.regulations.gov/document/FDA-2022-D-2628-0002" target="_blank">Docket No. FDA-2022-D-2628</a>) within 90 days of publication in the Federal Register, by July 3, 2023. FDA hosted a public webinar for medical device manufacturers and other stakeholders to discuss the draft guidance on April 13, 2023. Webinar materials, including the presentation slides and transcript, are available <a href="https://www.fda.gov/training-and-continuing-education/cdrh-learn" target="_blank">here</a>.Morrison Foerster continues to closely monitor developments regarding AI/ML and FDA’s regulation of medical devices. For questions or assistance, please contact the authors.[1] Draft guidance at 5.[2] Id. at 6.[3] Id. (citations omitted).[4] Id. at 16.[5] Id.[6] Id. at 15.[7] Id. at 8.

Brigid Bondoc

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Brandy Guarda

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FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

Recent Digital Health-Related FDA Announcements

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On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine learning device software function (ML-DSF) while continuing to provide reasonable assurance of device safety and effectiveness. FDA is accepting comments on the draft guidance until July 3, 2023.

FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, <a href="https://lifesciences.mofo.com/topics/prevent-a-clinical-trial-from-turning-into-a-criminal-trial" target="_blank">Prevent a Clinical Trial from Turning into a Criminal Trial</a>, the United States has recently seen a surge in clinical trial fraud investigations and enforcement actions, highlighting the need to ensure that appropriate compliance measures are in place to mitigate enforcement risks.Meanwhile, across the pond, the European Union adopted the <a href="https://ec.europa.eu/health/document/download/f724d198-9ec8-4cad-9ce7-b6d2ac1ec44e_en" target="_blank">Clinical Trials Regulation</a> (CTR or “Regulation”) in 2022, which will apply to all newly submitted clinical trials from January 31, 2023. One of the aims of the CTR is to increase public transparency in the way clinical trials are conducted in Europe. This means that sponsors will have to follow a strict regime of publication rules, allowing for greater scrutiny of the trial data by regulators, researchers, and the general public.In this article, we give an overview of the transparency requirements that sponsors face under the CTR, and we summarize other key aspects of the new EU clinical trial regime that sponsors should be aware of when developing compliance strategies for clinical trials conducted in the EU and the European Economic Area (EEA).BackgroundThe CTR applies to interventional and low-interventional clinical trials with medicinal products for human use.[1] It replaces the <a href="https://ec.europa.eu/health/document/download/1b90a1ed-9959-4e18-948a-4c02e6d6b1fa_en" target="_blank">Clinical Trials Directive</a> (CTD) and national implementing legislation in the EU Member States. Since January 31, 2023, all clinical trial applications have been subject to the CTR. However, trials approved under the CTD before January 31, 2023, can continue to be regulated under the CTD until January 31, 2025.The CTR aims to simplify and accelerate the authorizing process of clinical trials, as well as harmonize administrative procedures across the EU and the EEA. It is directly applicable in the EU Member States without the need for transposition into national law. Other regulatory aspects, such as authorization and monitoring procedures, are governed by the <a href="http://data.europa.eu/eli/dir/2001/83/2022-01-01" target="_blank">Directive 2001/83/EC</a> and <a href="http://data.europa.eu/eli/reg/2004/726/2022-01-28" target="_blank">Regulation (EC) 726/2004</a>.Increased transparency requirementsAmong other things, the CTR focuses on increasing public transparency of clinical trial data. In the past, there have been concerns about selective reporting of trial results, where only positive results are published and negative or inconclusive results are not. This can lead to a biased view of the safety and efficacy of a particular treatment.The CTR requires the sponsor to make all clinical trial information available in the recently launched Clinical Trial Information System (CTIS) for access by the competent authority of the Member State(s) where the trial is being conducted. This includes information such as the trial protocol, clinical trial results, and adverse events. After a review process, the information is made publicly available on the <a href="https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en" target="_blank">CTIS website</a>. The information must be updated throughout the trial, and once the trial is completed, the sponsor must publish a summary of the results, including a layperson summary, within one year of the end of the trial.Sponsors may request a delay in the publication or redaction of certain information if the disclosure of such information would jeopardize the protection of personal data, trade secrets, or the sponsor’s legitimate commercial interests. However, it should be noted that certain information, such as essential characteristics of a clinical trial or reasons for the temporary halt and early termination of a clinical trial, is generally not considered confidential. Furthermore, a delay of publication of confidential information in results of the clinical trial may be granted only for a limited time.In summary, more information needs to be made available to national competent authorities and the public, including data that was not previously made available. This increases transparency and enables patients and healthcare professionals to make informed treatment decisions. For the sponsor, however, there is a risk that potentially confidential information may be inadvertently disclosed to the public, which could, for example, be detrimental to the sponsor’s ability to secure patent protection for inventions that are the subject of, or made during, the clinical trial.Consent requirementsWhen conducting a clinical trial, the sponsor must also be aware of different consent requirements.The CTR simplifies the informed consent process by laying out procedures to obtain effective consent of patients participating in the clinical trial, which in principle apply in all EU and EEA countries. This also includes more detailed guidelines for vulnerable subjects like minors or incapacitated people and pregnant or breastfeeding women. It also allows for a simplified consent process for low-risk trials, which could reduce the burden on trial participants and investigators.Data protection considerations for consentSponsors should clearly distinguish between informed consent for purposes of conducting the trial, and consent obtained for purposes of data protection. The <a href="https://eur-lex.europa.eu/eli/reg/2016/679/oj" target="_blank">General Data Protection Regulation</a> (GDPR) requires a legal basis whenever personal data are processed. Where explicit consent is relied upon as a legal basis under GDPR, in particular to process health and genetic data, this should be obtained separately from the informed consent under the CTR.However, in the EU there is no clear consensus on whether explicit consent is always appropriate in a privacy context for the processing of personal data for research activities. In its <a href="https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_opinionctrq_a_final_en.pdf#_blank" target="_blank">opinion concerning the Q&A on the interplay between the CTR and the GDPR</a>, the <a href="https://edpb.europa.eu/concernant-le-cepd/concernant-le-cepd/who-we-are_en#_blank" target="_blank">European Data Protection Board</a> (EDPB), a consortium of national EU data protection authorities, concluded that consent may not be the appropriate legal basis in some cases. Legal bases other than consent, such as public interests in the area of health or scientific research, should preferably be relied upon. However, these other legal bases require a corresponding implementation in national Member State law, which not all Member States may have arranged for at this time.Other key considerationsOther notable changes under the CTR regime that are relevant to sponsors of clinical trials are the following:1. Simplified application process: The CTR harmonizes the procedures for obtaining authorization and conducting clinical trials across the EU and in EEA countries, by introducing a single application process through the CTIS. This allows sponsors to submit a single application for authorization to conduct a clinical trial in several European countries, making the conduct of such multinational trials more efficient. The CTIS also allows national regulators to collaboratively process clinical trial applications, request information, authorize or refuse a trial, and oversee an authorized trial. This aims to stimulate innovation and research in the EU by facilitating the conduct of larger clinical trials in several EU/EEA countries.2. Shorter authorization and response times: The timeline to authorize clinical trials is set at 60 days. If no decision is made within this period, the trial may go ahead (“tacit approval”). Decisions on applications for substantial modifications of clinical trials must be made within 49 days. Where no decision is issued, the authorization is considered to have been given. However, the other side of the coin is that response times for sponsors have also drastically shortened. Sponsors now have a maximum of 12 days to respond to application queries or requests for information. Otherwise, applications will lapse by default.3. Simplified safety reporting:The CTR strengthens safety monitoring by requiring the sponsor to submit safety reports on unexpected adverse reactions to regulatory authorities within strict timelines between 7 and 15 days. However, whereas the CTD required multiple safety submissions to national competent authorities and ethics committees, the CTR requires all safety reporting via EudraVigilance and allows for submission of a single report for all trials involving more than one investigational medicinal product.4. Harmonization of ethical review: The CTR aims to harmonize the ethical review process. Although the ethical review must be performed by an ethics committee in accordance with the law of the respective EU or EEA country concerned, the procedures and the timelines for the ethical review must be compatible with the authorization procedure stipulated by the Regulation.ConclusionGiven that all future clinical trial applications in the EU will be subject to the CTR rules, it is high time for sponsors to develop and adopt appropriate compliance measures for their upcoming clinical trials. Sponsors would be well advised to consider the shortened response times and increased transparency and reporting requirements. They should put in place rapid response teams and processes to ensure that the relevant information is made available to the national competent authorities in a timely manner. Sponsors should also be aware that the burden of requesting a deferral of publication or a redaction of confidential information or personal data rests with the sponsor. Therefore, mechanisms should be put in place to ensure that such deferral and redaction requests are made for all documents containing such information. If such information is relevant to patent protection, the filing strategy and timing should be considered as well. Watch our blog for further news on clinical trials.[1] There is a simpler framework at the European level for clinical investigations of medical devices and in vitro diagnostic medical devices. The <a href="http://data.europa.eu/eli/reg/2017/745/2020-04-24" target="_blank">Medical Devices Regulation</a> (MDR) and <a href="http://data.europa.eu/eli/reg/2017/746/2022-01-28" target="_blank">In Vitro Diagnostic Medical Devices Regulation</a> (IVDR) form the core legal framework (read more about the MDR and IVDR on our MoFo Life Sciences Blog).

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Counsel

Robert advises companies from the technology and life sciences sectors on a wide range of commercial, intellectual property (IP) and regulatory matters. His clients range from multinational corporations to startups and scaleups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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Managing Partner, Amsterdam and Brussels

Alex van der Wolk, co-chair of Morrison Foerster’s preeminent Global Privacy & Data Security practice and managing partner of the firm’s Amsterdam and Brussels offices, employs his nearly 20 years of experience to advise global companies on their most complex data strategies and compliance programs governing all aspects of information management. 

With more than a decade of experience, Mr. van der Wolk helps clients develop privacy strategies for digital transformations, industrial IoT, telematics, Big Data, commercial and marketing programs, a

Alex van der Wolk

Alex van der Wolk, co-chair of Morrison Foerster’s preeminent Global Privacy & Data Security practice and managing partner of the firm’s Brussels office, employs his nearly 20 years of experience to advise global companies on their most complex data strategies and compliance programs governing all aspects of information management.

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Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation

Is 2021 the Value-Based and Shared Savings Revolution?

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Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a Clinical Trial from Turning into a Criminal Trial, the United States has recently seen a surge in clinical trial fraud investigations and enforcement actions, highlighting the need to ensure that appropriate compliance measures are in place to mitigate enforcement risks.

Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation

This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1) <a href="https://www.fda.gov/media/155038/download" target="_blank">Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency</a> (the “Enforcement Policy Transition Guidance”) and 2) <a href="https://www.fda.gov/media/155039/download" target="_blank">Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)</a> (the “EUA Transition Guidance”), both dated March 27, 2023. These final guidance documents finalize the corresponding draft guidances issued on December 23, 2021, and both set out a 180-day transition period.Enforcement Policy Transition GuidanceThe 180-day transition period under the Enforcement Policy Transition Guidance will start on the “implementation date,” which will be May 11, 2023, unless the PHE declaration is renewed another time contrary to the <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf" target="_blank">Administration’s current plan</a>. The Enforcement Policy Transition Guidance applies to devices that fall under 15 FDA COVID-19 enforcement policies, where FDA has indicated that it does not intend to object to certain modifications or distribution of certain devices in the following categories:<ol><li>remote digital pathology devices;</li><li>imaging systems;</li><li>non-invasive fetal and maternal monitoring devices;</li><li>telethermographic systems;</li><li>digital health devices for treating psychiatric disorders;</li><li>extracorporeal membrane oxygenation and cardiopulmonary bypass devices;</li><li>remote ophthalmic assessment and monitoring devices;</li><li>infusion pumps and accessories;</li><li>face shields, surgical masks, and respirators;</li><li>gowns, other apparel, and gloves;</li><li>sterilizers, disinfectant devices, and air purifiers;</li><li>ventilators and accessories and other respiratory devices;</li><li>FDA-cleared molecular influenza and RSV tests;</li><li>coagulation systems; and</li><li>viral transport media.</li></ol>These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023.The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after the implementation date—expected to be from May 11 to August 8, 2023); Phase 2 (the second 90 days after the implementation date—expected to be from August 9 to November 6, 2023); and Phase 3 (180 days after the implementation date—expected to begin on November 7, 2023). In the Enforcement Policy Transition Guidance, FDA provides phase‑by‑phase compliance guidance for manufacturers of a device that falls under any of the FDA COVID-19 enforcement policies mentioned above. It is important to note that some of the guidance applies to manufacturers regardless of whether they intend to continue distribution of the device after a certain phase. For example, manufacturers should send a notification of intent to FDA regardless of whether they intend to continue distribution of their device after Phase 2.EUA Transition GuidanceThe 180-day transition period under the EUA Transition Guidance, on the other hand, will start when the corresponding EUA declaration terminates (the “EUA termination date”). The EUA Transition Guidance applies to devices that are authorized under any of the EUA declarations related to COVID-19 such as the <a href="https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency" target="_blank">EUA declaration for COVID-19 in vitro diagnostics</a> (the “EUA devices”). As FDA explains in the guidance, an EUA declaration is not dependent on the PHE declaration, which means that the 180-day transition period for the EUA devices may start well after the PHE declaration expires, that is, possibly well after May 11, 2023.The EUA Transition Guidance requests manufacturers of the EUA devices that FDA deems to be “reusable life-supporting or life-sustaining” to submit a letter of intent to FDA as soon as possible, regardless of their intent to continue distribution of the device after the EUA termination date. Note that this request is effective as of March 27, 2023, and manufacturers should not wait until the transition period or the EUA termination date to submit the intent letter. Section A of the guidance provides the details including the product codes relevant to this request and the information to include in the letter.The EUA Transition Guidance also provides recommendations and policies for manufacturers seeking a full marketing authorization for a device related to any of their EUA devices. The guidance indicates that FDA does not intend to object to continued distribution of the EUA device after the EUA termination date, if (i) the manufacturer submits a marketing submission for a candidate device that is the same as, derivative of, or next generation of the EUA device, (ii) FDA formally accepts the marketing submission before the EUA termination date, and (iii) FDA has not taken a final action on the marketing submission. Since FDA’s formal acceptance of the marketing submission could be delayed due to various reasons, including administrative incompleteness of the submission, manufacturers are advised to submit well before the EUA termination date.FlexibilitiesNotably, both guidance documents indicate FDA’s willingness to be flexible in certain areas. For example, the guidance documents indicate that real-world data from the actual use of the device during the COVID-19 pandemic may be included in the marketing submission. Both guidance documents also recommend manufacturers to engage with FDA early in the transition period to discuss extenuating circumstances such as an ongoing clinical study that makes it difficult to meet certain deadlines provided in the guidance. Further, both guidance documents acknowledge that there may be unique quality system compliance considerations for certain manufacturers and suggest requesting an exemption or variance from a device quality system requirement within the first 90 days of each transition period.Finalization of these guidances does not necessarily mean that the COVID-19 EUA declarations will be terminated soon or that FDA will soon cease accepting and reviewing new EUA requests. At the same time, however, it certainly gets us closer to such transitions. This is an important development, and manufacturers who have distributed devices under an EUA or under one of these enforcement discretion policies during the pandemic should seek the advice of counsel to ensure compliance with the transition.

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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.

Brigid DeCoursey Bondoc

FDA Issues Final Transition Guidances for COVID-19 Devices