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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Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the ag

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FDA and Real-World Evidence in 2019 | MoFo Life Sciences

Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the agency in evaluating the potential use of real-world evidence (RWE) in regulatory decisions involving drug and biological products.[2] The Framework laid out a “three-part approach” identifying data quality, study design, and regulatory requirements as focal points of the evaluation. In addition, the Framework pointed to the importance of data standards in enabling efficient processing of real-world data (RWD), from which RWE is derived. In 2019, to refine its understanding of these four areas (data quality, study design, regulatory requirements, and data standards) in the context of RWE, FDA coordinated a multifaceted effort including demonstration projects, development of guidance documents, the Sentinel System, and active engagement with sponsors and other stakeholders.In 2019, FDA expanded some of its existing demonstration projects, while funding new ones. In April, Aetion announced that FDA and Brigham and Women’s Hospital/Harvard Medical School will expand the scope of their demonstration project to include predicting seven ongoing randomized control trials (RCTs) with RWE, in addition to the original scope of replicating 30 completed RCTs.[3] In August, a San Francisco-based company Syapse announced that it will work with FDA to assess the potential of RWE especially in the context of precision medicine.[4] While some have criticized these studies,[5] demonstration projects seem to remain a core part of FDA’s Real-World Evidence Program (the “Program”).In May, FDA published a draft guidance entitled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.”[6] The industry reaction was mixed, some cautioning while others encouraging the use of RWE.[7] Notably, some of the pharmaceutical companies asked the agency to consider data from Expanded Access programs as a source of RWD, in response to the draft.[8] While expanding the scope of RWD in such a way may incentivize companies to more actively engage in FDA’s Expanded Access and Right to Try programs,[9] it remains to be seen how the agency’s subsequent treatment of RWE interacts with the level of industry participation in those programs.The Sentinel contract in September marked another step forward in FDA’s endeavor to incorporate RWE into its regulatory practice. According to Jacqueline Corrigan-Curay, FDA’s Director of CDER’s Office of Medical Policy, the contract “will really enable FDA to continue to grow its own RWE capabilities.”[10] The contract will fund up to $220 million for five years starting in 2019, for the next phase of the Sentinel System,[11] which is to become a platform that generates RWE for FDA.[12]Lastly, FDA supported and sponsored workshops to exchange insights with stakeholders. In July, through a public workshop titled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes,” FDA explored the potential use of RWD not only in single-arm trials but also in randomized clinical trials.[13] Also in July, FDA sponsored a workshop titled “FDA-AACR Real-world Evidence Workshop,” discussing the use of large genomic databases and digital data as RWD, among other things.[14] In October, at a conference entitled “Developing Real-World Data and Evidence to Support Regulatory Decision-Making,” FDA and various stakeholders exchanged thoughts on the key evaluation areas laid out in the Framework.[15] Through these workshops, FDA has shown that it is open to a wide range of creative solutions, while understanding that it may have to take one step at a time.[16]In parallel with its pursuit under the Program, FDA in September announced a Technology Modernization Action Plan.[17] In justifying the timeliness of this plan, FDA explained that a modernized technical infrastructure will be necessary for the agency to accept and process RWD and to derive RWE for its regulatory decision-making, specifically referring to the Framework and the Program. This explanation seems to reach beyond the scope of the Program (and the congressional mandate by the 21st Century Cures Act), which simply sets out to evaluate the potential use of RWE.[18]Finally, it is worth noting how RWE continued to play a role in supporting drug approvals in 2019, especially in the context of cancer and rare diseases. For instance, FDA’s Oncology Drugs Advisory Committee last month unanimously recommended accelerated approval of a drug (tazemetostat) for a rare form of cancer,[19] where the approval was supported in part by a Natural History Study.[20] Further, FDA in April approved a new indication of a drug (palbociclib) primarily based on RWD such as electronic health records and post-marketing reports.[21] The approval is one of the rare cases where FDA accepted RWE to support an effectiveness decision (rather than a safety evaluation), and will serve as a precedent for future drug approvals. Given FDA’s willingness apparent in the Framework to further explore the use of RWE in effectiveness decisions, it seems likely that RWE will play a bigger role in drug approval processes in 2020.In short, FDA in 2019 tapped into multiple channels to gather input from stakeholders and also to broaden its own experience with RWD and RWE. Although the exact outcome of these endeavors remains to be seen in 2020, the agency appears to be slowly but surely getting ready to incorporate more RWE into its regulatory decisions. [1] Framework for FDA’s Real-World Evidence Program, FDA (December 2018)[2] <a target="_blank" href="https://www.fda.gov/drugs/webinar-framework-fdas-real-world-evidence-program-mar-15-2019">Webinar: Framework for FDA’s Real-World Evidence Program, FDA (March 2019)</a>[3] <a target="_blank" href="https://www.prnewswire.com/news-releases/fda-expands-real-world-evidence-partnership-with-brigham-and-womens-hospital-and-aetion-300829517.html">FDA Expands Real-World Evidence Partnership with Brigham and Women’s Hospital and Aetion, PR Newswire</a>[4] <a target="_blank" href="https://www.syapse.com/news/press-releases/syapse-fda-research-collaboration">Syapse Announces Research Collaboration with the FDA Focused on the Regulatory Use of Real-World Evidence (August 2019)</a>[5] <a target="_blank" href="https://www.statnews.com/2019/07/03/replicate-clinical-trials-real-world-evidence">Attempt to Replicate Clinical Trials with Real-World Data Generates Real-World Criticism, Too, Matthew Herper (July 2019)</a>[6] <a target="_blank" href="https://www.fda.gov/media/124795/download">Draft Guidance: Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics, FDA (May 2019)</a>[7] <a target="_blank" href="https://www.policymed.com/2019/09/industry-reaction-mixed-to-fda-draft-guidance-on-real-world-data-and-evidence.html">Industry Reaction Mixed to FDA Draft Guidance on Real World Data and Evidence, Thomas Sullivan (September 2019)</a>[8] Gilead and Novartis Seek to Expand What FDA Considers as Real-World Data and Real-World Evidence, Zachary Brennan (July 2019)[9] Public Meeting Report: Leveraging Real World Treatment Experience from Expanded Access Protocols, Silver Spring (November 2018); Pre-Approval Access and Real-World Evidence: A Win-Win Proposition, Jane Reese-Coulbourne (November 2017); Working Group on Compassionate Use & Preapproval Access Frequently Asked Questions (“If companies see expanded access programs as a source of valuable RWE, they may become more willing to run expanded access programs alongside their clinical trials.”)[10] <a target="_blank" href="https://healthpolicy.duke.edu/events/developing-real-world-data-and-evidence-support-regulatory-decision-making">Developing Real-World Data and Evidence to Support Regulatory Decision-Making, FDA & Duke-Margolis Center for Health Policy (October 2019)</a>[11] <a target="_blank" href="https://www.populationmedicine.org/pressrelease/Sentinel">Harvard Pilgrim Health Care Institute Funded up to $220 Million for The Next Phase of FDA Sentinel System, Harvard Department of Population Medicine (September 2019)</a>[12] <a target="_blank" href="https://www.fda.gov/media/120333/download">Sentinel System: Five-Year Strategy 2019-2023, FDA (January 2019)</a>[13] Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes, FDA & Duke-Margolis Center for Health Policy (July 2019), <a target="_blank" href="https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/leveraging-randomized-clinical-trials-generate-real-world-evidence-regulatory-purposes">https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/leveraging-randomized-clinical-trials-generate-real-world-evidence-regulatory-purposes</a>; <a target="_blank" href="https://healthpolicy.duke.edu/events/leveraging-randomized-clinical-trials-generate-real-world-evidence-regulatory-purposes">https://healthpolicy.duke.edu/events/leveraging-randomized-clinical-trials-generate-real-world-evidence-regulatory-purposes</a>[14] FDA-AACR Workshop: Real-world Evidence, FDA & AACR (July 2019), <a target="_blank" href="https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-aacr-workshop-real-world-evidence-07192019-07192019">https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-aacr-workshop-real-world-evidence-07192019-07192019</a>; <a target="_blank" href="https://www.fda.gov/media/128598/download">https://www.fda.gov/media/128598/download</a>[15] <a target="_blank" href="https://healthpolicy.duke.edu/events/developing-real-world-data-and-evidence-support-regulatory-decision-making">Developing Real-World Data and Evidence to Support Regulatory Decision-Making, FDA & Duke-Margolis Center for Health Policy (October 2019)</a>[16] <a target="_blank" href="https://healthpolicy.duke.edu/events/developing-real-world-data-and-evidence-support-regulatory-decision-making">E.g., Developing Real-World Data and Evidence to Support Regulatory Decision-Making, FDA & Duke-Margolis Center for Health Policy (October 2019)</a> (“We know that today data (does) not just seamlessly flow from the EHR or claims data for use in research. Today we’re going to hear maybe how we might get one step closer to that: whether that will require re-imagination of the EHR and the clinical work flow to capture data that is relevant to both quality practice and research … or maybe it’s more relying on natural language processing and artificial intelligence.”)[17] <a target="_blank" href="https://www.fda.gov/media/130883/download">FDA’s Technology Modernization Action Plan, FDA (September 2019)</a>[18] <a target="_blank" href="https://www.fda.gov/drugs/webinar-framework-fdas-real-world-evidence-program-mar-15-2019">Webinar: Framework for FDA’s Real-World Evidence Program, FDA (March 2019)</a>[19] <a target="_blank" href="https://medcitynews.com/2019/12/fda-panel-recommends-approval-of-epizyme-drug-for-rare-cancer/?rf=1">FDA Panel Recommends Approval of Epizyme Drug for Rare Cancer, Alaric Dearment (December 2019)</a>[20] NDA211723: Tazemetostat for the Treatment of Patients with Metastatic or Locally Advanced Epithelioid Sarcoma Who Are Not Eligible for Curative Surgery, Epizyme (December 2019)[21] <a target="_blank" href=" https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_ibrance_palbociclib_for_the_treatment_of_men_with_hr_her2_metastatic_breast_cancer">U.S. FDA Approves Ibrance® (Palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer (April 2019)</a>

FDA and Real-World Evidence in 2019

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