SARA GERKE [email protected] 617-495-5147 ♦ 23 Everett Street, Cambridge, MA 02138 PROFESSIONAL EXPERIENCE Aug. 2018–present The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Cambridge, United States of America Research Fellow, Medicine, Artificial Intelligence, and Law The Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL); collaborators at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen; this research is supported by a Novo Nordisk Foundation-grant for a Collaborative Research Programme (grant agreement number NNF17SA027784) Apr. 2018–June 2018 The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Cambridge, United States of America Visiting Researcher The ethics and law of in vitro gametogenesis (IVG) in the United States (U.S.) and Europe, reproductive and regenerative medicine, U.S. patent and Food and Drug Administration (FDA) law Oct. 2016–Mar. 2018 Institute for German, European and International Medical Law, Public Health Law and Bioethics of the Universities of Heidelberg and Mannheim, Germany General Manager External presentation of the Institute, contact person for inquiries, supervision of the 24 student assistants, organization of conferences (e.g., Ethics Symposium), acquiring third-party funded projects, annual and financial reports Apr. 2016–Mar. 2018 Institute for German, European and International Medical Law, Public Health Law and Bioethics of the Universities of Heidelberg and Mannheim, Germany Co-Investigator Project: ClinhiPS – A Scientific, Ethical and Comparative Legal Analysis of the Clinical Application of Human Induced Pluripotent Stem Cells in Germany and Austria; sponsored by the BMBF (German Federal Ministry of Education and Research); funds: 657,678.00 EUR Jan. 2014–June 2015 Institute for German, European and International Medical Law, Public Health Law and Bioethics of the Universities of Heidelberg and Mannheim, Germany Research Assistant Various projects in the areas of medical law, public health law and bioethics; teaching of law students at the University of Mannheim, Germany; correction of/assessor in examinations Sept. 2012 Dr. iur. Bianka S. Dörr Bühlmann, LL.M., Attorney-at-Law, University of Zurich, Switzerland Research Assistant Medical Law, Human Rights 1/7 Aug. 2012–Sept. 2012 Law firm Bender & Philipp, Munich, Germany Research Assistant Assistance with the commentary on sections 1–19, 28–45b SGB XI; Kreikebohm, R., Spellbrink, W. and Waltermann, R. (eds.) (2013) Kommentar zum Sozialrecht [Commentary on Social Law]. 3rd ed. Munich: C. H. Beck. Dec. 2009–Sept. 2010 University of Augsburg, Germany Student Assistant Medical Law, Health Sciences and Civil Law PUBLICATIONS EDITED BOOK 2019 (forthcoming) Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann, H. (eds.) Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen - Ein Stakeholder-Sammelband [The Clinical Application of Human Induced Pluripotent Stem Cells – A Stakeholder Anthology]. Berlin, Heidelberg: Springer (expected publication date: Spring 2019). CHAPTER IN BOOK 2019 (forthcoming) Gerke, S. (2019) Die klinische Translation von hiPS-Zellen in Deutschland [The Clinical Translation of hiPSCs in Germany], in: Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann, H. (eds.) Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen - Ein Stakeholder-Sammelband [The Clinical Application of Human Induced Pluripotent Stem Cells – A Stakeholder Anthology]. Berlin, Heidelberg: Springer (expected publication date: Spring 2019). 2019 (forthcoming) Gerke, S. and Hansen, S. (2019) Die klinische Anwendung von hiPS- Zellen: ein Überblick [The Clinical Application of hiPSCs: An Overview], in: Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann, H. (eds.) Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen - Ein Stakeholder-Sammelband [The Clinical Application of Human Induced Pluripotent Stem Cells – A Stakeholder Anthology]. Berlin, Heidelberg: Springer (expected publication date: Spring 2019). 2019 (forthcoming) Gerke, S., Hansen, S., Blum, V., Bur, S., Heyder, C., Kopetzki, C., Meiser, I., Neubauer, J., Noe, D., Steinböck, C., Taupitz, J., Wiesemann, C. and Zimmermann, H. (2019) Empfehlungen des Verbunds ClinhiPS [Recommendations of the Consortium ClinhiPS], in: Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann, H. (eds.) Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen - Ein Stakeholder-Sammelband [The Clinical Application of Human Induced Pluripotent Stem Cells – A Stakeholder Anthology]. Berlin, Heidelberg: Springer (expected publication date: Spring 2019). 2019 (forthcoming) Gerke, S., Kopetzki, C., Blum, V., Noe, D. and Steinböck, C. (2019) Eine rechtsvergleichende Analyse der klinischen Translation von hiPS- Zellen in Deutschland und Österreich [A Comparative Analysis of the Clinical Translation of hiPSCs in Germany and Austria], in: Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann, H. (eds.) Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen - Ein Stakeholder-Sammelband [The Clinical Application 2/7 of Human Induced Pluripotent Stem Cells – A Stakeholder Anthology]. Berlin, Heidelberg: Springer (expected publication date: Spring 2019). Jan. 2018 Gerke, S. and Taupitz, J. (2018) Rechtliche Aspekte der Stammzellforschung in Deutschland: Grenzen und Möglichkeiten der Forschung mit humanen embryonalen Stammzellen (hES-Zellen) und mit humanen induzierten pluripotenten Stammzellen (hiPS-Zellen) [Legal Aspects of Stem Cell Research in Germany: Limits and Possibilities of Research Using Human Embryonic Stem Cells (hESCs) and Human Induced Pluripotent Stem Cells (hiPSCs)], in: Zenke, M., Marx-Stölting, L. and Schickl, H. (eds.) Stammzellforschung: Aktuelle wissenschaftliche und gesellschaftliche Entwicklungen [Stem Cell Research: Current Scientific and Social Developments]. Baden-Baden: Nomos, pp.209-235. JOURNAL ARTICLE May 2018 Gerke, S. and Cantz, T. (2018) ELSA: Eine neue Fachgruppe des GSCN, ELSA: A New Working Group of the GSCN, Zukunft der Stammzellforschung: Jahresmagazin des German Stem Cell Network (GSCN) 2017/18, Future of Stem Cell Research: Annual Magazine of the German Stem Cell Network (GSCN) 2017/18, pp.47-51. Jan. 2017 Gerke, S. and Pattinson, S. (2017) EU Marketing Authorisation of Orphan Medicinal Products and Its Impact on Related Research, European Journal of Health Law, 24(5), pp.541-564. Apr. 2015 Taupitz, J., Geisthövel, F., Coester-Waltjen, D., Frister, H., Frommel, M., Gerke, S., Hermes, B., Hufen, F., Ochsner, A., Beier, H. and Thaler, C. (2015) V. Mannheimer Workshop zur Fortpflanzungsmedizin: Ein juristischer Diskurs zur Präimplantationsdiagnostik und Embryonenspende auf der Basis neuerer reproduktionsbiologischer Prämissen [5th Mannheim Workshop on Reproductive Medicine: A Legal Discourse on Preimplantation Diagnosis and Embryo Donation Based on Recent Reproductive Biological Premises], Journal für Reproduktionsmedizin und Endokrinologie [Journal of Reproductive Medicine and Endocrinology], 12(2), pp.42-56. GUIDELINE May 2018 Informed Consent Sample Text for the Donation of Somatic Cells for Human Induced Pluripotent Stem Cell (hiPSC) Research, GSCN (German Stem Cell Network) together with the ELSA working group and the PluriCore Network. BLOG Nov. 2018 Gerke, S. and Feldman J. (2018) The Tricky Task of Defining AI in the Law, Bill of Health. June 2018 Gerke, S. (2018) The German Stem Cell Network Has Compiled a Sample Text for Informed Consent, Bill of Health. May 2018 Gerke, S. (2018) The EU’s GDPR in the Health Care Context, Bill of Health. WHITE PAPER 2019 (forthcoming) Arney, D., Senges, M., Gerke, S., Canca, C., Haaber Ihle, L., Kaiser, N., Karkarmath, S., Kupke, A., Gajeelee, A., Lynch, S. and Melendez, L. (2019) A User-Focused Transdisciplinary Research Agenda for AI- Enabled Health Tech Governance. 3/7 VIDEO Dec. 2018 Stakeholder-Conference: The Clinical Translation of Human Induced Pluripotent Stem Cells, ClinhiPS, Department for Medical Ethics and History of Medicine, University Medical Center Göttingen, Germany. SCHOLARSHIPS Aug. 2018–present Research Fellowship, Medicine, Artificial Intelligence, and Law; Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; Cambridge, United States of America July 2015–Nov. 2015 Scholarship for Doctoral Students sponsored by the DAAD (German Academic Exchange Service) Oct. 2009–present E-fellows.net Scholarship GRANT WRITING Apr. 2016 Research Project: ClinhiPS – A Scientific, Ethical and Comparative Legal Analysis of the Clinical Application of Human Induced Pluripotent Stem Cells in Germany and Austria; sponsored by the BMBF (German Federal Ministry of Education and Research); funds: 657,678.00 EUR; term: Apr. 2016–Mar. 2018 PRESENTATIONS (SEL.) Nov. 2018 How Will AI Transform Healthcare? CELLS (Center for Ethics and Law in the Life Sciences) 10 Year Anniversary Celebration, Leibniz University Hannover, Germany Oct. 2018 AI in Drug Discovery and Clinical Trials, Panel IV: Innovations in Drug Discovery and Policy, Drug Pricing Policies in the United States and Globally: From Development to Delivery, Harvard Law School, Cambridge, United States of America Oct. 2018 Artificial Intelligence and the Explosion of Health Data: Global Ethical & Legal Issues (together with