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 Cohen, I. G.), Technology & Health Seminar Series, Harvard Global Health Institute, Cambridge, United States of America Sept. 2018 Precision Medicine, Artificial Intelligence, and the Law (together with Cohen, I. G.), CeBIL Annual Symposium 2018, University of Cambridge, England Oct. 2017 The Clinical Translation of Human Induced Pluripotent Stem Cells: Legal Challenges and Hurdles? The Clinical Translation of Human Induced Pluripotent Stem Cells: A Stakeholder Conference on the Evaluation of Innovative Risk Research, Göttingen, Germany Sept. 2017 ELSA – Proposal of a New Strategic Working Group; 5th Annual GSCN (German Stem Cell Network) Conference; together with Cantz, T.; Jena, Germany Sept. 2017 Human Induced Pluripotent Stem Cells: Selected Aspects of the German Regulatory Position, University of Vienna, Austria June 2017 Poster Presentation of the “ClinhiPS” Project, ISSCR (International Society for Stem Cell Research) 2017 Annual Meeting, Boston, United States of America

4/7 Jan. 2017 Research in Europe: An Experience Report, Information Seminar on National and European Research Grants, Mannheim, Germany Apr. 2016 CRISPR/Cas9 – Genome Editing: The Ethical and Legal Situation in the United Kingdom, BRZ (Federal Association of the German Centers for Reproductive Medicine), Berlin, Germany Mar. 2016 Regulatory Hurdles for Bringing Limbal Stem Cell Research to Clinical Application in Germany and the UK, Durham CELLS (Center for Ethics and Law in the Life Sciences), United Kingdom

ORGANIZATION & MODERATION OF CONFERENCES, WORKSHOPS, ETC. (SEL.)

Dec. 2018 Moderator of the Panel Discussion: AI in Health Care, Seventh Annual Health Law Year in P/Review, Harvard Law School, Cambridge, United States of America Sept. 2018 Organizer and moderator (together with Cantz, T.) of the Symposium: ELSA – Ethical, Legal and Social Aspects of Stem Cell Research, including three workshops: . Workshop 1: Cell Therapy and Genome Editing; . Workshop 2: Organoids; . Workshop 3: Gametes (chair); as part of the 6th GSCN (German Stem Cell Network) Annual Conference; German Cancer Research Center (DKFZ), Heidelberg, Germany June 2018–Aug. 2018 Organizer and moderator of the Working Sessions: Nudging and AI Governance, as part of the Health and Wellbeing Working Group, Berkman Klein Center, Harvard University, Cambridge, United States of America Oct. 2017 Organizer and moderator (together with Hansen, S. L.) of the Workshop: Requirements for Securing Donor Rights, The Clinical Translation of Human Induced Pluripotent Stem Cells: A Stakeholder Conference on the Evaluation of Innovative Risk Research, Göttingen, Germany

TEACHING EXPERIENCE & CORRECTION OF / ASSESSOR IN EXAMS (SEL.)

Sept. 2016 Introduction of the Major Subject “Medical and Health Law” University of Mannheim, School of Law and Economics, University Mannheim, Germany Mar. 2015 Assessor, Oral Exam “Medical and Health Law”, Prof. Dr. Jochen Taupitz, University of Mannheim, Germany Jan. 2015 Teaching, Crash Course in Civil Law, undergraduate students, Integrated LL.B. and State Examination Program in Law, University of Mannheim, Germany, including the correction of 34 mock exams Jan. 2015 Creation of the PowerPoint slides (266 slides), Lecture: Medical Law, Prof. Dr. Jochen Taupitz, University of Mannheim, Germany Sept.–Dec. 2014 Teaching, Tutorial Civil Law 1.2, undergraduate students, Integrated LL.B. and State Examination Program in Law, University of Mannheim, Germany, including the correction of 17 mock exams Sept.–Dec. 2014 Teaching, Tutorial Civil Law 1.1, undergraduate students, Integrated LL.B. and State Examination Program in Law, University of Mannheim, Germany, including the correction of 18 mock exams

5/7 Apr. 2014 Correction of 10 Orientation Exams in Civil Law, Prof. Dr. Jochen Taupitz, University of Mannheim, Germany Mar. 2014 Assistance in the drafting of the case and solution to the case for the Orientation Exam in Civil Law, Prof. Dr. Jochen Taupitz, University of Mannheim, Germany Jan. 2014 Revision of the Script “Medical Law” (163 pages), Lecture: Medical Law, Prof. Dr. Jochen Taupitz, University of Mannheim, Germany

EDUCATION

July 2015–Mar. 2016 Durham University, United Kingdom Visiting Research – Law Field of study: Legal framework for bringing stem cell research to clinical application in the EU, Germany and the UK Supervisor: Prof. Shaun D. Pattinson

Feb. 2014–present University of Mannheim, Germany Doctorate in Law (Dr. iur.) Thesis: Stem Cell Research – From Laboratory to Clinic in the EU Supervisor: Prof. Dr. Jochen Taupitz

Sept. 2012–Dec. 2013 King’s College London, United Kingdom M.A. in Medical Ethics and Law Modules:

. Medical Law I: Consent, Refusal . Moral Theory and Medical Ethics and Request . Ethics at the End of Life

. Law at the End of Life . Topics in Medical Ethics . Law and Reproduction

Dissertation: A Market in Human Organs from the Living or an Opt-Out System? A Legal and Ethical Analysis to Identify a Way to Address the Organ Shortage in the United Kingdom (Mark: 75, A) Apr. 2009–July 2012 University of Augsburg, Germany Erste Juristische Prüfung and Dipl.-Jur. Univ. Major field of study: Biolaw, Health Law and Medical Law (14.6 points, A+) Final paper: The Transplantation of Organs – What are the Rights of Organ Donors and Organ Recipients?

Oct. 2006–Mar. 2009 University of Passau, Germany Law Studies

Oct. 1998–May 2006 Gymnasium Landschulheim Schloss Heessen, Hamm, Germany Allgemeine Hochschulreife (1.1, A+)

Aug. 1997–Oct. 1998 Gymnasium St. Christophorus, Werne, Germany

6/7 FURTHER EDUCATION (SEL.)

Jan. 2018 Food and Drug Law, taught by Peter Barton Hutt, Harvard Law School, Cambridge, United States of America Nov. 2017 The New European Data Protection Law – Recommendations for Companies in the Health Sector, Seminar BBLife, Potsdam, Germany Nov. 2017 The Product is the Process – Is it? Quality Aspects of the Manufacture of ATMP, Seminar BBLife, Berlin, Germany Sept. 2016–Nov. 2016 HLS4X: Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics; e-learning course taught by Glenn Cohen, Professor of Law, Harvard Law School; Cambridge, United States of America (final grade: 100 %, A+)

VOLUNTARY WORK / MEMBERSHIPS (SEL.)

Oct. 2018–present Advisory Board, iPStemRNA, Generation of GMP-Compliant Induced Pluripotent Stem Cells from Universal Donors, Helmholtz Center Munich, Germany Sept. 2017–present Initiator of the Strategic Working Group ELSA (Ethical, Legal and Social Aspects of the Modern Life Sciences), GSCN (German Stem Cell Network), Germany Aug. 2015–present Member of Durham CELLS (Center for Ethics and Law in the Life Sciences), United Kingdom Feb. 2015–present Member of the ISSCR (International Society for Stem Cell Research), Skokie, United States Nov. 2014 Jury member of the Negotiation Competition 2014, ELSA (European Law Students’ Association) Mannheim e.V., Germany July 2014–Oct. 2016 Probation officer of “Neustart”, non-profit private limited company, Mannheim, Germany Mar. 2014–present Member of the Association for the Promotion of German, European and International Medical Law, Health Law and Bioethics in Mannheim and Heidelberg, Germany

REVIEWER

Interdisciplinary Anthology, Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann, H. (eds.) ClinhiPS: Ein Stakeholder-Sammelband [ClinhiPS: A Stakeholder Anthology]. Berlin, Heidelberg: Springer (expected publication date: Spring 2019).

IT SKILLS

Microsoft Office (Word, Excel, PowerPoint, Outlook); Citavi Operating systems: Windows, Mac OS X Website maintenance: www.ClinhiPS.de (Apr. 2016–Mar. 2018; German and English)

LANGUAGES

German Native language English Business fluent French Good knowledge Spanish Basic knowledge 7/7