Hagit Hoch-Marchaim, Ph.D.
Home address: 10 Hazait St., Aseret.
Most of the submissions were for biologics, but work on a PMA supplement (for a combination product) and on a Class II device (the device used for EVICEL application) was also done.
A BLA Project Manager, managing all activities required for BLA submission, in-house and outsourced. Prepared and submitted a BLA-FFMU for a combination product.
QA related activities: A member of the Quality System Improvement Plan core team, review and approval of validation protocols and reports as well as change control documents, taking part in decisions on batches with manufacturing deviations and deviation reports to the FDA, participating in FDA and IMOH inspections.
Product Manager, Regulatory Affairs Department, Kamada Ltd. Preparation of regulatory submissions of a biological innovative product, management of activities required by the regulatory bodies for these submissions (EMEA and FDA), management of one RA employee.
Pre-clinical Development Manager, designed and monitored outsourced pre-clinical studies; responsible for review and revisions of pre-clinical reports and writing the relevant chapters for regulatory submissions (FDA and EMEA).
Set up in vivo and in vitro models for an anti cancer drug, management of 3 employees.
Directors and Officers Course, The College of Management.
Ph.D. thesis: Characterization of Novel proteins derived from the mouse mammary tumor virus (MMTV) in T-cell lymphomas.
Ph.D. studies under the supervision of Prof. Jacob Hochman.
M.Sc studies in Microbiology, with distinction, under the supervision of Prof. Jacob Hochman and Prof. Uriel Bachrach.
M.Sc. thesis: Expression of cell adhesion molecules in mouse lymphoma cells: A comparative analysis of malignant vs. non-malignant cells derived from them.
B.Sc. in Biology, with distinction.
Undergraduate research projects under the supervision of Prof. Y. Becker, Prof. P. Lazarovici and Prof. J. Hochman.
Lecturer, Bio Medical Research and Development course, The College of Management
- H. Hoch-Marchaim, A. M. Weiss, A. Bar-Sinai, M. Fromer, K. Adermann and J. Hochman: The leader peptide of MMTV Env precursor localizes to the nucleoli in MMTV derived T-cell lymphomas and interacts with nucleolar protein B23. 2003, Virology, 313: 22-32.
- H. Hoch-Marchaim, T. Hasson, E. Rorman, S. Cohen and J. Hochman: Nucleolar localization of mouse mammary tumor virus proteins in T-cell lymphomas. 1998, Virology 242: 246-254.
- N. Assaf, T. Hasson, H. Hoch-Marchaim, J. Pe’er, H. Gnessin, M. Deckert-Schuluter, O. D. Wiestler and J. Hochman: An experimental model for infiltration of malignant lymphoma to the eye and brain. 1997, Virchows Arch 431: 459-467.
- Lazarovits Janette, Hagai Yocheved, Plaksin Daniel, Vogel Tikva, Nimrod Abraham, Mar-Haim Hagit, Szanton Esther, Richter Tamar, Amit Boaz, Kooperman Lena, Peretz Tuvia & Levanon Avigdor: Isolated molecules comprising epitopes containing sulfated moieties, antibodies to such epitopes, EPO Patent 1406930-A2 (Application Number EP20010994330 20011231Application Date:2001-12-31, Publication Date:2004-04-14); PCT Patent WO/2002/053700 (Application Number: PCT/US2001/049442, Application Date2001-12-31,Publication Date: 2002-07-11); Korea Patent 1020037008890 (Application Number: 1020037008890 Publication Number: 1020030091953,Application Date: 2003-06-30, Publication Date: 2003-12-03); Hong Kong Patent 1082259 (Application Number: 06101388.2, Application Date: 2006-02-01, Publication Date: 2006-06-02).
- Avigdor Levanon, Yocheved Hagay, Daniel Plaksin, Tikva Vogel, Abraham Nimrod, Hagit Mar-Haim, Ester Szanthon, Tamar Richter, Boaz Amit, Lena Cooperman, Tuvia Peretz, Janette Lazarovits: Multimers – isolated molecules comprising epitopes containing sulfated moieties, antibodies to such epitopes, and uses thereof. Application No. 20040001839, Filed: December 31, 2001; Issued: January 1, 2004.
- Avigdor Levanon, Yocheved Hagay, Daniel Plaksin, Tikva Vogel, Abraham Nimrod, Hagit Mar-Haim, Esther Szanthon, Tamar Richter, Boaz Amit, Lena Cooperman, Tuvia Peretz, Janette Lazarovits: Y1-isolated molecules comprising epitopes containing sulfated moieties, antibodies to such epitopes, and uses thereof. Application No. 20040001822, Filed: December 31, 2001, Issued: January 1, 2004.
- Levanon, Avigdor , Ben-levy, Rachel, Plaksin, Daniel, Szanton, Esther, Hagai, Yocheved, Mar-chaim, Hagit Hoch: Antibodies and Uses Thereof. Application Number: 10/611588. Publication Date: 10/21/2004. Filing Date:06/30/2003.
- Lazarovits Janette, Nimrod Abraham, Hoch Mar-chaim Hagit & Levanon Avigdor: Compositions and Methods for Therapeutic Treatment. United States Patent Application 20040202665. Application Number: 10/610843. Publication Date:10/14/2004. Filing Date: 06/30/2003.
Proceedings and Abstracts:
- H. Hoch-Marchaim, T. Hasson, E. Rorman, S. Cohen and J. Hochman: Nucleolar MMTV proteins generated from the env precursor in a T-cell lymphoma. 1998, A Cold Spring Harbor laboratory meeting on dynamic organization of nuclear function, p. 107.
- H. Hoch-Marchaim, T. Hasson, E. Rorman and J. Hochman: Mouse mammary tumor virus (MMTV) antigens expressed in the nuclei of variant lymphoma cells. 1997, Proceedings AACR Vol. 38 p. 158.
- H. Hoch-Marchaim, T. Hasson, E. Rorman and J. Hochman: Nuclear localization of mouse mammary tumor virus (MMTV) antigens in S49 lymphoma. 1997, The 27th Annual meeting of the immunological society, p. 55.
- H. Hoch-Marchaim, T. Hasson, E. Rorman, E. Braun & J. Hochman: A search for genes involved in cell adhesion, tumorigenicity and immunogenicity of mouse lymphoma cells. 1996, 26th Annual meeting of the Israel Immunology society, p.67.
- J. Hochman, N. Assaf, M. Bergel, H. Gnessin, T. Hasson, H. Hoch-Marchaim & J. Pe’er: An experimental model for intraocular metastasis of malignant lymphoma. 1996, Investigative ophthalmology & visual science, 37: S225.
- H. Hoch-Marchaim, M. Bergel & J. Hochman: Expression of cell adhesion molecules in S49 mouse T-cell lymphoma correlates with the malignant state. 1995, First lower Saxony-Israel symposium in the life sciences.
- J. Hochman, N. Assaf, E. Banin, M. Bergel, T. Hasson, H. Hoch-Marchaim, E. Levi, E. Okon, & J. Pe’er: A mouse model for infiltration of malignant lymphoma to the eye and brain. 1995, Annual meeting of the Israel society for eye and vision research.