Publications

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Hess R D, Aumer D M and Schulz S D. “Implementation of IVDR and MDR Into National Legislation.” Regulatory Focus. September 2019. Regulatory Affairs Professionals Society.

 

Hess, RD, Leister B, Rosenthal, F. “Quo vadis ancillary materials”, manuscript in preparation (RAPS).

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Hess, RD, Laaff H. (2017). Biorepositories and Biomarker Development: Regulatory Challenges. Biomark J. Vol.3 No 3:15.

 

Hess RD, Mathieu M, Russmann D. (2015).  “Ebola—Expedited Pathways for Drugs and Vaccines in Europe: The EMA Perspective.” Regulatory Focus. July 2015. Regulatory Affairs Professionals Society.

 

Hess RD, B Sall, A Kappes, D Russmann. (2015). How to leverage CE data of implants used for CE marking in the U.S. for PMA approval. European Cells and Materials Vol. 29. Suppl. 2, 2015 (page 15) ISSN 1473-2262.

 

Longhurst, S; Hess RD (2014): Bioassay Transfer. in: Technology Transfer and Knowledge Management Book, eds: Mark Gibson & Siegfried Schmitt, Davis Healthcare International Publishing LLC.

 

Hess RD, Weber, F, Watson K and Schmitt S. (2012) “Regulatory, Biosafety and Safety Challenges of Novel Designer Cells as Substrates for Human Vaccines”. Vaccine  30(17):2715-27, doi 10.1016/j.vaccine.201202.05.

 

Hess RD. (2012) Biomarker: Regulierung der In-vitro Diagnostika in Europa: Herausforderungen der Zukunft, begleitdiagnostische Verfahren. Forum Newsletter, April, 2012, http://www.forum-institut.de/de/vergabe-newsletter/newsletter-april-2012/.

 

Hess RD (2011). Comments on DRAFT EMA Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. (EMA/CHMP/BMWP/86289/2010), November 18, 2010 Newsletter, Therapeutic Protein Immunogenicity Focus Group, January 2011, Volume 1, Issue 1.

 

Hess, RD, Watson, K, Schmitt S. (2010). What is an Advanced Therapy Medicinal Product, GMP Review, vol 9: 23-25, 2010.

 

Hess RD, (2010) Advanced Therapy Medicinal Products in the EU: navigating the regulatory maize. RAJ Devices Mar/Apr, 1-7.

 

Hess RD and Partha Gosh (2009). “Vaccines: preventive and therapeutic vaccines and adjuvants on the rise”. J Clin Studies, July 2009: 40-43.

 

Hess RD and Russmann D (2009). “Understanding Immunogenicity Responses”, February 2009, Pharmaceutical Technology Europe, Volume 21, Issue 2.

 

Schmitt S and Hess RD (2008): in: Quality for Biologics Report, chapter contribution, “Specifications and drug substance for lot release”, Biopharm Knowledge Publishing, 2008

 

Huzly D, Hess RD (2007). "Möglichkeiten und Grenzen der serologischen Epstein-Barr-Virus-Diagnostik". "Potential and Limitations of Serological Epstein-Barr Virus Diagnostics"; Dtsch. med Wochenschr (DMW) 132: 151-154.

 

Hess RD (2006). Das H5N1-Influenza-A-Virus. MTA Dialog, vol 4: 2-7.

 

Hess RD, Gaertner BC, Garrett P (2005). Meeting Report, Part III: Notes from the Twentieth Annual Clinical Virology Symposium, April 25-28, 2004, Clearwater Beach, Florida, USA J Clin Virol, 33: 83-87.

 

Hess RD, Gaertner BC, Garrett P (2005). Meeting Report. Part II: Notes from the Twentieth Annual Clinical Virology Symposium. J Clin Virol, 32: 342-346.

 

Hess RD, Gaertner BC, Garrett P (2005). Meeting Report on Molecular Virology Workshop (April 23-23, 2004) and the 20th Annual Clinical Virology Symposium, Clearwater, FL, USA (April 25-28, 2004). J Clin Virol, 32: 259-262.

 

Hess RD, (2004). Routine Epstein-Barr virus diagnostics from the laboratory perspective: still challenging after 35 years. J Clin Microbiol 42: 3381-3387.

 

Csango PA, Pedersen JE, Hess RD (2004). Comparison of four Mycoplasma pneumoniae IgM-, IgG-, and IgA-specific commercially available enzyme immunoassays in healthy blood donors and patients with other diseases. Clin Microbiol and Infection 10: 1094-1098.

 

Gärtner BC, Hess RD, Bandt D, Kruse A, Rethwilm A, Roemer K, Mueller-Lantzsch N (2003). Evaluation of four commercially available Epstein-Barr Virus Enzyme Immunoassays with an immunofluorescence as the reference method. Clin Diag Lab Immunol 10: 78-82.

 

Hess RD (2002): Aktuelle virale Darminfektionen: Erreger, Klinik und Diagnostik. Teil 2 Klinik und Diagnostik, MTA Dialog, vol 11: 964-969.

 

Hess RD (2002): Aktuelle virale Darminfektionen: Erreger, Klinik und Diagnostik. Teil 1 Erreger und Systematik, MTA Dialog, vol 9: 750-754.

 

Metzger C, Terletskaia-Ladwig C, Hess RD, Enders G (2001). Rationale und rationelle Enterovirus-Diagnostik. Dt. Med. Wochenschrift (DMW) 126: 289-293.

 

Hess RD, Lieske R, Klopfer G, Acheson DWK (1999). Conclusions from a questionnaire on STEC/VTEC diagnostics in the federal republic of Germany. Poster presentation ASM, Chicago, Il, USA, June 1st, 1999.

 

Hess RD, Lieske R, Klopfer G, Acheson DWK (1999). Conclusions from a questionnaire on STEC/VTEC diagnostics in the Federal Republic of Germany. J Lab Med 23: 427-436.

 

Hess RD, Lieske R, Weber B (1999). The 2nd International Symposium of the European Study Group on Enterohemorrhagic Escherichia coli (EHEC). Emerging Infectious Diseases 5: 730-733.

 

Merlin T, Brandner G, Hess RD (1998). Cell cycle arrest in ovarian cancer cell lines does not depend on p53 status upon treatment with cytostatic drugs. Int J Oncol, 13: 1007-1016.

 

Siegel J, Brandner G, Hess RD (1998). Cross-reactivity of the monoclonal antibody 9E10 with murine c-MYC. Int J Oncol, 13: 1259-1262.

 

Hess R (1998). Leserbrief zur EHEC-Diagnostik. ÄBW, 1: 12.

 

Ihling C, Haendeler J, Hess RD, Schaefer HE, Zeiher AM (1998). Coexpression of p53 and MDM2 in human atherosclerosis: implications for the regulation of cellularity of artherosclerotic lesions. J Pathol, 185: 303-312.

 

Brandstetter T, Ninci E, Falken U, Wagner E, Hess R, Bauknecht T (1998). RHG-CSF affects genes involved in mitogen signalling and early gene expression in the ovarian cancer cell line HEY. Int J Cancer 75: 847-854.

 

Obert M, Pleuger H, Hanagarth H, Schulte-Mönting J, Wiesmüller KH, Braun DG, Brandner G, Hess RD (1998). Protection of mice against SV40 tumours by Pam3Cys, MTP-PE and Pam3Cys conjugated with the SV40 T antigen-derived peptide K(698)-T(708). Vaccine, 16: 161-169.

 

Hess RD, Brandner G (1997). DNA-damage-inducible p53 activity in SV40-transformed cells. Oncogene 15: 2501-2401.

 

Merlin T, Hess RD, Einzmann T, Bauknecht T, Brandner G (1997). p53-dependent and independent apoptosis, and cell cycle arrest in ovarian cancer cell lines after treatment with cisplatin, etoposide, gemcitabine and paclitaxel. J Cancer Res Clin Oncol, 123: 33.

 

Hess RD & Brandner G (1996). p53 in normal and neoplastic tissue: analysis and function. (invited review) El J Pathol Histol, 961-07.

 

Hess RD and Brandner G (1996). DNA damage by filtered, tar- and aerosol-free cigarette smoke in rodent cells: a novel evaluation. Toxicol Lett, 88: 9-13

 

Ihling C, Menzel G, Hess R, Hoh M, Friedrich G, Schaefer HE, Zeiher AM (1996). P53-Akkumulation, MDM2-Expression und Apoptose bei humaner Atherosklerose. Verh. Dtsch. Ges. Path: 80, 672.

 

Ihling C, Menzel G, Hess RD, Friedrich G, Schaefer HE, Zeihe, M (1996). Evidence for MDM2/p53 complex formation in advanced human atheroscleosis: implications for the regulation of atherosclerotic lesion cellularity. Circulation 94 (8), 3425 (Suppl.).

 

Plaumann B, Fritsche M, Rimpler H, Brandner G and Hess RD (1996). Flavonoids activate wild-type p53. Oncogene, 13: 1605-1614.

 

Ihling C, Menzel G, Hess R, Welles E, Schaefer HE, Zeiher AM (1996). Topographical association between the cyclin-dependent kinase inhibitor p21 and cellular proliferation in human atherosclerotic tissue. Circulation 94 (8), 3734 (Suppl.).

 

Siegel J, Fritsche M, Mai S, Brandner G and Hess RD (1995). Enhanced p53 activity and accumulation in response to DNA damage upon DNA transfection. Oncogene 11: 1363-1370

 

Brandner G, Schulze-Lutum A, Hess R (1995). Genotoxicity of filtered, tar- and aerosol-free tobacco smoke in rodent cells. Zentralblatt Hygiene 198: 4

 

Siegel J, Hess RD, Plaumann B, Haessler C and Brandner G (1995). Uptake of single-or double-stranded DNA sensitizes cells for the accumulation of p53 in response to DNA damage induced by mitomycin C. J Cancer Res Clin Oncol 121, 69.

 

Schulze-Lutum A, Siegel J, Schmidt RJ, Plaumann B, Braun C, Haessler G and Hess RD (1995). Filtered, Tar-and aerosol-free cigarette smoke elicits accumulation of p53 in rodent cells. J Cancer Res Clin Oncol 121, 28.

 

Schmidt RJ, Siegel J, Haessler C, Brandner G and Hess R.D (1995). P53 accumulation elicited by lipopolysaccharide (LPS) combined with interferon-gama and by NO-generating agents. J Cancer Res Clin Oncol 121, 12.

 

Hess RD, Kuther M, Haessler C, Paetzold, S., Braun DG and Brandner G (1995). Quantitative cytofluorimetric determination of cell-membrane-associated large tumor antigen on SV40-transformed cells. Cytometry, 20, 81-85.

 

Agostini HJ, Gerstenecker B, Haessler C, Braun DG, Brandner G and Hess RD (1995). Monospecific polyclonal anti-anti-idiotypic antibodies to the carboxyterminal undecapeptide of the SV40 large tumor-antigen. Scand J Immunol, 41, 256-262.

 

Hess R, Plaumann B, Schulze-Lutum A, Haessler C, Heinz B, Fritsche M and Brandner G (1994). Nuclear accumulation of p53 in response to treatment with DNA damaging agents. Toxicol Lett 72: 43-52.

 

Schulze-Lutum A, Siegel J, Plaumann B, Braun C, Haessler C, Brandner G and Hess RD (1994). Filtered, tar- and aerosol-free cigarette smoke causes accumulation of the tumor suppressor protein p53 in murine cells in vitro. Int J Oncol 5, 1405-1409.

 

Fritsche M, Siegel J, Hess R, Plaumann B, Haessler C, Heinz B and Brandner G (1994). Nuclear accumulation of p53 in response to treatment with DNA-damaging agents: Detection of possible carcinogens. Zentralblatt Hygiene 195: 150.

 

Hess R, Rau P, Schwab M, Paetzold S, Kuther M, Obert M, Agostini H, Haessler C, Braun DG and Brandner G (1994). Covalent immunochemical membrane labelling of viable cells with K698-T708, a simian virus 40 tumor antigen-derived peptide. Peptide Research 7: 146-152.

 

Hanagarth HG, Obert M, Hess R, Haessler C, Braun DG, Brandner G (1994). Cell-binding carboxyterminal undecapeptide of SV40 tumor antigen provides immunity. Vaccine 12: 1197-1202.

 

Hess R, Oberbeck J, Grussenmeyer T, Schoeffel-Keller A, Haessler C, Braun DG and Brandner G (1994). PAb1614, a monoclonal antibody reactive with the tumor antigens of SV40, JC, BK, and polyoma virus and other JC virus tumor antigen crossreactive antibodies of the PAb1601-1636 panel. Intervirology 37:47-52.

 

Siegel J, Fritsche M, Hess R, Haessler C and Brandner G (1993). P53 accumulation assay: detection of possible carcinogens. J Cancer Res Clin Oncol 119: 85

 

Obert M, Hess R, Kuther M, Rau P, Haessler C, Braun DG and Brandner G (1993). Prevention of SV40 tumor growth by a bacterial lipopeptide derivative. J Cancer Res Clin Oncol 117:58.

 

Hess R, Hanagarth HG, Haessler C, Brandner G (1991). A peptide vaccine against simian virus 40 tumors. J Cancer Res Clin Oncol 117: 11.