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Cv uwe totzke 20110609

Route de Bellegarde 36; 1284 Chancy/Geneva; Switzerland [+ 41] (0)79/ 83 83 856 (cell) / (0)22/ 756 06 44 (landline) Work Experience
Co-founder and Owner, Healthcare Consultant TOTZKE & DREHER SCIENTIFIC SA, Geneva, Switzerland Freelance Healthcare Consultant and Writer TOTZKE SCIENTIFIC Writing, Medical Affairs & Communication, Geneva, Switzerland Areas of expertise: Consultancy on regulatory and publication strategies; writing of clinical
documents for Regulatory Affairs (study protocols, reports, Module 2 of Common Technical
Documents; life cycle management: switch and repricing applications) and Medical Communication
(peer review journal publications)
June 2009 – March 2011 employed by Merck Serono SA, Geneva, Switzerland (Global Clinical Development Unit Rheumatology) Key accountabilities: Conceptualizing and supporting Phase I-III clinical trials in osteoarthritis and
cartilage injury in accordance with Clinical Development Plans; Acting as Clinical Trial Director (e.g.
NCT01066871); preparation/review of submission activities (e.g. briefing books, IND, IMPD, and
IB); presentation at scientific advice meetings; supporting early development projects; contributing to
due diligence assessments of in-licensing opportunities; supporting communication and alignment
between non-clinical research and clinical development; authoring global SOPs on the creation of
Clinical Development Plans, Study Concept Sheets, and Protocols.
October 2004 – October 2008 employed at HPM Healthcare Project Management SA, Geneva, Switzerland Head of Medical Writing (4 direct reports) & Management board member Key accountabilities: Building up the Medical Writing department, leadership and management of
the team, including responsibility for profit and loss; bidding; scientific consultancy; statistical
analysis; publication management; supervision of key projects (>40 CTD and >20 publication
projects); participation in HPM’s strategy planning.
Key accountabilities: Reviewing, editing and writing documents in compliance with GxP and
guidelines for competent authorities (e.g., CTDs, Clinical Expert Reports/Statements (CER/CES), trial
protocols and reports, Risk Management Plans, IMPDs, Safety Reports; narratives and causality
assessments) as well as for the public domain (manuscripts for peer-reviewed journals,
registries/websites; investigator and marketing brochures).
April 1999 – September 2004 employed at MDS Pharma Services Central Laboratory, Hamburg, Germany Key accountabilities: Set-up of new analytical techniques according to GLP-, NCCLS-, and FDA-
guidelines: check of feasibility, capacities, profitability; supervision of the validation; data analysis;
writing of Validation/Analytical Reports and SOPs; scientific support to internal departments and to
clients (technical information on methods; medical/clinical significance of lab tests and results);
member of the global scientific committee on the harmonisation of analysis procedures.
Senior Project Manager (4 direct reports) Key accountabilities: Set-up, supervision and management of all central lab actions in a clinical trial
according to GCP, the study protocol and sponsor´s requirements: set-up of the database; writing of in-
and external instruction documents as well as design of the blood collection kits for investigators;
presentations of study specific procedures on investigator meetings; supervision of the delivery of lab
material to and the pick-up of samples from the investigators, medical review and release of lab
results, coordination of affiliate laboratories in South America, South Africa, Australia, and Asia.
Research Experience
Institute of Zoology, Dept. Ethology, University of Vienna, Austria (Prof. Dr. J. Dittami) Research topics: Behavioural changes before and during onset of different variants of spongiform
encephalopathy (BSE; CJD) in Rhesus monkeys (EU-project in colaboration with G. Eder, Immuno
AG Vienna, A. Aguzzi, Zürich, and J. Collinge, London). Winter ecology of birds in reed beds; control
mechanisms of winter fattening in bearded tits (in colaboration with F. Bairlein (Wilhelmshaven).
October 1992 – October 1998 employed at Institute of Avian Research, Wilhelmshaven, Germany (Prof. Dr. F. Bairlein) Postdoctoral Research Associate (DFG Ba 816/12-1) Research topics: Control mechanisms of the migratory fattening in passerine birds; evaluation of
similarities to mammalian obesity by means of glucose tolerance and hormone response tests.
Colaboration with I. Schmidt (MPI, Bad Nauheim) on the effects of leptin on birds.
Research topics: Validation of heterologous immunoassays for the evaluation of hormone levels in
birds (in colaboration with A. Hübinger, Diabetes-Forschungsinstitut, Düsseldorf); seasonal variations
of blood metabolite and hormone levels in a migratory bird species (Sylvia borin); influence of food
shortage on seasonal hyperlipemia and hyperglycemia; influence of thyroidal and pituitary effectors on
fattening. Supervision of a project concerning the influence of fasting on blood composition in herring
gulls (in colaboration with O. Hüppop, Helgoland).
Institute of Biochemistry, Deutsche Sporthochschule (DSHS), Cologne, Germany (Prof. Dr. M. Donike) Research topics: Evaluation of the relevance of pituitary hormone and creatinine concentrations in the
urine of athletes for doping analysis; routine chemical preparation of urine samples preceding GC/MS
analysis for the detection of steroids.
Diploma in ‘Pharmaceutical Medicine’, European Center of Pharmaceutical Medicine (ECPM), University of Basle, Switzerland Dr. rer. nat. (PhD), University of Cologne, Germany Diploma in Biology (MSc), (Zoology, Botany, Biochemistry, Genetics), University of Cologne, Germany Prediploma in Biology (BS), University of Cologne, Germany Abitur; Candidate Stiftung des Deutschen Volkes Vocational Training
Statistics for Non-Statisticians Program, 2009-2010, Merck Serono Global Biostatistics • EMWA Professional Development Program, Foundation and Advanced Level Certificate, 2009, European Medical Writer Association (EMWA) • Action Leadership Program, 2003, Niagara Institute • Fachkunde Strahlenschutz, 1993, University of Hannover Expertise/Therapeutic Areas
• Clinical Research, Pharmaceutical and Laboratory Medicine • Good Practices (GLP, GCP, GPP) • Biosafety: EBSA-delegate; familiar with animal experimentation under Biosafety Level (BSL) 3 and 4 conditions; certified handle radioactive isotopes • Oncology, Osteoarthritis, Osteoporosis, Pain, Endocrinology, Diabetes, Metabolism, Technical Skills and Personal Traits
• Languages: German (native), English (business fluent), French (fluent) • MS Office Power user, SPSS, SigmaPlot • Well versed in statistics and in common analytical and laboratory techniques • ambitious and persistent (experienced marathon and ultra marathon runner and cyclist) CURRICULUM VITAE
Teaching and Expert Experience
• Contribution to lectures at the University of Vienna • Instruction and supervision of graduate and undergraduate students and trainees • Referee for a number of scientific journals (Austral Ecology, Canadian Journal of Zoology, Comparative Biochemistry & Physiology, Contemporary Clinical Trials, Functional Ecology, Journal of Comparative Physiology, Journal of Ornithology, Journal of Zoology, Zoology) Personal References
Publications (as main author)
• Totzke U (1995): Klinisch-chemische Charakterisierung und erste Befunde zur endokrinen Regulation der zugzeitlichen Fettdeposition der Gartengrasmücke (Sylvia borin). J. Ornithol. 136: 363 (Abstract).
• Totzke U (1995): Validierung heterologer Immunoassays zur Bestimmung von Hormonen des Energiestoffwechsels an Kleinvögeln. J. Ornithol. 136: 363-364 (Abstract).
• Totzke U, Bairlein F, Hübinger A (1996): Variations of plasma metabolites and hormones during migratory fat deposition of the garden warbler (Sylvia borin). Verh. Deutsch. Zool. Ges. 89.1: 191 (Abstract).
• Totzke U (1996): Klinisch-chemische Charakterisierung und Befunde zur endokrinen Regulation der zugzeitlichen Fettdeposition der Gartengrasmücke (Sylvia borin). Dissertation Universität Köln. • Totzke U, Bairlein F, Hübinger A (1997): The fat deposition of migratory birds: metabolic changes as in human type-IIb-diabetes ? Exp. Clin. Endocrinol. Diab. 105, Suppl. 1: 29 (Abstract).
• Totzke U, Hübinger A, Bairlein F (1997): A role for pancreatic hormones in the regulation of the autumnal fat deposition of the garden warbler (Sylvia borin)? Gen. Comp. Endocrinol. 107: 166-171.
• Totzke U, Hübinger A, Bairlein F (1998): Metabolic and hormonal adaptations in the garden warbler (Sylvia borin) during the premigratory fat deposition. Biol. Cons. Fauna 102: 346 (Abstract).
• Totzke U, Hübinger A, Bairlein F (1998): Glucose utilization rate and pancreatic hormone response after oral glucose loads are influenced by the migratory condition and fasting in the garden warbler (Sylvia borin). J.
158: 191-196.
• Totzke U & Bairlein F (1998): Implications of food supply and fattening in the migratory garden warbler (Sylvia borin). Ostrich 69: 385-386 (Abstract).
• Totzke U & Bairlein F (1998): The body mass cycle of the migratory garden warbler (Sylvia borin) is associated with changes in plasma metabolite levels. Comp. Biochem. Physiol. 121A: 127-133.
• Totzke U (1999): Grenzen der äußerlichen Depotfettmengenschätzung bei Zugvögeln. J. Ornithol. 140: 253 (Abstract).
• Totzke U & Bairlein F (1999): Ähnlichkeiten bei der Fettdeposition für den Zug und für den Winter? J. Ornithol. 140: 244 (Abstract).
• Totzke U, Hübinger A, Korthaus G, Bairlein F (1999): Fasting increases the plasma glucagon response in the migratory garden warbler (Sylvia borin). Gen. Comp. Endocrinol. 115: 116-121.
• Totzke U, Fenske M, Hüppop O, Raabe H, Schach N (1999): Influence of fasting on blood and plasma composition in herring gulls (Larus argentatus). Physiol. Biochem. Zool. 72(4): 426-437.
• Totzke U, Hübinger A, Dittami J, Bairlein F (2000): The autumnal fattening of the long-distance migratory garden warbler (Sylvia borin) is stimulated by intermittent fasting. J Comp Physiol B 170: 627-631
• Totzke U & Kuyas C (2005): Non-frozen transports of whole blood samples do not cause relevant bias for global coagulation tests in clinical trials evaluating the drug safety. Contemp. Clin. Trials 26(4): 488-502.
Publications (as co-author)
• Bairlein F & Totzke U (1992): New aspects on migratory physiology of trans-Saharan passerine migrants.
Ornis Scand. 23: 244-250.
• Büdinger L, Neuser N, Totzke U, Merk HF, Hertl M (2001): Preferential usage of TCR-Vß17 by peripheral
and cutaneous T cells in Nickel-induced contact dermatitis. J. Immunol. 167: 6038-6044.
• Lim K & Totzke U (2004): Die Integration des Problem-based Learning in die Ausbildung zum
Physiotherapeuten. Z. Physiotherapeuten 56: 33-41.
• Dittami J, Meran I, Bairlein F, Totzke U (2006): Winter patterns of foraging, fat deposition and
corticosterone differ between Bearded and Blue Tits: Is this an expression of egalitarian or depositic winter
flocks? J. Ornithol. 147 suppl: 158 (Abstract).
• Lopatka L, Totzke U, Schmid A, Käufeler R (2007): Die Traubensilberkerze in der Behandlung
menopausaler Beschwerden – Ergebnisse einer Therapiebeobachtung mit Cimifemin® uno. J. Menopause
14(2): 16-21.
• Steinmetz HT, Hellmich M, Neise M, Aldaud A, Lerchenmüller C, Tsamaloukas A, Fandel F, Weiligmann C, Totzke U, Schmitz S (2007): Prediction of the responsiveness to treatment with erythropoiesis-stimulating
factors - a prospective clinical study in patients with solid tumors. Oncologist 12: 748-755.
• Haschke-Becher E, Vockenhuber M, Niedetzky P, Totzke U, Gabriel C (2008): A new high-throughput
screening method for the detection of chronic lymphatic leukemia and myelodysplastic syndrome. Clin Chem
Lab Med
46(1): 85-88.
• Steinmetz HT, Totzke U, Söling U, Groschek M, Mittermüller J, Schweigert M, Tesch H, Nawka S, Schmitz
S, Tsamaloukas A (2008): Hemoglobin levels that trigger ESA treatment decisions for cancer associated
anemia – examination of practice in Germany. Curr Med Res Opin 24(10): 2751-2756.
• Haschke-Becher E, Totzke U, Afazel S, Johansson T, Schwarz M, Ladurner G, Wild C (2009): Clinical
decision rules for the use of liquor diagnostics in hospitalised neurology patients reduced costs without
affecting clinical outcomes. Int J Technol Assess Health Care 25(2): 208-13.
• Steinmetz HT, Totzke U, Tsamaloukas A, Schweigert M, Mittermüller J, Nawka S, Tesch H, Groschek M,
Söling U, Hellebrand E, Schmitz S (2011): A prospective observational study of anaemia management in
cancer patients - results from the German Cancer Anaemia Registry. Eur J Cancer Care 20: 493-502
• Isbaniah F, Wiyono WH, Yunus F, Setiawati A, Totzke U, Verbruggen M (2011): Echinacea along with zinc,
selenium, and vitamin C to alleviate exacerbation of chronic obstructive pulmonary disease: results from a
randomised controlled trial. J Clin Pharm Therap. [Epub ahead of print]
• Apprich S, Mamisch TC, Welsch GH, Stelzeneder D, Albers C, Totzke U, Trattnig S (2011): Quantitative T2
Mapping of the patella at 3.0 Tesla is sensitive to early cartilage degeneration, but also to unloading of the
knee. Eur J Radiol [Epub ahead of print]
Publications with acknowledged contributions
• Scheiffarth G, Wahls S, Ketzenberg C, Exo KM (2002): Spring migration strategies of two populations of bar-tailed godwits, Limosa lapponica, in the Wadden Sea: time minimizers or energy minimizers? Oikos
96(2): 346–354.
• Bairlein F (2002): How to get fat: nutritional mechanisms of seasonal fat accumulation in migratory songbirds. Naturwissenschaften 89(1): 1-10.
• Kunz I, Meier KM, Bourson A, Fisseha A, Schilling W (2008): Effects of rimonabant, a cannabinoid CB1 receptor ligand, on energy expenditure in lean rats. Int. J. Obesity 32(5) 863-870.
• Haschke-Becher E, Brunser O, Cruchet S, Gotteland M, Haschke F, Bachmann C (2008): Urinary D-lactate excretion of infants receiving Lactobacillus johnsonii with formula. Ann. Nutr. Metab. 53(3-4):240-244
• Steinmetz T, Tsamaloukas A, Schmitz S, Wiegand J, Rohrberg R, Eggert J, Breuer F, Tessen HW, Eustermann H, Thomas L (2010): A new concept for the differential diagnosis and therapy of anaemia in
cancer patients. Support. Care Cancer [Epub ahead of print]
• Apprich S, Welsch GH, Mamisch TC, Szomolanyi P, Mayerhoefer M, Pinker K, Trattnig S (2010). Detection of degenerative cartilage disease: comparison of high-resolution morphological MR and quantitative T2
mapping at 3.0 Tesla. Osteoarthritis Cartilage 18(9):1211-7
• The Leishmaniasis East Africa Platform (LEAP) group (2010): Geographical variation in the response of visceral leishmaniasis to paromomycin in East Africa: a multicentre, open-label, randomized trial. PLoS Negl.
Trop. Dis.
26(4) e709.
• Saupe N, Zubler V, Hodler J, Zanetti M, Mamisch TC, Pfirrmann CWA (in press): Intraarticular delayed gadolinium-enhanced mri of cartilage of the hip. When to image after direct arthrography? Radiology • Parmar S, Stingl JC, Huber-Wechselberger A, Kainz A, Renner W, Langsenlehner U, Krippl P, Haschke- Becher E (submitted) The impact of the UDP-glucuronyltransferase 2B7 polymorphism on progression free survival of epirubicin-treated breast cancer patients. J. Clin. Oncol. • Schmitz S, Chatsiproios D, Potthoff K, Hellebrand E, Link H (submitted): A two-day cross sectional survey suggests a paradigm change for the treatment of cancer-associated anaemia in Germany. Support. Care Cancer Congresses and invited lectures
127th Annual Meeting DO-G, Wilhelmshaven, Germany, 21.-26.9.1994 (2 poster)
89th Annual Meeting DZG, Oldenburg, Germany, 27.5.-1.6.1996 (lecture)
41st Symposion DGE, Lübeck, Germany, 6.-8.5.1997 (lecture)
Max-Planck-Institut für Verhaltensphysiologie, Andechs, Germany, 24.2.1997 (invited lecture)
1st Meeting EOU, Bologna, Italy, 28.-30.8.97 (poster)
Konrad-Lorenz-Institut für vergleichende Verhaltensforschung, Austrian Academy of Sciences, Vienna,
22nd IOC, Durban, South Africa, 17.-22.8.98 (poster)
131st Annual Meeting DO-G, Jena, Germany, 7.-11.10.1998 (1 poster, 1 lecture)
133rd Annual Meeting DO-G, Leipzig, Germany, 19.-25.9.2000 (poster)
14th Spring Meeting EMWA, Malta, 17.-21.5.2005
18th European Meeting DIA, Paris, France, March 2006
15th Spring Meeting EMWA, Lyon, France, May 2006
24th IOC, Hamburg, Germany, 13.-19.8.2006 (poster)
19th European Meeting DIA, Vienna, Austria, 26.-28.3.2007
9th Autumn Meeting EMWA, Basle, Switzerland, 1.-3.11.2007
20st European Meeting DIA, Barcelona, Spain, 3.-5.3.2008
• Annual Meeting of the German, Austrian, and Swiss Societies for Haematology and Oncology (DGHO,
ÖGHO, SGMO, SGH), Vienna, Austria, 10.-14.10.2008 • 17th Spring Meeting EMWA, Ljubljana, Slovenia, 26.-30.5.2008
OARSI 2009 World Congress on Osteoarthritis, Montreal, Canada, 10.-13.9.2009
9th World Congress ICRS, Sitges/Barcelona, Spain, 26.-29.9.2010
Professional Memberships
• ICRS, International Cartilage Repair Society (2010 – current) • TIPPA, The International Publication Planning Association (2008 – current) • SWAPP, Swiss Association of Pharmaceutical Professionals (2007 – current) • DIA, Drug Information Association (2006 – current) • EMWA, European Medical Writer Association (2005 – current) • EBSA, European Biosafety Association (2000 – 2004) • DO-G, Deutsche Ornithologen-Gesellschaft (1997 – 2008)



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