Curriculum Vitae
`
`Uwe Christians, M.D., Ph.D.
`
`Professor (with tenure)
`Department of Anesthesiology
`University of Colorado, Anschutz Medical Campus
`
`Professor für Experimentelle und Klinische Pharmakologie und Toxikologie (apl.)
`Institut für Pharmakologie
`Medizinische Hochschule Hannover
`Hannover, Germany
`
`Address for correspondence
`iC42 Clinical Research & Development
`University of Colorado
`Bioscience 2, Suite 200
`12705 East Montview Boulevard
`Aurora, Colorado 80045-7109
`
`Phone: 303 724 5665 (direct)
`303 724 5670 (administration)
`Fax: 303 724 5662
`e-mail: uwe.christians@cuanschutz.edu
`
`Castle Rock, Colorado, October 20, 2021
`
`MYLAN - EXHIBIT 1033
`
`

`

`
`
`2 of 105
`
`Medizinische Hochschule Hannover
`
`Medizinische Hochschule Hannover
`
`Medizinische Hochschule Hannover
`
`Stanford University, School of Medicine
`
`University of California, San Francisco,
`School of Pharmacy
`
`University of Colorado, Denver
`
`Board certified
`Pharmacologist and
`Toxicologist
`
`Ph.D.
`
`Board certified
`Clinical
`Pharmacologist
`
`Post-doctorate
`
`1992
`
`1995
`
`1996
`
`Experimental and Clinical
`Pharmacology and
`Toxicology
`
`Residency in Clinical
`Pharmacology
`
`1996-1999
`
`1996-2000
`
`
`2005
`
`Cardiothoracic Surgery/
`Transplant Immunology
`
`Biopharmaceutical
`Sciences
`
`Clinical Pharmacology
`
`2007
`
`Master in Research Quality
`Assurance
`
`Education (Undergraduate, Graduate, Postgraduate, Fellowships)
`
`
`___________________________________________________________________________________________________________
`
`
`
`
`
`
`
`
`
` YEAR
`
`FIELD OF STUDY
` INSTITUTION AND LOCATION
`
`
` DEGREE
` CONFERRED
`
`___________________________________________________________________________________________________________
`
`
`
`
`
`Medizinische Hochschule Hannover,
`M.D.
`1988
`Medicine
`
` Hannover, Germany
`(with highest
`Undergraduate and graduate
`
`honors)
`student
`
`
`
`Residency in Pharmacology
`
`and Toxicology
`
`
`
`
`
`
`
`
`
`
`
`Post-doctorate
`
`
`
`
`
`Diplomate,
`
`American Board of
`Clinical
`
`Pharmacology
`
`
`
`British Association of Research Quality Assurance Research Quality
`Specialty, Subspecialty
`Assurance
`
`
`Professional Licensure
`
`
`
`
`1988 (active)
`1988 (active)
`
`1993 (active)
`
`1996 (active)
`
`May 1997- May 1998
`
`August 2005 (active)
`
`December 2005 (active)
`
`License to practice medicine, Germany
`Educational Commission for Foreign Medical Graduates (ECFMG),
`certificate number 427-538-4
`Board certified pharmacologist and toxicologist (Medical Board of the
`State of Lower Saxony, Germany)
`Board certified clinical pharmacologist (Medical Board of the State of
`Lower Saxony, Germany)
`Restricted license to practice medicine at the University of California,
`San Francisco (according to § 2111)
`Distinguished Teaching License to practice medicine in the State of
`Colorado
`Diplomate, American Board of Clinical Pharmacology
`
`
`Uwe Christians, Curriculum vitae, revised 10/20/2021
`
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`3 of 105
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`
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`Academic and Professional Positions Held
`
`
`1988-1995
`
`Head of the Laboratory of Therapeutic Drug Monitoring and Drug
`Metabolism, Institut für Allgemeine Pharmakologie, Medizinische
`Hochschule Hannover, Hannover, Germany
`
`Instructor in Pharmacology and Toxicology, Instrumental Analytics
`
`“Privatdozent” (Assistant Professor), Medizinische Hochschule
`Hannover, Germany
`
`Visiting Assistant Professor, Department of Biopharmaceutical
`Sciences, University of California, San Francisco
`
`Professor of Clinical and Experimental Pharmacology and Toxicology
`(adj.), Medizinische Hochschule Hannover, Germany
`
`Associate Professor, Department of Anesthesiology, University of
`Colorado Health Sciences Center, Denver Colorado, with joint
`appointment in Pharmaceutical Sciences
`
`Director, Mass Spectrometry Core of the Clinical Nurtition Research
`Unit
`
`Director of Pharmacology, Bionovo Inc.
`
`Professor (with tenure), Department of Anesthesiology, University of
`Colorado Health Sciences Center, Denver Colorado
`
`Appointment in Biomolecular Structure
`
`1989-1995
`
`1995- 1999
`
`1997-2001
`
`1999- present
`
`2001-2004
`
`2002-2010
`
`2005-2008
`
`2005- present
`
`2006- present
`
`
` 2007- 2008
`
`
`Other Administrative Positions Held
`
`1992-1995 Member of the Board of Directors, SFB280 Center grant (Deutsche
`Forschungsgemeinschaft)
`
`1993-1994 Member of the Board of Directors of the Department of Pharmacology and
`Toxicology, Medizinische Hochschule Hannover
`
`1994-1995 Admissions committee for the School of Medicine, Medizinische Hochschule
`Hannover
`
`
`
`
`
`General Manager/ President Eurofins/Medinet Colorado
`
`
`Uwe Christians, Curriculum vitae, revised 10/20/2021
`
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`4 of 105
`
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`1995 Member of the Examination Committee for the Second Part of the Medical
`Licensing Exam (Pharmacology/Internal Medicine), Medizinischen Hochschule
`Hannover
`
`2001- 2007 Member of the Executive Committee of the Department of Anesthesiology,
`University of Colorado Health Sciences Center
`
`2001-present Member University of Colorado Hospital Clinical Laboratory Services
`Committee
`
`2001- present Executive Committee, Colorado Center for Human Nutrition
`
`2001- 2006 Executive Committee, Colorado Center for Altitude Medicine and
`Physiology
`
`2002- 2003 Member Faculty Senate, School of Medicine
`
`
`Memberships in Scientific, Professional and Scholarly Societies
`
`
`1991- present
`
`Deutsche Gesellschaft für Experimentelle und Klinische Pharmakologie
`und Toxikologie (German Society of Experimental and Clinical
`Pharmacology and Toxicology)
`International Society of the Study of Xenobiotics (ISSX)
`Arbeitsgemeinschaft Massenspektrometrie (Work Group Mass
`Spectrometry of the German Chemical Society)
`Deutsche Gesellschaft für Klinische Chemie (German Society of
`Clinical Chemistry)
`American Association of Clinical Chemistry
`International Association of Therapeutic Drug Monitoring and Clinical
`Toxicology
`American Association of Pharmaceutical Scientists
`American Society of Transplantation
`American Society of Clinical Pharmacology and Therapeutics
`American Association of Pharmaceutical Sciences (AAPS)
`
`Award of the “Freunde der Medizinischen Hochschule” Foundation for
`best thesis in 1988
`Young Investigator Award of the International Society of Therapeutic
`Drug Monitoring and Clinical Toxicology
`“Heisenberg” grant of the Deutsche Forschungsgemeinschaft
`
`1992- present
`1994- present
`
`1995- present
`
`1995- 2001
`1995- present
`
`1998-2000
`2004- present
`2005- present
`2007- present
`
`
`
`Honors and Awards
`
`
`1989
`
`1995
`
`1995
`
`
`Uwe Christians, Curriculum vitae, revised 10/20/2021
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`

`

`
`
`1997
`
`2008
`2009-2010
`
`2010-2011
`
`2015
`
`5 of 105
`
`Best Paper in “Drug Metabolism and Disposition” Award of the
`American Society of Pharmacology and Experimental Therapeutics
`Top Referee 2008, Journal of Chromatography B
`Named Vice-Chair Therapeutic Drug Monitoring and Toxicology
`Section (THE), American Association of Clinical Pharmacology and
`Therapeutics (ASCPT)
`Named Chair Biomarker and Imaging Section (BIO), American
`Association of Clinical Pharmacology and Therapeutics (ASCPT)
`C.E. Pippenger Award for Outstanding Contributions to Therapeutic
`Drug Monitoring, International Association of Therapeutic Drug
`Monitoring and Clinical Toxicology
`
`
`
`Doctoral Theses Completed under Mentorship
`
`1. Strohmeyer S. Biology (Universität Hannover, Hannover, Germany): Metabolism of
`cyclosporine and its metabolites by liver microsomes and hepatocytes. 1989
`
`2. Budniak J. Pharmacology (Medizinische Hochschule Hannover, Hannover, Germany):
`Cyclosporine metabolite patterns in blood and 24h- urine of liver transplant patients. 1991
`
`3. Deters M. Pharmacology (Medizinische Hochschule Hannover, Hannover, Germany):
`Drug interactions of H2- or calcium channel blockers with cyclosporine metabolism by
`human or rat microsomes or by rat hepatocytes. 1992
`
`4. Sattler M. Biochemistry (Universität Hannover, Hannover, Germany). Cytochrom P450-
`dependent extrahepatic metabolism of the immunosuppressive macrolides FK506 and
`rapamycin and of the undecapeptide cyclosporine. 1992
`
`5. Almeida VMF. Pharmacology (Medizinische Hochschule Hannover, Hannover,
`Germany). Development of an in vitro system to study drug interactions at the cytochrome
`P450 enzyme level. Drug interactions between cyclosporine and antibiotics and
`antimycotics. 1993
`
`6. Braun F. Pharmacology (Medizinische Hochschule Hannover, Hannover, Germany).
`Development of a specific and sensitive assay to measure FK506 and its metabolites in
`blood, bile and urine of liver graft patients. 1994
`
`7. Holze I. Pharmacology (Medizinische Hochschule Hannover, Hannover, Germany).
`Synergistic immunosuppressive effects of combinations of FK506 and its metabolites 13-
`O-demethyl FK506 and 13,15-O-didemethyl FK506 in vitro. 1994
`
`8. Lampen A. Biochemistry (Universität Hannover, Hannover, Germany). The cytochrome
`P450 system as a component of the transepithelial barrier of the gastrointestinal tract- Its
`influence on absorption and bioavailability of the immunosuppressants tacrolimus and
`sirolimus. 1994
`
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`9. Sürig T. Surgery (Medizinische Hochschule Hannover, Hannover, Germany). The
`clinical significance of cyclosporine metabolite patterns after liver transplantation. 1995
`
`10. Gonschior AK. Pharmacology (Technische Universität Braunschweig, Braunschweig,
`Germany). Metabolism and pharmacokinetics of the immunosuppressant FK506 in liver
`and kidney graft patients. 1995
`
`11. Schmidt G. Pharmacology (Medizinische Hochschule Hannover, Hannover, Germany).
`The influence of other drugs on the metabolism of FK506 (tacrolimus) by human liver
`microsomes. 1995
`
`12. Thiesemann C. Pharmacology (Medizinische Hochschule Hannover, Hannover,
`Germany). Diltiazem- cyclosporine drug interactions- Gender differences in male and
`female kidney graft patients. 1996
`
`13. Lampen A. Pharmacology (Tierärztliche Hochschule Hannover, Hannover, Germany).
`Caco-2 cells as a model for intestinal transport and metabolism. 1996
`
`14. Serkova N. Chemistry (Universität Bremen, Bremen, Germany). Effect of
`immunosuppressive drugs on the cell metabolism of neuronal and glial cell lines studied
`by multinuclear NMR spectroscopy. 1996
`
`15. Lopez-Puche V. Pharmacology (Medizinische Hochschule Hannover, Hannover,
`Germany). Development and validation of an in vitro mutagenicity test based upon stable
`co-cultures of human and animal hepatocytes. 1996
`
`16. Streit F. Chemistry (Universität Braunschweig, Braunschweig, Germany). Structural
`identification and quantification of the macrolide immunosuppressant sirolimus and its
`metabolites using electrospray mass spectrometry. 1997
`
`17. Jacobsen W. Biochemistry (Universität Braunschweig, Braunschweig, Germany) In
`vitro drug interactions with the HMG-CoA reductase inhibitors lovastatin and pravastatin-
`inhibition of their metabolism in liver and small intestine. 1998
`
`18. Rust A. Pharmacology (Medizinische Hochschule Hannover, Hannover, Germany).
`Quantitative analysis of cyclosporine metabolites as a liver function parameter after
`allogenic bone marrow and stem cell transplantation. 2000
`
`19. Djuve S. Pharmacy (University of Oslo, Oslo, Norway). Evaluation of drug-drug
`interactions between ranolazine and HMG-CoA reductase inhibitors in vitro. 2001
`
`20. Miljus J. (Universität Bremen) Evaluation of the effects of tyrosine kinase inhibitors
`on the metabolism of human tumor cells using an NMR-based biochemical profiling
`strategy. 2006
`
`
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`21. Klawitter J (Universität Bremen) The development and use of new methods and
`strategies for the monitoring of nephrotoxicity and the study of renal physiology:
`proteomics- and metabonomics-based studies. 2006 (won price for best thesis in 2007)
`
`22. Zaghow N (Medizinische Hochschule Hannover) Metabolism of the proliferation
`inhibitor Biolimus A9 in the human liver, 2007
`
`23. Anderson N (Medizinische Hochschule Hannover) Time-dependent metabolic effects
`of imatinib on human leukemia cells as evaluated by magnetic resonance spectroscopy
`(MRS), 2008
`
`24. Bohra R. (UC Denver, Biomolecular Structure PhD Program) The mechanisms of
`mTOR inhibitor nephrotoxicity in combination with calcineurin inhibitors, 2012
`
`25. Heischmann S (Universität Bremen) Strategies to evaluate the potential differences of
`GI toxicity caused by different mycophenolic acid formulations. 2013
`
`26. Klepacki J (UC Denver, Biomolecular Structure PhD Program) Mass spectrometry-
`based multiplexing strategies for the quantification of urinary protein kidney dysfunction
`markers. 2014
`
`27. Hartmann, M (Medizinische Hochschule Hannover). The drug metabolism and
`pharmacokinetics of temsirolimus in pediatric patients with solid tumors. 2016
`
`
`Master Theses Completed under Mentorship
`
`1. Kruse C. Biochemistry (Universität Hannover/ Medizinische Hochschule Hannover,
`Hannover, Germany) Metabolism, derivatization and
`inhibition of
`lymphocyte
`proliferation of the immunosuppressant FK506 and its metabolites. 1990
`
`2. Siefken R. Biochemistry (Universität Hannover/ Medizinische Hochschule Hannover,
`Hannover, Germany) Isolation and characterization of cytochrome P450 enzymes from rat
`liver microsomes. 1992
`
`3. Nietsche T. Biochemistry (Universität Hannover/ Medizinische Hochschule Hannover,
`Hannover, Germany) Induction of the metabolism of FK506 in organotypical hepatocyte
`cultures. 1993.
`
`4. Riedel R. Hochschule Esslingen (Biotechnology) Unterschiede in den molekularen
`Mechanismen der Immunsuppressiva Tacrolimus (Tac), Everolimus (EVL) und Sirolimus
`(SRL) auf die Zelllinie RPTEC (Normal Human Renal Proximal Tubulue Epithelial Cells).
`Bachelor, 2012
`
`
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`
`5. Lutter K. Hochschule Esslingen (Biotechnology) Entwicklung und Validierung einer
`quantitativen
`HPLC/MS-
`Analysenmethode
`zur Messung
`von
`fünf
`Antikrebsmedikamenten aus der pädiatrischen Onkologie. Bachelor, 2014
`
`6. Bodenberger, N. Universität Ulm/ Hochschule Biberach (Biotechnology) Development
`and Validation of an HPLC-MS/MS Method for the Quantification of Tacrolimus in
`Human Whole Blood and Dried Blood Spots. Master, 2014
`
`
`Doctoral Exam Committees
`
`Medizinische Hochschule Hannover:
`1995 Thiesemann C., Pharmacology
`1995 Beitze D., Molecular Pharmacology
`1995 Kuhn M., Pharmacology and Toxicology
`
`Universität Hannover
`1995 Lampen A., Biochemistry
`1996 Eh, M., Chemistry
`
`Tierärztliche Hochschule Hannover
`1996 Lampen A., Pharmacology
`
`Universität Bremen
`1996 Serkova N., Chemistry
`2006, Klawitter J, Biochemistry
`2006, Miljus J, Biochemistry
`
`University of Alberta, Edmonton, Canada
`2001 Gallant-Haidner H, Clinical Pathology
`
`University of Hong Kong
`2003/2004 Chang, J., Internal Medicine
`
`University of Colorado Health Sciences Center
`2001/2 Zhou H, School of Pharmacy
`2005-2007 Guo W, School of Pharmacy
`
`University of Colorado, Boulder
`2005- 2010, Prior J, Department of Bioengineering
`
`University of Oslo, Norway
`2012-2013, Ivanova L, Oslo Veterinary Institute
`
`
`
`
`
`
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`
`Service to Educational, Governmental, and other Agencies
`
`1995- present: Reviewer for grant applications, Deutsche Forschungsgemeinschaft,
`Bonn, Germany (equivalent to NIH)
`
`2001-present: Ad hoc reviewer, NIH ZDK1-GRB-4J1, NIDDK ZDK1-GRB-W M1,
`MOSS D04, CICS, NICHD RFA-02-001, ZRG1 DKUS-A (58), ZDK1-GRB-G-M3,
`ZRG1 BST-J (50) R, ZRG1 BST-J (50) R (Regional Metabolomics Resources), ZAI1
`ALW-I(M1)1 (Clinical Trials in Organ Transplantation (CTOT)(U01), 2014 ZAI1 TT-M
`J3 1 (U44 SBIR Fasttrack grants), 2015/05 ZGM1 PPBC-Y (PG) (NIGMS
`Pharmacogenomics Grant Applications), 2015/10 ZAI1 PA-I (S1) (PAR-13-150: NIAID
`Clinical Trial Planning Grant (R34), 2015/10 ZRG1 ETTN-B (50) R (Development of
`Appropriate Pediatric Formulations and Pediatric Drug Delivery System), 2015/10 ZAI1
`PA-I (S1) NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement,
`2016/01 NIAID ZAI1-TT-M-C1, 2016/01 NIAID ZAI1-TT-C2, 2016/05 ZRG1 BDCN-L
`(03) M, 2017/05 ZDK1 GRB-1 (M2) 1 (P50 Pediatric Nephrology Centers), 2017/05
`ZHL1 CSR-I (M1) 1 (Collaborative Projects in Organ Fibrosis), 2017/10, ZTR1 DPI-9
`01, TRND 4 (NCATS, Review of Therapeutics for Rare and Neglected Diseases),
`2018/03, ZRG1 BST-X(50) (RFA-RM-17-013, Compound Identification Development
`Cores (U2C), 2019/07, RFA-HD-19-025, ZHD1 DSR-Z (50) 1, HEAL Initiative:
`Antenatal Opioid Exposure Longitudinal Study Consortium, 2020/05 ZGM1 BBCB-4
`(NR) S, NIGMS National and Regional Resources (R24)
`
`2004: reviewer, NASA, Clinical Research and Medical Technology Panel
`
`2007- 2009: reviewer, Norwegian Research Council (equivalent to NIH)
`
`2008- 2009: reviewer, Swiss Science Foundation (equivalent to NIH)
`
`2014- present: Medical Research Council (UK), College of Experts (equivalent to NIH)
`
`2019- present: National Science Foundation, Poland (equivalent to NIH)
`
`2020- present: Italian Ministry of Health (MOH), General Directorate for Health and
`Innovation Research (equivalent to NIH)
`
`
`
`Service to Scholarly and Professional Journals
`
`
`1990
`1991-present
`1992
`1992
`1992
`1994-present
`
`Reviewer, Pharmacology
`Reviewer, European Journal of Clinical Pharmacology
`Reviewer, Chromatographia
`Reviewer, Pharmacology Research
`Reviewer, Clinical Nephrology
`Reviewer, Clinical Chemistry
`
`
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`
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`10 of 105
`
`1994-present
`1996
`1997-present
`1999-present
`2001-present
`2002
`2002- present
`2003- present
`2003- present
`2004- present
`2005-present
`2006- present
`2006-present
`2006-present
`2008-present
`2010-present
`2010-present
`2010-present
`2010-present
`2010-present
`2011-present
`2011-present
`2011-present
`2011-present
`2011-present
`2012-present
`2012-present
`2012-present
`2013-present
`2013-present
`2013-present
`2013-present
`2015-present
`2018-present
`2018-present
`2018-present
`
`
`
`
`Reviewer, Clinical Pharmacokinetics
`Reviewer, Clinical Drug Investigation
`Reviewer, Drug Metabolism and Disposition
`Reviewer, Journal of Experimental Pharmacology and Therapeutics
`Reviewer, The American Journal of Transplantation
`Reviewer, Addiction
`Editorial Board, Therapeutic Drug Monitoring
`Reviewer, Clinical Pharmacology and Therapeutics
`Reviewer, Clinical Biochemistry
`Reviewer, Principles in Medicine
`Reviewer, Transplantation
`Reviewer, Journal of Chromatography B
`Reviewer, Biochemical Pharmacology
`Reviewer, Toxicology
`Editorial Board, European Jounal of Clinical Pharmacology
`Reviewer, Biochimica Biophysica Acta Proteomics
`Reviewer, Journal of Pharmaceutical and Biomedical Analysis
`Reviewer, Journal of Toxicology
`Reviewer, Journal of Clinical Pharmacology
`Reviewer, Regulatory Toxicology and Pharmacology
`Reviewer, Journal of Proteomics
`Reviewer, Proceedings of the National Academy of Sciences (PNAS)
`Reviewer, Nature Reviews in Nephrology
`Reviewer, Cell Metabolism
`Editorial Advisory Board, Drug Metabolism and Disposition
`Reviewer, Therapeutics and Clinical Risk Management
`Reviewer, Biosimilars
`Reviewer, Rapid Communications in Mass Spectrometry
`Reviewer, Toxicology Letters
`Reviewer, Cell Biochemistry and Function
`Reviewer, Analytical and Bioanalytical Chemistry
`Reviewer, Analytical Chemistry
`Reviewer, Scientific Reports
`Reveiwer, Molecules
`Reviewer, American Journal of Kidney Diseases
`Reviewer, Journal of Medicinal Chemistry
`
`
`
`
`Editor-in-Chief, Therapeutic Drug Monitoring
`Associate Editor, Tranplantation
`
`
`2016-
`2020-
`
`Consultant or Service as a Professional Expert
`
`
`1990-1995
`
`1990-1995
`
`Consultant. Laves Arzneimittel, Hannover, Germany. Co-administration
`of an E.coli extract and 5-Fu for the treatment of colon cancer
`Clinical studies and sample analysis, consultant. Sandoz AG, Nürnberg,
`Germany. A new oral form of cyclosporine
`
`
`Uwe Christians, Curriculum vitae, revised 10/20/2021
`
`

`

`
`
`
`
`
`1990-1995
`
`1990-1992
`
`1991-1994
`
`1993-1995
`
`1993- 2000
`
`1995- 1997
`
`1997- 2000
`
`1997-1998
`
`1998- 2002
`
`1998-2003
`
`1999-2003
`
`1999-2011
`
`2000
`
`2001-2004
`2001-2006
`
`2003- 2006
`2003- 2006
`2004- 2006
`2004- 2010
`2004- 2010
`
`2004- 2007
`2006- 2008
`2010- 2011
`2016-present
`2016-present
`
`11 of 105
`
`Consultant. Fujisawa GmbH, Munich, Germany. HPLC/MS of
`tacrolimus and its metabolites
`Research project, consultant. Wyeth-Ayerst, Princeton, NJ. Metabolism
`of the macrolide immunosuppressant rapamycin.
`Research project, consultant. Abbott Laboratories, Abbott Park, IL.
`Development of immunoassays for immunosuppressive drugs.
`Research project, consultant. Takeda GmbH, Frankfurt, Germany. Drug
`interactions with the Na+/H+ -ATPase inhibutor lanzoprazole
`Clinical study, in vitro studies, consultant. Bristol-Myers Squibb,
`Princeton, NJ. Pravastatin and lovastatin drug interactions
`Clinical studies, consultant. Arzneimittelwerk Dresden GmbH, Dresden,
`Germany. Development of an oral generic cyclosporine formulation and
`bioequivalence studies
`Development of a cyclosporine formulation bioequivalent to NeoralR,
`SangStat Medical Corp., Menlo Park, CA
`Development of a generic cyclosporine formulation, Abbott Immune
`Venture, Abbott Park, IL
`Pharmacokinetic drug interactions of the partial pFOX inhibitor
`ranolazine, CV Therapeutics, Palo Alto, CA
`Reference laboratory for calibration standards, Dade-Behring Inc.,
`Cupertino, CA
`Development of an injectable depot formulation of the opioid antagonist
`naltrexone, Drug Abuse Sciences, Hayward, CA
`Development of application notes for automated samples extraction
`procedures (column switching) for LC/MS and LC/MS-ion trap analysis
`of drugs for therapeutic drug monitoring, Agilent Technologies, Palo
`Alto, CA
`Clinical Consultant, Novartis Pharma (East Hanover, NJ), global
`everolimus phase III studies
`Scientific Advisory Board, OxoN Medica Inc., South San Francisco, CA
`Development of the cyclosporine-derivative ISA247 as
`immunosuppressant after kidney transplantation, Isotechnika Inc.,
`Edmonton, Alberta
`Scientific Advisory Board, Isotechnika Inc., Edmonton, Canada
`Scientific Advisory Board, Drugabuse Sciences, Paris, France
`Scientific Advisory Board, Bionovo, Berkeley, California
`Consultant, Biosensors Inc., Newport Beach, CA, Drug eluting stents
`Consultant, Microgenics, Fremont, CA, Sirolimus clinical
`immunoassays
`Consultant, Abbott, Abbott Park, IL, Drug eluting stents
`Consultant, Cardiomind Inc., Sunnyvale, CA, Drug eluting stents
`Consultant, Orbus Neich Inc., drug-eluting stents
`Consultant, Nektar Inc., opioids
`Consultant, Biotronik-CRC, anti-proliferative drugs
`
`
`Uwe Christians, Curriculum vitae, revised 10/20/2021
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`History of Research Funding
`
`
`1989
`
`1990
`
`1990
`
`1991
`
`1991-1992*
`
`1992-1995*
`
`1992
`
`1993-1995
`
`1993-1996*
`
`1993
`
`1993
`
`1993-1996
`
`1995-1997
`
`1996-1999
`
`1996
`
`1996-1997
`
`1997-1999
`
`1997-2000
`
`Research award of the “Freunde der Medizinischen Hochschule” Foundation,
`US$ 3500 (PI)
`Research award of the “Freunde der Medizinischen Hochschule” Foundation,
`US$ 10,000 (PI)
`Industry sponsored grant, Sandoz AG (Basel, Switzerland), Analytics of
`cyclosporine and metabolites in blood of transplant patients. US$ 60,000
`Industry sponsored grant, Fujisawa GmbH (Munich, Germany). Development
`of a specific LC/MS assay for the quantification of FK506 and its metabolites
`in blood of liver transplant patients. US$ 10,000
`Grant Pi 11-4 D5, Deutsche Forschungsgemeinschaft
` Analytics and toxicity of cyclosporine and its metabolites in transplant
`patients, US$ 100,000 (PI)
`Grant SFB265 A7, Deutsche Forschungsgemeinschaft (renewal of Pi 11-4,
`D5), Association between toxicity and metabolism of immunosuppressants.
`US$ 165,000 (PI)
`Equipment grant of the Volkswagenstiftung for an LC/MS-system
`US$ 300,000 (PI)
`Grant Fa 94-1, Mildred-Scheel-Stiftung (German Cancer Society)
`Development and validation of an in vitro mutagenicity test based upon stable
`co-cultures of human and animal hepatocytes;
`US$ 90,000 (Co-PI)
`Grant SFB280 A8, Deutsche Forschungsgemeinschaft
`The cytochrome P450 system as a component of the transepithelial barrier in
`the gastrointestinal tract. Its influence on the absorption and bioavailability of
`drugs. equipment: US$ 10,000, salaries and consumables: US$ 210,000 (PI)
`Research award of the “Freunde der Medizinischen Hochschule” Foundation:
`US$ 10,000 (PI)
`Industry sponsored grant, Bristol-Myers Squibb (Princeton, NJ), Comparison
`of the clinical drug-drug interactions of lovastatin and pravastatin with
`cyclosporine in stable kidney transplant patients. US$ 65,000
`Sandoz Foundation, Interaction between the Immune System and Cytochrome
`P450 Enzymes in the Liver, US$ 165,000 (Co-PI)
`Grant PL950658, Biomed 2 program, European Community
`Drug Hepatotoxicity: An Integrated Clinical and Mechanistic Investigation.
`US$ 40,000 (Co-investigator, 30%; M.P. Manns principal investigator)
`Grant Ch 95/6-1, “Heisenberg-Program”, Deutsche Forschungsgemeinschaft,
`US$ 50,000/ year, (PI, 100%)
`Industry sponsored grant, Bristol-Myers Squibb (Princeton, NJ) In vitro
`metabolism and drug interactions of HMG-CoA reductase inhibitors, US$
`20,000
`Industry sponsored grant, Wyeth-Ayerst (Mammoth Junction, NJ), Evaluation
`of the pharmacokinetic drug interaction between sirolimus and ketoconazole in
`healthy volunteers. US$ 205,000
`Industry sponsored grant, Fujisawa Inc. (Deerfield, IL) Evaluation of ethnic
`differences of tacrolimus pharmacokinetics and drug-interactions with
`fluconazole in healthy volunteers, US$ 375,000
`Industry sponsored grant, Novartis Pharma AG (Basel, Switzerland),
`Comparison of the effects of RAD001 and sirolimus on brain and kidney
`energy metabolism alone and in combination with cyclosporine. US$ 495,000
`
`Y
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`Uwe Christians, Curriculum vitae, revised 10/20/2021
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`1998
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`1999-2000
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`1999-2000
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`2000-2001
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`1999-2002
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`2000-2002
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`2002-2003
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`2002-2003
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`2002-2003
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`2002-2003
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`2003
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`2002-2003
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`2002-2003
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`2001-2004
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`2001-2004
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`2002-2004
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`2002-2004
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`2002-2004
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`13 of 105
`
`Industry sponsored grant, The p170-glycoprotein transporter as a potential site
`of the ranolazine/digoxin drug-interaction, US$ 18,000
`Ch95/6-2, renewal of Heisenberg grant, Deutsche Forschungsgemeinschaft,
`US$ 50,000/ year (PI, 100%)
`Industry sponsored grant, CV Therapeutics (Palo Alto, CA) Evaluation of
`drug-drug interactions between ranolazine and HMG-CoA reductase inhibitors
`in vitro, US$ 120,000
`Industry sponsored grant, Drug Abuse Sciences (Hayward, CA) Evaluation of
`the human cytochrome P450-dependent metabolism of naltrexone in vitro,
`$36,000
`Industry sponsored grant, Development of application notes for automated
`samples extraction procedures (column switching) for LC/MS and LC/MS-ion
`trap analysis of drugs for therapeutic drug monitoring, Agilent Technologies,
`Palo Alto, CA, US$ 95,000 (PI)
`NIH/NCI 3 P50 CA58207-08S2, Bay Area Breast Cancer Translational
`Research Program. US$ 15,000 (co-investigator, 10%), principal investigator
`J.W. Gray, M.D. (UCSF)
`Industry sponsored grant, Orbus Medical (Ft Lauderdale, FL). Development of
`drug-eluting stents, US$ 70,000 (PI)
`Industry-sponsored grant, Biosensors-USA (Newport Beach, CA), Clinical
`development of everolimus and rapamycin derivative-eluting stents. US$
`25,000 (PI)
`Industry sponsored grant, Medtronic AVE (Santa Rosa, CA). Development of
`stents eluting the rapamycin derivative ABT-573. US$ 55,000 (PI)
`Industry sponsored grant, Guidant, Development of everolimus-eluting stents.
`US$ 28,000 (PI)
`Industry-sponsored grant, Endobionics (St Leandro, CA), Distribution of
`ABT-578 in coronary arteries after infusion via a microsyringe. US$ 21,300
`(PI)
`Industry sponsored grant, OxoN Medica Inc. (South San Francisco, CA),
`Evaluation of the potential protective effect OX-0025 on ischemia/ reperfusion
`injury in the kidney, US$ 48,000 (PI)
`Industry sponsored grant, Isotechnika Inc. (Edmonton, Canada), Comparison
`of the effects of cyclosporine and the cyclosporine derivative ISATX247 on cell
`metabolism in the kidney using MRS. US$ 7,000 (PI)
`Industry sponsored grant, Novartis Pharma AG (Basel, Switzerland)
`Therapeutic drug monitoring of the immunosuppressant everolimus in phase
`III clinical multicenter studies. US$ 250,000 (PI)
`NIH/NIGMS GM47502-10, Pulmonary uptake and kinetics of IV anesthetics,
`US$ 1,081,684 (co-investigator, 31%), principal investigator T.K. Henthorn,
`M.D.
`Industry sponsored grant, Immerge BioTherapeutics (Charlestown, MA),
`Xenotransplantation of hepatocytes from pig to monkey, US$ 60,000 (PI)
`Industry sponsored grant, Dade-Behring (Glasgow, Delaware), Generation of
`Sirolimus and Tacrolimus metabolites as reference material for testing and
`development of clinical immunoassays, US$ 50,000 (PI)
`Industry sponsored grant, OPUS Diagnostics/ Seradyn Inc. (Fort Lee, NJ),
`Development of a clinical immunoassay for the immunosuppressant
`everolimus, US$ 23,000 (PI)
`
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`Uwe Christians, Curriculum vitae, revised 10/20/2021
`
`

`

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`2003-2005
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`2003-2004
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`2003-2004
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`2003-2004
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`2001-2004
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`2005
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`2005
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`2005-2006
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`2006
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`2006
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`2006
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`2006
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`2006-2007
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`2006
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`2006-2007
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`2007
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`2006-2008
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`2006-2008
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`14 of 105
`
`NIH, Mass spectrometry core (PI, 10%), Colorado Center for Human Nutrition
`(vergleichbar mit einem DFG Sonderforschungsbereich, NIH P30 DK48520)
`US$ 300,000
`Industry sponsored grant, Abbott Laboratories, Evaluation of the human
`hepatic metabolism of ABT-578, US$ 151,480 (PI)
`Industry sponsored grant, Biosensors-USA, Evaluation of the metabolism of
`the mTOR-inhibitor Everolimus Plus in vitro, US$ 191,400 (PI)
`Industry sponsored grant, Biosensors, Evaluation of the metabolism of
`Biolimus A-7 and A-9 in humans in vitro, US$ 148,000 (PI, 10%)
`NIH/NIGMS GM47502-10, Pulmonary uptake and kinetics of IV anesthetics,
`US$ 1.081.684 (co-investigator, 20%), principal investigator T.K. Henthorn,
`M.D.
`Industry sponsored grant and gift, McNeil Pharmaceuticals (New Brunswick,
`NJ), Development of MS/MS-based assays for the quantification of incretins in
`human plasma. US$ 565.000 (gift for an API5000 mass spectrometer), US$
`145.000 (research grant for assay development) (PI)
`Industry-sponsored grant, Biosensors International-USA (Newport Beach,
`CA), Safety and tolerance of Biolimus A9 in healthy subjects in a single
`ascending dose study. US$ 548.000 (PI, 10%)
`Industry-sponsored grant, Biosensors International-USA (Newport Beach,
`CA), Safety and tolerance of Biolimus A9 in healthy Japanese subjects in a
`single ascending dose study. US$ 122.000 (protocol, pharmacokinetics, safety
`monitoring, report in ICH E3 format) (PI, 10%)
`Industry-sponsored grant, Biosensors International-USA (Newport Beach,
`CA), Safety and tolerance of Biolimus A9 in healthy subjects in a multiple
`ascending dose study. US$ 122.000 (protocol, pharmacokinetics, safety
`monitoring, report in ICH E3 format) (PI, 10%)
`Industry-sponsored grant, DrugAbuseSciences (Paris, France), Comparative
`pharmacokinetics of two sustained release injection formulations of naltrexone
`in dogs. US$ 26.000 (PI)
`Industry-sponsored grant, Devax Inc. (Irvine, CA), Pharmacokinetics of
`Biolimus A9 after elution from a drug coated stent in swine. A GLP study.
`US$22.500 (PI)
`Industry sponsored grant, Bionovo Inc., A Randomized, Double-Blind, Placebo-
`Controlled, Single Dose, Oral, Dose Escalation Phase 1 Study to Evaluate the
`Safety and Tolerance of MF 101 as well as the Pharmacokinetics of Its Key
`Active Components in Healthy Post- Menopausal Women. US$ 648.000 (PI)
`Industry sponsored grant, Biosensors Inc., Pharmcokinetics during Phase I
`clinical development, US$ 134.000 (PI)
`Industry sponsored grant, Cardiomind Inc., In vitro metabolism of SAR-943.
`US$ 50.000 (PI)
`Industry sponsored grant, Cardiomind Inc. Synthesis of a novel sirolimus
`derivative for coating on a drug-eluting stent. US$ 106.000 (PI)
`Industry-sponsored grant, Devax Inc., Evaluation of PK and tissue distribution
`of Biolimus A9 after impantation of Devax stents in pigs, US$ 42.000 (PI)
`Industry-sponsored grant, Novartis AG. Evaluation of potential differences in
`mechanisms and potency of nephrotoxicity of the combinations of sirolimus
`and everolimus with calc