WORKSHOPS 

Sunday October 4, 2009, 0800-1000, Workshops W111, W112 Workshop W111: Practical LC-MSMS for Clinical Drug Analysis – a workshop sponsored by the TDM/Toxicology Division of the American Association for Clinical Chemistry Workshop W112: What Would a Benchmark TDM Service Look Like?- Models of Service Delivery   Sunday October 4, 2009, 1030-1230, Workshops W121, W122, W123 Workshop W121: Methods Development for Quantitative HPLC-Tandem Mass Spectrometry Workshop W122: Monitoring the Clinical Toxicology Aspects of the Complementary and Alternative Medicine Workshop W123: Practical Aspects of Oral Fluid On-site Tests for DOA   Sunday October 4, 2009, 1300-1500, Workshops W131, W132, W133 Workshop W131: Young Scientist Workshop Workshop W132: Pitfalls in Workplace Drug Testing: Diluted Urine, Use of Adulterants and Drugs Not Included in Test Panels Workshop W133: Managing Epilepsy Therapy with the Help of Measured Drug Levels: Critical Issues, Case Examples and Third Generation Drugs   Sunday October 4, 2009, 1530-1730, Workshops W141, W142, W143 Workshop W141: Applications of Pharmacogenetics for Personalized Pain Management Workshop W142: Biomarkers for Pharmacodynamic Monitoring of Immunosuppressive Therapy – Analytical Aspects Workshop W143: Antifungal Drugs TDM : An Update   Monday October 5, 2009, 1545-1845, Workshops W211, W212, W213 Workshop W211: Monitoring Therapeutic Immunosuppressive, Cytokines and Chemokines Workshop W212: Personalized Medicine, How Pharmacokinetic and Pharmacokinetic/pharmacodynamic Models are Made and Can Aid Daily Practice to Personalize Drug Treatment Workshop W213: Alternative Sampling Methods in TDM: Dried Blood Spot and Fingerprick Sampling and Sampling by Reverse Iontophoresis   Tuesday October 6, 2009, 1545-1745, Workshops W311, W312 Workshop W311: Pharmacogenomics of Addiction and Drugs of Abuse Workshop W312: What are the Differences Between Clinical and Forensic Toxicology? How are we Dealing with Both? Workshop W313: Pharmacodynamic Biomarkers of Anticancer Drugs     SUNDAY OCTOBER 4, 2009, 0800-1000, Workshops W111, W112   Workshop W111: Practical LC-MSMS for Clinical Drug Analysis – a workshop sponsored by the TDM/Toxicology Division of the American Association for Clinical Chemistry H. Chip Walls, B.S., Technical Director, Forensic Toxicology Laboratory, Dept. of Pathology, University of Miami, Miami, Florida, USA Tania Sasaki, Ph.D., Technical Marketing Manager, Applied Biosystems, Inc., Foster City, California, USA Andrea Terrell, Ph.D., Laboratory Director, AIT Laboratories, Indianapolis, Indiana, USA Alan Wu, Ph.D., Division Chief, Clinical Chemistry & Toxicology, San Francisco General Hospital, Professor, Dept. of Laboratory Medicine, University of California, San Francisco, San Francisco, California, USA     This workshop is intended for laboratory scientists familiar with HPLC and GCMS who are transitioning to LC-MS/MS for clinical drug analysis. Practical aspects of instrument selection, method development, validation, and quality assurance will be discussed. 1) "Comparison of various mass analysis technologies for LC-MS/MSMS of commonly encountered drugs"; H. Chip Walls, B.S. 2) "How to avoid the most common errors in LC-MSMS method development"; Tania Sasaki, Ph.D. 3) "Choosing a sample prep method for your clinical LC-MS/MSMS drug assay"; Andrea Terrell, Ph.D. 4) "Comparing the performance of difference qualitative identification strategies for LC-MSMS drug assays"; Alan Wu, Ph.D.   Objectives: At the conclusion of this workshop the participant will be able to: Recognize and prevent common liquid chromatography and mass spectrometry problems encountered during LC-MSMS method development; Describe the advantages and disadvantages of different specimen prep techniques and the qualitative identification criteria used in quantitative LC-MSMS drug analysis; Compare and contrast currently available mass analysis alternatives (single quadrupole, triple quadrupole, linear ion trap, TOF, hybrid) in order to select the most suitable platform for different analytical tasks. Click here: H. Chip Walls biography H. Chip Walls H. Chip Walls received his B.S. from the University of Alabama at Birmingham in 1972 during which time he was a research associate in the Department of Chemistry. His professional career has covered over 30+ years including 12 plus years at the University of Miami Miller School of Medicine, and 21 years with the Alabama Department of Forensic Sciences-Birmingham Division toxicology section and Onondaga County Medical Examiner's Office toxicology laboratories. His experience encompasses post-mortem forensic toxicology, clinical toxicology, probation urine drug testing, and driving under the influence cases. Currently, he is the Technical Director of the Forensic Toxicology Laboratory at the University of Miami, Miller School of Medicine within the Department of Pathology. An active member of several toxicology organizations, he has chaired national committees and has organized numerous workshops on many aspects of the principals and practices of forensic toxicology for annual meetings of various professional organizations. He has been an invited speaker on drug detection in pregnancy, the role of toxicology in prosecuting impaired drivers, and information resources in forensic toxicology, marijuana, antidepressants, anti-epileptics, psychotropic medications, narcotics, sedative-hypnotics and alcohol. He has had work published on such topics as cocaine, marijuana, and benzodiazepines and forensic toxicology in peer-reviewed scientific journals or books, and presented at national forensic science meetings. He has served the Society of Forensic Toxicologist (S.O.F.T.) as Past-President (1997), President (1996), Vice-President (1995), Board of Directors (1991-1994), the Executive Board (1995), and the Editorial Board of ToxTalk (1994-present). In addition, he has served on or chaired the following committees: Driving Under the Influence of Drugs (Chair), Meeting Resources (Chair), Joint Committee on Education and Training in Toxicology (JCETT) and Health/Safety. He was S.O.F.T. Special Issue Guest Editor of the Journal of Analytical Toxicology (1992). His eccentricity is widely known to fellow toxicologists concerning his collection of information about the practice of forensic toxicology. In 2006 he was presented the Ray Abernathy award by the American Academy of Forensic Sciences Toxicology section for "Recognition of an Outstanding Forensic Toxicology Practitioner". He serves as a laboratory inspector for the National Laboratory Certification Program: Federal Workplace Forensic Urine Drug Testing 1990 to Present (SAMSHA). ------------------------------------------- Click here: Tania A. Sasaki biography Tania A. Sasaki, Ph.D. I graduated from Pomona College with a B.A. in chemistry, followed by a M.S. and Ph.D. in chemistry from UC Riverside under the direction of Charles Wilkins. My dissertation topic was "Advances in Multi-dimensional Gas Chromatography with Fourier Transform Infrared and Mass Spectral Detection." After graduate school, I spent 2.5 years doing GC/MS analyses in an analytical R&D lab before leaving to pursue a job in LC/MS. I joined Applied Biosystems in 2003 and spent 5 years as a Sr. Applications Specialist in the demo/applications lab before taking a position as a Technical Marketing Manager, with an emphasis on forensic toxicology and clinical research applications. I have almost 15 years of mass spectral experience ranging from pharmaceutical applications (PK, ADME) to forensic toxicology and drug screening. ------------------------------------------- Click here: Andrea Terrell biography Andrea Terrell, Ph.D., DABCC Andrea Terrell, Ph.D., DABCC has served as laboratory director of AIT Laboratories since 2003 and chief scientific officer since 2008. Dr. Terrell earned her bachelor’s degree in biology from Indiana University and her doctorate in biochemistry and molecular biology from Colorado State University. As a graduate student, she was honored with several fellowships, including one from the Colorado Institute for Research in biotechnology. She then completed a postdoctoral fellowship in clinical chemistry and laboratory medicine at the Washington University School of Medicine in St. Louis, Missouri. She is an active member of the American Association of Clinical Chemistry (AACC) and currently serves as the chair-elect of the Ohio Valley local section, member of the AACC Press Board of Editors, and a member at large on the executive committee of the TDM/Toxicology Division. She also holds memberships with the American Association of Pharmaceutical Scientists (AAPS) and the Society of Forensic Toxicologists (SOFT) as well as diplomate status with the American Board of Clinical Chemistry (ABCC). Dr. Terrell’s interests include development of analytical methods using state-of-the-art mass spectrometry instrumentation and developing the next generation of leadership at AIT. Her work has been published in Biochemistry, Clinical Chemistry, the Journal of Biological Chemistry, and Pharmacotherapy. ------------------------------------------- Click here: Alan Wu biography Alan Wu, Ph.D., D.A.B.C.C. Alan H.B. Wu, Ph.D., is Chief of Clinical Chemistry and Toxicology at San Francisco General Hospital and Professor of Laboratory Medicine, University of California, San Francisco. He received B.S. degrees in chemistry and biology at Purdue University, West Lafayette, Indiana, and a Ph.D. degree in analytical chemistry at the University of Illinois, Champaign-Urbana, Illinois. He completed a postdoctoral fellowship in clinical chemistry at Hartford Hospital. He is certified by the American Board of Clinical Chemistry in Clinical Chemistry and Toxicological Chemistry. Dr. Wu’s research interest has been in three areas within the field of clinical chemistry laboratory. He has been involved at the national and international levels with development and use of biochemical markers for cardiovascular disease including CK-MB, myoglobin, troponin, B-type natriuretic peptide, and markers of myocardial ischemia, and stroke. As also has a long history of analytical, clinical, and forensic toxicology. In both of these areas, Dr. Wu has co-authored the National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines. More recently, Dr. Wu has developed research and clinical programs in pharmacogenomics in support of the UCSF clinical pharmacogenomics laboratory. Among the areas of interest include pharmacogenomics for anticoagulants, especially warfarin, chemotherapeutics (tamoxefin, irinotecan), and drugs that can induce hypersensitivity reactions (abacavir, anticonvulsants). ------------------------------------------- Go to top Workshop W112: What Would a Benchmark TDM Service Look Like?- Models of Service Delivery Ross Norris, A/Prof., Research Consultant, Australian Centre for Paediatric Pharmacokinetics, Mater Health Services, Raymond Terrace, South Brisbane, Australia Raymond Morris, PhD, Chief Medical Scientist, Clinical Pharmacology, The Queen Elizabeth Hospital, Woodville, South Australia. Affiliate Associate Professor, Discipline of Pharmacology, University of Adelaide, Adelaide, Australia Vanessa Steenkamp, Director Phytomedicine Unit, Department of Pharmacology, University of Pretoria, South Africa Phillip Morgan, PhD CChem MRSC, Department of Clinical Biochemistry, King’s College Hospital, London, UK Edgar P. Spencer, MSc PhD CChem FRSC MBA, Principal Clinical Scientist, Medical Toxicology Unit, St Thomas’ Hospital, London, UK Donald F. LeGatt, Ph.D, FCACB, Clinical Biochemist, Clinical Professor, Department of Laboratory Medicine and Pathology, Alberta Health Services - Capital Health, University of Alberta Hospital, Edmonton, Canada     This workshop will be conducted under the auspices of the Standards of Laboratory Practice Committee. At present there is no recognised benchmark model of service delivery. This workshop will consider the hypothetical and practical elements of a benchmark TDM service and in particular models of service delivery, with opportunity for participant involvement.   Professors Norris and Morris will discuss results of a recent survey of TDM in Australia and New Zealand which indicated that the practice of TDM is of variable standard. The three other international speakers from Canada, South Africa and the UK will present how TDM is delivered in their institutions. They will consider pre-analytical, analytical and post-analytical aspects of the service, including regional service delivery models and national practices and guidelines.   Objectives: At the conclusion of this workshop the participant will be able to: Evaluate a TDM service against a benchmark with respect to quality of laboratory data and effectiveness of patient management.; Understand and appreciate the various models of TDM service delivery that are effective and the factors, including funding models, that influence the choice of service model; Understand and appreciate issues related to different models of TDM service delivery for rural and urban services. Click here: Ross Norris biography A/Prof Ross Norris Ross Norris obtained his BAppSc (App Chem) degree in 1979, his MAppSc degree in 1985 and his PhD from the University of Queensland (UQ) in 2003. He has a strong background in drug analysis and therapeutic drug monitoring, having worked in bioanalytical chemistry since 1979, mostly in the area of TDM. Ross was appointed to the position of Lions Research Scientist in Clinical Pharmacology at the Princess Alexandra Hospital (PAH) from 1979 to 1982 and worked in the Conjoint Internal Medicine Laboratory at Royal Brisbane Hospital from 1982 to 1985, obtaining a MAppSc degree for studies on protein binding of the antiarrhythmic agent disopyramide in 1985, and returning to Clinical Pharmacology at the PAH in the same year. In 1990 he was appointed as the Chief Scientist in this department. From 1996 to 2000 he worked full-time on a PhD studying the toxicokinetics of a blue-green algal toxin, cylindrospermopsin, in an animal model. From 2000-2002 Ross held a range of laboratory and other management positions across the Queensland Public Sector, subsequently taking up the joint positions of Research Consultant, The Australian Centre for Paediatric Pharmacokinetics (ACPP) and Senior Scientist in the Therapeutic Advisory Service, Mater Pharmacy Services, at Mater Health Services in Brisbane, where he has been since 2002. In this role his primary achievement has been the development of all aspects of the ACPP into a viable pharmacokinetic research centre with both strong clinical and academic collaborations formed, attracting increasing research funding. He also currently holds adjunct appointments with Griffith University, School of Pharmacy (A/Prof) and the University of Queensland, School of Pharmacy (senior lecturer). Current interests include the establishment of the Australasian TDM Collaboration, a broad web-based group of professionals with an interest in TDM, after recently leading a survey of TDM practices in Australia and New Zealand. His current primary interest is in promoting the application of pharmacokinetics to dose individualisation to improve patient outcomes, in both adult and paediatric/neonatal patients in the clinical setting. Ross has published more than 50 publications primarily in the areas of drug analysis, therapeutic drug monitoring and pharmacokinetics. ------------------------------------------- Click here: Raymond Morris biography Raymond Morris, PhD Ray Morris received his PhD degree in 1982 from University of Adelaide, South Australia, having held a grant-funded Research Officer position for 7 years. He then moved to The Queen Elizabeth Hospital in Adelaide to a medical scientist position in Clinical Pharmacology in the therapeutic drug monitoring laboratory with active research interests. He has remained in this department since and has headed the department for more than 15 years. His research interests have focussed around therapeutic drug monitoring, particularly immunosuppressant drugs, and he authored/co-authored more than 115 papers and 135 conference abstracts. Activities in more recent years include; acting as Convenor of the Adelaide Pharmacology Group. Contributions to the International Association of Therapeutic Drug Monitoring & Clinical Toxicology (IATDMCT) have included; Co-chaired the Congress in Cairns in 1999, 2 terms of 2-yr as Chair of the Clinical Pharmacokinetics Committee, 2 terms of 2-yr as Councillor, 1 term as Director of Education, and 2 terms of 2-yr on Executive Committee as Treasurer. He is a member of the Editorial Boards of the journals Clinical Biochemistry, and Therapeutic Drug Monitoring. ------------------------------------------- Click here: Vanessa Steenkamp biography Prof. Vanessa Steenkamp Prof Vanessa Steenkamp’s research interest involves various aspects of traditional herbal remedies. Presently she heads the Phytomedicine Unit in the Department of Pharmacology, University of Pretoria. Prof Steenkamp is the author and co-author of >45 scientific papers. She has received 19 awards for her research both nationally and internationally, amongst others the prestigious Friedel Sellschop award, formerly known as the University of the Witwatersrand Young Researcher in 2001 and Exceptional Young Researcher of the University of Pretoria in 2006, two of the leading academic institutions in the country. In 2007 she received two international awards in recognition of her research from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology and the American Association of Clinical Chemistry. She is the President of the South African Association of Clinical Biochemistry, Vice-President of the Toxicology Society of South Africa, Secretary-General of the South African Association of Basic and Clinical Pharmacology. She serves as reviewer for 14 international peer-reviewed journals and is on the editor board of two journals. She has 149 conference contributions and has been the invited speaker on 13 occasions. ------------------------------------------- Click here: Phillip Morgan biography Phillip Morgan, PhD CChem MRSC After obtaining a degree in Applied Chemistry, he trained as an analytical toxicologist with Dr Edgar Spencer and Professor Robert Flanagan in the TDM section of the Medical Toxicology Unit, Guy’s & St Thomas’ Hospital, London, where he worked for ten years. Having obtained his PhD while at the Medical Toxicology Unit he has moved on, and now works at King’s College Hospital, London, within the department of Clinical Biochemistry, where a TDM service specialising in the analysis of atypical antipsychotics has been set up, and which is expanding into other areas relevant to TDM. His interests are in the application of modern instrumental methods for the selective assay and quantitation of drugs in biological matrices, particularly using HPLC. These include sample preparation, the use of smaller particle packings, and LC-tandem MS techniques. He is also interested in mechanisms of retention in HPLC, especially ion-exchange, as applied to drugs. Current areas of work include simplification of sample preparation and assay for antipsychotic drugs in plasma/serum; development and implementation of TDM assays for other classes of drug; evaluation of fused-core and sub-2 µm column packings; and the investigation of automated methods for plasma drug assays. ------------------------------------------- Click here: Edgar Spencer biography Edgar P. Spencer MSc PhD CChem FRSC MBA Edgar Spencer is Principal Clinical Scientist at the Medical Toxicology Unit, St Thomas’ Hospital, London. He has worked in the analytical sciences for over 25 years, in the UK, Germany and the USA. He is well known for his work in the TDM of clozapine, olanzapine and other antipsychotic drugs over the last 14 years. He has co-authored over 20 peer-reviewed articles primarily in the field of drug analysis and a similar number of international conference abstracts. He is currently involved in establishing a TDM service for antiretroviral drugs at Thomas’ Hospital, London. ------------------------------------------- Click here: Donald F. LeGatt biography Donald F. LeGatt, Ph.D, FCACB Dr. LeGatt is a Clinical Biochemist who has been head of the Clinical Toxicology and Therapeutic Drug Monitoring Laboratory at University of Alberta Hospital, Capital Health, Edmonton for twenty seven and a half years. He is a Clinical Professor at the University of Alberta with teaching responsibilities in the Faculty of Medicine and Dentistry and is an Alberta Health Services Regional Consultant. Dr. LeGatt has also been a Consultant Toxicologist at DynaLIFEDx Diagnostic Laboratory Services, Edmonton for eleven years. He has been a member of IATDMCT since 1990 and has served on many IATDMCT committees including the Board as Councilor and Director of Education. Dr. LeGatt’s research interests span the areas of toxicokinetics, applied pharmacokinetics and method development. He is an avid proponent of progressive, rational clinical toxicology testing and has been a major force in development of a clinical practice guideline on this issue. He has over 100 publications, abstracts and book articles to his credit. ------------------------------------------- Go to top     SUNDAY OCTOBER 4, 2009, 1030-1230, Workshops W121, W122, W123   Workshop W121: Methods Development for Quantitative HPLC-Tandem Mass Spectrometry Paul Taylor, Senior Scientist, Department of Clinical Pharmacology, Princess Alexandra Hospital, Brisbane, Australia Christoph Seger, Head of the Division of Mass Spectrometry and Chromatography, Central Institute of Medicinal and Chemical Laboratory Diagnostics (ZIMCL), University Hospital, Innsbruck, Austria     HPLC-mass spectrometry is a powerful analytical tool that is increasingly used for drug quantification. The focus of this workshop will be on the development of quantitative bioanalysis using HPLC-atmospheric pressure ionisation-triple quadrupole tandem mass spectrometer (HPLC-MS/MS). While HPLC-MS/MS offers advantages over other techniques, there are many parameters in methods development that must be addressed. This workshop will include a step-by-step guide on the development and optimization of quantitative HPLC-MS/MS. Practical examples will be used to illustrate the challenges of methods development. Such issues as the interrelationship between sample preparation and chromatography and matrix effects will be discussed.   Click here: Paul Taylor biography Paul J. Taylor Paul Taylor currently holds the position of Senior Scientist, Department of Clinical Pharmacology, Princess Alexandra Hospital, Brisbane, Australia. The focus of his research, over the past 15 years, has been on the application of LC-mass spectrometry to the clinical setting with emphasis on therapeutic drug monitoring, pharmacodynamic monitoring, biomarkers, assay development, and method validation. Paul’s current research has centred on the improved diagnosis of primary aldosteronism using LC-mass spectrometry, improved patient outcomes through individualisation of the newer immunosuppressant drugs and detection of the iron biomarker, hepcidin, by LC-mass spectrometry. Paul has published over 70 peer reviewed papers and 120 abstracts. He has presented numerous times as an invited speaker. Paul is on the editorial board of Therapeutic Drug Monitoring and Journal of Chromatography B. In 2003, he was awarded the International Association of Therapeutic Drug Monitoring and Clinical Toxicology “Young Investigator Award”. ------------------------------------------- Click here: Christoph Seger biography Christoph Seger PhD Christoph Seger, a chemist by training (PhD University of Vienna), is currently heading the Division of Mass Spectrometry and Chromatography at the Institute of Medical and Chemical Laboratory Diagnostics (ZIMCL), University Hospital Innsbruck, Austria. The research efforts of his team is focussed on developing and validating LC-MS/MS assays for a typical clinical routine environment. Christoph has authored / co-authored more than 50 peer reviewed papers and about 130 conference abstracts. ------------------------------------------- Go to top Workshop W122: Monitoring the Clinical Toxicology Aspects of the Complementary and Alternative Medicine Vanessa Steenkamp, Director Phytomedicine Unit, Department of Pharmacology, University of Pretoria, South Africa Esther Giesbrecht, M.Sc., Manager Clinical Laboratory, Centre for Addiction and Mental Health, Toronto, Ontario, Canada Zul Verjee, Ph.D., D. Clin. Chem, FCACB, Division of Clinical Biochemistry, The Hospital for Sick Children, and Clinical Biochemistry & Clinical Toxicology, Centre for Addiction and Mental Health, Toronto, Ontario, Canada Marc Purcell, Ph.D., Director PureCell Technologies, Montreal, Quebec, Canada Robert Winkler, MD, Novartis Oncology Global, Drug Development, New Jersey, USA Manuela Neuman, Ph.D., Assistant Prof Pharmacology, University of Toronto, Director, In Vitro Drug Safety and BioTechnology, MaRS Discovery Centre, Toronto, Ontario, Canada     This workshop is intended for laboratory scientists, clinical chemists, pharmacology scientists, clinical toxicologists and veterinary medicine specialist. The participants will learn about the clinical and laboratory aspects of toxicology and plant-derived analysis. Practical aspects of instrument selection, method development, validation, and quality assurance will be discussed. In addition critical models of plant derived toxicity or plant derived protection in humans and animal models will be presented 1) "Comparison of various analysis technologies for identification of pyrrolizidine alkaloids from Senecio sp" Vanessa.Steenkamp Ph.D.; 2) "Determination of different fractions from poisonous and non-poisonous berries "; Esther Giesbrecht M.Sc., Zul Verjee Ph.D. FCACC, Manuela G. Neuman M.Sc. Ph.D. FCACC 3) "Protective effects of thylakoids from spinach extract" Marc Purcell, Ph.D. 4) "Clinical and laboratory toxicology of pyrrolizidine alkaloids"; Manuela G. Neuman M.Sc., Ph.D. and Robert Winkler M.D.   Objectives: At the conclusion of this workshop the participant will be able to: Recognize and prevent common liquid chromatography and mass spectrometry problems encountered during LC-MSMS method development; Recognize and prevent common problems encountered when using complementary and alternative medicine; Describe the advantages and disadvantages of different species used as herbal medicine; Learn techniques and models used in identification of possible toxicological problems; Understand the application of herbal medicine monitoring and clinical toxicology; with the aim of optimizing clinical complementary medicine use and maximizing the clinical and economic benefits; Select the most suitable platform for different pre-clinical models in herbal medicine; Enhance communication between scientists and physicians of all disciplines involved in complementary alternative medicine monitoring and clinical toxicology. Click here: Vanessa Steenkamp biography Vanessa Steenkamp Prof Vanessa Steenkamp’s research interest involves various aspects of traditional herbal remedies. Presently she heads the Phytomedicine Unit in the Department of Pharmacology, University of Pretoria. Prof Steenkamp is the author and co-author of >45 scientific papers. She has received 19 awards for her research both nationally and internationally, amongst others the prestigious Friedel Sellschop award, formerly known as the University of the Witwatersrand Young Researcher in 2001 and Exceptional Young Researcher of the University of Pretoria in 2006, two of the leading academic institutions in the country. In 2007 she received two international awards in recognition of her research from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology and the American Association of Clinical Chemistry. She is the President of the South African Association of Clinical Biochemistry, Vice-President of the Toxicology Society of South Africa, Secretary-General of the South African Association of Basic and Clinical Pharmacology. She serves as reviewer for 14 international peer-reviewed journals and is on the editor board of two journals. She has 149 conference contributions and has been the invited speaker on 13 occasions. ------------------------------------------- Click here: Esther Giesbrecht biography Esther Giesbrecht Have been involved in toxicology and drug analysis for over 30 years. Currently I am the lab manager at the Centre for Addiction and Mental Health , and prior to that was the supervisor of the toxicology lab at the Hospital for Sick Children. I have an Honours BSc from the University of Toronto, and advanced certification in Clinical Chemistry from the Canadian Society of Laboratory Technologists, and have been a member of IATDMCT for over 10 years. ------------------------------------------- Click here: Zul Verjee biography Zul Verjee, Ph.D., D. Clin. Chem, FCACB Zul Verjee, Ph.D., D. Clin. Chem, FCACB works as Clinical Biochemist at The Hospital for Sick Children Division of Clinical Biochemistry and is a consultant in Clinical Biochemistry and Clinical Toxicology for the Centre for Addiction and Mental Health as well as a consultant for Clinical Biochemistry for the University Health Network, Toronto Hospital. He also serves as a Program Director at the Research Institute, Hospital for Sick Children and an Assistant Professor, Department of Laboratory Medicine and Pathobiology, University of Toronto. His research interests are: Therapeutic Drug Monitoring in Pediatrics; Measurement of Free Drugs in Body Fluids; Drug levels in Breast Milk: Analysis and Interpretation; Screening for Drug Overdose and Adverse Reaction in Emergency Toxicology with particular reference to Drugs of Abuse, Date Rape Drugs and some Herbal medication; Advances in Analytical Methods for Immunosuppressive Drugs, azathiopurine metabolites and new anticonvulsants. Research and Development activities are cantered around the new approaches to Therapeutic Drug Monitoring of Immunosuppressive Drugs cyclosporine, tacrolimus, sirolimus and mycophenolic acid using the Tandem Mass Spectrometry. Future applications of Tandem Mass Spectrometry to screening for drug overdoses in Emergency Medicine; High Pressure Liquid Chromatography methods for the quantitation of Azathioprine and metabolites in patients with inflammatory bowel disease; immunoassay: issues related to cross reactivity, misdiagnoses and interpretation; identification of unknown compounds by routine HPLC methods. ------------------------------------------- Click here: Marc Purcell biography Marc Purcell Marc Purcell is Director of PurGenesis Technology, Quebec, Canada. Dr. Purcell earned a BSc (Physiology) from the University of Sherbrooke in 1987, and obtained is Ph.D. in biophysics from University - Québec in Trois-Rivières (UQTR) and did post-doctoral work at Harvard University (USA) in Molecular Biology. He paid special attention to the biochemistry of plant at a molecular level. He was assistant professor in the Department of Chemistry-Biology at UQTR. He published more than 20 scientific articles and present is work to more than 30 congresses and symposiums in several countries. He founded PureCell Technologies in March 1999, in order to continue his work and to combine his two main fields of interest: plant biochemistry and product development for human health. ------------------------------------------- Click here: Robert E. Winkler biography Robert E. Winkler, MD Robert E. Winkler, MD holds a Senior Medical Director position at Novartis Oncology Global Drug Development working on Afinitor - Novartis Oncology leading drug in development.Dr Winkler has almost a decade worth of Biotech/Pharmaceutical expertise which includes international assignments and Global development and medical Affairs roles at Novartis and Schering-Plough. In his capacity, Dr Winkler is an expert in drug development from strategy to execution, clinical pharmacology and throughout all four phases of clinical studies, developing regulatory documents and leading successful interactions with Health Authorities, as well as developing pharmacovigilance risk management programs. Dr Winkler has been involved in new technology assessments in the past as a biotech's CEO strategic consultant as well as being currently part of Novartis Due-Diligence business development team.Robert E. Winkler graduated cum lauda from the Hebrew University and Hadassah Medical school in Jerusalem, has been trained in Israel and US and holds a Internal Medicaine board certification. Dr Winkler has been invited speaker to international congresses as well as published in peer review journals. ------------------------------------------- Click here: Manuela Neuman biography Manuela G. Neuman M.Sc., Ph.D., FCACC Dr. Neuman is Assistant Professor of Pharmacology at Faculty of Medicine, The University of Toronto and founder and CEO In Vitro Drug Safety and Biotechnology, at MaRS Discovery District, Toronto, Canada. Dr. Neuman received her M. Sc. from in Biology & Virology and her Ph.D., in Physiology and Pharmacology. She also completed her post-doctoral fellowship on the Gastroenterology and Clinical Pharmacology at the University of Toronto, Toronto, Canada. Additional post-graduate work includes a fellowship in liver disease and fellowship in Immunology. Dr. Neuman has authored numerous scientific publications. She has published extensively in the areas of chronic viral hepatitis, drug-induced liver disease, alcohol-induced liver disease, liver immunology, and primary biliary cirrhosis. Dr. Neuman has served the University of Toronto in many capacities including Head of the In Vitro Biotechnology Platform. Her laboratory “In Vitro Drug Safety and Biotechnology” performed many studies in collaboration with different pharmaceutical companies and laboratories. Dr. Neuman’s research activities includes of the important issues regarding evaluation of safety profiles of different drugs of use (sulphonamides, anticonvulsants, non-steoidal-anti-inflammatory agents, protease inhibitors and complimentary and alternative medicine and compare the biochemical and immunological changes in patients that encounter hepatocytotoxicity or dermatoxicity with those agents. Moreover alternative options for therapeutic class are provided. Her research activities discuss the overall favorable record of hepatic safety of drugs along with comments on the use of these agents in patients with underlying liver disease in different scientific and industrial fora. Another important subject of Dr. Neuman’s research is efficacy of therapies as shown by: expression of Toll-like receptors (TLRs) and other pathogen recognition receptors in the liver, and signaling pathways involved in liver injury and the role of immune system in viral hepatitis, interactions of cytokines and chemokines receptors as a mechanism regulating inflammation and steatosis in the liver, the role of monoclonal antibodies (in inflammation and immunity as well as fibrogenesis – antifibrogenesis imaging. ------------------------------------------- Go to top Workshop W123: Practical Aspects of Oral Fluid On-site Tests for DOA Pascal Kintz, PharmD, PhD, Head of the Scientific Affairs, ChemTox Laboratory, Strasbourg, France     Particular interest in oral fluid has been expressed by law enforcement agencies for roadside testing of intoxicated drivers or in occupational medicine. The presence of drug metabolites in urine of potentially impaired subjects can be interpreted as evidence of relatively recent exposure. However, this does not necessarily mean that the subject was under the influence at the time of sampling. It has been claimed that the concentrations of many drugs in oral fluid correlate well with blood concentrations, which suggests that the oral fluid matrix can be a complementary matrix to blood since it represents active exposure. The use of oral fluid as an alternative to urine testing would facilitate the procedure to screen for recent drug use on-site. The possibility of supervising the sampling without the intrusion of privacy is especially important for police officers, nurses or medical doctors to avoid adulteration of the sample. The possibility of substitution or contamination appears as minimal; hence, it is less liable to cheating in comparison with urine. The application of the immuno-chemistry based devices for screening of oral fluid has not produced satisfactory results to date, particularly for cannabis.   Objectives: At the conclusion of this workshop the participant will learn: The anatomy of oral fluid, pharmacokinetics of drugs of abuse; The lessons of ROSITA-2, the European roadside testing study; An evaluation of current on-site tests. Why is cannabis so difficult to detect ?; New perspectives in drug testing in oral fluid.   Click here: Pascal Kintz biography Pascal Kintz PhD Dr. Pascal Kintz has a degree in Pharmacy (1985), a Diplôme d'Etudes Approfondies in Molecular Pharmacology and a PhD in Toxicology (1989) of the Université Louis Pasteur in Strasbourg. He was Associate Director of the Institute of Legal Medicine of Strasbourg and Associate Professor of Legal Medicine until the end of 2004 where he teached forensic toxicology at the Faculty of Medicine. Currently, he is Head of the Scientific Affairs at ChemTox Laboratory, a private structure in Strasbourg, France. His main topics of interest include: alternative specimens with a special focus on hair and oral fluid, pharmacology of drugs of abuse, postmortem toxicology and doping control. He is active in several national and international scientific societies, such as Société Française de Toxicologie Analytique, SFTA (President 1997-2003), The International Association of Forensic Toxicologists, TIAFT (President 2005-2008) and the Society of Hair Testing (Founding Member in 1995, President since 2008). He received the TIAFT Award for Excellence in 2001 He is an Expert for Justice for the French Supreme Court for Pharmacology / Toxicology, and blood alcohol determination and an Expert certified by the Gesellschaft für Toxicologische und Forensische Chemie (Germany) and Eurotox. Dr Kintz has published more than 250 papers in peer-reviewed journals. He is associate editor of Journal of Analytical Toxicology and regular reviewer for Journal of Chromatography, Forensic Science International, Clinical Chemistry, Journal of Pharmaceutical Sciences, and Annales de Toxicologie Analytique. ------------------------------------------- Go to top     SUNDAY OCTOBER 4, 2009, 1300-1500, Workshops W131, W132, W133   Workshop W131: Young Scientist Workshop Frank T. Peters, Institut für Rechtsmedizin, Universitätsklinikum Jena, Jena, Germany (Chair) Denise A. McKeown, Analytical Unit, Division of Cardiac & Vascular Sciences, St George's, University of London, London, UK (Co-Chair) Markus R. Meyer, Dipl. Pharm., M.Sc., Pharmacist - Research Assistant, Department of Experimental and Clinical Toxicology, Institute of Experimental and Clinical Pharmacology and Toxicology, Saarland University, Homburg (Saar), Germany Franck Saint-Marcoux, Hospital Clinical Chemist, Department of Pharmacology and Toxicology, Limoges University Hospital, Limoges, France Susannah Davies, BSc MSc, Senior Bioanalyst and GLP Facility Co-ordinator, Forensic Toxicology Service, Analytical Unit, St Georges University of London, London, UK Jennifer Button, BSc, DipFMS, Head of Toxicology, Forensic Toxicology Service, St. George's University of London, London, UK     The workshop will consist of two sections. In the first section, basic topics of TDM and CT will be addressed in oral presentations. The first talk will address a topic relevant to both TDM and CT discussing polymorphisms of metabolic enzymes and their clinical relevance. In the second talk the basics of Bayesian estimates in pharmacokinetic modelling and dose adjustment will be presented. The third will give an overview on new designer drugs found in seized preparations and the clinical symptoms associated with toxicity following use of these drugs. The second section will be an Open Forum Discussion.   Objectives: At the conclusion of this workshop the participant will be able to: Understand which of the major metabolic enzymes are polymorphically expressed and how this may affect clinical drug treatment; Understand how Bayesian Estimates may be used to model individual pharmacokinetics and how this information may be used in dose adjustment; Understand which new designer drugs have become popular in recent years and which symptoms of intoxication are associated with these drugs. Outline:  1) Polymorphisms of Metabolic Enyzmes and their Clinical Relevance, Markus R. Meyer This presentation will give some general insights into the metabolism of xenobiotics which is important for their detoxification, elimination and/or bioactivation. Furthermore, most metabolizing enzymes that are polymorphically expressed will be presented and discussed (e.g. CYP2D6, CYP2C19 and UGTs). Their clinical relevance which is given in many fields of pharmacological therapy (e.g. antidepressants and anticoagulants) will be mentioned. Finally, the fact that pharmacogenetic influence on metabolism must not be seen equal to pharmacological influence is clarified and some examples will be given. In this session the participant will gain: • Knowledge about metabolic enzymes that are polymorphically expressed; • Knowledge about relevance in clinical drug treatment; • Knowledge about influence on metabolic enzymes beyond pharmacogenetic. 2) Bayesian Estimates in PK Modelling and Dose Adjustment, Franck Saint-Marcoux The INSERM research unit “Pharmacology of the immunosuppressive drugs in transplantation” (Limoges, France) has developed PK models and Bayesian Estimators from large populations of transplanted patients enrolled in PK studies promoted and coordinated by the Limoges University Hospital, other academic institutions, or by pharmaceutical laboratories. These tools allowing the estimation of main PK parameters and exposure indices using sparse individual data have been implemented in in-house modelling software, but also in more worldwide PKpop packages. An expert system for ImmunoSuppressants Bayesian dose Adjustment (ISBA) was further developed and rendered these PK tools accessible through a free website dedicated to the TDM of immunosuppressive drugs. Dr Saint-Marcoux’ presentation will discuss the designs of PK studies allowing the development of user-friendly and routinely usable PK tools, and the different modelling or Bayesian forecasting approaches (e.g., iterative two-stages and non-linear mixed effect) used at University Hospital Limoges. After this workshop, the participant should be able to discuss the feasibility of implementing PKpop packages and Bayesian estimators in routine TDM ------------------------------------------- 3) New Designer Drugs, from Seized Preparations to Clinical Symptoms–Part 1, Susannah Davies The widespread use of the Internet and the constant search for new legal and illegal ‘highs’ has lead to an increase in the availability of novel designer drugs. Many of these products, sold as ‘legal highs’, ‘herbal highs’ or ‘party pills’ from UK based websites and shops, are promoted as ‘safe, legal alternatives to illicit drugs’. They appeal to a growing, and lucrative, market of clubbers and young professionals who seek a stimulant that is both legal and safe. These products are not subject to any quality control or regulation and labelling is insufficient or inaccurate. It is only by the analysis of these products that the true extent of what is being consumed is revealed. We present data from recent website and shop test purchasing and drug amnesty bins from a variety of venues and music festivals. The clinical and toxic effects of some of these compounds seen in UK emergency departments (ED) are described in this presentation. Routine toxicological screening does not cover the scope of these new compounds, however, due to our partnership with a major inner city ED, we present data from presentations resulting from administration of some new legal designer drugs. ------------------------------------------- 4) New Designer Drugs, from Seized Preparations to Clinical Symptoms–Part 2, Jennifer Button The widespread use of the Internet and the constant search for new legal and illegal ‘highs’ has lead to an increase in the availability of novel designer drugs. Many of these products, sold as ‘legal highs’, ‘herbal highs’ or ‘party pills’ from UK based websites and shops, are promoted as ‘safe, legal alternatives to illicit drugs’. They appeal to a growing, and lucrative, market of clubbers and young professionals who seek a stimulant that is both legal and safe. These products are not subject to any quality control or regulation and labelling is insufficient or inaccurate. It is only by the analysis of these products that the true extent of what is being consumed is revealed. We present data from recent website and shop test purchasing and drug amnesty bins from a variety of venues and music festivals. The clinical and toxic effects of some of these compounds seen in UK emergency departments (ED) are described in this presentation. Routine toxicological screening does not cover the scope of these new compounds, however, due to our partnership with a major inner city ED, we present data from presentations resulting from administration of some new legal designer drugs. -------------------------------------------   Click here: Frank T. Peters biography Dr. rer. nat. Frank T. Peters Frank T. Peters was born in Trier, Germany, in 1971. After studying pharmacy at the Johann-Wolfgang-Goethe University in Frankfurt/Main, Germany, and one year of practical training, he obtained the licence to practice as a pharmacist in 1998. Thereafter, he worked as a research assistant and PhD student of Prof. Dr. Dr. h.c. Hans H. Maurer at the Department of Experimental and Clinical Toxicology of the University of Saarland in Homburg, Germany, where he finished his PhD thesis in June 2003. Until the end of 2008, he worked in the same department as a post-doc and deputy of Prof. Maurer. Since 2009 he is Head of Toxicology in the Institute of Forensic Medicine at Friedrich Schiller University of Jena, Germany. The main research interests of Frank T. Peters are biotechnological synthesis of drug metabolites, enantioselective analysis of amphetamines and amphetamine-like designer drugs, analysis of new designer drugs in blood samples, metabolism of drugs and poisons, determination of sedating drugs in the context of declaration of brain death, and experimental designs and statistical procedures for analytical method validation. Frank T. Peters is author or co-author more than 50 peer-reviewed publications, one book and six book chapters and he was an invited speaker at ten international meetings. Frank T. Peters is a member of The International Association of Forensic Toxicologists (TIAFT), the German Pharmaceutical Society (DPhG), the Society of Toxicological and Forensic Chemistry (GTFCh), and of the International Association of Therapeutic Drug Monitoring &Clinical Toxicology (IATDMCT). Frank T. Peters is chairman of IATDMCT’s Young Scientist Committee and secretary of TIAFT’s Young Scientist Committee. In 2003, he received the TIAFT Young Scientist Award for Best Paper Published in 2002. In 2007, he received the Young Scientist Award of the GTFCh. ------------------------------------------- Click here: Denise A. McKeown biography Denise A. McKeown, MSci Denise McKeown graduated in 2002, from the University of Strathclyde, Glasgow, with an MSci in Forensic and Analytical Chemistry. Since December 2002, she has worked in Prof David W. Holts group, at St George’s - University of London, pursing her interest in analytical chemistry. Denise specialises in the development and validation of hyphenated chromatographic and mass spectrometric methods for the qualitative and quantitative detection of drugs, their metabolites and endogenous compounds for application in the areas of clinical (e.g. TDM of immunosuppressives and antiretrovirals, clinical trials) and forensic toxicology. Denise is actively involved in research in these areas and has written and contributed to several peer-reviewed publications and two book chapters, and presents at local and international conferences. She is a member of the International Association of Therapeutic Drug Monitoring & Clinical Toxicology (IATDMCT), Royal Society of Chemistry, London Toxicology Group and The International Association of Forensic Toxicologists (TIAFT). Denise A. McKeown is Secretary of the IATDMCT’s Young Scientist Committee and the Associate Editor for the IATDMCT quartley newsletter – The Compass. ------------------------------------------- Click here: Franck Saint-Marcoux biography Franck Saint-Marcoux Dr. Franck Saint-Marcoux obtained a doctorate in Pharmacy in 2003, a DEA (1st year in PhD) in analytical chemistry in 2001, and a PhD in Pharmacokinetic modelling in 2004. Under the tutelage of Prof. Pierre Marquet, this thesis was about dose adjustment of immunosuppressive drugs in transplantation. He currently holds a Hospital Clinical Chemist position in the department of Pharmacology and Toxicology of the Limoges University Hospital (France) and is a member of the INSERM research unit “Pharmacology of the immunosuppressive drugs in transplantation”. His current research activity is focused on the development of PK tools useful for a routine activity of TDM, mainly IS, but also antibiotics or anticancer drugs. ------------------------------------------- Click here: Markus R. Meyer biography Dipl. Pharm. Markus R. Meyer, M.Sc. Apotheker Markus R. Meyer was born in 1980 and grew up in Schmelz, Germany, where he also went to elementary school. After high school and graduation in 1999, he did community service (in lieu of military service) in a hospital in Lebach, Germany. He started studying pharmacy at the Saarland University in Saarbruecken, Germany. In 2004, he finished his studies with the 2nd State Pharmacy Examination. Afterwards, Markus worked with Prof. Hans H. Maurer at the Department of Experimental and Clinical Toxicology of the University of Saarland in Homburg, Germany where he obtained an MSc degree in Pharmacy with his thesis on "New Designer Drug 4´-Methyl-alpha-pyrrolidino-butyrophenone (MPBP) – Studies on the Identification of its Metabolites, Toxicological Analysis, and Cytochrome P450 Isoenzymes Involved in its Main Metabolic Steps". After a half year of practical training at a pharmacy he finished his education with the 3rd State Pharmacy and Examination and obtained the licence to practice as a pharmacist in 2005. Thereafter, he started working as a research assistant and PhD student of Prof. Hans H. Maurer. The main research interests of Markus R. Meyer are P450 dependent (enantioselective) metabolism of designer drugs and metabolism of drugs and poisons. Markus is actively involved in research in these areas and has written and contributed to several peer-reviewed publications, and presents at local and international conferences. He is a member of The International Association of Forensic Toxicologists (TIAFT), the German Pharmaceutical Society (DPhG), the Society of Toxicological and Forensic Chemistry (GTFCh), and of the International Association of Therapeutic Drug Monitoring & Clinical Toxicology (IATDMCT). In 2008, he received the TIAFT Young Scientist Award for Best Oral Presentation at the TIAFT meeting in La Martinique for his work on "The Role of Human Hepatic Cytochrome P450 Isozymes in the Metabolism of the Racemate and the Enantiomers of MDMA." ------------------------------------------- Click here: Susannah Davies biography Susannah Davies, MSc Susannah Davies is a bio analyst in the Forensic Toxicology Section of the Analytical Unit, St George’s, University of London. Susannah graduated with a BSc in Biomedical Science and an MSc in Forensic Science, and is now specialising in the areas of clinical and forensic toxicology. Her main areas of work are forensic toxicology, the development of hyphenated chromatographic and mass-spectrometric assays, and ensuring the laboratory is compliant with the principles of Good Laboratory Practice. Through additional work with TICTAC Communications Ltd, Susie has over four years experience in the analysis of illicit and general tablets, capsules and powders. Susannah is actively involved in research in these areas and has written and contributed to several peer-reviewed publications, and presents at local and international conferences. Susannah is an active member of the IATDMCT Young Scientist Committee. In addition, she is a member of the Forensic Science Society, London Toxicology Group and The International Association of Forensic Toxicologists. ------------------------------------------- Click here: Jennifer Button biography Jennifer Button, BSc, DipFMS Jennifer Button joined the Analytical Unit, St George’s, University of London, as a trainee technician in 1997. Since then she has progressed through the ranks and now heads the busy Forensic Toxicology Section, in addition to being the Deputy Quality Assurance Officer for the Unit. The main focus of her work is post-mortem toxicology and the investigation of drug-facilitated crimes; she has also been involved in the measurement of immunosuppresive and anti-arrhythmic drugs, and the management of GLP compliant clinical drug trials. Jennifer initiates and conducts research in these areas and has written and contributed to several peer-reviewed publications, and presents at local and international conferences. Jennifer studied part time for a Degree in Biomedical Sciences, for which she achieved a 1st class (Hons) in 2003. She was also awarded the Presidents prize from the Institute of Biomedical Science for outstanding achievement in the subject. Following her degree she studied for a post graduate diploma in Forensic Medical Science, which she obtained in October 2007. Jennifer is an active member of the IATDMCT Young Scientist Committee. In addition she is also a member of the Forensic Science Society, London Toxicology Group, UK Forensic Toxicology Network and The International Association of Forensic Toxicologists. ------------------------------------------- Go to top Workshop W132: Pitfalls in Workplace Drug Testing: Diluted Urine, Use of Adulterants and Drugs Not Included in Test Panels Amativa Dasgupta, Professor, Department of Pathology and Laboratory Medicine, University of Texas-Houston Medical School, Houston, Texas, USA Albert D. Fraser, PhD, FCACB, DABCC-TC, DABFT, Clinical Division Head of Clinical Biochemistry, Laboratory Medicine, Saint John Regional Hospital, Provincial Forensic Toxicologist, Province of New Brunswick, Saint John, Canada Loralie Langman, PhD, Director, Toxicology and Drug Monitoring Laboratory, Department of Laboratory Medicine and Pathology, Associate Professor of Laboratory Med/Pathology, College of Medicine, Mayo Clinic, Rochester, USA     Workplace drug testing is a common practice in today’s work environment but these drug testing programs also have limitations. People try to beat drug testing by using flushing and detoxifying agents, using in vitro urinary adulterants as well as by substituting a specimen by synthetic urine. If such factors are not identified prior to testing, a person abusing drugs may pass a drug test. In addition, several drugs such as oxycodone, meperidine, fentanyl analogs etc. are hard to detect in urine if present. In addition, use of a prescription pain medication may cause positive test results. This workshop will focus on these issues and how to rectify such problems. 1) Diluted urine and drug testing at concentrations below the standard cut-off values, Albert D. Fraser 2) How to identify the presence of adulterants in specimens submitted for workplace drug testing? Amitava Dasgupta 3) Drugs that escape detection in workplace drug testing and clinical false positive test results due to use of prescription medications, Loralie Langman   Objectives: At the conclusion of this workshop the participant will be able to: Identify the presence of adulterants by using spot tests or especially designed urine dipstick test; Be aware of limitations of workplace drug testing and may be able to expand the scope of workplace drug testing; Be an effective consultant to the Medical Review Officer. Click here: Amitava Dasgupta biography Dr. Amitava Dasgupta Dr. Amitava Dasgupta is a Professor of Pathology and Laboratory Medicine at the University of Texas Health Sciences Center at Houston and also the Director of Clinical Chemistry, Toxicology and Point of Care Services at the Memorial-Hermann Hospital Laboratories, the major teaching hospital of the University of Texas Medical School at Houston. He received his PhD in chemistry from Stanford University and completed his fellowship in clinical chemistry from the University of Washington at Seattle. He is certified in both clinical chemistry and toxicology by the American Board of Clinical Chemistry. Dr. Dasgupta’s major research interest is in the field of therapeutic drug monitoring and drugs of abuse testing. He has published 175 papers, many reviews and edited three books and wrote two books. He is on the editorial board of American Journal of Clinical Pathology, Archives of Pathology and Laboratory Medicine, Therapeutic Drug Monitoring, Clinica Chimica Acta and Journal of Clinical Laboratory Analysis. ------------------------------------------- Click here: Albert D. Fraser biography Albert D. Fraser PhD, FCACB, DABCC-TC, DABFT Dr. Albert D. Fraser received his doctorate degree in biochemistry at Boston University, Boston, USA. Dr. Fraser was certified by the Canadian Academy of Clinical Biochemistry, the American Board of Clinical Chemistry (Toxicological Chemistry) and the American Board of Forensic Toxicology. He is Clinical Division Head of Clinical Biochemistry, Laboratory Medicine, Saint John Regional Hospital, New brunswick and provincial forensic toxicologist, Province of New Brunswick, Canada. He is a former president of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. Dr. Fraser was a laboratory inspector for the US Substance Abuse and Mental Health Services Administration (SAMHSA) for >10 years. Since 1991, he has been a technical advisor for the urine drug-testing programme of the Correctional Service of Canada. In addition, Dr. Fraser is a member of the Doping Control Review Board of the Canadian Centre for Ethics in Sport. This board reviews applications for therapeutic drug use by Canada’s elite athletes and interpretation of test results from the World Anti Doping Agency (WADA) laboratory in Montreal, Quebec. ------------------------------------------- Click here: Loralie Langman biography Loralie Langman PhD Loralie Langman, Ph.D. got her BSc in Laboratory Medicine and Pathology, CSMLS, and ASCP certifications at the University of Alberta and University of Alberta Hospital. After working for a few years as a laboratory technologist, she then went back to school and completed her Ph.D. in Medicine – Laboratory Medicine and Pathology at the University of Alberta. She completed her Clinical Chemistry training at the University of Toronto, specializing in Forensic Toxicology and Molecular Genetics. Prior to coming to Mayo Clinic Rochester, she was in Vancouver, British Columbia, at the Provincial Toxicology Centre and BC Biomedical Laboratories as a Forensic Toxicologist/Clinical Chemist. Dr. Langman was certified with the Canadian Academy of Clinical Biochemistry (CACB) and is the first individual to have achieved Diplomat status with the American Board of Clinical Chemistry (ABCC) in all three disciplines (Clinical Chemistry, Molecular Diagnostics, and Toxicological Chemistry). She is also a Diplomat with the American Board of Forensic Toxicology. Dr. Langman is a member of and serves on committees for several professional organizations including: The Society of Forensic Toxicologists; the American Academy of Forensic Sciences; the National Academy of Clinical Biochemistry; the American Association for Clinical Chemistry; the Canadian Society of Clinical Chemists; The International Association of Forensic Toxicologists, and The International Association of Therapeutic Drug Monitoring and Clinical Toxicology as a member of the Clinical Toxicology Committee and incoming Treasure. Currently, Dr. Langman is Director of the Toxicology and Drug Monitoring Laboratory at Mayo Clinic Rochester. She has over 30 publications and over 40 abstracts/presentations at National and International meetings. Her areas of expertise include: toxicology; drugs of abuse (particularly amphetamine-type stimulants and cocaine); post-mortem toxicology; therapeutic drug management; and pharmacogenetics. Her current research interests include metabolism and pharmacogenomics of amphetamine-type stimulants and cocaine; and genotype phenotype relationships of psychoactive medications. ------------------------------------------- Go to top Workshop W133: Managing Epilepsy Therapy with the Help of Measured Drug Levels: Critical Issues, Case Examples and Third Generation Drugs Dave Berry, Medical Toxicoloy Laboratory John Wilson, Dept of Toxicology, William Beaumont Hospital, Royal Oak, Michigan, USA James Ritchie, Emory University, Core and Special Chemistry Laboratories, Atlanta, Georgia, USA     Pharmaceutical treatment is the primary method of managing epilepsy and many newer drugs have become available. Approximately 30 % of epileptic patients are uncontrolled on medication and it is imperative that the clinical laboratory is able to provide the necessary support to personalize and optimize patient management. This work shop, will describe issues with clinical and analytical options for the 2nd and 3rd next generation of AEDs. The effect of differences in physiological states and drug metabolism will be discussed and in particular the need to monitor AEDs in pregnancy and post partum. Practice guidelines for AED use will be reviewed.   Objectives: At the conclusion of this workshop the participant will be able to: Appreciate the analytical methodology issues related to the antiepileptic drugs (AEDs); Understand the basic pharmacokinetics and disposition of the second and third generation AEDs and be exposed to some typical case scenarios which will give them a good understanding regarding the precise value of Therapeutic Drug Management in the epilepsy field. Click here: Dave Berry biography Dave Berry Dave Berry is a Fellow of the Royal College of Pathologists and holds a PhD from Surrey University where he studied under Prof. Dennis Park. He has worked at the Medical Toxicology Laboratory since 1967 and currently holds the position of Consultant Clinical Scientist in the Therapeutic Drug Management section where he has specialized in the management of epilepsy with the help of measured drug levels since 1970. Dr Berry’s main interests are analytical method development and subsequent application to drug pharmacokinetics and patient management. He has published more than 90 peer reviewed papers, other articles and given numerous posters and oral presentations at International and National Congresses. ------------------------------------------- Click here: John Wilson biography John Wilson Dr. Wilson has a doctoral degree in Pharmaceutics from the University of Washington, and Bachelor of Science degrees in Chemistry and Clinical Chemistry from the University of Washington and Seattle University, respectively. He currently holds a position of Clinical Chemist in Toxicology at William Beaumont Hospital in Royal Oak, Michigan. Previously he was Director of the Pharmacokinetic Service and Therapeutic Drug Monitoring and Toxicology Labororatory as well as the Worcester County Drug Analysis Laboratory at the University of Massachusetts Medical Center. Dr. Wilson’s interests include TDM method development, clinical pharmacokinetic applications, and the use of mass spectrometry for quantitative and qualitative use. He is the author of Abused Drugs:A Laboratory Pocket Guide and numerous publications and articles describing analytical methods and clinical applications. He is currently a member of the Editorial Advisory Boards of Clinical and Forensic Toxicology News and the Midwest Association for Toxicology and Therapeutic Drug Monitoring. ------------------------------------------- Click here: James C. Ritchie biography James C. Ritchie James C. Ritchie has been continuously involved in therapeutic drug monitoring and neuropharmacology research since 1969. He received his Bachelor of Science in Zoology in 1970 and a Masters in Public Health Epidemiology in 1976 both from the University of Michigan . He received his Ph.D. in Pharmacology from Duke University in 1995. Today, Dr. Ritchie is the director of the Emory University Core and Special Chemistry Laboratories and also as co-director of the ComACC post-doctoral training program at Emory. He has been active in AACC and the TDM division since 1984 He served as chairman of the Southeast Section in 1998, and as the secretary/treasurer of the section from 1999 until 2000. He was a founding member of the AACC Proteomics division and currently serves as chair of the division. His research interests include the pharmacology of antidepressants and antiepileptics during pregnancy as well as the development of multiplexed toxicology and proteomic techniques for tissue analyses. ------------------------------------------- Go to top     SUNDAY OCTOBER 4, 2009, 1530-1730, Workshops W141, W142, W143   Workshop W141: Applications of Pharmacogenetics for Personalized Pain Management Saeed A. Jortani, Ph.D., DABCC, FACB, Department of Pathology and Laboratory Medicine, University of Louisville, Louisville, USA     In managing pain, clinicians and their patients often face decisions which involve choosing the most appropriate pharmacological agent to contemplating non-pharmacologic modalities. Opioids are capable of relieving pain, induce sleep, are often addictive and can cause stupor, coma, or death (in higher doses). Despite their popularity in clinical practice, their inadequacies are often noted for both lack of effectiveness in some patients as well as being the primary cause of respiratory suppression in others. In this workshop, we will focus on the postoperative pain management using opioids. The role of genetic variations in metabolism and clinical efficacy of opioids will be discussed.   Objectives: At the conclusion of this workshop the participant will learn: To recognize the clinical indications of opioid analgesics and circumstances of their administration especially for post-operative pain management; To describe the role of genetic variations in metabolism of opioid analgesics; To address polymorphisms in OPRM1 gene relative to the analgesic efficacy of opioids; To discuss several cases of interaction of opioids with other CNS depressants with special emphasis on their pharmacogenetic interaction.   Click here: Saeed A. Jortani biography Saeed A. Jortani, PhD, DABCC, FACB Dr. Jortani is a faculty at University of Louisville School of Medicine where he directs the Forensic Toxicology Program (FTP), is the Director of the Toxicology Section of the University of Louisville Hospital’s Clinical Laboratory, and is the Associate Director of Diagnostic Reference Laboratory. His research interests are proteomics, detection and measurement of drugs, therapeutics and poisons, herbal medicine poisonings, and use of pharmacogenetics in pain management and for postmortem investigations. He serves on several national organizations in the area of laboratory medicine such as the AACC and the ABCC. He is also on editorial boards for Clinica Chemica Acta and Clinical Proteomics. ------------------------------------------- Go to top Workshop W142: Biomarkers for Pharmacodynamic Monitoring of Immunosuppressive Therapy – Analytical Aspects Gunnar Brandhorst, Universitätsmedizin Göttingen, Georg-August-Universität, Abteilung Klinische Chemie / Zentrallabor, Göttingen, Germany Mercè Brunet, Head of Pharmacology and Toxicology Department, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona University, Spain Petra Glander, PhD, PharmD, Head of Pharmacodynamic Lab, Department of Internal Medicine, Nephrology, Charité-Universitätsmedizin, Berlin, Germany Eberhard Wieland, MD, Professor of Clinical Chemistry and Laboratory Medicine, Medical Director, Center for Clinical Pathology, Pharmacy and Hygiene (CCPPH), Central Institute for Clinical Chemistry and Laboratory Medicine, Katharinenhospital, Stuttgart, Germany Claudia Sommerer, MD, Department of Nephrology, University of Heidelberg, Heidelberg, Germany     Pharmacodynamic monitoring measures the individual biological response to a drug, which may provide a novel aproach to tailor immunossuppressive therapy. Several biomarkers have been identified either assessing the specific effect of a particular drug or reflecting the efficacy of the immunosupprsseive regiment in general in a non specific manner. So far there are only single center experiences due to pre analytical obstacles. Furthermore, analytical methods to asses biomarkers, particularly those representing immune cell function, are not well standardized. The workshop is aimed to shed light on the various biomarkers with emphasis on analytical aspects of pharmacodynamic monitoring by bringing together experts in the field.   Outline:  Immune cell function – ATP, Gunnar Brandhorst Immune cell function – Cytokines, Mercè Brunet Previous studies indicate that there is a medical need for surrogate biomarkers, which enables prediction of long term outcomes after transplantation and a subsequent personalized immunosuppressive therapy. Several cytokines and specific T-cells surface antigens have been evaluated as surrogate biomarkers that may reflect the specific mechanism of an immunosuppressive drug, the personal response to a particular drug, and some of them may also be predictive of the risk of rejection or drug-toxicity. The analytical aspects and standardization for the measurement of these surrogate biomarkers are of critical importance to evaluate the clinical impact of this pharmacodynamic monitoring in achieving a personalized treatment in transplant recipients. Objectives of this presentation At the conclusion of this session the participant will understand: • Specific analysis for some cytokines strongly related with the mechanisms of action of some immunosuppressive drugs; • Role of these cytokines in assessing the risk of rejection and/or as a predictive biomarkers for personal response to a particular drug; • Correlation between pharmacokinetics and pharmacodynamics (drug exposure and cytokine expression). ------------------------------------------- Target enzymes, Petra Glander Serum markers, Eberhard Wieland Gene expression, Claudia Sommerer   Objectives: At the conclusion of this workshop the participant will be able to: Understand the potential of biomarkers to guide immunosuppressive therpay; Understand the difference between specific and non specific biomarkers; Estimate the analytical performance of various biomarkers and to know the pre-analytical pitfalls. Click here: Gunnar Brandhorst biography Gunnar Brandhorst 1997-2004: Medical School, University Hospital Goettingen, Germany 2003-2004: Internship, Georg August University Goettingen, Germany 2004 Thesis, Institute of Human Genetics, Goettingen, Prof. Dr. med. W. Engel. Title: „Molecular characterisation of the testicular expressed gene Tep22“ 2004-2005: Internal Medicine, Ev. Krankenhaus Goettingen Weende, Department of Internal Medicine, Prof. Dr. med. M. Karaus Since 2005: Laboratory Physician / Clinical Chemistry, University Hospital Goettingen, Department of Clinical Chemistry, Prof. Dr. med. Dr. h. c. M. Oellerich ------------------------------------------- Click here: Mercè Brunet biography Mercè Brunet PhD Graduated as a Philosophy Doctor from the Faculty of Pharmacy of Barcelona, Spain. Currently is the Head of Pharmacology and Toxicology Department of the Biomedical Diagnostic Center at the Hospital Clínic of Barcelona. IDIBAPS. Barcelona University. Coordinator of the Biomarker Working Group of the Cientific Committee of Immunosuppressive drugs of the IATDMCT. New Councillor of the IATDMCT (2009-2011) Field of research: Analysis of some biomarkers that may reflect the personal response to immunosuppressive drugs. Main purpose: Therapeutic drug monitoring, based on the combination of pharmacokinetic and pharmacodynamic parameters, as a base to achieve a personalized tretament. ------------------------------------------- Click here: Eberhard Wieland biography Prof. Dr. med. Eberhard Wieland, MD, EurClinChem Dr. Wieland is professor of Clinical Chemistry and Laboratory Medicine. He was appointed medical director of the Central Institute of Clinical Chemistry and Laboratory Medicine Klinikum Stuttgart, Germany in 2003 and executive head of the Centre of Clinical Pathology, Pharmacy and Hygiene in 2008. Dr. Wieland received his MD from the University of Heidelberg in 1983. He started his training in Clinical Chemistry and Laboratory Medicine in 1983 at the University Hospital in Heidelberg and from 1985 to 1985 he was awarded a postdoctoral fellowship at the Department of Endocrinology and Metabolism at the University of California San Diego by the Volkswagen Foundation. Back in Germany he finished his training in Clinical Chemistry and Laboratory Medicine at the University of Goettingen in 1996. From 1996 to 2000 he served as senior physician at the Department of Clinical Chemistry. Following an appointment as associate professor at the University of Goettingen he moved to Stuttgart in 2003. Dr. Wieland is an active referee for German accreditation bodies. His research interests span the areas of transplantation medicine, immunosuppressive drugs, lipid metabolism, and oxidative stress. He contributed over 90 articles to scientific journals and books. Dr. Wieland has presented more than 100 invited lectures at universities, research institutes and symposia in the United States, Australia, Austria, Belgium, Bulgaria, Canada, England, Germany, Italy. He is member of the Editorial Boards of the journals Clinical Biochemistry, Journal of Laboratory Medicine, and Folia Medica. ------------------------------------------- Go to top Workshop W143: Antifungal Drugs TDM : An Update Eliane Billaud, Paris, France Jan-Willem C. Alffenaar, Hospital Pharmacist, Department of Clinical and Hospital Pharmacy, University Medical Center Groningen (UMCG), Groningen, Netherlands David Andes, Madison, USA David Burger, Nijmegen, Netherlands Shahid Husain, MD, MS, Assistant Professor of Medicine in the Division of Infectious Diseases, Director of Transplant Infectious Diseases, University Health Network and University of Toronto, Toronto, Canada This workshop is presented by the IATDMCT Antifungal Drugs TDM Committee     Objectives: This workshop will provide an update in the emergent field of antifungal drugs TDM, concerning : The respective potential use of the different drugs already available (amphotericin, azoles, echinocandins) and the corresponding concentrations and doses target in the different invasive fungal diseases and underlying immuno-compromised situations (haematology, solid organ transplantation, ageing...); PK applications of azole drugs TDM such as quantitative approach in azoles drug-drug interactions management, antifungal combinations rationale and in special populations management; The first results of the external quality control of azole drugs . Outline:  Clinical and Therapeutic Issues of Mould infections in Immunocompromised Hosts, Shahid Husain Immunocompromised hosts are at a higher risk of developing mould infections. The risk of development of fungal infections is varies between the types of solid or stem cell transplant recipients. Among the solid organ transplant recipients, lung transplants recipients carry the highest risk of developing mould infections while allo bone marrow transplant recipients carry the highest risk among stem cell transplant recipients. The risk factors for the development mould infections can be broadly divided into the higher state of immunosuppression and unique risk factors associated with the type of organ transplants. Wide spread prophylaxis with anti mould agent have decreased the overall incident of the disease, however concerns have been raised regarding the development of resistance in moulds. The role of single vs. combination therapy for the treatment of mould infections is not well ascertained. Recent data has emerged correlating the adverse events and outcome with drug level monitoring. Recent cohort studies have reported lower incidence of mortality. Learning Objectives: At the end of the talk the participants should be able to: • Appreciate the epidemiology of mould infections in immunocompromised hosts • Understand the risk factors for the development of mould infections in immunocompromised hosts • Recognize the prophylactic and therapeutic rationale for mould infections in immunocompromised hosts • Comprehend the status of therapeutic drug monitoring in the management of mould infections in immunocompromised hosts ------------------------------------------- • Pharmacological Background, David Andes, Eliane M Billaud   • International Interlaboratory Proficiency Testing Program for the Measurement of Azole Antifungal Plasma Concentrations, D Burger   • ICU Management, JCW Alffenaar   • Ongoing Clinical Trials, Antifungal Drugs TDM Committee     Click here: Jan-Willem Alffenaar biography Jan-Willem C. Alffenaar Jan-Willem C. Alffenaar started his career in 2002 as pharmacist at the department of Clinical Pharmacy and toxicology of the University Medical Center Groningen in the Netherlands. From 2005-2008 served as a hospital pharmacist in residence at the same hospital. During his routine TDM training he developed great interest into infectious diseases in critically ill patients. This resulted in a PhD studentship, which is supervised by Prof. DRA Uges Ph.D., Prof. TS van der Werf, Ph.D. and JGW Kosterink,Ph.D.. The subject of his thesis is “The pharmacokinetics and TDM of antimicrobial agents, in particular antifungal agents and anti-TB drugs in critically ill patients”. In the laboratory of the Hospital Pharmacy the required methods of bio-analysis were developed and validated for routine TDM and to support his studies (i.e. fluconazole, itraconazole and metabolite, voriconazole and posaconazole). A method for echinocandins is being developed at this moment. For routine TDM and clinical trials we are monitoring the anti-TB drugs rifampicin, isoniazid, claritromycin, amikacin, linezolid and ethambutol. Examples of his clinical studies are “pharmacokinetics of voriconazole in critically ill patients”; “pharmacokinetics and toxicity of linezolid in patients with MDR-TB”, “pharmacokinetics of claritromycin and rifampicin in patients with M. ulcerans infection”. At this moment he is coordinating investigator and working on a randomised controlled clinical trial of therapeutic drug monitoring of voriconazole in patients with haematological malignancies in collaboration with 12 other hospitals in The Netherlands. At the end of 2009 he will finish his PhD and is also planning to finish his clinical pharmacology track. ------------------------------------------- Click here: Shahid Husain biography Shahid Husain MD, MS Dr. Husain completed his internal medicine residency from Cook County Hospital and completed infectious diseases fellowship from University of Pittsburgh Medical Center with specialized training in Transplant Infectious Diseases. He has completed his Masters in Clinical Trials from University of Pittsburgh. Dr. Husain is an internationally recognized expert in the field of Lung Transplant Infections research and is a past chair of Infectious Diseases Council of International Society of Heart and Lung Transplantation. He is actively involved with other professional societies and is an active contributor in the development of guidelines for the management of infections in solid organ transplant recipients on the behest of American Thoracic Society and American Society of Transplantation. Dr. Husain’s research has focused on the risk factors and outcomes of infections in solid organ transplant recipients. His current clinical research is directed towards evaluation of diagnostic tests for early diagnosis of invasive aspergillosis, development of appropriate antiviral and antifungal prophylactic strategies. He has particular interest in the relationship of the infections to rejections in lung transplantation. Dr. Husain has published more than 50 peer reviewed publications and has authored more than 5 book chapters. He is an editorial consultant for Journal of Heart and Lung Transplantation. He also serves as a reviewer in various transplant Journals. -------------------------------------------   Go to top     MONDAY OCTOBER 5, 2009, 1545-1845, Workshops W211, W212, W213   Workshop W211: Monitoring Therapeutic Immunosuppressive, Cytokines and Chemokines Manuela G. Neuman, Ph.D., In Vitro Drug Safety and Biotechnology and Department of Pharmacology, University of Toronto, Toronto, Ontario, Canada Robert Winkler, MD, Novartis Oncology Global, Drug Development, New Jersey, USA Nir Hilzenrat, McGill University, Montreal, Quebec, Canada Shurjeel Choudhri, Senior Vice President & Head, Medical and Scientific Affairs, Bayer Inc., Canada     Cytokines and related molecules such mTor inhibitor and chemokines are implicated in most human diseases including cancer, infectious diseases, gastrointestinal diseases, asthma as well as cardiovascular diseases. Both cytokine antagonists and agonists play a vital role in the treatment of these diseases and the market for cytokine related drug continues to be enormous and growing rapidly. "Monitoring Therapeutic Cytokines and Beyond" will cover many important aspects of cytokine-related drug discovery and monitoring. From this workshop the audience will learn the successful stories of existing cytokine related drugs, the areas to enhance and improve these drugs, up to the monitoring cytokine-therapies in clinical trials and the need to monitor the cytokines and their receptors in clinical practice. How immuno-genomics and proteomics influence the monitoring of cytokine-related drugs also will be covered. Our workshop will enable the attendees to comprehend the up to date technology development, and the opportunities ahead. 1) This workshop will serve the need of information exchange for toxicologist, biochemists and clinical toxicologists as well as drug development researchers in biomedical and diagnostic companies; 2) This workshop will cover many important aspects of cytokine-related drug discovery and monitoring; 3) Participants will learn the successful stories of existing cytokine related drugs, the areas to enhance and improve these drugs, up to the monitoring cytokine-therapies in clinical trials and the need to monitor the cytokines and their receptors in clinical practice.   Objectives: At the conclusion of this workshop the participant will: Hear about the progress with the newer cytokines, their development as therapeutics, and monitoring them; Review the progress for currently marketed cytokines and their blockers in a variety of clinical conditions as well as their continued development for additional indications; Network with with your colleagues, academic and industrial scientists, involved in cancer, inflammation and infectious disease research. Outline:  Monitoring Cytokines, Chemokines and Cytokine-Like Endogenous Multifunctional Immune Alarmins, Manuela G. Neuman Cytokines, like hormones, are endogenous intercellular signals but they function in host defense development and restoration of homeostasis. There are also endogenous molecular immune alarmins that have non-cytokine functions, but interact with protein coupled receptors (PCR). They include antimicrobials such as: α defensins and β defensins, which interact with CCR6 and also activate TLR4 on immature dendritic antigen presenting cells (iDC). They include antigens using CCR5, and/or autoantigens involved in inflamation, that utilize CXCR5 and or CXCR3. These antimicrobial peptides and autoantigens can like many cytokines interact and influence innate and or adaptive immune responses. The monitoring of cytokines and chemokines in sera of the patients with Hepatitis will be presented. ------------------------------------------- Monitoring the Inhibition of TNF Signaling, Nir Hilzenrat Tumor necrosis factor (TNF) promotes inflammation in rheumatoid arthritis, inflammamtory bowel disease and numerous other conditions. Several anti-TNF therapies, based on soluble decoy receptors and monoclonal antibodies, have proven efficacious in human inflammatory diseases. TNF-alpha antibodies block TNF signaling via binding or stimulate signaling thorough TNF receptors and retain the capacity interact with native TNF. The native TNF sequestered into them is rendered biologically inactive. The selectivity of anti-TNFs should be monitored with the goal to retain the anti-inflammatory functions of TNF while preserving effective response to infection. Such selective anti-TNFs have the expected efficacy profile but should be monitored for the profound affect innate immunity. ------------------------------------------- Commonly Used Endpoints in Oncology Clinical Trials: Challenges and Opportunities, Shurjeel Choudhri In oncology clinical trials, a new molecule must show direct evidence of clinical benefit or improvement in an established surrogate for clinical benefit. Improvement in overall survival (OS) has been considered an appropriate measure of clinical benefit. Many of the cancer drug approvals in the 1970s, were based on overall objective response rate (ORR). The approval process later expanded to include improvements in a patient’s quality of life (QOL), improved physical functioning, or improved tumour-related symptoms. However, a relationship between these benefits and ORR was not always demonstrated. As oncology drug development evolved, other surrogate endpoints such as time to progression (TTP), progression free survival (PFS), disease free survival (DFS) (adjuvant), started to be accepted in the approval process. For example, OS, PFS, TTP and DFS have all been used as primary or secondary endpoints in randomized controlled trials of the multikinase inhibitor, sorafenib. Recent advances in cancer management mean that patients have multiple treatment options at different stages of their disease. This poses significant challenges in interpreting clinical trial results, even for widely accepted endpoints such as OS, due to the effects of crossover and sequential therapies. In this setting, endpoints such as PFS and TTP can be observed earlier (prior to crossover), and are not confounded by cross-over or subsequent treatments. -------------------------------------------   Click here: Manuela G. Neuman biography Manuela G. Neuman M.Sc., Ph.D., FCACC Dr. Neuman is Assistant Professor of Pharmacology at Faculty of Medicine, The University of Toronto and founder and CEO In Vitro Drug Safety and Biotechnology, at MaRS Discovery District, Toronto, Canada. Dr. Neuman received her M. Sc. from in Biology & Virology and her Ph.D., in Physiology and Pharmacology at Tel-Aviv University, Israel. She also completed her post-doctoral fellowship on the Gastroenterology and Clinical Pharmacology at the University of Toronto, Toronto, Canada. Additional post-graduate work includes a fellowship in liver disease and in Immunology. Dr. Neuman has published extensively in the areas of chronic viral hepatitis, drug-induced liver disease, alcohol-induced liver disease, liver immunology, and primary biliary cirrhosis. Dr. Neuman has served the University of Toronto in many capacities including Head of the In Vitro Biotechnology Platform. Her laboratory “In Vitro Drug Safety and Biotechnology” performed many studies in collaboration with different pharmaceutical companies and laboratories. Dr. Neuman’s research activities includes of the important issues regarding evaluation of safety profiles of different drugs of use and mis-use as well as complimentary and alternative medicine. Moreover alternative options for therapeutic class are provided. Her research activities discuss the overall favourable record of hepatic safety of drugs along with comments on the use of these agents in patients with underlying liver disease in different scientific and industrial fora. Another important subject of Dr. Neuman’s research is efficacy of therapies as shown by: expression of pathogen recognition receptors and signaling pathways involved in liver injury. Other subjects include the role of immune system in viral hepatitis, interactions of cytokines and chemokines receptors as a mechanism regulating inflammation and steatosis in the liver, the role of immunity as well as fibrogenesis and imaging. ------------------------------------------- Click here: Nir Hilzenrat biography Nir Hilzenrat Dr. Nir Hilzenrat is associated professor of Medicine in McGill University. He is the head of the Liver Disease Unit in SMBD- Jewish General Hospital and a staff member in the Gastroenterology Division of McGill University. Dr. Hilzenrat graduated Medical School in the Faculty of Health Sciences, Technion-Israel Institute of Technology in Haifa, Israel and completed his internal medicine residency in Soroka Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Later, he did his training in Gastroenterology in McGill University in Montreal, Canada. The main research interests of Dr. Hilzenrat are: 1-understanding the mechanism and treatment of portal hypertension and 2-viral hepatitis- treatment and extrahepatic manifestations. Dr. Hilzenrat is an active member in the Canadian and American Associations of Gastroenterology and the Study of Liver Diseases. ------------------------------------------- Click here: Robert E. Winkler biography Robert E. Winkler, MD Robert E. Winkler, MD holds a Senior Medical Director position at Novartis Oncology Global Drug Development working on Afinitor - Novartis Oncology leading drug in development.Dr Winkler has almost a decade worth of Biotech/Pharmaceutical expertise which includes international assignments and Global development and medical Affairs roles at Novartis and Schering-Plough. In his capacity, Dr Winkler is an expert in drug development from strategy to execution, clinical pharmacology and throughout all four phases of clinical studies, developing regulatory documents and leading successful interactions with Health Authorities, as well as developing pharmacovigilance risk management programs. Dr Winkler has been involved in new technology assessments in the past as a biotech's CEO strategic consultant as well as being currently part of Novartis Due-Diligence business development team.Robert E. Winkler graduated cum lauda from the Hebrew University and Hadassah Medical school in Jerusalem, has been trained in Israel and US and holds a Internal Medicaine board certification. Dr Winkler has been invited speaker to international congresses as well as published in peer review journals. ------------------------------------------- Click here: Shurjeel Choudhri biography Shurjeel Choudhri MD, FRCPC Dr. Choudhri obtained his MD from the University of Manitoba and also did his specialty training in Internal Medicine and sub-speciality training in Infectious Diseases in Manitoba. Following completion of his training, he completed a senior research fellowship in Nairobi, Kenya. In 1996, he was awarded the Young Investigator Award by the Canadian Association of HIV Researchers. Dr. Choudhri has authored or co-authored over 100 scientific abstracts and has contributed to over 40 publications in peer reviewed journals. Prior to joining Bayer, Dr. Choudhri was an Assistant Professor in the Departments of Medical Microbiology and Internal Medicine at the University of Manitoba in Winnipeg, Manitoba. He was also the Director of the AIDS program at the St. Boniface General Hospital in Winnipeg; and the Manitoba Satellite Director for the Canadian HIV Clinical Trials Network. Dr. Choudhri has had significant experience with the Bayer US medical and Global Medical organizations. Before assuming his current role as Head of M&SA in Canada, Dr. Choudhri was the Global Clinical Leader, Anti-Infectives with the Bayer Global Clinical Development group. -------------------------------------------   Go to top Workshop W212: Personalized Medicine, How Pharmacokinetic and Pharmacokinetic/pharmacodynamic Models are Made and Can Aid Daily Practice to Personalize Drug Treatment Alexander A. Vinks, PharmD, PhD, FCP, Professor of Pediatrics and Pharmacology, University of Cincinnati, School of Medicine, Director, Division of Clinical Pharmacology and Pediatric Pharmacology Research Unit, Cincinnati Children's Hospital Medical Center, Cincinnati, USA Daniel J. Touw, Hospital Pharmacist and Clinical Pharmacologist, Apotheek Haagse Ziekenhuizen, ’s-Gravenhage, Haga Teaching Hospital, The Hague, Netherlands Jeffrey S. Barrett, Ph.D., Research Associate Professor, Pediatrics, Director, Pediatric Pharmacology Research Unit, Laboratory for Applied PK/PD, Clinical Pharmacology & Therapeutics, The Children's Hospital of Philadelphia, KMAS (Kinetic Modeling & Simulation), Institute for Translational Medicine, University of Pennsylvania, Philadelphia, USA Franck Saint-Marcoux, Hospital Clinical Chemist, Department of Pharmacology and Toxicology, Limoges University Hospital, Limoges, France Roger W. Jelliffe, Professor of Medicine, Laboratory of Applied Pharmacokinetics, School of Medicine, University of Southern California, Los Angeles, USA     Sophisticated software packages for planning and adjusting drug dosage regimens are usually not user-friendly and useful for daily routine in pharmacokinetic interpretations. Which packages are available? What are the strengths and weaknesses of available packages. Presenters will present what modelling approaches they use and what software their respective centres/groups use. This will be Illustrated with a few cases and some demonstrations will be given. This part of the session is open and interactive; the audience is asked in advance to think about a list of features. Are there easy-to-use programs for clinicians or should pharmacokinetic calculations be done by specialists. Objectives: To discuss the importance of using population pharmacokinetic models in pharmacokinetics based decision support systems; To identify and to evaluate critical steps in population pharmacokinetic model development; To apply population PK models to plan initial dosage regimens, and Bayesian adaptive control to the TDM data as decision support systems; To learn how to construct functional requirements for decision support systems that match the critical factors used to assess and guide pharmacotherapy with the views, summarizations and forecasting routines used to inform caregivers; To learn how to construct retrospective and prospective evaluations of model-based TDM guidance that provide clinical assessment of the approach and quantitative results supporting the return on investment; To assess the performance of drug dashboards for tacrolimus and methotrexate piloted at the Children’s Hospital of Philadelphia and examine the next steps in these evolving decision support systems as part of a larger pediatric knowledgebase initiative; After this workshop, the participant should be able to discuss the maximally precise clinical approach to the planning, monitoring, and adjustment of drug dosage regimens for patients. Presentations include:  • The Importance of PK/PD Modelling, Alexander Vinks • Pitfalls With Models, Daniel Touw Clinical Evaluation of Decision Support Systems Guiding Pediatric Pharmacotherapy: Experience with Methotrexate and Tacrolimus, Jeffrey Barrett • Learn how to construct functional requirements for decision support systems that match the critical factors used to assess and guide pharmacotherapy with the views, summarizations and forecasting routines used to inform caregivers; • Learn how to construct retrospective and prospective evaluations of model-based TDM guidance that provide clinical assessment of the approach and quantitative results supporting the return on investment; • Assess the performance of drug dashboards for tacrolimus and methotrexate piloted at the Children’s Hospital of Philadelphia and examine the next steps in these evolving decision support systems as part of a larger pediatric knowledgebase initiative. ------------------------------------------- Pharmacometric Tools to Optimize Control of Drug Pk/Pd Models for Best Patient Care, Roger Jelliffe During this session, the participants will be introduced to maximally precise tools for the management of drug dosage regimens for patients, and to representative clinical cases illustrating their use. After this workshop, the participant should be able to discuss the maximally precise clinical approach to the planning, monitoring, and adjustment of drug dosage regimens for patients. -------------------------------------------   Click here: Alexander Vinks biography Alexander Vinks PharmD, PhD, FCP Alexander (Sander) Vinks is Professor of Pediatrics and Pharmacology at the University of Cincinnati, Colleges of Medicine and Pharmacy. He is director of the Division of Clinical Pharmacology, principal investigator of the NIH Pediatric Pharmacology Research Unit and Director of the Laboratory of Applied Pharmacokinetics and Therapeutic Drug Management at Cincinnati Children Hospital Medical Center. Dr. Vinks received his pharmacy and pharmacology training with honors at Leiden University in the Netherlands and the University of Toronto, Canada. He received specialty training in clinical pharmacy (PharmD) and clinical pharmacology (PhD) at The Hague Hospitals Central Pharmacy and Leiden University. Dr. Vinks is board certified in Clinical Pharmacology and Toxicology. Before joining the Division of Clinical Pharmacology at Cincinnati Children’s, he was Director of the centralized Clinical Pharmacology & Toxicology Laboratory serving all hospitals and nursing homes in the city of The Hague, the Netherlands. His major research interests include pharmacokinetic-pharmacodynamic (PK/PD) modeling, pharmacogenetics (PG) and the application of genomic, population and simulation approaches (Pharmacometrics) to clinical trial design, Therapeutic Drug Monitoring (TDM) and individualized Bayesian dosing strategies. His current research includes the development of pharmacogenetic and biomarker assays for the prediction of therapeutic response and side effects of immunosuppressive drugs. Dr. Vinks has ongoing NIH funding to further advance PK/PD/PG modeling and simulation in pediatric patients with a focus in optimizing immunosuppressive and antimicrobial therapies. He is directing several clinical pharmacology cores for ongoing multi-center clinical studies evaluating target controlled therapies using population model-based approaches. Dr. Vinks has received several distinctions for his research, including the Huizinga Award for Research in Hospital Pharmacy in the Netherlands. Dr. Vinks is president-elect (2009) of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT). He also serves on the Coordinating Committee on Scientific Sections (CCSS) of the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and is a fellow of the American College of Clinical Pharmacology. He is on the Editorial Board of Antimicrobial Agents and Chemotherapy, Clinical Therapeutics, Therapeutic Drug Monitoring, Journal of Pediatric Pharmacology and Therapeutics, and the Journal of Clinical Medicine (Bulgaria). Dr. Vinks is an internationally renowned speaker with more than 150 presentations at national and international meetings. He has authored over 70 peer-reviewed publications and 14 book chapters and reviews in the areas of PK/PD modeling, pharmacogenetics and TDM. ------------------------------------------- Click here: Daniel Touw biography Daniel J. Touw Daniel Touw graduated as pharmacist from Leiden University in 1984. After his military service, he was trained at Apotheek Haagse Ziekenhuizen to become a hospital pharmacist. He was certified as hospital pharmacist in 1989 and as clinical pharmacologist in 1994. From 1995 - 2000 he worked at the University Hospital Vrije Universiteit, Amsterdam as deputy director of the pharmacy and director of the clinical pharmacological and toxicological laboratory. He earned his doctorate in 1996 on a thesis on pharmacokinetics of intravenous and inhaled drugs in Cystic Fibrosis. From 2000 to present he works at the Apotheek Haagse Ziekenhuizen, ’s-Gravenhage as hospital Pharmacist and clinical pharmacologist, and at the Haga teaching Hospital. He is director of the hospital laboratory involved with chemical and microbiological analyses for quality control of raw materials and compounded drugs (GcLP accredited), and clinical pharmacological and toxicological analyses (CCKL/RvA accredited). He is member of several European Pharmacopoeia expert groups, director of the Dutch organisation of quality control for therapeutic drug monitoring and clinical toxicology (KKGT). ------------------------------------------- Click here: Jeffrey Barrett biography Jeffrey S. Barrett,PhD, FCP Dr. Barrett is Associate Professor of Pediatrics and Pharmacology at the Children's Hospital of Philadelphia (CHOP) and University of Pennsylvania. He is also the Director of the Laboratory for Applied PK/PD within the Clinical Pharmacology and Therapeutics Division at CHOP. Prior to joining CHOP, Dr. Barrett spent 13 years in the pharmaceutical industry most recently at Aventis Pharmaceuticals where he was Global Head of Biopharmaceutics supporting late stage development. He received his B.S in Chemical Engineering from Drexel University in 1986 and his Ph.D. in Pharmaceutics from the University of Michigan in 1990 under Dr. John G. Wagner. He has been a faculty member of the Pharmaceutical Education and Research Institute (PERI) as a lecturer for the Pharmacokinetics and Nonclinical Statistics training courses since 1992. and was a member of both the PhRMA and FDA Expert Panels on Individual and Population Bioequivalence. Dr. Barrett has co-authored over 50 manuscripts and has given 35 invited lectures on a variety of topics related to clinical drug development. He founded the Mid-Atlantic Population Approach Users Group in 1992 and is a member of the Advisory Boards of the East Coast Population Approach Group, the American Association of Pharmaceutical Scientists (AAPS) Bioequivalence and Population Pharmacokinetics Focus Groups, and the Innaphase Corporation. Dr. Barrett is a member of AAPS, ASCPT, ACCP and ASPET and was former Chair of the Delaware Valley Drug Metabolism Discussion Group. He was elected to Fellow of the American College of Clinical Pharmacology in 2000 and was awarded the Tanabe Young Investigator Award in 2002. Dr. Barrett was also recently elected to the Board of Regents of ACCP and as Vice-Chair of the Clinical Sciences Section of AAPS. Dr. Barrett’s current efforts in conjunction with the mission of the Clinical Pharmacology and Therapeutics Division are focused on the investigation of sources of variation in pediatric pharmacokinetics and pharmacodynamics. Applied clinical pharmacologic investigation coupled with modeling and simulation strategies are pursued with the intention of developing rational dosing guidance in various pediatric populations for both marketed and exploratory compounds. Clinical trial simulation is to be utilized prospectively to explore design dependencies and parameter sensitivities. Dr. Barrett also directs the Laboratory for Applied PK/PD which is focused on the development of pharmacometric approaches to advance PK/PD, novel biomarker development and disease progression modeling. ------------------------------------------- Click here: Franck Saint-Marcoux biography Franck Saint-Marcoux Dr. Franck Saint-Marcoux obtained a doctorate in Pharmacy in 2003, a DEA (1st year in PhD) in analytical chemistry in 2001, and a PhD in Pharmacokinetic modelling in 2004. Under the tutelage of Prof. Pierre Marquet, this thesis was about dose adjustment of immunosuppressive drugs in transplantation. He currently holds a Hospital Clinical Chemist position in the department of Pharmacology and Toxicology of the Limoges University Hospital (France) and is a member of the INSERM research unit “Pharmacology of the immunosuppressive drugs in transplantation”. His current research activity is focused on the development of PK tools useful for a routine activity of TDM, mainly IS, but also antibiotics or anticancer drugs. ------------------------------------------- Click here: Roger Jelliffe biography Roger W. Jelliffe MD Roger Jelliffe graduated from Harvard College in 1950 and Columbia University College of Physicians and Surgeons in 1954. He trained at University Hospitals of Cleveland, Ohio, and at the VA Hospital, Cleveland, Ohio. He was an Instructor in Medicine at USC School of Medicine in 1961, then Assistant and Associate Professor, and has been Professor of Medicine there since 1976. He was certified by the American Board of Internal Medicine in 1962 and its Subspecialty Board of Cardiovascular Disease in 1965. He developed the first computer software for modeling the pharmacokinetic behavior of digitalis glycosides and individualizing their dosage regimens in 1967. He was the first to relate the renal elimination rate constant of drugs to creatinine clearance. He developed the first method for estimating creatinine clearance when serum creatinine is rapidly changing. He founded the USC Laboratory of Applied Pharmacokinetics in 1973, and developed the USC*PACK computer programs for individualizing drug dosage regimens. His laboratory developed the Research Resource for Population Modeling at the San Diego Supercomputer Center (and its satellite centers in Oslo and Singapore), and the nonparametric adaptive grid (NPAG) population modeling approach. This is most naturally linked to the “Multiple Model” clinical method and software for developing maximally precise drug dosage regimens, which has now become the MM-USCPACK clinical computer software. His principal interest now is in nonlinear PK/PD population modeling and in developing optimally precise single and optimally coordinated combination drug dosage regimens for patient care. ------------------------------------------- Go to top Workshop W213: Alternative Sampling Methods in TDM: Dried Blood Spot and Fingerprick Sampling and Sampling by Reverse Iontophoresis Leo M. Stolk, Ph.D., Hospital Pharmacist/Clinical Pharmacologist/Toxicologist, Head of Laboratory for Therapeutic Drug Monitoring and Clinical Toxicology, University Hospital of Maastricht, Maastricht, The Netherlands Jeff Millership, Ph.D., Senior Lecturer in Pharmaceutical Chemistry, Queen’s University, Belfast, Ireland Peter M. Edelbroek, Ph.D., Clinical Pharmacologist, Toxicologist, Head Clinical Chemistry and Clinical Pharmacology Laboratory, SEIN, Epilepsy Institute in the Netherlands, Heemstede, The Netherlands M. Begona Delgado-Charro, Ph.D., Senior Lecturer in Pharmaceutics, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK Pleasant F. Hooper, M.D. Founder and Chief Science Officer of Therapeutic Monitoring Services, TMS BioScience, New Orleans, USA Bert Ooms, New Business Development Manager, Spark Holland, Emmen, Netherlands     Objectives: At the conclusion of this workshop the participant will: Have a workable knowledge of several new sampling methods and techniques in therapeutic drug monitoring: 1) dried blood spot method, 2) fingerprick sampling and 3) transdermal reverse iontophoresis ; Become familiar with important co-variates, practical applicability and quality control concerning the three techniques; Be informed about experience with the techniques in every day practice. 1) Review of Therapeutic drug monitoring with the dried blood spot method, Leo M Stolk A overview will be given about dried blood spot (DBS) sampling in therapeutic drug monitoring. Many assays have been reported in literature and will be reviewed. The technique involved in and factors that may influence the accuracy and reproducibility are also discussed Objectives of this session: At the conclusion of this presentation, the participant will: 1) Be familiar with the technique of the dried blood spot (DBS) method in TDM; 2) Have knowledge of available assays for TDM with DBS; 3) Have knowledge about relevant co-variates in TDM with DBS. ------------------------------------------- 2) The use of dried blood spot (DBS) sampling for the determination of drugs in children and neonates, Jeff Millership The session will cover a brief outline of investigations involved in drug level determinations using dried blood spot (DBS) sampling in children and in neonates. Details will presented of determinations using HPLC/UV and HPLC/MS/MS and specific examples of sample preparation will be addressed. The application of DBS with respect to sparse sampling and pharmacokinetic studies will be detailed. Objectives of this session: At the end of the presentation the participant will have an understanding of: 1) The specific issues associated with DBS sampling in neonates and children in relation to drug level determinations; 2) The importance of the nature of the sample (capillary versus venous blood and blood versus plasma); 3) Sparse sampling methodology in children and neonates. ------------------------------------------- 3) The use of finger stick sampling for TDM of immunosuppressants, Pleasant F. Hooper The use of finger stick sampling for TDM of immunosuppressants has been described and put into limited clinical utilization. In collaboration with the Tulane Abdominal Transplant Program, we have performed a study that demonstrates clinical equivalence of TDM of sirolimus using capillary blood samples obtained by finger-stick. In order to promote further practical implementation of this method of TDM, we have developed a novel monitoring system, HomeTrak™, utilizing blood samples obtained at-home by patients. The samples, delivered to our lab by post, are analyzed for therapeutic drug levels and specific clinical chemistries which provide the clinical team the data required to determine critical dosing for maintenance immunosuppression. Objectives of this session: 1) To familiarize the audience with work previously done demonstrating the equivalence of capillary blood samples obtained by finger-stick method for therapeutic drug monitoring of immunosuppressants (TDM-IS) limited to cyclosporine A and tacrolimus in transplant patients; 2) To present my group's work which includes the demonstration of effective TDM-IS of sirolimus with capillary blood samples obtained by finger-stick, in conjunction with TDM-IS of cyclosporine and tacrolimus, by multiplex testing with liquid chromatography coupled with ESI - tandem mass spectrometry (LC-MS/MS); 3) To introduce a novel system of outpatient transplant monitoring, HomeTrak, that includes TDM-IS and basic chemistry / hematology panels on small volume blood samples obtained by patients at-home by finger-stick method and present results of one year follow-up of transplant patients being monitored by the HomeTrak system. ------------------------------------------- 4) DBS sampling in clinical epileptic practice and research, Peter Edelbroek During the session a DBS method for analysis of 13 antiepileptic drugs together in one spot including a number of applications and results of the method in clinical practice and research will be presented. Pitfalls and limitations of the DBS method which are important issues for an adequate application of the method will be discussed. Finally, suggestions will be given for further improvement and development of the DBS method. Objectives of this session: 1) To become familiar with a DBS method for antiepileptic drugs and its clinical applications; 2) To have knowledge of pitfalls and limitations of DBS methods; 3) To know strategies for further development of DBS methods. ------------------------------------------- 5) Transdermal reverse iontophoresis in TDM, M. Begona Delgado-Charro The session will include a Power Point presentation which will illustrate how transdermal iontophoresis samples drugs and markers non-invasively across the skin. Next, a series of examples with drug/markers will be used to discuss: (a) which type of drugs are good candidates to be sampled in this innovative way; (b) what are the advantages of reverse iontophoresis as a sampling method, (c) what are the limitations and disadvantages of the technique and, finally what is needed before the technique is ready for wide application. It will be targeted to a wide audience interested in alternatives methods for drug sampling and time will be left for an open discussion with the attendants. Objectives of this session: At the conclusion of this presentation, the participant will: 1) Become familiar with the mechanisms of transport underlying drug sampling via transdermal iontophoresis; 2) Become familiar with the properties required by a drug to be a candidate for non-invasive iontophoretic sampling; 3) Become aware of the advantages, challenges and limitations of transdermal reverse iontophoresis. ------------------------------------------- 6) Finger prick TDM using on-line coupling of blood sample carriers to LC-MS/MS, B. Ooms In this session, I will discuss analytical challenges of dried blood samples and strategies to deal with them. In particular options for automation of sample clean-up and analysis of dried blood samples will be presented and discussed. I will also show results from our own lab with on-line desorption, clean-up and LC-MS analysis of dried blood samples. Objectives of this session: At the conclusion of this presentation, the participant will: 1) Become aware of analytical challenges/advantages of dried blood samples; 2) Learn about practical options for sample clean-up and analysis for dried blood samples; 3) Gain knowledge about automation options for analysis of dried blood samples. -------------------------------------------   Click here: Leo Stolk biography Leo M. Stolk, Ph.D. Leo M. Stolk, Ph.D., Hospital Pharmacist/Clinical Pharmacologist/Toxicologist is head of the laboratory for Therapeutic Drug monitoring and Clinical toxicology of the University Hospital of Maastricht, The Netherlands. He is also chair of the New Sampling Strategies Scientific Committee of IATDMCT. He is author/co-author of six international publications about dried blood spot sampling of a total of about 70 publications in peer reviewed international journals. ------------------------------------------- Click here: Jeff Millership biography Jeff Millership BSc PhD C.Chem FRSC Senior Lecturer in Pharmaceutical Chemistry, Queen’s University Belfast Jeff Millership studied chemistry at Salford University and remained there to work for a PhD in synthetic organic chemistry. On completion he undertook a Post Doc at the School of Pharmacy, University of London. Following this period in London he took up a lecturing post in Pharmaceutical Chemistry at the School of Pharmacy, Queen’s University Belfast (QUB) where he has remained ever since. Jeff’s research interests are now firmly focused on aspects of pharmaceutical analysis (chromatographic and spectroscopic) and their application in clinical analyses (in children and in neonates). Jeff has been a member of Clinical and Practice Research Group within the School of Pharmacy for twelve years and during that time the group has set up the Children’s Medicines Research Group (CMRG) which comprises researchers and clinicians from the School of Pharmacy, the Royal Belfast Hospital for Sick Children and the Royal Neonatal Intensive Care Unit. The work of this group is in two main areas 1) development of Analytical Methods for analysis in small volume plasma samples, Dried Blood Spots and urine and 2) Population Pharmacokinetic and Pharmacodynamic studies. The CMRG presently has 17 members and is actively collaborating with several national and international groups in Glasgow, London, Birmingham, Singapore and Kansas City. Presently the main focus of the groups work is the utilisation of Dried Blood Spot sample collection and analytical determinations of a range of drugs in children and in neonates. Jeff is a committee member of the Local Section of the Royal Society of Chemistry, a member of the steering committee of the Research Forum for the Child in QUB and a member of the Northern Ireland Clinical Research Network Children’s Clinical Management Group. ------------------------------------------- Click here: Pleasant Hooper biography Pleasant F. Hooper, M.D. Pleasant Fite Hooper, M.D. is the Founder and Chief Science Officer of Therapeutic Monitoring Services - TMS BioScience. Dr. Hooper spent several years in private clinical practice and continued his education with a fellowship in molecular & cell biology. He implemented metabolic screening of newborns by tandem mass spectrometry for the Louisiana Office of Public Health in 2004. Since then, he founded TMS BioScience to provide therapeutic drug monitoring by LC-MS/MS for client programs and provide home-based monitoring by his HomeTrak™ proprietary system (patent applied for). TMS BioScience has celebrated their first anniversary in providing unique monitoring of renal transplant patients for Tulane Transplant Program and is in the process of expansion of client programs. ------------------------------------------- Click here: Peter Edelbroek biography Peter M. Edelbroek PhD Peter M Edelbroek PhD, Clinical Pharmacologist and Toxicologist is head of the Clinical Chemistry and Clinical Pharmacology Laboratory of SEIN, Epilepsy Institute in the Netherlands, Heemstede, The Netherlands. He is co-chair of the New Sampling Strategies Scientific Committee of the IATDMCT. He is author/co-author of 59 articles in peer-reviewed journals. His main fields of interest are TDM of antiepileptic drugs and the dried blood spot technique. He has a long standing experience of more than 9 years with dried blood spot analysis of antiepileptic drugs. ------------------------------------------- Click here: M. Begoña Delgado-Charro biography M. Begoña Delgado-Charro, PhD M. Begoña Delgado-Charro, PhD. Senior Lecturer in Pharmaceutics, Department of Pharmacy and Pharmacology, University of Bath, UK. My research involves the use of iontophoresis both to deliver drugs transdermally, and as a tool for non-invasive drug monitoring and pharmacokinetics, and to optimize drug delivery to the nail. We have investigated the reverse iontophoresis of glucose, urea, valproate, phenytoin, lithium, lactate, amino acids and iohexol. I have published 61 peer-reviewed articles, 8 book chapters, 90 congress abstracts, and 2 patent applications. Our work on iontophoretic drug delivery has been funded by the Parkinson’s Disease Society, UK, by the Medical Research Council and by several pharmaceutical companies. I am member of the IATDMC, the Biophysical Society, EUFEPS, the Academy of Pharmaceutical Scientists (APS), the Controlled Release Society, and the Medicines for Children Research Network - Formulation Sub-group. ------------------------------------------- Click here: Bert Ooms biography Bert Ooms Bert Ooms has a degree in analytical chemistry and has been involved in HPLC-instrumentation development for nearly 30 years. As R&D manager, Research manager and presently as New Business Development manager, he has always been at the forefront of product innovation at Spark Holland. ------------------------------------------- Go to top     TUESDAY OCTOBER 6, 2009, 1545-1745, Workshops W311, W312, W313   Workshop W311: Pharmacogenomics of Addiction and Drugs of Abuse Amitava Dasgupta, Professor, Department of Pathology and Laboratory Medicine, University of Texas-Houston Medical School, Houston, Texas, USA Hans H. Maurer, Professor, Department of Experimental and Clinical Toxicology, Saarland University, Homburg/Saar, Germany Steven Wong, Professor, Department of Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA     Vulnerability to alcohol, drug addiction and drugs of abuse are influenced by pharmacogenomics factors. In this workshop recent developments in understanding wide variations in addiction patterns among people on the basis of genetic variation will be addressed. The strong heritability of alcoholism suggests the existence of functional variants of genes that alters metabolism of alcohol. Pharmacogenetics can be used to identify individuals at a greater risk of specific drug dependencies and may help in individualization of detoxification treatment. The role of clinical toxicology in this management of patients undergoing detoxification program with an emphasis on pharmacogenomics will also be addressed. The major metabolic pathways and the involved isoenzymes in humans will be summarized for the drugs of abuse and other drugs relevant in clinical and forensic toxicology. It will also provide an overview on the implications of the presented data for possible interactions of drugs of abuse with other xenobiotics for better understanding pharmaco-/toxicokinetics and pharmacogenetic variations, for evidence-based case interpretation, for toxicological risk assessment, for developing toxicological analysis procedures, and for understanding pitfalls in drug testing.   Outline:  1) Pharmacogenomics of alcohol and drug addiction, Steven Wong 2) Specific drug of abuse pattern: pharmacogenomics issue, Hans H. Maurer 3) Therapies for Substance Abuse Disorders: Pharmacogenomics Issues, Amitava Dasgupta   Objectives: At the conclusion of this workshop the participant will: Understand role of genetic polymorphism of CYP enzymes in addiction and toxicity of abused drugs; Know how laboratory testing can identify individuals with high abuse potential; Understand recent advances in substance of abuse detoxification programs. Click here: Amitava Dasgupta biography Dr. Amitava Dasgupta Dr. Amitava Dasgupta is a Professor of Pathology and Laboratory Medicine at the University of Texas Health Sciences Center at Houston and also the Director of Clinical Chemistry, Toxicology and Point of Care Services at the Memorial-Hermann Hospital Laboratories, the major teaching hospital of the University of Texas Medical School at Houston. He received his PhD in chemistry from Stanford University and completed his fellowship in clinical chemistry from the University of Washington at Seattle. He is certified in both clinical chemistry and toxicology by the American Board of Clinical Chemistry. Dr. Dasgupta’s major research interest is in the field of therapeutic drug monitoring and drugs of abuse testing. He has published 175 papers, many reviews and edited three books and wrote two books. He is on the editorial board of American Journal of Clinical Pathology, Archives of Pathology and Laboratory Medicine, Therapeutic Drug Monitoring, Clinica Chimica Acta and Journal of Clinical Laboratory Analysis. ------------------------------------------- Click here: Hans Maurer biography Professor Dr. Dr. h.c. Hans H. Maurer Hans H. Maurer is full Professor of Pharmacology & Toxicology at the Faculty of Medicine and at the Faculty of Pharmacy, University of Saarland, since 1992. He is head of the Department of Experimental and Clinical Toxicology. His main two areas of research are analytical toxicology (GC-MS, LC-MS of drugs, poisons and their metabolites) and in-vitro and in-vivo metabolism (phase I and phase II, isoenzyme identification, pharmacogenomics). He has published extensively in both areas (besides original papers, reviews and proceedings, handbooks and computer databanks on GC-MS). He is editorial board member of the Journal of Chromatography B, Therapeutic Drug Monitoring, Analytical and Bioanalytical Chemistry, Current Pharmaceutical Analysis, Current Drug Metabolism, Drug Metabolism Letters, Forensic Toxicology, Annales Pharmaceutiques Françaises, SUCHT - German Journal of Addiction Research and Practice He was guest editor of special issues of Journal of Chromatography B (1998), Therapeutic Drug Monitoring (2002 and 2004) and Analytical and Bioanalytical Chemistry (2007). In his career, Dr. Maurer received several scientific awards, among which the Young Investigator Award of the Medical Faculty presented in Homburg 1983, the Irving Sunshine Award for Outstanding Contributions to Clinical Toxicology of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDM-CT) presented in Vancouver 1997, "Membre d'Honneur" de la Société Française de Toxicologie Analytique (SFTA) presented in Dinard 2003, and finally the Alan Curry Lifetime Achievement Award of TIAFT for Outstanding Contributions to Forensic Toxicology presented in Melbourne 2003. In 2007, he received the Doctor honoris causa (honorary) degree of the University of Ghent in Belgium for his outstanding scientific achievements. Besides his membership in several national and international scientific societies, Dr. Maurer is President of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDM-CT, 2007-2009) and is TIAFT executive board member (2005-2011), treasurer of the Society of Toxicological and Forensic Chemistry (GTFCh, since 1987), chairman of the GTFCh Committee "Clinical Toxicology", since 1997, and finally chapter president of Saarland of the German Pharmaceutical Society (DPhG, 2004-2006). ------------------------------------------- Click here: Steven Wong biography Steven H.Y. Wong, Ph.D. DABCC(TC), FACB Dr. Wong is Professor of Pathology, Psychiatry and Behavioral Medicine, and Population Health – Epidemiology., and Director, Toxicology, TDM, Pharmacogenomics and Proteomics, Pathology Dept., Medical College of Wisconsin, and Toxicology Scientific Director at the Milwaukee County Medical Examiner’s Office. He received his Ph.D. in Nuclear Chemistry from Virginia Polytechnic Institute and State University. He was an Associate Professor of Laboratory Medicine at University of Connecticut School of Medicine, and an Associate Professor of Pathology at Johns Hopkins University School of Medicine. His scientific and clinical interests encompass inter-related areas of TDM, toxicology, pharmacogenomics, pharmacoproteomics, Personalized Medicine and Personalized Justice. He is the principal investigator of a multicenter study for assessing pharmacogenomics for certifying 1100 methadone fatalities. In addition to over 114 publications and 138 abstracts, he edited/co-edited four books, with the most recent: Pharmacogenomics and Proteomics: Enabling the Practice of Personalized Medicine. He serves on editorial boards for TDM, Clinical Chemistry and Laboratory Medicine, Annuals of Clinical & Laboratory Science, the Egyptian Journal of Hospital Medicine, and Pharmacogenomics., and a reviewer for NIH grants. He is a member of the National Academy of Clinical Biochemistry, International Association for TDM and Clinical Toxicology (Founding President), Society of Forensic Toxicologists, American Academy of Forensic Sciences (Associate Member), and the American Association for Clinical Chemistry (AACC). He has been active in AACC, currently serving as the chair-elect of the Proteomic Division, past chairs of TDM-T and Molecular Pathology Divisions, Board of Director, and a candidate for President-Elect in 2006. ------------------------------------------- Go to top Workshop W312: What are the Differences Between Clinical and Forensic Toxicology? How are we Dealing with Both? Donald R.A. Uges, Professor, Clinical and Forensic Toxicologist, Head of the Laboratory for Clinical and Forensic Drug Analyses, University Medical Center Groningen, The Netherlands Eric J.F. Franssen, Department of Pharmacy and Clinical Pharmacology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands Cynthia L. Morris-Kukoski, Pharm. D., DABAT, Forensic Examiner Toxicology Federal Bureau of Investigation, Quantico VA and Clinical Pharmacologist/Toxicologist United States Navy Reserves     Whether it is day or night, patients arrive at the hospital with an unexpected or unexplained clinical picture. If the patient has been poisoned, there may be a variety of potential causes (e.g. intentional, iatrogenic, or accidental) that may not be immediately apparent. A country's customs, procedures, and laws may sufficiently differ such to affect the case. Oftentimes, it is not clear what the decisive factor(s) should be: justice, patient privacy, professional confidentiality, or other factors. This workshop we encourage discussion between the participants on the basis of different real cases.   Objectives: At the conclusion of this workshop the participant will be able to: Recognize the challenges and differences between clinical and forensic toxicological cases; To describe the role of genetic variations in metabolism of opioid analgesics; Evaluate cases as clinical and/or forensic and understand the possible consequences of this choice; Compare and contrast the differences in these types of cases in different countries.   Click here: Donald Uges biography Professor Donald R.A. Uges Professor Donald R.A. Uges is a clinical and forensic toxicologist and head of the Laboratory for Clinical and Forensic Drug Analyses of the University Medical Center Groningen, The Netherlands. He graduated as a pharmacist in 1972. In 1997 he was appointed Professor in clinical and forensic toxicology. He is lecturing in forensic sciences (criminalistics and forensic medicine), clinical and forensic toxicology, therapeutic drug monitoring, clinical pharmacology and drug analysis in the faculties of Law, Medicine and Pharmacy and in post graduate courses. During the opening ceremony of the 8th IATDMCT in Basel, Switzerland he received the IATDMCT Irvine Sunshine Award for Outstanding Contribution to Clinical Toxicology. ------------------------------------------- Click here: Eric Franssen biography Dr. Eric J.F. Franssen Eric J.F. Franssen graduated at the State University in Groningen. He received a Ph.D degree in pharmacology and organic chemistry in 1992. His Ph.D thesis was entitled “drug targeting to the kidney with low molecular weight proteins”. Thereafter he was trained in hospital pharmacy and radiopharmacy at the University Medical Center in Groningen. He worked as a staff hospital pharmacist and radiopharmacist in the University Medical Center in Groningen until 1998. His main research interest were development of radiopharmaceuticals for positron emission tomography. In 1998 he became staff pharmacist and radiopharmacist at the Free University Medical Center in Amsterdam. In 2001 he was registered as a clinical pharmacologist. From 2004 untill now, Eric Franssen is Director of Pharmacy and teacher of hospital and clinical pharmacy at the “Onze Lieve Vrouwe Gasthuis” a large teaching hospital in the Centre of Amsterdam. Clinical pharmacology and toxicology are his main interests now. ------------------------------------------- Click here: Cynthia L. Morris-Kukoski biography Dr. Cynthia L. Morris-Kukoski, Pharm. D., DABAT I am currently a Forensic Examiner in the Chemistry Unit – Toxicology Subunit for the Department of Justice (DoJ) FBI Laboratory Quantico VA and a Clinical Pharmacist/Toxicologist in the United States Navy (USN) Reserves. As a Forensic Examiner, I receive evidence from around the world, analyze it using cutting edge technology, interpret my findings, submit written reports to contributors, and provide expert testimony. As Naval Officer, I fulfill my duties as a clinical pharmacist/toxicologist at Navy Medical Center Portsmouth. I have been an active member of AACT since 1991, a Diplomat of the American Board of Applied Toxicology (ABAT) since 1996, and a member of the Society of Forensic Toxicologist and the International Association of Forensic Toxicologists since 2006. For AACT, I have served as a Co-Chairman for the Medico-Legal Interest Group AACT since 2000 (previous called the Forensic Toxicology Interest Group 2000-2002), and Coordinator for the Forensic Toxicology Interest Group AACT (1998-2000). For ABAT, I have served on the Re-certification Committee as a Chairman (2005-2007) and Co-Chairman (2003-2004), and currently serve as the Vice President (2008-present). I have authored scientific articles, abstracts, and book chapters, and have been a research investigator for several research projects for DoJ and USN. I have provided lectures for the Armed Forces (Navy, Air Force, Marine Corps, & Army) medical personnel and attorneys, the American Academy of Forensic Science, FBI Academy, and many academic institutions in forensic toxicology, drug-facilitated sexual assault, postmortem toxicology, and clinical toxicology. ------------------------------------------- Go to top Workshop W313: Pharmacodynamic Biomarkers of Anticancer Drugs Yusuke Tanigawara, Ph.D. Professor, Keio University School of Medicine, Tokyo, Japan Toshiyuki Sakaeda, Ph.D., Graduate School of Pharmaceutical Sciences, Kyoto University, Japan Nick Holford, Department of Pharmacology and Clinical Pharmacology, University of Auckland, Auckland, New Zealand Kazuto Nishio, M.D. Department of Genomic Biology, School of Medicine, Kindai University, Japan Shiew Mei Huang, Ph.D., Food & Drug Administration, USA     Biomarkers are quite important in predicting the efficacy and adverse reactions of administered drugs. Although TDM has been utilized to determine the schedule of drug administration by the pharmacokinetic / toxicokinetic analysis of drug concentrations in blood, the concept of TDM may be expanded to include the pharmacodynamic and toxicodynamic evaluation of administered drugs in the near future. In this session, we will discuss on the importance of determining blood concentrations of pharmacodynamic biomarkers to predict efficacy and adverse reactions of drugs. Drs. Tanigawara, Nishio, Sakaeda and additional two researchers from the US and Europe will present their recent data.   Objectives: At the conclusion of this workshop the participant will: Understand the role of pharmacodynamic / toxicodynamic biomarkers in evaluating the efficacy and adverse reactions of administered drugs including anticancer drugs; Understand the importance of pharmacodynamic / toxicodynamic modeling, in order to correctly evaluate and utilize the blood levels of biomarkers; Realize that the concept of TDM may be expanded to include the analysis of biomarker levels in blood for the personalized medicine.   Presentations include:  Pharmacokinetics and pharmacogenomics in esophageal cancer chemoradiotherapy, Toshiyuki Sakaeda Treatment approaches for esophageal cancer depend on the location of the primary tumor, the disease stage, patient characteristics and co-morbidities, and occasionally the histological subtype of the tumor. Surgical resection of the primary site has been the standard treatment, especially for localized squamous cell carcinoma. However, considerable efforts to ensure a better clinical outcome have resulted in 5-fkuorouracil (FU)/cisplatin (CDDP)-based chemoradiotherapy, which is now often conducted with or without surgical resection. Given the substantial inter- and/or intra-individual variation in clinical outcome, future improvements will likely require the incorporation of a novel anticancer drug, pharmacokinetically guided administration, and the identification of potential responders through genetic profiling of patients prior to treatment. Currently, although limited information is available for the pharmacokinetics and pharmacogenomics of 5-FU and CDDP in patients with esophageal cancer, there is an increasing body of evidence that plasma concentration monitoring and genotyping of a certain class of proteins results in optimization of therapy. In this presentation, the latest information will be summarized for future individuation of the therapy. ------------------------------------------- Time course and pharmacodynamics of non-small cell lung cancer size changes in patients treated with gemcitabine, Nick Holford Quantitation of tumour size had been recently shown to be a predictor of survival in patients with non-small cell lung cancer (Wang, Sung et al. 2009). A similar model has been used to simulate the outcome of a phase III clinical trial of capecitabine in colo-rectal cancer (Claret, Girard et al. 2009). It has been suggested that anti-cancer drug development would be more efficient if it used tumour size response models to determine effective doses (Bruno and Claret 2009). These reports have used empirical models for describe tumour size changes and have not used information about the time course of tumour changes to predict survival. A mechanism based tumour response model has been used to describe primary lesion shrinkage in non-small cell lung cancer over time and determine if concentration based exposure metrics for gemcitabine, or that of its metabolites, 2’,2’-difluorodeoxyuridine (dFdU) or gemcitabine-triphosphate (dFdCTP) are better than gemcitabine dose for prediction of individual response (Tham, Wang et al. 2008). The model was able to describe treatment specific effects on the time course of tumour shrinkage and regrowth after stopping treatment. The time course of tumour growth can be included in models for survival. This is important because it can distinguish if the tumour is still shrinking or has started to regrow - a factor missing from the published studies relating tumour size to survival. Bruno, R. and L. Claret (2009). "On the use of change in tumor size to predict survival in clinical oncology studies: toward a new paradigm to design and evaluate phase II studies." Clin Pharmacol Ther 86(2): 136-8. Claret, L., P. Girard, et al. (2009). "Model-Based Prediction of Phase III Overall Survival in Colorectal Cancer on the Basis of Phase II Tumor Dynamics." J Clin Oncol. Tham, L. S., L. Wang, et al. (2008). "A pharmacodynamic model for the time course of tumor shrinkage by gemcitabine + carboplatin in non-small cell lung cancer patients." Clin Cancer Res 14(13): 4213-8. Wang, Y., C. Sung, et al. (2009). "Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development." Clin Pharmacol Ther 86(2): 167-74. ------------------------------------------- Surrogate Tissue Analysis for Molecular Target Therapy, Kazuto Nishio The “omic” approach has spurred a variety of techniques in a host of model systems. The combination of “omic” technologies with surrogate tissue analysis has led to a rapid increase in the amount of data concerning levels of transcripts, proteins, metablolites, sugar chain, other molecules present in the tissues. The main attraction of surrogate tissue analysis lies in its obvious accessibility. Now we should know how they may be put to beneficial use. Blood and circulating samples are the typical surrogate tissues. We previously demonstrated the possibility of somatic mutations of tumor derived genome in serum and correlation EGFR somatic mutation in blood samples and clinical outcome in using the high sensitive mutation detection assay (ScorpionArms). This assay can apply to the secondary mutation of EGFR to monitoring of the patients treated with EGFR-TKI in blood samples. In CRC patients, K-Ras mutation is approved to be a predictive biomarker for anti-EGFR antibodies in CRC patients. Detection of K-Ras mutation in blood samples is new subject of investigation. Molecular profiling of circulating tumor cells and monitoring of circulating endothelial cells and its progenitor (CEC/CEP) are of interests for investigators. Gene expression profiling of blood cells are also investigating in a clinical setting. The purpose of this approach is proof of concept of the new drugs. Monitoring of CEC/CEP and the gene expression profiling of mononuclear cells allows us to monitor the pharmacodynamic effects of several molecular target drugs. Proteomics reseach of blood samples has been intensively applied for detection of the predictive biomarkers for molecular targeted therapy including EGFR-TKI. We also have tried to apply glycobiological technology to biomarker studies. The plasma samples from breast cancer patients treated with a monotherapy of trastuzumab were analyzed. We demonstrated plasma ?-L fucosidase (FUCA) activities were correlated with PFS. On high sensitive N-glycan analysis for plasma samples, we identified 31 specific N-glycans and demonstrated that a single N-glycan expression correlates significant RR and PFS. These “omic” approach and surrogate tissue paradigm holds great promise but also create new challenges. -------------------------------------------   Click here: Toshiyuki Sakaeda biography Dr. Toshiyuki Sakaeda I received Ph.D. from Kyoto University, Japan in 1988 under the supervision of Professors H.Sezaki and M.Hashida, and worked as a research staff at the University of Kansas, USA under the direction of Professor V.J.Stella, from 1991 to 1993. I joined the University of Kobe, Japan, as Vice Director and Associate Professor in the Department of Hospital Pharmacy from 1998 to 2007. To date, I have published 146 original articles and 10 reviews in international journals, and my current research interests include optimization of pharmacotherapy via therapeutic drug monitoring and genotyping; diagnostic biomarker discovery via proteome; and therapeutic target discovery via transcriptome and proteome. ------------------------------------------- Click here: Nicholas Holford biography Dr. Nicholas HG Holford, MBChB, FRACP Dr Holford is Professor of Clinical Pharmacology at the University of Auckland. He is also an Honorary Professor at the University of Queensland and Adjunct Professor at the University of California San Francisco. His research interests include population PKPD analyses of clinical trials of drugs, clinical trial simulation, PKPD in neonates and children and rational approaches to anti-cancer drug use. He is currently developing the use of disease progress models for understanding clinical pharmacology with an emphasis on the effects of levodopa in Parkinson's Disease, drugs affecting post-menopausal bone loss, the progression of diabetes mellitus and predicting clinical outcome events through biomarker driven hazard functions. He is also active in developing methods to describe how size and maturation influence physiology and pharmacokinetics in very young babies, children and adults. ------------------------------------------- Click here: Kazuto Nishio biography Kazuto Nishio, M.D. Ph.D. 1986 - M.D. Wakayama Med Univ 1992-1996 - Research Staff, Pharmacology Div, National Cancer Center 1996-2006 - Head, Section of Drug Resistance, National Cancer Center Res Inst 2002-2007 - Invited Professor, Clinical Proteome Center, Tokyo Med Univ 2008- Professor, Dept Genome Biology, Kinki Univ School of Med Specialty and Research Field of Interest Molecular target therapy, Biomarker research, Molecular Tumor Biology Recent Selected Publications 1. Matsumto K, Nishio K, et al. mTOR signal and HIF-1regulate CD133 expression in cancer cells. Cancer Res (in press) 2. Hosoi F, Nishio K et al. N-myc downstream regulated gene 1/Cap43 suppresses tumor growth and angiogenesis of pancreatic cancer through attenuation of IKKbeta expression. Cancer Res (in press) 3. Okabe T, Nishio K, et al. Addition of S-1 to the epidermal growth factor receptor inhibitor gefitinib overcomes gefitinib resistance in non-small cell lung cancer cell lines with MET amplification. Clin Cancer Res 2009, 15(3): 907-13 4. Takeuchi K, Nishio K, et al. Mitogen-activated protein kinase phosphatase-1 modulated JNK activation is critical for apoptosis induced by inhibitor of epidermal growth factor receptor-tyrosine kinase. FEBS J 2009, 276(5):125: 5-65 5. Matsumoto K, Nishio K, et al. Identification of predictive biomarkers for response to trastuzumab using plasma FUCA activity and N-Glycan identified by MALDI-TOF-MS. J Proteome Res. 2009, 8(2):457-62 6. Tanaka K, Nishio K, et al. SRPX2 is overexpressed in gastric cancer and promotes cellular migration and adhesion. Int J Cancer 2009, 124(5):1072-80 7. Honma K, Nishio K, et al. RPN2 gene confers docetaxel resistance in breast cancer. Nature Med. 2008, 14(9), 939-48 8. Fukai J, Nishio K, et al. EphA4 promotes cell proliferation and migration through a novel EphA4-FGFR1 signaling pathway in the human glioma U251 cell line. Mol Cancer Ther 2008, 7(9), 2768-78 9. Fujii T, Nishio K, et al. Expression of HER2 and estrogen receptor alpha depends upon nuclear localization of Y-box binding protein-1 in human breast cancers. Cancer Res 2008, 68(5), 1504-12 10. Nakayama T, Nishio K, et al. Aberrant expression of Fra-2 promotes CCR4 expression and cell proliferation in adult T-cell leukemia. Oncogene 2008, 27(23), 3221-32 -------------------------------------------   Go to top

 

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