ROUNDTABLES 

Monday October 5, 2009, 0700-0800, Roundtables R201, R202, R203, R204, R205 Roundtable R201: Inosine triphosphatase (ITPase) and Azathioprine Intolerance Roundtable R202: How Much Sample Preparation for LC-MS(/MS)? Roundtable R203: Pharmacogenetic Variability in Children Roundtable R204: Clinical Tools to Optimize TDM and Individualized Dosage Regimens Roundtable R205: Clinical Utility of Monitoring Free Drug Concentrations   Tuesday October 6, 2009, 1130-1230, Roundtables R301, R302, R303, R304, R305 Roundtable R301: Bisphenol A (BPA) - The Latest Toxicity Studies and Government Actions Roundtable R302: OTC Medicines - The Need for Public Health Awareness Campaigning as a Monitoring and Evaluation Tool for Iatrogenic Outcomes Roundtable R303: Ethyl Glucuronide in Hair - What is the Best Cutoff to Discriminate Heavy Alcohol Drinkers? Roundtable R304: MS Detection Techniques in TDM/Toxicology - Guidance Documents on Identification Criteria Roundtable R305: Cocaine - Do You Know What You Are Snorting?   Wednesday October 7, 2009, 0700-0800, Roundtables R401, R402, R403, R404, R405 Roundtable R401: GC/MS - Automated Evaluation of Data Files Roundtable R402: Dermatotoxicity- Clinical and Laboratory Monitoring of Steven-Johnson Syndrome Roundtable R403: The Preanalytical Phase of the Test Cycle in TDM Roundtable R404: Diagnostic Pathways in Clinical Toxicology Roundtable R405: Dried Blood Spot Sampling and TDM of Immunosuppressant Drugs   Thursday October 8, 2009, 1130-1230, Roundtables R501, R502, R503, R504 Roundtable R501: Pharmacogenomics for Personalized Justice and Personalized Medicine Roundtable R502: HCV RNA Monitoring in Patients Undergoing Antiviral Therapy Roundtable R503: LC-MS-TOF in Clinical Toxicology Roundtable R504: GHB, GBL, 1,4-BD, GVL, GHV Overview Roundtable R505: Preanalytic Aspects: An Underestimated Cause of Errors in a TDM/TOX Laboratory Roundtable R506: Therapeutic Drug Monitoring of Clozapine and Other Antipsychotics       MONDAY OCTOBER 5, 2009, 0700-0800, Roundtables R201, R202, R203, R204, R205   Roundtable R201: Inosine triphosphatase (ITPase) and Azathioprine Intolerance Thursday, 1130-1230 Eberhard Wieland, M.D., Medical Director (Ärztlicher Zentrumsleiter), Center for Clinical Pathology, Pharmaceutics and Hygiene, Medical Director (Ärztlicher Direktor), Central Institute of Clinical Chemistry and Laboratory Medicine, Klinikum Stuttgart, Stuttgart, Germany Recently, polymorphic variation in the gene encoding the enzyme inosine triphosphatase (ITPase) has been associated with risk of thiopurine-related toxicity. This roundtable reviews the evidence of ITPase deficiency as predictor of azathioprine toxicity and discusses it with respect to clinical and laboratory practice.   Objectives: At the conclusion of this roundtable the participant will be able to: Critically appraise the association between azathioprine intolerance and ITPase polymorphisms; Critically appraise analytical aspects of ITPase genotype and phenotype determination. 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     Roundtable R202: How Much Sample Preparation for LC-MS(/MS)? Monday, 0700-0800 Katharina Rentsch, Ph.D., Institute for Clinical Chemistry, University Hospital Zurich, Switzerland Nowadays LC-MS(/MS) is very often used for therapeutic drug monitoring and more and more also for toxicological screening analyses. In order to shorten the analysis time chromatography is more and more shortened or even eliminated and sample preparation is often reduced to simple protein precipitation. In this roundtable different online and offline sample preparation methods will be discussed and procedures will be presented which can be used to describe interferences from coeluting compounds.   Objectives: At the conclusion of this roundtable the participant will: Know different sample preparation techniques and their advantages and disadvantages; Be able to test if the selected sample preparation technique is sufficient for a selected method. Go to top     Roundtable R203: Pharmacogenetic Variability in Children Monday, 0700-0800 Gideon Koren, MD, FRCPC, FACMT, Director, The Motherisk Program, The Hospital for Sick Children, Professor of Pediatrics,Pharmacology, Pharmacy and Medical Genetics, The University of Toronto, Toronto, Ontario, Canada; Professor of Medicine, Pediatrics and Physiology/Pharmacology and the Ivey Chair in Molecular Toxicology, The University of Western Ontario, London, Ontario, Canada Pharmacogenetic variability may lead some young children, exposed to opioids, either through breast milk, or therapeutically, to be at life threatening risks. While there is focus on metabolizing enzymes , such as CYP 2D6, there is almost no discussion on the pharmacodynamic sensitivity in young children. These will be discussed through several case presentations of recent fatal opioid toxicities in young children.   Objectives: To familiarize participants with the role of pharmacogenetics in therapeutic drug monitoring; To describe the pharmacogenetics of codeine in the context of life threatening pediatric poisoning. Click here: Gideon Koren biography Gideon Koren, MD, FRCPC, FACMT Gideon Koren is Professor and Director of the Motherisk Program, The hospital for Sick Children in Toronto and the University of Toronto, and the Ivey Chair in Molecular Toxicology at the University of Western Ontario. Dr Koren is author of 1100 peer reviewed manuscripts and 15 medical books in the field of developmental pharmacology and maternal-fetal toxicology. He serves as Editor in Chief (North America) of the journal Therapeutic Drug Monitoring. ------------------------------------------- Go to top     Roundtable R204: Clinical Tools to Optimize TDM and Individualized Dosage Regimens Monday, 0700-0800 Roger W. Jelliffe, MD, USC Laboratory of Applied Pharmacokinetics, University of Southern California, Los Angeles, California, USA This roundtable will discuss the tools which now exist for planning maximally precise drug dosage regimens, the use of three different Bayesian tools to develop individualized patient PK models based in intelligent TDM monitoring protocols, and, once again, maximally precise dosage adjustments based on that information. The capabilities of nonparametric population modeling over parametric models, the development of miltiple model design of dosage regimens, the Bayesian methods, and relevant clinical cases will all be discussed.   Objectives: At the conclusion of this roundtable the participant will be able to: Describe the General approach to Target-Oriented, Model Based, Individualized Drug Therapy; Discuss the Clinical capabilities of Nonparametric Population Modeling; Explain the principles behind Multiple Model, maximally precise, Dosage Design. 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     Roundtable R205: Clinical Utility of Monitoring Free Drug Concentrations Monday, 0700-0800 Amitava Dasgupta, Ph.D., Professor, Department of Pathology and Laboratory Medicine, University of Texas-Houston Medical School, Houston, Texas, USA Drug which is not bound to serum protein (free drug) is pharmacologically active while protein bound drug is inactive. For strongly protein bound drugs (>80% protein binding) monitoring total drug concentration may be misleading for patients with uremia, liver disease or hypoalbuminemia because of disproportionate increases in free drug levels. In this roundtable, clinical conditions where free drug monitoring is essential will be discussed with an emphasis on monitoring free anticonvulsants and mycophenolic acid, an immunosuppressant. Although digoxin is only 25% protein bound, monitoring free digoxin is essential in patients overdosed with digoxin being treated with Digibind.   Objectives: At the conclusion of this roundtable the participant will be able to: Understand when free drug monitoring is useful; Implement free drug monitoring in his or her laboratory; Be more effective consultant to clinicians recommending when free drug monitoring is needed. 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. ------------------------------------------- Go to top         TUESDAY OCTOBER 6, 2009, 1130-1230, Roundtables R301, R302, R303, R304, R305   Roundtable R301: Bisphenol A (BPA) - The Latest Toxicity Studies and Government Actions Tuesday, 1130-1230 Donald L. Frederick, Ph.D., Peoria Tazewell Pathology Group, USA Bisphenol A (BPA) has received a lot of publicity over the last several years especially regarding its presence in food containers such as baby bottles. The round table will discuss the latest information on safety studies and government actions regarding its use in the plastics industry.   Objectives: At the conclusion of this roundtable the participant will be able to: Decide which analytical strategies to use in the laboratory; Decide which analytical strategies to use in the laboratory; Get information about indications (abuse, therapeutics, date and rape, etc.), pharmacokinetics, the substances, analytical methods actually used, statistics of different countries and new analytical methods. Click here: Donald Frederick biography Donald L. Frederick Dr. Frederick received a B.S. degree in chemistry from Eastern Mennonite College (1963), an M.S. degree from the University of Virginia (1972) and a Ph.D. in pathology from the Medical College of Virginia, Richmond, Virginia (1976). He worked as Assistant Professor in the Pathology Department at the University of Oklahoma Health Science Center where he was Director of the Clinical Toxicology Laboratory. He was Director of Quality Assurance for the U.S. Air Force drug-testing program for 5 years and Director of Toxicology for Franciscan Shared Laboratory in Milwaukee for 2 years. He joined Peoria Tazewell Pathology Group in 1996. Dr. Frederick is board certified as a high-complexity clinical Laboratory Director by ABB and as a forensic toxicologist by ABFT. He has a special interest in forensic toxicology and laboratory information services. ------------------------------------------- Go to top     Roundtable R302: OTC Medicines - The Need for Public Health Awareness Campaigning as a Monitoring and Evaluation Tool for Iatrogenic Outcomes Tuesday, 1130-1230 Bisi Bright, LiveWell Initiative LWI, Lagos, Nigeria There is an urgent need need for public health awareness campaigning as a monitoring and evaluation tool for iatrogenic outcomes of the use of OTC medicines. This need is more compelling as such events may be resultant to the use of non-prescription medicines, or complimentary medicines. Promotive healthcare empowers people to make informed decisions on their health; which can influence healthcare outcomes. Thus, there is an increasing need to further empower the people through a feedback system of healthcare reporting by making OTC-induced iatrogenicity notifiable.   Objectives: At the conclusion of this roundtable the participant will be able to: Understand the need for drug toxicity monitoring within the community as a tool for improving public healthcare and community-based preventive healthcare; Monitor the iatrogenic outcomes of non-prescription medicines. Click here: Bisi Bright biography Bisi Bright Mrs. Bright is a Consultant Clinical Pharmacist and Public Health Manager. A Fellow of the Pharmaceutical Society of Nigeria, and Fellow of the West African Postgraduate College of Pharmacists (WAPCP), she also holds a Masters’ qualification in Public Health and is immediate past Secretary General of the College, WAPCP. She is currently the 1st Vice Chairman and CEO of LiveWell Initiative LWI, a registered health promotion non-governmental organization with focus on reducing health illiteracy and improving life expectancy. The NGO reaches out to Nigerians and other Africans with a view to reaching out to the world at large. Please visit the website at www.livewellng.org. With a track record of over twenty years in hospital pharmacy practice; during which period she studied further and qualified as a clinical pharmacist; she subsequently joined the WAPCP in 1998 as a Faculty Member. Having published over 60 (sixty) articles, some of which are in peer-reviewed journals, she has won several awards , among which are, the Merit Award of the Pharmaceutical Society of Nigeria (Lagos), the Surgimed Shield Award (University of Zimbabwe), Fellowship award of the Pharmaceutical Society of Nigeria FPSN, and, the Wall Street Journal/CNBC Complimentary Delegateship to the World Health Congress (USA). She ia a two-time International Membership Award winner of the IATDMCT (International Association of Therapeutic Drug Monitoring and Clinical Toxicology), and she presented a Poster at the IATDMCT Congress in Vancouver, Canada. A member of the National Health Promotion Committee of government, she is a candidate for the Executive committee position for Africa on the FIP. Two years ago, in 2006, she was invited as keynote speaker at the joint national medical & pharmacy annual conference in Harare, Zimbabwe. In line with her recognition as an expert in the field of Public Health Pharmacy, she was recently invited to deliver a paper on Public Health, Advocacy and Outreach at the FIP Congress in Basel, Switzerland. A member of the National Health Promotion Committee of government, was recently appointed to the Executive Committee position for Africa and the Middle East, on the FIP PI Section. ------------------------------------------- Go to top     Roundtable R303: Ethyl Glucuronide in Hair - What is the Best Cutoff to Discriminate Heavy Alcohol Drinkers? Tuesday, 1130-1230 Pascal Kintz, PharmD, PhD, Head of the Scientific Affairs, ChemTox Laboratory, Strasbourg, France Ethyl glucuronide (EtG) determination in hair was reported for the first time in the early 2000. At that time it was already clear that this phase II metabolite of ethanol could be of great interest as a marker of excessive alcohol consumption. More promising results were assessed during the recent years, with a notable improvement in method efficiency both by LC-MS/MS and GC-MS/NCI in order to detect pg/mg amounts of EtG incorporated into hair. A significant correlation was found between EtG hair concentration and ethanol daily intake. As there is in interest for differentiating social and heavy drinkers, several authors have suggested a cut-off to discriminate both populations. For the same classification, the following values have been proposed : 23, 25, 27, 30 and 50 pg/mg. Because ethanol is not a forbidden substance, the definition of a cut-off value in hair able to effectively discriminate moderate from non-moderate (i.e. ≥60 g/day) use is crucial for appropriate clinical and forensic applications. This roundtable will focus on the different approaches published in the literature and the factors that can modify EtG incorporation into hair, including hair colour and cosmetic treatments.   Objectives: At the conclusion of this roundtable the participant will: Understand incorporation of ethyl glucuronide in hair and parameters that can affect it; Have their own idea about the discriminative cut-off between social and excessive drinkers. Click here: Pascal Kintz biography Pascal Kintz 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 Court of Appeal of Colmar since 27 November 1992 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     Roundtable R304: MS Detection Techniques in TDM/Toxicology - Guidance Documents on Identification Criteria Tuesday, 1130-1230 Frank T. Peters, IInstitut für Rechtsmedizin, Universitätsklinikum Jena, Jena, Germany Qualitative and quantitative methods employing mass spectrometry coupled to chromatographic separation techniques play an important role in clinical and forensic toxicology as well as in TDM. The versatility of mass spectrometric detection is mainly due its sensitivity and selectivity/specificity. However, the latter largely depends on the detection mode; i.e., fullscan or monitoring of selected ions/transitions. Several guidance documents have established identification criteria to be used for unambiguous compound identification. The content of these documents and its implications for daily routine work will be discussed.   Objectives: At the conclusion of this roundtable the participant will be able to: Understand pros and cons of criteria for mass spectrometric compound identification as defined in relevant guidance documents; Understand differences of mass spectrometric detection techniques with respect to compound identification; Select adequate ions/transitions for selected-ion or monitoring (SIM)- or multiple reaction monitoring (MRM)-based methods in daily routine work. Click here: Frank T. Peters biography 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. ------------------------------------------- Go to top     Roundtable R305: Cocaine - Do You Know What You Are Snorting? Tuesday, 1130-1230 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, Alberta, Canada Cutting agents are deliberately added to illicit drugs at some stage of production, packaging, or distribution to provide a similar or complimentary effect with a cheaper compound, to attenuate side effects, and/or extend the supply, thus increasing profits. These substances can be toxic, introducing another level of risk to health and well-being, in addition to that posed by the illicit drug itself. Cocaine cutting agents used, the role of clinical laboratories in the identification of cutting agents in patient specimens, and the emerging toxicity associated with one particular cutting agent, levamisole, will be discussed.   Objectives: At the conclusion of this roundtable the participant will be able to: Describe various cutting agents used for cocaine; Understand the toxicity associated with use of a relatively novel cutting agent, levamisole; Appreciate the importance of clinical laboratories in identification of these substances. 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         WEDNESDAY OCTOBER 7, 2009, 0700-0800, Roundtables R401, R402, R403, R404, R405   Roundtable R401: GC/MS - Automated Evaluation of Data Files Wednesday, 0700-0800 Markus R. Meyer, MSc, Pharmacist-Research Assistant, Department of Experimental and Clinical Toxicology, Institute of Experimental and Clinical Pharmacology and Toxicology, Saarland University, Homburg/Saar, Germany The discussion should focus on fully automated evaluation of (mainly) gas-chromatography mass spectrometry data files. The purpose of this automation is to simplify and to reduce time consumption in systematic toxicological analysis, in routine work as well as in emergency cases. The application of the computer program AMDIS (Automated Mass Spectral Deconvolution and Identification System) will be the starting point of this scientific discourse. Attendees are encouraged to report their own experiences with AMDIS and/or with other software used in the above mentioned context.   Objectives: Knowledge about the possibility to automate STA; Knowledge about software that may be used in automated STA; Assets and drawbacks of automated STA. Click here: Markus R. Meyer biography Markus R. Meyer, MSc 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 civil 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 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 national 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." ------------------------------------------- Go to top     Roundtable R402: Dermatotoxicity- Clinical and Laboratory Monitoring of Steven-Johnson Syndrome Wednesday, 0700-0800 Manuela Neuman, In Vitro Drug Safety and BioTechnology Laboratory, Department of Pharmacology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada All therapies or stopping a therapy can have side effects in some people. The work discussed is based on the hypothesis that these differences have a genetic, metabolic and immunological basis, and the roundtable studies intend to examine the impact genes can have on how individuals respond to medicines. The initial studies are focused on identifying the genetic markers associated with drug-related Steven Johnsons Syndrome (SJS, a severe form of skin necrosis). The identification of these genetic variations is believed to be essential to develop safer drugs while also identifying patient populations for whom a medicine will have the greatest likelihood of providing medical benefits with the fewest risks. Toxic epidermal necrolysis (TEN) is a more severe form of SJS and has potentially life threatening disease that is often associated with prior exposure to aromatic antiepileptic drugs (AEDs) and sulfamethoxazole (SMX). We have used an in-vitro lymphocyte toxicity assay (LTA) to investigate systemic hypersensitivity reactions (HSRs) to these drugs and applied the same technology to investigate TEN. Objectives: 1-Validation of an in-vitro LTA for assessing TEN from AEDs or SMX; 2-Identification of specific immuno-responses, and 3-Correlation of serum cytokine levels with the LTA. The LTA technique appears to be accurate for differentially diagnose the drug incriminated in TEN. The differences in chemokines and cytokine profiles may represent differences in the pathogenesis of TEN vs. HSR and may be used to monitor the severity and the changes in underlying diseases.   Objectives: To convey to the audience that patients respond differently to medicines and all medicines can have side effects in some people and the necesity of monitoring the therapies in these individuals; To identify the genetic markers associated with drug-related Steven Johnsons Syndrome, a severe form of skin necrosis; To examine the impact of race can have on how individuals respond to medicines; To identify immunological-variants useful in predicting the risk of drug-related serious adverse events.   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     Roundtable R403: The Preanalytical Phase of the Test Cycle in TDM Wednesday, 0700-0800 Sandra Solari, Pontificia Universidad Catolica de Chile In the session the three phases of the test cycle will be described and the pre-analitical one will be discussed in detail. Each one of the components of this phase (test request, patient identification and preparation, sample collection, handling and transport to the laboratory, and the activities that are required prior to the analysis like centrifugation, pipetting, aliquoting, sorting, etc.) will be review in the context of the drugs that are under routine TDM. Also quality assurance for the preanalytical phase will be discussed regarding indicators and specifications for the different steps of this phase.   Objectives: To identify the different phases in a laboratory test and thier principal aspects; To give value to the importance of the preanalytical phase in the result of a Lab test; To describe the components of the preanalytical phase and it's application in TDM. Go to top     Roundtable R404: Diagnostic Pathways in Clinical Toxicology Wednesday, 0700-0800 Jürgen Hallbach, Head of Toxicology and TDM, Associate Director of the Department for Clinical Chemistry, Munich City Hospital, Munich, Germany A working group with members from laboratory medicine, poison information service and clinical toxicology has been established. This activity is sponsored by the German Society for Laboratory Medicine (DGKL). Parallel activities are under progress beside toxicology, i.e. nephrological diseases, neurological diseases and others. The aim of the working group is to introduce interdisciplinary coordinated and verified pathways for a rapid and convenient laboratory strategy in cases of acute intoxication.   Objectives: To learn about diagnostic pathways in hospital medicine; To discuss such a diagnostic strategy at the example of acetaminophen; To develop and discuss such a strategy for another example. Click here: Jürgen Hallbach biography Jürgen Hallbach 12/04/1955 Date of birth in Ludwigshafen, Germany From 1975 Studies in biochemistry (FU Berlin, University Tübingen) and food chemistry (TU München) 1984 Consultant in Clinical Chemistry at Munich City Hospital Bogenhausen 1986 PhD Thesis 1991 Clinical chemist (DGKL) 1998 registered Eur Specialist in Clinical Chemistry and laboratory medicine 2006 Clinical toxicologist (GTFCh) Position: Head of toxicology and TDM at Munich City Hospital (4000 beds), associated director of the department for clinical chemistry at Munich City Hospital Scientific organisations: Member of DGKL, IATDMCT, TIAFT, GTFCh, EAPCCT, BNLD, GBM Chairman of toxicology working group (DGKL), co-chairman of clinical toxicology section (GTFCh) ------------------------------------------- Go to top     Roundtable R405: Dried Blood Spot Sampling and TDM of Immunosuppressant Drugs Wednesday, 0700-0800 Leo M. Stolk, PhD, Hospital Pharmacist/Clinical Pharmacologist/Toxicologist, Head of the Laboratory for Therapeutic Drug Monitoring and Clinical Toxicology, University Hospital of Maastricht, Maastricht, The Netherlands In this roundtable Therapeutic Drug Monitoring of immunosuppressant drugs with the dried blood spot method will be discussed. First the general techniques of the dried blood spot method analysis will be reviewed. Then information will be given about the assays of tacrolimus and everolimus with the dried blood spot method with tandem mass spectrometry, developed in our laboratory. Finally experience with the dried blood spot method in every day practice of patient care will be gone into.   Objectives: At the conclusion of this roundtable the participant will: Be familiar with the general techniques of the dried blood spot method (DBS); Have knowledge of the DBS assays of tacrolimus and everolimus; Be informed about the author's own experiences with DBS assays in everyday practice. Click here: Leo M. Stolk biography Leo M. Stolk, PhD 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. ------------------------------------------- Go to top         THURSDAY OCTOBER 8, 2009, 1130-1230, Roundtables R501, R502, R503, R504, R505, R506   Roundtable R501: Pharmacogenomics for Personalized Justice and Personalized Medicine Thursday, 1130-1230 Steven H. Wong, Ph.D., Medical College of Wisconsin and Milwaukee County Medical Examiner’s Office, Milwaukee, Wisconsin, USA Pharmacogenomic biomarkers are increasingly used to optimize clinical drug therapy and drug discovery and development, resulting in possible practice of Personalized Medicine. Since genetic variations of drug metabolizing, receptors and other genes affect drug efficacy, the variable response of the patient - “ client “ might change behavior such as driving and working performance. As DNA fingerprinting is used for identity testing, the use of pharmacogenetic diagnosis as an adjunct may be introduced as evidence in legal proceedings – an emerging form of Personalized Justice.   Objectives: To understand the emerging forensic application of pharmacogenomics in personalized justice; To link the outcome of personalized medicine to personalized justice; To appreciate the use of alternate, non-invasive samples such as oral fluid and hair for genotyping and toxicological analysis as part of the emerging personalized justice. Click here: Steven Wong biography Steven H. Wong Dr. Wong is Professor of Pathology., and Director, Toxicology, TDM, Pharmacogenomics and Proteomics, Pathology Dept., 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 a faculty member at University of Connecticut School of Medicine, and Johns Hopkins University School of Medicine. His scientific and clinical interests encompass TDM, toxicology, pharmacogenomics and pharmacoproteomics. He is the principal investigator of a multicenter study for assessing pharmacogenomics for certifying 1100 methadone fatalities. In addition to over 100 publications and 126 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, and the Egyptian Journal of Hospital Medicine. ------------------------------------------- Go to top     Roundtable R502: HCV RNA Monitoring in Patients Undergoing Antiviral Therapy Thursday, 1130-1230 Manuela Neuman, In Vitro Drug Safety and BioTechnology Laboratory, Department of Pharmacology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada There has been considerable progress in antiviral therapy for hepatitis C since 1989 when six months of interferon monotherapy was shown first to be effective in normalizing serum alanine aminotransferase (ALT) levels in a proportion of patients with chronic non-A, non-B hepatitis, known as viral hepatitis C (HCV). However, once the hepatitis C virus was identified, it became apparent that only a small proportion of these patients cleared virus after treatment. Extending the course of treatment to a year doubled the rate of viral clearance. More impressively, the addition of the oral nucleoside ribavirin to the interferon regimen dramatically increased the durable viral clearance rate compared to interferon alone. However, the initial studies of the combination of interferon and ribavirin found that viral genotype had a significant impact on interferon sensitivity and treatment response. Indeed, in patients infected with genotype 2 or 3 the sustained viral response (SVR) was the same whether they received 6 or 12 months of treatment. Thereafter, the duration of therapy was modified according to the genotype of the infecting virus. This tailoring of therapy continued as pegylation of the parent interferon drug extended its half-life, allowing greater exposure to the drug despite less frequent dosing. When combined with ribavirin, pegylated interferons increased the SVR to more than 50%. Treatment was further customized with the concept of stopping rules that modified treatment based the viral response, or rather the lack of response, during the initial weeks of treatment. Failure to reduce the HCV RNA level by at least 2 logs after the first 3 months of treatment (early viral response; EVR) predicted treatment failure and justified discontinuation of therapy. Therefore to distinguish between the different methods to determine HCV-RNA and their sensitivity is essential in monitoring the antiviral therapies.   Objectives: To identify patient populations for whom the antiviral therapy will have the greatest likelihood of providing medical benefits with the fewest risks; To identify and monitor the viral markers associated with response to therapy; To characterize the immunomodulatory effects of antiviral therapy (iv) to monitor the levels of cytokines with response to therapy for those who received therapy; To identify immunological-variants useful in predicting the risk of drug-related serious adverse events in individuals receiving the anti-viral therapy.   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     Roundtable R503: LC-MS-TOF in Clinical Toxicology Thursday, 1130-1230 Jürgen Hallbach, Head of Toxicology and TDM, Associate Director of the Department for Clinical Chemistry, Munich City Hospital, Munich, Germany Using time of flight mass spectrometry and lock mass correction makes it possible to measure the molecular mass of low and medium molecular weight substances (<3000 dalton) with a mass error not exceeding a few ppm. Therefore the measurement of the exact mass of an unknown substance leads directly to the atomic composition and the empirical formula. The results can be confirmed by (1) retention time comparison with pure standards analysed by the same way and (2) mass spectral agreement of the anayte and library hit. In our opinion LC-MS-TOF has the potential to become a very valuable method for general unknown screening.   Objectives: To understand the functionality of TOF analysis of small molecules; To understand the differences between targeted and non-targeted library screening; To discuss the limits of TOF analysis. Click here: Jürgen Hallbach biography Jürgen Hallbach 12/04/1955 Date of birth in Ludwigshafen, Germany From 1975 Studies in biochemistry (FU Berlin, University Tübingen) and food chemistry (TU München) 1984 Consultant in Clinical Chemistry at Munich City Hospital Bogenhausen 1986 PhD Thesis 1991 Clinical chemist (DGKL) 1998 registered Eur Specialist in Clinical Chemistry and laboratory medicine 2006 Clinical toxicologist (GTFCh) Position: Head of toxicology and TDM at Munich City Hospital (4000 beds), associated director of the department for clinical chemistry at Munich City Hospital Scientific organisations: Member of DGKL, IATDMCT, TIAFT, GTFCh, EAPCCT, BNLD, GBM Chairman of toxicology working group (DGKL), co-chairman of clinical toxicology section (GTFCh) ------------------------------------------- Go to top     Roundtable R504: GHB, GBL, 1,4-BD, GVL, GHV Overview Thursday, 1130-1230 André Scholer, Ph.D., Retired, Head of Clinical Chemistry Laboratory, University Hospital, Basel, Switzerland In many countries gamma-hydroxy-butyrate (GHB) is still a substance of abuse, a well known date and rape drug (mostly used as the precursor drugs gamma-butyrolactone, GBL or seldom 1,4-Butandiol 1,4-BD) and as a therapeutic drug for treatment of narcolepsy. The analytical methods for the determination in serum and urine are sophisticated and no sensitive onsite test is available to date. Information about the abuse or intentional criminal use of the similar acting substances gamma-hydroxy-valerolacton (GVL, precursor) and gamma-hydroxy-valerate (GHV) are rare and should therefore be a point of discussion (pharmacokinetics, pharmacodynamic and methods of determinations). New methods for urgency testing will also be discussed.   Objectives: Decide which analytical strategies to use in the laboratory; To get information about indications (abuse, therapeutics, date and rape, etc.), pharmacokinetics, the substances, analytical methods actually used, statistics of different countries and new analytical methods. Click here: André Scholer biography André Scholer, PhD Head of clinical chemistry department at the university hospital Basel, Switzerland from 1982 to November 2008, specialist in clinical toxicology, Clinical Toxicologist GTFCH (2007), 1982 - 2010 teacher at the university of Basel, technical high school FHNW (since 2007), (clinical chemistry, clinical toxicology), interests in science: method development in clinical toxicology (chromatography, immunoassays, etc.), case studies in all faculties mentioned, studies in the field of drug of abuse testing for drug substitution programs, president of the swiss working group on drugs of abuse testing AGSA, member of IATDMCT, TIAFT, GTFCH, AACC, SGKC/SSCC, DGKL. ------------------------------------------- Go to top Roundtable R505: Preanalytic Aspects: An Underestimated Cause of Errors in a TDM/TOX Laboratory Thursday, 1130-1230 Pierre Wallemacq, PhD, EurClinChem, Laboratory of Toxicology and Special Chemistry, University Hospital St Luc - Brussels, Brussels, Belgium Due to the progress in analytical techniques and in the quality control systems, the vast majority of the remaining laboratory errors occurs during the preanalytic or post-analytic phases. Most of the errors currently found in the activities of therapeutic drug monitoring and toxicology belong to the following categories: errors in timing for blood sampling, wrong tubes sampling, stability issues including degradation and non-specific adsorption, analytical interferences by endogenous compounds or by chemically related structures, etc.   Objectives: An analytical result may be misleading, even obtained from the best analytical platform under the supervision of a well trained staff; To identify the main causes of preanalytical errors in TDM/toxicology; To prevent such errors and provide recommendations. Click here: Pierre Wallemaq biography Pierre Wallemacq, PhD, EurClin Chem Dr. Pierre Wallemacq, PhD is Professor at the Université Catholique de Louvain, Medical school in Brussels, Belgium. He teaches clinical chemistry, toxicology and clinical pharmacokinetics, and is the vice president of the biomedical sciences school. He is responsible of a research unit (LBCM) in the Medical School and supervises several PhD theses and post-doc fellows. He is also head of laboratory in the Cliniques universitaires St Luc, Brussels, in charge of the analytical biochemistry platform regrouping activities such as TDM, clinical toxicology, forensic toxicology, but also special chemistry (GC, HPLC, UPLC, LC-MSMS, GC-MS). He started working in the field of TDM since 1982 with his PhD thesis on cyclosporine, and is author or co-author of more than 130 peer-reviewed manuscripts and nine textbook chapters. He has presented at more than 170 conferences on invitation. Most of his work was dedicated to immunosuppressive drugs, but he also published works in other clinical chemistry of TDM/TOX areas. Pierre Wallemacq has been elected president of the Royal Belgian Society of Clinical Chemistry (SBCC-BVKC) in 2008, and president of the Belgian and Luxemburg society of Toxicology (BLT) in 2007. He is member of the Editorial Boards of several International Journals such as Therapeutic Drug Monitoring (TDM), Clinical Biochemistry (CLB), Clinical Chemistry and Laboratory Medicine (CCLM). Effective July 2009 he became an Associate Editor for Clinical Biochemistry. He has served as a Guest Editor, and has been involved as member of the scientific organization committees of several international congresses. Recently, he has been elected Director of Education in the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT). ------------------------------------------- Go to top     Roundtable R506: Therapeutic Drug Monitoring of Clozapine and Other Antipsychotics Thursday, 1130-1230 Philippe Vincent, Pharmacist, M.sc., Louis-H. Lafontaine Hospital, Montreal, Quebec, Canada Clozapine is a precious last chance drug for patients suffering from resistant schizophrenia, but it has frequent side effects, a delayed onset of action, and requires strict monitoring of neutrophil count. Therapeutic drug monitoring of clozapine is routinely used in European countries, but has found resistance to its global implantation in the Americas. The usefulness of TDM to optimize the prescription of clozapine has been discussed for over 20 years in the medical community. A very precise therapeutic range has been consistently described in the literature. Furthermore, there are numerous published methods for fast analysis of plasma samples of clozapine with HPLC alone or coupled with MS. Finally, experience from Germany shows us that results need to be interpreted along with some clinical data that's communicated beforehand to the laboratory. To optimise the treatment of patients suffering from schizphrenia, we will discuss all the steps required to implement routine analysis of clozapine in your laboratory.   Objectives: At the conclusion of this roundtable the participant will be able to: Describe clozapine’s singular pharmacology; Identify the therapeutic range and its clinical meaning; Give basic comments on TDM results; Argue for the development of routine TDM of clozapine in his laboratory. Click here: Philippe Vincent biography Philippe Vincent Philippe Vincent has 5 years experience as clinical pharmacist at Louis-H. Lafontaine Hospital in Montreal. He works mainly with the first psychotic episode team. He is continually engaged in teaching pharmacy students, and he has recently been appointed adjunct professor of clinic at the Faculty of Pharmacy at University of Montreal. He just came back from a 3 month internship with TDM world expert Professor Hiemke, from Mainz University Hospital. His ambition is to offer routine TDM for psychotropic drugs in Quebec in a fast and clinically useful way. ------------------------------------------- Go to top

 

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