2017년 6월 14일~17일 미국 보스톤 컨벤션 센터에서 ISSCR이 개최되었다. Shinya Yamanaka, Magdalena Zernicka-Goetz, Daley, George Q., George Church 등 iPSCs와 hematopoietic stem cell, epigenetics, organoid 등 여러 분야의 유명인사들이 한 자리에 모여 강연했으며, concur- rent 및 poster presentation 부문에도 무수히 많은 전세계의 연구자들이 참가하여 학회 기간 내내 활발한 의견 교류의 장을 형성했다.
2017년 6월 24일부터 27일까지 체코 프라하에서 유럽임상약리학회(EACPT)가 개최되었다. 유럽임상약리학회는 약물의 효과적이고 안전한 개발 및 사용을 목적으로 하는 유럽의 학회이다. 약 500여명의 세계 각지에서 모인 임상약리학자들이 학회 기간 내내 활발한 의견 교류의 장을 형성하였다.
왼쪽부터 서울대학교 장인진 교수님, 신상구 명예교수님, 배균섭 교수님, 서울대학교 전공의 선생님, 그리고 본인.
Key Words: EACPT, Clinical Pharmacology, Pharmacokinetics, Modeling and Simulation
주요 발표 내용
6월 24일 주요 내용 토요일
젊은 임상약리학자 세션 (Young clinical pharmacologists session)
‘Metaanalysis and systematic review’에서는 Matthieu Roustit (University Grenoble Alpes, France), Joaquín Sáez-Peñataro (Hospital Clínic Barcelona, Spain) 두 임상약리학자 간의 메타분석과 체계적 고찰에 대한 토론이 있었다. 메타분석이 없이는 체계적 분석이 이뤄질 수 없다는 큰 원칙 하에 높은 수준의 의학 정보를 생산해내기 위한 최선의 방법론을 참석자들과 공유하였다. 두가지 연구 방법의 우열을 가릴 수 없으며 가능한 자원을 최대한 활용할 수 있는 연구 방법을 택해야 한다는 결론을 내릴 수 있었다.
이후 본 저자를 포함한 총 네 명의 임상약리학자들이 구연발표를 진행하였다. 첫번째 연자인 Emmanouela Kampouraki (뉴캐슬 대학교, 영국)는 CYP4F2 유전형이 만성 와파린 치료를 받는 소아에서 순환 혈장 비타민 K의 농도에 영향을 준다는 연구 결과를 발표하였다.
INHIBITORY INTERACTION POTENTIAL OF LINEZOLID ON SOLUTE CARRIER FAMILY (SLCO)-1B1 and-1B3 TRANSPORTERS MEDIATED RIFAMPIN UPTAKE, IN VITRO
인제대학교의 박사는 Linezolid와 rifampicin 간의 약물상호작용에 대해 논하였다.
- N Kaisar1, MM Parvez1, YJ Lee1, HJ Shin1, JA Jung2, J-G Shin1,2
- Inje University College of Medicine, South Korea
- Inje University Busan Paik Hospital, Busan, South Korea
SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE DOSE JPI-289, A NOVEL POLY (ADP-RIBOSE) POLYMERASE-1 INHIBITOR IN FIRST-IN-HUMAN STUDY OF HEALTHY VOLUNTEERS
- Sungpil Han1, Yo Han Kim1, Hee Youn Choi1, Dong-Jun Soh2, Jung-Min Kim2, Joon-Woo Nam2, Jong-Woo Kim2, Kyun-Seop Bae1 Hyeong-Seok Lim1
SEPSIS BIOMARKER PROGNOSTIC SIGNIFICANCE – PRESEPSIN ROLE IN REAL CLINICAL PRACTICE
- speaker: Mariya Lukina, Mariya Chukina, Tatiana Andruchichina, Tatiana Morozova
- I.M.Sechenov First Moscow State Medical University, Russia
PLENARY SESSION: “Adverse drug reactions – state of the art in 2017”
EMA (European Medicines Agency)의 June Raine이 “약물이상반응 - 2017년의 최신지견”이라는 제목의 plenary session을 열었다. 유럽에서는 ‘PRIME’, FDA에서는 ‘Breakthrough Therapy’를 획득하여 빠른 개발의 필요성이 인정받는 경우를 말한다. 이 경우에는 더더욱 이상반응(adverse events)을 빠르게 발견, 평가 및 이해가 필요하다.
약물의 빠른 개발과정에서 이상반응의 감시 뿐만 아니라 약물 시판 후의 안전성을 감시하는 Pharmacovigilance의 중요성도 갈수록 커지고 있다.
ADR (Adverse Drug Reactions)에 대한 현재의 이해, 그리고 앞으로의 연구방향에 대해 진단하였습니다. Pharmacovigilance의 중요성. ADR의 연구와 활용에 많은 도전과 어려운 점이 있습니다.
- ‘Detection, assessment, understanding and prevention of adverse effects or related problems’
- signal detection, better characterised risks, ongoing evaluation, risk minimization, monitor risk minimization effectiveness
- Evolution of PV -> 1980년대에은 자발적인 케이스 리포트 -> 2. 역학 데이타 3. proactive risk 4. continuous risk monitor
- 약물 허가 시점에 우리는 ADR에 대해 많이 알고 있지 못할 것.
- Landmark - Thalidomide, Practolol, 2000 - Cerivastatin, HRT, SSRI, coxib, rosiglitazone, gadolinium CA 급격히 많아지는 시점이 2000년대임. - 임상약리학의 역할이 컸을 것이다.
- EMA의 PV risk assessment committee가 조성되어 PV에 대해 많은 국가들이 협력적인 관계를 맺고 있다.
- meeting highlights (PRAC) 새로운 약물의 PV에 대해 모여서 회의하게 된다.
- Spontaneous ADR report - “Signal”
- increasing volume으로 인하여 이것을 일일이 확인하기란 참 어려움.
- HPV vaccine - risk of fatigue syndrome - no increase in CFS observed vs expected rates using max sequential | 사실상 큰 차이 없음.
PV activity: signal detection and invetigation
SGLT2 inhibitors & DKA: type 2 DM,
fluoroquinolones - risk characterization - already characterized. nothing new. but full characterization은 여전히 진행 중.
benefit risk evaluation - Gad and tissue accumulation: nephrogenic system fibrosis
Risk minimization effectiveness - valproate - developmental disorders - increased autistic spectrum disease
valproate의 사용이 유럽의 여러 국가마다 크게 다른데 왜 그러한지? 프랑스에서는 bipolar에 60%가 처방하는데 그렇지 않은 경우가 많다.
Challenges - biological medicines, earlier access to new med and vaccines
- biological medicines Rebif - increaingly unwell -> htn, arf - thbombocytopenic - TMA (thrombotic microangiopathy) -> small vessel damage (2016)
- BMJ - Evolution of biological safety
- Access to innovative med
- Pembrolizumab - safety specification, PV plan, Risk minimization
Opportunities for PV - collaborative education & training, digital transformation, social media(new data source)
ADR reporting communication materials
IMI WEB-RADR mobile app - anyone can report
patterns of abuse - twitter
systems biology approaches - genome, microbiome, metabolome, nutrition, lifestyle - integration
LIFETIME ACHIEVEMENT AWARD: “Steps towards safe and predictable drug treatment - picks from five decades”
- chairs: Tabassome Simon, Ylva Böttiger
- speaker: Pertti J. Neuvonen, University of Helsinki, Finland
- Gemfibrozil - statins by inhibiting CYP2C8 enzyme in vivo (even in small doses < 100 mg)
- Tizanidine - centrally acting m. relaxant - clonidine like alpha2-adrenoceptor agonist
- >20 years - clinical use
- flyvoxamine drastically interacts with tizanidine -> hypotension
- Clopidogrel + which statin? - what’s the best?
6월 25일 주요 내용 일요일
이 날은 오전 일찍 Elsevier 출판사에서 주최로 논문을 잘 쓰기 위한 방법에 대해 강의하였다.
또한 신장내과 약물에 대한 세션에 참여하였다.
How to write a paper, 2017-06-25
논문을 잘 쓰기 위해 알아두어야 할 기본적인 내용과 저자가 주의해야 할 점에 대해 공유하는 시간이었습니다.
- speaker: Elsevier publisher
- Effective manuscript writing - 7 words - google scholar, humorous title - lower rank.
- Clinical Therapeutics - purpose, methods, findings, implication
- Peer review
- KPXBDR / www.publishingcampus.elsevier.com/workshops
- Chairs: Milan Grundmann, University of Ostrava, Czech Republic Teun van Gelder, Erasmus Medical Center, The Netherlands
Pharmacotherapy after organ transplantation
- Speakers: Ondrej Viklicky, Institute for Clinical and Experimental Medicine, Czech Republic
- Transplantation wo immunosuppression is not possible
- induction: anti-CD25 or rATG - (antithymocyte globulin) for all patients
- Tacrolimus + mycophenolate mofetil
- low dose steroids in most patients, still question when to eliminate
- How to deal with IS
TDM and pharmacogenetics in transplantation: What does the evidence say? (30 min.)
TDM은 좋아. CYP3A5 -> Tac dose requirement, donor CYP3A5 -> intrarenal tacrolimus metabolism
- speaker: Teun van Gelder, Erasmus Medical Center, The Netherlandsi
- Graveyard of immunosupp - ISA247, FTY720, FK778
- Tacrolimus + Myco mofetil
- TDM (concentration controlled) vs non-TDM - incidence of BPAR, graft loss, death = No difference
- Summary of FDCC study
- UGT1A9-275T>A/-2152C>T polymorphisms - low MPA exposure and acute rejection in MMF/Tacrolimus-Treated Kidney Transplat
- CYP3A5 (+) -> higher Tac needed. / (-) not need high dose of Tac.
Effect of CYP3A4*22, CYP3A5*3, POR*28, and PPARA RS4253728 on tacrolimus exposure and neurotoxicity in kidney transplant recipients
Tac의 부작용으로 진전과 두통이 있는데 SNP의 변화가 이것을 유발하지는 않았다.
- speaker: Jean-Baptiste Woillard1, Nicolas Picard1, Marie Essig1, Pierre Merville2, Caroline Monchaud1, Pierre Marquet1 (CHU Limoges; Univ Limoges, France CHU Bordeaux, France)
- Tac AE: Tremor, headache
- substrate: CYP3A4, CYP3A5
- R packages:
- No significant influence of the SNPs
- Electrolyte imbalance: Hypermanesia can cause neurological Sx. -> not explored.
Choice of renal function estimator may affect adverse outcomes with dabigatran
Dabigatran은 Atrial Fibrilation의 치료에 쓰이는데 CrCl, eGFR 둘중에 뭘 택해야 하나?
- speaker: Bryan Simpson, David Reith, Natalie Medlicott, Alesha Smith (University of Otago, New Zealand)
- Dosing dabigatran by renal function is clearly relevant and the best estimator is yet to be determined.
- Different estimators produce different risk profiles.
- It is unknown what the clinical significance is when dabigatran is dosed according to different estimates of renal function (CrCl, eGFR) for treatment of atrial fibrillation (AF) in clinical practice
Factors associated with vancomycin concentration variability in routine clinical care
Vancomycin Trough Concentration에 영향을 미치는 GFR은 Vanco 치료 시작할 때 사용되어야 한다.
- speaker: Ksenia Zagorodnikova, Maria Kostitcyna, Alla Murzina (North-Western State Medical University N.A.I.I.Mechnikov, Russia)
- GFR is an important factor explaining VTC variability even in patients with normal renal function and it should be used in selection of the starting dosing regimen to provide faster achievement of target VTC.
PHARMACOKINETICS Advances in pharmacokinetics: Towards optimised drug treatments
- Chairs: Jaroslav Chladek, Charles University, Czech Republic Janne Backman, University of Helsinki, Finland
Recent advances in developmental pharmacokinetics in children
Microdose of paracetamol, 가바펜틴의 모델링 (GAPP, GAbapentin in Pediatric Pain)
- speaker: Saskia de Wildt (Radboud University, The Netherlands)
- Microdose neonate
- Age affects metabolism of paracetamol
- Drug transporter: major information gap
- PopPK - Gabapentin (GAPP - GABApentin in paediatric pain)
- Towards optimal individualized dosing
Complex drug-drug interactions: Mechanisms and clinical relevance
복합 약물 상호작용은 드물지 않고, 약물 농도의 예측과 디자인을 어렵게 합니다.
- speaker: Janne Backman, University of Helsinky, Finland
- Necessity: Unrecognized DDI - harmful, PolypharmacoTx. - common, withrawal of drugs due to DDI, drug development can be influenced.
- Complex DDI
- cerivastatin - CYP3A4 + CYP2C8 - itraconazole increased the AUC by 15% only.
- muscle toxicity, rhabdomyolysis
- gemfibrozil -> raises conc of cerivastatin
- gem-glucuronide -> strong inhibitor of CYP2C8
- itraconazole (CYP3A4 inhibitor)
- cyclosporine (CYP3A4 inhibitor)
- no meaningful effect on PK of OATP1B1 substrate simvastatin
- Clop-glucuronide - inhibition of metabolism.
- conclusion: not common, challenges to prediction, design of clinical DDI studies, evaluation of complex DDI (time-dependent, auto inhibition of victim) -> comprehensive approach
Population modelling in haemophilia and potential usage in the clinic
혈우병 환자에서 집단약동학 모델링을 통해서 정확한 농도를 예측할 수 있고 이를 통해 dose를 조절할 수 있다.
- Siv Jönsson, Uppsala University, Sweden
- PopPK- mainly PK modelling, coagulant activity measured.
- Factor 8: 0.04-0.06 mainly in plasma, binds to vWF.
- Factor 9: interstetial fluid V 0.15-0.20 L/kg vascular endothelial cells.
- Abrantes 2017: n=754
- Factor 9: inter-occasion variability
- Can we use this to the clinic?
- posteriori - TDM + model-based dose individualization
- Sampling timing is important.
- doseme.com.au tdmx.eu insight-rx.com
Hepatic disposition of [11C]erlotinib at micro- and therapeutic doses assessed with pet imaging
uptake of a microdose of [11C]erlotinib occurred via a carrier-mediated process
Martin Bauer1, Akihiro Matsuda1, Beatrix Wulkersdorfer1, Cecile Philippe1, Lukas Nics1, Eva-Maria Klebermass1, Johann Stanek1, Wolfgang Wadsak1,2, Marcus Hacker1, Markus Zeitlinger1 Medical University of Vienna, Austria Centre for Biomarker Research in Medicine - CBmed GmbH, Graz, Austria AIT Austrian Institute of Technology GmbH, Seibersdorf, Austria
BackgroundGo The tyrosine kinase inhibitor erlotinib displays large inter-individual variability in plasma PK. Erlotinib undergoes hepatobiliary clearance and is a substrate and/or inhibitor of different hepatic ABC and SLC transporters (P-gp, BCRP, OATPs). In this PET study we assessed hepatic disposition of 11C-erlotinib both at micro- and therapeutic doses to investigate the involvement of carrier-mediated processes in the hepatic clearance of erlotinib.
MethodsGo Six healthy volunteers (mean age: 27 ± 6 years) underwent two consecutive abdominal [11C]erlotinib PET scans and arterial blood sampling. The first scan was performed after administration of a microdose of 11C-erlotinib (<20 µg). In the second scan a microdose of 11C-erlotinib was administered at 3 hours after oral treatment with a therapeutic erlotinib dose (300 mg). Radiolabelled metabolites of 11C-erlotinib in plasma were assessed with a solid-phase extraction protocol. PET and blood data were analysed with compartment modelling.
ResultsGo During the PET scans only a low amount (<5%) of radiolabelled metabolites of [11C]erlotinib was detected in plasma both for the micro- and therapeutic dose scans. As compared with the microdose scan, AUC values of concentration-time curves of 11C-erlotinib in plasma were significantly increased in the therapeutic dose scan by 99 ± 27%, whereas AUC values in the liver and liver-to-plasma AUC ratios were decreased by 55 ± 5% and 77 ± 5%, respectively. For the therapeutic dose a significant decrease (-39 ± 18%) in the influx rate constant of 11C-erlotinib from blood into hepatocytes was found, whereas the efflux rate constant from hepatocytes into gall bladder and bile duct remained unchanged.
ConclusionsGo Our data show that liver uptake of a microdose of [11C]erlotinib occurred via a carrier-mediated process, which became inhibited at therapeutic erlotinib doses. Active uptake transport of erlotinib into the liver may account for variability in plasma PK and potentially play a role in transporter-mediated drug interactions.
Characterization of absorption, metabolism, and elimination of Niraparib, an investigational poly (ADP-ribose) polymerase inhibitor, in cancer patients
niraparib 의 PK를 밝혀냄.
- speaker: Zhi-Yi Zhang1, Vikram Kansra1, Lotte van Andel2, Matthijs Tibben2, Hilde Rosing2, Sharon Lu1, Shefali Agarwal1, Lorraine Hughes1, Jan H. M. Schellens3,4, Jos H. Beijnen2,4 (TESARO Inc, Waltham, USA)
BackgroundGo Niraparib is an investigational oral, once daily, selective poly (adenosine diphosphate [ADP] ribose) polymerase (PARP)-1 and PARP-2 inhibitor. In the pivotal phase 3 ENGOT-OV16/NOVA study, niraparib met its primary endpoint of improving progression-free survival (PFS) in adult patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer who achieved complete or partial response to platinum-based chemotherapy. Significant improvements in PFS were seen in all patient cohorts regardless of biomarker status (i.e., germline BRCA mutation and homologous recombination deficiency). Here, we present the absorption, metabolism, and elimination of niraparib, assessed in a dedicated clinical study (PR-30-5015-C).
Methods Both cold and 14C-labeled niraparib were used to first determine its oral bioavailability, followed by evaluating its metabolic profile and mass balance (6 patients/study). High performance liquid chromatography-tandem mass spectrometry (LC/MS/MS) and radioactive detection methods were used to quantify niraparib and its major metabolites. LC/MS/MS and LC-high resolution MS were used to elucidate the structure of metabolites.
ResultsGo Niraparib was rapidly absorbed and highly bioavailable (73%) in humans. Metabolism of niraparib was primarily hepatic via carboxylesterase-catalyzed amide hydrolysis, leading to the formation of an inactive acid metabolite (M1) which then underwent glucuronidation. Cytochrome P450 enzymes play a negligible role in niraparib metabolism in humans. Niraparib exhibited a long terminal half-life (~2 days), consistent with a once-daily dose regimen. Compound-related material, excreted comparably via renal and fecal routes, was well recovered (86%), suggesting minimal long-term body retention.
ConclusionsGo The high bioavailability and long terminal half-life of niraparib may explain in part its anticancer activity and efficacy in treating ovarian cancer in the ENGOT-OV16/NOVA trial.
Pharmacokinetics and pharmacodynamics of Elobixibat, a novel ileal bile acid transporter inhibitor
IBAT을 억제. 변비의 치료.
Yuji Kumagai1, Hideki Amano1, Yoshinobu Sasaki1, Chie Nakagawa1, Mika Maeda1, Ichiro Oikawa2, Hidetoshi Furuie3 Kitasato University Hospital, Kanagawa, Japan EA Pharma Co., Ltd., Tokyo, Japan Osaka Pharmacology Clinical Research Hospital, Japan
BackgroundGo Elobixibat is a novel oral inhibitor of the ileal bile acid transporter and is currently under development for the treatment of chronic constipation. We performed a Phase I study to evaluate the safety, pharmacokinetics, and pharmacodynamics of elobixibat in Japanese patients with chronic constipation.
MethodsGo The study consisted of 2 parts. In part 1, a single dose of elobixibat (2.5, 5, 10, 15 or 20 mg) or placebo was administered to 60 patients (10 received placebo) in a randomized double blind design. In part 2, elobixibat was administered to 60 patients for 2 weeks in the same manner as in part 1. The main purpose of part 1 was safety and pharmacokinetics, while the main objective of part 2 was the pharmacodynamic effect of elobixibat. Plasma cholest-4-en-7α-ol-3-one (C4), a biomarker reflecting bile acid synthesis, and the number of stool passages were measured as pharmacodynamic parameters.
ResultsGo Elobixibat displayed linear pharmacokinetics with very low systemic exposure. When compared to fasting conditions, the plasma exposure of elobixibat decreased to 20-30% with breakfast. After repeated administration, plasma concentrations reached steady state after 7 days and no accumulation was found up to the dose of 15 mg. Plasma levels of C4 increased in response to each dose level, however the increase was blunted at 20 mg. LDL cholesterol levels were decreased from the dose of 5 mg onwards. Constipation was improved in a dose dependent manner. The change in the number of spontaneous bowel movements and C4 levels correlated well when the data were pooled from all dose groups. Elobixibat was well-tolerated except for mild gastrointestinal symptoms.
ConclusionsGo Elobixibat showed a dose dependent effect in patients with chronic constipation and was well-tolerated. The effect on bowel movements correlated well with increased plasma C4 levels, a marker of its pharmacological action.
ORAL COMMUNICATIONS 2
- Chairs: Gerard Rongen, Dinko Vitezic
What is the current knowledge about the cardiovascular risk for users of cannabis-based products? A systematic review
뇌졸중에서 대마초의 위험성
- speaker: Emilie Jouanjus, Valérie Wolff (Centre Hospitalier Universitaire, Toulouse, France)
- cannabis exposure
- pre-clinical data - what’s the mechanism? hypothesis: triggering
- cardiovascular risk for cannabis-based product users. Currently, this evidence is stronger for ischemic stokes
Multimorbidity, guidelines and polypharmacy
- speaker: Matthew Doogue1,2, Annabelle McGowan1,2, Murray Barclay1,2, David Jardine1,2
University of Otago, New Zealand Canterbury District Health Board, New Zealand
Transition study of biosimilar infliximab in patients with inflammatory bowel disease
- Niels Boone, Limmie Lui, Marielle Romberg, Laurence Duijsens, Hugo van der Kuy, Rob Janknegt, Ad van Bodegraven (Zuyderland Medical Center, The Netherlands)
Effect of high dose acetaminophen on liver function tests in healthy subjects
- speaker: Yuji Kumagai1,2, Ildae Song1, Mika Maeda1,2, Rieko Tanaka1, Yasutoshi Sakamoto1, Masako Aso2, Yoshiro Saito3, Kyoko Maekawa3, Tomoe Fujita1,2
Kitasato University, Kanagawa, Japan Kitasato University Hospital, Kanagawa, Japan National Institute of Health Sciences, Tokyo, Japan
Drug-induced acute pancreatitis: A four-year single-centre experience
- speaker: Karel Urbánek, Kateřina Schillerová, Ondřej Krystyník, Jaromíra Gajdová (Palacký University, Olomouc, Czech Republic)
Sex differences in spontaneous reports on adverse drug events for antihypertensive drugs
- speaker: Diana Rydberg1,2, Stefan Mejyr1,2, Desirée Loikas2,3, Karin Schenck-Gustafsson1,2, Mia von Euler1,2, Rickard Malmström1,2 (Karolinska University Hospital, Stockholm, Sweden)
ORAL COMMUNICATIONS 3 Chairs: Tabassome Simon, Matthias Schwab Investigating real-world Clopidogrel pharmacogenetics in stroke using a bioresource linked to electronic medical records Aleksi Tornio, Robert Flynn, Steve Morant, Elena Velten, Colin N.A. Palmer, Thomas M. MacDonald, Alex S.F. Doney University of Dundee, United Kingdom Effects of carboxylesterase 1 genetic variants on its gene expression, and Clopidogrel pharmacokinetics and antiplatelet effects Mikko Neuvonen1, Katriina Tarkiainen1, Aleksi Tornio1, Päivi Hirvensalo1, Matti Itkonen1, Mikko Holmberg1, Ville Männistö3, Jussi Pihlajamäki2,3, Janne Backman1, Mikko Niemi1 University of Helsinki and Helsinki University Hospital, Finland Kuopio University Hospital, Finland University of Eastern Finland, Kuopio, Finland Pharmacogenetic algorithm for acenocoumarol dosing improve anticoagulation control: A multicenter randomized clinical trial Hoi Tong1, Alberto M. Borobia1,2, María Rodríguez Dávila1, Nuria Ruiz-Giménez3, Manuel González Viñolis1, Olga Madridano4, Ana López Parra5, Pilar Llamas Sillero6, Jesús Frías1,2, Antonio Carcas Sansuán1,2 La Paz University Hospital, IdiPAZ, Madrid, Spain School of Medicine. Autonomous University de Madrid, Spain La Princesa University Hospital, Madrid, Spain Infanta Sofía University Hospital, Madrid, Spain
Complutense University of Madrid, Spain Fundación Jiménez Díaz University Hospital, Madrid, Spain Innate immune genetic markers predict postoperative morphine consumption in an ethnicity-dependent manner Andrew Somogyi1, Daniel Barratt1, Ene-Choo Tan2, Alex Sia2 University of Adelaide, Adelaide Medical School, Australia KK Women’s and Children’s Hospital, Singapore
17:00 to 18:30 Room Meridian NEUROLOGY Chairs: Milan Grundmann, University of Ostrava, Czech Republic Marie Besson, Geneva University Hospitals, Switzerland Speakers: Neurological side effects of drugs (20 min.) Regis Bordet, University of Lille, France Epilepsy treatment introduction (20 min.) Vilem Novak, University Hospital Ostrava, Czech Republic Improving the safety of new antiepileptic agents by individualized dosing (30 min.) Anders Helldén, Karolinska Institutet, Sweden, Sweden GABAA subtypes-selective modulation: A novel mechanism-based approach to the treatment of neuropathic pain Alain Matthey1, Youssef Daali1, William Ralvenius2, Hanns Urlich Zeilhofer2,3, Jules Desmeules1, Marie Besson1 Geneva University Hospitals, Switzerland University of Zurich, Switzerland Swiss Federal Institute of Technology (ETH) Zurich, Switzerland Mortality related to benzodiazepines or other psychotropic drugs in patients with cancer Berangere Baricault1,2, Aurore Palmaro1,2, Maryse Lapeyre-Mestre1,2 Universite de Toulouse, France UMR INSERM 1027, France
17:00 to 18:30 Room Zenit e-HEALTH Chairs: Jan Strojil, Palacky University Olomouc, Czech Republic Ylva Böttiger, Linkoping University, Sweden
Digital health technologies in hospital medicines management (30 min.) Jamie Coleman, University of Birmingham, UK
Decision support systems for medicines – paths for the future (30 min.) Birgit Eiermann, Karolinska Institutet, Sweden
Dabigatran exposure and outcomes: A PK/PD/PV study David Reith, Bryan Simpson, Natalie Medlicott, Aesha Smith University of Otago, New Zealand
Do electronic prescribing systems in English hospitals support antimicrobial stewardship? An analysis of ‘start smart – then focus’ functionality Imun Madar1, Jamie Coleman1, Ann Slee2, Sarah Pontefract1 University of Birmingham, United Kingdom NHS England, London, United Kingdom
Utilisation of New Zealand primary care electronic data to guide clinical decision support system design—a retrospective cohort for Dabigatran Bryan Simpson, David Reith, Natalie Medlicott, Alesha Smith University of Otago, New Zealand
17:00 to 18:30 Room Nadir BIOMARKERS AND PRECISION MEDICINE Chairs: Jitka Patockova, Medical and Radiology Clinic Prague, Czech Republic Matthias Schwab, Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Germany
6월 26일 주요 내용 월요일
ORAL COMMUNICATIONS 4 Chairs: Donald Singer, Marie Besson Medicines communications using digital media: Findings from a survey of member organisations of the European medicines agency’s patients and consumers and health professionals working parties (PCWP and HCPWP) Donald Singer1, Ivana Silva2, Maria Mavris2 EACPT EMA London, UK Investigator initiated clinical trials: Portuguese case Emília Monteiro, Catarina Madeira Portuguese Clinical Research Infrastructure Network (PtCRIN), Portugal European Clinical Research Infrastructure Network (ECRIN), Portugal Nova Medical School, Portugal Over exposure to Efavirenz plasma concentrations among Beninese HIV patients treated by a 600 mg daily dose Aurel Constant Allabi1, Mikal Kiki1, Marcel Zannou1, Jean-Claude Alvarez2 Université D’Abomey-Calavi/ FSS/Unité de Pharmacologie, Benin Fac de Médecine PIFO, INSERM U-1173 CHU Garches, AP-HP, Benin Does patient health empowerment go hand in hand with privacy empowerment? Leticia Pereira, David García, Silvia Fernández, Neus Riba, María Jesús Bertran Hospital Clínic of Barcelona, Spain Public knowledge, beliefs, and behavior regarding the use of antibiotics in Serbia Olga Horvat, Tinde Halgato, Ana Tomas, Milica Paut, Zdenko Tomić, Ana Sabo University of Novi Sad, Serbia Low dose vs. standard dose adjuvant olanzapine in chemotherapy induced nausea and vomiting: A prospective, randomized, double blinded, controlled study Sandip Mukhopadhyay, Premnath Dutta, Biswamit Bhattacharya, Sanatan Banerjee, Supreeti Biswas, Basabdatta Samanta-Mukhopadhyay Burdwan Medical College, India 8:00 to 9:00 Room Nadir HOW TO SESSION How to review a paper 9:00 to 10:30 Room Meridian ONCOLOGY Chairs: Monday 26 June Regina Demlova, Masaryk University, Czech Republic Caroline Samer, Geneva University Hospitals, Switzerland Speakers: Immunotherapy of cancer (20 min.) Ana Arance, Hospital Clinic Barcelona, Spain Are the host-dependent variables the forgotten key to personalised medicine? (20 min.) Regina Demlova, Masaryk University, Czech Republic Benefits and challenges of fast-track drug approval in oncology (20 min.) Curt Peterson, Linköping University, Sweden Computational Horizons in Cancer (CHIC) (20 min.) Georgios Stamatakos, National Technical University of Athens, Greece (on behalf of the CHIC consortium) 9:00 to 10:30 Room Zenit SYMPOSIUM OF SFPT The Rennes disaster: Lessons to be drawn Chairs: Francesco Salvo, University Hospital Bordeaux, France Gonzalo Calvo, EACPT, Spain Speakers: The Rennes disaster – Lessons to learn (35 min.) Bernard Bégaud, French Drug Agency, France The measures of French regulatory agency for clinical trials conduction after the Rennes disaster (15 min.) Anne Gimbert, REVIES, France Practical implication of the last EMA regulation for clinical trials (20 min.) Gonzalo Calvo, EACPT, Spain Is there a need for independent investigation of accidents in human clinical research? (20 min.) Brian Edwards, ISoP, UK 9:00 to 10:30 Room Nadir GLOBAL HEALTH Access to medicines (ensuring the supply chain for access to safe and effective medicines) Chairs: Jozef Glasa, Slovak Medical University in Bratislava, Slovakia Donald Singer, EACPT, UK Speakers: Monday 26 June Securing the supply chain of medicines: Whose responsibility? (20 min.) Mike Isles, EAASM, UK Challenges and solutions for policy makers for access to medicines (20 min.) Jozef Glasa, Slovak Medical University in Bratislava, Slovakia Fight against falsified medicines: Serbia’s example and coordinated actions at EDQM level through the Medicrime Convention (20 min.) Pavle Zelic, Medicines and Medical Devices Agency, Serbia Discussion Panel Jozef Glasa, Donald Singer, Mike Isles, Pavle Zelic, June Raine 10:30 to 11:00 Exhibition Area COFFEE BREAK 11:00 to 12:30 Room Meridian PHARMACOGENOMICS AND EPIGENOMICS Joint session with IUPHAR Chairs: Guilherme Suarez-Kurtz, Cancer Treatment Center Rio de Janeiro, Brazil Ingolf Cascorbi, University of Kiel, Germany Speakers: Genetic and epigenetic mechanisms of TKI resistance (25 min.) Ingolf Cascorbi, University of Kiel, Germany Pharmacogenomics of colorectal cancer: From discovery to clinical implementation and back (25 min.) Erika Cecchin, National Cancer Institute Aviano, Italy ADME gene regulation through miRNA – role of inflammation (25 min.) Ulrich Zanger, IKP Stuttgart, Germany Pharmacogenetics of chemotherapy response in osteosarcoma: A genetic variant in SLC7A8 is associated with progressive disease Marieke Coenen1, Hanneke Vos1, Johanne Groothuismink1, Hans Gelderblom2, Henk-Jan Guchelaar2, Maroeska te Loo1, Genetics of Osteosarcoma consortium3 Radboud University Medical Center, The Netherlands Leiden University Medical Center, The Netherlands W.T.A. van der Graaf, U. Flucke, H.W.B. Schreuder, M.M. Hagleitner, T. van der Straaten, E.S.J.M. de Bont, L.C.M. Kremer, J. Bras, H. Caron, R. Windsor, J. Whelan, A. Patiño-García, A. González-Neira, G. McCowage, S. Nagabushan, D. Catchpoole, F.N. van Leeuwen 11:00 to 12:30 Room Zenit
EACPT MEETS THE ASIAN SOCIETIES Joint session with KSCPT
- Chairs: Tabassome Simon, EACPT, France Jae Gook Shin, KSCPT, Rep. of Korea
Education and training of clinical pharmacology in Korea (20 min.) Kyun-Seop Bae, Asan Medical Center, Univ. of Ulsan, Rep. of Korea
Biologic treatment of rheumatoid arthritis treatment, current status and future perspectives (20 min.) Karel Pavelka, Institute of Rheumatology Prague, Czech Republic
Pharmacometrics in academia: Role for clinical researches and dissemination to industry in Korea (20 min.) Dong-Seok Yim, The Catholic University of Korea, Rep. of Korea
Biological therapy for high-prevalence diseases (20 min.) Caridad Pontes, Autonomous University of Barcelona, Spain
11:00 to 12:30 Room Nadir ANTI-INFECTIVES Chairs: Karel Urbanek, Palacky University Olomouc, Czech Republic Gerard Rongen, Radboud University Medical Center, The Netherlands Speakers: Advances and challenges in vaccine therapy (30 min.) Ronald de Groot, Radboud University Medical Center, The Netherlands Antibiotic utilization and bacterial resistance (30 min.) Milan Kolar, Palacky University Olomouc, Czech Republic Effectiveness of nurse-driven HIV screening targeting key populations in emergency departments in metropolitan Paris: The ANRS DICI-VIH cluster-randomized two-period crossover trial Judith Leblanc1, Carole Jegou2, Nadia Fossoux3, Cécile Lancien4, Théophile Bastide5, Rachel Verbrugghe6, Cécile Jauneau7, Hélène Piquet8, Anne-Claude Crémieux9, Tabassome Simon10 Groupe Hospitalier des Hôpitaux Universitaires Est Parisien/ Université Paris Saclay-Université Versailles St Quentin, Garches, France Hôpital Avicenne, Bobigny, France Hôpital Bicêtre, Le Kremlin-Bicêtre, France Centre Hospitalier de Saint Denis, Hôpital Delafontaine, Saint Denis, France Hôpital Lariboisière, Paris, France Hôpital Tenon, Paris, France Centre Hospitalier de Gonesse, Gonesse, France Hôpital Saint Antoine, Paris, France Hôpital Saint Louis, Paris/ Université Versailles St Quentin, Garches, France Groupe Hospitalier des Hôpitaux Universitaires Est Parisien / Sorbonne Universités, UPMC Univ Paris 06, France Monday 26 June Outpatient antibiotic prescriptions with high risk of bacterial resistance in France: A national healthcare insurance database analysis Marie-Céline Casaurancq, Manuela Rueter, Bérangère Baricault, Emilie Patras de Campaigno, Mélanie Araujo, Maryse Lapeyre-Mestre, Agnès Sommet University Hospital, University Toulouse 3, France Target-site pharmacokinetics of the echinocandin antifungal anidulafungin in ascites and pleural effusion during critical illness René Welte1, Ingo Lorenz1, Philipp Eller2, Michael Joannidis1, Romuald Bellmann1 Medical University of Innsbruck, Austria Medical University of Graz, Austria 12:30 to 14:00 Poster Area LUNCH (Exhibition Area) – GUIDED POSTER SESSION 3 14:00 to 15:30 Room Meridian CARDIOVASCULAR Chairs: Otto Mayer, Charles University, Czech Republic Tabassome Simon, EACPT, France Speakers:
Impact of recent advances in management of dyslipidemia on cardiovascular morbidity and mortality
speaker: Tomas Stulc, Charles University, Czech Republic
Lowering LDL-C - primary intervention to reduce CV risk
Greater LDL-C reduction, the greater decrease of the risk
ezetimibe - moderate LDL-reduction, modest reduction of CV risk in post-MI patients, profit limited to patients with diabetes
PCSK9 inhibitors - reduce LDL-C by 50%, moderate reduction of CV risk
Antidiabetic treatment of T2DM and cardiovascular risk (30 min.) Hana Rosolova, Charles University, Czech Republic
Causes of death in anticoagulated patients with venous thromboembolism
- Antonio Gómez-Outes1, Ana-Isabel Terleira-Fernández2, Ramón Lecumberri3, Gonzalo Calvo-Rojas4, Mª.Luisa Suárez-Gea1, Emilio Vargas-Castrillón2
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, Spain Hospital Clínico San Carlos and Universidad Complutense, Madrid, Spain Clínica Universidad de Navarra, Pamplona, Spain Hospital Clinic, Barcelona, Spain
On demand sildenafil as a treatment of Raynaud’s phenomenon: A series of N-of-1 trials
- Matthieu Roustit1,2,3, Joris Giai4,5,6, Olivier Gaget3, Myriam Mouhib3, Adrien Lotito3, Charles Khouri3, Sophie Blaise2,3, Christophe Seinturier3, Sunita Vohra7, Jean-Luc Cracowski1,2,3
Univ. Grenoble-Alpes, France Inserm, HP2 UMR 1042, Grenoble, France CHU Grenoble-Alpes, France Université de Lyon, France CNRS, UMR5558, Villeurbanne, France
Hospices Civils de Lyon, France University of Alberta, Edmonton, Canada Modelling of outcome postponement for cardiovascular outcomes in statin trials Morten Rix Hansen1, Anton Pottegård1, Asbjørn Hróbjartsson2,3, Per Damkier1,5, René dePont Christensen1, Jesper Hallas1,2 Clinical Pharmacology And Pharmacy University of Southern Denmark, Odense, Denmark Odense University Hospital, Denmark Center for Evidence-Based Medicine University of Southern Denmark, Denmark Research unit for general practice, Denmark Department of Clinical Research, University of Southern Denmark, Denmark 14:00 to 15:30 Room Zenit BIG DATA BPS block Chair: Munir Pirmohamed, University of Liverpool, UK Speakers: Big Data in pharmacoepidemiology (30 min.) Patricia McGettigan, QMUL London, UK Can we use social media for pharmacovigilance (30 min.) Simon Maskell, University of Liverpool, UK Use of genomics for drug discovery (15 min.) Matt Nelson, University of North Carolina, USA Combining genomics and electronic health records data for disease development and drug response (15 min.) Mads Melbye, University of Copenhagen, Denmark 14:00 to 15:30 Room Nadir PHARMACOECONOMICS Chairs: Tomas Dolezal, Institute of Health Economics and Technology Assessment Prague, Czech Republic Dinko Vitezic, University of Rijeka Medical School, Croatia Speakers: Opportunities and constraints to harmonize pharmacoeconomic methods across European countries (20 min.) Zoltan Kalo, Eötvös Loránd University, Hungary HTA trends in middle and low income countries – example of CEE region (20 min.) Monday 26 June Tomas Dolezal, Institute of Health Economics and Technology Assessment Prague, Czech Republic
Cost-effectiveness of genotype-guided warfarin dosing in the patients with mechanical heart valve replacement under fee-for-service system Dong-Jin Kim1, Ho-Sook Kim1, Minkyoung Oh1, Eun-Young Kim1,2, Jae-Gook Shin1,2 University College of Medicine, Busan, South Korea University Busan Paik Hospital, Busan, South Korea
PLENARY DEBATE: It is difficult to successfully communicate the risk to benefit ratio of medicines to the patient
Chairs: Caridad Pontes, Tabassome Simon Speakers: Pro: Rosa González-Quevedo, EMA London, UK Con: Mikael Hoffmann, The Swedish Society of Medicine, Sweden 17:00 to 18:30 Room Nadir SYMPOSIUM
Therapeutic Drug Monitoring - MS-based approaches at the University Hospital of Vienna
- speaker: Thomas Stimpfl, Medical University - General Hospital of Vienna, Austria
- TDM, LIMS-integration, Immunosuppressants - Cyclosporin A, Everolimus, Sirolimus, Tacrolimus
- LIMS (Lab info management system)
- LC-MS (mainly) - non-LC-MS (some)
- MS-based approach in TDM - expand analytes with random access
- MS-based clinical research - GLP certification
- EMA - guideline - lloq, calibration, accurary, precision …
이번 학회는 16번째로 열리는 IASP (International Association for the Study of Pain)의 meeting으로 전 세계에서 통증 전문가들이 모여 통증에 대한 전반적인 주제를 다루었다. 5일간 진행된 학회에서는 1,700개 이상의 포스터가 소개되었으며 다양한 주제에 대한 통증 전문가들의 강의가 진행되었다. 하루에 20개 남짓의 강의가 이루어졌지만 동시간에 진행이 되었기 때문에 하루에 약 2개 정도의 workshop에 참여할 수 있는 구조였다. 그 외 plenary session도 매일 오전, 오후 각 1번씩 참가할 수 있었다.
여러 강연에서 다양한 동물 모델을 이용하여 통증을 재현하고 연구하는 실험에 대한 소개가 많았다는 점이 인상적이었다. 또한 포스터 세션 동안에는 세계 각국에서 온 발표자들과 아주 가까운 거리에서 궁금한 점에 대해 토의를 할 수 있었다. 통증에 관한 연구가 무척 다양한 방면에서 이루어지고 있다는 점이 놀라웠으며 통증을 하나의 감각 자극으로만 받아들이던 과거에 비해 통증을 개개인 마다 가지는 유일무이한 경험으로 정의하며 총체적인 실체로서의 통증에 대한 이해를 가지고자 하는 것이 통증 관련 연구의 큰 흐름임을 느낄 수 있었다. 그러나 방대한 연구양에 비해 임상적으로 효율적인 통증 조절법 개발은 요원함을 느끼기도 한 자리였다. 한편 2년 후로 계획되어 있는 17번째 WCP가 벌써부터 기대가 되기 시작하였다.
젊은 임상약리학자들 간의 소통과 교류가 활성화되길 바라며 모든 참가자에게 2018년 말까지 EACPT 멤버십을 발행하였다.
WELCOME SESSION AND OPENING CEREMONY
- Chairs: Milan Grundmann (Czech Republic), Tabassome Simon (France), Ylva Böttiger (Sweden)
- Introduction of EACPT and welcome to first-time attendees
- Evolution of the EACPT over the last years
- Challenges and opportunities for EACPT and Clinical Pharmacology
- Welcome talks from chair of the congress
The U-PGx Project: Implementation of pharmacogenomics in Europe (30 min.) Henk-Jan Guchelaar, Leiden University Medical Center, The Netherlands
Predictive markers for prognosis and drug therapy in renal cancer (30 min.) Matthias Schwab, Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Germany Drug transporter variants as predictors of cancer chemotherapy-induced toxicity (30 min.) Donald Singer, EACPT, UK
18:30 to 19:30 Room Nadir EACPT ASSEMBLY
9:00 to 10:30 Room Meridian Rational use of drugs in Europe - what can we learn from cross-national comparisons of drug utilization A symposium dedicated to the late Ludvík Štika Joint session with EuroDURG Chairs: Robert Vander Stichele, EuroDURG, University of Gent, Belgium Jiri Vlcek, Charles University, Czech Republic Speakers: A tribute to a pioneer in Drug Utilization Research: Ludvik Stika (10 min.) Ulf Bergman, Karolinska Institute, Sweden Drug consumption of antibiotics and anticoagulant agents from ecological and longitudinal perspectives – recent possibilities and role of drug consumption studies in the Czech Republic (25 min.) Jiri Vlcek, Charles University, Czech Republic Jana Mlada, SUKL, Czech Republic Lessons from CNC for the appraisal of access to medicines, prescribing, and pharmaceutical policies (25 min.) Robert Vander Stichele, University of Gent, Belgium Five-year antimicrobial susceptibility trends among bacterial isolates from King Faisal Hospital tertiary health-care facility in Kigali, Rwanda Donald RJ Singer1, Makeda Carroll2, Ashok Rangaiahagari3, Emmanuel Musabeyezu4, Onyema Ogbuagu5 Fellowship of Postgraduate Medicine, London, UK Department of Public Health, Philadelphia, Pennsylvania, USA SMBT Institute of Medical Science and Research Center, Nashik, India King Faisal Hospital, Kigali, Rwanda Yale University School of Medicine, New Haven, Connecticut, USA
10:30 to 10:45 Exhibition Area COFFEE BREAK
10:45 to 12:00 Room Meridian EACPT scientific award and joint EACPT- EPHAR awards Lifetime educator and young educator awards Presentation of winners of EPHAR/EACPT young translational investigation award CLOSING CEREMONY Chairs: Tabassome Simon, Ylva Böttiger
ORAL COMMUNICATIONS 1
Chairs: Jan Strojil, Caroline Samer Gene expression of anaesthetic and analgesic drug receptors is associated with clinical metastatic spread in breast cancer Cara Connolly1,2, Stephen Madden3, Donal Buggy1,2,4, Helen Gallagher1,2 University College Dublin, Ireland Mater Misericordiae University Hospital, Dublin, Ireland Royal College of Surgeons in Ireland, Dublin, Ireland Cleveland Clinic, Ohio, USA Evolution of dihydropyrimidine dehydrogenase (DPD) diagnostics in a single center in a time-period of seven years Bianca Van Den Bosch1, Aimée Paulussen1, Marc Breuer1, Martijn Lindhout1, Demis Tserpelis1, Anja Steyls1, Jörgen Bierau1, Marieke Coenen2 Maastricht University Medical Center+, Maastricht, The Netherlands Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands Relationship between infliximab serum concentrations and risk of infections in patients treated for spondyloarthritis Theodora Bejan-Angoulvant1,2, David Ternant1,2, Fadela Daoued1,2, Frédéric Médina1,2, Louis Bernard2, Saloua Mammou2, Gilles Paintaud1,2, Denis Mulleman1,2 Université François-Rabelais, Tours, France CHRU de Tours, Tours, France The pharmacodynamic effects of Rituximab at very low doses Christian Schoergenhofer1, Christa Firbas1, Ulla Derhaschnig1, Robert Mader1, Raute Sunder-Plaßmann1, Petra Jilma-Stohlawetz1, Kalpna Desai2, Priya Misra2, Ulrich Jäger1, Bernd Jilma1 Medical University of Vienna, Austria Apotex Inc., Toronto, Canada Safety and efficacy of the C1S complement inhibitor TNT009 in a first-in-human trial Johann Bartko1, Ulla Derhaschnig1, Jim Gilbert2, Sandip Panicker2, Shirley D’Sa3, Ulrich Jäger1, Bernd Jilma1 Medical University of Vienna, Austria TrueNorth Therapeutics Inc., South San Francisco, USA University London College Hospitals, United Kingdom 8:00 to 9:00 Room Nadir HOW TO SESSION
9:00 to 10:30 Room Zenit EDUCATION Chairs: Jan Strojil, Palacky University Olomouc, Czech Republic Simon Maxwell, University of Edinburgh, UK Speakers: Preparing to prescribe (30 min.) Tim Dornan, Queen’s University Belfast, UK EACPT study on assessment and curricula (20 min.) David Brinkman, VU University Medical Center, The Netherlands Academic detailing in Norway – caring for GPs where they are Roar Dyrkorn, Harald Langaas Dept. For Clinical Pharmacology, RELIS, Norway Learning by donning in the student-run pharmacovigilance programme Tim Schutte1,2, Jelle Tichelaar1,2, Michael Reumerman1,2, Rike van Eekeren3,4, Lean Rolfes3,4, Eugene van Puijenbroek3,4, Milan Richir1,2, Michiel van Agtmael1,2 Sunday 25 June VU University Medical Center, Amsterdam, The Netherlands RECIPE, Amsterdam, the Netherlands The Netherlands Pharmacovigilance Centre Lareb (Lareb),‘s Hertogenbosch, the Netherlands University of Groningen, The Netherlands Psychological insuline resistance. Descriptive observational study in 123 patients with Type 2 diabetes mellitus not taking insulin in Paris area, France Stephane Mouly, Jean-Francois Bergmann, Pierre-Jean Guillausseau AP-HP-Hopital Lariboisière-University of Paris Diderot, France A multifaceted intervention to improve guideline adherence among prescribing physicians at surgical wards Jacqueline Bos1, Stephanie Natsch2, Patricia van den Bemt3, Hans Pot4, Elsbeth Nagtegaal4, Andre Wieringa5, Gert Jan van der Wilt2, Peter de Smet2, Cornelis Kramers1,2 Canisius Wilhelmina Hospital, Nijmegen, The Netherlands Radboud University Medical Center, Nijmegen, The Netherlands Erasmus University Medical Center, Rotterdam, The Netherlands Meander Medical Centre, Amersfoort, The Netherlands Isala Hospital, Zwolle, The Netherlands 9:00 to 10:30 Room Nadir REGULATORY Chairs: Regina Demlova, Masaryk Univerzity, Czech Republic Caridad Pontes, Autonomous University of Barcelona, Spain Speakers: Integration of pharmacogenomics from regulatory perspective (30 min.) Ondrej Slanar, Charles University, Czech Republic Actual value of subgroups analyses to support regulatory applications (30 min.) Julia Carolin Stingl, University of Bonn, Germany Comparative analysis of regulatory systems for expanded access to investigational drugs in three countries: The Netherlands, Turkey and the United States of America Nikkie Aarts, Eline M. Bunnik, Suzanne van de Vathorst Erasmus MC - University Rotterdam, The Netherlands Clinical pharmacology and implementation of the EU clinical trials regulation in Slovakia. Roles and responsibilities taken Jozef Glasa, Helena Glasova Slovak Medical University in Bratislava, Slovakia Slovak Society of Clinical Pharmacology, Slovakia Sunday 25 June Variability of clinical chemistry parameters in healthy volunteers and overview of Bayer in-house Phase I trials from 2000-2013 Georg Wensing, Michael Böttcher Bayer AG, Germany
11:00 to 12:30 Room Meridian EPHAR/EACPT SESSION New therapeutic approaches, from bench to bedside Chairs: Gerard Rongen, Radboud University Medical Center, The Netherlands Thomas Griesbacher, Medical University of Graz, Austria Speakers: The first molecule interacting with a host protein for the inhibition of multiple viruses (20 min.) Maurizio Botta, University of Siena, Italy Gene therapy for heart failure (20 min.) Jean-Sebastien Hulot, ICAN Paris, France The challenges of cell therapy control for safe, EU-approved Advanced Therapy Medicinal Products (20 min.) Graziella Pellegrini, University of Modena and Reggio Emilia, Italy TDM as a tool for novel targeted anticancer therapy (20 min.) Thierry Buclin, University Hospital Center of the Canton de Vaud, Switzerland Investigation of signalling pathways underlying hypoxic stress in IPS-derived, beating human cardiomyocytes Aisling Williams1, Katie O’Sullivan2,3, Cathal Tobin-O’Brien1, Lauren MacDonagh1, Eamon Breen1, Donal Buggy1,2,3,4, John Hurley3, Helen Gallagher1,3 University College Dublin, Ireland Mater Private Hospital, Dublin, Ireland Mater Misericordiae University Hospital, Dublin, Ireland Cleveland Clinic, Ohio, USA 11:00 to 12:30 Room Zenit EDUCATION BPS block Chair: Simon Maxwell, University of Edinburgh, UK Speakers: Prescribing safety assessment: Ensuring that new graduates are competent to prescribe and supervise the use of medicines in modern healthcare (20 min.) Simon Maxwell, University of Edinburgh, UK Sunday 25 June Swiss assessment for clinical pharmacology specialists (20 min.) Caroline Samer, Geneva University Hospitals, Switzerland Teaching Resource Centre: A leading resource for students learning about the clinical pharmacology of commonly used drugs (20 min.) Robert Rissmann, Leiden University, Netherlands Developing a training environment to introduce students to the use of Electronic Patient Records and ePrescribing (30 min.) Sarah Pontefract, University of Birmingham, UK Kurt Wilson, University of Manchester Medical School, UK 11:00 to 12:30 Room Nadir PHARMACOVIGILANCE Chairs: Karel Urbanek, Palacky University Olomouc, Czech Republic Gonzalo Calvo, EACPT, Spain Speakers: Risk minimisation measures: A critical review of their effectiveness (30 min.) Dolores Montero, Spanish Medicines Agency, Spain Adverse drug reactions in the elderly (15 min.) Martin Wawruch, Comenius University Bratislava, Slovakia Adverse drug reactions in children (15 min.) Petra Matalova, Palacky University Olomouc, Czech Republic Safety profile of intravitreal anti-VEGF drugs: An analysis of the Italian spontaneous reporting system Paola Maria Cutroneo1, Claudia Giardina1, Valentina Ientile1, Simona Potenza2, Laura Sottosanti2, Carmen Ferrajolo3, Costantino Trombetta1, Gianluca Trifirò1 University of Messina, Italy Italian Medicines Agency, Rome, Italy University of Campania, Naples, Italy Opinions of national competent authorities regarding patient reporting of adverse drug reactions Cristiano Matos1, Linda Härmark2, Florence van Hunsel2 University of Seville, Spain Netherlands Pharmacovigilance Centre Lareb,’s-Hertogenbosch, The Netherlands Admission to emergency room during direct oral anticoagulation therapy: Observational study from 2012 to 2016 in French hospital Johana Béné1, Alain-Eric Dubart2, Catherine Senis2, Régis Bordet1, Sophie Gautier1 CHU Lille, Univ.Lille 2, Inserm, Centre Régional de Pharmacovigilance du Nord- Lille, France Sunday 25 June Centre Hospitalier de Béthune, France 12:30 to 14:00 Poster Area LUNCH (Exhibition Area) – GUIDED POSTER SESSION 2 14:00 to 15:30
Room Meridian PSYCHIATRY Chairs: Milan Grundmann, University of Ostrava, Czech Republic Edoardo Spina, University of Messina, Italy Speakers: Novel treatment options in depression and psychosis (30 min.) Eva Ceskova, Masaryk University, Czech Republic Personalized pharmacotherapy in psychiatry (30 min.) Christoph Hiemke, University Mainz, Germany Cannabis exposure in young children: Increasing rate of hospitalisation in France in the recent years Maryse Lapeyre-Mestre1,2,3, Emilie Chauvin1, Emilie Jouanjus1,2,3, Vanessa Pauly4, Margaux Laforie1, Anne Roussin1,2,3 Centre Hospitalier Universitaire de Toulouse, France Université de Toulouse, France UMR Inserm 1027, France Assistance Publique des Hopitaux de Marseille, France Pharmacodynamic and pharmacokinetic interaction between alcohol and energy drinks Clara Pérez-Mañá1,2, Julian Mateus1,2, Patricia Díaz1, Adriana Baggerman3, Esther Menoyo1, Marta Pérez1, Soraya Martín1, Mitona Pujadas1, Francina Fonseca1,4, Rafael de la Torre1,5 IMIM-Hospital Del Mar Medical Research Institute, Barcelona, Spain Universitat Autònoma de Barcelona-UAB, Spain Universitat de Barcelona-UB, Spain Institut de Neuropsiquiatria i Addiccions (INAD), Barcelona, Spain Universitat Pompeu Fabra-UPF, Barcelona, Spain Insight gained from genome-wide interaction and enrichment analysis on weight gain during citalopram treatment Henrik Corfitsen1,2, Antonio Drago2 Aarhus University, Denmark Psychiatric Research Unit, Herning, Denmark 14:00 to 15:30 Room Zenit SPECIAL POPULATIONS Chairs: Ivana Kacirova, University of Ostrava, Czech Republic Gerard Rongen, Radboud University Medical Center, The Netherlands Speakers: Sunday 25 June Risk of malformations with antiepileptic drugs (20 min.) Dina Battino, IRCCS Milan, Italy Importance of TDM during pregnancy and breastfeeding (20 min.) Ivana Kacirova, University of Ostrava, Czech Republic Pharmacotherapeutic consequences of (morbid) obesity (20 min.) Catherijne Knibbe, St. Antonius Hospital Nieuwegein, The Netherlands Teratogenic risk of macrolides during the first trimester of pregnancy: A study with two complementary approaches within the EFEMERIS database Thuc Lê Nguyen, Mélanie Araujo, Caroline Hurault-Delarue, Isabelle Lacroix, Christine Damase-Michel, Agnès Sommet UMR 1027, University Hospital, University Toulouse 3, France Risk of major congenital malformations after first trimester exposure to topical azoles Reut Rotem1, Boris Fishman1, Gidi Koren1,2, Sharon Daniel1,3, Eitan Lunenfeld3, Amalia Levy1 Ben-Gurion University of The Negev, Israel MAccabi Health Services, Israel Soroka Medical Center, Beer-Sheva, Israel Once-daily aminoglycosides dosing regimen in paediatric cystic fibrosis (CF) patients: A single centre outcomes evaluation Hundie Tesfaye, Blanka Jedlickova, Richard Prusa, Jana Bartosova, Veronika Skalicka, Vendula Martinù, Vaclav Koucky, Tereza Dousova University Hospital in Motol, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic 14:00 to 15:30 Room Nadir
17:00 to 18:30 Room Zenit ORAL COMMUNICATIONS 5 Chairs: Milan Grundmann, Edoardo Spina Effect of ABCB1 inhibition at the blood-brain barrier on brain distribution of the ABCB1 substrate ®-[11C]verapamil in elderly versus young subjects Martin Bauer1, Rudolf Karch1, Beatrix Wulkersdorfer1, Wolfgang Wadsak1, Marcus Hacker1, Markus Zeitlinger1, Oliver Langer1,2 Medical University of Vienna, Austria AIT Austrian Institute of Technology GmbH, Austria Bioequivalence studies of highly variable drugs - an example of Itraconazole Viktorija Dragojevic-Simic1, Aleksandra Kovacevic1, Nemanja Rancic1, Vesna Jacevic1, Snezana Djordjevic1, Vesna Kilibarda1, Zoran Segrt1, Momir Mikov2 Military Medical Academy, Belgrade, Serbia Institute for Pharmacology, Clinical Pharmacology and Toxicology, Medical Faculty, Novi Sad, Serbia Posaconazole tablets versus posaconazole oral suspension in lung transplant patients: Which consequences on immunosuppressive therapy? Elodie Gautier-Veyret1,2,3, Sebastien Chanoine1,3, Hélène Pluchart1,3, Julia Tonini3, Xavier Fonrose3, Christophe Pison1,3, Pierrick Bedouch1,3, Françoise Stanke-Labesque1,2,3 Monday 26 June Univ. Grenoble Alpes, HP2, Grenoble, France INSERM U1042, Grenoble, France Centre Hospitalier Universitaire des Alpes, Grenoble, France Population pharmacodynamic analysis of effect of three increasing doses of fludrocortisone on phenylephrine-mean arterial pressure dose-response relationship in healthy volunteers Karima Hammas1,2, Noureddine Hamitouche1, Clément Palpacuer1,2, Fabrice Lainé1, Eric Bellissant1,2, Bruno Laviolle1,2 Inserm, CIC 1414 Clinical Investigation Centre, Rennes, France Rennes University Hospital, Clinical Pharmacology, Rennes, France Results of the population PK modelling of rtxmb83, a rituximab biosimilar candidate in patients with diffuse large B-cell lymphoma (DLBCL) Myrna Candelari1, Derlis Gonzalez2, Marcia Torresan3, Daniel Bar4, Amalia Florez5, Alexandra Paravisini5, Francisco Fernandez5, Susana Millan5 Instituto Nacional de Cancerología, Tlalpan, Sección XVI, Mexico DF, México Instituto Privado de Hematología E Investigación Clínica (IPHIC), Asunción, Paraguay Hemocentro da Universidade Estadual de Campinas/ UNICAMP, Campinas, São Paulo, Brazil Hospital Iturraspe, Santa Fe, Argentina Mabxience Evidenced based drug-drug interaction alerts in an e-prescribing system Matthew Doogue1,2, Amanda Crawford1, Hayleigh Miller1, Philip Drennan2, QianYi Chuah2, Matthew Strother1,2, Paul Chin1,2 University of Otago, Christhcuch, New Zealand Canterbury District Health Board, New Zealand Is pharmacogenetics of antidepressant-related metabolic genes applicable to clinical reality of recurrent depression? Diana Pendicheva1, Reni Tzveova2,3, Radka Kaneva2,3, Ivo Duhlenski4 Medical University-Pleven, Bulgaria Molecular Medicine Center, Sofia, Bulgaria Medical University-Sofia, Bulgaria Diagnostic Consultation Center II, Pleven, Bulgaria