Program

 

Day 1 

 
 13:00 PMRegistration and Welcome Coffee 
 14:00 PMOpening 
 Session 1:  Preparation for Transplantation 
 14:05 PMImmunology in Transplantations
Arjan Lankester
Leiden University, the Netherlands
 
 14:45 PMPre-Transplant Assessment of Infectious Diseases
Mary Slatter
The Newcastle upon Tyne Hospitals, United Kingdom
 
 15:10 PMUpdate on Donor-Related Infections
Michael Green
University of Pittsburgh, United States
 
 15: 35 PMImmunization in a Pre-Transplant Population
Klara Posfay-Barbe
University of Geneva, Switzerland
 
 16:00 PMDiscussion 
    
 16:15 PMCoffee Break 
    
 Session 2: Bacterial Infections in Pediatric Transplant
 
 16:45 PM

Antimicrobial Prophylactic Strategies Before and After Solid Organ Transplantation
Marian Michaels
Children's Hospital of Pittsburgh, United States

 
 17:05 PMManaging Emerging Multidrug Resistant Organisms in Transplant Patients
Anita Verma
King College Hospital, United Kingdom
 
 17:25 PMPrevention of Healthcare-Associated Infections in Transplant Patients: What You Should Know
Joshua Schaffzin
Cincinnati Children's Hospital, United States
 
 17:45 PMThe Real Life Situation: Clinical Case Presentation
Anita Verma
King College Hospital, United Kingdom

Rossitsa Rousseva
King College Hospital, United Kingdom

 
    
 18:15 PMWelcome Reception  
    
 19:00 PM

Workshop Dinner

 
    
 

Day 2 

 
 Session 3: Viral Infections in Pediatric Transplant
 
 08:30 AMEBV in Pediatric SOT
Upton Allen
SickKids Hospital, Canada
 
 08:55 AMCMV in Pediatric SOT: How the TTS Guidelines Apply to Children
Lara Danziger-Isakov
Cincinnati Children's Hospital, United States
 
 09:20 AMAdenovirus in Pediatric Stem Cell Transplant Recipients
Caroline Lindemans
Princess Maxima Center & UMC Utrecht, the Netherlands
 
 09:45 AMChallenging Cases in Respiratory Viruses in Pediatric Stem Cell Transplant Recipients
Janet Englund
Seattle Children's Hospital, United States
 
 10:10 AMDiscussion 
    
 10:20 AMCoffee Break 
    
 Session 4:  Fungal Infections in Pediatric Transplant
 
 10:50 AMEpidemiology and Risk Factors: Who is the Patient at Risk?
Adilia Warris
University of Exeter, United Kingdom
 
 11:15 AMFungal Diagnostics: How to Spot the Fungus
Paul Verweij
Radboud University, the Netherlands
 
 11:40 AMTreatment and Prophylaxis: How to Get Rid of the Fungus
Theo Zaoutis
Children's Hospital of Philadelphia, United States
 
 12:05 PMClinical Case
Arnaud L'Huillier
University of Geneva, Switzerland
 
 12:30 PMDiscussion 
    
 12:40 PMLunch 
    
 Session 5: Prophylaxis and Treatment Options in Development
 
 13:40 PMVarious Industries will be invited to present on their pipeline developments 
 14:30 PMRound Table Discussion: What Does the Field Need for Prevention and Treatment of ID Infections in Transplant Patients 
 15:00 PMClosing Remarks 
    
 15:10 PMEnd of the Meeting 

 

Program

The program of ICPAD 2019 will consist of state of the art lectures, oral abstract presentations and poster viewing sessions. Ample time will be allocated for discussions.

* The below agenda is subject to change.


 

Day 1 - Thursday, 21 November 2019

 
 08:00Registration and welcome coffee 
 Session 1: Redesigning studies and endpoints with immuno oncology
Chairs: Howard Gurney & Nielka van Erp
 
 08:30

Ruth Plummer, MDChanges and challenges in early phase trial endpoints
Ruth Plummer
Newcastle University, UK

 
 

09:00

Calvo, Emiliano 2019 120x160New designs for early clinical trials of IO drugs
Emiliano Calvo
START Madrid, Centro Integral Oncológico Clara Campal, Hospital Madrid Norte Sanchinarro, Madrid, Spain
 
  Abstract-driven presentations 
 09:30

Prediction of Capecitabine induced Severe Toxicity using Machine Learning Techniques (#01)
Maël Steunou, France

 
 09:45Long term pemetrexed-based cancer treatment leads to nephrotoxicity (#02)
Nikki De Rouw, the Netherlands
 
 10:00Discussion & session evaluation 
    
 10:30Coffee Break 
    
 Session 2: Imaging, genetics and environment
Chairs: Nielka van Erp & Stijn Koolen
 
 11:00Jorritsma-Smit, Annelies 2019 120x160The use of radiolabeled and fluorescent monoclonal antibodies for molecular imaging in oncology
Annelies Jorritsma-Smit
University Medical Center Groningen, The Netherlands
 
 11:30Schalken, Jack 2019 120x160The long and winding road of the clinical introduction of a biomarker
Jack Schalken
Radboud University Medical Centre, The Netherlands
 
  Abstract-driven presentations
 
 12:00

Epigenetic Regulation of OCTN1-mediated Cytarabine Transport in Acute Myeloid Leukemia (#03)
Jason Anderson, USA

 
 12:15Comprehensive Pan-Cancer analysis of somatic mutations in drug transporters to reveal acquired and intrinsic drug resistance in 3149 metastatic cancer patients (#04)
Wesley Van De Geer, the Netherlands
 
 12:30Discussion & session evaluation 
    
 13:00Lunch 
    
 Session 3: PK/PD studies and new strategies
Chairs: Maria Jesus Garrido & Lena Friberg
 
 14:00

Piet van der Graaf, PhDHow system pharmacology can facilitate clinical drug development in oncology
Piet van der Graaf
Certara, the Netherlands

 
 14:30

Mats Karlsson, PhD, FCP, FISoPImpact of immortal time and selection bias on exposure-response modelling
Mats Karlsson
Uppsala University, Sweden

 
 15:00

Clinical pharmacology strategy for development and labelling of new medicine in the era of targeted therapy and accelerated approvals in oncology
Berges, Alienor 2019 120x160

Alienor Berges
Astrazeneca Cambridge, UK 


Schalkwijk, Stein 2019 120x160

Stein Schalkwijk
Astrazeneca Cambridge, UK

 
  Abstract-driven presentations 
 15:30Quantitative modeling of inter-lesion and inter-organ variability of tumor size (#05)
Sreenath Krishnan, Sweden
 
 15:45Population pharmacodynamics modelling of circulating lymphocyte count over time in chronic lymphocytic leukemia patients under ibrutinib treatment (#06)
Fanny Gallais, France
 
 16:00Discussion & session evaluation 
    
 16:30Poster viewing session 1 (#13-21) & welcome drinks 
    
 18:00Networking dinner (optional) 
    
 

Day 2 - Friday, 22 November 2019

 
 Session 4: Optimal study design & biomarker selection and validation
Chairs: Michelle Rudek & Etienne Chatelut
 
 08:30

Optimal study design of oncology trials
Patricia LoRusso
Yale Cancer Center, USA

 
 09:00Jamois, Candice 2019 120x160Challenges in the development of immunotherapy
Candice Jamois
Roche, Switzerland
 
  Abstract-driven presentations 
 09:30Pharmacokinetics and safety of pazopanib in frail elderly patients (#07)
Félicien Le Louedec, France
 
 09:45Population pharmacokinetic and pharmacogenetic analysis of mitotane in adrenocortical carcinoma patients: towards individualized dosing (#08)
Anyue Yin, the Netherlands
 
 10:00Discussion & session evaluation 
    
 10:30Poster viewing session 2 (#22-29) & coffee break 
    
 Session 5: Drug-Drug / Drug-Food / Drug-environmental interactions
Chairs: Ron Mathijssen & Howard Gurney
 
 11:00

Nielka van Erp, PharmD, PhDDrug - Food interaction an unrealized potential
Nielka van Erp
Radboud University Medical Centre, The Netherlands

 
 11:30

Etienne Chatelut, PharmD, PhDChallenges in treating geriatric patients with cancer
Etienne Chatelut
Toulouse University Cancer Institute-Oncopole, France

 
  Abstract-driven presentations 
 12:00Modulation of CYP3A activity to increase the oral bioavailability of ibrutinib (#09)
Eric Eisenmann, USA
 
 12:15Effects of dietary restriction in cancer patients receiving irinotecan (#10)
Ruben Van Eerden, the Netherlands
 
 12:30Discussion & session evaluation 
    
 13:00Lunch 
    
 Session 6: Dose individualization approaches
Chairs: Michelle Rudek & Etienne Chatelut
 
 14:00

Neeltje Steeghs, MD, PhDDose individualization potential for oral targeted oncolytics
Neeltje Steeghs
Netherland Cancer Institute, the Netherlands

 
 14:30

Stijn Koolen, PharmD, PhDDose individualization potential for checkpoint inhibitors
Stijn Koolen
Erasmus Medical Centre, The Netherlands

 
  Abstract-driven presentation 
 15:00Influence of probenecid on the pharmacokinetics and pharmacodynamics of sorafenib (#11)
Koen Hussaarts, the Netherlands
 
 15:15Correlation between sunitinib exposure and toxicity in a real-life patient cohort (#12)
Kim Westerdijk, the Netherlands
 
 15:30Discussion & session evaluation 
    
  Closing of the workshop by the conference chairs 

 


 

Program

The International Workshop on Clinical Pharmacology of Tuberculosis Drugs collaborates with a committed group of international experts in the field of clinical pharmacology of tuberculosis drugs. By working together with our extensive global network of experts from various backgrounds in the field, we will deliver the most relevant and state-of-the-art program.

 

Tuesday, 10 September 2019

  08:30

Workshop Opening
Rob Aarnoutse, PharmD, PhD
Radboud University Medical Center, The Netherlands

 Session 1: Pharmacokinetics and Pharmacodynamics of New and Repurposed TB Drugs
  08:45 Oxazolidinones for TB: Current Status and Future Prospects
Dr. Lawrence Geiter
  Discussion
  Oral Abstract Presentations
  09:15 Evaluating Hepatotoxicity of Bedaquiline Treatment in Multi-Drug Resistant Tuberculosis Patients
Lénaïg Tanneau
 
  09:30Relationship Between Plasma and Intracellular Concentrations of Bedaquiline and its M2 Metabolite in South African Patients with Drug-Resistant TB
Precious Ngwalero
 
  09:45Co-Administration of Pretomanid with Rifampin or Rifabutin Among Patients with Pulmonary TB: Interim PK Results from “Assessing Pretomanid for Tuberculosis” (APT) Trial
Dr. Elisa Ignatius
 
  10:00Pharmacokinetics and Early Bactericidal Activity of Meropenem (with Amoxicillin/Clavulanate), With and Without Rifampicin, for Drug-Susceptible TB
Dr. Ahmed Aliyu Abulfathi
 
 

 10:15    Discussion

 10:30Coffee Break
  
 Session 2: Pharmacokinetics and Pharmacodynamics of Established TB Drugs
  Oral Abstract Presentations
  11:00Pharmacogenetics and Pharmacokinetics of First-Line Anti-Tuberculosis Drugs in the HIRIF Trial
Dr. Elizabeth Mackay
  11:15Increased Bactericidal Activity but Dose-Limiting Tolerability at 50 mg/kg Rifampicin
Dr. Lindsey Te Brake
 
  11:30Ethionamide Population Pharmacokinetic Model and Monte Carlo Simulation in Patients with Multidrug-Resistant Tuberculosis
Dr. Charles Peloquin
 
  11:45Exposures to First-Line Drugs in African and Indian Children with Drug-Susceptible Tuberculosis using Novel Fixed-Dose-Combination Tablets at WHO Dosing Recommendation in the SHINE Trial
Dr. Chishala Chabala
 
  12:00The OptiRIF Study: Pharmacokinetics of High-Dose Rifampicin in Children
Dr. Elin Svensson
 
  12:15Discussion 
    
  
 12:30Lunch
  
 

13:15

Guided Poster Session
Dr. Charles Peloquin 
 

Mechanistic Modelling of Time-to-Positivity and Colony-Forming Unit in Tuberculosis Patients on High-Dose Rifampicin to Improve Understanding of Biomarker Relation
Ahmad Rami Ayoun Alsoud

Population Pharmacokinetics and Model-Informed Precision Dosing of Isoniazid in Tuberculosis Patients
Dr. Elin Svensson

Optimal Dose Individualisation of Rifampicin needs to Account for Between-Occasion Variability
Lina Keutzer

Levofloxacin Urine Kinetics and Development of a Colorimetric Assay for Therapeutic Drug Monitoring Among People Living with HIV and TB
Daniel Van Aartsen

Mathematical Modeling using In Vitro Checkerboard Assay Data: Clofazimine as a Potentially Synergistic Anti-TB Drug
Dr. Charles Peloquin

Comparison of a Bayesian Forecasting Algorithm Handling Inter-Occasion Variability and a Linear Regression Approach for Dose Individualization of Rifampicin
Selma El Messaoudi

Protein Binding Determination of Second-Line Anti-Tuberculosis Drugs In Vitro using an Ultrafiltration Technique
Dr. Charles Peloquin

 Session 3: Population Pharmacokinetics and Pharmacokinetic-Pharmacodynamic Modelling
  14:00Pharmacokinetic-Pharmacodynamic Analysis in TB Drug Development and the Role of the WHO
Dr. Ernesto Jaramillo
  Discussion
  Oral Abstract Presentations
  14:30Can Longitudinal PKPD Biomarkers be used to Forecast Treatment Outcome Instead of M2 Conversion? A Population Pharmacokinetic-Pharmacodynamic Analysis in Drug Sensitive Pulmonary Tuberculosis
Dr. Frank Kloprogge
 
  14:45PK-PD of Isoniazid Given at Different Doses Among Patients with MDR-TB with INH Resistance Mediated by inhA Mutations: Modeling Results from ACTG A5312
Kamunkhwala Gausi
 
  15:00Population Pharmacokinetics of Linezolid in TB Patients: Dosing Regimens Simulation and Target Attainment Analysis
Dr. Charles Peloquin
 
  15:15Levofloxacin Target Attainment Analysis in MDR-TB Patients: Time is Ripe for Proactive TDM
Dr. Mathieu Bolhuis
 
  15:30    Discussion
 15:45Coffee Break
  
 Session 4:  TB Drug Development and Optimization: Approaches and Tools
  16:15

Combined use of Biomarker Data and Drug Exposures to Predict TB Treatment Response
Dr. Elin Svensson

Discussion

  16:45An Assay to Measure Drug Tolerance of M. Tuberculosis in the Caseous Center of Pulmonary Lesions
Jansy Sarathy
 
  17:00A PBPK Modelling Approach to Simulate the Rifampicin-Moxifloxacin Drug-Drug Interaction in TB Patients
Carlijn Litjens
 
  17:15Stratified Dosage Regimens from Early Bactericidal Activity Studies: An Application to Pretomanid
Dr. Michael Lyons
 
  17:30Drug Effect of Clofazimine on Persistent Mycobacteria Explain an Unexpected Increase of Bacterial Load in Patients
Alan Faraj
 
  17:45Discussion 
    
  18:00Closure and Adjournment
  
  Reception
  
 19:30Networking Dinner
  

 

Program

 Disclaimer:  This conference will be held in English with no simultaneous translation.

22 November

08:30Registration and Walk-In Coffee
 
09:00Workshop Opening
 Session 1: Natural History and Epidemiology

 
09:10

Tsochatzis, Emmanuel 2015_120x160

Natural History of NASH
Emmanuel Tsochatzis MD, MSc, FEBTM, FRCP, PhD
Royal Free Hospital, United Kingdom

 
09:40

Jeffrey Lazarus, PhD, MIH, MAIsglobal, Hospital Clínic, Univ of Barcelona, Spain

NASH Epidemiology and policy
Jeffrey Lazarus, PhD, MIH, MA
Isglobal, Hospital Clínic, Univ of Barcelona, Spain

10:10

Pryke, Rachel 2019 120x160

NASH Diagnosis and Management in General Practice
Rachel Pryke, MBBS MRCGP FRCP
Winyates Health Centre, United Kingdom

10:40Discussion
11:00Coffee Break
 Session 2: Clinical Management of NASH - Diabetes and Obesity

11:30

Oben, Jude 2019

Practical Guidance Obesity Management - Introductory Talk 
Jude Oben, MD
University College London, United Kingdom

12:00

Gonzalez Aguilera, Beatriz - 2019 120x160

Practical Guidance Diabetes management - Introductory Talk
Beatriz Gonzalez, MD
Hospital Universitario Virgen Macarena

12:30

Discussion

12:35Lunch and Poster Viewing
 Session 3: Clinical Management of NASH - Special Populations

13:45

Younes, Ramy 2019 120x160

Management of Lean NASH
Ramy Younes, MD
University of Turin, Turin, Italy

14:15

Baker, Alastair 2019

Practical guidance on pediatrics NAFLD  (incl. clinical cases) 
Alastair Baker, MB, ChB, FRCP, FRCPCH, MBA
King's College Hospital NHS Foundation Trust, United Kingdom

14:45

NASH in HIV
Berend van Welzen, MD
UMC Utrecht, the Netherlands

15:15Discussion
15:30 Coffee Break
 Session 4: NASH Management

16:00

Manuel Romero-Gomez, MDUniversity of Seville, Spain

New Biomarkers in NAFLD
Manuel Romero-Gomez, MD
University of Seville, Spain

16:30

Zelber-Sagi Shira, 2018 120x160

How to Implement a Healthy Lifestyle in NAFLD/NASH Patients
Shira Zelber-Sagi, PhD
Tel Aviv Sourasky Medical Center, Israel

17:00Roundtable Discussion: The Interface of Primary and Secondary Care
Moderator: Emmanouil Tsochatzis, MD, PhD, Royal Free Hospital, United Kingdom
17:30Open Poster Session and Welcome Reception
19:30Workshop Dinner

23 November

 Session 5: NASH and Comorbidities

09:00

Reeves, Helen 2019 120x160

NASH/NAFLD as Cause for HCC
Helen Reeves, MD, PhD
Newcastle Universtity, United Kingdom

09:20

Andrade, Raul (new) 2019 120x160

Drug-Induced Liver Injury and NASH
Raúl Andrade, MD, PhD
University Hospital Virgen de la Victoria, Malaga, Spain

09:40

Schattenberg,Joern 2018

Cardiovascular Risk in NAFLD
Jörn M. Schattenberg, MD
Johannes Gutenberg-Universität Mainz, Germany

10:00

Arias Loste, Maria Teresa 2019 120x160

NASH and Immune-Mediated Diseases
Maria Teresa Arias-Loste, MD
Hospital Universitario Marques de Valdecilla, Santander, Spain

10:20Discussion
10:30Coffee Break
 Session 6: Future Treatment and Management Options

11:00

Ratziu, Vlad - 2019 120x160

Invited Lecturer
Vlad Ratziu, MD, PhD 
Pierre and Marie Curie University, Paris, France

11:30

Pujol, Maite 2019 120x160

Patient Perspective
Maite Pujol
ASSCAT, Barcelona Spain

&
Casanovas, Teresa 2019 120x160

Teresa Casanovas, MD
ELPA, ASSCAT, Barcelona, Spain

11:45Round Table Discussion: Current guidelines -  still relevant or in need for review?
(moderator to be confirmed)
12:15Closing Remarks
12:30Closure of the Workshop

 

Program

 

Tuesday, 23 October 2018

  08:30Workshop Opening
Rob Aarnoutse, PharmD, PhD
Radboud University Medical Center, The Netherlands
 Session 1: Pharmacokinetics and pharmacodynamics of new TB drugs
Chairs: Rob Aarnoutse & Jan-Willem Alfenaar
  08:45New developments in pediatric TB treatment
Anneke Hesseling
Desmond Tutu Tuberculosis Centre, South Africa
  09:15Discussion
  Oral abstract presentations
 9:30 CPK/PD Support for a Phase 1 Study of TBA-7371
Jerry Nedelman, PhD
#1
 9:45Bedaquiline appears to antagonize its own main metabolite’s QTcF interval
prolonging effect
Lénaïg Tanneau, PhD
#2
 10:00Translational pharmacokinetic modelling & simulation of an experimental long-acting injectable formulation of bedaquiline
An Vermeulen, PhD
#3
 10:15TPreclinical and Clinical Pharmacokinetics and Pharmacodynamics Analysis of Delamanid
Suresh Mallikaarjun, PHD, FCP
#4
  
 10:30Coffee Break + Poster session I
Posters 21 - 27
  
 Session 2: Pharmacokinetics and pharmacodynamics of approved TB drugs
Chairs: Geraint Davies & Helen McIlleron
  Oral Abstract presentations
 11:15Higher rifampicin and isoniazid concentrations in epithelial lining fluid are associated with improved response to treatment in pulmonary TB
Andrew McCallum, MBChB
#5
 11:30Rifampicin, isoniazid and pyrazinamide exposures in children with DS-TB on
WHO-recommended FDCs in the SHINE trial
Helen McIlleron, MBChB, PhD
#6
 11:45Nevirapine pharmacokinetics in HIV-infected persons receiving rifapentine and isoniazid for TB prevention
Anthony Podany, PharmD
#7
 12:00Fluoroquinolones in the treatment of multidrug-resistant tuberculosis: experience from three US TB treatment centers
Charles Peloquin, PharmD
#8
 12:15Clofazimine pharmacokinetics in South African patients with drug-resistant tuberculosis
Sean Wasserman, MBChB, MMed
#9
 12:30Pharmacokinetic-Pharmacodynamic Target Attainment Analysis of Cycloserine in TB Patients
Charles Peloquin, PharmD
#10
  
 12:45Lunch & Group Photo
  
 13:30Poster Session II
Posters 28 - 35
  
 Session 3: Population pharmacokinetics and pharmacokinetic-pharmacodynamic modeling
 Chairs: Jerry Nedelman & Eric Nuermberger
  14:15Treatment of Multi-Drug Resistant TB
Bob Horsburgh
  14:45Discussion
  Oral abstract presentations
 15:00High peak rifampicin concentrations accelerate the slow phase of bacterial elimination in tuberculosis patients
Antal Martinecz
#11
 15:15The Clinical value of Model-based Therapeutic Drug Monitoring in Tuberculosis Treatment – Optimized Target for Rifampicin
Robin J Svensson
#12
 15:30Model-based meta-analysis of rifampicin exposure and mortality in phase II
tuberculosis meningitis trials
Elin M Svensson
#13
 15:45Pharmacokinetic-pharmacodynamic modeling of pretomanid in pulmonary
tuberculosis patients
Michael Lyons, PhD
#14
  
 16:00Coffee Break + Poster Session III
Posters 36 - 43
  
 Session 4: Drug development and optimization: approaches and tools
Chairs: Charles Peloquin & Kelly Dooley
  Oral Abstract presentations
 16:45Clinical Validation of Intracellular Pharmacodynamic (PDi) based modelling for the prediction of Fluoroquinolone activity against TB
Ghaith Aljayyoussi, PhD
#15
 17:00PK-PD arguments for bedaquiline and delamanid replacement of aminoglycosides in MDR-TB regimens
Jansy Sarathy, PhD
#16
 17:15Pharmacodynamic Correlates of Linezolid Activity and Toxicity in a Mouse TB Model
Kristina Bigelow, MS
#17
 17:30Delamanid Central Nervous System Pharmacokinetics in Tuberculous Meningitis
Elizabeth Tucker, MD
#18
 17:45Protein binding of rifampicin is not saturated when using high-dose rifampicin
Carlijn  Litjens, MSc
#19
 18:00Using Mycobacterium tuberculosis single nucleotide polymorphisms to predict fluoroquinolone treatment response
Timothy Rodwell, MD PhD MPH
#20
  18:15Closure and adjournment
Charles Peloquin, PharmD
  
 18:15Reception
  
 19:30Dinner at Restaurant La Passione
  

 

Program

The 1.5 day course consists of 10 invited lectures with ample time for Q&A, and breakout sessions. The preliminary agenda is as follows. The program is subject to change. Please stay tuned with us.

Download a pdf version of the program.

7 November
8:00 AMRegistration & Welcome coffee
8.20 AMOpening, introduction and pre-test
8.30 AMThe clinical and economic importance of optimizing dose
Mark Ratain, The University of Chicago
9.30 AMPlacing preclinical drug metabolism and pharmacokinetic data in context
Magnus Ingelman-Sundberg, Karolinska Institutet
10:30 AMCoffee break
11.00 AMRedefining the primary objective of phase 1 trials
Ruth Plummer, Newcastle University
12.00 PMClinical endpoints useful for guiding early clinical development
Jaap Verweij, Erasmus Medical Centre
1.00 PMLunch & Breakout session slots
2.00 PMPharmacometrics for the non-pharmacometrician
Lena Friberg, Uppsala University
3.00 PMUsing genetic and pharmacokinetic data from early clinical trials to guide subsequent clinical development
Magnus Ingelman-Sundberg, Karolinska Institutet
4.00 PMCoffee break
4.30 PMOptimizing the use of pharmacodynamic biomarkers
Mark Ratain, The University of Chicago
5:30 PMEnd of Day 1
6.00 PMNetworking dinner (optional)
8 November
8.00 AMBreakfast & Breakout session slots
9.00 AMTrial designs for the development of combinations of an investigational drug and a marketed drug
Jaap Verweij, Erasmus Medical Centre
10.00 AMSpecial challenges for the development of immunotherapy drugs and combinations
Ruth Plummer, Newcastle University
11:00 AMCoffee break
11.30 AMUse of clinical trial simulation in oncology drug development
Lena Friberg, Uppsala University
12:30 PMPost-test and Closure of the course

 

FACULTY

Program

Developed by an international Organizing Committee of leading experts in the field of NASH, the workshop program will offer interactive sessions with state of the art presentations and abstracts.

Below is a preliminary overview of what you can expect during the workshop in May. A PDF of this program can be downloaded hereSign up for our email list to be notified.

Please note that the program presented here is subject to change.

Friday 18 May 2018

Session 1: Regulatory and third party payer perspectives on NASH biomarkers
8:30Workshop opening
8:40Pathways and priorities for biomarker assessment
Peter Stein, MD
U.S. Food and Drug Administration, Silver Spring, MD, USA
9:00Integrating science, logistics and cost in approval of hierarchical testing strategies for NASH - The payer's perspective
Robert LoNigro, MD
Heritage Provider Network, Northridge, CA, USA
9:20Panel discussion
10:00Coffee break
Session 2: Milestones and road map for biomarker development
10:30Linking “intended use” to evidence needed for bringing a biomarker to market
John Sninsky, PhD
CareDx Brisbane, CA, USA
11:00Repeatability, reproducibility and analytic standards for biomarker development
Abbas Bandukwala
U.S. Food and Drug Administration, Silver Spring, MD, USA
11:20What is needed to link device approval to clinical application approval
David Litwack, PhD 
U.S. Food and Drug Administration, Silver Spring, MD, USA
11:40Reporting standards: STARD & TRIPOD
Patrick Bossuyt, PhD
AMC-UvA, Amsterdam, the Netherlands
12:00Quality standards for imaging studies
Claude Sirlin, MD 
UC San Diego, San Diego, CA, USA
12:20Panel discussion
13:05Lunch & Poster viewing
Session 3: Context of use - Diagnosis of “at risk” pre-cirrhotic NASH
14:05Case definitions for use as reference standards
Mohammed Siddiqui, MD
VCU Medical Center Richmond, VA, USA
14:25Contexts of use and implications for study design
Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRCP 
Newcastle University, Newcastle, United Kingdom
14:45Machine Learning Analysis Framework in Diagnosis of Advanced Fibrosis and Prediction of Fibrosis Improvement in Patients with Advanced Fibrosis due to NASH
Lulu Wang, PhD
Gilead Sciences, Foster City, CA, USA
15:05Oral abstract presentations:

Validation of NIS4 algorithm for detection of NASH at risk of cirrhosis in 467 NAFLD patients prospectively screened for inclusion in the RESOLVE-IT trial.
Rémy Hanf

A sequential circulating Fibroblast Activation Protein (cFAP) based model is superior to Hepascore alone in excluding significant fibrosis in non-alcoholic fatty liver disease.
 Mark Gorrell

15:35Discussion
16:15Coffee break
Session 4: Context of use - Diagnosis of cirrhosis
16:45Defining the reference standard for biomarker development - Histology versus clinical outcomes
Kathleen Donohue, MD
U.S. Food and Drug Administration 
17:05

Oral abstract presentations:
A Context of Use Framework for Bioanalytical Validation of the CK18 Apoptosis Biomarker for NASH Drug Development
Sumit Kar

Serum markers of collagen formation are associated with the severity of Liver fibrosis and Non-Alcoholic Steatohepatitis (NASH) histological features and to impaired renal function (IRF) in a NAFLD cohort
Samuel Daniels

Algorithm to identify non-alcoholic steatohepatitis (NASH) patients with a NAS≥4 and F≥2: algorithm derived in an American screening cohort and validation in a British non-alcoholic fatty liver disease (NAFLD) cohort
Celine Fournier

17:50Round Table Discussion: Redefining cirrhosis for the 21st century
18:30Welcome Reception & Poster viewing
19:30Workshop Dinner

Saturday 19 May 2018 - Day 2

Session 5: Context of use - Assessment of therapeutic response
8:30Defining therapeutic response in precirrhotic and cirrhotic NASH
Manal Abdelmalek , MD
Duke University, Durham, NC, USA
8:50Study design to validate biomarkers of therapeutic response for pre-cirrhotic NASH
Brent Tetri, MD
Saint Louis University, St. Louis, MO, USA
9:10Study design to validate biomarkers of therapeutic response in cirrhosis due to NASH
Detlef Schuppan, MD, PhD
University of Mainz, Mainz, Germany
9:30Oral abstract presentations:
Use of plasma PRO-C3, PRO-C5, and PRO-C6 for the diagnosis and follow-up of fibrosis stage in patients with nonalcoholic fatty liver disease (NAFLD).
Diana Leeming

 

NGM282 Rapidly Decreases PRO-C3 Levels in Biopsy-Confirmed NASH Patients Correlating with Changes in MRI-PDFF, ALT and Liver Histology: Results from a Phase 2 Dose-Finding Study.
Stephen Rossi

10:00Panel discussion
10:20Coffee break
Session 6: Integrated uses of biomarkers - From Bench to Bedside
10:50The clinical need for integrated assessment of NASH diabetes and heart disease
Arun Sanyal MD, MBBS
Virginia Commonwealth University Richmond, VA, USA
11:10Neoepitope fragments of extracellular matrix as markers of fibrosis in chronic liver disease: Insights into clinical and preclinical utilization for unfolding disease pathogenesis 
Diana Leeming, PhD
Nordic Biosciences A/S, Herlev, Denmark
11:30Oral abstract presentations:
Repeatability and Reproducibility of Multiparametric Magnetic Resonance Imaging of the Liver 
Andrea Dennis

 

Feasibility of Using Deep-learning-based Techniques for Liver Couinaud Segmentation and Proton Density Fat Fraction (PDFF) Estimation
Hashem Almahmoud

12:00Special Lecture: Generating evidence to meet regulatory and third party payer needs for approval - Lessons learned from cologuard
Berry Berger, MD
Exact Sciences, Madison, WI, USA
12:20FDA perspective on parallel review
Rochelle Fink, MD, JD
U.S. Food and Drug Administration, Silver Spring, MD, USA
12:40Discussion
13:00Closure of the workshop
13:05Workshop end

 

Program

Below the program for the International Workshop on NASH Biomarkers is published.

Download the final program as PDF:

NASH Biomarkers - final program

Friday 5 May 2017 - Day 1

8:00 AMRegistration & walk-in Coffee
  Session 1: Priorities in Biomarker Development for NASH
  
Chairs: Veronica Miller & Arun Sanyal
9:00 AMWorkshop Opening
9:10 AMOpening Lecture:
A pathologist, a radiologist and a hepatologist walked into a bar
Brent Tetri, MD
Saint Louis University Health Sciences Center, St. Louis, MO USA
9:40 AMInnovation in histological assessment of NASH
Pierre Bedossa, MD, PhD
University of Paris-Diderot, Paris, France
10:00 AMPanel discussion
Many perspectives, one goal
Panel members:

Pierre Bedossa, MD, PhD - University of Paris-Diderot
Brent Tetri, MD - Saint Louis University Health Sciences Center
David Kleiner MD, PhD - Center for Cancer Research, National Cancer Institute 
Sophie Megnien, MD - Genfit 
Raj Vuppalanchi, MBBS - Indiana University School of Medicine

 
11:00 AMCoffee break
 
  Session 2: Pathways to Biomarker Qualification and Acceptance
  
Chair: Chris Leptak
11:30 AMView from the Top - Potential impact of 21st Century Cures Act?
Peter Stein, MD
FDA Center for Drug Evaluation and Research, Silver Spring, MD
12:00 PMEU Perspective
Elmer Schabel, MD
European Medicines Agency, London, UK
BfArM, Bonn, Germany
12:15 PMDiscussion
12:30 PMCollaboration in action: BEST
Chris Leptak, MD, PhD
FDA Center for Drug Evaluation and Research, Silver Spring, MD
12:40 PMCollaboration in action: FNIH
Roberto Calle, MD, FACE, FACP

Foundation for the National Institutes of Health (FNIH), Bethesda, MD, USA
12:50 PMCollaboration in action: IMI
Quentin Anstee, BSc, MBBS, PhD, MRCP(UK), FRCP

Newcastle University, Newcastle, United Kingdom

1:00 PMPanel Discussion
Building synergy across the Atlantic
 
1:30 PMLunch break
2:15 PMPoster Tour 1
 
  Session 3: Circulating biomarkers
 
 Chairs: Sudha Shankar & Brent Tetri
3:00 PMLipidomics and Proteomics
Puneet Puri, MD
Virginia Commonwealth University, Richmond, VA, USA
3:20 PMRole of Genetic assessments
Quentin Anstee, BSc, MBBS, PhD, MRCP(UK), FRCP
Newcastle University, Newcastle, United Kingdom
3:40 PMCirculating nucleic acids and combination panels
Sven Francque MD, PhD
Antwerp University Hospital, Antwerp, Belgium
4:00 PMDiscussion
 
4:30 PMCoffee break
 
  Session 4: Imaging Biomarkers
  Chairs: Chris Leptak & Lara Dimick-Santos
5:00 PMMRI; what can it deliver
Claude Sirlin, MD
UC San Diego, San Diego, CA, USA
5:20 PMTransient elastography & other techniques
Raj Vuppalanchi, MBBS
Indiana University School of Medicine, Indianapolis, IN, USA
5:40 PMOral abstract presentations
6:00 PMPanel Discussion
Panel members:
Daniel Krainak, PhDFDA Office of In Vitro Diagnostics and Radiological Health
Claude Sirlin, MDUC San Diego
Raj Vuppalanchi, MBBSIndiana University School of Medicine
  
6:30 PMOpen Poster Session/Welcome Reception
7:00 PMWorkshop Dinner
 

Saturday 6 May 2017 - Day 2

 
  Session 5: Quantative assessment of hepatic health
 
 Chairs: Roberto Calle & Puneet Puri
8:00 AMBreath tests
M. Shadab Siddiqui, MD, FACP
Virginia Commonwealth University, Richmond, VA, USA
8:15 AMPrinciples of kinetic measures
Greg Everson, MD, FACP
University of Colorado Denver, Denver, CO, USA
8:30 AMOral abstract presentations
9:20 AMPanel discussion
Learning from functional, imaging and circulating biomarkers: Challenges of qualification in absence of highly effective therapy

Panel members:
Greg Everson, MD, FACP - University of Colorado Denver
Shadab Siddiqui, MD, FACP - Virginia Commonwealth University
Irene Tebbs, PhD - FDA Office of In Vitro Diagnostics and Radiological Health
Chris Leptak, MD, PhD - FDA Office for New Drugs
Eric Lefebvre, MD - Allergan
 
10:00 AMCoffee break
 
  Session 6: Challenges Opportunities in integrating 'OMICS
  Chairs: tbc
10:30 AMBig Data vs. the individual liver from a regulatory perspective
Robert Schuck, PharmD, PhD
FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA
10:45 AMBig Data vs. the individual liver from a developer's perspective
José María Mato de la Paz, PhD
CIC BioGUNE, Derio, Spain
11:00 AMFuture scenarios of algorithm building
Tom Travison, PhD
Harvard Medical School & Hebrew SeniorLife Institute for Aging Research, Boston, MA, USA
11:15 AMOral abstract presentations
11:45 AMPanel Discussion
 
12:15 PMLunch break
 
  Session 7: The Liver in Context
 
Chairs: Veronica Miller & Arun Sanyal
1:15 PMIntegrated Assessment of diabetes, cardiovascular and liver risks and its potential application in the clinical management of NAFLD
Arun Sanyal, MD, MBBS
Virginia Commonwealth University, Richmond, VA, USA
1:55 PMNavigating NASH biomarkers: From discovery to clinical practice
John Sninsky, PhD
CareDx, Brisbane, CA, USA
 
2:15 PMRound table discussion: 
The way forward

Panel members:
Malina Arazy, MD - Exalenz Bioscience
Claude Cohen-Bacrie, PhD - SuperSonic Imagine
Elizabeth Fagan, MS, MD - Perspectum Diagnostics
Céline Fournier, PhD - Echosens
Rémi Hanf, PhD - Genfit
Pablo Ortiz, MD, PhD - OWL Metabolomics
Steve Williams, MD, PhD - Somalogic
3:00 PMClosure of the workshop
 
3:00 PMEnd of workshop

 

Private: Program

The program for the Symposium on Key Issues in Liver Transplantation for NASH is published below. 

Please click here to download a PDF of the program

Monday 14 November

 6.30 pmWelcome & Dinner Buffet
 

7.00 pm

Opening of the Symposium 
Arun Sanyal, MD, MBBS
Virginia Commonwealth University, Richmond, VA, USA

 
  Session 1:  Pre-Transplant – Optimizing Candidacy
  Chairs: Michael Charlton, MD, Intermountain Medical Center, Salt Lake City, UT, USA
Norah Terrault MD, MPH, University of California, San Francisco, CA, USA

7.10 pm

Kaplan, Lee 2016 120

Role of Weight Reduction (BMI Target) and Medical Treatments
Lee Kaplan, MD, PhD
Massachusetts General Hospital, Boston, MA, USA

7.30 pm

Kowdley, Kris 2016 120

Role of Bariatric Surgery – Pre-, during, or Post-transplant
Kris Kowdley, MD, FACP, FACG, AGAF, FAASLD
Swedish Medical Center, Seattle, WA USA

7.50 pmPanel Discussion
 
  Session 2:  Post-Transplant – Reducing Risk of NASH Recurrence
  Chairs: Arun Sanyal, MD, MBBS, Virginia Commonwealth University Richmond, VA, USA
Russel Wiesner, MD, Mayo Clinic Minnesota Rochester, NY, USA

8.20 pm

Siddiqui, Mohammed web 120

Optimizing Immunosuppression
Mohammed Siddiqui, MD 
Virginia Commonwealth University, Richmond, VA, USA 

 8.40 pmPanel Discussion
 

9.00 pm

Closure of the Symposium 
Norah Terrault MD, MPH
University of California, San Francisco, CA, USA

 

Program

Sunday 15 October 2017

7.30 -08.30 AMRegistration
8.30 AM

Workshop opening
Rob Aarnoutse, PharmD, PhD 
- Radboud University Medical Center, Netherlands

Session 1: Pharmacokinetics & Pharmacodynamics of New & Repurposed TB Drugs
Chairs: Rob Aarnoutse & Rovina Ruslami
8.45 AM

Searching for a Universal Regimen for Tuberculosis Treatment with a Shorter Duration of Therapy
Khisi Mdluli, PhD - TB Alliance, USA

 Abstract presentations
9.15 AM

Exposure-Response Analysis of Lee 1810, a Lead Spectinamide Antibiotic in Mycobacterium tuberculosis Infected Mice
Santosh Wagh - University of Tennessee Health Science Center, USA

9.30 AMImproved efficacy of a cofactor-independent InhA inhibitor revealed by the C3HeB/ FeJ mouse model
Gregory Robertson - Colorado State University, USA
9.45 AMPharmacokinetic modeling and simulation of pretomanid in pulmonary tuberculosis patients
Michael Lyons - Colorado State University, USA
10.00 AMHigh dose rifampicin for the treatment of TB meningitis: a dose finding study
Rob Aarnoutse - Radboud University Medical Center, Netherlands
10.15 AM Discussion
10.30 AMCoffee Break
Session 2: Pharmacokinetics & pharmacodynamics of approved TB drugs
Chairs: Gerry Davies & Paolo Denti
11.00 AM

A Cardiac Risk Algorithm to Predict the Probability of Drug-Induced Torsades de Pointes with Novel Anti-TB Agents
Alexander Berg, PharmD, PhD, FCP, - Critical Path Institute; Tucson, USA

 Abstract presentations
11.30 AM Optimizing the Dose of Levofloxacin: Pharmacokinetic Results from the Opti-Q Study
Charles Peloquin - University of Florida, USA
11.45 AMOtotoxicity is associated with exposure to kanamycin and capreomycin in the treatment of multidrug-resistant tuberculosis
Mohammed Aslshaer - University of Florida, USA
12.00 PMPyrazinamide sterilizes necrotic lesions in tuberculosis infected lungs
Veronique Dartois - Rutgers University, USA
12.15 PMMoxifloxacin as the fluoroquinolone of choice to treat TB?
Jansy Sarathy - Rutgers University, USA
12.30 PM Discussion
12.45 PMLunch
13.30 PM                Guided Poster Session
  
Session 3: Population Pharmacokinetics and Pharmacokinetic-Pharmacodynamic Modelling
Chairs: Khisi Mdluli & Dakshina Chilukuri
2.00 PM

Benefits of data collaboration – personalized tailoring regimens
Rada Savic, PharmD, PhD - University of California, USA

 Abstract presentations
2.30 PMPharmacokinetics of rifampicin in African children - Evaluation of the new WHO dosing guidelines
Paolo Denti - University of Cape Town, South Africa
2.45 PMPrediction of increase in time-to-positivity after higher doses of rifampicin based on pharmacokinetic-pharmacodynamic modelling
Robin Svensson- Uppsala University, Sweden
3.00 PMRelating rifampicin exposure to treatment response in patients with pulmonary tuberculosis – potential for treatment shortening with higher doses
Elin Svensson- Radboud University Medical Center, Netherlands
3.15 PMPopulation Pharmacokinetic Modeling of Clofazimine in Adult Tuberculosis
Patients: Implications for Dosing
Stella Belonwu - University of California, USA
3.30 PM Discussion
3.45 PMCoffee Break
Session 4: Drug development and optimization: approaches and tools
Chairs: Eric Nuermberger & Charles Peloquin
4.15 PM

Translation of pre-clinical models to clinical outcomes
Tawanda Gumbo, MD, - Baylor Institute for Immunology Research, USA

 Abstract presentations
4.45 PMQuantitative Analysis of MGIT Time to Positivity Using a Two-Part Longitudinal Model in Patients with Pulmonary Tuberculosis: A Meta-Analysis of 11 Clinical Studies Including 30 Unique Regimens
JF Marier - Certara, Canada
5.00 PMInfluence of Bacterial Growth Rate on Dose Optimization of Linezolid for Treatment of Tuberculosis
Kristina Bigelow - Johns Hopkins University, USA
5.15 PMA pharmacokinetic/pharmacodynamic drug-drug interaction study of rifampicin and metformin in type II diabetic tuberculosis patients
Lindsey te Brake - Radboud University Medical Center, Netherlands
5.30 PMPersonalized tuberculosis treatment through Bayesian dosing of rifampicin
Stijn van Beek - Radboud University Medical Center, Netherlands
5.45 PM Discussion
6.00 PMReception
7.00 PMDinner

 

Program

Click on the following link to download the workshop flyer with the program: FLYER

Confirmed Speakers

 

Program

Click on the following link to download the final program of the workshop: Final program 7TBPK

Invited speakers
The following invited speakers have confirmed their contribution to the workshop:

 

 

Program

Confirmed invited speakers An exciting new program has been set up with the following speakers:

Program

Confirmed invited speakers An exciting new program has been set up with the following speakers: