international workshop on clinical pharmacology of ... · the clinical pharmacology workshop: •...

CLINICAL PHARMACOLOGYOF TUBERCULOSIS DRUGS

9TH INTERNATIONAL WORKSHOP ON

LIVERPOOL, UNITED KINGDOM • 24 OCTOBER 2016

EVALUATION REPORT

2EVALUATION REPORT: 9th International Workshop on Clinical Pharmacology of Tuberculosis Drugs 24 October 2016, Liverpool, United Kingdom

EXECUTIVE SUMMARY

The 9th International Workshop on Clinical Pharmacology of Tuberculosis Drugs, held at the Hilton Liverpool City Centre Hotel in Liverpool, United Kingdom on 24 October 2016 was very successful. The 2016 edition has attracted 64 pharmacists, pharmacologists as well as researchers and clinicians to discuss the latest important scientific findings in the tuberculosis clinical pharmacology field.

PROGRAMThe meeting consisted of 4 invited lectures, 16 abstract presentations and 3 poster viewing sessions. The participants were very pleased with the overall event experience. 100% of the participants rated the overall event experience “excellent/good”. All of the participants would recommend the workshop to their peers and everyone intends to attend the workshop next year. This was the first time the workshop was held in Europe. It was scheduled prior to The Union Meeting that may have contributed to the large number of participants, which was the highest in the history of this workshop.

ABSTRACTSA record number of 35 abstracts were submitted this year. All abstracts were accepted for either oral or poster presentations.

FEEDBACKMany positive remarks were given:

“Very good workshop.”

“Well organized. Good way to discuss thoroughly the important aspects of the problem and how to address them.”

“A must-attend meeting.”

The participants are less enthusiastic about the time allocated for discussion and the poster viewing sessions during breaks. The Organizing Committee will review whether the number of talks should be reduced and what would be the best way to organize the poster presentations.

FUTUREThe aim of this abstract-driven workshop, to make a significant contribution to the optimization of TB treatment, by bringing experts together and having them present and discuss the latest important scientific findings in the TB clinical pharmacology field, has most certainly been achieved.

The Organizing Secretariat and the Organizing Committee will take the comments into account for the preparation of next year’s event.


CONTENT

Executive Summary ............................................................................. 2

Workshop Description .......................................................................... 4

Background .............................................................................................4

Meeting Objectives ..................................................................................4

Format ....................................................................................................4

Unique Meeting Features .......................................................................4

Target Audience ......................................................................................4

Meeting Demographics ......................................................................... 5

No. of Registrations ................................................................................5

No. of Young Investigators ......................................................................5

Geographical Distribution of Participants ..............................................5

No. of Returning/New Registrations ......................................................5

Professional Background of Participants ...............................................6

Organizing Committee .......................................................................... 7

Scientific Committee ............................................................................ 8

Participants’ Feedback ......................................................................... 9

Number of Participants Respondents ....................................................9

Meeting Objectives ..................................................................................9

Number of Abstracts ..............................................................................9

General Conference Experience ...........................................................10

Organization ..........................................................................................10

Lectures ................................................................................................11

Poster Viewing Session ........................................................................13

Workshop Metrics ................................................................................14

Publicity ................................................................................................14

Conclusion ...........................................................................................15

Acknowledgements .............................................................................16

List of Participants ...............................................................................17


WORKSHOP DESCRIPTION

The 9th International Workshop on Clinical Pharmacology of TB Drugs was held on 24 October 2016 at the Hilton Liverpool City Centre Hotel in Liverpool, United Kingdom.

BACKGROUNDThe treatment of tuberculosis is increasingly becoming a challenge worldwide. All around the world experts in the field are involved in intensive research to be able to cope with the various concerns with regard to treatment. The aim of this abstract-driven workshop is to make a significant contribution to the optimization of TB treatment, by bringing experts together and having them present and discuss the latest important scientific findings in the TB clinical pharmacology field. Additionally, scientific, regulatory or strategy issues that are highly relevant to the optimization of TB treatment have been exchanged and discussed.

MEETING OBJECTIVES• To gather experts involved in the pharmacology of

TB drugs from different disciplines in an interactive workshop setting

• To provide a platform for presentation and discussion of the latest scientific developments in the field

• To map all current studies and results related to available and new TB drugs

• To help translate new in vitro and in vivo pharmacological data into new drug treatment combinations for TB

FORMATThis meeting consists of invited lectures, abstract presentations and poster viewing sessions. The meeting is abstract-driven. It is known as an excellent platform for young investigators to present their research. This year a record number of 35 abstracts have been submitted. To ensure the quality of accepted abstracts, all submitted abstracts go through a blind, peer-reviewed process conducted by the members of the Organizing Committee and the Scientific Committee.

UNIQUE MEETING FEATURESThe Clinical Pharmacology workshop:

• is the premier tuberculosis pharmacology meeting in the world

• has a strong community of clinical pharmacologists and other healthcare professionals involved in this field

• is an independent scientific platform for discussion and debate

TARGET AUDIENCEThe target audience consists of preclinical and clinical pharmacology researchers ( pharmacists, pharmacologists, microbiologists, physicians) from academic institutions and pharmaceutical companies, PhD students, representatives from pharmaceutical companies and representatives from regulatory or non-governmental organizations active in the TB-field, as well as clinicians involved in daily care for TB patients.


MEETING DEMOGRAPHICS

NO. OF REGISTRATIONSIn 2016, a record number of 64 people from an array of countries registered for this workshop, with 59 participants on the day.

NO. OF YOUNG INVESTIGATORSWe welcomed 14 young investigators to the workshop this year.

GEOGRAPHICAL DISTRIBUTION OF REGISTRANTSLocation # participants USA + Canada Europe Africa Asia

1 TBPK Toronto, Canada 58 29 21 3 5

2 TBPK San Francisco, CA, USA 44 27 11 3 3

3 TBPK Boston, MA, USA 50 29 12 6 3

4 TBPK Chicago, IL, USA 46 30 7 4 5

5 TBPK San Francisco, USA 40 26 9 3 2

6 TBPK Denver, CO, USA 41 27 9 2 3

7 TBPK Washington, DC, USA 51 36 11 2 2

8 TBPK San Diego, CA, USA 45 31 6 4 3

9 TBPK Liverpool, United Kingdom 64 26 32* 5 1

* 14 registrants from the United Kingdom, of whom 12 from Liverpool.

NO. OF RETURNING/NEW PARTICIPANTSReturning / new participants

2012 2013 2014 2015 2016

40 41 51 45 64


PROFESSIONAL BACKGROUND OF PARTICIPANTSThe population of this meeting has been stable for a few consecutive years. However, this year’s workshop attracted the highest number of participants ever. It also attracted more pharmacists (17% to 7% in 2015) and more MDs (29% to 20% in 2015), but less researchers compared to last year (23% to 41% in 2015).

Employer Occupation

Area of Expertise

Other:• Absorption

• Infection Drug Discovery

• PK Predicton / Simulation

• Clinical

• Data Science

• Invasive Fungal Disease

• AMR

MEETING DEMOGRAPHICS


ORGANIZING COMMITTEE

ROB AARNOUTSE, PHARMD, PHD

Radboudumc Nijmegen, The Netherlands

HELEN MCILLERON, MBCHB, PHD

University of Cape Town Cape Town, South Africa

KHISI MDLULI, PHD

TB Alliance New York NY, USA

ERIC NUERMBERGER, MD

Johns Hopkins University Baltimore MD, USA

GERAINT DAVIES, MD

University of Liverpool Liverpool, United Kingdom

CHARLES PELOQUIN, PHARMD

University of Florida Gainesville FL, USA


SCIENTIFIC COMMITTEE

Dakshina Chilukuri, PhD ........................................................... FDA, USA

Véronique Dartois, PhD ............................................................. Rutgers, The State University of New Jersey, Newark, USA

Paolo Denti, PhD ........................................................................ University of Cape Town, South Africa

Kelly Dooley, MD, PhD ............................................................... Johns Hopkins University, USA

Tawanda Gumbo, MD ................................................................. Soutwestern Medical Center, USA

Richard Hafner, MD.................................................................... National Institutes of Health, USA

Scott Heysell, MD, MPH ............................................................. University of Virginia, USA

Russell Kempker, MD, MSc ....................................................... Emory University School of Medicine, USA

Steven Kern, PhD ....................................................................... Bill & Melinda Gates Foundation, USA

Christian Lienhardt, MD, PhD .................................................... WHO – Stop TB Department, Switzerland

Rovina Ruslami, MD, PhD .......................................................... Padjadjaran University, Indonesia

Ulrika Simonsson, PharmD, PhD .............................................. Uppsala University, Sweden

Susan Swindells, MBBS ............................................................. University of Nebraska Medical Center, USA

Andrew Vernon, MD .................................................................. CDC, TBTC, USA

Robert Wallis, MD, .................................................................... FIDSA The Aurum Institute, South Africa


PARTICIPANTS’ FEEDBACK 2016

The Organizing Commitee and the Organizing Secretariat highly value the opinion of the participants in order to further improve the quality of the workshop. Participants were asked to complete an evaluation form to share their opinion on several subjects.

From 36 of the 57 participants (more than 63%) we have received a completed evaluation form.

NUMBER OF PARTICIPANTSNumber of participants present

Session 1 50

Session 2 57

Session 3 54

Session 4 48

NUMBER OF ABSTRACTS# abstracts Oral Poster

1 TBPK 24 abstracts

2 TBPK 14 abstracts

3 TBPK 26 abstracts 13 13

4 TBPK 17 abstracts 16 1 late breaker

5 TBPK 23 abstracts





MEETING OBJECTIVES (Strongly)

AgreeNeutral (Strongly)

DisagreeN/A

To make significant contribution to the optimization of TB treatment, by bringing experts together and having them present and discuss the latest important scientific findings in the TB clinical pharmacology field.

95% 5% 0% 0

To exchange and discuss scientific, regulatory or strategy issues that are highly relevant to the optimization of TB treatment.

97% 3% 0% 0



GENERAL CONFERENCE EXPERIENCE(Very) Good

Average (Very)

Poor

N/A

Overall event experience 100% 0% 0% 0

Opportunity of networking 90% 10% 0% 0

Content of the educational activity 100% 0% 0% 1

(Strongly) Agree

Neutral (Strongly) Disagree

N/A

Sufficient time allocated for discussion 76% 21% 3% 0

Sufficient time allocated per presentation 86% 14% 0% 0

No commercial bias (product selling) perceived 97% 3% 0% 0

I would recommend this event to my peers 100% 0% 0% 1

Plan to attend this event next time 100% 0% 0% 0

ORGANIZATION

(Very) Good Fair (Very) Poor N/A

Content of electronic announcements (newsletters) 85% 13% 2% 2

Frequency of electronic announcements (newsletters) 85% 13% 2% 2

Information on the conference website 85% 6% 9% 1

Online registration process 81% 16% 3% 3

Online abstract submission process 89% 11% 0% 7

Meeting venue 100% 0% 0% 0

Meeting room 100% 0% 0% 0

Audiovisuals 97% 3% 0% 0

Food & beverage 94% 6% 0% 0

Onsite logistics 100% 0% 0% 0

Service level of Conference Secretariat 97% 3% 0% 1


LECTURES

MONDAY 24 OCTOBER

Session 1: Pharmacokinetics & pharmacodynamics of new & redeveloped TB drugs

A new model for early clinical development of TB drugs and its application to Q203 and BTZ043 Norbert Heinrich, MD

(Strongly) Agree

Neutral (Strongly)Disagree

N/A

Topic is interesting 100% 0% 0% 1

Content is relevant to my work 86% 11% 3% 1

Abstract-driven Presentations

A model-based analysis to describe bedaquiline’s exposure-response relationship and predict the impact of drug-drug interactions E. Svensson, O_01

(Strongly) Agree


N/A



Population pharmacokinetics of AZD5847 in adults with pulmonary tuberculosis C. Peloquin, O_02

(Strongly) Agree


N/A



Pharmacokinetic modeling and simulation of the interaction between moxifloxacin and rifapentine in healthy volunteers M. Imperial, O_03

(Strongly) Agree


N/A



Population pharmacokinetic modeling to assess the non-linear increase in exposure following increasing doses of rifampicin R. Svensson, O_04

(Strongly) Agree


N/A



Session 2: Pharmacokinetics & pharmacodynamics of existing TB drugs

Rifampin vs. Rifapentine: a debate over the preferred rifamycin Kelly Dooley, MD, PhD Charles Peloquin, PharmD

(Strongly) Agree


N/A






Lung tissue concentrations of pyrazinamide among patients with tuberculosis R. Kempker, O_05

(Strongly) Agree


N/A



Early interventions for diabetes related tuberculosis hasten sputum microbiological clearance in Virginia, USA S. Heysell, O_06

(Strongly) Agree


N/A



Sub-therapeutic concentrations of anti-tuberculosis drugs in children when treated according to indian dosing recommendation B. Guiastrennec, O_07

(Strongly) Agree


N/A



A need for altering tuberculosis dosing regiments for patients with HIV-associated tuberculous meningitis G. Aljayyoussi, O_08

(Strongly) Agree


N/A



Session 3: Population pharmacokinetics and pharmacokinetic-pharmacodynamic modelling

Lost in translation: learning from preclinical data Gerry Davies, MD, United Kingdom

(Strongly) Agree


N/A




Development of a novel multi-compartment granuloma model to predict local drug distribution and its impact on pharma codynamics and disease progression in tuberculosis R. Rose, O_09

(Strongly) Agree


N/A



Application of a multi-compartment permeability-limited lung model to predict lung concentrations of moxifloxacin in virtual human subjects O. Hatley, O_10

(Strongly) Agree


N/A



A translational modelling and simulations approach to exploit pre-clinical tuberculosis data S. Wicha , O_11

(Strongly) Agree


N/A





The relationship between pyrazinamide pharmacokinetics (PK) and microbiologic outcomes in patients with pulmonary TB receiving standard- or high-dose rifampicin: PK/PD results from TBTC trials 27 and 28 and PanACEA MAMS K. Dooley , O_12

(Strongly) Agree


N/A



Session 4: Drug development and optimization: approaches and tools

Long acting (LA) drug delivery in TB treatment, Andrew Owen, PhD, United Kingdom

(Strongly) Agree


N/A




Simulation of long-acting administration of antituberculosis agents using pharmacokinetic modelling R. Rajoli , O_13

(Strongly) Agree


N/A



High drug tolerance of mycobacterium tuberculosis in caseum

J. Sarathy , O_14

(Strongly) Agree


N/A



Rifapentine plus isoniazid eradicates mycobacterium tuberculosis among rhesus macaques with latent TB infection H. Blumberg , O_15

(Strongly) Agree


N/A



Exploration of non-replicating mycobacterium tuberculosis in vitro system through mathematical modelling A. Schipani , O_16

(Strongly) Agree


N/A



POSTER VIEWING SESSION (Strongly)

AgreeNeutral (Strongly)

Disagree

N/A

The poster session was a valuable element in the program

95% 5% 0% 1

The combination poster session and break was well programmed

97% 3% 0% 1



PUBLICITY

Attention was drawn to this meeting by:

17

11

7

4

10 0 0

0

2

4

6

8

10

12

14

16

18

IND

IVID

UAL

RES

PON

SE

MOTIVATIONMotivation to attend this meeting:

28

20

15 15

12

10

8

5

00

5

10

15

20

25

30

Content of the

scientific program

Opportunity of

networking

Meeting objectives

Experience from

previous meeting

Timing prior to the Union

Meeting

Faculty of the

scientific program

Meeting location

Free registration

as YI

Other

INDI

VIDU

AL R

ESPO

NSE

WORKSHOP METRICS


The Organizing Secretariat is pleased with the results of the ninth edition of the International Workshop on Clinical Pharmacology of Tuberculosis Drugs.

All participants were very satisfied with the overall event experience. They all intend to return next year and would recommend this workshop to their peers. The majority was impressed by the quality of the scientific content.

Due to the success of the meeting, there was less time for networking. The poster viewing sessions were held during the breaks as well. As the opportunity for networking was an important motivation, the set-up of the 2017 program will be certainly a subject for discussion with the Organizing Committee.

This was the first time the meeting was held in Europe. It was scheduled prior to the annual Union Meeting that may have contributed to the larger number of participants, which was the highest ever. A third of the respondents mentioned that the proximity to the Union Meeting was a motivation for them to attend our workshop. This will be taken into account when deciding on the location and timing of next year’s edition.

It can be concluded that the evaluation results and the participants’ comments proved the success and the importance of this workshop.

The Organizing Committee has been requested to review the evaluation report and to prepare the organization of the 2017 workshop. The meeting prospectus for next year’s edition will be provided shortly.

The Organizing Secretariat would like to thank the Bill & Melinda Gates foundation, TB Alliance and other supporters for their generous support. We will look for your support again for the 10th International Workshop on Clinical Pharmacology of Tuberculosis Drugs in 2017.

CONCLUSION


ACKNOWLEDGEMENTS

The 9TH INTERNATIONAL WORKSHOP ON CLINICAL PHARMACOLOGY OF TUBERCULOSIS DRUGS has been made possible by the generous (financial) support of:

SCIENTIFIC SUPPORTERS

ENDORSER


LIST OF PARTICIPANTS

Last Name, First Name Institute Country

A

Alffenaar, Jan-Willem University Medical Center Groningen The Netherlands

Aljayyoussi, Ghaith Liverpool School of Tropical Medicine United Kingdom

Ayuso Parejo, Pedro University of Liverpool United Kingdom

B

Biagini, Giancarlo Liverpool School of Tropical Medicine United Kingdom

Blumberg, Henry Emory University USA

C

Chen, Chunli Uppsala Universitet Sweden

Chirehwa, Maxwell University of Cape Town South Africa

Clewe, Oskar Uppsala University Sweden

D

Davies, Gerry University of Liverpool United Kingdom

Davies Forsman, Lina University of Liverpool Sweden

de Knegt, Gerjo Erasmus Medical Center The Netherlands

de Steenwinkel, Jurriaan Erasmus Medical Center The Netherlands

Denti, Paolo University of Cape Town South Africa

Doi, Norio Japan Anti-Tuberculosis Association; RIT Japan

Dooley, Kelly Johns Hopkins University USA

G

Gardner, Iain Simcyp (a Certara company) United Kingdom

Gheuens, Jan Bill & Melinda Gates Foundation USA

Guiastrennec, Benjamin Uppsala Universitet Sweden

H

Hanna, Debra Critical Path Institute USA

Heinrich, Norbert Medical Center of the University of Munich Germany

Hermann, David Certara Pharmacometrics USA

Heysell, Scott University of Virginia USA

Hölscher, Michael University of Munich Germany

Horsburgh, Robert Boston University School of Public Health USA

I

Imperial, Marjorie University of California - San Francisco USA

K

Kempker, Russell Emory University USA

L

Laughon, Barbara NIAID, NIH USA

Lenaerts, Anne Colorado State University USA

Leyva, Francisco NIH USA

Lyons, Michael Colorado State University USA

M

McIlleron, Helen University of Cape Town South Africa

N

Nuermberger, Eric Johns Hopkins University School of Medicine USA


O

Owen, Andrew University of Liverpool United Kingdom

P

Peloquin, Charles University of Florida USA

Pertinez, Henry University of Liverpool United Kingdom

Phillips, Patrick University College London United Kingdom

Pushpakom, Sudeep University of Liverpool United Kingdom

R

Rajoli, Rajith University of Liverpool United Kingdom

Romero, Klaus Critical Path Institute USA

S

Sarathy, Jansy Rutgers, New Jersey Medical School USA

Savic, Rada University of California - San Francisco USA

Schipani, Alessandro University of Liverpool United Kingdom

Siccardi, Marco University of Liverpool United Kingdom

Simonsson, Ulrika Uppsala University Sweden

Smit, Hans Janssen Research & Development Belgium

Stott, Katherine University of Liverpool United Kingdom

Svensson, Elin Uppsala University Sweden

Svensson, Robin Uppsala University Sweden

Swindells, Susan University of Nebraska USA

T

Te Brake, Lindsey Radboudumc The Netherlands

V

Veenhof, Herman University Medical Center Groningen The Netherlands

Velásquez, Gustavo Harvard Medical School USA

Vernon, Andrew Centers for Disease Control and Prevention USA

Vinnard, Christopher Public Health Research Institute USA

W

Ward, Steve Liverpool School of Tropical Medicine United Kingdom

Weld, Ethel Johns Hopkins University USA

Wells, Charles Sanofi-U.S. USA

Wicha, Sebastian Uppsala Universitet Sweden

Z

Zuur, Marlanka University Medical Center Groningen The Netherlands

LIST OF PARTICIPANTS

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