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EVALUATION REPORT

3RD INTERNATIONAL WORKSHOP ON

AMSTERDAM, THE NETHERLANDS • 8 - 9 NOVEMBER 2018

CLINICAL PHARMACOLOGY OF ANTICANCER DRUGS

2Evaluation Report - 3rd International Workshop on Clinical Pharmacology of Anticancer Drugs www.expertmedicalevents.com

EXECUTIVE SUMMARY

The third International Workshop on Clinical Pharmacology of Anticancer Drugs (ICPAD) was organized on the 8th and 9th 2018 in Amsterdam, the Netherlands. It attracted 61 participants from 11 countries, including 23 young investigators from 8 countries.

The meeting gathered a cross-disciplinary team of experts and trainees involved in anticancer drug research, in order to present and discuss the latest developments and strategies for the future, in an interactive and science-focused setting. The workshop consisted of expert plenary lectures, oral abstract presentations and poser viewing session. In order to ascertain interaction, much time had been allocated to Q&A and discussions; thus providing a unique opportunity to meet colleagues in a scientific focused setting. Special attention was given to the empowerment of young investigators in this region who received a complimentary registration upon acceptance of their abstract.

Needs assessment

A needs assessment was conducted during the event. 95% of the respondents reported that there is a need for a scientific program on clinical pharmacology of anticancer drugs. The respondents indicated that the field would benefit most from the discussions on dose selections strategies (24%), PK-PD modelling (20%), mechanism of interaction (19%), novel diagnostic monitoring approaches (19%), and drug development (18%). 87% of the respondents (strongly) agreed that this year’s program met the mentioned needs/gaps.

Facts and figures

11 countries

15 lectures

6 1 attendees

28 abstract submissions

10 oral abstract presentations

Top 5 most interesting lectures

• Rationale for selecting combinations with immunotherapy (Howard Gurney)• Targeted agents and monoclonal antibodies (Joseph Ciccolini)• Using pharmacogenetics to improve drug therapy: a 12 year experience with clinical implementation (Ron van Schaik)• How studies can be optimized by simultaneous use of PK/PD outcome measurement? (Alwin Huitema)• Cytotoxic agents (Markus Jörger)

Top 5 most relevant lectures

• Targeted agents and monoclona antibodies (Joseph Ciccolini)• Cytotoxic agents (Markus Jörger)• Using pharmacogenetics to improve drug therapy: a 12 year experience with clinical implementation (Ron van Schaik)• How studies can be optimized by simultaneous use of PK/PD outcome measurement? (Alwin Huitema)• Rationale for selecting combinations with immunotherapy (Howard Gurney)


TABLE OF CONTENTS

Executive summary 2

Meeting description 4

Committees 5

Demographics of participants 7

Participants’ feedback 12• Invited lectures & abstract presentations 12• Meeting and learning objectives 16• Onsite organization 16• General conference experience 17• Participants’remarks 18

Needs assessment 19

Conclusion 20

Acknowledgement 21


MEETING DESCRIPTION

BACKGROUND

Understanding the pharmacology of anticancer drugs is pivotal to designing optimal treatment. Drug exposure is significantly influenced by drug interactions, transporter mediated interactions, and patients’ physiologic and genetic characteristics. These factors are central for therapeutic efficacy, failure or toxicity. Despite great progress, many pharmacologic opportunities to improve both efficacy and quality of life still exist.

The meeting gathered a cross-disciplinary team of experts and trainees involved in anticancer drug research, in order to present and discuss the latest developments and strategies for the future, in an interactive and science-focused setting.

The workshop consisted of expert plenary lectures and abstract-driven presentations. In order to ascertain interaction, much time was allocated to Q&A and discussions.

MEETING OBJECTIVES

The meeting aims at:• To gather professionals in the field of pharmacology of

anticancer drugs in an interactive workshop setting; • To provide a platform for presentation and discussion of

the latest pharmacological developments in the field;• To map current studies and latest results;• To translate new data into treatment opportunities;• To educate clinicians on pharmacological challenges

that need to be addressed with the implementation of current and new drugs.

FORMAT

This 1.5 days regional meeting consisted of invited lectures, oral abstract- and poster presentations. In order to ascertain an interactive workshop setting, much time was allocated to discussion. As the meeting was abstract driven, it was an excellent platform for young investigators to present their research. To ensure the quality of the accepted abstracts, all submitted abstracts went through a blind, peer-reviewed process conducted by the members of the Organizing and Scientific Committees.

UNIQUE MEETING FEATURES

This workshop provided a unique international translational platform for interchange between clinical pharmacologists, (hospital) pharmacists, industry researchers and government representatives. • This workshop is intended as a compact, focused

meeting to encourage crossdisciplinary scientific dialogue and in-depth discussions among all attendees, including presenters.

• This meeting is a stepping stone for young medical professionals to present their research in an informal and encouraging setting. We encourage their participation by offering them a complimentary registration (for more information see meeting website).

• Participants have a great opportunity to meet with their international colleagues and expand their network.

TARGET AUDIENCE

The target audience of this meeting consisted of medical oncologists, internal medicine doctors, clinical pharmacologists, hospital pharmacists, industry researchers, government representatives and other experts involved in this field of research.


COMMITTEES

ORGANIZING COMMITTEE

Etienne Chatelut, PharmD, PhD

University Institute Cancer Toulouse Oncopole, France

Howard Gurney MBBS, FRACP

Macquarie University, Westmead Hospital,

Australia

Nielka van Erp PharmD, PhD

Radboud University Medical Center, the Netherlands

Michelle Rudek PharmD, PhD

Johns Hopkins University, USA

Maria-Jesus Garrido PhD

University of Navarra, Spain

Lena Friberg PharmD, PhD

Uppsala University, Sweden

CHAIRS

Nielka van Erp PharmD, PhD

Radboud University Medical Center, the Netherlands

Michelle Rudek PharmD, PhD

Johns Hopkins University, USA

Ron Mathijssen MD, PhD

Erasmus Medical Center the Netherlands


COMMITTEES

Dinesh de Alwis, PhD - Merck Research Labs

Barbara Brennan, PhD - Roche

René Bruno, PhD - Genentech

Owen Jones, PhD - Astra Zeneca

Elisabeth Rouits, PharmD, PhD - Debiopharm

INDUSTRY LIAISON COMMITTEE


DEMOGRAPHICS OF PARTICIPANTS

Netherlands 30

France 8

Australia 4

Germany 4

Sweden 4

United Kingdom 3

Spain 2

Switzerland 2

United States 2

Denmark 1

Israel 1

Total 61

GEOGRAPHICAL DISTRIBUTION OF PARTICIPANTS

RemarksIn total 61 registrations from 11 countries attended the meeting.

Number of participants throughout the years

Year Location Number

2018 Amsterdam, the netherlands 61

2017 Madrid, Spain 54

2016 Amsterdam, the netherlands 68

13delegates from previous editions returned.

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Occupation

N=51 (NA=10)

Type of organization

N=51 (NA=10)

PROFESSIONAL BACKGROUND

Primary area of expertise

N=51 (NA=10)

Remarks

The majority of the attendees works in a (university) hospital (43%) and a university (26%).

Target audience set for this program are:

Medical oncologists, internal medicine doctors, clinical pharmacologists, hospital pharmacists, industry researchers.

This year’s meeting mainly attracted specialists in the field of pharmacology (57%), oncology (39%) and other (4%).

Most of the attendees are a reseacher (42%).




PROFESSIONAL BACKGROUND

Not indicated 20%

1 - 50 30%

51 - 100 10%

151 -200 10%

More than 250 30%

Average number of patients per year

Prescriber status

N=51 (N/A=10)



MOTIVATION TO ATTEND THE MEETING

N=51 (NA=10)



COMMUNICATION

Question(s) answered during registration

Awareness of the meeting

N=51 (NA=10)

Question(s) answered during the meeting

N=22 Too frequent Sufficient Not enough N/A

Frequency of electronic announcements (VE newsletters) 9% 86% 5% 7

N=21 Yes No N/A

Did the newsletters encourage you to register for this meeting? 62% 38% 8


PARTICIPANTS’ FEEDBACK

THURSDAY, 8 NOVEMBERSession 1: Pharmacological Challenges of Immunotherapeutics N=29

New Issues During First-In-Human Trials With IO Agents

Jean-Pierre DelordIUCT Oncopole, France

(Strongly) Agree Neutral (Strongly) Disagree N/A

Topic is interesting 86% 11% 3% 0

Content is relevant to my work 70% 19% 11% 2

Quantitative clinical pharmacology considerations for the development of Avelumab

Akash KhandelwalMerck Group, Germany




Biomarker in immuno-oncology, are we close?

Josep María PiulatsCatalan Institute of Oncology, Spain




Correlation between nivolumab exposure and treatment outcome in NSCLC

Sander Bins (#1)




Session 2: Dose individualization approaches N=29

Cytotoxic agents

Markus JörgerCantonal Hospitals, Switzerland




Targeted agents and monoclonal antibodies

Joseph CiccoliniAix-Marseille Université, France




INVITED LECTURES & ABSTRACT PRESENTATIONS

Attendees were asked to evaluate each presentation. The Organizing Secretariat distributed 61 feedback forms in both days. An average of 52 participants attended the meeting each day. An average number of 28 feedback forms were collected per day. This means the response rate was 53%.



Using pharmacogenetics to improve drug therapy: a 12 year experience with clinical implementation

Ron van SchaikErasmus Medical Centre, the Netherlands




A pharmacometric framework for dose individualisation of sunitinib in GIST

Maddalena Centanni (#2)




Therapeutic drug monitoring as a tool to reduce the occurrence of paclitaxel-associated peripheral neuropathy in patients with advanced NSCLC

Francis Ojara Williams (#3)




Session 3: Combination therapy – old school is becoming new school again N=28

Immunotherapy of prostate cancer and urothelial cancer. Future directions Winald GerritsenRadboud University, the Netherlands




Rationale for selecting combinations with immunotherapy Howard GurneyWestmead Hospital, Australia




A randomized bayesian phase 1 design combining an MPS-1 inhibitor with paclitaxel:A strategy to improve determination of the incremental toxicity of a novel compoundover a known backbone therapy Florence Atrafi (#4)






Session 4: Drug-Drug/Drug-Food/Drug-environmental interactions N=28

Drug-Drug interactions with targeted oncolytics (in particular PPIs and TKIs) Ron MathijssenErasmus Medical Centre, the Netherlands




Pharmacotherapy of Comorbities: Cancer Patients with HIV/AIDS Michelle RudekJohns Hopkins University School of Medicine, USA




Drug-drug interaction management with DDI-Predictor Michel TodFaculté de Médecine Lyon-Sud, University of Lyon, France




Novel online drug-drug interaction resource reveals clinically relevant interactions in >20% of the searches Stefanie Krens (#5)




Food intervention to make therapy with pazopanib more patient friendly and affordable Floor Lubberman (#6)




Session 5: Approaches to shorten phase II studies by the use of different read out endpoints N=28

The value of surrogate endpoints in the benefit-risk assessment of new drugs Gabe SonkeNetherlands Cancer Institute, the Netherlands


Topic is interesting 39% 46% 15% 0% 0% 0

Content is relevant to my work 18% 46% 29% 7% 0% 0

(Strongly) DisagreeClinical relevance of liquid biopsy in cancer patients Catherine Alix-PanabièresUniversity Medical Centre of Montpellier, France


Topic is interesting 50% 32% 14% 4% 0% 0

Content is relevant to my work 32% 25% 29% 11% 3% 0



A Pharmacokinetic-Pharmacodynamic binding model of Bevacizumab to VEGF as a tool to optimize treatment Apostolos Papachristos (#7)




A generalisable pharmacokinetic-pharmacodynamic (PKPD) model of savolitinib, a novel MET tyrosine kinase inhibitor, to explore extent and duration of target inhibition required for optimal efficacy across a range of tumour xenograft models Rhys Jones (#8)




Session 6: PK/PD studies and new strategies N=28

How studies can be optimized by simultaneous use of PK/PD outcome measurement?

Alwin HuitemaNetherlands Cancer Institute, the Netherlands




Altering dose and schedule to change the mechanism of action of targeted agents

Henk VerheulVU University Medical Centre, the Netherlands




The relationship between busulphan AUC and the incidence of sinusoidal obstruction syndrome in haematopoietic stem cell transplants Parth Upadhyay (#9)




Translation from mouse to human of pharmacokinetic-pharmacodynamic modelling of biomarker response – learnings from the AstraZeneca Oncology portfolio Rhys Jones (#10)






MEETING OJBECTIVES

N=28 (Strongly) Agree Neutral (Strongly) Disagree N/A

To gather professionals in the field of pharmacology of anticancer drugs in an interactive workshop setting 100% 0% 0% 1

To provide a platform for presentation and discussion of the latest pharmacological developments in the field 96% 4% 0% 1

To map current studies and latest results 93% 7% 0% 1

To translate new data to treatment opportunities 74% 26% 0% 1

To educate clinicians on pharmacological challenges that need to be addressed with the implementation of current and new drugs 92% 8% 0% 2

LEARNING OJBECTIVES


Recognize the pharmacological challenges of immunotherapeutics 98% 2% 0% 2

List different dose optimizations approaches for different agents 95% 5% 0% 2

Describe the different drug-drug/drug-food/drug-environmental interactions 93% 7% 0% 1

Reflect on the role of PK/PD in designing studies 80% 20% 0% 3

ONSITE ORGANIZATION

N=29 (Very) Good Average (Very) Poor N/A

Meeting venue 77% 23% 0% 7

Meeting rooms 95% 5% 0% 7

Audiovisuals 91% 9% 0% 7

Food & Beverage 91% 9% 0% 7

Onsite logistics 95% 5% 0% 7

Service level of Conference Secretariat 95% 5% 0% 7



GENERAL CONFERENCE EXPERIENCE

N=28 (Very) Good AAverage (Very) Poor N/A

Overall event experience 96% 4% 0% 2

Opportunity of networking 81% 15% 4% 2


Content was presented clearly 92% 4% 4% 2

Content is relevant to my practice 77% 23% 0% 2

N=28 0% 25% 50% 75% 100% N/A

What percentage of the content was new for you? 4% 19% 46% 23% 8% 2


Content was free from commercial bias (product selling) 84% 12% 4% 3

N=28 Too much Sufficient Not enough N/A

Time allocation for discussion 0% 96% 4% 2

Time allocation per presentation 8% 92% 0% 2


I plan to attend this event next time 88% 8% 4% 2

I would recommend this educational event to my peers 96% 4% 0% 2

POSTER VIEWING


The poster sessions were a valuable element to the program. 94% 6% 0% 12

The combination of the poster session and break was well-scheduled. 53% 41% 6% 11



Participants’ remarks

“Great opportunity to network and most importantly understand current trends in oncology drug development and treatment approaches.”

“Very informative workshop. Nice to hear the recent highlights of clin pharm in oncology in a concise manner.”

“Very pleased with positive/constructive/open discussions.”

“Very valuable meeting, lots to learn!! Thanks for organizing.”

“It is a very interesting meeting that offers the opportunity to learn new data and research approaches, new ideas of research. In addition, a lot of the presented data can be adapted to daily clinical practice.”

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NEEDS ASSESSMENT

N=20 Strongly Agree

Agree Neutral Disagree Strongly Disagree

N/A

There is a need for a program on clinical pharmacology of anticancer drugs 60% 35% 0% 0% 5% 0

Needs/gaps the respondents felt the field suffers from most (3 choices allowed): This year’s program met these needs/gaps?

Number of responses % Yes No N/A

Mechanism of interaction 10 19% 88% 12% 12

PK/PD modelling 11 20% 82% 18% 11

Drug development 10 18% 70% 30% 10

Novel diagnostic monitoring approaches 10 19% 70% 30% 10

Dose selections strategies 13 24% 85% 15% 7

A needs assessment was conducted during the meeting. 60% of the respondents (strongly) agreed that there is a need for a program on the clinical pharmacology of anticancer drugs. The respondents indicated that the scientific/research gaps they feel need to be addressed most urgently are understanding the dose selections strategies is urgently needed (24%). An average of 78% of the respondents agreed that this year’s program met the needs/gaps identified.

Remark

60% strongly agreed that is a need for program

on clinical pharmacology of anticancer drugs.

24% indicated that understanding the dose

selections strategies is urgently needed.

78% reported that this year’s program met the gaps

identified.


CONCLUSION

The Organizing Secretariat and Organizing Committee are pleased with the results of the 3rd International Workshop

on Clinical Pharmacology of Anticancer Drugs (ICPAD) as many participants indicated appreciation for the content of

the program. The majority also reported that their overall event experience was very good and that they plan to attend

this meeting again next time. Both the evaluation results and the needs assessment demonstrate the success and

importance of this workshop.

The Organizing Secretariat and the Organizing Committee will take all the feedback into consideration for the preparation

and development of the scientific program for 2019 edition.


ACKNOWLEDGEMENT

CONTRIBUTOR LEVEL

CORPORATE SUPPORT

ORGANIZER

ENDORSERS

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