INTERNATIONAL WORKSHOP ON CLINICAL PHARMACOLOGY...

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EVALUATION REPORT

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CLINICAL PHARMACOLOGY OF ANTICANCER DRUGS 13 - 14 September 2017 • Madrid, Spain

2ND INTERNATIONAL WORKSHOP ON

EVALUATION REPORT

2Evaluation Report - 2nd International Workshop on Clinical Pharmacology of Anticancer Drugs 13-14 September 2017, Madrid, Spain

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The second International Workshop on Clinical Pharmacology of Anticancer Drugs (ICPAD) was organized on the 13th and 14th September 2017 in Madrid, Spain. It attracted 45 participants from 10 countries, including 11 young investigators from 4 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 ASSESSMENTA needs assessment was conducted during the event. 94% 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 (29%), PK-PD modelling (28%), mechanism of interaction (17%), drug development (17%), and novel diagnostic monitoring approaches (9%). 93% of the respondents (strongly) agreed that this year’s program met the mentioned needs/ gaps.

INTENT TO CHANGEThe conference was very well received which is reflected by the evaluation results. 93% of the respondents indicated that the lectures given in this workshop have increased their knowledge of clinical pharmacology of anticancer, 59% agreed that the program was beneficial for the clinical management of their patients, 63% reported that they intended to incorporate the new information into the care of their patients.

PROGRAMThe program included 12 invited lectures, 10 oral abstract presentations and regular poster viewing sessions. Ample time was allocated for discussion. The evaluation scores of the presentations can be found on pages 14 - 17.

ABSTRACTSThe Organizing Committee received 19 abstracts, of which 10 were accepted for oral presentations and 18 for poster presentations.

89% of the respondents reported that the poster session was a valuable element to the program, and 89% indicated that the combination of poster session and welcome drinks was well scheduled.

FUTUREThe majority of the respondents very much appreciated the conference to such an extent that they would recommend the meeting to their colleagues (93%) and plan to attend the 2018 meeting (77%).

The Organizing Secretariat and the Committee shall revisit and take the comments given by the attendees into account for the preparation of next year’s event.

The ICPAD 2018 is scheduled to take place on the 8th and 9th November 2018 in Amsterdam, the Netherlands. In addition, a one day course dedicated to the industry participants will also be organized prior to the main event.

EXECUTIVE SUMMARY

“Excellent groups of experts, good scientific and educational content!”

“Interesting, very open, friendly atmosphere and easy for connecting with colleagues. Sessions very actual and speakers’ performance is really nice.”



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

Meeting Description .............................................................................. 5

Committees ........................................................................................... 6

Registrant Demographics ..................................................................... 8

Meeting Metrics .................................................................................. 10

Attendee Demographics ..................................................................... 11

Results of Needs Assessment ............................................................ 12

Results of Meeting Evaluation ............................................................ 13

Invited lectures, abstract-driven presentations ..................................14

Poster viewing and social programs ...................................................18

Intent to change ....................................................................................18

Meeting objectives ................................................................................19

Conference organization .......................................................................19

General conference experience ............................................................19

Participants’ remarks ...........................................................................20

Conclusion .......................................................................................... 21

Acknowledgements ............................................................................ 22

TABLE OF CONTENTS



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.

FORMATThis 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 AUDIENCEThe 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.

MEETING DESCRIPTION


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

George Demetri MD

Harvard Medical School, USA

Michelle Rudek PharmD, PhD

Johns Hopkins University, USA

Maria-Jesus Garrido PhD

University of Navarra, Spain

Lena Friberg PharmD, PhD

Uppsala University, Sweden


COMMITTEES

SCIENTIFIC COMMITTEE

INDUSTRY LIAISON COMMITTEEDinesh de Alwis, PhD Merck Research Labs, USA

Barbara Brennan Roche, USA

René Bruno, PhD Genentech, France

Owen Jones, PhD Astra Zeneca, United Kingdom

Bart Ploeger Bayer, Germany

Elisabeth Rouits, PharmD, PhD Debiopharm, Switzerland

Stephen Ackland, MBBS, FRACP, GAICD Calvary Mater Newcastle Hospital, Australia

Federico Innocenti, MD, PhD The University of North Carolina at Chapel Hill, USA

Stijn Koolen, PharmD, PhD Erasmus Medical Center, the Netherlands

Jan Schellens, MD Netherlands Cancer Institute, the Netherlands



REGISTRANT DEMOGRAPHICS

This section outlines key statistical information of the meeting registrants. Registrants were the persons who had pre-registered for the workshop, but not necessarily attended the workshop in the end.

NUMBER OF REGISTRATIONS45 registrations from 10 countries.

NUMBER OF YOUNG INVESTIGATORS11 young investigators joined the workshop this year.

The Netherlands 4 Germany 3

France 3 Australia 1

GEOGRAPHICAL DISTRIBUTION OF REGISTRANTSMost of the attendees came from the Netherlands (18%) followed by France (16%), United States (16%), Spain (13%) and Germany (11%).

Netherlands 8

France 7

United States 7

Spain 6

Germany 5

Australia 4

United Kingdom 3

Sweden 2

Switzerland 2

Italy 1

PROFESSIONAL BACKGROUND OF REGISTRANTS29% of the registrants work mainly as a pharmacist (PharmD), 16% are researchers (PhD), and 16% are pharmacologists. 37% of the registrants indicated that they work in the area of pharmacology and 27% work in oncology.

Occupation Type of organization

N= 45 (answers) out of 45 registrants N=45 (answers) out of 45 registrants



REGISTRANT DEMOGRAPHICS

Area of expertise

Multiple answers were allowed.N=70 (answers) out of 45 registrants



How did you become aware of this conference:

Multiple answers were allowed.

N=33 (answers) out of 31 feedback forms

I was motivated to attend this meeting because of:

Multiple answers were allowed.

N=74 (answers) out of 31 feedback forms

MEETING METRICS



ATTENDEE DEMOGRAPHICS

This section shows the number of the participants who actually attended the event. During the meeting, they were asked to fill out a needs assessment survey, and evaluate each presentation, logistical arrangements, and overall event experience. Their responses and feedback can be found on the next pages.

NUMBER OF PARTICIPANTS45 participants attended the ICPAD 2017.

PERCENTAGE OF RETURNING AND NEW PARTICIPANTASN=58 (answers) out of 60 feedback forms

NUMBER OF PARTICIPANTS PER SESSION13 September 14 September

AMSession 1: 44 Session 5: 38

Session 2: 42 Session 6: 37

PMSession 3: 42

Session 4: 41



RESULTS OF NEEDS ASSESSMENT

A needs assessment was conducted on Day 1 of the event. 94% 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 (29%), PK-PD modelling (28%), mechanism of interaction (17%), drug development (17%), and novel diagnostic monitoring approaches (9%). 93% of the respondents (strongly) agreed that this year’s program met the mentioned needs/ gaps.

BACKGROUND OF RESPONDENTSThirty-four percent of the respondents work mainly as pharmacists, followed by pharmacologists (21%), and researchers (18%).

Occupation There is a need for a scientific program on clinical pharmacology of anticancer drugs

N=44 (answers) out of 31 assessment forms Multiple answers were allowed.

N=31(answers) out of 31 assessment forms

Discussions on, which scientific gaps do you feel the field would benefit most from

This year’s program has met the above-mentioned needs/gaps you selected

N=87 (answers) out of 31 assessment forms Multiple answers were allowed.

N=29 (answers) out of 31 assessment forms



NUMBER OF RESPONDENTS PER DAY13 September 14 September

N=31 N=29

BACKGROUND OF RESPONDENTSThirty-six percent of the respondents are from pharmaceutical companies, followed by university (32%), and hospital (32%). 37% of them are pharmacists, pharmacologists (30%), and researchers (14%). Over 50% work in the field of pharmacology, followed by oncology (41%).

Type of organization Occupation

Multiple answers were allowed. N=66 (answers) out of 60 feedback forms

Multiple answers were allowed. N=84 (answers) out of 60 feedback forms

Area of expertise

Multiple answers were allowed.N=73 (answers) out of 60 feedback forms

Others:• Applied Mathematics (N=2)• Regulator (N=1)• Not specified (N=1)

RESULTS OF MEETING EVALUATION



INVITED LECTURES, ABSTRACT-DRIVEN PRESENTATIONS

WEDNESDAY 13 SEPTEMBER Session 1: PK of Monoclonal Antibodies N=31

ADA-formation and its effect on Mab PK Maria-Jesus Garrido, Spain

(Strongly) Agree Neither agree nor disagree

(Strongly) Disagree N/A

Topic is interesting 90% 10% 0% 1

Content is relevant to my work

67% 23% 10% 1

PK and PKPD considerations for dose selection in the development of pembrolizumab Dinesh de Alwis, USA





83% 14% 3% 0

Session 2: TDM for Targeted Therapies N=31

Model-based TDM for oncology drugs Ron Keizer, USA





71% 26% 3% 0

Physiologically based PK model vs. Population PK approach during drug development Italo Poggesi, Italy





80% 13% 7% 1

Session 3: Drug-Drug Interaction N=31

Oncology DDI Website Nielka van Erp, the Netherlands





74% 13% 13% 0

Clinical case discussions Howard Gurney, Australia





68% 22% 10% 0

Clinical case discussions Guillemette Benoist, the Netherlands





69% 24% 7% 0




Trough dabrafenib plasma concentrations can predict occurrence of adverse effects requiring dose reduction in metastatic melanoma. (Abstract # O_01) Marine Rousset, France





68% 26% 6% 0

Evaluation of a physiological based pharmacokinetic model to evaluate the influence of covariates on sunitinib exposure (Abstract # O_02) Ashley Hopkins, Australia





72% 19% 9% 0

Session 4: Drug Transporters and Epigenetic N=31

Drug transporters as modulators of chemotherapy toxicity Alex Sparreboom, USA



Topic is interesting 100% 0% 0% 3%


77% 17% 6% 0%

DNA-methylation of ADME genes Matthias Schwab, Germany





67% 20% 13% 0

Association of NR1I2, CYP3A5 and ABCB1 genetic polymorphisms with variability of temsirolimus pharmacokinetics and toxicity in patients with metastatic bladder cancer (Abstract # O_03) Litaty Mbatchi, France





69% 21% 10% 1

Quantification of anti-drug-antibodies impact on drug exposure of a new anti-cancer drug using a population PK (Abstract # O_04) Candice Jamois, Switzerland





70% 15% 15% 0




THURSDAY 14 SEPTEMBER Session 5: Optimal Study Design N=29

Optimal design – potential application in oncology drug development and clinical practice Andrew Hooker, Sweden





90% 7% 3% 0

Modeling of cardiac biomarkers in breast cancer patients treated with anthracycline and trastuzumab regimens (Abstract # O_05) Aureila De Vries Schultink, the Netherlands

Strongly (Agree) Neither agree nor disagree

Strongly (Disagree) N/A



75% 21% 4% 0

The use of mathematical modelling to predict efficacious doses and schedules from pre-clinical data for the ATM inhibitor AZD0156 in combination with irinotecan (Abstract # O_06) Michael Davies, UK





68% 21% 11% 0

Session 6: Cancer Drug Regulation N=29

Treatment optimisation in cancer drug regulation, adults / paediatrics Lucas Moreno, Spain





81% 15% 4% 0

Drug-exposure response models for safety and efficacy in the use of doxorubicin plus lurbinectedin (Abstract # O_07) Carlos Fernandez, Spain





74% 15% 11% 0

Assessment of the release of daunorubicin from liposomes after administration of daunoXome® using population pharmacokinetics (Abstract # O_08) Martina Liebich, Germany





56% 24% 20% 1




The impact of dose and simultaneous use of acid reducing agents on the effectiveness of vemurafenib in metastatic BRAF V600 mutated melanoma: a retrospective cohort study (Abstract # O_09) Nielka van Erp, the Netherlands





80% 16% 4% 1

Development of an online drug-drug interaction resource to support prescribing of oncolytics (Abstract # O_10) Nienke Lankheet, the Netherlands





79% 13% 8% 1




POSTER VIEWING AND SOCIAL PROGRAMS

N=27

(Strongly) Agree Neither agree

nor disagree


The poster session was a valuable element to the program 89% 11% 0% 1

The combination of the poster session and welcome drinks was well scheduled 89% 7% 4% 1

The workshop dinner (Networking Dinner) was well organized 100% 0% 0% 0

INTENT TO CHANGE

N=27

(Strongly) Agree Neither agree

nor disagree


The lectures given in this workshop have increased my knowledge of clinical pharmacology of anticancer drugs

93% 4% 3% 0

This program is beneficial for the clinical management of my patients 58% 42% 0% 14

I intend to incorporate the new information into the care of my patients 64% 27% 9% 14

%

I will be able to implement the gained knowledge without any problems 14%

Some of the following factors might prevent me from implementing the gained knowledge:

%

My current office and practice systems might not accommodate the changes 29%

My patients/ client might have trouble complying with these changes/ strategies 14%

These changes might be too time consuming 14%

The medications/ procedures discussed might not be available for my patients/ clients 5%

Other reason(s), please specify 24%

Other reasons:

• I don’t treat patients.

• Many clinicians in my hospital aren’t of PK, they don’t trust pharmacology, thus it is difficult to convince them to perform TDM.

• Impact is more on research.




MEETING OBJECTIVES

N=26

(Strongly) Agree Neither

agree nor

disagree


To gather professionals in the field of pharmacology of anticancer drugs in an interactive workshop setting

92% 8% 0% 0

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

88% 8% 4% 0

To map current studies and lastest results 62% 23% 15% 0

To translate new data into treatment opportunities 76% 12% 12% 1

To educate clinicians on pharmacological challenges that need to be addressed with the implementation of current and new drugs

84% 4% 12% 0

CONFERENCE ORGANIZATIONN=28 (Very) Good Average (Very) Poor N/A

Content of electronic announcements (newsletters) 88% 8% 4% 2

Frequency of electronic announcements (newsletters)

87% 13% 0% 3

Information on the conference website 85% 11% 4% 1

Online registration process 75% 13% 12% 4

Online abstract submission process 78% 11% 11% 11

Meeting venue 89% 11% 0% 0

Meeting room 82% 11% 7% 0

Audiovisuals 93% 7% 0% 0

Food & Beverage 100% 0% 0% 0

Onsite logistics 97% 3% 0% 0

Service level of Conference Secretariat 96% 4% 0% 1

GENERAL CONFERENCE EXPERIENCE N=28 (Very) Good Average (Very) Poor N/A

Overall event experience 100% 0% 0% 0

Opportunity of networking 100% 0% 0% 0

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

Time allocation for discussion 93% 7% 0% 0

Time allocation per presentation 96% 4% 0% 0

(Strongly) Agree Neither

agree nor

disagree


No commercial bias (product selling) perceived 96% 4% 0% 1

I would recommend this educational event to my peers 93% 7% 0% 0

I plan to attend this event next time 77% 23% 0% 1




PARTICIPANTS’ REMARKS• Excellent groups of experts, good scientific and educational content!

• Inspiring!

• Interesting, useful for networking, good panel of speakers.

• A nice choice of current (hot) topics and methods in the area of oncology bridging novel research and clinical practice. Great opportunity to network, and get in contact with colleagues with similar interests, from all over the world.

• Interesting, very open, friendly atmosphere and easy for speaking with everybody. Sessions very actual and speakers’ performance is really nice.

• Great organization.

• Great!

PROGRAM SUGGESTION• Program specialised/ worker representative to special area and modelling, network

development, etc.

• More PBPK& PKPD modelling.

• Modelling in the area/ connecting pharmacoeconomic aspects, invite speakers from EMAI for ?

• Combined principal and translational topics would be interesting.

• More place for pharmacological / clinical case in order to better share ideas and day-to-day practice either from academic/industry constraints.

• Include a choice of recline phard characteristics of latest confounds.

• Dare to go for at least 2 full days.

• Interested and development focus (now somewhat too academic focus) from drug industry & regulations.

• Less abstract driven presentation and more invited speakers. More session about new trial design.

• Strong communications/ focusing on original.

• Program of Day 1 was too long, please till around 16.30 hour.

• The poster that were also presented in oral presentation: this is a little bit double work. I really learned a lot form the invited speakers!




The Organizing Secretariat and the Organizing Committee are pleased with the results of the

second International Workshop on Clinical Pharmacology of Anticancer Drugs (ICPAD). Most of

the participants were impressed by the quality of the scientific content and the time allocation

for the discussions. The majority also reported that they were satisfied with the overall meeting

logistical arrangements and agreed it was a well-organized event. Both the evaluation results

and the participants’ remarks proved the success and the importance of this conference. The

Organizing Secretariat and the Organizing Committee will further discuss the preparation and the

development of the scientific program for the 3rd edition in 2018, scheduled to take place on the 8th

and 9th November 2018 in Amsterdam, the Netherlands. In addition, a one day course dedicated to

the industry participants will also be organized prior to the main event.

CONCLUSION

“Inspiring!”

“Great opportunity to network, and get in contact with colleagues with similar interests, from all over the world.”



ACKNOWLEDGEMENTS

SUPPORTER LEVEL SPONSORS

PARTNERS

MEDIA PARTNER

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