www.expertmedicalevents.com

ECADDCPCourse on emerging concepts in anticancer drug development and clinical pharmacology

Amsterdam, the Netherlands • 7-8 November 2018

Competitive insights for optimizing professional

performance and staying ahead of the curve

Accelerated learning for industry professionals

2www.expertmedicalevents.com Course on Emerging Concepts in Anticancer Drug Development and Clinical Pharmacology (ECADDP) - meeting prospectus

COURSE DESCRIPTION

TARGET AUDIENCEOncologists and clinical pharmacologists, particularly those in industry

Course DirectorMark Ratain, MDThe University of Chicago

The complex landscape of oncology drug development is moving away from traditional dosing based on toxicity. As conventional strategies

are becoming obsolete, it is vital for industry professionals to keep abreast of the novel approaches and modern tools that are becoming available in the development of anticancer drugs.

The course instructors are all internationally recognized experts in oncology drug development and/or clinical pharmacology, led by Mark J. Ratain, MD. This advanced course will focus on new directions in drug development strategies and will include discussion of drug combinations, immunotherapy, and oral dosing regimens. Mathematical approaches will be introduced, including studies on pharmacodynamic biomarkers and pharmacometric modelling of efficacy and toxicity.

This ambitious program will be delivered by the five internationally recognized oncology experts and thought leaders in an intimate and flexible setting, with generous time allocated to audience participation and availability of confidential sessions for company groups. A limited enrolment policy will also be put in place and will provide optimal networking opportunities and direct dialogue in a relaxed, informal, yet highly productive setting. This is a unique opportunity for oncologists and clinical pharmacologists involved in early clinical trials to optimize their professional performance and practice in an ever-changing and competitive landscape.

Welcome to the ECADDCP course.

FormatThis will be a small course limited to 30 participants, to allow maximal interactions with the five internationally recognized faculty. The course will include 10 lectures over 1 1/2 days, with ample opportunity for questions and discussions after each lecture. In addition, there will be five intimate breakout sessions over the lunch on Day 1 and over the breakfast on Day 2, each led by a faculty member, allowing attendees the opportunity to obtain individualized advice regarding subjects of their choice.

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COURSE DESCRIPTION

Unique course featuresThis course provides a unique opportunity for learning from international experts in oncology drug development and clinical pharmacology.

• Limited enrolment to ensure adequate opportunity for direct dialogue with course instructors

• Breakout sessions to discuss specific clinical pharmacology issues identified by participants, including an optional opportunity for confidential discussions with a course instructor

NEEDS STATEMENTTraditional oncology dosing paradigms focused on maximally tolerated dosage are no longer appropriate in the context of immunotherapy and target-based therapeutics. Virtually all new oncology drugs have a maximal effective concentration, yet oncology drug development continues to utilize outdated clinical trial designs with little attention to key clinical pharmacology issues (i.e., pharmacokinetics and pharmacodynamics), particularly in the context of immunotherapy and oral drug delivery. This course aims to fill that gap through a combination of lectures and breakout sessions with thought leaders in oncology drug development and clinical pharmacology in an intimate setting.

Course objectivesThis is an advanced course aimed at medical oncologists and clinical pharma-cologists working in the pharmaceutical industry. Although oncology drugs are markedly different than the drugs of the past, the industry continues to focus on defining the maximally tolerated dose. This course will discuss more sophisti-cated approaches to dose-finding that include evaluation of pharmacokinetics, pharmacodynamic biomarkers and pharmacometric modeling. Challenges in the development of combinations will also be discussed.

• To educate oncologists and clinical pharmacologists, particularly those working in industry, regarding emerging concepts in anticancer drug development and clinical pharmacology

• To provide an opportunity for course participants to consult with thought leaders in oncology drug development and clinical pharmacology

• To facilitate networking among course participants and thought leaders in the field

Learning objectives At the conclusion of the activity, participants will be able• To define appropriate strategies for identification of the optimal therapeutic

dose (and/or schedule) of a drug alone, or in combination with other drugs• To identify appropriate tools, such as biomarkers, pharmacometrics, and

simulation, to address common problems in oncology drug development• To interpret clinical pharmacokinetic and pharmacodynamic results in the

context of preclinical drug metabolism and pharmacokinetic data

PROGRAM OVERVIEW

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7 NOVEMBER

8:00 Registration & Welcome coffee

8:20 Opening and introduction

8:30 The clinical and economic importance of optimizing dose and scheduleMark Ratain, The University of Chicago

9:30

Placing preclinical drug metabolism and pharmacokinetic data in contextMagnus Ingelman-Sundberg, Karolinska Institutet

10:30 Coffee break

11:00 Redefining the primary objective of phase 1 trialsRuth Plummer, Newcastle University

12:00 Clinical endpoints useful for guiding early clinical developmentJaap Verweij, Erasmus Medical Centre

13:00 Lunch & Breakout session slots

14:00 Pharmacometrics for the non-pharmacometricianLena Friberg, Uppsala University

15:00

Using genetic and pharmacokinetic data from early clinical trials to guide subsequent clinical developmentMagnus Ingelman-Sundberg, Karolinska Institutet

16:00 Coffee break

16:30 Optimizing the use of pharmacodynamic biomarkersMark Ratain, The University of Chicago

17:30 End of Day 1

18:00 Networking dinner (optional)

8 NOVEMBER

8:00 Breakfast & Breakout session slots

9:00

Trial designs for the development of combinations of an investigational drug and a marketed drugJaap Verweij, Erasmus Medical Centre

10:00

Special challenges for the development of immunotherapy drugs and combinationsRuth Plummer, Newcastle University

11:00 Coffee break

11:30 Use of clinical trial simulation in oncology drug developmentLena Friberg, Uppsala University

12:30 Closure of the course

The program is subject to change.

FACULTY

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speaker

Magnus Ingelman- Sundberg PhD, BSc.Med Karolinska Institutet Sweden

Magnus Ingelman-Sundberg is Professor of Molecular Toxicology since 1996 and research group leader in Pharmacogenetics at the Department of Physiology and Pharmacology, Karolinska Institutet since 2006. He has more than 420 original papers, 24 500 citations (32 000 in Google Scholar) and an h-factor of 85 (ISI) or 104 (Google Scholar).

He is a member of The Nobel Assembly at Karolinska Institutet since 2008, a member of Academia Europaea and a member of Editorial Advisory Boards of e.g. Trends in Pharmacological Sciences (Edit Board), Pharmacogenetics and Genomics, Pharmacogenomics, Human Genomics, Drug Metabolism Reviews, Drug Metabolism and Disposition. His research focuses on genetics, epigenetics, polymorphism, regulation, function and toxicology of the hepatic ADME system with aims at understanding interindividual differences in drug response. Furthermore, he develops novel hepatic in vitro systems for studying liver function and validation of drug targets.

speaker

Lena Friberg PhD Uppsala University Sweden

Lena Friberg is a professor in pharmacometrics at Uppsala University, Sweden. She received her PhD in pharmacokinetics and drug therapy in 2003 from Uppsala University and spent nearly 2 years as a postdoc at University of Queensland, Australia. Her research focuses on development of population pharmacokinetic (PK) and pharmacodynamic (PD) models that increase the understanding of drugs’ desired and adverse effects, with a focus on anticancer drugs and antibiotics. She has received the Giorgio Segré Prize from EUFEPS for distinction in the field of PK and PD, serves as the chair of the scientific committee for the annual PAGE meeting on pharmacometrics and is deputy editor in chief for the journal CPT: Pharmacometrics & Systems Pharmacology.

She has published over 90 peer reviewed papers. Her current research is focused on development of predictive PKPD-models useful for quantitative translation of longitudinal drug effects from preclinical information to patients and from early to late clinical development. In the oncology area relationships between biomarkers, different adverse effects, tumor size, tumor activity and survival are evaluated to allow for improved understanding of correlations between the variables and for investigating consequences of different dosing regimens, both on a population and an individual level.

speaker

Ruth Plummer MD, PhD Newcastle University United Kingdom

Ruth Plummer is Professor of Experimental Cancer Medicine at the Northern Institute for Cancer Research, Newcastle University and an honorary consultant medical oncologist in Newcastle Hospitals NHS Foundation Trust. She is Director of the Sir Bobby Robson Cancer Trials Research Centre within the Northern Centre for Cancer Care, which is a dedicated clinical trials unit based within the regional cancer centre. She leads the Newcastle Experimental Cancer Medicine Centre and also the CRUK Newcastle Cancer Centre. She trained at Cambridge and Oxford Universities obtaining both a medical degree and scientific PhD before moving back home to Newcastle and settling with her family in Northumberland.

Her clinical practice involves leading on the systemic therapies for skin cancer, with a portfolio of trials across all phases of drug development. In addition, she runs a phase I all-comers practice, taking responsibility for one of the most active phase I unit’s in the UK.

Her research interests are in the field of DNA repair and early phase clinical trials of novel agents, taking the first in class PARP inhibitor into the clinic in 2003, ATR inhibitor in 2012 and MCT1 inhibitor in 2014.

This research is either based in the Sir Bobby Robson Cancer Trials Research Centre or in the Northern Institute for Cancer Research of which she is a deputy director. Nationally she chairs the Cancer Research UK New Agents Committee, and sits as a member of Cancer Research UK’s Clinical Research Committee and until recently Science Committee. She is a member of the MRC Stratified Medicine Group.

speaker

Mark Ratain MD University of Chicago United States of America

Mark Ratain is a graduate of Harvard College (A.B., 1976) and Yale University School of Medicine (M.D., 1980). His postgraduate training was completed at Johns Hopkins Hospital (Internal Medicine, 1980-3) and the University of Chicago Hospitals (Hematology/Oncology, 1983-6). He has been a faculty member in the Department of Medicine at The University of Chicago since 1986, and is currently the Leon O. Jacobson Professor of Medicine, Director of the Center for Personalized Therapeutics and Chief Hospital Pharmacologist. In addition, he serves as the Associate Director for Clinical Sciences in the University’s Comprehensive Cancer Center, and leads the University of Chicago’s phase I oncology trials program. Dr. Ratain is also one of the cofounders of Vi3C (Value in Cancer Care Consortium, www.vi3c.org), and currently serves as its Director and Treasurer.

Dr. Ratain’s research focuses on the development of new oncology drugs and diagnostics, and he is an international leader in phase I clinical trials, pharmacogenomics, and clinical trial methodology, with over 300 original publications. He served as the first chair of the Steering Committee of the National Institutes of Health Pharmacogenetics Research Network, as well as one of the first co-chairs of the National Cancer Institute Investigational Drug Steering Committee. He currently serves as co-Editor of Pharmacogenetics and Genomics, and is a past Associate Editor of the Journal of Clinical Oncology. He is the recipient of multiple awards, including the Research Achievement Award in Clinical Pharmacology and Translational Research from the American Association of Pharmaceutical Scientists, the Rawls-Palmer Progress in Medicine Award from the American Society for Clinical Pharmacology and Therapeutics, the Translational Research Professorship from the American Society of Clinical Oncology, a Honorary Fellowship from the American College of Clinical Pharmacology, and the Award in Clinical Excellence from the Pharmaceutical Research and Manufacturers Association Foundation.

FACULTY

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FACULTY

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speaker

Jaap Verweij MD, PhD Erasmus UMC The Netherlands

Jaap Verweij is Professor of Medical Oncology, and Vice-Dean of the Faculty of Medicine at Erasmus University Medical Centre. He served as chair of the Department of Medical Oncology, and chair of the Daniel den Hoed Cancer Center at the Erasmus University Medical Centre from 2008-2013, and as Dean of the Faculty of Medicine and Vice-Chairman of the Board of directors of Erasmus University Medical Center from April 2013 – September 2017. He currently also serves as Founing Dean of the Faculty of LifeSciences at the University of Siegen, Germany, since October 2017.

His main scientific interests are new drug development, including the performance of clinical phase I and early phase II trials, and the inclusion of pharmacokinetics and pharmacodynamics in these studies. He also has a major interest in the design aspects of early clinical studies. Besides his clinical activities, he has been the chairman of the Early Clinical Studies Group of the European Organisation for Research and Treatment of Cancer (EORTC) from 1993-1996, chairman of the EORTC Soft Tissue and Bone Sarcoma Group from 1996-1999, chairman of the EORTC New Treatment Committee, the EORTC New Drug Advisory Committee, and Vice-President of EORTC. He has also been president of the Connective Tissue Oncology Society (CTOS), chairman of the RECIST working group, and chairman of the Scientific Council of the Dutch Cancer Foundation. He has been editor of the European Journal of Cancer and associate editor of the Journal of Clinical Oncology.

He currently serves as vice-chairman in the Board of Governors of the Dutch Cancer Foundation, and as member of the Board of the American Society of Clinical Oncology (ASCO). In 2011 Jaap Verweij was appointed as fellow of the Royal Netherlands Academy of Arts and Sciences, and in 2017 as Fellow of the American Society of Clinical Oncology (ASCO). He has authored or co-authored over 700 scientific papers, and has given numerous lectures on a variety of topics at international meetings.

WHO SHOULD ATTEND

Oncologists and clinical pharmacologists, particularly those in industry, are encouraged to attend the course. Seats are limited as the course is intended for an intimate setting. Please register now to secure a space.

Online registration: www.ExpertMedicalEvents.com

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Early Fee 2000 eurosBefore/on 6 May

Full fee 2500 eurosFrom 7 May to 6 September

Late fee 3500 eurosFrom 7 September to 6 November

Networking dinner(optional item)

80 euros each

Breakout sessions ComplimentaryOnly available for the first 25 registrants*

Additionalnon-confidential

breakout sessions(optional item)

500 euros per person

The opportunity is possible upon request. It is subject to availability and requires that the instructor(s) of interest be identified.

Conditions:1. Attendees of the session might be from different companies2. Maximum of one instructor session

Confidential breakout sessions

(optional item)

2500 euros per session

The opportunity is possible upon request. It is subject to availability and requires that the instructor(s) of interest be identified.

Conditions:1. Attendees of the session have to be from the same company2. Maximum 5 participants3. Maximum of one confidential session per instructor

FEES

ENROLMENT

Logistical information

Date: 7-8 November 2018

Location: Amsterdam, the Netherlands

Venue:to be announced

This registration fee includes:• Access to the plenary talks• Course materials• Refreshments during the coffee breaks• Lunch on Day 1• Complimentary sign up for 1 breakout session for the first 25 registrants*

* There will be five intimate breakout sessions over lunch on Day 1 and over breakfast on Day 2, each led by a faculty member, allowing attendees the opportunity to have in-depth discussions with the expert of their choice. Each session allows a maximum of 5 attendees. Registrants may indicate their preferences for which expert they wish to meet with upon registration. The slots will be assigned on the basis of first-come, first-served.

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CONTACT

For more information, please contact us at:

Expert Medical EventsBiltstraat 106,3572 BJ UtrechtThe Netherlands

www.expertmedicalevents.comEmail: kun-chieh@expertmedicalevents.comMobile: +31 623 711 706Office: +31 30 230 7142

Kun-Chieh WuProject Manager