The document is about the 3rd Annual Adaptive Trials conference held in December 2009 in Brussels, Belgium, focusing on maximizing the potential of adaptive clinical trials. It outlines the conference agenda, including keynote speakers, case studies, and discussions on regulations, trial designs, and best practices in adaptive trials. The event features a variety of pharmaceutical companies, regulatory agencies, and experts aiming to share knowledge on effective trial methodologies and regulatory strategies.

1. Silver Sponsor: Sponsor: Organised by:
3rd Annual
Adaptive Trials 2009
Tuesday 8 and Wednesday 9 December 2009, Brussels, Belgium
Maximising the potential of your adaptive clinical trials
KEYNOTE SPEAKERS:
Sue-Jane Wang, Professor Andy Grieve,
Assoc. Dir., ADAPTIVE Department of Public
DESIGN, FDA Health Sciences, KING’S
COLLEGE LONDON
Michel Krams, Assistant
Vice President, Adaptive Christian Sonasson,
Clinical Trials, Clinical Information Science Office, This e
Development WYETH vent i
(provisional)
ASTRAZENECA
co-loc s
ate
with t d
Catarina Mattsson,
Bryan McDowell, Clinical Clinical Project Manager,
Explo he
Trial Head, Dermatology, ASTRAZENECA
NOVARTIS
ra
Pavel Pisa, Translational
Clinic tory
Thomas Sudhop, Director Medicine Leader, ROCHE
al Tria
and Professor, Head of
the Division for Scientific Philip De Ridder, Director,
ls
Services, BFARM JOHNSON AND JOHNSON
Dr Solange Rohou, Director Hans Ulrich Burger,
European Regulatory Biostatistics, Section
Affairs, ASTRAZENECA Leader, ROCHE
Alun Bedding, Director, THREE HIGHLIGHTS OF THE CONFERENCE
GSK
• Learn how new and existing
regulations are shaping the
future of adaptive trials
• Analysis of seamless phase II/III
adaptive trials and how their design
TOP COMPANIES REPRESENTED and logistics can maximise the
efficiency of your clinical trials
• GlaxoSmithKline • Schering-Plough
• Roche • Vifor Pharma • A selection of roundtable
• Novartis • Johnson and discussions to enable you to
• AstraZeneca Johnson exchange ideas and experiences on
• Merck & Co all aspects of adaptive design
Register now:
Online: www.adaptivetrials-events.com/2009 Email: book@arena-international.com
Tel: +44 (0)207 7753 4268 Fax: +44 (0)20 7915 9773

2. Programme Day one Tuesday 8 December 2009
08.30 Registration in order maximise the likelihood of regulatory acceptance for seamless trials
● Highlighting the differences between regulatory bodies to ensure that
09.00 Opening remarks from the Chair global adaptive designs are compliant internationally
● Phase III: identifying safety concerns and data validity in late
keynote openinG aDDress: phase trials
● Case studies to illustrate when an adaptive Phase III design is likely to
09.10 An industry update: defining the role of adaptive trials be acceptable
in a difficult economic environment and identifying Thomas Sudhop, Director and Professor, Head of the Division for
opportunities to use more efficient trial designs Scientific Services, BFARM
● Running an adaptive trial in an environment of restricted resources: Prof Bruno Flamion, FEDERAL AGENCY FOR MEDICINES AND HEALTH
ascertaining how the recession is affecting the trials PRODUCTS, BELGIUM
● Analysing progression in adaptive trials: how is the format developing Ingvild Aaløkken, Head of Section, NMA
and what trends are being observed and what does it mean for your
strategy? 12.10 Case Study: Dissecting successful and unsuccessful
● An appraisal of this year’s trials: tracking the successes in order to submissions to identify business critical factors that
identify opportunities enable you to succeed first time
● Forecasting how the adaptive market will progress in order to ascertain ● Analysing some unsuccessful attempts: identifying why the trials were
areas of growth not approved and the lessons that were learned
● Key questions to be answered regarding adaptive trials and their ● Achieving regulatory acceptance: identifying the characteristics of an
usefulness: identifying the lessons that need to be learned acceptable design
Provisional Speaker: Michael Krams, Assistant Vice President, Adaptive ● The research process: ascertaining whether or not the trial is well suited
Clinical Trials, Clinical Development, WYETH to an adaptive approach
● The design: how we went about fulfilling regulatory requirements
DeDucinG what the reGulators want: ● Answering key questions from the agency: identifying areas of
learninG their reQuireMent regulatory concern and redesigning the trial to take these into account
● Ensuring that interim analyses and final evaluation results in viable data
09.40 An update from the FDA: evaluating their position that meets the regulator’s approval
Sue-Jane Wang, Assoc. Dir., ADAPTIVE DESIGN, FDA Dr Solange Rohou, Director European Regulatory Affairs, ASTRAZENECA
Sue-Jane Wang will provide new insight into the FDA perspective
of adaptive clinical trials and the scientific principles involved. The 12.40 Optimising your approach towards Real Time Data
excusive content will help you to better understand the FDA attitude
Collection, Management and Reporting in order to
towards adaptive design and how they see the use of such trials
developing in the future. streamline the data analysis process:
● How to use an eProtocol tool to create an effective protocol design
10.10 Adaptive clinical designs: understanding the evolving ● Developing In-stream DB development using CDISC/ODM XML
Examining real-time data capture in adaptive trials: overcoming the
interface between developers and the FDA and other ●
challenges and creating the most effective possible stategy
regulators ● Real-time simulations, analysis and decision making: establishing new
● Going for an adaptive clinical study design: a “strategic game” with a solutions
corporate and a regulatory player Richard Young, Director, Business Development, Cmed
● Regulators on a learning curve: is it a deterrent for developers and how
can the situation be improved? 13.10 Lunch
● Trading inherent uncertainty for added insight: a challenging approach
for both sides but how can the risks be reduced? Stream A: Clinical Stream B: Statistics
● Trial simulations: developing joint roadmaps for handling clinical Establishing the Streamlining the design
decision scenarios logistical implications process: setting the
● Analysing pre-scheduling collaborative reviews, discussion and
reconsideration in adaptive designs
of running a successful groundwork for running a
● Establishing U.S. developments: evolution of the FDA position since the adaptive trial seamless adaptive trial
May 2006 Medical Device draft
● Understanding European regulatory frameworks: evolution of the EMEA 14.30 Case Study: 14.30 Designing an
position since the March 2006 “Reflection Paper” Enabling an effective drug adaptive clinical trial:
● Developments at the ICH: towards a globalized position on adaptive designs supply and distribution analysing the costs and
Hermann A. M. Mucke, H.M. PHARMA CONSULTANCY system: avoiding costly benefits from a statistics
10.40 The European regulator’s perspective on adaptive mistakes point of view
● Ensuring that the supply ● Uncovering the latest
designs: Ensuring that your trial is accepted department is sufficiently developments in statistics in
● What are the NMA and EMEA looking for in adaptive trial submissions? capable of dealing with the adaptive trials and the lessons
Developing a more thorough understanding of the key factors increased complexity of the that have been learned as the
● How can you make sure your submissions are successful? Establishing supply requirements for an number of completed trials
the critical characteristics of a successful submission adaptive algorithm increase
● Examining European case studies to identify which have been ● Just in time delivery: ● Key considerations when
successful and the characteristics which set them apart coordinating your approach designing an adaptive trial:
● Analysing areas of regulatory concern in late phase trials and identifying and avoiding overage and the preparing you for a new
possible solutions accompanying financial and approach
● Forecasting the future for adaptive trials from a regulatory perspective logistical consequences ● Identifying the types of
Ingvild Aaløkken, Head of Section, NMA ● If a dose arm is created or the adaptive trial and how to
11.10 Morning refreshments sample size changed, how can determine which variant is
outage be effectively avoided? most suitable
11.40 Regulatory Panel discussion: An exclusive opportunity ● Setting up your IVRS systems to ● Determining the most cost
to discover first hand what the regulators are looking cope with increased complexity: and time effective solution for
for and what the future might hold with a view to the basis for an effective supply your drug
clarifying your own approach chain ● Spotlight on resources:
● Analysing key requirements in early phase adaptive trials: a guide to ● Forecasting potential planning for the time
reducing the regulatory risk of embarking on an adaptive design changes to dosage and people involved in
● Evaluating areas of concern and pinpointing the key considerations

3. Programme Day one Tuesday 8 December 2009
levels and the patient profile: factoring in complexity in order to more designing an adaptive trial as opposed to a more traditional
accurately control costs and reduce error format
Michael Richter, Global Clinical Supply Coordinator, F. Hoffmann ● Use of Bayesian techniques in adaptive trials
LA-ROCHE Alun Bedding, Director, GSK
15.00 The implementation of a seamless trial from inception 15.00 Establishing the roles of short term endpoints in
to final report: running an effective trial clinical trials in order to plan more effectively
● Assessing what is required of your database: ensuring that you are ● Analysing the criteria for the use of a surrogate endpoint
equipped to deal with the increased heterogeneity and quantity of data ● Short term endpoints in Phase II proof of concept studies
and are able to access it quickly in order to record, and respond to, ● Incorporating short term endpoints in Phase II adaptive dose
interim analysis finding
● Developing an effective strategy when planning your trial: avoiding ● Using a short term endpoint in a Phase III study with delayed
costly mistakes response
● Understanding how electronic technology can shape adaptive clinical ● Short and long term endpoints in a seamless Phase II/III trial
trials Professor Christopher Jennison, Statistics, Bath University
● Identifying common pitfalls and how they can best be avoided
● Understanding the logistics of the final report, how it differs from that 15.30 Data analysis and trial adaptation for dose-finding
of a traditional trial and how to produce the best possible reports studies: making the right choices in order to
Bryan McDowell Clinical Trial Head, Dermatology, NOVARTIS maximise efficiency
● Determining the appropriate type of adaptation: correctly
15.30 Coordination and trial planning: maximising the identifying which change should be made
benefits of an adaptive design through effective ● Choosing the statistical analysis method taking the adaptive
management nature of the trial into account
● Critical insight into the breakdown of people involved in an adaptive ● Analysing which outcomes can be used to identify a necessary
rather than a traditional trial: preparing for a more flexible operation adaptation: early outcomes, primary endpoints and safety
● Coordinating more people under increased time pressure: maximising results
your efficiency in order to take best advantage of the potential benefits ● What are the implications for the logistics of the trial?
● Ensuring that your study managers are equipped to deal with adaptive ● Clarifying how to implement early stopping possibilities of an
trials: establishing the training implications adaptive trial in order to save money without compromising the
● Adapting communication strategy to ensure that with increased trial’s integrity
numbers of investigators involved, protocol amendments can be made Frank Miller, Principal Scientist, Statistics & Informatics,
quickly in order to save time and resources AstraZeneca R&D
Catarina Mattsson, Clinical Project Manager, ASTRAZENECA 16.00 Afternoon refreshments
16.00 Afternoon refreshments 16.30 Case study: Phase II adaptive design: worked
16.30 Effectively managing patients during a complex example using prior data and optimal design
adaptive trial theory
● Maximising the potential for increased efficiency in recruitment: ● Understanding the main aims of Phase II including
minimising the necessary patient numbers and devising an effective characterising dose-response and appropriate dose-selection
system for maintaining the optimum number of patients as the needs ● Adaptive designs based on dose re-selection after collecting
of the trial change some initial data appear attractive: analysing the potential
● Creating and maintaining a fast and efficient communication strategy benefits
capable of ensuring that your investigators and patients are fully aware ● Revealing more about an adaptive design that addresses the
of what the trial requires of them following issues:
● Ensuring that data collected during interim analysis does not ● Initial dose-selection
compromise the trial’s blindness in order to meet the requirements of ● Parametric model fitting to this initial data supported with
the regulator prior
● Randomisation challenges: as dosage arms change how can ● data from a drug with the same MOA
randomisation be effectively achieved? ● Final stage doses selected using optimal design theory
● The implications for patient information: ensuring that your patient is Dr Patrick Johnson, Statistician, VIFOR PHARMA
aware of the logistical implications of participation in an adaptive trial
in order to reduce patient drop out and maintain the integrity of the 17.00 Maximizing the usefulness of adaptive trials in
data collected early development
Pavel Pisa, Traslational Medicine Leader, ROCHE ● Why early development is a good setting for adaptive clinical
trials?
17.00 Panel discussion: Developing clinical best practice in ● Which early development trials are most suited for adaptive
adaptive trials clinical trials?
● Co-ordinating the trial from a personnel perspective: avoiding the ● Finding the right balance between statistical rigor and practical
pitfalls in order to create the most efficient strategy feasibility
● Effective data management in an adaptive trial: maintaining the ● What to worry about when considering a adaptive trial
integrity of your trial by handling data effectively ● Simulation as an indispensable tool to assess performance and
● Focusing on the supply chain in order to reduce wastage and maximise feasibility at the design stage
efficiency ● Exploring some case studies and analysing their outcomes
● Do the benefits of adaptive trials outweigh the costs? Filip De Ridder, Director, Biostatistics and Programming,
● What does the future hold for adaptive trials? Creating a clearer picture JOHNSON & JOHNSON PHARMACEUTICAL R&D
of their potential
Pavel Pisa, Translational Medicine Leader, ROCHE 18:00 End of Day One
Bryan McDowell, Clinical Trial Head, Dermatology, NOVARTIS
Michael Richter, Global Clinical Supply Coordinator, F. HOFFMANN
LA-ROCHE
Catarina Mattsson, Clinical Project Manager, ASTRAZENECA
18:00 End of Day One

4. Programme Day two Wednesday 9 December 2009
8.30 Registration ● Analysing the lessons learned and looking at how they can be
implemented in the future
9.00 Opening remarks from the Chair Professor Andy Grieve, Department of Public Health Sciences, KING’S
COLLEGE LONDON
9.10 Roundtable morning sessions
Round table discussions will enable delegates to choose 14.30 Design and Analysis Issues for Multi-Armed Adaptive
to join whichever debates are most relevant to their current Designs
challenges. All delegates will have the opportunity to ● Flexible adaptive designs: discussing the options
participate in 3 different groups. ● Multiple testing in multi-armed adaptive designs: uncovering effective
treatment arms
rounDtable 1: ● Sample size reassessment as an additional task: devising an optimum
strategy
Making it work for you: can a seamless phase II/III save ● Designing options relevant for assessing the statistical performance
time and money? ● Estimating the effect size in multi-armed designs
Weighing up the opportunities and risks of a seamless trial with a ● The need for comprehensive and user friendly software
view to reducing the risk involved Professor Gernot Wassmer, PhD., Institute for Medical Statistics,
Catarina Mattsson, Clinical Project Manager, ASTRAZENECA University of Cologne and Managing Director, ADDPLAN
rounDtable 2:
15.00 Case Study: How to design and manage a seamless
The supply process phase II/III trial in order to maximise the potential cost
An opportunity to develop a more thorough knowledge of the best
saving
method to reduce overage and avoid inefficacies
● Under what circumstances is a phase II/III trial viable and beneficial?
Thomas Kerbusch, Section Head PK-PD, SCHERING PLOUGH
● Scrutinising the design process: what was learned and what would we
do differently?
rounDtable 3: ● Overcoming challenges during the trial’s execution: what issues came
Statistical solutions: how does the design process up, why did they arise and how can they be avoided?
differ? ● The regulatory response: the key to a successful submission
Answering your questions on trial design and debating areas of ● Assessing how the write up and the next stages of drug development
concern with statisticians from across the therapeutic spectrum and are affected by choosing an adaptive trial
with experience in different areas of adaptive trials. Marc Vandemeulebroecke, Expert Statistician, NOVARTIS
Hans Ulrich Burger, Biostatistics section leader, ROCHE
15.30 Afternoon refreshments
rounDtable 4:
When is adaptive design appropriate? establishinG the business case for aDaptive
A chance for clinicians and statisticians to discuss the medical and trials: unDerstanDinG the financial risks anD
statistical characteristics of a trial that is well suited to an adaptive
benefits in orDer to MaxiMise the opportunity
approach
Marc Vandemeulebroecke, Expert Statistician, NOVARTIS for efficiency
rounDtable 5: 16.00 Taking a broad view: making adaptive designs work for you
● Learning practical lessons from case studies of adaptive trials and
Trial management logistics: co-ordinating a more relevant traditionally designed trials
complex operation ● Planning for the right decisions at early and final analyses
Ascertaining best practice in communication, training, and reporting ● Combining clinical, statistical, regulatory, commercial and operational
and ensuring that you are able to achieve the speed necessary to concerns to design the best trial
maximise the advantages of an adaptive trial ● Weighing the savings against the additional complexity of an adaptive
Christian Sonasson, Information Science Officer, ASTRAZENECA design
Robert Cuffe, Principal Statistician, Infectious Diseases Medicine
rounDtable 6: Development Centre, GSK
Regulation in adaptive trials: establishing what works 16.30 Panel discussion: Assessing the business viability of
and what doesn’t adaptive trials in all phases
An opportunity to discuss the new guidelines and share experience
● Does the time saved during the execution of the trial justify the extra
regarding how to reduce the regulatory risk involved in an adaptive trial
time taken during the design process?
Prof Bruno Flamion, FEDERAL AGENCY FOR MEDICINES AND HEALTH
● What is the potential for time savings and what savings are actually
PRODUCTS, BELGIUM
being achieved?
● Examining where improvements could be made in order to enable
12.30 Lunch adaptive trials to reach their time-saving potential
● Can time and money be saved on recruitment or does the increased
key case stuDies: pavinG the way for your complexity of the operation cancel out potential efficiency gains from
running seamless trials or ending trials early?
future efficiencies
● The supply chain: has the drug supply and distribution process proved
cheaper than it would be with a traditional trial of similar scale?
14.00 Case Study: Implementing a complex Bayesian adaptive ● Applying this knowledge to future trials: do adaptive trials save money
design in drug development and time and how can the savings be maximised?
● The importance of understanding the dose–response for successful Hans Ulrich Burger, Biostatistics Section Leader, ROCHE
drug development Thomas Kerbusch, Section Head PK-PD, SCHERING PLOUGH
● Efficient characterisation of dose-response Dr Patrick Johnson, Statistician, VIFOR PHARMA
● Planning the study: including regulatory interactions Pavel Pisa, Translational Medicine Leader, ROCHE
● Study results and learnings
● Avoiding key pitfalls: focusing on the challenges and how they were
overcome in order to develop effective strategies for the future 17.00 Closing remarks from the Chair and close of Day One

5. pre-conference workshop silver sponsor
Cmed provides CRO services and
Adaptive and Group unique clinical data technology.
Sequential Designs
Services include: clinical project
management and monitoring, data management (eDC/paper)
and statistical services. Cmed is rapidly gaining a reputation for
Professor Chris Jennison, University of Bath leadership in the adaptive trial design community through its
unrivalled ability to conduct complicated adaptive design studies
The workshop will introduce adaptive and group sequential
using patented intelligent data acquisition/management (iDAM)
methods for Phase II and Phase III clinical trials, with examples and
technology. As Cmed combines both CRO services and technology
opportunity for discussion of participants' own problems.
within a single organisation it can execute these studies particularly
About the workshop: efficiently without sponsors to coordinate multiple service
The workshop will introduce adaptive designs which make it providers. www.cmedresearch.com
possible to modify a clinical trial in mid-course. In Phase II,
treatment allocation rules can be based on the emerging shape of sponsor
the dose-response curve. In Phase III, it is possible to modify design ADDPLAN GmbH was founded in 2002 by
while preserving the type I error rate. Factors that can be changed Gernot Wassmer and Reinhard Eisebitt
include: sample size, treatment definition, primary endpoint, patient as a result of their collaboration with the
population, and the null hypothesis of superiority or non-inferiority. aim to apply the theory of adaptive study design to clinical research.
Topics will be illustrated by examples and discussion of problems The software package 'ADDPLAN Adaptive Designs - Plans and
posed by the participants. Analyses' started as a loose collection of programmes for adaptive
sample size calculation, which later were transformed uniformly
Workshop agenda into object oriented programming language and complemented by
further modules for the simulation and analysis of adaptive trials. The
9.30 Registration and coffee current release ADDPLAN 5 MC comprises sample size reassessment
10.00 Introduction and motivation procedures, planning and analysis issues for adaptive treatment
selection multiple comparison procedures, population enrichment
10.15 Combination tests designs, and much more.
10.30 Sample size modification for a nuisance MeDia partners
parameter Pharmaceutical Business Review:
10.45 Rescuing an under-powered study The Business Review websites are your
number one stop for all the latest news,
11.00 The role of group sequential tests comment and industry information.
Each Business Review website offers
11.45 Switching from testing for superiority to non-
content that is produced by a dedicated team of journalists and global
inferiority
industry experts. In addition to the free content made available on
12.00 Open discussion of examples and problems the sites an intelligence store will provide you with premium market
analysis reports from the leading global suppliers of market research
12.30 Lunch and industry analysis. Pharmaceutical Business Review is the world's
1.30 Testing multiple hypotheses leading pharma website, being used by over 100,000 visitors every
month. For further information contact jsharp@industryreview.com
2.00 Mid-study changes to treatment or endpoint
2.30 Enrichment: switching focus to a sub-population World Pharmaceutical Frontiers:
World Pharmaceutical Frontiers
The pharmaceutical industry is changing
www.worldpharmaceuticals.net
3.00 Break fast. There are more regulations, technologies, faster product
3.30 Adaptive dose allocation in Phase II trials launches and shorter product life cycles than ever before. World
Pharmaceuticals frontiers is, and will continue to be, at the forefront
4.00 Combining data from Phases II and III of these changes, so visit us at www.worldpharmaceuticals.net and
stay up to date with all latest developments.
4.15 Seamless Phase II/ Phase III trials: benefits vs
logistics ThePharmYard provides instant access
4.30 Case studies and discussion to a unique database of specialist
information which is particularly relevant
5.00 Close of workshop to individuals working within the medical
and pharmaceutical industries around the world. Titles from a
diverse range of independent publishers are available to purchase in
About the workshop leader
electronic document format for immediate access.
Christopher Jennison is Professor of Statistics and Dean of the
Visit www.ThePharmYard.com
Faculty of Science at the University of Bath, UK. He was awarded his
PhD from Cornell University for research into the sequential analysis
of clinical trials and he has continued to work in this area for the
supportinG association
past 25 years. He has written widely, particularly with Professor The Society for Clinical Data Management is a
Bruce Turnbull, on group sequential methods and adaptive designs nonprofit professional organization dedicated to
for clinical trials and their 2000 book "Group Sequential Tests with promoting excellence in clinical data management
Applications to Clinical Trials" remains a key reference in this area. through professional development, education and
certification. Key products and programs include
Good Clinical Data Management Practices, webinars
Do you wish to exhibit your proDucts anD services at this
exclusive event? and online courses, CCDM certification, an annual executive-level
Leadership Forum and an Annual Conference.Established in 1994,
If you want to be part of this leading industry event, please contact
SCDM has more than 2,600 members with an interest in advancing
Paul Adams in our sponsorship team. Email: pauladams@arena-
data management practices. For additional information, please visit
international.com or call: +44 (0) 20 7753 4259
www.scdm.org

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3rd Annual Adaptive Trials 2009, Tuesday 8 and Wednesday 9 December 2009, Brussels, Belgium
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Purchase Order No.
■ I enclose a cheque drawn on a UK bank (please make cheque payable to SPG Media Limited and write reference ADTR1209 on the reverse)
■ I will transfer payment to your Lloyds TSB account City Branch, London, UK: 01492549, sort code 30-00-02 (using reference ADTR1209)
■ I would like to pay with my credit card ■ Visa ■ Mastercard ■ AMEX ■ Maestro ■ Solo
Card Number: Expiry Date: Issue Date: CSV*:
Cardholder's Name:
Cardholder's Address:
*The CSV number is the last 3 digit number on the reverse of the card
■ Yes, I have read and understood the terms and cancellations conditions and am happy to proceed with my registration
Signature Date