Making the most of the investments into developing new cancer therapies will not only increase the profits of pharma and biotech companies but will also radically alter the landscape in tackling all forms of cancer and give hope to sufferers that the disease is not the death sentence it once was. However there are still a lot of challenges facing pharma and biotech comapnies. Running oncology trials pose different challenges to those experienced with traditional clinical development. The whole clinical process from patient recruitment through to data analysis and regulatory frameworks is challenging. This is where expertise and learning from experienced professionals makes all the difference.

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Enhancing patient recruitment and streamlining
clinical processes to speed time to market
2-Day Conference: 27th – 28th April 2010
Pre-Conference Workshop Day: 26th April 2010
Venue: Le Meridien, Piccadilly, London, United Kingdom
www.OncologySummit.co.uk
Benefit from interactive case-study Engage with an expert speaker panel made up
of 15 leading oncology pharma and biotech
driven content that will enable you to: representatives
• Improve your patient selection and retention strategies by Ridwaan Jhetam, Global Tomas Skacel,
learning best practice from Wyeth, Oxigene and Eisai Clinical Operations Head: International Medical
Oncology Senior Director, Amgen
• Take away ideas on how to reduce cost and effectively project Director, Johnson
manage the trial from GlaxoSmithKline, Roche, Schering Jai Balkissoon, Senior
and Johnson
Plough and Johnson and Johnson Medical Director,
Mike Burgess, European Director of Oncology,
• Develop more robust processes for high quality data capture Head of Oncology Oxigene
and analysis to facilitate the different trial designs –Roche, Clinical Research and
Shanna
and Bristol Myers Squibb and present their experiences Early Development,
Stopatschinskaja, Global
Roche
• Learn how you can make best use of biomarkers throughout Medical Director
your trial from Michael Shi, Director, Biomarker Project Leader, Michael Zaiac, Assistant Oncology, Schering
Exploratory Oncology Department, Novartis Vice President, Medical Plough
Affairs EMEA,
Michael Herschel,
Join us on 26th April to gain in-depth insight into key clinical Transplant, Oncology and
Director Clinical
oncology challenges: GI, Wyeth
Research,
Workshop A: Effective risk management in clinical trial designs Michael Shi, Director, GlaxoSmithKline
This workshop will cover key issues including: Biomarker Project
Benedicte Akre, Medical
• The "Cradle to Grave" concept of managing risk Leader, Exploratory
Science Manager –
• Benefit:Risk management for oncology trials and global considerations Oncology Department,
Oncology, Bristol Myers
• Designing an effective Target Product Profile (TPP) Novartis
Squibb
• Development of a Clinical Development Plan (CDP) Denis Mir, Senior
• Mitigating risk with Risk Management Plans (RMP) / Risk Maps Manager, Clinical
Dana
Ghiorghiu,Research
Led by: Helen Usmar, Director, PharmaTracks Ltd Operations – Oncology,
Physician, Imaging
Workshop B: The use of biomarkers in oncology trials for more Eisai Global Clinical
Clinical Biomarkers
effective drug development Development
Group, AstraZeneca
You will walk away from this workshop with new information and Angus Dalgleish,
ideas on: Christiane Langer,
Foundation Professor of
• The validation of biomarkers Oncology, St Georges
Group Medical Director,
• The use of biomarkers for personalised medication Hospital Medical School
Oncology Clinical
• Advances in biomarker research and development Research Europe, Bristol
Led by: Michael Shi, Director, Biomarker Project Leader, Exploratory Giorgio Massimini, Myers Squibb
Oncology Department, Novartis Administrative Head of
Oncology – Thore Nederman, Head
What others have said about Pharma IQ events:
Europe,Roche of Clinical Development,
Great mix of presenters covering a comprehensive range Active Biotech
of topics-well done. Superb networking opportunity. Pfizer Tel: +44 (0)20 7368 9300
Very valuable, learned a lot, inspired Fax: +44 (0)20 7368 9301
Novartis Pharma AG Email: enquire@iqpc.co.uk
Media partners

2. Workshop A:
Effective risk management in clinical trial designs
10am – 1pm A
This workshop will discuss strategies to reduce trial risks and errors through effective trial design to ensure that the trial risk
factors are clearly identified. The aim is to match trial design to the goals of the study to minimise risks during latter trial
phases and maximise the success of early phase trials.
This workshop will cover key issues including:
• The "Cradle to Grave" concept of managing risk
• Benefit:Risk management for oncology trials and global considerations
• Designing an effective Target Product Profile (TPP)
• Development of a Clinical Development Plan (CDP)
• Mitigating risk with Risk Management Plans (RMP) / Risk Maps
Your workshop facilitator: Helen Usmar, Director, PharmaTracks Ltd
Workshop B:
The use of biomarkers in oncology trials for more effective drug development
2pm – 5pm
This workshop focuses on biomarker applications in oncology clinical development and will explore how to apply biomarkers to
B
address key challenges and opportunities in developing novel cancer therapeutics. The aim is to identify how to verify the
impact of novel drugs by monitoring pharmacodynamic biomarkers, evaluating molecular response and increasing drug
development predictability.
You will walk away from this workshop with new information and ideas on:
• Validation of biomarkers
• Use of biomarkers for personalised medication
• Advances in biomarker research and development
Your workshop facilitator: Michael Shi, Director, Biomarker Project Leader, Exploratory Oncology Department, Novartis
About Pharma IQ
Become a member of Pharma IQ and receive complimentary access to resources that will keep you at the
forefront of industry change. You will receive access to our growing library of multi-media presentations from
industry leaders, an email newsletter updating you on new content that has been added, free aggregated news feed from over
1000 global news sources tracking your industry and special member only discounts on events.
Become a member here: Web: www.pharmaceuticaliq.com Phone: +44(0)20 7368 9301
Media partners
Every weekly issue of Cancer Drug News reports the important news on the
companies, products, alliances and research that are shaping global cancer
markets with regular sections on cancers affecting the brain, breast, GI tract,
genito-urinary system, gynaecological system, blood and lung as well as
melanoma/sarcoma. For further information please visit: www.espicom.com/cdn
Medical News Today is the largest independent medical and health news site on
the web - with over 2,000,000 unique monthly users it is ranked number one for
medical news on Google and Yahoo!. Medical News Today is used by Blue Chip
pharmaceutical and health organizations, advertising agencies, PR companies and
vertical ad networks to deliver targeted disease/condition and general health
campaigns. For more information contact peter@medicalnewstoday.com or visit
www.medicalnewstoday.com.
www.OncologySummit.co.uk
Tel: +44 (0)20 7368 9300 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk

3. 08:30 Registration 14:10
Break-Out Roundtable Discussions: Participants will be able to choose
09:00 Pharma IQ Welcome and Chairperson’s Opening Address
between the different roundtables and spend 45 minutes discussing the
Mike Burgess, European Head of Oncology Clinical Research and
points outlined below before feeding back to the group
Early Development, Roche
Roundtable A
OPTIMAL PATIENT RECRUITMENTAND RETENTION STRATEGIES Planning and managing recruitment and retention
FOR SUCCESSFUL TRIAL SETUP Optimising patient recruitment strategies to ensure the right patient profile for
09:10 Successful patient retention through communication and studies and ensure long term trial success
understanding the motivation to participate in an oncology study Ridwaan Jhetam, Global Clinical Operations Head: Oncology Senior Director,
•
Working with patients to engage them in the study and establishing Johnson and Johnson
the most effective methods to reach them Roundtable B
•
Listening to study volunteers and developing sustainable relationships
Effective use of adaptive trial models to reduce the length of trials
throughout the trial
Utilising suitable trial adaptations to enable flexibility in the conduct of clinical
•
Knowing what patients want and need in order to maximise retention
studies
Michael Zaiac, Assistant Vice President, Medical Affairs EMEA,
Tomas Skacel, International Medical Director, Amgen
Transplant, Oncology and GI, Wyeth
Roundtable C
09:50 Effective marketing and communication approaches for maximising The use of biomarkers for personalised treatment in oncology
patient recruitment for a clinical study Obtaining accurate data on patient outcomes to allow investigators to make
•
Targeted marketing techniques to make best use of research budgets improved clinical decisions throughout the study
and speed the time to market for new treatments Michael Shi, Director, Biomarker Project Leader, Exploratory Oncology
•
Understanding the critical importance of effective communication Department, Novartis
with physicians
•
Providing consumable information for oncologists to communicate 14:55 Roundtable Facilitators’ Feedback to the Entire Delegation
with patients
15:15 Networking Coffee Break
•
Innovative techniques to reach prospective patients and investigators
•
Determining the most effective options in directly informing patients OPTIMISING IMAGING TECHNIQUES IN ONCOLOGY
about your trial DEVELOPMENT FOR IMPROVED PATIENT OBSERVATIONS
Jai Balkissoon, Senior Medical Director, Director of Oncology, Oxigene
15:45 Imaging techniques to generate reliable and time sensitive data
10:30 Networking Coffee Break during a clinical study
11:00 Developing successful strategies to maximise patient enrolment •
The potential of imaging techniques to advance clinical development in
•
Optimising your approach to recruiting patients with the right profile oncology
for your study •
Applications for the monitoring of treatment response during clinical
•
Compiling a comprehensive recruitment strategy to meet enrollment studies
objectives •
Utilising current technology to determine patient suitability for a trial
•
Key indicators to guide sponsors in determining the plan for recruitment •
Attaining faster, more reliable and accurate patient data to ensure a
•
Engaging with study sites, CRAs and other stakeholders cost and time efficient trial
•
Pinpointing problems during the recruitment stage – addressing lack •
How imaging innovations can impact cancer care in the future
of information and working with medical professionals to increase Dana Ghiorghiu, Research Physician, Imaging Clinical Biomarkers
patient enrolment Group, AstraZeneca
Denis Mir, Senior Manager, Clinical Operations – Oncology, Eisai Global EFFICIENT DESIGN AND PROJECT MANAGEMENTTO KEEP
Clinical Development TRIALS ON TRACK
QUICKER CLINICAL DEVELOPMENTTHROUGH THE APPLICATION
16:25 The changing nature of the pharma/academia relationship and the
OF ADAPTIVE TRIAL DESIGN
implications for successful early clinical development
11:40 Designing an adaptive clinical trial: the costs and benefits for long •
Identifying key trial goals and establishing effective communication
term clinical development in oncology with clinical research partners
•
Developments in statistics for greater use of adaptive trial models •
Establishing effective problem-solving strategies to manage trial
•
Considerations when designing an adaptive trial and identifying the challenges
most suitable model •
Agreeing action points to prevent problems with patient enrolment
•
Determining the most cost and time effective solution for oncology trials •
Validating the success rate of early phase trials
•
Adopting a Bayesian approach using formal, probabilistic statements Mike Burgess, European Head of Oncology Clinical Research and Early
Development, Roche
of uncertainty to determine how information from various sources will
be combined and how the design will change
Tomas Skacel, International Medical Director, Amgen 17:05 Overcoming operational challenges in large phase III/IV oncology
studies
12:20 Networking Lunch Break •
Identifying key goals of the phase III/IV trial and validating the success
rate of phase III trials
13:30 Panel discussion: Making the right choice in trial adaptation to
maximise efficiency and speed time to market •
Outlining risk factors for the phase III/IV trial to minimise the numbers
of failures
•
Analysing outcomes to identify possible adaptations
•
Understanding regulatory issues and compliance with data guidelines
•
Identifying what can be changed through analysis of early outcomes
Michael Herschel, Director Clinical Research, GlaxoSmithKline
•
The implications for trial logistics when changes to trial design are made
•
Maintaining trial blindness to ensure trial integrity 17:45 Chairperson’s Closing Remarks and Close of Day One
•
Assessing the pros and cons of adaptive designs

4. 08:30 Registration 14:10
Break-Out Roundtable Discussions: Participants will be able to choose
09:00 Pharma IQ Welcome and Chairperson’s Opening Address between the different roundtables and spend 45 minutes discussing the
Ridwaan Jhetam, Global Clinical Operations Head: Oncology Senior points outlined below before feeding back to the group
Director, Johnson and Johnson
Roundtable A
EFFECTIVE APPROACHES TO DATA COLLECTION AND MANAGEMENT TO Execution of clinical trials in small countries – defining the right target
FACILITATE REGULATORYAPPROVAL PROCESSES patient population and integration of biomarkers
Overcoming challenges in recruiting patients for smaller, localised trials and
09:10 Oncology data collection, integration and analysis
practical approaches to observing patient outcomes
•
Making the best use of available electronic tools to gather and share
Benedicte Akre, Medical Science Manager – Oncology, Bristol Myers Squibb
data quickly and efficiently in oncology trials
•
Identifying critical data elements for the most commonly used Roundtable B
oncology clinical trial endpoints Phase II trial designs in oncology - what really matters?
•
Managing different points of data entry – effective monitoring of data Designing a phase II oncology trial to ensure an optimal outcome using common
and innovative methods and preventing failure of the trial at a later stage
entry and quality
•
Overcome the challenge of integrating data sets across multiple trial sites Christiane Langer, Group Medical Director Oncology Clinical Research Europe,
Bristol Myers Squibb
Benedicte Akre, Medical Science Manager – Oncology,
Bristol Myers Squibb Roundtable C
9:50 Effective partnerships in oncology trials Effective partner selection and project management processes
• Optimal outsourcing strategies to safeguard trial design and aims Choosing and managing CROs - building proactive relationships for effective trial
• Solutions for cutting costs without compromising drug development management
Thore Nederman, Head of Clinical Development, Active Biotech
activities
• Identifying expertise and finding the right trial partner to fit the needs 14:55 Roundtable Facilitators’ Feedback to the Entire Delegation
of the trial
• Project management and monitoring to minimise delays and cost 15:15 Networking Coffee Break
overruns SAFETY MONITORING AND REPORTING STANDARDS FOR
Angus Dalgleish, Foundation Professor of Oncology, St Georges GREATER COMPLIANCE
Hospital Medical School
15:45 Panel discussion: Understanding the regulatory considerations
10:30 Networking Coffee Break surrounding cancer clinical trials
11:00 Managing the complexities of phase III paediatric oncology trials •
Amendments to clinical trials guidelines for continuous safety
monitoring and reporting requirements
•
Understanding the unique challenges and difficulties with paediatric
•
Detailed guidance on the collection, verification and plans for assuring
clinical trials
compliance with adverse event reporting
•
Maximising patient populations in phase III development
•
Monitoring the progress of trials and safety of participants and
•
Using biomarkers for effective patient analysis and trial adaptation
assessing the toxicity and effectiveness of a treatment intervention
•
Managing the transition from phase I/II to phase III trials
•
Guidance on Investigational Medicinal Products (IMPs) used in clinical
Giorgio Massimini, Administrative Head of Oncology – Europe, Roche
trials
SUCCESSFUL PROJECT MANAGEMENT OF CLINICAL PARTNERS •
Regulatory aspects of safety reporting, general MTD, MABEL
TO REDUCE TRIAL RISKS concepts, and IMP vs NIMP definitions and implications
11:40 Improving cost control in oncology trials through better supply chain MAXIMISING THE VALUE OF TARGETED THERAPIES: A CASE
management and internal communication STUDY IN PERSONALISED MEDICINE
•
Ensuring that drugs are where you need them, when you need them 16:25 Exploring Erbitux and Kras: lessons learned for personalised medicine
•
Variations in import restrictions across multiple trial sites
•
Establishing the purpose of personalised medicine
•
Working with manufacturing divisions throughout the planning process
•
Lessons learned from Erbitux: clinical benefit without and with patient
•
Establishing accurate drug estimates through collaboration with selection based on Kras
marketing, manufacturing and operations
•
Effective project management techniques for ensuring your study
•
Understanding implications for current and future development of
targeted drugs
runs smoothly
Shanna Stopatschinskaja, Global Medical Director Oncology,
•
Identifying special considerations in terms of research and
development, regulatory approval and commercial aspects
Schering Plough Christiane Langer, Group Medical Director, Oncology Clinical
12:20 Networking Lunch Break Research Europe, Bristol Myers Squibb
13:30 Effective internal and external partnerships in oncology trials EFFECTIVE APPLICATION OF BIOMARKERS FOR A BETTER
UNDERSTANDING OF PATIENT OUTCOMES
•
Optimal outsourcing strategies to safeguard the trial design and aims
of the study 17:05 Validating biomarkers in oncology drug development
•
Solutions for cutting costs without compromising drug development •
The use of biomarkers in clinical studies to develop novel cancer therapies
activities •
Utilising biomarkers in early clinical drug development to identify trial
•
Identifying expertise and finding the right trial external partners to fit errors early
the needs of the trial •
Techniques to generate accurate decision-making data
•
Making the matrix work for cross-functional teams involved in drug •
Increasing drug development predictability using biomarkers
development Michael Shi, Director, Biomarker Project Leader, Exploratory Oncology
•
Project management and monitoring to minimise delays and cost overruns Department, Novartis
Ridwaan Jhetam, Global Clinical Operations Head: Oncology Senior
Director, Johnson and Johnson 17:45 Chairperson’s Closing Remarks and Close of Day Two

5. WHO SHOULD ATTEND > Directors, senior managers and managers from the following
areas within pharmaceutical manufacturers and
biotechcompanieswith responsibility for:
• Oncology
• Clinical researchand development
• Clinical trials
• Clinical operations
• Medical affairs
• Drug development
• Pharmacokinetics and dynamics
• Biomarkers
• Imaging
Directors and researchers from oncology-focused
institutes and research organisations involved in:
• Oncology
• Clinical research and development
• Clinical trials
• Clinical operations
Sponsorship Opportunities Why Now?
Optimising Clinical Development in Oncology Between 2000 and 2020, the World Health Organization has
will be attended by senior officials and decision- predicted a 50% rise in the global incidence of cancer. To keep
makers from industry worldwide, bringing pace with the health needs of the growing number of young and
together buyers and suppliers in one location. old afflicted with cancer globally, clinical development in
Focused and high-level, the event will be an oncology is one of the fastest growing areas within the Pharma
excellent platform to initiate new business industry. The market is now valued at $55 billion and is forecast
relationships. With tailored networking, to increase to $78 billion by 2012.
sponsors can achieve the face-to-face contact
that overcrowded trade shows cannot deliver. Pharma and biotech companies are under pressure to find
Exhibiting and sponsorship options are innovative ways of speeding development times in order to
extensive, and packages can be tailor-made to claim their share of this lucrative area. However, oncology
suit your individual company's needs. poses unique patient recruitment, trial design and operational
challenges – issues that can waste invaluable resource and slow
For more information please contact regulatory approval.
sponsorship on +44 (0)207 368 9300
or email sponsorship@iqpc.com
What Does Pharma IQ’s Optimising Clinical
Development in Oncology offer?
This conference provides a unique platform for drug developers
to discuss practical, proven ideas to save time and money and
ensure that companies have the knowledge they need to take
their drugs to market fast.
This case study driven agenda will help you uncover ways to make
the incremental improvements to your clinical trials that can
greatly reduce the time it takes to get your treatments to market.
www.OncologySummit.co.uk

6. OPTIMISING CLINICAL DEVELOPMENTIN ONCOLOGY
2-Day Conference: 27th – 28th April 2010 Pre-Conference Workshop Day: 26th April 2010
Venue: Le Meridien, Piccadilly, London, United Kingdom
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