Focus session
Innovations in clinical trial design: How are translational research, and adaptive and randomized trials, creating opportunities to reduce attrition and improve dose selection in oncology?

12.00 Moderator’s introduction
Giulio F. Draetta, MD, PhD, Vice President, Worldwide Basic Research Oncology Franchise Head, Merck Research Laboratories

12.05 Making better use of translational research in the clinic: What role is it playing and what has it delivered to date?

• Providing early efficacy data
• What is the impact on patient stratification?
• Decision-making to drive and guide clinical trials
• Debating the pros and cons of the phase zero approach in oncology

Kerry L. Blanchard, PhD, MD, Chief Operating Officer - Discovery Research, Eli Lilly & Company

12.25 Questions & discussion

Case studies: Novel Proof of Concept approaches to support the decision to advance to phase III

12.30 Opportunities for joint phase I/II studies

• Benefits and limitations of phase I/II designs
  • Endpoints- other ways to consider common endpoints
  • Response rate - tumor measurement - waterfall plots
  • Progression - event counts, event rates
• Examples of the use of biomarkers - selection of targeted patient populations, dose selection

Renee Bailey Iacona, PhD, MPH, Director- Statistical Science, Oncology, AstraZeneca Phamraceuticals

12.50 Questions & discussion

12.55 Phase II: To randomize or not to randomize

• When should you do randomized studies in oncology?
• If you are adding your new drug to a regimen how can you prove effectiveness without randomization?
• What are the time, cost and value implications?
• What impact have randomized phase II trials had on attrition rates?

Dr Jeremy Barton, Senior Director, Medical Research, Biogen Idec

1.15 Questions & discussion

1.20 Buffet lunch in the exhibition area

OR | Working lunch sessions
(Very informal, discussion-based optional sessions for a maximum of 12 participants)

• Debating the pros and cons of target versus spectrum selective kinase inhibitors for current and future oncology applications
• Addressing the shortage of oncologists – what should industry and government be doing?

2.30 Case study
Randomized phase II trial design and execution in oncology

• Random or randomized - the role of early stage controlled clinical trials in the emerging biopharmaceutical company
• Controlled trials - where, when, how
• Controlled trials - regulatory perspectives and precedents
• Controlled trials - maximizing asset value
• Controlled trials - ten practical lessons learned

Dr Gary Acton, Chief Medical Officer, Antisoma

2.50 Questions & discussion

2.55 Adaptive trials for phase II and III studies in oncology

• Benefits of adaptive design
• Logistical and regulatory issues
• Using predictive probabilities
• A seamless phase I/II trial
• Two simultaneous phase I trials in one
• Finding the relevant tumor type for a drug
• A seamless phase II/III trial
• The future: Personalized medicine in research: Using many drugs in one trial; incorporating biomarkers, imaging, and adaptive randomization

Professor Donald Berry, Chairman, Department of Biostatistics & Frank T. McGraw Memorial Chair of Cancer Research, MD Anderson Cancer Center

3.15 Questions & discussion

3.20 Case study & panel discussion
How is adaptive design and PKPD modeling helping to define a biologically effective dose?

• What types of margins are necessary for oncology – wide or narrow?
• Dose selection for combination products
• Dose selection for targeted therapies

Jerald S. Schindler, DrPH, Vice President, Biostatistics & Research Decision Sciences, Late Stage Clinical Development Statistics, Merck Research Laboratories

3.55 Moderator’s closing summary

4.00 Close of session followed by afternoon tea in the exhibition area

OR | Workshop
Planning the development path to support pricing, reimbursement and launch strategies for premium-priced oncology products
- How might Patient Reported Outcomes be factored in and with what impact on price and reimbursement?
(Highly interactive session for a maximum of 30 participants)

12.00 Moderator’s introduction
Global pricing and reimbursement considerations in oncology: What are the biggest opportunities and pitfalls to be aware of?

• Reimbursement facts and figures: A look at the major markets globally and how they differ
  • Private vs national/public reimbursement and routes of access
• How are Patient Assistance Programs used globally?
  • How are they used to cap financial exposure in a given year?
• How are Patient Reported Outcomes (PROs) being applied to pricing and reimbursement decisions globally?
• Risk sharing and money back guarantees: Is it a sustainable model?
  • Taking a close look at the degree of exposure by product class
• How and why does off-label use vary from market to market and with what implications for launch?
• Dose range finding

W. Neil Palmer, Vice President, Pricing & Reimbursement, RTI Health Solutions

12.25 Questions & discussion

12.30 Case study
Examining pricing and reimbursement strategies for a premium-priced combination therapy

• Anticipating the right "comparator" regimens
• Reimbursement of regimens with more than one targeted therapy
• Accounting for differences across regions

Sharon Isonaka, MD, MS, Executive Director, Global Pricing & Payer Planning, Amgen

12.50 Questions & discussion

12.55 Case study
Building access strategies into development, registration and launch timing
Alison Ayers, Worldwide Commercial Head for Oncology, Pfizer

1.15 Questions & discussion

1.20 Buffet lunch in the exhibition area

OR | Working lunch sessions
(Very informal, discussion-based optional sessions for a maximum of 12 participants)

• Debating the pros and cons of target versus spectrum selective kinase inhibitors for current and future oncology applications
• Addressing the shortage of oncologists – what should industry and government be doing?

2.30 Case study
Pricing and reimbursement issues to consider when launching with a companion diagnostic

• Key factors influencing value capture
• Differences in diagnostic vs. therapeutic business environments
• The whole is more important than the parts

M. J. Finley Austin, PhD, US Head, External Research & Innovation Environment, Hoffmann-La Roche Inc

2.50 Questions & discussion

2.55 Presentation followed by panel discussion
When and how will Patient Reported Outcomes have a significant impact on reimbursement decisions and pricing strategies in oncology?

• What would regulators and payers want to see in terms of cost-effectiveness and value when it comes to PROs?
• What changes are required for the tools and questionnaires to be validated and accepted by regulators and payers?
• Putting a value on reducing the side effects of cancer treatment
• Patient and physician perspectives on the rise of evidence-based medicine and the application of PROs
• Generating PROs through patient registries – will they become the default position?

Michael Pollock, Vice President, Global Health Economics, Biogen Idec, Inc

3.55 Moderator’s closing summary

4.00 Close of session followed by afternoon tea in the exhibition area

Followed by:
Afternoon plenary session
Where is better characterization of the disease getting us in terms of increasing survival for cancer patients?

4.40 Moderator’s introduction
In the light of our new biological and molecular understanding, how adequate is the current characterization of a type of cancer?

• by cancer stage
• by cancer type
• Discovering and characterizing new drugs - are we looking in the right places?
  

Dr Jeffrey Hanke, Vice President, Cancer Research, R&D Boston, AstraZeneca

5.00 Genomics and cancer: Now that the human body can be sequenced at relatively low cost, what impact will there be on the landscape of cancer prevention, diagnosis and survival?

• How will we use it to understand susceptibility to cancers?
• Can we use it to predict toxicities?
• How will we use it for better diagnostics?
• What impact is it having in the clinic?
• What new technologies might help?
• In 10 years time we might all know our genome and cancer susceptibility – what will we do with that information?

Dr Richard D. Hockett, Senior Clinical Research Physician, Group Leader for Genomic Medicine, Department of Diagnostics & Experimental Medicine, Eli Lilly and Company

5.25 Questions & discussion

5.30 Panel discussion
What will it take to achieve a significant impact on survival?

• Increasing efforts in geno-mapping and connectivity to find the drivers of the disease
• Applying systems biology thinking to cancer drug development
• Developing new biologic combination treatment regimens that result in improved response rates and survival

6.00 End of day 1 followed by a themed cocktail reception in the exhibition area

Day 2 - Wednesday 29th October

7.30 Registration & buffet breakfast in the exhibition area

Morning plenary session
Proving clinical effectiveness in oncology
• How are alternatives to mainstream pathways and end points evolving, and with what impact on clinical trial design and approval?

9.00 Chair’s introduction
Robert J. Spiegel, MD, FACP, Senior Vice President & Chief Medical Officer, Schering-Plough Research Institute

9.05 Regulatory perspectives
How do EU and US alternatives to mainstream approvals in oncology compare?

• To what extent are the agencies collaborating?
  • Orphan drug status
  • Conditional approval and drug safety monitoring during conditional approval period
• Where do the main areas of inconsistency lie and how might this evolve?
• What is the advice for companies wanting to make compatible efforts to satisfy EU and US regulatory agencies?
  • What if regions use a different standard of care as a comparator? How open to this are the regulators
• Recent controversies in FDA product approval
  • Avastin approved despite a "no" vote from its Advisory Committee, and no demonstration of survival or quality-of-life improvement
  • Provenge not approved despite a "yes" vote from its Advisory Committee, and clear demonstration of survival improvement

Professor Eva Skovlund, Senior Adviser, Norwegian Medicines Agency
Gary E. Fishbein, MD, MPH, Senior Medical Director, Oncology, PharmaNet Development Group, Inc

9.45 Questions & discussion

9.50 Getting the most out of peri-approval trials: Conception, planning and execution

• Peri-approval trials are a way of gathering information on the potential for drugs being developed in oncology and offer an unprecedented opportunity to explore the scope of effectiveness across indications and combinations
• The extent of the opportunity can be thought of as a "jigsaw" that when put together will provide a complete picture of where the drug fits in the therapeutic arena
• The process needs to be controlled centrally and be structured around a robust plan
• The planning process has to take into account the mode of action of the drug and how it would best be utilized
• The appropriate use of advisory boards and Target Profiling will guide this process
• The implementation of these studies needs to be carefully controlled and economies of scale maximized and unnecessary duplication minimized
• The peri-approval process offers a further opportunity to create interest in the drug but preferably with studies that are shown to be properly conducted and with sufficient data to provide convincing results

Dr Robert M. Miller FRCS MBBS FFPM, Chief Medical Officer, Fulcrum Pharma plc

10.10 Questions & discussion

10.15 Case study
Avastin registration for treatment of metastatic breast cancer

• What were the main issues in the pivotal study from the regulatory perspective?
• What lessons have been learned regarding Progression-free survival (PFS) versus overall survival, particularly in open label studies?
• What registration differences between the EU and the US does this case study highlight and with what lessons for future submissions?
• How can we narrow the gap between clinical practice and regulatory expectations?

Christopher Bowden, MD, Senior Group Medical Director, BioOncology Development - Avastin, Genentech Inc

10.35 Questions & discussion

10.40 Panel discussion
Revisiting the notion of inferiority / superiority in an era where we have biomarkers that can characterize subsets of the population

• What do inferiority / superiority really mean in an era of population subsets?
• Demonstrating superiority in a population subset in the absence of a validated marker
• Is there a possibility of gaining approval for a biomarker selected population across all tumor types i.e. anyone who expresses a certain marker in their tumor rather than doing a separate trial in each tumor type?
• What are the views of the patient and physician community – how would they define and determine superiority?
• What would it take to design a clinical trial based on Patient Reported Outcomes which would meet with regulatory approval?
• How might the treatment of an ageing population lead to adaptation of end points in oncology?

Panellists:
Richard Simon, DSc, Chief, Biometric Research Branch, National Cancer Institute
Robert Glassman MD, Managing Director, Healthcare Investment Banking, Merrill Lynch & Co

11.20 Morning coffee in the exhibition area

Focus session
The economics of oncology clinical trials: Practical case studies illustrating how biopharma can control and reduce the cost of each element of oncology drug development

12.00 Moderator’s introduction
Identifying the key economic metrics of clinical trial management – and ultimately how to speed up the process and reduce costs

• Trial start up: Minimizing the time and cost of translating from the lab to the clinic by dissecting out the core cost elements:
  • Regulatory review
  • Scientific review
  • Safety Risk Management
  • Patient and physician recruitment
  • Reimbursement for patient care
• What are the alternatives to imaging technologies - and with what impact on the economics of clinical trials?
  • Biomarkers
  • Adaptive trials

Dr Howard Fingert, Senior Director & Clinical Lead, Signal Transduction Development Program, Pfizer Oncology

12.25 Questions & discussion

12.30 Case study
Cohort selection and patient stratification: How is upfront segregation of patients impacting the economics of trial design and execution?

• Using gene expression profiling or flow cytometry to stratify patients for risk
  • What are the cost implications?
• Should we conduct clinical trials guided by biomarkers?
  • Do we know enough to take the risk?
  • What are the pros and cons economically?
• How does patient stratification impact the cost of patient and physician recruitment?
• Upfront patient selection vs stratification (with predefined analysis) vs retrospective analysis of trial data

Dr David D. Chang, Vice President, Global Clinical Development, Oncology Therapeutics, Amgen

12.50 Questions & discussion

12.55 Case study
Investigating the economics of clinical trial design for combination products in oncology

• How and when to cooperate at the company level and the clinical level
• Who pays for what?
• Addressing the IP issues

Dr Robert E. Martell, Vice President & CMO, MethylGene

1.15 Questions & discussion

1.20 Buffet lunch in the exhibition area

OR | Lunch workshop | Sponsored by
(Highly interactive session for a maximum of 50 participants)
Strategic considerations for global oncology studies: Recruitment, retention, vendor management and quality
- Recent FDA interaction with FDA on percentage of US patients in registration trials
- Data quality, and Standard- of-Care considerations for global programs
- Impact of study start-up & close-out timelines that influence country selection
- Perception vs reality- oncology case study experience
Panellists:
Evette Riegel, RN, Director, Clinical Operations, Beardsworth
Art Gertel, Vice President, Strategic Regulatory Consulting, Medical Writing, & QA, Beardsworth

OR | Working lunch session
(Very informal, discussion-based optional sessions for a maximum 12 participants)
What are responsible and practical approaches to cancer drug development for rare pediatric indications?

2.30 Case study
Examining innovative approaches to physician recruitment in the US: What has been the impact on cost and speed of clinical trials?

• What initiatives are being used to help get the right patients into the clinic faster?
• How is physician reimbursement impacting recruitment rates?

Julie D. Maltzman, MD, Director, Oncology Medicine Development Center, GlaxoSmithKline

2.50 Questions & discussion

2.55 Case study
Patient recruitment and global capacity: What are the economics and practical challenges of conducting global oncology clinical trials?

• Medical practice
  • Therapeutic strategy with comparators by region
  • Availability and standardization of biomarkers
  • Technology availability (eg pathology slides, laboratory testing)
• Definition of the patient population
  • Elements that need central review
  • Defining and adjudicating an efficacy or safety endpoint
• Selection of endpoints - PFS vs OS
  • Lack of convergent validity between regions may occur as a consequence of differences in medical practice
  • Differences in regulatory acceptance in EU vs US
• PRO endpoints
  • Validated instruments across diverse geographies
  • No accepted single instrument
• Changing landscapes - European directives and evolving global regulatory and US safety landscape
• Results driven by non-US sites
  • Sample size issues
  • Biological plausibility of extrapolating to US population
  • Lack of convergent validity
• Logistics - local presence, local operating company, local clinical, operational and regulatory expertise, service provider models, local footprint vs fully outsourced vs functional service provider
• Post study commitments

Dr Roy Baynes, Vice President, Clinical Development, Therapeutic Area Head, Oncology Supportive Care, Amgen, Inc

3.15 Questions & discussion

3.20 Panel discussion
Developing effective cost sharing and collaboration initiatives for patient care during clinical trials

• How should the cost of comprehensive patient care be reimbursed for participation in clinical trials?
• What are the options for financing a comparator drug that may not be reimbursed as standard of care for that indication?
• What innovative examples are there of payer/sponsor collaboration, particularly for niche indications?
• What are the pros and cons of using a collaboration / consortia approach to develop and pay for clinical trials?
• Collaboration with venture philanthropic groups
• As post-marketing study requirements will become more widespread who will pay for the drugs in the study?

4.05 Moderator’s closing summary

4.10 Close of session followed by afternoon tea in the exhibition area

OR | Workshop
Establishing regulatory pathways in oncology for:
• End points other than survival
• Combination therapy approvals
• Patient subsets identified through biomarkers
(Highly interactive session for a maximum of 30 participants)

12.00 Moderator’s introduction
What are the interim end points, surrogate end points and decision points we should be focusing on in the clinic? What other options are there besides survival?

• Examining the hierarchy from tumor response / biological / chemical response to progression-free survival and to overall survival
• When is time-to-progression useful – always, sometimes, never?
• What is "progression" and how do you define it? (in light of recent immunotherapy advances)
• If you believe your drug is purely an anti-metastatic how do you prove its efficacy? What end points should you use?

Richard Simon, DSc, Chief, Biometric Research Branch, National Cancer Institute

12.25 Questions & discussion

12.30 Case study
Strategic implications of 505 (b) (2) regulatory pathway to first approved indication: Clinical and commercial

• Examining how to define a meaningful increase in progression free survival
• When do response rates matter?

Dr Julie Lisano, Senior Medical Director, Abraxis Oncology

12.50 Questions & discussion

12.55 Experiences of the regulatory stance on end points for specific indications in oncology

• Are there good surrogate end points that will ultimately predict benefit to patients?
• Tumor response can be used as a basis for approval in some cases but not others – why?

Athena M. Countouriotis, MD, Director, Oncology Clinical Development, Pfizer La Jolla

1.15 Questions & discussion

1.20 Buffet lunch in the exhibition area

2.30 Industry experiences on how the regulatory view on combination therapy approval is evolving in the oncology field

• To which agency do you submit your IND and approval?
  • What strategy should you take?
• Practical examples of how companies are conducting trials
  • How and when is the regulator involved?
  • How do they collaborate?
• If the control arm method of use isn’t registered, how will it risk your chances of registration of the new product?
  • IMP and non-IMP designations in EU
• Clarifying the data collection issues - how is this being standardized?

Dr Rajesh Shrotriya, CEO, Spectrum Pharmaceuticals

2.50 Questions & discussion

2.55 Which regulatory pathway is most applicable to new oncology drugs indicated for a subset through a biomarker?

• How does it impact clinical trial design?
• Examining both negative and positive population subsets to decide whether the drug could still be useful for the those without the marker
• How will the identification of new population subsets impact on the label?

Professor Eva Skovlund, Senior Adviser, Norwegian Medicines Agency

3.15 Questions & discussion

3.20 Panel discussion

Imaging / non-imaging biomarkers as surrogate end points: Can you make tough no-go decisions in the clinic based on these surrogates?
Panellist:
Donald P. Rosen, MD, Founder & Chief Strategy Officer, RadPharm Inc

4.05 Moderator’s closing summary

4.10 Close of session followed by afternoon tea in the exhibition area

Followed by:
Afternoon plenary session
What’s on the horizon?
• New targets versus lifecycle management

4.40 Moderator’s introduction
Which is more compelling: To grow by launching new oncology products or by focusing on combinations of new and older agents?

Jens Oliver Funk, MD, Head, Oncology Therapeutic Area, Merck Serono Research, Merck KGaA

4.50 Panel discussion
In with the new….
Surveying the landscape: Which new therapies and targets are showing greatest promise? What light is there on the horizon?

• Cancer stem cells – do they represent new business opportunities or is it still a scientific activity?
  • How important are they really for cancer pathogenesis and treatment?
  • If we can kill them will cancer treatment improve dramatically?
  • Will trials be very different if we are aiming to kill cancer stem cells?
• SiRNA – translation from preclinical to clinical trials
  • What are the timelines
  • What is the likelihood of success
  • What are the biggest hurdles
• Evaluating the potential future impact of immunotherapeutics in oncology
• What else should be on horizon and how can they be ramped up?
  ……and in with the old…..
  The pendulum is swinging back to re-examining the cytotoxins and making them more effective by identifying defects/opportunities in the DNA Damage Response Pathway
• What are the latest developments to target DNA repair, cell cycle control and apoptosis?
• Update on PARP inhibitors
• Update on targeting apoptosis through BCL2 pathways
• What does it take to reintroduce an old drug for oncology? How would you manage your way through the IP system? What about the development process?

Panellists:
Markus Warmuth, MD, Executive Director, Oncology Drug Discovery, Novartis Institutes for BioMedical Research
Christine A. Carberry, Vice President, Program & Alliance Management, Biogen Idec

6.00 End of day 2 followed by a themed cocktail reception in the exhibition area

DAY 3 - Tuesday 30th October

7.30 Registration & buffet breakfast in the exhibition area

Morning plenary session
What evidence is there that biomarkers will be much more than just hypothesis-generating?
• What impact are they having on predicting response, reducing late stage attrition and raising the standard of care?

9.00 Chair’s introduction
Robert Glassman MD, Managing Director, Healthcare Investment Banking, Merrill Lynch & Co

9.10 Keynote address
Beyond HER2: Can biomarkers and personalized medicine live up to the promise of moving forward the development and application of treatments in oncology?

• Review of the current status of therapies that have reasonable biomarkers versus those that don’t
• Limitations of current biomarkers
• Characteristics of the ideal biological characterization

Dr David Parkinson, President & CEO, Nodality, Inc.

9.35 Questions & discussion

Case studies
New biomarkers as opportunities for predicting response and reducing late stage attrition

• Developing complex multiplexed prognostic and/or predictive profiles
• What will their role be - as a diagnostic used to stratify patients?
• Will they complement or compete with genome sequencing and transcription profiling?
• How will data and test quality be ensured?
• Which companies may develop diagnostics in this area?
• Will they be used for determining prognosis for diseases beyond cancer?
• Eg microRNA
• Eg methylation of MGMT

9.40 Case study
Learnings to date with the EGFR inhibitors

• EGFR inhibitors in the context of biomarkers (EGFR and Ras)
• Clinical phenotype: Females vs males; adeno vs squamous
• A look at recent EMEA approval in wild type Ras patients based on a retrospective analysis
  

Dr Neil W. Gibson, Vice President, Oncology Research Therapeutic Area Head, Pfizer La Jolla

10.00 Case study
Dr J. Carl Barrett, Global Head of Oncology Biomarkers & Imaging, Novartis Institutes of BioMedical Research, Inc

10.20 Case study
KRAS mutations in colorectal and non-small cell lung cancer

• Response rates in patients with KRAS mutant and wild-type tumors
• Progression free and overall survival
• Predictive or prognostic?
• Evidentiary standards to include KRAS data in drug labels

Nicholas Dracopoli, PhD, Vice President, Biomarkers, Centocor Research & Development, Inc

10.40 Panel discussion
What is the best way to build up a picture of prognostic and predictive markers in the absence of a control in the untreated population?

• Making tough decisions on whether a marker is truly predictive of survival or response
• How can we finance the validation of prognostic markers when companies generally have little motivation to pay for it themselves as they are focused on predictive markers?

Panellist:
Dr Pearl S. Huang, Vice President, Franchise Integrator, Oncology, Merck & Co

11.10 Morning coffee in the exhibition area

Focus session
Making the business case for bringing a companion diagnostic to market and planning a fully integrated development path

11.50 Moderator’s introduction
Gary Palmer, MD, JD, MBA, MPH, Vice President, Medical Affairs, Genomic Health, Inc.

11.55 How does pharma value diagnostics economically?

• What are the incentives for co-development?
  • Premium pricing?
  • Better patent and marketing exclusivity?
  • Better insurance terms?
• Moving cancer treatment earlier: How much more value would there be in therapeutics if they could be used earlier through the use of a diagnostic tool?
• Will diagnostics really help with patient recruitment for clinical trials?
  • How can they be used for differentiation within the clinical trial process and for the final product?
  • Will personalized medicine be applicable to late development?
• Does pharma fear segmentation of the population or do they see it as a way to get approval for a drug that wouldn’t make it otherwise?
  • Is the financial risk of diagnostic development lower than the risk of moving towards pay-for-performance reimbursement?
• What data do you need to justify the investment?

Stafford O'Kelly, President, Abbott Molecular Inc

12.15 Questions & discussion

12.20 Case study
How do you bring a companion diagnostic to market? What are the pre-requisites for success?

• Frequency of the marker: How often does it need to be present to be commercially viable?
• Assay validation - reliability and reproducibility of the test
• Standardization and clinical validation
• Fully integrating the companion diagnostic into the early drug development plan for a new molecule
• At what point should the development of diagnostic tools and therapeutic tools be integrated? Is PoC too late?
• Strategic collaboration and partnerships between R&D within diagnostics and pharma
• Planning ahead to guarantee that the assay will be ready at the time of launch

Dr Gerd Maass, Head of Research & Development, Roche Applied Science,
Roche Diagnostics GmbH

12.40 Questions & discussion

12.45 Panel discussion
How can we ensure that the companion diagnostics being developed will have practical application to patients and physicians as well as demonstrating value to payers?

• Focusing on practical application and value rather than just diagnostic features
• How will the information be communicated so the diagnostic test can be used and interpreted properly by patient/clinician?
  • Do community oncology groups really understand the tests and how to interpret them properly?
  • Collaborating to ensure standardized reporting across the US
• Can they be appropriately applied to specific tumor targets?
• Payer, physician and regulatory perspectives on the practical application and value of companion diagnostics

Panellist:
Jerry Lanchbury, PhD, Executive Vice President of Research, Myriad Genetics, Inc

1.15 Moderator’s closing summary

1.20 End of session followed by lunch & close of the Oncology Leaders’ Forum 2008

OR | Workshop
Progress with the use of newer imaging technologies: Will they have value as internal decision making tools, indicators of efficacy, or for regulatory approval?
(Highly interactive session for a maximum of 30 participants)

11.50 Moderator’s introduction
Molecular imaging approaches: How could they help drug development?
Susanta K. Sarkar, PhD, Director, Clinical Imaging, Oncology Medicine Development Center, GlaxoSmithKline

Case studies
What is the business value of imaging technologies applied for different purposes and at different stages of the clinical development pipelines and what is the optimal balance of a company’s resources between them?

• As internal portfolio decision-making tools in early development?
• As indicators of efficacy in phase II
• As providers of supporting data in phase III

12.05 FDG-PET as a quantitative imaging biomarker in oncology

• Introduction to the FDG-PET imaging technique
• How to incorporate FDG-PET in early phase clinical trials
• Advantages of metabolic imaging versus anatomic evaluation
• Pitfalls to avoid in FDG-PET analysis

Eric Perlman, MD, Director, Molecular Imaging & Biomarkers,RadPharm Inc

12.25 Questions & discussion

12.30 Dynamic contrast-enhanced MRI measures of tumor vascularity

• Brief introduction to DCE-MRI and what information it provides
• Preclinical data supporting use of DCE-MRI for novel vascular target
• Information provided from FIH study
• Lessons learned for future studies incorporating DCE-MRI

Dr Jeffrey L. Evelhoch, Executive Director, Medical Sciences, Imaging Sciences, Amgen

12.50 Questions & discussion

12.55 Panel discussion
Will advancements in imaging technology provide the time and cost savings necessary or should we be focusing elsewhere?

• Circulating tumor cell assays – will they replace PET as a means of substantially reducing the time needed to assess responses in a clinical trial?

1.25 Moderator’s closing summary

1.30 End of session followed by lunch & close of the Oncology Leaders’ Forum 2008

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