|
Day one - Wednesday 15 October 2008
|
8.30am | Registration and coffee
|
8.50am | Chairman's opening remarks
|
| | Dr Peter MacLennan, Director of Project Devt & Scientific Affairs, Orion Clinical Services Ltd
|
9am | Direction and strategies for oncology treatments
- Current state of oncology drug development and reasons for failure
- Proposed alternative state for improving success in oncology drug development
- Examples of oncology drug development strategies for early decision-making and maximization of probability of success
|
| |
|
9.30am | The value of the oncology drugs in development
- Review of recent deals by stages of development
- Is there space in the market for so many new products?
- Reimbursement issues
- Deal valuation
|
| |
|
10am | Morning Tea
|
| REGULATORY PERSPECTIVE |
|
10.30am | European regulatory perspective
- Requirements for regulatory submission
- Conditional approval
- Progression free survival verses overall survival
|
| | Dr John Warren, Expert Medical Assessor, Medicines and Healthcare Products Regulatory Agency (MHRA)
|
11am | US regulatory perspective
- Provide a perspective on the regulatory mechanisms for accelerating anticancer agent development and approval in the U.S. and necessity of a comprehensive development plan
- Discuss the endpoints for oncology registration studies including potential FDA review issues and how proper planning can reduce the potential for ambiguity as an outcome
- Assess the regulatory challenges of targeted therapies on design of global registration studies
|
| |
|
| DEVELOPMENT |
|
11.30am | Improving decision making in early clinical trials
- Limitations of extrapolations of early development
- Appropriate deployment pf biomarkers
- Choice of study populations
|
| | Dr Glen Clack, Clinical Development Director, Oncology: Early Phase, Astrazeneca
|
12pm | Use of adaptive designs for developing oncology compounds
- Possible novel/adaptive designs to consider
- Strategies for implementation them
- Addressing (and taking) scientific risks
- Addressing regulatory concerns
|
| |
|
12.30pm | Lunch
|
1.30pm | Predictive biomarkers in oncology drug development
- Understanding the disease, target and therapy
- Preclinical models for the discovery of predictive biomarkers
- The interplay between positive and negative predictors
|
| |
|
2pm | A look at the laboratory aspects of Biomarker analysis for quantitative assays
- Overview of Biomarker Assay “Issues”
- Choice of Laboratory & scientific consensus
- AAPS - LBABFG Biomarker Committee
- Validation recommendations
- Case Studies
|
| |
|
2.30pm | Speed networking
This is a revolutionary, exciting and quick way to meet fellow delegates and industry peers in a 45 minute session. These meetings are the starting point for networking throughout the event. Make sure you bring plenty of business cards!
|
3.15pm | Afternoon tea
|
3.45pm | Exploratory Imaging in Oncology Drug Development
- What is exploratory imaging?
- What clinical questions can be answered and does the cost justify it?
- Challenges with imaging when implementing multinational, multi-centre oncology trials: Novartis experience
|
| | Dr Haren Rupani, Global Head, Oncology Imaging, Novartis Pharmaceuticals Corporation
|
4.15pm | Strategies to optimise phase III oncology trials
- Improving patient selection and retention
- Strategies to optimise the use of targeted agents
|
| | Dr Jay Mei, Senior Director, Oncology Clinical Development , Novartis Pharmaceuticals Corporation
|
4.45pm | Model simulated design for cancer therapies
- Integration of systems biology, modelling and simulation
- Illustrating the applications of these tools in increasing the efficacy and productivity
- Case study
|
| |
|
5.15pm | Closing remarks from the chair
|
|
Day two - Thursday 16 October 2008
|
8.30am | Registration and coffee
|
9am | European perspective; who pays for innovation?
- New targeted therapies/treatments that are hitting the market
- Gaining market access
- Cost of new treatment who pays
- European healthcare providers expectations from industry
|
| |
|
9.30am | Strategies for developing successful oncology therapies
- Targets: Mixing the chemists with the molecular biologists
- Markers. Mixing the pathologists with the imaging experts
- Phase 0,1,2: Mixing the academic clinicians with the preclinical teams
- Patients: Mixing with the ethicists, advocates, and all the above
- Funders: Mixing industry (large and small) with academia, not-for-profits, civil servants and patients
|
| |
|
10am | Morning coffee
|
10.30am | Partnering in oncology drug development, what is big pharma looking for?
- Forces reshaping the Pharma Industry
- Oncology: success and its consequences
- What is Roche looking for in oncology innovation and partnerships?
|
| | Warwick Bedwell, Vice President and Global Head Business Development, Roche
|
11am | Case study: partnering in oncology drug development
- Clinical Development Partnership programme
- Innovative new ways to progress new drug candidates
- Case study: AZD0424
|
| |
|
11.30am | Optimizing strategies to fully capitalize on opportunities
- The importance of internal co-ordination and organisation within a large pharma company
- The importance of communication and relationship building with potential partners
- Successes in building up an oncology pipeline
|
| | Dr Margaret Beer, Senior Director and Head, Licensing and External Research, Europe, Merck Sharp & Dohme
|
12pm | Panel discussion: discussing the future direction for oncology drug development and overcoming challenges
|
12.45pm | Lunch
|
1.45pm | Are therapeutic cancer vaccines the perfect drug?
- Scientific rationale
- Synergy with other cancer treatments
- Clinical results
- Biomarker signatures
|
| |
|
2.15pm | Key principles Amgen’s targeted Oncology pipeline
- Innovative interdiction of important targets in the treatment and supportive care of the cancer patient
- Optimizing the therapeutic modality for the given target
- Having science and biology focus the development strategy
- Employing informative biomarkers where possible for appropriate patient selection
|
| |
|
2.45pm | Afternoon tea
|
3.15pm | Challenges in the development of a targeted therapy: gefitinib
- Early clinical data
- Results of pivotal studies and efforts to delineate subgroups of increased sensitivity
- Learning for development of future targeted therapies
|
| |
|
3.45pm | Gaining approval of Tykerb (lapatinib) a first in class therapy for breast Cancer
- Successful strategies for developing a first in class anticancer drug
- Early clinical data and clinical results
- Biomarkers in targeted therapy development
|
| |
|
4.15pm | Therapeutic antibodies in oncology: enhancing anti-tumor activity through antibody engineering
- Overview of therapeutic antibodies in oncology
- Antibody engineering and technologies to modify activities and effector function
- Brief review of two specific examples : CD19 and CEA-Bite
|
| | Dr Bahija Jallal, Vice President Translational Science & Head of Oncology, Medimmune
|
4.45pm | Closing remarks from the chair
|
