What will follow monoclonal antibodies?
Examining key novel therapeutic modalities: What is the data to support claims that they will provide the next breakthrough in oncology?

Avoiding regulatory pitfalls associated with novel platforms in oncology

• The importance of a regulatory strategy to match the platform
• What to do when there are no pertinent guidelines
• How to optimize agency interactions to validate all stages of product development strategy
  

Dr Chris Holloway, Group Director of Regulatory Affairs & CSO, ERA Consulting Group

Short presentations & presentation-specific Q&A

RNAI and other oligonucleotide therapeutics
Delivering early clinical trial designs and data: What's the state of the art and chances of success for the field, and who are the biggest players now?
How are delivery issues being addressed
Active immunotherapeutics: What lessons has the sector learned in recent years and how is the pathway towards licensure being shaped?
How will they fit into the reimbursement picture given the likely need to combine them with other agents?
Can cancer stem cells inform drug development?
Antibody drug conjugates
Empowering antibodies to enhance targeted efficacy
Overcoming challenges to developing useful ADCs
SGN-35 – superiority of an ADC to a naked MAb in CD30+ malignancies
Understanding how to use ADCs in the clinic: drivers of safety and efficacy

Speakers:
Jeremy N. Rich, MD, Chair, Department of Stem Cell Biology & Regenerative Medicine, Cleveland Clinic; Professor, Department of Molecular Medicine, Cleveland Clinic Lerner College of Medicine at Case Western Reserve University; Co-Director, Center for Stem Cell & Regenerative Medicine, National Center for Regenerative Medicine
Dr David Urdal, Chief Scientific Officer, Dendreon Corporation
Dr Thomas C. Reynolds, Chief Medical Officer, Seattle Genetics
Jared A. Gollob, MD, Senior Director, Clinical Research, Alnylam Pharmaceuticals

...followed by panel discussion & extended audience Q&A
What is going to fuel oncology discovery pipelines in 5 years time?

• Is it really time to move on from kinases?
  • Has the area been fully mined, or have we not yet explored deeply enough?
• How must big pharma look to work with academia moving forwards given the potential shortfall in technologies entering their drug discovery engines over the coming years?
  • Is it time for a fundamental rethink on the pharma-academia relationship? Does pharma need to start partnering more aggressively with academia now?
  • Will/can Government help with combined pharma/academic discovery projects? What is pre- and what is pro-competitive in oncology in reality, and how should this enable more fruitful interactions between pharma, biotech, academia and other stakeholders?

Additional panellist:
Dr Cheryl Marks, Associate Director, Division of Cancer Biology, & Director, Mouse Models of Human Cancers Consortium (MMHCC), National Cancer Institute

Morning coffee in the exhibition area

Questions & discussion

Short presentations...

• Case studies: How do you incorporate a combination strategy into the early stages of R&D?
  

Dr Kevin Webster, Executive Director, Cancer BioScience, AstraZeneca

David Apelian MD, PhD, MBA, Senior Vice President of R&D & Chief Medical Officer, GlobeImmune, Inc

...followed by extended discussion & Q&A with the audience

• Given the financial repercussions, what is the optimal timing for commencing this work for both pharma and biotech companies?
• What predictive enabling technologies can assist in decision-making regarding combination strategy in the translational phases?

Short presentation...
What are the latest trial designs and data for combination therapies in development? How are the challenges in proving both safety and efficacy being addressed?

• Incorporating ADCS into the oncology armamentarium to improve patient outcomes. Case studies, to include:
  • Mylotarg
  • Traztuzumab-DM1
  • SGN-35

Dr Thomas C. Reynolds, Chief Medical Officer, Seattle Genetics

...followed by extended discussion/Q&A with the audience

• What is the optimal process for deciding on the best combination for your product?
• How should you meet the challenges presented by combinations of chemical and biological agents?
  

Moderator's closing summary

Lunch & close of the Phacilitate Oncology Leaders' Forum 2009

Working party
(Interactive panel & audience brainstorming session tasked with creating a 'road map' in 120 minutes)

Given the economic, healthcare and R&D trends, issues and advances discussed over the previous 2 days, what should the full R&D process, from basic research through to pivotal trials, licensure and reimbursement, look like for a cancer stem cell therapeutic entering the pipeline in the near future?
(Session ends with the Moderator's summary of the 'road map' and its key action points)

Panellists:
Roy Baynes, MD, PhD, Vice President, Global Clinical Development & Therapeutic Area Head Hematology/Oncology, Amgen, Inc
Dr Chris Holloway, Group Director of Regulatory Affairs & CSO, ERA Consulting Group
Dr Piyush Gupta, Researcher, Broad Institute
Dr Thomas W. Davis, Associate Director of Oncology, PTC Therapeutics

Lunch & close of the Phacilitate Oncology Leaders' Forum 2009