Phacilitate Oncology Leaders Forum 2006
Presentations
If you would like to purchase the documentation (Only available on CD) please email team@phacilitate.co.uk and we will confirm a price with you.
DAY 1 - Monday October 30th 2006
Morning plenary session
Government, industry and analyst perspectives on market potential and what it will take to commercialize novel combination and mono therapies for oncology
Chair’s introduction – VC perspective
Joel F. Martin, PhD - NO SLIDES PRESENTED
Analyst Keynote Address
5 year forecast of market size and potential opportunities for oncology therapeutics in US and globally
Thomas G. Roberts, MD, MSocSci
NCI Keynote Address
Working with FDA, CMS, industry, academia and patients to enhance oncologic drug development and improve their use for cancer patient care
Dr Gary J. Kelloff – SLIDES NOT AVAILABLE
Combining diagnostic capabilities with targeted therapeutics to expand post-approval markets: Case study of Campath, a monoclonal antibody targeting the CD52 antigen
Dr Blaine McKee
Panel discussion
Debating the future direction of combination, targeted and complementary therapies for oncology
Panellist:
Dr Gary Gordon - NO SLIDES PRESENTED
Main afternoon session
Early stage oncology development: Selecting the most promising targets and designing predictive preclinical and phase I/IIa trials
Chair’s introduction
Getting your drug into human trials quicker - how do you know when you have a hypothesis that’s worth testing in man?
Dr Jay Gibbons
What progress is being made with improving animal models as predictors of efficacy in humans?
Dr Cheryl Marks
Case study
Lessons from Erlotinib, a successful small molecule inhibitor of EGFR
Lee D. Arnold, PhD
Case study
Designing predictive phase II trials for targeted agents in oncology
Dr Rachel W. Humphrey
Panel discussion
Debating varying approaches to patient recruitment for early stage oncology trials
NO SLIDES PRESENTED
Breakout session
Optimizing benefit:risk ratios in oncology
Chair’s introduction
Dr Clet Niyikiza – SLIDES NOT AVAILABLE
Implementing risk management plans earlier in the development of oncology therapies
Dr Howard Fingert – SLIDES NOT AVAILABLE
Case study
Statistical issues in assessing benefit:risk in clinical trials
Dr Yusong Chen
Examining the effect on benefit:risk of using the accelerated approval mechanism to address Critical Path issues in drug development
Dr Grant A. Williams
Panel discussion
Strategically balancing safety with risk management concerns for industry, regulators and payers
NO SLIDES PRESENTED
Afternoon plenary session
How is industry moving forward with the development of combination therapies and the treatment of cancer as a chronic disease?
Developing therapies for chronic diseases: Similarities and differences in clinical development strategies between HIV and cancer
Dr Diane Harry
Panel discussion
Making progress with combination therapies – targeted/targeted and targeted/cytotoxic
Dr Diane Harry
Panellists:
Dr Joseph Purvis – NO SLIDES PRESENTED
Dr Grant A. Williams – NO SLIDES PRESENTED
DAY 2 - Tuesday October 31st 2006
Morning plenary session
Comparing current US, European and Japanese regulatory requirements for proving the safety and efficacy of novel oncology therapies
Chair’s introduction
Dr Michael Doherty – NO SLIDES PRESENTED
Keynote Regulatory Roundtable
US perspective
Dr Samir Khleif
European perspective
Regulatory requirements for proving the safety and efficacy of novel oncology therapies
Dr Bertil Jonsson
Japanese perspective
Toshi Kobayashi PhD
Imaging in oncology clinical trials
Dr Donald Rosen – SLIDES NOT AVAILABLE
Panel discussion
What needs to change to encourage the proactive development, validation and adoption of biomarkers and surrogate endpoints for oncology?
Panellist:
Dr Thomas Metcalfe – NO SLIDES PRESENTED
Lunch Briefing (sponsored by Althea Technologies)
From microarray data to clinical utility in less than 12 months: Applying a novel biomarker discovery and development engine for therapeutic success
Speakers:
Cyrus K. Mirsaidi
Joe Monforte, PhD
Panellist:
Gordon Vansant, PhD
Main afternoon session
Phase IIb and III trials for mono and combination oncology therapies
Chair’s introduction
Dr Joseph Purvis – NO SLIDES PRESENTED
Case study
Late stage clinical trials update on Tykerb as a mono and combination therapy for breast cancer
Maria Koehler MD, PhD
Case study
REVLIMID clinical development as monotherapy and as combination therapy
Dr Robert DeLap
Clinical development of panitumumab (VectibixTM) for the treatment of metastatic colorectal cancer
Dr David Chang – SLIDES NOT AVAILABLE
Case study
AbegrinT in melanoma: Clinical development and translational research
Dr Dirk Reitsma
Case study
Progress in the development of Provenge (sipuleucel-T) for the active immunotherapy of prostate cancer
Dr David Urdal
Panel discussion
Optimizing the timing and value of biomarker development during late stage clinical trials
NO SLIDES PRESENTED
Breakout session
Optimizing the application of imaging in the development of oncology therapeutics and diagnostics
Chair’s introduction
Dr Donald Rosen – NO SLIDES PRESENTED
Moving beyond RECIST with molecular imaging
Dr Carl K. Hoh
Case study
Practical considerations for imaging in clinical trials
Dr Haren D. Rupani
Panel discussion
Tackling the practicalities of integrating imaging information with other data collected throughout the clinical development cycle
Panellist:
Dr Donald Rosen – NO SLIDES PRESENTED
Afternoon plenary session
Panel discussion
Addressing the practicalities of data sharing and IP issues for tissue and blood-derived samples in oncology: Enabling pre-competitive collaboration via industry consortia
Moderator:
Dr Thomas Metcalfe
Panellists:
Dr Clet Niyikiza – NO SLIDES PRESENTED
Dr Bertil Jonsson – NO SLIDES PRESENTED
Dr Joseph Purvis – NO SLIDES PRESENTED
DAY 3 - Wednesday November 1st 2006
Morning plenary
Emerging business models for the co-development and reimbursement of diagnostics and drugs in oncology
Chair’s introduction:
What are the real opportunities in oncology diagnostics: How big will the market be?
Dr Charles C. Duncan
What are the emerging business models and practicalities for the successful co-development of diagnostics and drugs for oncology?
Roy D. Baynes, MD, PhD – SLIDES NOT AVAILABLE
Panel debate
How will the diagnostic element be valued and leveraged?
Panellists:
Kim Popovits
Julie Fleshman, JD, MBA – NO SLIDES PRESENTED
What reimbursement models are emerging for premium priced and combination products in oncology?
Thomas R. Barr
Panel discussion
What do patient advocacy groups need and how can industry work more effectively with them?
Panellists:
Julie Fleshman, JD, MBA
Dr Christopher Slapak – NO SLIDES PRESENTED
Main afternoon session
Case studies illustrating the route to approval for recent oncology therapies: How is patient benefit being assessed pre- and post-marketing?
Chair’s introduction
Dr Christopher Slapak
Case study
Approval of SUTENT for the treatment of patients with advanced renal cell carcinoma or gastro intestinal stromal tumor
Dr Charles Baum, MD, PhD
Genentech case study
Examining the recent approval of Tarceva for NSCLC and pancreatic cancer
Flavia Borellini, PhD
Panel discussion
How are phase IV study expectations and post-marketing surveillance differing?
NO SLIDES PRESENTED
Breakout session
Pricing novel and combination therapies for oncology
Chair’s introduction
Michael Pollock – NO SLIDES PRESENTED
Comparing pricing policies and regulations for oncology products in US, Canada and Europe
W. Neil Palmer
What strategic approaches are being taken to pricing oncology therapies?
Michael Pollock
Case study
Value based pricing in cancer diagnostics
Kim Popovits
Panel discussion
What pricing tools should be used and when?
NO SLIDES PRESENTED
