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Oncology Leaders' Forum
Agenda | Day 1

We are now bringing together the programme for the Oncology leaders' Forum 2009 and the latest information is posted below. Please pop back to this page again soon for news on newly confirmed speakers and presentations.

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DAY 1 \| Monday, November 9th, 2009
7.15	Registration & buffet breakfast in the exhibition area
Morning plenary session Proving the value of R&D innovation in an era of healthcare reform and financial stricture

9.00	Chair’s introduction Wayne A. Rosenkrans, Jr, PhD, Distinguished Fellow, MIT Center for Biomedical Innovation; Program in Ethics & Systems Medicine, Georgetown University; Chairman & President, Personalized Medicine Coalition; Vice President, Strategic Consulting, Fuld and Co; Chief Applications Officer, SciTech Strategies
9.15	The Hidden Blockbuster - generating income from intellectual property in R&D Stuart T. Henderson, Americas Life Sciences Pharma R&D Leader, IBM Global Business Services
9.35	Questions & discussion
9.40	Analyst's perspective Future of pharmaceutical pricing power Overview of current system - patent protection offers temporary monopoly to incentivize innovation Government intervention will be large determinant of pricing going forward Potential HC reform outcomes include - monopsony buyer, direct government price negotiation Data show reduction in pharmaceutical price growth with increase in the growth of government's share of total spending on pharmaceuticals Unlikely US will implement QUALY spend cap (i.e. UK NICE-like structure) Biosimilar payment mechanism will have meaningful impact on future of biologics pricing (single- vs multi-source) Continue to expect value for innovative therapies targeting high-severity diseases and 'personalized medicine', but slower price growth Recent NCI report on high cost of cancer drugs - cost of therapy grew exponentially with advent of a few biologics Pricing to be driven more by meaningful (vs incremental) benefit, and increasingly difficult to show clinical benefit over available therapies Steven D. Harr, MD, Managing Director & Analyst, Morgan Stanley
10.05	Questions & discussion
10.10	Morning coffee in the exhibition area
10.50	Private insurer's perspective Healthcare reform is inexorably linked to payment reform making value based purchasing a reality Healthcare reform must include payment reform Payment reform will certainly create a transparency of both cost and quality Payment reform will require healthcare providers and suppliers to be engaged with, have responsibility for, costs in the new "value-based" healthcare system Financial responsibility by providers (bundled or global payments) and patients (value based benefit designs) will add new dimensions to the "informed decision" process Healthcare reform in Massachusetts is already addressing public reporting of healthcare complications, cost drivers, and recommending a new risk adjusted global payment methodology (to replace fee-for-service) Dr John Fallon, Senior Vice President, Chief Physician Executive, Blue Cross Blue Shield of Massachusetts
11.15	Questions & discussion
11.20	Multiple stakeholders' panel discussion & extended Q&A with the audience What is the best way to conduct healthcare reform in order to preserve R&D innovation? What are the various potential scenarios for the US healthcare environment in the mid- to long-term What will each mean for industry R&D strategists Which model is most likely to prevail? What have been the pros and cons of NICE in terms of its impact on industry R&D innovation in the UK, particularly in the oncology field? What are the implications of a universal healthcare model on clinical trial costs and timelines? Is the industry's traditional value-generating model broken? What do we mean by value? What experimental models are being tested to better understand and defend the value of your drug? Getting buy-in from payers much earlier in development Generating evidence at the R&D stage that will justify the economic value of the drug Using public data to focus on the differentiating features of a product Comparative effectiveness in oncology: What benefit is worth reimbursement moving forwards, particularly in the context of adding to/replacing the Standard of Care? Is survival going to be enough (and if so, how long?) or will curative treatments be the only reimbursable option? What would the ideal model for oncology pricing and reimbursement look like? Panellists: Lee M. Nadler, MD, Dean of Clinical & Translational Research; Director, Harvard Catalyst; Virginia & D.K. Ludwig Professor of Medicine, Harvard Medical School, Senior Vice President, Experimental Medicine; Director, Center for Clinical & Translational Research; Pan Mass Challenge Senior Investigator, Dana-Farber Cancer Institute Dr Blaine McKee, Senior Vice President of Business Development, Oncology, Genzyme Corporation Louise M. Perkins, PhD, Chief Scientific Officer, Multiple Myeloma Research Foundation
12.30	Buffet lunch in the exhibition area OR \| Working lunches Alliance and business models to enable pharma and biotech to develop innovative medicines together Moderator: Dr Eric de La Fortelle, Global Head, External Research & Technologies, Roche OR \| How should we drive the development and commercialization of oncology therapeutics in the adjuvant setting moving forwards? Moderator: Dr Jean-Pierre Bizzari, Senior Vice President, Clinical Oncology/Hematology, Celgene Corporation (Very interactive, informal discussion-based sessions for a maximum of 12 participants each)
FOLLOWED BY YOUR CHOICE OF 2 PARALLEL SESSIONS:

Focus session Steering oncology R&D models down the path to competitive advantage, and to the required level of innovation at manageable cost • How do you accurately define the value proposition of your oncology drug candidate at each stage of the discovery and development process?

1.50	Moderator's introduction Market size aside, where are we seeing the greatest innovation in oncology? Dr Laura K. Richman, Director, Pathology, Translational Sciences - Research, MedImmune, Inc
2.00	Questions & discussion
2.05	A new era with targeted drugs: New development approaches are needed to achieve success Can we make more effective go / no-go decisions in early stages of drug development to pick the winners to combine with, or replace, standard care? Does the use of biomarkers help or hinder? Combining targeted therapies: Science based or clinically driven? Is personalized health care a dream or reality? Dr Geert Kolvenbag, Global Product Vice President, Oncology, AstraZeneca
2.25	Questions & discussion
2.30	Short presentation... Case study: Building an oncology business at Genzyme Dr Blaine McKee, Senior Vice President of Business Development, Oncology, Genzyme Corporation
2.45	...followed by extended discussion/Q&A with the audience How to leverage smaller oncology markets like kidney? How can these niche indications be used to drive innovation and market development?
3.10	Panel discussion & extended audience Q&A Large, mid-sized and small pharma and biotech perspectives: Defining key target selection criteria in a rapidly changing world As markets/indications become more fragmented, how are the criteria and processes for valuing technologies in oncology R&D changing? What does the 'orphan' approach to an oncology indication really look like in commercial terms? What steps can you take to accurately assess at an early stage whether or not your drug candidate will have a viable path to regulatory approval and reimbursement? How should the increasingly critical aspects of product differentiation and labeling be integrated into R&D decision making at an early stage? How can biotechs make sure they are more product-oriented from the get-go? How should they decide on the target indication for their platform technology? Panellists: Dr David Urdal, Chief Scientific Officer, Dendreon Corporation Iain Cockburn, Professor of Finance and Economics, Boston University School of Management Dr Thomas W. Davis, Associate Director of Oncology, PTC Therapeutics
3.55	Moderator's closing summary
4.00	Close of session followed by afternoon tea in the exhibition area

Workshop Troubleshooting oncology clinical development on a global basis to overcome patient recruitment challenges in the Western hemisphere • What are the pros and cons of conducting trials in the US/Europe versus developing regions of the world? (Highly interactive session for a maximum of 30 participants)

1.40	Moderator's introduction Optimizing clinical trial designs and tactics to gain competitive advantage in the patient recruitment space on a global basis What is the optimal Phase II trial design in terms of efficiently accessing sufficient numbers of suitable patients? What designs have resulted in the highest and lowest success rates for subsequent Phase III trials? Capitalizing on potential collaborative strategies (eg with patient advocacy groups and online patient affinity groups) Roy Baynes, MD, PhD, Vice President, Global Clinical Development & Therapeutic Area Head Hematology/Oncology, Amgen, Inc
2.00	Questions & discussion
2.05	De-risking oncology clinical development Dr Clare Wareing, Founder & CEO, Nexus Oncology Ltd
2.25	Questions & discussion
What are the trade-offs in choosing a global clinical development program in terms of speed, quality of data and cost?
2.30	Foreign data as a pivotal part of a US drug approval Recognizing the greater role foreign clinical data will play on FDA drug approvals Understanding the US approval process as to foreign data Meeting the criteria so your foreign data will be accepted The use of foreign data in the IND process Rules concerning foreign data which have not been part of an IND Gary L. Yingling, Partner, K&L Gates LLP
2.50	Questions & discussion
2.25	Case study What steps may be taken to overcome the challenge of varying Standards of Care in different nations involved in an oncology trial, and the potential impact on the relevance of the data in the US and Europe? Review of the current situation Steps to be taken (e.g. selection of end points, data quality Our own experience Dr Philip Breitfeld, Senior Medical Director, Global Clinical Development Unit - Oncology, EMD Serono, Inc
3.15	Questions & discussion
3.20	Working party (Interactive panel & audience brainstorming session tasked with creating a 'road map' in 60 minutes) Building a 2-3 tier clinical development model for a small biopharma company to share risk, speed development (as much as possible) and possibly bring in an international aspect, without compromising data quality Panellists: Dr Nancy Simonian, CMO, Millennium Pharmaceuticals, the Takeda Oncology Company Louise M. Perkins, PhD, Chief Scientific Officer, Multiple Myeloma Research Foundation
3.55	Moderator's summary of the 'road map' and its key action points
4.00	Close of session followed by afternoon tea in the exhibition area

Afternoon plenary session Delivering alternative funding and co-development models to drive oncology R&D

4.40	Roundtable discussion & extended audience Q&A How and when should large companies get involved at early stages in biotech research? (Eg. through option agreements, big pharma/big biotech venture arm investment) What are the keys for biotech to capitalize on the increasing opportunities to develop products from big pharma portfolios? What do the economics of co-development in oncology look like? How are partnering trends and strategies between pharma and biotech evolving in oncology R&D, and what are the keys to securing the optimal partner in an increasingly competitive environment? Foundation funding: What are the potential issues/opportunities? Defining the role of consortia and other public-private partnering models in achieving efficient, successful development of oncology therapeutics What can be done by public and private partners alike to incentivize each other to enter such partnerships? Chair: Dr Geert Kolvenbag, Global Product Vice President, Oncology, AstraZeneca Panellists: Darren J. Carroll, Vice President - New Ventures, Eli Lilly and Company Dr Peter Halle, Vice President, Early Stage Licensing, Merck Serono Louise M. Perkins, PhD, Chief Scientific Officer, Multiple Myeloma Research Foundation
5.35	End of day 1 followed by a cocktail reception in the exhibition area

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