Biotech Track

10:00 Track Chair’s Opening Remarks
Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World, Inc.

10:15 Utilizing External Partners as Sources of Innovation for Specialized Development and Commercialization: An Emerging Trend in Pharma Development and Commercialization 
The presentation will discuss the factors driving pharma's utilization and integration of external partners as sources for innovative specialized development and commercialization. Some pharmaceutical companies are already experimenting with new models for pharmaceutical development and even commercialization. These new models for collaboration will be discussed and reviewed within the context of the industry’s increasing reliance on the traditional biotech sector for innovative discovery and exploratory development. 

• Optimizing organizational lifecycle/development structures in large pharmaceutical companies for full exploitation of a product with multiple therapeutic utility 
• Discussion and examples of the increasing identification of drug targets with an initial application on one therapeutic area having multiple indication potential in the future
• Discussion about the increase in multi-therapeutic potential products occurring at a time of increased pharmaceutical development resource constraint 
• Increased competition in the pharmaceutical industry and the inevitable pressure from the Biotech originator to see their product fully developed for all its key indications
• Highlights of a few examples of recent novel partnerships between large pharmaceutical companies and smaller pharma/biotech

Sanjay Jariwala, Ph.D., Director, Business Development & License, Co-Founder, President and Director, Aspreva Pharmaceuticals Corporation

10:45 Networking Coffee Break

11:15 Impacting Success in Clinical Development: Disease Genes, Synthetic Biology, and Genetic Risk-Based Clinical Trial Designs
This session will discuss tools and shortened timelines during the translation from discovery to development. We will examine how to use genetics to understand disease biology, translate disease biology into measurable endpoints of drug action in human PhI and PhII clinical trials, and choose the patients most likely to respond to the novel therapeutic.

• Measuring the impact of synthetic biology & automation of laboratory processes
• Screening for potential toxicity to improve clinical success and reduce attrition
• Managing API production through just-in-time processes, transitioning from mg to kg API production under cGMP, and impact of outsourcing strategies, CMO and off-shore
• The deCODE experience of a Phase 3 clinical trial design

Mark Gurney, Senior Vice President, Drug Discovery & Development, deCODE genetics, Inc. 

11:45 Addressing Pipeline Challenges Through Drug Repositioning
Speaker to be determined, GeneLogic

12:15pm Track Chair’s Closing Remarks

Pharmaceutical Track

10:00 Track Chair’s Opening Remarks
Andrew Chadwick, Principal Consultant, Life Sciences & Healthcare Practices, PA Consulting

10:15 Using Novel Approaches to Enhance Productivity in Preclinical Development
The new Learn and Confirm model of Wyeth R&D has radically changed the drug development process resulting in enhanced and sustained R&D productivity. This presentation will discuss how the Chemical and Pharmaceutical Development function can minimize drug attrition through enhanced focus on formulation development and drug delivery and reduce cost and cycle time through application of science and data-driven decision making as key guiding principles. Results will be presented on how we:

• Increased API deliveries significantly with decrease in API cost per batch
• Eliminated risk of additional impurity qualification studies 
• Increased the level of utilization in clinical supplies
• Decreased the turn around time for analytical testing from weeks to days and hours
• Implemented Quality By Design initiatives that resulted in increased manufacturing efficiencies
• Increased the number of high quality global regulatory submissions incorporating advanced navigational features of eCTD 

Parimal R. Desai, Ph.D., Vice President, Preclinical Development, Wyeth Research 

10:45 Networking Coffee Break

11:15 Pipeline Strategies and Challenges Across Therapeutic Areas.

• Busy pipelines; how much is too much?
• Strategies in decision-making, using the right tools
• What is transferable?

Charles Morris, MD, Vice President, Clinical Development, Oncology, AstraZeneca

11:45 Assessing the Strength of a Pipeline Portfolio
Clinical research and development is a high risk, high reward endeavor. To maximize the chances for success, organization must apply adequate resources to projects and determine which projects are most likely to succeed. That process starts with a careful analysis of thepipeline, with particular attention to the timing and the likelihood of success for each program.  To assist in the process careful benchmarking to industry norms and realistic expectations ground the process. The end product is an assessment of the likelihood that a given pipeline will meet the goals of the organization.

• How does an organization factor in attrition risk in assessing the strength of a pipeline?
• How does time effect the strength of a portfolio
• Is a given pipeline likely to meet the organization's goals for growth?
• What tools are available to help make these judgments?

Michael Needle, M.D., Vice President, Strategic Medical Business
Development, Celgene Corporation

12:15 Track Chair’s Closing Remarks
Andrew Chadwick, Principal Consultant, Life Sciences & Healthcare Practices, PA Consulting

Session A
Translational Medicine’s Impact or Non-Impact on R&D Productivity in the Near Term

2:00 Breakout Session Chair Remarks
Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World, Inc.

2:10 Translational Medicine in Research and Early Development

• Expectations
• Scientific Approaches
• Organizational Issues
• Driving Forces
• Interactions between Translational Research, Drug Discovery Research and Early Development /Full Development

Hans Winkler, Ph.D., Senior Director, Functional Genomics & Translational Research, Johnson & Johnson Pharmaceutical R&D

2:35 The Financials of Biomarkers from Prioritization to Acceptance of Surrogates
Few translational medicine or biomarker development groups have difficulty conceiving of science that may enable improved development decisions. However some of these biomarkers may actually yield relatively low return on investment (ROI) compared to others. In a resource-constrained environment, it is important to consider prioritization of biomarker activities relative to expected ROI. On the other end of the supply chain, acceptance of biomarkers by regulators and external groups can be a long and arduous task. Should the development and decisions be carefully mapped out to achieve surrogacy or should decisions regarding acceptance be decided upon a cost-benefit analysis?

Wayne Carter, DVM, Ph.D., Executive Director, Global Clinical Technology, Pfizer Inc.

3:00 The Emerging Era of Translational Medicine: Yesterday, Today and Tomorrow
The development of useful and accurate biomarkers for predicting safety and outcomes is becoming more and more important. With the lay out of the human genome, opportunities abound to barcode individuals with their risk profiles. The massive increase of knowledge in DNA sequence information together with the development of new technologies such as genomics, proteomics, metabonomics and bioinformatics, has resulted in much greater capacity to determine individual risk profiles. The real challenge for the biomarkers is to allow earlier, more robust drug safety and efficacy measurements. There is no doubt that their role in drug development will continue to grow for the foreseeable future.
Claudio Carini, M.D., Ph.D., FRCPath, VP and Global Head of Translational Medicine, MDS Pharma

3:25 Use of PD-Biomarkers and PK/PD Modeling to Help Enable Informed Drug Development
One of the major goals of preclinical pharmacology and translational medicine is to quickly and efficiently translate novel scientific discoveries into new clinical therapies. To do this effectively, it is critical to enter clinical development with the scientific knowledge and tools to maximize therapeutic success and to enable informed decision making at key times in a molecule’s lifecycle. Pharmacodynamic biomarkers and PK/PD modeling are important tools to help realize these goals. Although these are powerful news tools for drug development, it is also important to understand the uses of and limitations of these tools. If used appropriately, these tools can help inform molecule selection, early estimation of human dosing, demonstration of mechanistic/biological activity, early go or no go decisions, and selection of maximally effective dosing regimens. 

• Definitions of Pharmacodynamic biomarkers and common misunderstandings
• Using PDB and PKPD to help guide drug development process
• When PDB and PKPD modeling are critical to decision making
• Discussion of the potential benefits and limitations of PDB and PKPD modeling

Paul J. Fielder, Ph.D., Director, Early Development Pharmacokinetic, Pharmacodynamic and Bioanalytical Sciences, Genentech, Inc.

Session B
The Globalization of Drug Development with Emphasis on China and India 

2:00 Breakout Session Chair Remarks
Marc L. Hoffman, M.D., Vice President, Global Regulatory Affairs/Medical Vigilance, Americas & Asia, Baxter Healthcare Corporation

2:20 Partnering Challenges Associated with Western Drug Development in Asia
The challenges faced in globalization of drug development by small- to mid-sized (bio)pharmaceutical firms are at the same time both similar to and more complex than those faced by large, multi-national firms. This is because small/mid-size firms must partner with foreign companies, which have their own, largely independent, management teams and business priorities. Partnerships often focus on limited steps in the drug development pathway (e.g. manufacturing & marketing). As Asian companies struggle to move up the global pharmaceutical business value chain, opportunities and challenges which are unique to Asia can be used as a framework for building strong business partnerships of these types. 

• Global challenges for drug development – similarities between East and West
• Research, manufacturing, regulatory, and marketing differences between West and East (emphasis on China) 
• Examples of types of partnerships that work
• Socio-cultural challenges faced when converging Western and Eastern partner management styles

Jeffrey L. Winkelhake, Ph.D., Vice President International Operations, Sinobiopharmaceuticals, Ltd. 

3:00 Strategic Planning for the Globalization of Clinical Trials with Emphasis on China and India

R&D Drivers for Clinical Development Entry into New Theatres of Operations

• Benefits of Doing Global Clinical Studies in Emerging Countries (India, China/Asia, Latin America)
• Guiding Principles

Country Selection

• Country Assessment Criteria
• Sources of Information for Country Assessment
• Country-by-Country Analysis
• Amgen’s Conclusions and Recommendations

Site Selection

• Site Assessment Criteria: What do Sponsors Look For?
• How Do Investigators Find Sponsors?
• What Can Investigator Sites Do To Improve Their Chances For Selection For Clinical Trials?
• What Are Some Of The Investigator Site Best Practices That We Have Seen?

Julio Camps, M.D., Director, Latin America Development, Latin, India and Asia Operations, Amgen, Inc.

Session C
How Should We Approach Our Portfolio Strategy Moving into the Future?

2:00 Breakout Session Chair Remarks
Chris Clement, Director & Head, Project Office, R&D Strategy & Operations, Millennium Pharmaceuticals, Inc.

2:10 To Be Determined
Richard Heaslip, Ph.D., Vice President, Project and Portfolio Management, Wyeth (tentative)

2:40 The Future of Project and Portfolio Management in the Biopharmaceutical Industry
Mastering standardized methodologies, developing rigid project technicians, and implementing complex software tools will not deliver long term, sustainable project and portfolio management value. We must move away from these types of tactical approaches toward a longer-term investment in the human and organizational capital necessary to support numerous successful projects in complex environments. Future top project leaders will not only have the technical project management skills needed to coordinate successful projects and measure return on investment, but also have the leadership skills to change the way the organization works. This session will characterize the current state of project and portfolio management at several companies and offer predictive thoughts as to where the future will take us as these competencies evolve to better serve a changing business landscape.

Timothy Noffke, PMP, Vice President, Life Sciences, Integrated Project Management Company

3:10 Understanding Collaborative Behaviors in Development Alliances and Processes to Ensure Your Success
The majority of drug development is done in partnership with other Pharma, Biotech, and Academic institutions. The requirement to collaborate effectively has never been so critical. In fact, a majority of the drugs approved by the FDA in 2002-2005 were involved in partnerships; yet, statistics show that over 65% of partnerships fail. Those partnerships that have had success have an overwhelmingly common focus on collaboration excellence and where learned alliance management techniques have aided in achieving collaboration success. A developing discipline continues to form around mastering alliance collaboration and is practiced in many of today’s top organizations. Good project management alone is no longer enough, without a focus on the partnership, many development projects will needlessly fail. Practicing these collaborative partnership principles may save you millions! Failing to strategically consider these factors will, in many cases, slow down or ultimately undermine your development partnership. 

• Define critical success factors and pitfalls to be aware of
  in any development alliance
• Explore tools, techniques and processes which may 
  make your development alliance more successful

Michael Leonetti, Head, Healthcare Partnerships, Boehringer Ingelheim Pharmaceuticals, Inc.

3:40 Refreshment Break

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