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Track B: From Idea to Market

Sponsored By:

AON Chubb Exelixis
MedImmune VWR

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Finding and Evaluating Technologies
9:15am – 10:45am

The panelists will share their lessons learned in harvesting innovation from internal and external resources, managing the relationships to ensure benefits are maximized, and transferring technologies between collaborating partners. This session will explore novel tools and techniques to achieve success in working in this virtual development environment. Our industry experts will provide insight into the key requirements of an R&D plan that will serve as the basis to guide the transfer of technology between both institutions and partners, critical research activities and disciplined decision making, team leadership, relationship management, aggressive risk management programs, and effective execution.

Panel Moderator:

Chad Nikel, PMP
Integrated Project Management Company

Panel Speakers:

Suzanne Haendel, J.D.
Technology Transfer Officer, Children's Hospital Oakland Research Institute

Ravi Kiron, Ph.D., MBA
Executive Director, New Technology Assessment and Planning
Alza Corporation (a division of Johnson & Johnson)

Eric Leire, Ph.D.
President and Chief Executive Officer, APT Therapeutics, Inc.


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Getting Past Yes: Negotiating as if Implementation Mattered:
Creating Successful and Long Lasting Alliances

11:00am – 12:30pm

Biotech firms need to partner to ensure their success. However, research shows that 70% of all partnerships run aground within three years and fail to achieve their economic objectives. This interactive panel will focus on tools, processes and core skills for creating successful, long lasting alliances. By emphasizing the key elements for successful alliance management, we show how to move from theory to reality. Participants will learn an elegant framework for addressing the needs of alliance relationships throughout a typical lifecycle. We will provide a time tested methodology for addressing the dual challenge of both negotiating the alliance at the front end and managing the alliance throughout its lifecycle. We will also discuss how to anticipate and handle operational challenges as they occur. This practical panel will give managers the tools they need to successful negotiate and manage their key partnerships. Panelists will discuss their experience with using a structured implementation approach; using an intervention to address relationship issues; and their thoughts on implications for the negotiation processes for future deals. Panel leader will use structured questions to elicit the inputs from the panelists. Audience questions and comments will be welcomed and elicited as well.

Panel Moderator:

Anton Gueth
Senior Consultant, Vantage Partners/Harward Negotiation Project

Panel Speakers:

Russell Bishop
Senior Consultant, Vantage Partners/Harward Negotiation Project

Simon Hayes
Senior Director, Strategic Alliances, Cisco Systems, Inc.

Andrew Heaton, M.D.
Vice President, Scientific/Regulatory Affairs, Chiron Corporation

Tom Smart
Vice President, Business Development, XOMA


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Search for Safe and Effective Cures: Development and Management of Clinical Trials
1:45pm – 3:15pm

Clinical trials require careful planning throughout the testing process to ensure safety and accurate results. Their success depends upon the interaction of highly trained professionals working for life science companies, contract research organizations (CROs), and clinical study sites across the U.S., and increasingly across the world. Topics that will be addressed by the panel include: review of the most pertinent Good Clinical Practices (GCPs) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines; strategies for managing delay points in clinical trials; legal issues of multinational clinical trials by U.S. entities; and working with CROs.

Panel Moderator:

Maureen Bennett
Partner, Squire, Sanders and Dempsey, LLP

Panel Speakers:

Lincoln Bynum, M.D.
Vice President, Medical Affairs, GloboMax Division of ICON Clinical Research

Mike Garolfalo
Director, Products & Excess Liability Syndication
Pharmaceutical/Chemical/Medical Devices Group, AON

Jan Murray
Squire, Sanders & Dempsey LLP

Mark Schwartz, Ph.D.
President & Chief Executive Officer, Bayhill Therapeutics


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