Strategic Alliance 

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Tuesday, February 5

7:30 am Conference Registration and Morning Coffee



OPERATIONAL IMPACT OF STRATEGIC ALLIANCES 

Shared Session between Strategic Alliances and Global Site Selection

8:00 Chairperson's Opening Remarks

Bonnie BresciaBonnie Brescia, Founding Principal, BBK Worldwide - Biography 







» 8:05 Keynote Co-Presentation: 

Part 1: Industry Partnerships and the Operational Impact of Strategic Alliances

Christine PierreChristine Pierre, President & Leadership Council Chair, Society for Clinical Research Sites (SCRS) - Biography 







Part 2: Making Partnerships Work: Aligning Incentives, Avoiding Traps

Douglas PeddicordDouglas Peddicord, Ph.D., Executive Director, Association of Clinical Research Organizations (ACRO) - Biography 

What do partnerships that work do? They negotiate meaningful metrics, they standardize operations, they assess quality - they align incentives, and they reward success. This panel will discuss the perspectives of investigators, sponsors and CROs in creating partnerships that work.
 


8:50 Global Trial Location and Strategy

Jorge Rodriguez-LarrainJorge Rodriguez-Larrain, Head, Global Site Management, Global Clinical Operations, Alcon - Biography 

9:15 Co-Presentation: Establishing and Implementing an Effective Vendor Selection Process

Lisa Sergas, Senior Manager, Strategic Outsourcing, Global Business Operations, Santen, Inc. - Biography 

Bruno GagnonBruno Gagnon, Vice President, Clinical Operations, BioMarin Pharmaceutical, Inc. - Biography 

There is a lot of risk associated with vendor selection and the performance of our vendors is critical for a successful trial. It is important to spend the time up front to ensure the appropriate vendor is selected and that risks are mitigated and documented from the beginning. We will discuss from a mid-size/small biotech perspective how to ensure the best-fit vendors are selected, selection criteria and considerations, time and resources needed and risk mitigation and expectation setting. We will also discuss the operational aspects and success factors of the selection process such as: ownership, decision making, governance structure and oversight models.

DSP Clinical10:00 Coffee Break in the Exhibit Hall



EFFECTIVE VENDOR SELECTION AND OVERSIGHT 

10:40 Chairperson's Remarks

Yogesh BahlYogesh Bahl, Partner, Deloitte Financial Advisory Services LLP - Biography




 

 

10:45 Co-Presentation: Benefits of Establishing a Strategic Partnership between the ARO/CRO and the Central IRB

Brooke Chandler, Site Start-up Specialist III, Duke Clinical Research Institute

Tim SchuckmanTim Schuckman, Director, Business Development, Copernicus Group IRB - Biography 

The ability of the ARO/CRO to truly partner with the study’s Central IRB improves the success of the trial from start-up to close-out. Unfortunately the importance and benefits of this relationship is often over-looked and underutilized. Our presentation will highlight the steps needed to create such a partnership and its proven positive effects on not only the study, but also the Sponsor-Site relationship.

11:30 Featured Presentation: Using the Balanced Scorecard to Manage Strategic Alliances

Adam ChasseAdam Chasse, MHA, COO, RxTrials - Biography 

Studies indicate that large percentage of strategic alliances fail, and this is most often back to poor execution and/or inadequate governance. Organizations need a simple way to define the strategic purpose of an alliance, identify mission critical tactics, and measure progress. The Balanced Scorecard is an effective way to accomplish this, and should facilitate better governance.

 

12:00 pm Lunch on Your Own



INTEGRATING AND MANAGING DATA IN MULTI-COMPANY PARTNERSHIPS 

Shared Session between Strategic Alliances and Electronic Data in Clinical Trials

1:25 Chairperson's Remarks

Keith HowellsKeith Howells, Senior Vice President, Product Development, OmniComm - Biography 







1:30 Featured Presentation: Integrated Data Environment for Clinical Trials

Munther BaaraMunther Baara, Senior Director, Development Business Technology, Pfizer - Biography 







1:55 Developing and Managing Clinical Data Standards in an Outsourced Model

Paul Bukowiec, Director, Oncology Standards Management, Millennium: The Takeda Oncology Company - Biography 

This presentation will highlight opportunities and challenges encountered when developing a clinical data standards strategy in an outsourced model. The focus will be on outsourcing under a preferred provider model. Attention will be given to alignment of sponsor and vendor strategies as well as utilization of industry standards.

PharmaPros2:20 The Impact of Analytics: Transforming Clinical Trials Data into Business Intelligence

Brion ReganBrion Regan, Head, Strategic Development, PharmaPros Corporation

Life sciences organizations are seeking new ways to access the intelligence residing in their clinical trials data. A critical first step in this effort is the need to centralize information in an automated way. With a hub where trialdata can be aggregated and stored commonly, organizations can leverage analytics for a wide variety of applications. From feasibility analysis of trial design and site selection, to modeling risk factors for source data verification, analytics can transform clinical trials data into powerful business intelligence.

2:35 Panel Discussion: Integrating and Managing Data in Multi-Company Partnerships

Moderator: Keith Howells, Senior Vice President, Product Development, OmniComm - Biography 

Panelists: Munther Baara, Senior Director, Development Business Technology, Pfizer - Biography 

Paul Bukowiec, Director, Oncology Standards Management, Millennium: The Takeda Oncology Company - Biography 

Keith Wenzel, Senior Director, Global Alliances, Perceptive Informatics 

  • Real-time access to data in an outsourced trial
  • Sponsor's control of clinical data
  • Clinical data standards strategy

DSP Clinical3:00 Refreshment Break in the Exhibit Hall



COMPLIANCE AND QUALITY MANAGEMENT 

3:40 Compliance Issues and Trends in Strategic Alliances

Yogesh Bahl, Partner, Deloitte Financial Advisory Services LLP 

Strategic alliances increasingly have become the norm within the modern life sciences research and development program, especially in the case of emerging markets. This session will outline and explore some of the compliance and governance considerations that impact those alliances, including anti-bribery legislation, global transparency requirements, as well as appropriate due diligence and oversight. This session will also explore leading practices on how clinical operations and corporate compliance professionals can collaborate more effectively in this area.

4:05 Featured Presentation: Ensuring Integrated Clinical Quality with CRO Alliance Partners

John HubbardJohn Hubbard, Senior Vice President, Research & Development; Head, Worldwide Development Operations, Pfizer, Inc. - Biography 

As the Biopharmaceutical industry continues to evolve outsourcing strategies the need to balance speed, cost and quality becomes even more critical. Regulatory, quality and compliance requirements continue to put pressure on both sponsors and service providers. These pressures require Biopharmaceutical companies and CROs to align on requirements at a much deeper and comprehensive level. The presentation will focus on Pfizer's approach using Quality by Design principles, Six-sigma and new innovative models to ensure quality and compliance requirements are aligned and deliver the highest value in an outsourced model.


4:30 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

TABLE: Managing Decision Making through Governance with Your Alliance Partner

Moderator: Paul Cook, Ph.D., Regional Operations Manager, Integrated Project Management

• Plan ahead for decision milestones and contingencies
• Resolve disagreements before they begin
• Manage the unknown through risk assessments

TABLE: Ensuring Your Internal Staff Understand the Goal of a Strategic Alliance

Moderator: Adam Chasse, MHA, COO, RxTrials

• Do they understand why the company has entered into this alliance and what the expected strategic (not just tactical) outcomes are?
• Are their day-to-day actions conducive to achieving those outcomes?
• Are they routinely updated on the big picture progress of the alliance?

TABLE: Metrics: How to Measure the Value of the Strategic Alliance? What are the Aggregate Benefits of the Relationship?

Moderator: Yogesh Bahl, Partner, Deloitte Financial Advisory Services LLP

• Is the value simply financial?
• What other types of metrics are important?
• What do you see the role of metrics playing in the future?


5:30 Welcome Reception in the Exhibit Hall

6:30 End of Day



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