Tuesday, April 10, 2007
Half-Day Pre Conference Workshops

8:00 Workshop Registration and Morning Coffee

9:00 Morning Workshops Begin

10:30 30-Minute Break

12:30 Morning Workshops Conclude;

Luncheon for Morning Workshop Participants

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UPDATED

B3	Developing the Perfect Business Development Professional

This half-day workshop is in its third year running. In 2005, the session theme centered around ideal skill sets for business development professionals with a concentration on the physical, mental, and emotional components. In 2006, the session centered around extensive dialogue from Pharma/Biotech Executives ("straight from the source") to business development and sales professionals at service companies to can gain a better understanding of positioning and creating the right value proposition to serve their clients through discussions, proposals, presentation, and management styles (including an extended session on verbal and non-verbal communication skill sets). This year, the symposium workshop will address important themes such as value, metrics and alignment in the service provider and pharma relationship through a focus on the following topics:

• Sales productivity/measurement and goals within service providers compared to outsourcing objectives within pharma/biotech: Are they aligned?
  
• Value for the customerís time and objectives: Are service providers and pharma customers aligned?
  
• Delivering and managing customer feedback internally: What is the most effective method? How do you effectively communicate and manage your internal clients? Are business development and operations on the same page?
  
• Service providerís senior management: Hear from pharma/biotech on striking the right balance: Are they too involved or not involved enough?
  
• Communications Plan/Governance Structures: When do they work and when do they not? What is the role of the Business Development, What is the role of objective metrics
  
• Account management: What is the right structure? Understanding customer segmentation and how to ensure business development professionals established value for the customer.

Chairpersons:
Samir Shah, Vice President, Strategic Development, RPS, INC

Patrick Lindsay, Senior Vice President, Strategy and Business Development, UNITED BIOSOURCE CORPORATION

Workshop Leaders:

James Kirwin, Assistant vice President, WYETH RESEARCH

Tony Carita, Director, Clinical Outsourcing, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION

Redge Santos, RN, BSN, MBA, Senior Director, Clinical Trial Support, SANOFI AVENTIS

Who Should Attend

• Business Development
  
• Account Management
  
• Sales Professionals 

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NEW

B4	Bridging the Disconnect between Clinical R&D, Procurement & Outsourcing Professionals

Pharma is spending big on outsourcing each year, and the message from senior management is that if they can save 1% on every outsourced project, they can fund another project. More and more, companies across the industry are seeing an increasing dominance of purchasing/procurement involved in the outsourcing space. Many feel that for procurement groups – purchasing agents that generally buy commodities and shop for price and availability – it's all about saving money. Clinical organizations, on the other hand, are all about maintaining speed and quality. Or is this a gross generalization? While there can exist a feeling of mistrust between the groups, the relationship is improving, and they still have a lot to learn about each other's needs and mandates. This session explores the dynamics and stereotypes of these groups and the integration of clinical activities and corporate purchasing into a cohesive team. It covers:

• What is strategic sourcing and what are the core competencies?
  
• Clinical Operations vs. Strategic Sourcing – why this mindset needs to change
  
• What has worked in terms of forging successful collaborations between procurement and clinical groups whether mandated or not
  
• Why was it successful if it occurred on its own or why was it successful if it was mandated?
  
• Are clinicians and procurement departments inseparable?
  
• How to manage internal stakeholders and external resources
  
• Where procurement adds value in the outsourcing process, and where it doesn't
  
• How to control the contract negotiation process
  
• How to win or lose the trust of clinical/functional line managers

Chairperson:
Sue Stempien, Director, Strategic Sourcing and Procurement, AMGEN

Workshop Leaders:
Samuel Dowell, MBA, CPM, Senior Director of Development Procurement, PFIZER

Maureen E. Hynes, Senior Clinical Contracts Manager, Corporate Purchasing, GENZYME CORPORATION

Jay Joyce, Purchases Group Manager, PROCTER & GAMBLE PHARMACEUTICALS

Sarb Shergill, Senior Director, Clinical Research, GENZYME CORPORATION

Who Should Attend

• R&D Procurement/Sourcing
  
• Corporate Purchasing
  
• Clinical Research
  
• Contracts and Outsourcing

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NEW

B5	Creating Value through Strategic Partnering

In the face of increasing market pressures, escalating R&D costs and unacceptable R&D productivity, the pharmaceutical industry must focus their internal resources on their core competencies and build strategic partnerships with CROs that allow them to more effectively integrate and streamline their drug development processes. During this workshop, you will hear key thought leaders in the industry explain how partnering with CROs is creating value for their companies while allowing them to achieve their cost, quality and deliver objectives.

Learn how these partnerships have resulted in:

• Reduced cycle times
  
• Reduced internal management time
  
• Improved overall quality
  
• Better allocation of management time
  
• Incremental value above and beyond the initial cost of those services

Chairperson:
Joe Herring, Chairman & CEO, COVANCE INC

Workshop Leaders:
John Watson, Vice President, Corporate Sales & Marketing, COVANCE INC

Dan Zabrowski, PhD, Global Head, Pharma Development Operations,Vice President, Pharma Development Nutley, ROCHE

Who Should Attend

• VP, Clinical Operations
  
• Director of Clinical Research
  
• Clinical Operations
  
• Outsourcing
  
• Contracting
  
• R&D Finance

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NEW

B6	Maximizing Efficiencies in Phase I/First in Human Studies

in Human studies are complex and challenging projects. The pressure to get as much information from one protocol is great, yet subject safety must remain the top priority. This session will explore the reasonable logistics of such studies and look into efficiencies that can save time and costs, while keeping ethical issues and subject safety paramount. Information presented will be useful to a wide range of professionals from clinical pharmacology scientists, clinical operations and outsourcing professionals.

This workshop addresses key elements of a Phase I study including:

• Essential components of a Phase I RFP
  
• Key things to look for in a Phase I Unit site assessment
  
• Avoiding pitfalls in First in Human study design
  
• Working with consultants on your study–how to avoid having "too many cooks in the kitchen
  
• Implementation of effective subject recruitment strategies in Phase I studies
  
• Implementation of a successful relationship with your Phase I/Clinical Pharmacology team

Workshop Leaders:
Brock G. Guernsey, PharmD, Executive Director, Clinical Pharmacology, QUINTILES

Dr Elizabeth Allen, B.Pharm. (Hons), PhD, M.R. PharmS, Director of Scientific Affairs, Guy's Drug Research Unit (GDRU), QUINTILES LTD

Rick Lewis, GLAXOSMITHKLINE

Who Should Attend

• Clinical Research
  
• Clinical Operations
  
• Project Management
  
• Outsourcing
  
• Business Development

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AFTERNOON PRE-CONFERENCE WORKSHOPS12:30-1:30 Registration for Afternoon Workshops

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1:30 Afternoon Workshops Begin

3:00 15-Minute Break

4:30 Afternoon Workshops Conclude

Don't Miss the Grand Opening of the Exhibit Hall and The CRO Partnerships Game with Bob Eubanks Immediately following the close of the workshops.

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NEW

B7	Partnering Efficiencies: Functional versus Full-Service Outsourcing

There is increasing pressure within biopharmaceutical companies to reduce operating margins, to aggressively meet the challenge of competitive products and to meet the needs of regulatory requirements. Recent industry trends in outsourcing seem to suggest a shift towards larger, more complex trials on a global scale partly driven by the need to collect the best safety and efficacy data as soon as possible. An annual growth rate of 15% in the global CRO industry seems to indicate that biopharmaceutical companies are relying more and more on the services of CROs to meet these challenges. With more than 1,000 CROs competing in this marketplace, it can be a daunting task for a biopharmaceutical company to select a partner who can become a critical part of the success of a product. Adding to the complexity are a growing number of functional or niche providers among the CRO landscape, offering limited but low cost services. These low cost services are attractive to a company's bottom line, but considering the shift towards larger, more complex trials, biopharmaceutical companies must carefully consider the appropriate use of a functional outsourcing strategy.

In this workshop, explore the critical factors to consider when designing your outsourcing strategy. Since the global capabilities and infrastructure of a CRO will impact the quality of the research, the accuracy of the results and the timeliness in completing the project, the panelists will discuss the type of trials that are most appropriate for functional or full-service outsourcing.

Other factors to be discussed include:

• Defining an outsourced "function"
  
• Whether or not portable functions should be offshored
  
• The impact of outsourcing strategies on internal resources
  
• The benefits of functional and full-service outsourcing in the short, medium and long term
  
• How a sponsor's outsourcing strategy impacts their choice of vendor and how a vendor impacts a sponsor's outsourcing strategy

Workshop Leader:
Randy Marchbanks, VP, Americas Business Development, PPD

Who Should Attend

• Clinical Operations
  
• Business Development
  
• Outsourcing
  
• Customer Relations
  
• Clinical Trials Management
  
• Project Management

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UPDATED

B8	Introduction to Clinical Trial Finance: Fundamentals of Costs and Budgets

Workshop Leaders:
Julie Duffy, Associate Director Clinical Contracts & Finance, Clinical Research, GILEAD SCIENCES, INC.

David Polakovs, Clinical Outsourcing Manager Development Outsourcing and Contracts, GENENTECH, INC

Lynn Newbould, MBA, Senior Associate,BioPharma/Clinical Research Consulting, RH BOUCHARD & ASSOC.

Jon Mead, Finance Manager, Development FP&A, AMGEN, INC

This half-day workshop walks participants through the mechanics of accurately anticipating study costs for outsourced studies, and creating an accurate and easily managed study budget between a sponsor and CRO. Workshop leaders discuss the basic elements to consider when estimating study expenses, including how to accurately estimate Investigator grant costs.

The workshop will cover how to:

• Design a Request for Proposal to ensure that you receive accurate bids
  
• Evaluate the costs in and across vendor bids
  
• Simply process from RFP to final contract
  
• Set-up a payment schedule to match accrued activities and simply budget forecasts
  
• Specify invoicing requirements
  
• Track the project financial progress
  
• Manage external vendor contracts and change orders
  
• Incorporate budget management with internal S-OX requirements
  

Applying consistent methodology to your study budgets can improve your contribution to the corporate budget and accrual process. The workshop is comprised of lectures followed by small group exercises that walk participants through how to simplify the budgeting process, prepare appropriate outsourcing documents (RFPs and Contracts), and manage and report on study expenditures.

Who Should Attend

• Clinical Outsourcing
  
• Contract Management
  
• Contract Analysis
  
• Procurement
  
• Department Heads with increasing financial responsibilities
  
• Clinical staff responsible for budget oversight

*Attendees should have some basic familiarity with study costing.

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UPDATED

B9	Working in Partnership with Sites for Increased Productivity

Our industry has focused its efforts to move sponsor and CRO relationships from a tactical commodity to a collaborative partnership; something that will benefit the world of clinical development. In that effort, however, it is important not to lose sight of some of the most important stakeholders—the patients. The access to these patients comes through the clinical sites with whom a partnership and effective relationship is critical for success. We will discuss some of the challenges that US sites face in conducting clinical trials in today's regulatory and financial environment and how the sponsor-CRO partnerships can impact them. Understanding what is important to your sites and, in turn, to their patients can help you work more productively with them. We all share the goal of wanting to improve the healthcare of the patient population and it will take a partnership between all parties to achieve that.

• Understand the types of sites available and how to determine which relationship best suits your protocol needs (e.g. private practice, university, community-based, clinics, independent sites, SMOs, physician collaborative, etc.)
  
• The cost of doing research (contracts and budgets): timely payment and the effect it may have on enrollment and/or performance; insurance reimbursement and compliance concerns
  
• Monitoring performance and compliance—it takes a team
  
• Ensuring your monitors are enhancing the relationship and improving quality
  
• How to manage the poor performing site

Workshop Leaders:
Deirdre F. BeVard, Executive Director, Clinical Research,HEALTHSOUTH; Formerly Senior Director, Clinical Operations, OTSUKA MARYLAND RESEARCH INSTITUTE

Nadina C. Jose, MD, CPI, MBA, President/CEO, RESEARCH STRATEGIES INC.

Steve Dobbin, Director of Operations, ARGINT INTERNATIONAL

Who Should Attend

• Clinical Operations
  
• Project Management
  
• Clinical Research
  
• Global Clinical Trials
  
• Patient Recruitment
• Site Management

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UPDATED

B10	Advancing Supplier Diversity in Clinical Trials

Pharma and biotech companies are encouraged and often mandated to create opportunities to work with small, minority or women-owned businesses to ultimately improve the diversity of a pharma company supplier base. This workshop addresses both how to establish the supplier diversity function within a company as well as some case examples of company-specific initiatives.

• How do you locate such companies, other than word-of mouth, and how can you help them grow their businesses?
  
• What due diligence is required?
  
• Should a sponsor work with company A if they are less qualified than company B, but they are woman or minority owned?
  
• Business case for supplier diversity
  
• Sourcing processes at sponsor companies
  
• The importance of small/diverse supplier certification
  
• Strategies pharma companies are developing to educate and train business partners, especially CROs

Workshop Leaders:
Kathleen Jones, Associate Sourcing Consultant, Supplier Diversity Development, ELI LILLY & COMPANY

Shellie Cholke, MPH, Paragon Biomedical,Director, Business Development, PARAGON BIOMEDICAL

Dana Caudle, Sourcing Manager, Supplier Diversity, GLAXOSMITHKLINE

Yvette Dukes, Sourcing Manager, Supplier Diversity, GLAXOSMITHKLINE

Kevin Kelly, Director of Procurement, Clinical Development, GLAXOSMITHKLINE

Ashlie Farnsley, Sourcing Associate, Global Procurement, ELI LILLY & COMPANY

Kate Chrisman, Director of Marketing & Communications, WBENC

Alexander McKissick, Associate Director, Worldwide Procurement, PFIZER INC

The Partnerships with CROs event is proud to bring back our Diversity Pavillion. At the conclusion of this workshop and throughout the event, be sure to visit the Diversity Pavillion in the Exhibit Hall to learn more about industry efforts to advance supplier diversity in your clinical development outsourcing programs.