2nd Effective Business Development for Clinical Trial Service Providers

DAY ONE, JULY 13,2010

PRE-CONFERENCE WORKSHOP SCHEDULE:
7:30 Workshop Registration and Continental Breakfast  
8:30 Workshops Begin
10:00 30-Minute Networking and Refreshment Break
12:00–1:00 Luncheon for Workshop Participants

CHOOSE WORKSHOP A OR B

A. Clinical Development 101 for Business Development Professionals:
A Primer on the Science, Process, Technology and Metrics of Clinical Development

Business Development professionals are often not as well integrated into the clinical operations process, which can result in unclear expectations and then less than optimal delivery of service. BD professionals need a firm understanding of the client, including and overview of drug development, trial conduct, constraints, process, culture and organization to better assist their Clinical Operations groups to deliver what BD sells. Learning goals of this workshop include gaining an understanding of:

• Fundamentals of getting a clinical trial planned and executed
• Nuances of resource planning and utilization
• Data acquisition, analysis and reporting
• The importance of site selection, management and monitoring
• Managing the project, and working as part of project team
• The technology and systems used to conduct the project
• Current industry and outsourcing trends

Workshop Leaders
Susan Seroskie, RN
Vice President
PHARMANET RESOURCE SOLUTIONS

Eileen Daniel
Director of Clinical Operations
ENDO PHARMACEUTICALS

Sue Maino Vetuschi
Project Manager
ACADIA PHARMACEUTICALS, INC.


B. First Impressions with Impact:
Building Meaningful Client Relationships from Cold Calls to Conferences

As a BD professional, you are continually striving to generate new leads, but the process of finding leads, and then turning them into prospects, opportunities and finally, closing the deal has become more challenging than ever. This workshop reviews issues facing all sales and business development personnel – how to make a great first impression when prospecting, and how to continue on to create a strong relationship with clients. This workshop addresses:

• Identifying the route to new business: Finding the best contact
• Ways to increase likeability in the eyes of clients
  Prospecting in a hyper-connected world: What is the impact of social networking?
• How to maximize the impact of emails and calls
• Finding your fit as a provider: What story are you selling?
• “You’re only as good as who you know” –fact or fiction?
• Building leads from conferences
• Presenting formal information and handling questions with skill

Workshop exercises include:

• “Turning it on” to control a room: The impact of non-verbal behaviors
• Thinking on your feet, using industry- specific scenarios
• Articulating the value proposition

Workshop Leader
Beth Rogers
President
POINT TAKEN

Workshop Panelists
Fredrick L. Naids, PhD
Senior Strategic Sourcing Director, Clinical Development Operations & Biometrics
SHIRE PHARMACEUTICALS

Raymond D. Starling, PhD, Sr. Director - Clinical Development & Operations
ATHERSYS, INC.

John Colby
Account Director, Business Development
PRA INTERNATIONAL

Dan Weddle
President and Founder
SITEAVAIL, INC.

MAIN CONFERENCE BEGINS

12:00
Main Conference Registration

1:10
Chairpersons’ Welcome and Opening Remarks

Chairs
Samir Shah
Executive Vice President, Global Strategic Development
RESEARCH PHARMACEUTICAL SERVICES (RPS)

Patrick Lindsay
Executive VP
UNITED BIOSOURCE CORPORATION

1:15
OUTSOURCING STATE OF THE INDUSTRY
A Challenging and Changing Environment in which BD Must Adapt their Strategies

There is a shift driven by expiring patents and declining revenues at pharma. Ramifications to CROs can include fewer trials, candidates killed earlier and project delays or cancellations. Our presenter provides a current snapshot of the industry’s response to financial pressure and the outlook for CROs and other providers.

Speaker
John Kreger
Equity Research Analyst
WILLIAM BLAIR & COMPANY

1:45
PANEL DISCUSSION
Provider Response: How to Thrive amidst Industry Challenges

It’s not just about winning new business, but about keeping existing business in a time of continued consolidation, a narrowing of focus within sponsor companies, biotechs disappearing, and more. Our panel of provider-side executives comment on:

• How to work with clients to better plan and align resources in an environment of delayed starts, project cancellation, and a longer selling cycle
• How providers have been redirecting and redeploying their resources
• Innovations CROs are employing to remain a step ahead
• How CROs have had to adapt their business as profitability has decreased

Moderator
John Kreger
Equity Research Analyst
WILLIAM BLAIR & COMPANY

Panelists
Elizabeth Thiele
Executive Vice President and Global Head of Business Development
ICON CLINICAL RESEARCH

Tami Klerr-Naivar, Senior Vice President, Worldwide Business Development
PRA INTERNATIONAL

Patrick LindsayExecutive Vice President
UNITED BIOSOURCE CORPORATION

Christopher L. Crucitti, MS
Senior Vice President, Business Development
INVENTIV CLINICAL SOLUTIONS, LLC

Barry Broughton
Vice President, Global Business Development
OMNICARE CLINICAL RESEARCH

2:30
Designing the Ideal BD Professional across Different
Relationship Models: What Does BD Look Like before, during and after the Award?

One of BD’s goals is to hear their clients say, “This vendor gets it.” “Getting it,” however, entails knowing the client’s expectations in a specific relationship model with an understanding of the culture of accountability at pharma—that pharma has commitments to senior management just as vendors have commitments to pharma. Our panel of sponsors provide commentary on:

• The difference between a preferred provider and a strategic alliance
• How BD should approach offering full service vs functional vs task outsourcing to help clients arrive at the best choice for the project
• How BD can help build and maintain the various relationships
• The status and value of the BD role once a strategic alliance is formed
• The “right” kind of person, role or partnership of BD and Clinical Operations to oversee a particular type of relationship
• New internal groups being formed at CROs to manage strategic relationships

Moderator
Steve Whittaker
Former Chief Operations Officer
Senior Director of Project Management, CV/Acute Care
ELI LILLY & COMPANY

Panelists
Solomon Babani, MBA
Director, Outsourcing & Vendor Management
CELTIC PHARMA DEVELOPMENT

Janis L. Hall MBA, COP, CPM
Director, Global Clinical Sourcing Operations, Global Pharma R&D Sourcing
JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, LLC

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


3:30
30-Minute Networking and Refreshment Break

CONCURRENT TRACKS
TRACK A: FUNDAMENTAL CHALLENGES OF BUSINESS DEVELOPMENT
TRACK B: ADVANCED STRATEGIES FOR WINNING AND KEEPING NEW BUSINESS

4:00, CHOOSE TRACK A OR B

A  Tailoring Presentations and Proposals to Clients
This stage is so critical, as both large and small providers alike have lost bids due to not being able to effectively convey how and why their organization is different from the others. You must have a clear understanding of your client’s organization and expectations and demonstrate creative, out-of-the-box thinking beyond e-technology.

This session covers:

• What details are needed in a proposal: Knowing what your potential client prefers and reviews (e.g., Do they just look at the bottom line?)
• How to get an RFI/RFP and how to respond
• Developing the scope of work/minimum RFP requirements
• How to respond accordingly when an RFP is poorly written and/or incomplete
• How to effectively convey your service offerings and figure out if you are talking the same language as the client
• 3 top things to focus on during bid defense

Speakers
Patrick Nealon
Senior Director, Clinical Research
GENZYME CORPORATION

Lisa Kaufman, MS, RN
former Director of Clinical Operations
STROMEDIX

B  Functional Collaboration between Providers and their Clients: Facilitating a Holistic Approach to Risk Management and Issue Escalation

This session addresses effective ways of managing issues between sponsors and providers through the support and involvement of Business Development. The following topics are addressed:

• Comparing the client’s expectations vs. the typical CRO mindset
• Factors that influence escalation behavior
  • Diligence in planning and communication
  • Rapid issue closure
• Understanding why projects or partnerships face adversity
• Learning to identify and mitigate emergent issues and facilitate issue escalation
• Promoting resolution as well as transfer learnings through collaboration

Speakers
Stephanie Roberson
CHORUS, Clinical Trial Consultant
ELI LILLY & COMPANY

Hillari Jacobs
Director, Strategic Accounts
OMNICARE CLINICAL RESEARCH

4:45, CHOOSE TRACK A OR B

A  How to Fix—but Ultimately Avoid—a Broken Relationship with Effective and Strategic Relationship Management Tools

We’ve either experienced or heard about relationships that have failed. The lessons are in knowing the root causes of the problems in order to reduce the risk of future projects following the same path. Relationship management—how to not break the relationship in the first place?

• How to win a client back
• Loss review process and learnings and rescue examples
• Where did customer service go?
• Fundamental drivers of repeat business
• Developing the right level of trust
• Striving for continuous improvement for long term benefits
  
  Speaker
  Mark A. Lanfear, Vice President, Strategic Alliances
  KFORCE CLINICAL RESEARCH, INC.

B  Global Account Management Strategies: Finding the Best Model Based on Customer Segmentation

The data are clear: Clinical studies are increasingly moving outside the US, making BD and Account Management roles more challenging. Providers may struggle with how to set up effective global operating models because their pharma and biotech clients have different sourcing and operating models. Continued consolidation has resulted in pharma’s need to operate within one single operating platform in a global manner. As spend increases in the emerging block, there will need to be sourcing and operations across the globe. This session addresses how service providers can set up strategies that provide robust account management and offer the right level of client interface. Our speakers cover:

• The roles and responsibilities of Global Account Managers and local representatives
• Sponsors’ need for simplicity and a single point of accountability
• The impact of client M&As and how to sell and manage a project when a client has multiple divisions all over the globe
• How to optimize interactions with multi-national companies who have decision makers across multiple regions
• Should your account management strategy differ depending where your client is based or shouldn’t it matter?
• How to manage and interface on operational and contractual matters

Speakers
Samir Shah
Executive Vice President, Global Strategic Development
RESEARCH PHARMACEUTICAL SERVICES, INC. (RPS)

Steve Whittaker
Former Chief Operations Officer
Senior Director of Project Management, CV/Acute Care
ELI LILLY & COMPANY

5:30
Day One Concludes

DAY TWO, JULY 14,2010

7:45
Continental Breakfast

8:25
Chairpersons’ Recap of Day One

8:30
TOWN HALL MEETING
Sponsors’ View of Provider Evaluation, the RFP Process and Post-Award Relationship Management

A panel of varied size sponsors gathers to address a series of questions to help the audience understand their companies’ perspective and strategy in working with outsourcing providers. This is an excellent opportunity for Business Development professionals to gather information to use to more effectively interact with these potential clients and others like them. Panelists take questions grouped into 1) provider evaluation, 2) the RFP process and 3) post award interactions. Questions posed to our panel range from how they determine their outsourcing strategy to how they evaluate providers to how preferred providers are selected and more.

Moderator
Janice Hutt
Vice President
THE AVOCA GROUP

Panelists
J. Chris Houchins
Vice President - Clinical Operations
ARNO THERAPEUTICS

Tracy Trainor Hudson
Senior Director, Clinical Outsourcing
SEPRACOR

Cory Gutterman
Associate Director, Outsourcing, Global Pharmaceutical R&D
ABBOTT LABORATORIES

Fran Grote
Senior Director, Clinical Outsourcing
MILLENNIUM, THE TAKEDA ONCOLOGY COMPANY

Elizabeth Shewell
Director, Outsourcing
INCYTE CORPORATION

Peter DiBiaso
Senior Director, Clinical Planning & Performance, Clinical Development Operations
VERTEX PHARMACEUTICALS

Patrick Nealon
Senior Director, Clinical Research
GENZYME CORPORATION

10:30
30-Minute Networking and Refreshment Break

11:00
How to Drive More Business and Improve Profits through Clinical Grants

Our presenter shares the results of an industry study of the criteria pharmaceutical companies stress in the decision to engage a CRO for an individual study or even as a preferred provider. The study highlights the importance of implementation detail. Dr. Glass demonstrates how leading CROs:

• Use grant budgeting detail as an implementation tool to help obtain new business in a quicker and more cost effective way, and
• Use third party databases and negotiating systems to reduce the time of site start-ups

In addition, the presentation covers how the use of Standard of Care™ financial data in particular can assist CROs to obtain new business by enhancing their implementation credibility, reducing sponsor company study costs, and improving CRO profitability.

Speaker
Harold E. Glass, PhD
Professor of Health Policy and Pharmaceutical Business
UNIVERSITY OF THE SCIENCES IN PHILADELPHIA
President
TTC, LLC

11:45
Luncheon for Conference Participants

Attention Senior Level BD Professionals: First 15 Registrants VP level and higher may RSVP to our invite-only, topic-driven luncheon for Heads of BD! One attendee per company.

If you are interested in hosting this luncheon, please contact Steve Decker at sdecker@exlpharma.com or 212-400-6234.

CONCURRENT TRACKS
TRACK A: FUNDAMENTAL CHALLENGES OF BUSINESS DEVELOPMENT
TRACK B: ADVANCED STRATEGIES FOR WINNING AND KEEPING NEW BUSINESS

1:30, CHOOSE TRACK A OR B

A  Balancing the Needs of External and Internal Clients

This session focuses on three key challenges provider-side Business Development and Clinical Operations face. Some of these challenges might overlap but some might be very different. As BD and Clinical Operations are driving toward the same goal, how should they marry their efforts and overcome all of their challenges? Our panel discusses:

• The alignment and divergence between BD and Clinical Operations
• Who are all the “clients” BD must answer to internally and externally?
• The evolution of BD into relationship management, involved with proposals and contracts teams
• BD’s role in ensuring quality and proper oversight of trials
• What if your internal team wants high rates but the sponsors have reduced budgets?

Moderator
Craig Coffman
Director, Clinical Business Operations and Outsourcing
ENDO PHARMACEUTICALS

Panelists
Brian Tanner
Director, Business Development
CLINOPS, LLC

Paul Colombo
Vice President, Business Development
ICON CLINICAL RESEARCH

Beth Cuccia
Project Director
INC RESEARCH

Joanne Hollenbach
Head of Operations,US
CMED, INC.

B  MCC UPDATE
How the Industry-Wide Effort to Develop and Implement Standardized Clinical Trial Performance Metrics Helps BD's Relationship with their Clients

In this session, presenters discuss the industry's efforts to develop standardized performance metrics, and how organizations are using metrics to drive improvements. Specifically, Business Development professionals and others with customer contact have the opportunity to:

• Review the updated set of standardized Clinical Trial Performance Metrics developed by a group of Biotechnology, Pharmaceutical and CRO organizations in the MCC, including new quality study start-up metrics
• Learn how organizations can and should utilize metrics to improve clinical trial performance and strengthen sponsor/CRO relationships
• Discuss ways that performance metrics can be successfully incorporated into contracts to be used to better manage sponsor/CRO relationships and improve business outcomes

Speaker
Guy A. Mascaro, President
METRICS CHAMPION CONSORTIUM

Elizabeth Shewell, Director, Outsourcing
INCYTE CORPORATION

Gary Urban, Director, Global Quality Management Systems
PARAGON BIOMEDICAL, INC.

2:30, CHOOSE TRACK A OR B

A  Serving Large, Mid-Sized and Small Clients: Similarities and Differences and Making them Work for You

Do your BD and Operations groups understand the difference between delivery to a small versus a large client? Through a role play exercise, our presenters break down the issue of client size as well as type of client, i.e. specialty versus traditional pharma versus biotech: Is there really a difference? Specifically, they present:

• How to serve a large client if you are a niche provider
• Getting around the preferred provider list at potential clients
• Creating and explaining your selling proposition: CRO differentiation
• Enterprise agreements versus deal-by-deal
• What does a preferred partnership really mean to clients and service providers?
• What do sponsors value versus what providers “think” they value?

Speakers

Fredrick L. Naids, PhD
Senior Strategic Sourcing Director, Clinical Development Operations & Biometrics
SHIRE PHARMACEUTICALS

Hansu Dong
Associate Director, Outsourcing and Financial Management
DAIICHI SANKYO

B  Merging Early Stage and Late Stage Business: The Art of Cross Selling and Sustaining Business through the Candidate Lifecycle

Selling early-stage through late-stage services is considered the holy grail of business development for providers offering a range of drug development services. Similarly, providers who specialize in late phase development can benefit from strategies for maintaining business continuity through the candidate lifecycle even though they do not conduct the early stage work. Challenges addressed include:

• Identifying and selling to two separate client groups within sponsors
• How to sell to biotech when many compounds are sold prior to Phase III
• How to pull Phase I compounds into Phases II and III, while maintaining continuity for your client
• Managing relationships with ancillary early phase sites to facilitate the transfer of the business to late stage
  
  Michael E. Laird, RPh
  CEO
  PIERREL RESEARCH USA
  Chief Marketing Officer
  PIERREL INTERNATIONAL
  
  
  5-Minute Break to Rejoin Audience for Closing Session
  
  
  3:35
  Closing Panel Discussion
  This is your opportunity for a final Q&A session with our speakers to address any remaining questions or concerns you have about optimizing your role as a BD professional. Discussion topics include, but are not limited to:

• How to grow your account from 2 million to 20 million
• Key factors that determine the success of BD’s relationship with a sponsor
• Strategies that must be used to sell to specific therapeutic areas within pharma/biotech companies

4:15
Conference Concludes