2nd Annual  

Outsourcing for Clinical Trials

Perfecting Quality Partnerships for Clinical Trial Success 

April 25-26, 2017

With CROs and other third-party vendors continuing to take on diverse and numerous clinical trial activities, the need for establishing quality partnerships with pharma and biotech companies continues to grow. Establishing outsourcing needs and relaying that into clear expectations for each partnership from the beginning is key to developing long-term, quality relationships, allowing for efficient and effective clinical trials. Cambridge Healthtech Institute’s Second Annual “Outsourcing for Clinical Trials” conference will examine best practices from sponsors, CROs, and vendors on how to optimize such relationships.

Tuesday, April 25

10:00 am Conference Registration

OUTSOURCING MODELS AND VENDOR SELECTION STRATEGIES

1:45 Chairperson’s Remarks

Thomas P. Lawler III, MBA, PMP, Founder & Managing Partner, BaywynSolutions, LLC

1:50 Transactional Outsourcing: Limited Time, Limited Resources, but the Expectations Remain the Same... Get that Study Outsourced

Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing – Development Operations, Nektar Therapeutics

Strategic partnership models don’t work for every company, especially smaller pharma and biotech. This talk will describe how Nektar Therapeutics has utilized the transactional model with a goal of reducing cost and increased speed to startup without sacrificing quality.

2:20 Fit for Purpose Outsourcing – Fulfilling the Varied Needs of Big Pharma

Vatche Kalfayan, Senior Director, Clinical Operations, Pfizer

Large drug development organizations require a broader range of outsourcing solutions that go beyond the Phase 1-3 paradigm. As the need to conduct more efficient trials continues to grow, matching the outsourcing solution to a clinical study requires a two-sided acceptance of needs, challenges, solutions, and a willingness to collaborate. Sponsors and CROs need to remain engaged as both sides pave the path forward to optimal outsourcing of clinical trial services.

2:50 Science Driving Service: A Step-by-Step Collaborative Approach Tailored to Virtual Biotechnology Firms

Lorraine M. Rusch, Ph. D., President, High Point Clinical Trials Center

Elias Sayias, Director, Business Development and Client Relations, High Point Clinical Trials Center

Virtual biotech firms fear finding themselves underserved and unable to find a CRO with the necessary flexibility and responsiveness to meet their needs. Their challenge is not to only to find a service provider, but also the one with the right operational structure and mentality. Dr. Rusch, will present a Case Study and elaborate on HPCTC’s “science driving service” principle. Elias will focus on the importance of the “internal champion” in cultivating trust and productive relationships.

3:20 Refreshment Break in the Exhibit Hall

4:05 PANEL DISCUSSION: Avoiding the Blame Game: Defining Deliverables before Selecting Your Vendors

The key to selecting an appropriate vendor begins with understanding exactly what is needed from them. This panel will discuss strategies for determining timeline and key activity needs and communicating them to all those involved in sourcing, evaluating, and procuring CRO partners and other vendors.

Moderator: Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing – Development Operations, Nektar Therapeutics

Panelists: Vatche Kalfayan, Senior Director, Clinical Operations, Pfizer

Darin Curtiss, PharmD, Vice President, Clinical Development, Trial Runners

Lorraine M. Rusch, Ph. D., President, High Point Clinical Trials Center

Elias Sayias, Director, Business Development and Client Relations, High Point Clinical Trials Center

5:05 Close of Day

5:05 Dinner Short Course Registration

Wednesday, April 26

8:30 am Interactive Breakout Discussion Groups with Continental Breakfast

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and 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.

KPIs for Creating and Maintaining Effective Outsourcing Relationships

Moderator: Barbara Skinn, Ph.D., Operations Portfolio Lead, Global Clinical Operations, Bristol-Myers Squibb

• Key metrics for measuring both sponsor and partnership effectiveness
• Establishing shared accountability for when things go wrong
• Challenges and insight in establishing and maintaining local vs. global partnerships

Transparency in Vendor Oversight

Moderator: Jessica Masarek, Director, Quality Assurance, Muse Clinical

• What should you do to assess your vendors before contracting (or after!)?
• From a compliance perspective, what are the expectations for managing and documenting oversight of third-party vendors?
• What are some ideas for how you can plan for and document oversight?
• How can poor oversight open you to risk?

9:25 Session Break

BUDGETING FOR AND CONTRACTING WITH VENDORS AND OUTSOURCED PARTNERS

9:40 Chairperson’s Remarks

Sholeh Ehdaivand, President and CEO, LMK Clinical Research Consulting

9:45 The Major Compliance Mistake You Are Making and How to Fix It Now

Sholeh Ehdaivand, President and CEO, LMK Clinical Research Consulting

10:00 PANEL DISCUSSION: Contracting Strategies for Today’s Clinical Trials

Moderator:
Thomas P. Lawler III, MBA, PMP, Founder & Managing Partner, BaywynSolutions, LLC

Traditional contracting strategies have been very “one-size-fits-all,” but the changing landscape of outsourcing models has given rise to alternative strategies, such as flexible contracts. This panel will discuss the evolution of business models that allow third-party vendors, CROs, and sponsors to develop custom contracts for modern clinical trials.

Panelists: Danielle Hyland, Senior Project Manager, Independent Consultant

David Kim, Vice President, Business Development and Executive Consultant, Celeritas Solutions

Natalia Romashkina-Timanova, Head, Project Management Office, Flex Databases

11:00 Coffee Break

11:30 Budget Forecasting and Tracking: Teamwork and Transparency

Kenneth Olovich, Chief Financial and Procurement Officer, Chorus

This talk will discuss how the application of budgetary and invoicing models can lead to increased trust. What do sponsors really need to help them manage CRO and trial related expenses? Some budgetary models require more effort to set up than others; when is it worth the investment? The timing of spend and the accurate projection of the same is just as important as the total spend -- this talk will discuss finding the balance.

12:00 pm Effective Management of Outsourced Site Contract Negotiation

Danielle M. Boram, Esq, MPA, Clinical Contracts Attorney, Associate Director of Contract Management, Clinical Development, ImmunoGen, Inc.

Efficient site contract negotiation is critical to support important clinical operation milestones around site activation. While the outsourcing model can provide increased flexibility and access to industry expertise, it is necessary to implement strategies to maximize the value of the collaboration. In this talk I will highlight important strategies for increasing the efficiency and effectiveness of outsourcing site contract negotiation.

12:30 Luncheon Presentation (Sponsorship Opportunity Available)

1:15 Session Break

DEVELOPING EFFECTIVE PARTNERSHIPS AND VENDOR RELATIONSHIPS

2:00 Chairperson’s Remarks

Danielle Hyland, Senior Project Manager, Independent Consultant

2:05 All About the Base: Developing a Solid Foundation with Our CRO Partners

Barbara Skinn, Ph.D., Operations Portfolio Lead, Global Clinical Operations, Bristol-Myers Squibb

Organizations talk about partnerships and the importance to success. Few teams take the time to consider the qualities and behaviors that develop and grow a strong and reliable partnership. This presentation will share team survey results about a study’s partnering, concerns, and strengths. Actions to enhance the partnership will also be presented.

2:35 Establishing a Team Atmosphere for Creative Problem Solving

Thomas P. Lawler III, MBA, PMP, Founder & Managing Partner, BaywynSolutions, LLC

Although we always plan for success, drug development projects are always a series of problems and solutions. When the going gets tough, teams often find themselves distracted from moving ahead, and instead, they start circling their wagons and looking for a person/partner to blame. This talk will look at how to create an atmosphere of trust within our teams to keep the focus on the end game as opposed to playing the blame game.

3:05 The Importance of Creating Effective Partnership Frameworks When Outsourcing Investigator Site Payments

Débora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim Pharmaceuticals, Inc.

Whether fully outsourcing a trial or only the investigator site payment piece, many sponsors fail to see the importance of constructing an effective framework early on for a successful partnership with CROs and site payment vendors. Investigator site payments should not be viewed as simply a line item and cost within CRO and vendor contracts which sponsors do not need to think about but rather they should be seen as a direct extension of the sponsor’s brand, ultimately affecting the relationship and trust with investigator sites.

3:35 Close of Conference. Arrive early to attend Patient Recruitment & Site Selection.