4th Annual Global Clinical Trial Partnerships Wrap up

by Kristin Brooks

Representatives and industry experts from big pharma and top CROs gathered at the Hyatt Regency in Princeton NJ for the 4th Annual Global Clinical Trial Partnerships conference on March 1-2, 2010.The meeting focused on cross-border outsourcing, examining regulatory processes and updates, best practices for effective governance and optimal clinical operations, risk sharing and strategic partnerships, and emerging markets in Asia and Latin America.

Throughout the conference, an open exchange of information and experiences among speakers and attendees was encouraged. Representatives from sponsor companies and CROs shared the floor, discussing the challenges in emerging markets, site selection, and identifying issues and obstacles that hinder sponsor/CRO relationships and the dreaded “communication breakdown.” Communication and trust were running themes throughout the conference and were embedded in all of the topics addressed. Both sponsors and CROs alike agree that there just isn’t enough.

Companies participating in the discussions included AstraZeneca, Bristol-Myers Squibb, Biogen Idec, Novartis, Pharmanet and Almac Clinical Services.

Session Highlights

Best Practices: Effective Governance & Optimizing Clinical Operations to Achieve Quality, Time and Cost to Market

Michael Schwartzman, associate director outsourcing alliance management at Daichii Sankyo, discussed governance objectives for the sponsor/CRO relationship, the primary goal of which is to optimize trial quality, time and cost, and “have the sponsor/vendor teams still talking to one another at the end.” He added that half don’t survive the relationship. Two failure points he mentioned are that the team doesn’t escalate issues consistently or in a timely manner, and that the operating committee doesn’t address issues. He emphasized that everyone needs to be able to be candid without anyone flying off the handle; he suggested leading by example as a solution: “It’s like training a puppy,” he remarked. “You have to make corrections every time, consistently.”

Lawrence Florin, AstraZeneca’s section director U.S. clinical outsourcing, added that setting up communication pathways and developing a method to communicate for each project is key to successful operational and executive oversight.

Effectively Sharing Operational Risk with Sponsors & CROs to Develop Strategic Partnering

The direction of this session topic deviated a bit. Dianne Kikta, Ph.D., MBA, vice president global clinical strategic resourcing at Pfizer, discussed sponsor/CRO relationships as they pertain to strategic partnerships with off-shore service providers. She contended that partnership performance management should cover the following points: performance metrics, productivity, productive capacity, and cost savings. However, the challenges in emerging regions make these measures more difficult to target.

Dr. Kikta added that more investment and training is required in emerging regions such as Asia/Pacific and Latin America, and the need to attract, grow and retain talent is imperative. Increasing capacity by going to other regions can easily translate into quality problems.

When it comes to the sponsor/CRO relationship, the clarity of roles and accountability becomes even more important when off-shoring. There is a great need for common terms for deliverables. She also emphasized that using reports can help sponsors overcome their micromanaging ways, stating, “You get what you measure,” and that useful metrics are crucial.

Focusing on Asia: Updates on Outsourcing, Regulatory Issues, Site Selection, Service Providers

Johanne Jiang, Ph.D. vice president, Fountain Medical Development (FMD), discussed recent changes and government initiatives in China. Dr.Jiang’s company is a regional Phase I-IV CRO based in China, a market that had an annual growth rate of 20% last year, and is predicted to be fifth largest in the world by 2012. Trials in the region grew 40% since 2007, fueling these heady growth projections.

Dr. Jiang laid out some of the reasons for this rapid upswing, including reduced timelines, and a population of 1.3 billion, 100 million of which are over age 60 — a patient population currently in demand by pharma companies. By 2015, she noted, this age-group is expected to be 200 million in size. Additionally, she mentioned that investments in the region by AstraZeneca, Roche, Novartis, GlaxoSmithKline, Pfizer and Bayer have topped $100 million. She pointed out that sponsors are including China at an earlier stage of development—as early as Phase Ib.

Recent government initiatives have also drawn interest to China. The Chinese government has implemented “A Thousand Talent Program” designed to entice professionals, as well as offer incentives to CROs establishing and expanding operations in the region. She also mentioned China’s SFDA has synergies with the U.S., EU and Japan regulatory authorities, and that data from trials in China can now be used in these regions — a significant factor for any company conducting trials in the region.

Event Exhibitors

Global Clinical Trial Partnerships also featured several exhibitors:

• TTC, llc, a provider of clinical cost benchmarking databases, offers five database products consisting of investigator site budgets from 60 countries. The company showcased its GrantPlan and CRO Cost Pro solutions.
• Medidata showcased its CRO Contactor (formerly Fast Track CROCAS), a benchmarking and analysis tool designed to optimize the relationship between sponsor and CRO. The tool helps to define expectations around data, job functions, resources, timelines, budgeting, and management issues.
• MNX Global Life Sciences Logistics, a provider of global cold chain transportation services, presented its transportation support services, such as worldwide clinical trial setup, protocol development, and management.
• McElroy Translation, a provider of linguistic resources for legal, technical, medical, and business translation, showcased its software and web localization services.
• Alpha Independent Review Board presented its complete nationwide IRB review services, dedicated to the rights of study subjects.
• Quorum Review, a review board, introduced its new processes including a new Phase I group, daily board meetings for amendments, electronic portal with all documents available, and in-house “Fast Track” translations.

For more information on Global Clinical Trial Partnerships, contact International Institute for Business Information & Growth at www.iibig.com.