The 4th Annual Outsourcing in Clinical Trials Southeast conference was recently held at the Embassy Suites in Cary, North Carolina on March 24-25th. This conference provided a unique platform for discussion alongside case-study-led presentations delivered by virtual, small and large Pharma/Biotech and Medical Device perspectives.
The agenda was designed in close collaboration with industry experts to ensure that relevant and timely topics were covered in depth. The agenda consisted of presentations, case studies, panel discussions and roundtables. The topics covered over the two-day event were: Encouraging New Partnerships, Building More Strategic Partnerships, Investigating Site-Specific Challenges, Benchmarking Your Company in a Dynamic Industry, Supporting Operational Advancements, Spotlighting Medical Devices and Diagnostics, and Delving into Quality and Regulatory Standards.
During the Building More Strategic Partnerships discussion, Ian Wyglendowski, Director of Strategic Partnering at UCB Biosciences, stated that “Outsourcing is a fact of life.” Ian described the comprehensive governance structure and operational approach UCB established with their two CRO partners. When talking about site-specific challenges, Todd Leathers, Senior Director of Strategic Solutions at Acurian, shared the statistic that phase II – IV patient enrollment timelines continue to be extended nearly twice their original duration. This results in a substantial cost to the sponsor. In the discussion of Operational Advancements, Stephen Porter, Chairman, Chief Executive Officer at VDDI Pharmaceuticals, spoke about tackling major issues when conducting clinical trials in China. He stated:
“In 1984, 80% of clinical trials were conducted in the US. In 2014 only 20% were conducted in the US.”
John Bilello, President and Chief Scientific Officer at Ridge Diagnostics, spoke about how to enhance sponsor-vendor partnerships through managing expectations regarding the quality of deliverables for indication-specific trials. John pointed out that managing expectations starts with creating the right level of sponsor-vendor interaction.
“A successful Partnership joins the ideas and resources of the participating organizations: Resulting in Synergies enhancing strength, while limiting weakness.” – John Bilello
The conference provided ample networking opportunities and a controlled sponsor-vendor ratio, which allowed for targeted and productive business discussions.