New Pharma Collaboration Focuses on Clinical Standards

By Allison Proffitt   

September 20, 2010 | A new big pharma collaboration has been launched to identify and solve common drug development challenges, starting with clinical study execution.   

TransCelerate BioPharma was created by ten companies—Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech (a member of the Roche Group), and Sanofi—all of which have pooled financial, personnel, and other resources to solve industry-wide challenges in a collaborative environment.   

TransCelerate was incorporated in early August 2012 and will file for non-profit status this fall, but acting CEO Garry Neil has been working on TransCelerate Biopharma for about a year, he told Bio-IT World. Neil is a partner at Apple Tree Partners, a joint venture and private equity firm, and was—until a few weeks ago—corporate VP, Science & Technology, Johnson & Johnson.   

Members of TransCelerate have identified clinical study execution as the initiative's initial area of focus, though Neil said the focus will expand in the future. "We've built an organization that's scalable and, if the members authorize it, will be able to move into other areas such as translational medicine or new target validation."  

Currently, five projects have been selected by the group for funding and development, including: development of a shared user interface for investigator site portals, mutual recognition of study site qualification and training, development of risk-based site monitoring approach and standards, development of clinical data standards, and establishment of a comparator drug supply model.  

“We’re taking on some of the most important challenges that we all face in clinical trials execution,” Neil said, “and we think it’s going to benefit not only our membership, but it’s going to benefit the entire research community.”   

TransCelerate’s first objectives are to accelerate data standards for specific disease states and the organization plans to work with CDISC (Clinical Data Interchange Standards Consortium). The work, “will enable everybody—not just industry but everybody doing clinical trials in those areas—to be able to collect data more efficiently in a standardized way.”   

The initiative hopes to work with representatives from the entire ecosystem, Neil said, including academics, patient advocates, and regulatory bodies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to set standards that will allow those organizations to more easily review data and, “potentially combine datasets where that’s desirable to do.”  

Neil says TransCelerate also plans to involve other industry alliances including Critical-Path Institute (C-Path), Clinical Trials Transformation Initiative (CTTI), Innovative Medicines Initiative (IMI), and contract research organizations.   

Corporate Structure  

TransCelerate BioPharma evolved from relationships fostered via the Hever Group, a forum for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges.   

The CEO will be a full time employee of TransCelerate and other full time staff will be hired as needed, said Neil. The Board of Directors includes R&D heads of ten member companies. Said Neil: “Most of the people working on the projects, though, are seconded or spending part of their time working on these projects because they are employees of member companies.”   

Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions. The required contributions are on a sliding scale to accommodate both small and large companies. “We want people to come in and be active participants,” Neil said.   

TransCelerate's headquarters will be located in Philadelphia, Penn.