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Shifting Clinical Trials into High Gear

Fri, 11/30/2012 - 3:06pm
Ted Agres, Contributing Editor

Illustration: Roger SchillerstromPharma’s big players seek faster results by pooling clinical trial resources.

Ten major pharmaceutical companies have established a nonprofit organization aimed at accelerating the development of new drugs, beginning with improving the efficiency of clinical trials. The organization, TransCelerate BioPharma Inc., will be the largest collaborative initiative of its type, organizers claim. Through it, drug manufacturers and biotech companies will seek to identify and solve common drug development challenges.

“The cost and time—and associated risk—to bring a new therapeutic medicine to market continue to increase for a variety of reasons including regulatory pressures, the increasing complexity of data, and the cost and complexity of healthcare systems,” says Garry Neil, MD, acting chief executive of TransCelerate.  

“There is widespread alignment among the heads of R&D at major pharma companies that there is a critical need to substantially increase the number and quality of innovative new medicines while eliminating inefficiencies that drive up R&D costs,” Neil told Drug Discovery & Development.

The 10 founding companies are Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Co., GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech (a part of Roche), and Sanofi. Each company’s R&D head sits on TransCelerate’s board of directors. Other pharmaceutical and biotech companies may join if they can participate in and benefit from shared solutions, Neil explains. The organization, headquartered in Philadelphia, was formed in August and plans to file for non-profit status by the end of the year.

TransCelerate members have identified clinical study execution as the first area of focus. Within this, five initial projects have been identified for funding and advancement: development of risk-based site monitoring approach and standards; development of a shared user interface for investigator site portals; mutual recognition of study site qualification and training; development of clinical data standards; and establishment of a comparator drug supply model. 

Risk-Based Monitoring

A standard framework and approach for risk-based monitoring will include common tools and triggers to identify risk and categorization criteria for low, medium, and high-risk trials.

 Investigator Site Portal. A gateway portal will utilize a single sign-on for investigators and site staff. “We will then harmonize taxonomy, technology selection, and a roadmap for capability deployment,” Neil says.

Site Qualification and Training. Criteria will be developed for mutual recognition of good clinical practice training and site qualification. A standard process for information requests will also be created.

Clinical Data Standards. A prioritized list of therapeutic areas will be developed and presented to the Clinical Data Interchange Standards Consortium (CDISC), another nonprofit organization. TransCelerate will also contribute harmonized therapeutic area standards and industry expertise to CDISC efforts and contribute funds and other resources to accelerate the development of therapeutic area standards. 

Comparator Drugs. A new model for comparator drug acquisition will be developed that enables direct shipment between participating companies. The new distribution model will include terms upon which members may purchase directly from each other, create master service agreements with participating companies, and select a vendor and complete pilot projects.

“Each member company has agreed to specific outcome-oriented deliverables and has clearly defined responsibilities,” Neil says. Each company will commit “significant financial resources and personnel” and establish guidelines for sharing meaningful data without disclosing competitively sensitive information. Additional activities will be undertaken if and when the group achieves its objectives in the clinical trials project, Neil says.

“We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development,” said Janet Woodcock, MD, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research. “This collaborative approach in the pre-competitive arena … has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients,” she said. 

Consortia Proliferate

TransCelerate evolved out of a series of discussions held at the Hever Group, a forum for executive R&D managers. The group enabled discussions of common R&D challenges and executives decided that an industry-wide organization should be formed to address them.

TransCelerate is the most recent collaboration to accelerate research and development in precompetitive and noncompetitive areas. In addition to TransCelerate and CDISC, other groups include the Clinical Trials Transformation Initiative, the Critical Path Institute (C-PATH), a nonprofit, public-private initiative with the FDA, and Europe’s Innovative Medicines Initiative. 

In September, CDISC and C-PATH announced they would form the Coalition for Accelerating Standards and Therapies. That initiative will seek to accelerate clinical research and product development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in five important public health areas: Parkinson’s, Alzheimer’s, tuberculosis, virology, and pain. 

During a workshop on clinical trial data-sharing held at the Institute of Medicine in October, Charles Hugh-Jones, North American vice president of medical affairs at Sanofi’s oncology division, outlined plans for Project Data Sphere, another new consortium whose members include many of the companies involved in TransCelerate. With Data Sphere, pharmaceutical companies and academic centers will pool data from oncology clinical trials. The hope is that sponsors can design more cost-effective trials and thereby reduce drug development costs by as much as 10%. 

To get things started, Sanofi has donated two recent Phase 3 datasets for breast and prostate cancers, Hugh-Jones said. When Data Sphere is launched in April 2013, he hopes 30 or more data sets will have been submitted by member companies of the Life Sciences Consortium, a task force of the CEO Roundtable on Cancer, a nonprofit convened in 2001 by then-President George W. Bush. “We can accomplish together what no single company might consider alone,” Hugh-Jones said of Data Sphere.

Cross-Pharma Investigator Databank Launched

Janssen Research & Development LLC announced the establishment of a global cross-pharmaceutical Investigator Databank designed to improve efficiencies of industry-sponsored clinical trials. Merck and Eli Lilly and Co. are the first two companies to join Janssen in this effort.  

The new Investigator Databank will serve as a one-stop repository where key information about clinical trial sites, such as infrastructure and Good Clinical Practice (GCP) training records, is housed. This will allow participating pharmaceutical companies to reduce time-consuming and sometimes redundant administrative work involved in identifying appropriate clinical trial sites.   

At the outset of every clinical trial, pharmaceutical companies initiate clinical trial site selection, prequalification, and GCP training, which can be paperwork-heavy and time-consuming for trial sponsors and investigators alike. By housing critical information about investigators and trial sites in one place, the databank will reduce time, cost, and duplicative efforts, making it easier for companies to identify appropriate trial sites and investigators for future clinical trials. Investigator sites that have opted-in to data sharing will have their relevant information accessible to pharmaceutical companies participating in the collaboration. This databank will not include any patient data.

“The current clinical trial environment is inefficient, costly, and unsustainable. The Investigator Databank can help expedite the process to achieve our most important goal—to deliver high-quality, effective novel medicines to the patients who are waiting for them,” said Andreas Koester, MD, PhD, head, Clinical Trial Innovation/External Alliances, Janssen Research & Development. “We are enthusiastic about working with other industry leaders to collectively apply our expertise, capabilities, and shared passion for advancing science and improving lives.”

Earlier this year, Janssen joined nine other companies to launch TransCelerate BioPharma Inc., the largest initiative of its kind, which aims to identify and overcome common drug development challenges in order to improve the quality of clinical studies and to bring new medicines to patients faster. The initiative identified the centralization of site prequalification and training as one of five key projects; the Janssen-led Investigator Databank project will serve as a foundation for the TransCelerate initiative. 

 “Industry collaboration, including pre-competitive data sharing, is critical to ensuring continued progress to improve industry-wide clinical trial practices,” said newly appointed CEO of TransCelerate BioPharma, Garry Neil, MD, Partner at Apple Tree Partners and formerly corporate vice president, science and technology, Johnson & Johnson. “This work is aligned with TransCelerate’s initial focus on clinical study execution and we encourage participation from our founding TransCelerate companies to solve industry-wide challenges in a collaborative environment.”

Member companies of TransCelerate who wish to join the Investigator Databank will automatically qualify for participation. It is anticipated that the Investigator Databank will be operational by the end of the year and incorporated into one of the priority projects within TransCelerate by mid-2013.  

The Investigator Databank will be hosted by DrugDev.org, an independent, third party with expertise in clinical trial information technology and investigator community management.

About the author
Contributing editor Ted Agres, MBA, is a veteran science writer in Washington, DC. He writes frequently about the policy, politics, and business aspects of life sciences.

 
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