18 Oct 2012, Vipul Murarka, BioSpectrum
Collaboration has emerged as the preferred way forward for pharmaceutical companies looking to address the patent cliff, a drying product pipeline and challenges associated with R&D. Toeing the line, the top 10 pharma giants have come together to form a not-for-profit organization to push drug discovery. TransCelerate BioPharma, as the initiative is called, has Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche and Sanofi as members and is the biggest-ever of its kind in the sector.
The name, TransCelerate BioPharma, refers to transforming and accelerating R&D functions across the biopharmaceutical industry, and the organization will focus on accelerating the developments of new medicines by building on the strengths of the partners.
Headquartered in Philadelphia, Pennsylvania, US, TransCelerate will combine financial resources and personnel of the founding companies to solve industry-wide challenges in a collaborative environment. "TransCelerate seeks to advance innovation in research and development, identify and solve common R&D challenges, and further improve patient safety with the goal of delivering more high quality medicines to the patients," says Mr Garry Neil, acting CEO, TransCelerate BioPharma.
While speaking about the importance of collaboration, Mr Venkat Jassi, CEO and chairman, Suven Lifesciences, pointed out at a recently held CEO conclave at the India-Asia Pacific International Pharma Business meet in Hyderabad, India, that, "collaboration is the key in this industry; be it collaboration among the industry and institutions or among the companies in the industry".
The members of TransCelerate have agreed to specific outcome-oriented deliverables and have clearly defined responsibilities. "Each company will be committing significant financial resources and personnel, and will establish guidelines for sharing meaningful data and information among members in a way that will advance the collaborative efforts without disclosing any competitively sensitive information," adds Mr Neil.
TransCelerate evolved from the existing relationships fostered via the Hever Group, which is a forum for executive R&D leadership to discuss relevant issues facing the industry. "In May 2011, we decided that we should see if we can bring this organization to reality," says Mr Neil. In August 2012, TransCelerate was incorporated.
The cost, time and associated risk to bring new therapeutic medicines to the market is increasing for a variety of reasons, including regulatory pressures, complexity of data, and cost and complexity of healthcare systems has increased the need for collaboration. "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," says Mr Neil. TransCelerate has a tiered membership system and fee that depends on how large the company is and the company's R&D spend. Mr Neil says the membership fee provides the capital to create the company.
Mr Neil believes that clinical trial execution is one of the several areas of R&D where there is significant potential to shorten time line and reduce costs by working together to eliminate redundant efforts and remove process bottlenecks. Hence TransCelerate has selected five initial projects out of 30 projects for funding in the area of clinical study execution.
These are shared user interface for an investigator site portal; mutual recognition of site training and qualification; risk-based monitoring approach and standards; clinical data standards; and a system for ensuring safe and timely supply of comparator drugs. The outcomes of these projects are expected in 2012 and 2013.
Accenture has given initial support to TransCelerate by providing 16 project managers. Each member company has representation on the board of directors and in the working groups. These members are involved in carrying out the projects based on their respective strengths and will be contributing funds towards the projects based on their respective R&D expenditure capabilities. "We are also looking at including new members to join. It is open to all biopharmaceutical companies, whether they are big small," says Mr Neil.