Quintiles to bring regulatory experience to biologics

Responding to the increasingly complex regulatory environment when producing biological drugs, the US-based contract research organisation (CRO) has set up a new unit to advise customers on development plans and regulatory submissions for biological products.

The team has been created in response to increasing customer demand for regulatory expertise in the biologics field.

This has been fuelled by the recent breakthroughs in the use of monoclonal antibodies as anticancer agents, emerging vaccines for infectious diseases and stem cell based therapies.

The biologics market was estimated to be worth $50bn (€37bn) in 2005 and is growing at twice the speed of the pharmaceutical market.

The new team will be led by Ed Tabor, a former FDA division director in both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), "Over the past several years, biologics have acquired an increasing share of new product development in the pharmaceutical and biotechnology industries," said Tabor.

"The experts in this new Quintiles Regulatory unit understand the major and minor differences between what regulatory authorities expect for the successful development of drugs and what is expected for biologics."

The team consists of eight members, each with a broad history in the regulatory market covering both US and European regulatory systems.

The expertise covers diverse areas such as anticancer drugs, haematology and various aspects of the biologics market such as vaccines, recombinant proteins, monoclonal antibodies, DNA products and cell therapies.

"Successful biologics development begins with good planning, and that starts with a clear understanding of the regulatory landscape," said Tabor.