Regulatory standards achieved offshore

As the US celebrates the 30th anniversary of Good Laboratory Practices (GLP), William Harrison, president and COO of MPI Research, discusses the integration of these standards in Shanghai, China.

In late 2007 MPI Research entered into a joint venture with Shanghai Medicilon forming Medicilon/MPI Preclinical Research-Shanghai. In September of 2009 the company will be conducting US Food and Drug Administration (FDA) GLP IND-enabling studies at the Shanghai facility – a goal set from the beginning of this journey.

The newly formed company provides preclinical drug discovery and development services to global pharmaceutical and biotechnology companies. ‘It was always part of the initial offshore strategy of MPI Research to bring FDA GLP and animal care standards to China,’ says president and COO William Harrison. Many multinational pharmaceutical companies are establishing R&D centres in China. The drug and medical product submissions of these companies are required to meet regulatory standards, including FDA and OECD GLPs. Chinabased companies seeking approval to market their products internationally must also meet these standards.

Until now the primary interest in Medicilon/ MPI Preclinical Research- Shanghai has been from European and North American biotech companies. ‘We are seeing increasing interest from multinational pharmaceutical companies, especially those with R&D sites in China along with companies located within the Pacific Rim,’ says Harrison.

Overcoming challenges
The implementation of these standards has been a challenging process. In the beginning it was difficult for the company to find quality suppliers of animals and animal feed. The company also adjusted its launch date for conducting GLP studies to guarantee the sponsors the highest quality. It was challenging for the two parent companies to find the right balance between local and US management styles given cultural differences that exist. The company had to overcome a number of obstacles, perhaps the greatest being the original search to locate the right partner. ‘We spent almost three years looking for the best match and we found that in Shanghai Medicilon,’ Harrison explains.

As former President of the Society of Quality Assurance, Harrison expresses his excitement for the adoption of GLPs in China: ‘we are taking standards that we have practised for 30 years into a country and culture that has been foreign to these practices until now.’ He attributes the success of the GLP initiative to the team at Medicilon/MPI Preclinical Research-Shanghai. The company identified a core team of five people from corporate headquarters in Mattawan, Michigan. That team accepted long-term assignments in China and trained local employees on GLP and AAALAC standards for animal care and use. This team was often supplemented with more than a dozen people based on scientific focus areas.

Dr Mingli Chen, VP of toxicology and Dr Lijie Fu, executive VP of operations were key players in this initiative. Originally from China, Dr Chen, MD, MS, DABT, a board-certified toxicologist, with significant large pharma and CRO experience in the US, returned to the country to apply her expertise. Dr Fu, PhD, another national returnee, brought substantial scientific experience along with experience from other China-based contract research organisations (CROs) to the company.

Although the company has made amazing advancements, Harrison recognises the challenges that are yet to come. He believes that the entire industry needs to work together to solve some common challenges. ‘It is important that all of the CROs succeed,’ he says. The failure of one CRO based in China could further create the perception that you cannot get quality products in China.

Quality regulation
Harrison ensures the standards of quality at the joint venture will be the same high standards that sponsors can count on at MPI Research. ‘We will do what we do in Mattawan; we have quality systems in place, proper SOPs, training programmes, an active QA staff, and we attract and recruit the best talent in the industry,’ he says.

Medicilon/MPI Preclinical Research-Shanghai will offer research services to support NDA-required preclinical studies. The company will apply for OECD GLP certification in 2010. Harrison adds: ‘bringing AAALAC and GLP standards to this new company is exciting, and I am proud to have been part of it.’

Company profile

As a newly formed joint venture located in China, Medicilon/MPI Preclinical Research Shanghai provides a portfolio of preclinical discovery and development services to pharmaceutical and biotechnology companies.

For more information, visit: www.medicilon.mpi.com.