Many hurdles for pursuing clinical drug development activities in China remain, acknowledged Engel, and overcoming these requires careful localized planning to consider regulatory lead times and protocols, patient recruitment issues, challenges related to transport/export of patient samples (especially blood), language and cultural barriers, the need for staff training, and issues related to standards of care and working practices.
Engel urged companies to consider taking their products to China to pursue innovative trial strategies, such as repositioning failed or killed compounds, exploring proof-of-concept in alternative indications, laying the groundwork for additional labeling, and evaluating dual drug development programs targeting markets in the East and West.
In his concluding remarks, Engel compared the pharmaceutical market in China to an onion, saying, “The market may look very much like markets worldwide, but when you peel the onion and look at the third or fourth layer, the market is considerably different and requires local knowledge and information to deal effectively with a very complicated system.”
Eric Meyers, vp of global initiatives at Cambridge Healthtech Associates (CHA, www.chacorporate.com), a professional services firm that organizes and facilitates multicompany collaborative projects in pharmaceutical R&D, presented the results of a case study, completed earlier this year, aimed at assessing the feasibility of conducting preclinical safety studies in China with a particular emphasis on GLP toxicology studies. The study evaluated factors related to current GLP-compliance status, cost and operational viability, optimum investment and implementation strategies, animal welfare concerns, and the potential tradeoffs associated with working in an emerging outsourcing paradigm.
Among the conclusions drawn from this study, Meyers emphasized that although SFDA has a GLP-accreditation process, it is not sufficiently robust to use as a proxy for U.S. accreditation. Furthermore, animal health and welfare regulations do not, in general, meet Western standards. Companies should carefully evaluate the quality of animals available for purchase, the quality of the supply chain, processes to ensure security at animal facilities, and animal health screening practices. One of the greatest deficiencies, Meyers noted, was the availability of expertise in veterinary pathology.
CHA’s cost modeling of a six-month GLP study in nonhuman primates, based on 2007 and projected 2012 costs, led Meyers to conclude that “there is a sustainable cost advantage” over at least the next five years. Based on total costs, savings are roughly 50% at present, rising to 60%. Similar results emerged from a cost modeling analysis of a one-month rat GLP study.
“The GLP mindset takes a while,” concluded Meyers, noting that a number of CROs in China are much closer to operating according to U.S. GLP standards.
“The laboratories in China seeking to work with Western countries understand that they can’t trip up right out of the box,” Meyers said. “Lab automation and computerization are rare, animal welfare standards and processes need improvement, English language capabilities are modest at most facilities, and the talent pool is shallow in some notable areas, particularly at the senior level.”