Pfizer plans more partnerships in Asia
In September Pfizer revealed to Outsourcing-Pharma how it plans to “tap into innovation in Asia” through partnerships with contract research organisations (CRO) and academics.
“The old model where almost all R&D within the pharma industry was conducted within captive sites served us well in the past”, said Bradley Marchant, head of clinical development in Asia at Pfizer. However, innovation is needed to tackle “soaring costs and diminishing productivity”.
India tightens clinical trial guidelines
To protect the rights and safety of clinical trial volunteers, as well as ensure the credibility of data, the Central Drugs Standard Control Organization (CDSCO) of India introduced stricter guidelines.
The CDSCO claims a tighter framework will provide direction for inspectors and CDSCO officers when conducting inspections of sponsors, CROs and clinical trial sites, wrote Outsourcing-Pharma in November.
Local CROs key to avoiding BRIC wall, says report
The large number of CROs in emerging markets, and Brazil, Russia, India and China (BRIC) in particular, allows sponsors to be more selective when choosing an outsourcing partner. In this competitive environment CROs must differentiate, with local knowledge being one possibility.
“[Local CROs] offer intimate knowledge of their country and region, providing benefits in regulatory filings, contracting with sites, finding investigators and patients, and managing the overall trial”, said Shaylyn Pike, senior clinical development analyst for Cutting Edge Information.
Norwich forming Indian CRO to support Alvogen & clients
In April Norwich Pharmaceuticals became the latest of many biopharm contract service providers to detail Indian expansion plans. As well as expanding geographically Norwich added new capabilities, moving beyond manufacturing and into clinical trial services.
Norwich set up in Bangalore, India to support its parent company, generics manufacturer Alvogen, and clients with services including pharmacovigilance monitoring, bioanalytical studies and medical writing.
Outsourcing to Asia is a “strategic imperative”; Quintiles
Outsourcing to Asia has shifted in recent years from being a tactical move to a “strategic imperative” as capabilities needed for high value work have been added, according to Quintiles.
In a white paper, titled Realizing the Promise of Asia-Pacific, the CRO said the region is coming of age and beginning to make “key contributions of drug discovery and research innovation”. Shortcomings remain but the region has the potential to have a big impact on drug development.