Bioanalysis Zone

Chinese New Year: a focus on Chinese bioanalytical work

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Coinciding with the Chinese New Year, on Bioanalysis Zone we have a  focus on the bioanalytical work carried out in China. To celebrate this event we have worked with experts from CRO’s and pharma, to bring you updates from the regulatory environment in China, the latest work conducted in Chinese bioanalytical laboratories and current industry trends in bioanalytical outsourcing.


Chinese new year image 2Highlights from 5th China Bioanalysis Forum Annual Conference
In this short conference report, the authors reivew the 5th China Bioanalysis Forum (CBF) Annual conference, which was held in Beijing Century Lotus Hotel (China) during 16–18 June 2017.

Highlighted opinion articles

1Recent China Food and Drug Administration reform: impact on the present and future of bioanalytical contract research organization laboratories in China

Abstract
Over the last 30 years, China’s economy has experienced continuous and substantial growth. Within the pharmaceutical industry sector, China is currently the third largest pharmaceutical market in the world and gaining on Japan, which is currently placed in the second place. This fast growth brings opportunities as well as challenges. Recognizing the sluggishness of the legal and government policies for new drugs and the poor quality of some generic drug products, in August 2015, the China State Council issued the Opinions on Reforming the Review and Approval System for Drugs and Medical Devices, urging the transformation of the pharmaceutical industry and improving drug products in order to meet the public needs [1]. This launched the largest pharmaceutical and medical regulatory reforms in recent history. What transpired in the years following is unprecedented, dramatic and in line with a Hollywood script as some people would describe it. Almost every month, the China Food and Drug Administration (CFDA) releases new policies, guidance or instructions, which creates turmoil, excitement, anxiety, speculation and opportunity for change [2–5]. The news is typically posted on the CFDA official website [6]. Unlike western countries, these may even be posted at midnight and within minutes word is spread via popular social media (e.g., WeChat App). By the following morning, it seems that many people both within and outside of China are talking about the latest announcements.

2Bioanalytical outsourcing strategy in China

Abstract
Improving R&D efficiency has been a focus of the Pharmaceutical industry over the past few decades. Externalization, such as outsourcing, is one of the strategic approaches that could give resource flexibility and increase cost–effectiveness. Since bioanalysis is an integral component of the preclinical and clinical evaluations of drug candidates, a well thought bioanalytical outsourcing strategy could lay a good foundation for future success.

Exclusive conference reports

3The fourth China Bioanalysis Forum Annual Meeting

Abstract
The fourth China Bioanalysis Forum annual conference, co-organized with the Nanjing International Drug Metabolism Conference, was successfully held in Nanjing, China, between 24–26 June 2016. The theme of the conference was ‘how to conduct regulated bioanalysis under China Food and Drug Administration (CFDA) regulations’. In addition, several hot topics including bioanalytical challenges, solutions for biomarkers, antidrug antibody (antibody–drug conjugates) and biologics were discussed. This Conference Report summarizes the major discussion topics from the conference.

4Clinical and pharmaceutical success from discovery to regulatory approval: biomarkers, modeling and analytical technologies

Abstract
The 8th Annual Shanghai Symposium on Clinical and Pharmaceutical Solutions through Analysis (CPSA): Clinical and Pharmaceutical Success from Discovery to Regulatory Approval: Biomarkers, Modeling and Analytical Technologies (CPSA Shanghai 2017); Renaissance Shanghai Pudong Hotel, Shanghai, China, 12–14 April 2017 was held on 12–14 April 2017 in Shanghai, China. The meeting was featured with highly interactive events including diversified symposia, workshops, roundtable discussions, conference awards and poster sessions. There were over 220 participants with 61 oral presentations and 20 posters presented. In addition, the meeting included a preconference workshop with an inaugural session on the evaluation of quality and efficacy for generic drugs in China.

Interview

5An overview of the China Bioanalytical Forum: interview with Daniel Tang

Abstract
Daniel Tang talks to Sankeetha Nadarajah, Commissioning Editor (Bioanalysis), regarding the China Bioanalysis Forum (CBF), in which Daniel was one of the co-founders and remains as its co-chair. Daniel is currently the CEO of UP Pharma, a biologics focused bioanalytical CRO in China.

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