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Pharma  Features  Story
The CRO Power
Nandita Singh & Eliza Yibing Zhou

Sep 1, 2007: Due to the recent economic slowdown in the west, the outsourcing business in life sciences, especially pharmaceuticals and biopharmaceutical business, has shown a surge.

Consider this. Globally, since 2001, spending by drug sponsors on clinical research services has grown 15 percent annually, outpacing the 11 percent rate for overall spending on development. Also, drug sponsors increased their reliance on contract research organizations (CROs). Headcount among major CROs grew six percent annually between 2001 and 2004, while sponsor headcount remained flat.

If that is not an indication enough, look at the size of business that has been outsourced. In 2004, leading CROs managed 23,000 phase I-IV clinical trials worldwide, monitored more than 150,000 clinical investigators, and enrolled more than 640,000 new subjects.

MNCs and global CROs are focused on reducing the drug discovery and manufacturing burden. Among sponsors, the general opinion is, projects with high CRO usage stay closer to schedule. Usually, high CRO usage projects are submitted more than 30 days closer to their projected submission date as compared to low CRO usage projects. Even though pivotal trials involving high CRO usage tend to be larger than those with low CRO usage, they are completed faster, especially during the study close-out period. Dr Bhaswat S Chakraborty, Sr VP, Cadila Research and Development shared these thoughts at a summit held in Goa, in India. The purpose of this summit organized, earlier this year, by research firm Frost & Sullivan was to highlight partnering opportunities to the CROs in India showcasing where the industry is headed and how to leverage on the global opportunity.

Be it clinical research or contract manufacturing the opportunity is too huge to miss out on. Though India & China have their advantages, India particularly for its relatively better IP climate, if you start taking stock of the business that is being outsourced in countries across Asia Pacific you would be amazed.

Dr Dennis Gillings, Chairman & CEO, Quintiles Transnational Corp

Dr Dennis Gillings Chairman & CEO Quintiles Transnational Corp

How do you see your position in the developing countries like India where leading companies are now making a beeline to set up CROs?

We are the leaders in our business in almost all the developing countries. When we are a leader and in a comfortable position we don’t have much to worry about. If two of our big competitors combine, maybe then we would think about acquisitions.

You have presence in both India and China. Which country do you feel gives better RoI?

India has been much better for us. The business in India is much bigger than in China. It is easy to do business in India because of the English-speaking people, which makes communication easy.

What made you look at China despite many drawbacks?

China also has large population. We want to be where our customers want us to be. To be honest, we went to China because of the customer demand and came to India because I thought it is a good idea. I felt India could be very good for our business.

CRO market gets globalized
Datamonitor’s recently published report R&D Strategies 2007 points out that the CRO market is becoming increasingly globalized. An Economist Intelligence Unit 2004 White Paper indicated that 70 percent of companies surveyed had overseas R&D functions, with more than half of those questioned indicating that their investment in overseas operations would increase over the next three years. Big Pharma has expanded its research presence overseas substantially in the last decade, and many Western multinationals have an R&D presence in emerging markets. Additionally, drug developers have become increasingly dependent on CROs, which themselves have become increasingly globalized. This is being driven by both the rise in the number of CROs in emerging market and the increasing internationalization of western CROs. The report points out that India and China are the most popular emerging countries for outsourcing CRO activity.

For instance, Taiwan a small country with a population of 23 million leads in the number of ongoing clinical trials. According to www.clinicaltrials.gov, Taiwan has 532 ongoing clinical trials followed by Japan with 328, China with 275 and India with 270 trials as on June 6, 2007. In Taiwan, the number of approved international clinical trials alone increased to 133 in 2006 as compared to 120 in 2005. 

As far as the trend in outsourcing goes, while various segments of the drug discovery value chain from the west is moving to the east, the business from the east is moving or expanding further east. In line with the trend, the number of CROs in Asian countries is swelling. 

According to a recent study, Advances in Biopharmaceutical Technology in China, conducted jointly by the Society for Industrial Microbiology and BioPlan Associates, China has more than 300 CROs providing a wide variety of services from drug discovery, development, preclinical and clinical trials to manufacturing.  The country’s largest CRO Excel PharmaStudies, in the next five years, aims to become Asia’s leading CRO. According to its CEO Mr William Xiong, there is a plan in place involving organic growth, acquisitions, and alliances with leading international partners.

In the last eight years, Excel has grown into a full service CRO providing comprehensive regulatory, clinical research and quality assurance services with regard to drug clinical development, Phase I-IV, bioequivalence studies, clinical monitoring, project management, patient recruitment, data management, biostatistics analyses, translation, medical report writing, and all other related services.

Chinese companies are not only becoming compliant with international standards they are also collaborating to bargain for collective benefits. In June 2007, three CROs, Sundia MediTech,  United PharmaTech, and HD Biosciences got together to form a CRO Service Alliance (CROSA) in Shanghai’s Zhangjiang Hi-Tech Park. The companies will provide services in new pharmaceuticals synthesis, lead optimization, molecular bio-assay development and tests, in vitro and in vivo PK/ADME research, and cGMP-required intermediates and API for clinical trials.

The investor interest is also growing in the sector. According to a study by Chinese consultancy company Zero2IPO, Sundia MediTech has made it to the list of top 16 firms to invest in China. Led by its Chairman and CEO Dr Xiaochuan Wang, the company is raring to go further.

The case is no different in India. The outsourcing of drug discovery research to India is on the rise. According to research firm Frost & Sullivan, the pharma outsourcing business in India will grow to around $7 billion by 2013. Another report by Pune-based research firm Value Notes, forecasts a growth of 23.6 percent annually for the industry up to 2010. This is not hype or hope, but a reality as global firms seek to leverage the advantages related to cost and quality that Indian companies offer in this field.

Dr Raymond Chua MD & Regional Medical Director, Eisai Clinical Research, Singapore

What inspired you to set up your clinical research subsidiary in Singapore?

Recognizing the growing opportunity for biomedical research in the Asia Pacific region, Eisai has established a regional office in Singapore. Only barely a year ago in July 2006, the company set-up a marketing subsidiary, Eisai (Singapore) Pte Ltd (ESN), and then in June 2007, a second subsidiary, Eisai Clinical Research Singapore (ECS), was created as the clinical research hub in the Asia Pacific, Oceania and Middle East region.

This group will focus on developing and enhancing operations to support clinical trial research, which will in turn, help to expedite registration of drugs in the company’s pipeline. Through building and strengthening relationships with investigators, clinical trial sites and partners, such as CROs, central laboratories, medical imaging, IVRS, training or clinical supply providers, ECS will ensure the successful management and execution of both global and regional clinical trials.

 

 

 

According to the Frost & Sullivan study, the Indian Contract Research and Manufacturing Services (CRAMS) market in India was valued at $895 million in 2006. Though manufacturing (Active Pharma Ingredients or APIs) and oral solid formulations (tablets and capsules) continue to be the major sources of revenue for India’s contract manufacturing industry, other segments in contract research, outsourcing of drug discovery research are slated to show the highest growth of 26 percent a year, according to the Value Notes report, Contract Research Opportunity for the Indian Pharmaceuticals Industry.

The signs of this trend are clearly visible with several multinational companies such as GSK and Bristol-Myers Squibb tying up with Indian companies for both drug development and manufacturing services. GlaxoSmithKline (GSK) signed a multi-million dollar contract with Tata Consultancy Services (TCS) to establish a global drug development support center in Mumbai to help meet the demands of the growing GSK pipeline. Bristol Bristol-Myers Squibb and Biocon’s Syngene have signed a research collaboration agreement. Further several Indian companies are also forming alliances or acquiring companies outside the country to enhance their capabilities and service offerings. For example, Bangalore-based Manipal Hospital group’s Manipal AcuNova Life Sciences has formed a strategic regional alliance with Kiecana Clinical Research (KCR), based in Warsaw, Poland, for leveraging operations in South Asia, Europe and Latin America. The objective of being globally competitive and seeking a symbiotic relationship is to facilitate their respective clients to bring out quality products in a short time.

Dr Shiv Prakash, CEO, Synchron, IndiaDr Shiv Prakash CEO, Synchron, India

What inspired you to set up your clinical research subsidiary in Singapore?

Recognizing the growing opportunity for biomedical research in the Asia Pacific region, Eisai has established a regional office in Singapore. Only barely a year ago in July 2006, the company set-up a marketing subsidiary, Eisai (Singapore) Pte Ltd (ESN), and then in June 2007, a second subsidiary, Eisai Clinical Research Singapore (ECS), was created as the clinical research hub in the Asia Pacific, Oceania and Middle East region.

 

This group will focus on developing and enhancing operations to support clinical trial research, which will in turn, help to expedite registration of drugs in the company’s pipeline. Through building and strengthening relationships with investigators, clinical trial sites and partners, such as CROs, central laboratories, medical imaging, IVRS, training or clinical supply providers, ECS will ensure the successful management and execution of both global and regional clinical trials.

 

 

 

India backs CROs
According to a report by the Boston Consulting Group (BCG), the CRO market growth is expected to be double digit in the next five years. India has a record of conducting clinical data management and biostatistics work for MNCs. It is expected to get major share of such work in near the future too. 

Currently, India conducts about 1.5 percent of the global clinical trials. This could rise to five percent by 2008 and 15 percent by 2011. And that is the percentage of a global total that itself is increasing by 10 percent every year.

Mr Shyam Bhartia, Chairman & MD, Jubilant Organosys, IndiaMr Shyam Bhartia Chairman & MD, Jubilant Organosys, India

What kind of competition do you have to face while pitching for business?
Overall, Indian pharma outsourcing industry is fragmented, with ticket sizes of the deals and the overall size of the players executing those deals both remaining small.

There is no single company as integrated as Jubilant or one which has the comparable scale/experience in outsourcing and competition from domestic quarters, basically emphasizes the cost advantage.

Incremental business for some Indian peers also comes via a scaling up of the existing relationship with global customers in the chosen product/service areas.

Internationally, competition typically comes from low-cost operations in other developing countries. China particularly is one such competitor, which relies on leveraging its volume advantages in manufacturing to compete in the market place.

However, India is very strong in regulatory compliance and supply chain management experience and that puts India into an advantageous position.

To support this growIng service sector, in its recent budget, the country’s central government announced exemption of service tax for  CROs. Welcoming the initiative, the industry, noted that it would  bring more customers to India and also more companies would start operations in this area.

The government has also committed $1 million fund to upscale the capacities and competence of the country’s clinical research organizations. Indian government’s Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR) are supporting this fund.

Besides the financial support, the Ministry of Health and Family Welfare has constituted the National Council for Clinical Establishments under the directorate of health services with a view to determine minimum standards for clinical establishments and to maintain and update a national register of clinical establishments in the country. The Director General of health service, at the Ministry, will head the council as Chairman.

Mr Alek Safarian CEO Novotech, AustraliaMr Alek Safarian CEO Novotech, Australia

 What according to Novotech is the most competitive location for conducting clinical trials in Asia Pacific?
Hard question!  The whole region is experiencing a boom that only seems to be picking up momentum. Everyone knows about India and China of course, but there are also other countries such as Korea, Malaysia, Taiwan and Thailand, as well as Australia and New Zealand, of course, that are increasingly on people’s radars these days. 

It’s difficult to pick a single country. There is no doubt the entire region is growing very fast and the interest level from the pharma and biotech industry with it.

The recent decision by the Indian government to eliminate service tax payable by CROs will certainly make India even more attractive than before.

 

 

 

The functions of the National Coun cil for Clinical Establishments shall be to determine the standards for clinical establishments; classify the clinical establishment into different categories; develop the minimum standards and their periodic review; compile, maintain and update a national register of clinical establishments; perform any other function determined by the Central government from time to time.

In the foreseeable future, the Indian CRO market is expected to undergo a composition change in the coming few years. Bioavailability and bioequivalence studies, that occupied a major share in the clinical research market pie, are likely to lose to other areas such as clinical trials (phase I-IV) and data management. The cost advantage will no longer be the prime-attracting factor for the Indian players. The importance would shift to factors such as quality, timeliness, and value added services that are being offered by the Indian CROs.

However, data security, manpower and public infrastructure still act as a bottleneck for the growth of the industry. And also the issue of the lag for phase I trials in India. But Frost & Sullivan noted that the nascent markets like phase I and pre-clinical toxicology will see growth due to the pressure from the industry on government and the industry’s need to become a one-stop solution for its clients. Once that is in place, Indian CROs can increase their share in the global CRO market.

Medical infrastructure
Hospitals: 14,000
Doctors: 5,00,000
Hospital beds: 7,00,000 (85 percent urban)
Medical colleges: 162
Medical graduates: 17,000 every year

Patient population estimates
40 million asthmatic patients
Approx 34 million diabetic patients
8-10 million people HIV positive
8 million epileptic patients
3 million cancer patients
>2 million cardiac related deaths
1.5 million patients with Alzheimer disease
15 percent population is hypertensive
1 percent of population suffers from schizophrenia

Source: Burrill India Life Sciences Newsletter October 2006

MNCs leverage India advantage
Quintiles Transnational, a leading global CRO with revenues touching $2 billion, has completed 10 years in India in 2007. Quintiles India contributes about three percent to its total global sales. And it is growing at a rate of 25 percent over the global growth rate of 20 percent. In 1997, Quintiles Transnational took a strategic decision to enter India and opened an office in Ahmedabad, though it was not a demand from its customers. In 10 years, it has emerged as the leading CRO in India.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Inspired by the growth and success of Quintiles India, the other global CROs like PPD, ICON, PRA, Parexel, Kendle, PharmaNet, Omnicare, Chiltern, ClinTec and Covance too felt the urge to start their operations in a country where economy is booming and has plenty of resources to do business in the CRO space. Most of these have set up shop only in last couple of years, thanks to the central government for its initiatives in the implementation of the patent regime in 2005, promoting medical tourism and announcing incentives to the CROs sector.

Depending on the risk and confidence level, these CROs opted different routes such as acquisition, alliance and direct presence to enter the Indian the market. CROs like PPD, Kendle, PharmaNet, Omnicare, Chiltern, ClinTec, RCC and Simbec opted for direct entry route while others such as PRA International and ICON decided to adopt the acquisition model. Some others like Parexel, Covance and INC Research to be on safer side, took the alliance partnership approach. 

Dr Kok Wei Yap President & CEO, GleneaglesCRC SingaporeDr Kok Wei Yap President & CEO, GleneaglesCRC Singapore

What are the challenges before the CRO sector in Asia Pacific region?
The challenges differ from country to country.  In Japan, the challenges include language barrier, very high costs of conducting the trials, too stringent regulations, and no patient benefits (people are covered under national insurance) and there is a gap between doctor and CRA. While in Taiwan the government is too supportive towards the local organizations. Although, Korea is opening up faster in CRO space than Japan still there are some challenges. In Korea, patients are willing to participate in clinical trials, the doctors are supportive to conduct trials.

PPD, a leading global CRO, set up its office in India in 2004 to provide patient recruitment and clinical monitoring for phase II-IV studies in key therapeutic areas. The Mumbai office expands its geographic footprint in Asia and enhances its ability to conduct global studies in industry-targeted therapeutics. Extending its drug development expertise to India allows PPD to assist clients in offering cost-effective clinical research opportunities to treatment-naïve patients for a number of therapies, including oncology and metabolic disease, such as diabetes.

With the goal of providing high-quality, cost-effective data management and biometrics services to its clients, ICON Clinical Research (a division of ICON plc), again another leading global CROs, has established an office in Chennai. This move will give ICON access to a large talent pool that includes many highly educated and experienced data management professionals. It also acknowledges the increasing importance of India as a center for technological expertise and clinical research. It also acquired a Chennai-based data management company, Biomines Research Solutions. In addition to providing data management and biometrics services, ICON has recruited several clinical research associates to support its growing clinical research activities in India.

Dr Jenny Zhang Director US Business Development, Excel PharmaStudies

China is projected to become the fifth largest pharmaceutical market by 2010. Many MNC pharmas have established R&D centers in China over the past two years. Chinese CROs understand the local regulatory frameworks better, and they can help MNC pharmas launch their products to the Chinese market in a shorter period of time. We can offer quality-assured services in conformity with international standards at about one-third cost of the West.

PRA International, a leading global CRO, entered India in 2006 by acquiring Sterling Synergy Systems Pvt Ltd, a CRO based in Mumbai and Pune. This acquisition establishes a solid foundation for PRA in India and greatly increases its access to clinical sites, investigators and patients. PRA’s clinical operations are based out of Mumbai while it has a data management center in Pune. With the Pune center, PRA will be able to provide integrated around-the-clock data management capability, augmenting its existing facilities in Lenexa, Kansas; Victoria, British Columbia; and Swansea, Wales.

 

 

 

 

 

 

However, Covance, a leading and most comprehensive drug development solution provider, entered into an alliance with SIRO ClinPharm in 2003 to offer drug development services in India to support domestic and international customers. It has the people, global resources and problem-solving culture to respond to even the most demanding challenges of drug development services.

Mr William Xiong CEO Excel PharmaStudies, ChinaMr William Xiong CEO Excel PharmaStudies, China

How challenging is the CRO business and what is Excel doing to meet those challenges?
As the total cost of new drug development has doubled since 1997, and process of that development has also been prolonged due to increasingly stringent regulations. Multinational pharmaceutical and medical device companies are dramatically increasing demand for pre-clinical and clinical research services.

Conversely, however, there are also an increasing number of CROs throughout the world, and this has raised the level of competition and reduced profit margins for all CROs. The challenge that Excel faces every day is tough combination for new business while still maintaining sufficient profits to grow the business. 

Our next five-year plan is to grow from the leading Chinese CRO into the leading Asian CRO.  This expansion will be by a combination of: (1) organic growth; (2) acquisitions; and (3) building wide-spectrum alliances with leading international partners.

Similarly Spacelabs Medical Data, a leading US-based global cardiac safety monitoring service provider, formed a strategic alliance with SIRO in December 2004. The alliance aims at providing companies conducting trials in India with centralized cardiac safety monitoring services (i.e. 12 lead ECG, Holter monitoring, Ambulatory Blood Pressure monitoring etc.).

GCPSiro, a US-based CRO has entered into a partnership with SIRO in 2006 to offer immediate clinical development solutions to pharmaceutical and biotechnology companies operating in that country. The partnership seeks to offer clients the necessary project management and other drug development support services in real time as well as in their respective time zones. inVentiv Clinical Solutions, a leading US-based pharmaceutical commercialization services provider offering solutions in clinical staffing, biostatistics and data management, has entered into a joint venture with SIRO. inVentiv-SIRO (India) will provide pharmaceutical and biotech companies access to a broad pool of offshore talent who will design databases, conduct data and statistical analysis. This joint venture is also capable of providing large-scale off-shore services to fulfil clinical data management and biometrics requirements in a cost-effective manner.

Mr Dave Spaight President, MDS, US

Mr Dave Spaight President, MDS, US

Could you outline the future of the CRO business and how MDS plans to leverage on the industry’s growth?
We expect to see continued globalization and consolidation in the CRO industry, which is currently quite fragmented, as well as a growing focus on specific therapeutic areas and the involvement of children in clinical trials.

In response to these trends, in Phase II-IV, we are pursuing continued geographical expansion, particularly in Asia Pacific and Latin America, along with innovative solutions for data flow through further investments in IT for electronic data capture and electronic document management, which are critical to the management of large global trials.

 

We are also focusing on the specific therapeutic areas of oncology, metabolic disorders such as diabetes and cardiovascular disease, vaccines and infectious diseases. We are leveraging our experience in those therapeutic areas and our experience of working in Asia to position MDS Pharma Services for future growth opportunities.

 

 

 

 

INC Research and GVK Biosciences entered into a 50:50 joint venture to form INC GVK BIO in 2006. The JV will establish a dedicated resource capability to offer phase I-IV clinical development programs in India for INC’s global clients. The joint venture will enable INC research to conduct its global clinical trials in the areas of oncology, CNS, infectious diseases and pediatrics involving phase I-IV studies.

Parexel International Corporation, a leading global CRO, entered into a joint venture arrangement with Synchron Research Services in 2006, pursuant to which it purchased a majority stake in a newly formed entity, Parexel International Synchron into which Synchron moved its clinical trial business operations to Bangalore. Parexel also acquired a minority equity interest in the clinical pharmacology business of Synchron Research in Ahmedabad. However, Parexel entered into an exclusive strategic collaboration with Synchron in 2004.

CRO

Ownership

Location

Service

Quintiles Translational

US

Beijing

Clinical

Excel PharmaStudies

Sino-US

Beijing, Shanghai

Clinical

Covance

US

Beijing

Clinical

Apex International CRO

Taiwan

Shanghai, Beijing

Clinical

EPS (China)

Japan

Shanghai

Clinical

MD Pharma Services

US

Beijing

Clinical

Beijing KendleWit
Medical Consulting

Sino-US

Beijing

Clinical

Venturepharm Group

Sino-US-Canada

Beijing

Full services

CCBR

Denmark

Beijing

Clinical

Bridge Pharmaceuticals

US

Beijing

Preclinical, bioanalytical

IgCROM

Japan

Shanghai

Clinical

Starvex

Chinese

Shanghai

Preclinical

Beijing Joinn Pharmaceutical Center

Chinese

Beijing

Preclinical & clinical

Giant Med-Pharma
Services

Chinese

Beijing

Clinical

Beijing Union-Genius Pharma Tech

Chinese

Beijing

Preclinical

Sun Yat-sen Univ.
Medicine Dev. Center

Chinese

Guangzhou

Preclinical & clinical

The presence of leading global CROs including the top 10, will encourage the others to look at India as a global market for CRO services, which is growing rapidly with a focus on India and other emerging economies. India will witness more activities in the near future with the entry of more global CROs.

Ms Nermeen Varawalla, VP, Corporate Development PRA International, UK Ms Nermeen Varawalla
VP, Corporate Development PRA International, UK

How challenging is the CRO business and what is PRA International doing to meet those challenges?
One of the key challenges the global clinical development sector faces is resourcing. Product development pipelines are richer and more complex than ever before with sponsors seeking to outsource increasing proportions of their drug development activities. Recruiting and retaining talented people able to deliver on demanding clinical trials is perhaps the biggest challenge for the CRO industry. We at PRA International are striving to be an Employer of Choice for some of the best talent in the industry throughout the world. We are doing so by investing in the development of our people—we have own Training Institute and a structured Career Development Program. Also, we continuously seek to recruit talented individuals with a range of experience and skills. We are not complacent about any of the fore mentioned initiatives but strive to improve in recognition of the importance of people for not only our organization but also for the global industry.

 

Taiwan emerging

Taiwan, a small country with a population of 23 million, is eager to leverage on this opportunity. And it is already ahead of countries like India and China in conducting quality clinical trials for multinational companies.

According to www.clinicaltrials.gov, Taiwan is leading the pack with 532 ongoing clinical trials in the country. This is followed by Japan with 328, China with 275 and India with 270 trials as on June 6, 2007. The number of approved international clinical trials alone in Taiwan has increased to 133 in 2006 from 120 in 2005.

Taiwan has excellent infrastructure for clinical trials and research, with national centers of excellence for clinical trials, and clinical research set up in several major university teaching hospitals. A good number of hospitals in Taiwan have several thousand beds, making them the largest hospitals in the region. Taiwan has 22 medical centers, 61, teaching hospitals and 556 hospitals with 34000 physicians and 146,382 beds in the country. About 136 hospitals have accreditation for conducting trials.

Government initiatives
A comprehensive regulation, GCP guidelines for clinical trials protocols, informed consent, biospecimen collection, Institutional Review Boards (IRBs), clinical trial inspections, training and support for local hospitals are in place in Taiwan. The IRBs are of high international standards and leading hospitals in Taiwan have passed the international accreditation for conducting clinical trials.

The Department of Health, a local regulatory authority has amended and expanded the hospital level for executing clinical trials in 2005 in order to increase the execution rate and encourage clinical research at qualified teaching hospitals. In addition it has supported medical centers to form a general clinical research center. Hence four medical centers—National Taiwan University Hospital, Tri-Science General Hospital, National Cheng Kung University Hospital, and Wan Fang Hospital—established Centers of Excellence for clinical trials and research in 2006. To achieve the goal of setting up an international clinical trial center as well as to enhance the mechanism and monitor the control of national clinical trials, a virtual team for a new drug clinical trial center has also been set up.

Besides, the Department of Health, the Ministry of Economic Affairs (MOEA) offers substantial financial incentives to companies so as to encourage them to carry out their preclinical or clinical R&D activities in Taiwan. MOEA has also set up single window services for the promotion of these activities in Taiwan.

A number of sizable contract research organizations have set up base in Taiwan. The leading CROs in Taiwan include Quintiles, ICON, Apex, Covance, & Omnicare.

Mr Albert Liou,  Chairman & CEO, Apex International, TaiwanMr Albert Liou
Chairman & CEO, Apex International, Taiwan

According to you, which is the most competitive location for conducting clinical trials in Asia Pacific?
Each country has its strength and limitations in conducting clinical trials, and it definitely requires extensive knowledge of the requirements from the product development side and what the country can offer. For example, not all countries share the same standard medical practice or national medical insurance policies; these factors may well impact the selection of countries to participate in a global trial.

Having said that, we still have the best outlook for China; according to IMS, China will become one of the top five pharmaceutical market in the world due to its forecast pharmaceutical growth in the next three-four years. Therefore, many pharmaceutical companies will aim for that market and continue to develop products there.

However, the key challenge for any CRO is primarily the resources issue. It is essential to have the expertise and professionals within the organization to deliver excellent service to our clients.

 

 

 

 

 

 

© BioSpectrum Bureau
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