Pharma Outlook 2010

Cold Chain Efficiency



In the past, pharmaceutical cold chain logistics and other perishable cold chain logistics have very little overlap, mostly because of the higher standards and higher prices that the pharmaceutical industry requires and is willing to bear. The picture is starting to change.

First of all, a lot of the same equipment is used throughout the cold chain logistics industry as a whole. What sets the difference is how well the cold chain is enforced through best practices, traceability and compliance monitoring.

Such practices in the cold chain transportation of other perishables continue to improve, and the adaptation of cold chain across other perishables is driving down the cost of best practice in general. We should start to see some cross application of technology in 2010.

A Japan International Co-operation Agency (JCIA) sponsored immunization program recently selected a temperature recorder that is commonly used by quick service restaurants. This was for cold chain compliance monitoring of vaccines that are supplied to Cambodia. They have determined that their chosen unit, which costs less than half of any others that are commonly used in the pharmaceutical industry, is of equal if not better quality and reliability for their purposes. With competition, companies that adapt quickly and remain efficient thrive, and the consumer wins.

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Stepping Up Pharmacovigilance



External expenditure on training is one of the easiest and earliest items to be slashed in economic hard times. The economic consequences of the global financial crisis have also resulted in the consolidation of activities, including the regional co-ordination of pharmacovigilance.

For some major companies, this has resulted in the closure of activities in Sydney, Australia in favor of Shanghai, China. The economic upturn will see increased expenditure by companies on Asiafocused pharmacovigilance training in 2010 and beyond. Both commercial organizers and not-for profit societies will be involved, with conferences or workshops that have already been advertised for Shanghai and Hong Kong.

The second development is not a consequence of the economic situation but a growing maturity of regional regulatory agencies. Both the European Medicines Agency and the US Food and Drug Administration are frequently requiring commitments to additional post-marketing pharmacovigilance activities and product-specific risk minimization activities - as a condition for the marketing of new active substances and major extensions of indications.

Regulatory agencies in Asia Pacific will start to demand to be informed of the commitments in Europe and the US, and to receive the results of those activities.

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Increasing Productivity



From an analytical system point of view, technologies that are capable of increasing productivity and reducing operating costs should see greater adoption. Ultimately, these technologies can have a great impact on a company.

Liquid chromatography systems have been an essential tool that is used by the pharmaceutical industry. Sample analysis throughput, reduction of operating costs and environmental friendliness will be key selling points moving forward.

Since the introduction of Ultra Performance Liquid Chromatography (UPLC) technology in 2004, separation science has shifted, demonstrating its capability to meet the requirements of the pharmaceutical industry and has significantly impacted business performance. Expanding UPLC into multiple applications from research to manufacturing will continue to increase the adoption of this technology.

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Advancing Automation



We are seeing improving business in the Asia's pharma space for the industry automation business. With the major mergers and acquisitions that are taking place today with the Big Pharma companies, it is hopeful that the momentum will continue - driven by increasing demand for quality medicine in the Asian region and new drug developments internationally.

While India and China are both key growth engines, we are also experiencing increasing activity in the rest of Asia.

For example, 2009 has seen a flu vaccine plant coming on stream in Taiwan to meet recent pressing demands. In 2010 we expect a major liquid formulation plant to be coming online in the Philippines. In Singapore, Baxter and Alcon have adopted automation platforms. We should also see more activities in the Process Analytical Technology (PAT) area.

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Raising the Bar in Quality



Increased Quality Control and the adoption of international standards is crucial for success in the pharmaceuticals industry. Regulatory requirements (eg, FDA) is especially important for exports. Electronic batch recording "right first time" support results in stronger user guidance for improving process and product quality - this is the biggest challenge for Parma.

We should see a rise of PAT in pilot projects. Pertaining to the Quality by Design (QbD)/PAT approach, Manufacturing Execution Systems (MES) manifests itself as a leading solution for process performance management, product quality monitoring and continuous quality verification. QbD is also growing in importance in R&D as quality is vital for the design of new products.

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Regional Growth



As we look into 2010 and beyond, biopharmaceutical companies will continue to expand their drug discovery and development programs in Asia Pacific. This is because of larger patient populations, faster recruitment compared to Europe and the US, and the large, centralized hospitals that Asia offers. We have already seen an increased desire by countries in this region to conduct global trials, which we expect to continue this year.

Governments in these countries will continue to enact regulatory changes to ensure that trials are performed according to good clinical practice and International Conference on Harmonization (ICH) guidelines. Contact Research Organizations (CROs) will support this effort through increased training.

In addition, we will see more inspections than in the past and at earlier stages as a safeguard to ensure ethical and quality standards. In China, for example, improvements in regulatory timelines and intellectual property protection - two of the major challenges to conducting clinical research in the country, will continue as the country places greater value on intellectual property.

We also expect more Western-trained physicians to return to their home countries such as India and China, adding to the pool of experienced investigators that are available in the region. As a result of these measures, companies should become more comfortable working in Asia Pacific and realize that this is a region where they can conduct high quality research.

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Process Optimization



From the human genome, the proteome and the transcriptome to Ribonucleic Acid interference (RNAi), each has been an achievement its own right.

My hope for 2010 is to spare the industry yet another "breakthrough". And the chances are good: Much of the hype in the life science community over the last decade has been to accrue functional data beyond a critical limit.

Incorporating aspects of previous breakthroughs, life science has edged towards a more quantitative discipline, gradually becoming more predictable for therapy development. Eventually, much of the current drug discovery paradigm will find itself upended. For example, the identification of effective drugs will be preceding the isolation of drug targets.

Target-free visual approaches already allow for a faster identification of effective drug candidates, which in turn are used to identify their targets in a secondary routine. Imaging, in parallel, allows for target free optimization, saving valuable time. These technologies, many of which are being developed in Korea, will transform our industry.

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Asian Expansion



The year 2009 was characterized by muted activity and investments in the pharmaceutical industry in most of Asia, except China. With the economy recovering in 2010, we foresee that activities and investments will start to trickle in.

The big pharmaceutical companies' growth will be slow, as their sales are being eroded by mid-sized companies as well as local generics drugs manufacturers. Big pharmaceutical manufacturers in Asia are experiencing the same Mergers and Acquisitions (M&A) as in the US and Europe. The success with this wave of M&A will come from companies that are working on oncology and Central Nervous System (CNS) drugs, due to their biologic nature being less prone to competition from the generics pharmaceutical manufacturers. Biological drugs will be the strongest growth area for the Big Pharma.

In terms of R&D, the investments from Big Pharma are not reflected heavily in Asia. However, many governments in the region will continue to drive the R&D activities together with the pharmaceutical companies. Many of the multinational pharmaceutical organizations are utilizing the expertise and infrastructure that are found in universities, to conduct R&D activities. This trend should continue and expand with the collaboration between state-funded research institutes and the private industry.