EDITOR’S COMMENT

WPhN The lifescience business is a global business

Dr Patricia Lobo, RSA Consulting

Valuing People

In a fast moving industry, we have to keep up with the rapid pace of change! Soon after writing my welcome letter in the first issue of World Pharma Network in July, I joined RSA (see panel) as a managing Partner to develop RSA Consulting, a division of the group.

I’m delighted to be part of an organisation that has been built on a culture of integrity, respect for the individual and quality services. The overwhelming majority of lifescience businesses strive to follow the same principles. an organisation that adheres to these principles is able to develop a close understanding of other companies’ cultures to enable it to find the right partner to work with or the right people to fit into a company or to find the best solutions for them. Here at WPhN we listen carefully and respond to the needs of the marketplace. Keep in touch as we move ahead into what I’m sure will be a challenging and interesting year.

The Triple Whammy in Milan

In Autumn I attended the “trio” event in Milan - CPhI Worldwide 2007 - this time with ICSE and P-MEC - the industry’s largest annual trade event for pharmaceutical ingredients, services and equipment providers. CPhI held its first show in Italy in 1991 in the suburbs of Milan at Monte Fiori. It was a nice cosy event with many generics manufacturers. When I attended the next CPhI event hosted in Milan (in 2000), I could see all the exhibition stands from a maze of escalators surrounding the halls and visit many service providers within one day. The only problem encountered at that time was transport to and from the exhibition. This time, things were entirely different. The event has become a “must attend business progress event” rather than a “find the supplier or product” event. At a rough guess, i’d say there were more than 20,000 visitors and industry exhibitors. It’s important to book accommodation months in advance, book train tickets the day before the event and wear comfortable shoes – I didn’t expect the walk from the nearest Metro station to the exhibition hall to take me 20 minutes. The three exhibitions were held in seven halls of the new and impressive Fiera Milano Rho Exhibition Centre but, for me, three days still wasn’t enough time to visit colleagues in one hall let alone all seven halls!

Congratulations in place

Congratulations to Avecia Biologics, DSM Pharmaceutical Products and Dowpharma who were named as winners of the gold, silver and bronze medals respectively in the 2007 CPhI Innovation Awards. Annemiele Timmers, the new CPhI Events Director, was upbeat about the event as it showed how, “the industry is rising to the challenges and drivers of regulation, cost and product efficiency and minimized environmental footprint.”

Avecia has developed a new technology, dubbed pAVEway (advanced protein expression), which is a cost- and time-reducing technology that will help to speed up the process from research to production of biopharmaceuticals with reduction in long-term manufacturing costs. The new technology enables class-leading (>10g/L) microbial production of a wide range of therapeutically useful proteins (vaccines, cytokines and growth factors). At ICSE, Vetter Pharma-Fertigung GmbH & Co. KG, world leader in the production of aseptically prefilled injection systems, won this year’s European Outsourcing Award in the category “Most improved Process/Plant/Facility.” The prize recognised the outstanding new facility Ravensburg Vetter South (RVS), which began operations at the beginning of the year.

Going East ...

In this issue we focus on India and its place in global clinical development reviewed by Nermeen Varawalla. To find out more about clinical development on India, the DIA will be hosting the Drug Discovery and Clinical Development event on 18-23 November 2007 in Mumbai, India. Hope you see you there!

According to CentreWatch, clinical research is experiencing huge growth in business – the Indian market is estimated at $100 million and is expected to reach $300 million by 2010. India and China represent the biggest potential for emerging markets for clinical research in Asia. India is a region of massive opportunity with a population of 1.1 billion representing under 20% of the total population of the world. There is a well developed R&D sector in existence already. Membership of the ICR (Institute of Clinical Research) is expanding rapidly and is expected to reach over a thousand members by the end of this year.

The DIA meeting offers an excellent opportunity to collaborate with established clinical research professionals and learn the priority issues such as making use of the best use of local knowledge and resources that need to be addressed for success. Meanwhile, CPhI’s global event family keeps growing – on 23-25 November 2007 – together ICSE and P-MEC India will be held in Mumbai. In our News, Charles Horth reports on recent developments in India’s Pharma Industry.

Five-fold increase in drug fakes over 2006

In June 2007, The European Commission released figures showing that there has been a dramatic and alarming increase in pharmaceutical counterfeiting, with seizures in Europe hitting an all time high of over 2.5 million items. In 2006, the most popular targets for counterfeiters were Pfizer’s blockbuster drug Viagra (sildenafil citrate), Eli Lilly’s Cialis (tadalafil) and Bayer’s Levitra (vardenafil) – all products for the treatment of erectile dysfunction. Other medications commonly faked over the past year included anti-cholesterol and osteoporosis drugs and those used to control hypertension. “The harmful effects of the illicit trade in counterfeit goods are well known,” the EC report comments. “The marketing of fake goods does considerable damage to rights holders, as well as lawabiding manufacturers and traders and more and more attention is being drawn to the dangers to the consumers’ health and safety.” Despite efforts by the pharmaceutical industry to combat the illegal trade in counterfeit versions of its products and protect supply chains, counterfeiters appear to be slipping through the net and continuing to peddle their fake goods.

The current number one source for counterfeit drugs entering the EU is India, where over 30 per cent of the fakes originate, closely followed by the United Arab Emirates and China. These three countries combined accounted for over 80% of all counterfeit medicines in Europe. Although India was the main culprit for counterfeit pharmaceuticals, some European countries were also to blame, with Norway creeping in at joint sixth position. Germany was also highlighted by the EC as reporting a staggering increase in counterfeit goods seizures, the total jumping from 15.5 million articles in 2005 to over 140 million articles in 2006. There are several initiatives being brought on line by the EC which could help fight the trade in counterfeit goods, and may also partly account for the vastly increased haul in fake goods over 2006.

For example, a specific Supply Chain Security Pilot Project is being developed with the aim of tightening end-to-end supply chains between Asia and Europe. The project will involve data-exchange relating to goods traded between China, the Netherlands and the UK, with particular emphasis being laid on establishing “secure lanes” for sea containers moving between China and main European maritime ports. As well as this, the EC has been working to further develop its RIF management system to lead to better coordination between EU member states. The RIF consists of an electronic exchange of information between customs authorities. It allows customs authorities to exchange electronic messages once they have detected risks on certain products. For example, if Belgian customs authorities seize counterfeited goods imported by an ‘unknown’ importer, the RIF system would allow the information to quickly be relayed to the 26 other EU administrations so that they can focus their attention on the suspicious importer.

With reports of counterfeit drugs cropping up with alarming regularity, these tightened security measures along with EU plans to enforce criminal sanctions on those found guilty of counterfeiting seem to be increasingly necessary. No matter what sophisticated gadgetry is introduced in an effort to protect the pharmaceutical supply chains, it would seem that a little human diligence to supplement the technology might also help. Thomas Volcker from Schreiner ProSecure looks at the challenging task of securing the pharma supply chain and products and Masters, a drug wholesaler in the US reviews counterfeiting prescription drugs and the threat they pose to global world health.

Other Developments

Aesica, a newcomer to the industry has taken two transformational steps towards its vision of becoming the number one supplier of APIs and formulated products to the pharmaceutical industry. In September 2007, Aesica acquired the chemical and pharmaceutical facilities and operations at Abbott’s Queensborough site, UK and in 2006 the chemical manufacturing facility at Ponders End, UK from MSD Ltd. Biotech should continue to become more global as companies, particularly in the US, look to the emerging markets for their manufacturing needs and to conduct clinical trials. But our most promising tip for the near future is the emergence of biosimilars, which are poised to revolutionise the pharmaceutical industry.

In the next issue of WPhN we will feature Canada as our country focus. Thanks for your interesting and informative articles and please keep them rolling! To all our readers we hope you enjoy this issue of WPhN.

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