Bibiana Campos-Seijo is a former editor of Pharmaceutical Technology Europe.

Bibiana Campos-Seijo

It is time for me to move on. Being Editor of 

(PTE) has been a fantastic experience and I would like to say thank you. Thank you to the team at Advanstar; firstly for giving me the opportunity and then for making my job extremely enjoyable and fulfilling. Thank you to all the representatives I met at the different trade shows and conferences I attended — you constitute a very friendly face to an industry that too often gets very bad press. Last but not least, I would like to thank the readers for their continued support and constructive advice. Without you we are nothing! 

Please allow me to introduce the new Editor of PTE, Fedra Pavlou. 

It is with real pleasure that I join the PTE team at what promises to be both a changing and, subsequently, challenging time. Whilst none of us can know what the fallout from the current economic climate will be for the pharmaceutical profession, our editorial team will continue to best suit your needs as readers by bringing you relevant, topical and unbiased information — not just in print, but with additional exclusive web content at 

 our weekly e-newsletter and also through new digital products. 

As Editor of this publication, I pledge to provide you with interesting and engaging content that you will find both enjoyable and beneficial. Our job is to serve you to the best of our ability and, during the coming months, I look forward to meeting with some of you, speaking with you and hearing what we can do to make your job easier. I would also encourage you to continue to send your feedback to us.  

We look forward to continuing to make a real contribution to promoting improvements and best practice in your profession.  

Articles

Goodbye and hello

A series of new challenges and regulatory changes, including accession to the European Union in 2007, over the past two decades have forced the Romanian pharmaceutical industry to adapt to international and European standards, a process that has required the investment of tens of millions of dollars. Although still small in comparison with Western European markets, the Romanian domestic market fares well among those of its neighbors, currently ranking fifth after Russia, Poland, Hungary, and the Czech Republic (1). 

Some analysts predict the country will continue to succeed as a location for generic drug manufacturing to become the third largest pharmaceutical market in the Eastern and Central Europe by 2015 (1). Others, however, believe the Romanian market has stagnated. According to an October 2008 report, "Pharmaceutical Market in Romania 2008: Development Forecasts 2008–2010," from the Poland-based market research firm PMR, the country's pharmaceutical market grew approximately 30% per year between 2004 and 2006, but only grew 11% in 2007. PMR's estimated growth figure for 2008 was 8%, and between 2008 and 2010, that figure is expected to be around 9.5% year over year, reaching nearly €2.4 billion ($3.6 billion) (2).  

 Between June 2007 and June 2008, the Romanian pharmaceutical domestic consumer market grew only 2% to approximately €1.78 million ($2.23 million), with 70% of the total value generated by mainly innovative imported drugs, according to Raiffeisen Investment Romania, a subsidiary of the mergers and acquisitions advisory firm Raiffeisen Investment AG (3). In terms of volume, generic drugs absorbed 70–75% of the total market during that time period (3). 

"The Romanian pharmaceutical market is very dynamic, and the growth recorded in these past few years might be considered unbelievable compared to the growth registered in the well-established markets," says Dan Zaharescu, executive director of the Romanian Association of International Drug Manufacturers, a trade association. Still, the market has experienced a decline compared with previous years, and its future is uncertain.  

The Romanian government continues to play a critical role in the market's transformation. Although "relations between the pharmaceutical industry and the government are good," says Zaharescu, on occasion, the control that the authorities exert in price policies for retailers, for example, has resulted in big losses for the sector. In an import-dominated market, fluctuating exchange rates are a risk and, even though current legislation states that drug prices should be adjusted to reflect exchange rates on a quarterly basis, the government has not enforced the rule since 2007, possibly because of the country's 2008 elections (3). Along with the country's depreciated currency, many importers and drug companies have experienced huge, unnecessary losses as a result. Some companies went as far as refusing to deliver drugs to pharmacies for several days in April 2008 in an attempt to compel the authorities to enforce the price adjustments (3).   

Another government initiative likely to affect the industry negatively has to do with acceptable markups for distribution and retail. In the past, wholesalers were allowed to add a 7.5% distribution margin and an 8.5% margin for import activities. The government wants to eliminate the import percentage because as an EU-member nation, Romania enjoys negligible import costs when bringing in goods from other EU nations. "The pricing regulation is penalizing the local pharmaceutical industry, without bringing significant advantages for the healthcare system," says Zaharescu. 

In addition, the government continues to favor large multinational companies by regulating prescription rules to provide more benefits for the use of branded products. In the past, for example, a pharmacist was able to offer a patient all available products within an INN (international nonproprietary name) class. Under the new laws, pharmacists are not allowed to do this, and patients must ask their doctor to add a note to prescriptions to indicate preference for a generic drug.  

Aside from regulatory issues, one major challenge facing the Romanian drug producers is fierce competition from multinational companies. Although local firms such as Sicomed–Zentiva Romania, Terapia (the largest independent generic drug player in Romania now owned by India's Ranbaxy Laboratories), and Antibiotice, have achieved a larger global presence, they are constantly battling companies such as GlaxoSmithKline (London) and Pfizer (New York), which have established a strong foothold in the area.  

Cost is also a problem. Increasing manufacturing costs, rules against including research and development (R&D) costs in production budgets, and a lack of finances for product development have left local companies with no option but to focus on generic drugs. Even though the generic drug market seems to be more stable in terms of value, real growth is likely to be recorded only for innovator drugs.  

Romania has several things going for it such as low-cost production, low drug prices, and a large generics market. These benefits have helped the country to expand its pharmaceutical manufacturing sector and welcome in multinational companies. To avoid stagnation, however, the market still has a long way to go. Local manufacturers may be forced to sign in-licensing deals with multinational companies to keep afoot financially. Others may need to seek investment in R&D as well as partnerships with academia and research institutes in search of new innovator drugs.  

In addition, the Romanian government must continue to invest in quality and productivity to become a real competitor within the European Union market, especially as competition from China and India mounts. These investments will also be key for Romanian companies who wish to enter the US market, where regulations and costs are significantly higher. 

 1.  Ruxandra Ciulu, "Diversification Strategy in the Pharmaceutical Industry," 

Pharmaceutical Market in Romania 2008: Development Forecasts 2008–2010 

 3.  Ioana Filipescu for Raiffeisen Investment Romania, "Romanian Pharmaceutical Market," 

The Romanian pharmacetuical market has grown significantly in recent years, but with stagnation on the horizon, a path forward is needed.

Report from: Romania

January was another very bleak month financially, but luckily it ended on a bit of a political high. On 20 January, Barak Obama's Inauguration ceremony was followed with anticipation by millions of people worldwide.

Researchers in the US have been looking forward to his arrival for a long time. Obama has indicated that he wants to make his mark in two specific areas — climate change and stem cells research — that the Bush administration had neglected or ignored for a number of years. Indeed, compared with his predecessor's anti-intellectual stance when faced with sciencerelated issues, Barak Obama is a breath of fresh air and has been hailed as being "good for science" by academics and scientists from both the US and Europe. George W. Bush, in his two mandates, didn't do much to earn their respect. First, he waited more than 1 year to appoint a scientific advisor while at the same time continuing to make decisions about climate change and other significant scientific issues. Secondly, he has left a poor legacy of alleged weakening of environmental regulations, defending corporate and political interests and influencing decision-making processes at agencies such as EPA. It is thus that academics and scientists expect Obama to initiate a good 'working relationship' by first restoring their budgets or increasing funding and then recovering some of the integrity of the government's judgment in scientific issues.

On the other side of the coin — the coin being the pharmaceutical and chemical industries — manufacturers are concerned about the potential tax rises and increased regulatory burden that, they warn, may render the industry non-competitive in the international market. With experts describing the mood in government as anti-business, manufacturers want to ensure that the President considers the industry and their need for large amounts of natural gas and petroleum.

A lot, therefore, now rests on Obama's shoulders. Reconciliating the wants and needs of academia and industry is no easy task, but he has made a great start by successfully surrounding himself with experts from a variety of disciplines (marine biology, physics, engineering, etc.) to create a team that includes two Nobel prize winners and many well-known scientists. Will this become the "science dream team"?

January was another very bleak month financially, but luckily it ended on a bit of a political high...

The dream team

Christmas is over. Everybody is back at work feeling a bit hungover, a lot poorer and alarmingly heavier. We have all enjoyed time with our families, made wonderful 'New Year resolutions' that we are sure to have forgotten in less than 10 days and exchanged gossip about the office Christmas party. Then we look forward to 2009 and wonder what it has in store for us. What do we see? Not a lot. Worse, we see a big ugly picture of darkness and credit crunch, peppered with images of job losses, house repossessions and rising energy bills. The media are not helping; in fact, they are doing a good job of painting a very bleak picture of the situation, rightly so, perhaps, but it doesn't help the feeling of unsettlement and mild panic that has set into our hearts.  

Does the fact that it is a global phenomenon help people get on with the situation? I'm not sure. Personally, seeing it as a global occurrence helps me accept that it is going to be difficult for a while, and that we'd better keep fighting and moving forward. No matter who you are or where you are, you'll be affected. For others, the global scale of the crisis will make it even worse, more worrying, upsetting and frustrating. No matter what you do or how long you've prepared for this, you'll have to bear it.          

Horrible as it is, the crisis is here to stay (with any luck only for a short while) and some global companies have announced the first (and hopefully last!) round of job cuts. Sony, the world's second biggest maker of consumer electronics will lose 8000 employers globally. RioTinto, one of the world's biggest mining companies, has confirmed 14000 job losses worldwide. The list continues and it is likely, in the coming months, to include some names from the pharmaceutical industry.  

Let's hope the casualties are few and that the business models our companies adhere to are solid enough to withstand the blow. Let's hope the majority make it through and we see each other at the other end. Amidst all this doom and gloom, I would like to offer a ray of hope: say "it will pass" and that by 2010 we'll all be laughing and remembering 2008 and 2009 as a couple of bad years that, at least financially, are best forgotten.  

 team I would like to wish you a very happy and successful 2009. 

Christmas is over. Everybody is back at work feeling a bit hungover, a lot poorer and alarmingly heavier...

Happy 2009!

The first 2 weeks of October witnessed the closure of CPhI (30 September–2 October) and the whole of Biotechnica (7–9 October). 

 had a presence at both events, which took place in Frankfurt and Hanover (both Germany), respectively. With record-breaking numbers of attendees, roundtables and conferences of the highest quality, and exhibitors from bio and pharma companies from all over the world, these two events are a must in the calendars of many in the biotech and pharmaceutical industries. 

CPhI is by far the bigger of the two events and, although I was aware of its size and the numbers involved, I was not ready for what I encountered: halls and more halls connected by escalators in extremely long corridors and stands busy with the activity generated by swarms of visitors. It reminded me of an anthill but, as one would expect in an anthill, the chaos was only surface deep; behind which was perfect organization and complete control. I was very impressed and must congratulate the organizers on their success. 

During CPhI, I was very fortunate to attend the 

, where Guy Villax, CEO of Hovione, not only delivered an excellent presentation on APIs issues, but also provided me with a wonderful quote. On the issue of drug traceability he compared the food industry, where very tough control measures were imposed because of the BSE crisis, with the pharma industry that, in spite of incidents such as the heparin scare, fails once more to learn the lesson. He concluded: "There is better traceability between a cow and your steak than between an aspirin and its producer." 

Biotechnica, gathered the crème-de-la- crème of the biotech world. Now on an annual basis, it not only keeps exceeding expectations in terms of participation, but has also succeeded in establishing a wonderful synergy between industry and academia, with a large number of demonstrations and workshops on offer for all the students invited to the event. On a different note, something that caught everybody's attention at the exhibition hall was the sponsored remote-controlled manta ray that hovered gracefully and silently over our heads. It moved very slowly and its movements had some strange hypnotic effect... I want one! 

We hope that everybody had a very successful and enjoyable time at CPhI and Biotechnica and are looking forward to seeing you all again next year! 

During November, we will be uploading interviews, stories and personal reviews from our time at CPhI and Biotechnica onto our webiste (

), so please keep an eye on our Out and About section (

Send your questions and comments by email to 

The first 2 weeks of October witnessed the closure of CPhI (30 September–2 October) and the whole of Biotechnica (7–9 October). Pharmaceutical Technology Europe had a presence at both events, which took place in Frankfurt and Hanover (both Germany), respectively. With record-breaking numbers of attendees, roundtables and conferences of the highest quality, and exhibitors from bio and pharma companies from all over the world, these two events are a must in the calendars of many in the biotech and pharmaceutical industries.

It's showtime

Fundamentally, nanotechnology is about making things on the scale of atoms. By manipulating matter on the atomic and molecular scale, it is possible to create new materials and devices that can be smaller, stronger or faster; for example carbon nanotubes possess extraordinary strength and unique electrical properties, and have been described as 'the most important material in nanotechnology today'.

Nature also works on the molecular scale. Naturally occurring molecular assemblies that regulate and control biological systems are the most complex and highly functional nanoscale processes we know. The volume of a single molecule biodevice, such as a protein, is between one-millionth and one-billionth of the volume of an individual cell. If these natural processes were fully understood it might be possible to influence or interact with them, opening a new path to innovative pharmaceuticals. It could also be possible to stimulate the body to successfully repair diseased or damaged tissues.

However, predicting the impact of new technologies is difficult and there are many concerns regarding the use of nanotechnology, including what unintended and unwanted effects it could have on the environment and human health.

Nanotechnology can be defined in a number of ways, but is usually accepted as 'the ability to do things — measure, see, predict and make — on the scale of atoms and molecules, and exploit the novel properties found at that scale'.

  The units of measurement involved are difficult to comprehend. A single nanometer is equivalent to one thousandth of a micron or one billionth of a metre, which has been likened to comparing the size of a marble to the size of the Earth.

Although open to interpretation, the nanoscale is generally said to comprise anything measuring 1–100 nm. At this scale, materials often exhibit different physical, chemical and biological properties; for example, the melting point of a substance may change because of the change in surface area, chemical activity may increase or a substance may acquire the ability to cross tissue barriers. This creates new possibilities to optimize drug targeting and delivery. In what is reminiscent of a science fiction novel, researchers have also speculated that it could be possible to use nanorobots that patrol the body diagnosing and treating ailments.

Many of these medical and pharmaceutical applications may not be possible for many years, as any product would have to be subjected to strict testing and validation procedures. However, there are already hundreds of products on the market that utilize nanotechnology, many of which we use in our daily lives including batteries, computers, kitchenware, clothing, cosmetics, toothpastes, sun creams and paints. It has been estimated that nanotechnology consumer products are coming on the market at a rate of 3–4 per week.

  Nanotechnology is also used in some pharmaceuticals, such as Abraxine, which was recently launched in India by Biocon (India) and Abraxis BioScience (CA, USA),

 and is available in more than 30 countries. The drug is administered as albumin-bound particles of approximately 130 nm.

The first documented introduction to nanotechnology is Richard Feynman's lecture entitled "There's Plenty of Room at the Bottom", which he gave at an American Physical Society meeting in 1959. Although the term nanotechnology was not used then, Feynman spoke about the possibility of manipulating matter on the atomic scale. However, nanotechnology and nanoparticles had unintentionally been used long before this by glaziers in medieval forges who produced colours with gold nanoparticles of different sizes to decorate glass.

It wasn't until 1974 that the term 'nanotechnology' was used by Norio Taniguchi from the Tokyo Science University (Japan) to describe precision micromachining, and discussions regarding the topic didn't really take place until 1980s. That decade saw the invention of the scanning tunnelling microscope, publication of the first nanotechnology book, Kim Eric Drexler's 

Engines of Creation: The Coming Era of Nanotechnology

, and the formation of the Foresight Nanotech Institute (CA, USA) — the first organization dedicated to educate society about the benefits and risks of nanotechnology. At the end of the decade, it was also discovered that the scanning tunnelling microscope could be used to move single atoms when IBM scientist, Don Eigler, moved individual atoms of xenon gas to spell out the IBM logo. The ability to accurately position individual atoms led to other new discoveries; for example, Eigler's team later created a wall of iron atoms to study how electrons behaved in tightly constrained spaces.

Nanomedicine is a relatively new concept that was first used in1999 when Robert A. Freitas Jr.'s book 

Nanomedicine, Volume I: Basic Capabilities

 was published, describing the potential medical applications of nanotechnology and nanorobotics. In a more recent review, there are said to be three major potential uses for nanotechnology in medicine: delivering the exact dose of a drug to the intended location, providing new ways to grow and repair body tissues, and detecting single molecules in diagnosis.

 Nanotechnology is already aiding drug delivery by improving bioavailability. Many of the current 'nano' drug delivery systems are considered to be remnants of conventional drug delivery systems that happen to be in the nanometer range, such as liposomes, polymeric micelles, nanoparticles, dendrimers and nanocrystals.

 For example, in 2007 Johnson & Johnson Pharmaceutical R&D (NJ, USA) submitted an application to FDA for a long-acting injectable paliperidone palmitate that uses Elan's Nanocrystal technology.

 The Nanocrystals enhance the older drug's solubility by reducing particle size.

Nanoparticles can also cross the blood–brain barrier, which could make them useful for delivering drugs that target brain tumours or diseases that affect the central nervous system. Further research must still be conducted as it is yet unknown whether there are any potentially negative side-effects of using nanoparticles.

There has been growing excitement about the potential of nanotechnology to help treat some of the most debilitating diseases, including cancer and Alzheimer's.

 Research has been conducted as to how nanotechnology may aid cartilage loss and even repair spinal cord injuries,

 but these developments are in the early stages and it will be many years before tests in humans are conceivable.

One promising treatment for cancer is nanoshells, which consist of a spherical core surrounded by a shell that is only a few nanometres wide. The shells can absorb or scatter specific wavelengths of light. Gold-encased nanoshells can convert these wavelengths into heat.

 In laboratory tests, scientists have used nanoshells to 'cook' tumour cells without harming surrounding healthy cells.

Much research has been conducted into improving the detection of cancer, and nanotechnology could offer a solution as it may help with the long-term tracking of cells and molecules. In 2005, researchers attached nanocrystals to antibodies and used them to identify the molecule p-glycoprotein,

  which makes cancer cells resistant to chemotherapy. The method meant that a single molecule of p-glycoprotein on the cell surface could be detected. Magnetic nanoparticles have also been used to help locate tumours in magnetic resonance imaging scans. 

Nanotechnology could also offer advantages for medical implants as some nanomaterials, such as nanocrystalline ceramics, have properties that include hardness, wear resistance and biocompatibility. In the future, nanosized sensors could also be used, for example, to monitor blood sugar levels in diabetes. 

"Grey goo" and the future of nanotechnology

, he introduces the possibility of scientists engineering synthetic life forms that could in turn generate self-replicating nanorobots that would spread around the Earth making life as we know it extinct. This "grey goo" scenario (as termed by the author) has triggered many of the doubts and fears that are commonly associated with nanotechnology.

Advances in this field have often been unwelcome by public opinion because of concerns regarding toxicity and the ethical issues that surround it. With regard to toxicity, although there is no direct evidence to support this, it has been suggested that finely divided chemicals might be more toxic and more effective at getting into our bodies than the same chemicals as we normally use them. With regard to ethical issues, it is feared that society may lose control and blur the lines between man and machine by engineering synthetic forms of life that are better suited to living on Earth than equivalent living organisms.

How realistic is this? The answer is unrealistic. We should not worry about "grey goo" as it is unlikely that scientists will be able to produce better, more efficient nanoscale living forms than nature itself has already produced.  

So what is the future of nanotechnology? It is difficult to say. Public opinion seems to be against it, but the technological advances that have been and will be made as a result of it are life changing. Currently, we have very little understanding of how biology operates and many of its processes remain a mystery; however, nanotechnology may help scientists paint a clearer picture by allowing certain processes and functions to be mimicked and studied. In the field of IT, cheap and powerful computing systems combined with mass storage and ultra-fast processing systems are forecast to revolutionize society. 

Let's give nanotechnology the benefit of the doubt and not assume that it is dangerous. In the next 20 years it will be important to exploit and control the technology and keep the public well informed of the benefits and advantages it brings us. 

 is Editor of Pharmaceutical Technology Europe. 

 is Assistant Editor of Pharmaceutical Technology Europe. 

2. UK Department of Trade and Industry — New Dimensions for Manufacturing. A UK Strategy for Nanotechnology, June 2002. 

5. The Project on Emerging Nanotechnologies, "An inventory of nanotechnology-based consumer products currently on the market" (2008). 

6. Abraxis BioScience, "Biocon and Abraxis BioScience Launch ABRAXANE in India for Treatment of Breast Cancer" (2008). 

Exploring the World of Nano Medical Devices

10. Going Small for Big Advances: using Nanotechnology to Advance Cancer Diagnosis, Prevention and Treatment (US Department of Health and Human Services, January 2004). 

12. Brown University, "Brown researchers work towards aiding cartilage loss" (2008). 

13. Northwestern University, "Promising new nanotechnology for spinal cord injury" (2008). 

14. A.P. Alivisatos, "Less is more," in Scientific American, Ed., 

 (Warner Books, New York, New York, USA, 2002) pp 56–69.

Nanoparticles can also cross the blood–brain barrier, which could make them useful for delivering drugs that target brain tumours or diseases that affect the central nervous system.