Rich Whitworth is the Editor in Chief of 

Rich Whitworth

"The patent expiry of several major blockbuster drugs worth $150 billion [€119 billion] between 2010 and 2017 will fuel the growth of the global generic pharmaceuticals market," so says a press release announcing new analysis from Frost & Sullivan. Good news for generics companies and for patients who will potentially have access to lower cost medication, but what about Big Pharma? This lost revenue comes in the midst of an economic low and at a time when R&D pipelines are looking a little shaky. It is unclear as to whether this number also includes biosimilar opportunities; if not, then it could be double trouble. It was interesting to read in the media this week two quite different strategies to counter the patent cliff.  

In anticipation of the patent expiry of Diovan (valsartan, a medication to manage high blood pressure), Novartis recently announced a US workforce restructure totalling some 2000 job losses, mainly in sales. While Novartis acknowledged that the steps to be taken were difficult, it also stated that they were necessary to free up resources to invest in the future—presumably in the form of strengthened R&D efforts. The changes are expected to take place in the second quarter of this year.  

On the other side of the coin though, according to recent reports, Pfizer's Lipitor sales have levelled off rather than continuing to plummet since losing US patent protection on November 30. If media reports are to be believed, the reason for Pfizer being able to hang onto a lion's share of market is down to fighting hard on the frontline of sales and a heavily advertised copay programme called "Lipitor For You". This is a somewhat unusual tactic; in the past, generic competition and subsequent declining revenue was considered a lost cause. All eyes are on Pfizer. 

This optimistic versus pessimistic approach puts me in mind of questions over R&D strategies. Hopeful companies are throwing extra resources at R&D while others are cutting back, but frankly, neither camp is fully confident about the risks of their choice.  

One thing is certain: generics are destined for continued growth. The question that remains is what effect spiralling prices from increasing cost competition could have on quality. 

Articles

"The patent expiry of several major blockbuster drugs worth $150 billion between 2010 and 2017 will fuel the growth of the global generic pharmaceuticals market," so says a press release announcing new analysis from Frost & Sullivan.

Cliffhanger

Firstly, Happy New Year! Please help yourself to a slice of cake. 

Towards the end of last year, I attended the 8th bioProcessUK conference in Glasgow, Scotland, with the tagline "Advancing Next Generation Therapies." The meeting was held in the very fitting Glasgow Science Centre, a place where children young and old can be inspired by the science around them—the next generation of pharma industry employees perhaps? There was a clear agenda to the conference—how to ensure that advances made in research result in actual therapies. 

In all areas of pharmaceutical development, one of the recurring challenges is scale-up, so of particular interest was a thought-provoking talk given by Roslin Cell's Aidan Courtney on scaling up cell manufacture from the point of view of translating research protocols into GMP processes. He noted, "the destination defines the journey," i.e., depending on the application of a particular cell therapy, the quantity of cells required for treatment becomes a crucial parameter. Courtney went on to provide numbers for a couple of example scale-up scenarios; ischemia therapy would probably require 10

  cells per treatment, so estimating perhaps 10,000 treatments per year, the numbers start multiplying faster than the cells... He concluded that GMP translation and scale-up are challenges best addressed in tandem. 

Bridging the gap between discovery into development and onto commercial scale manufacturing is something that our sister publication, BioPharm International, is addressing in collaboration with BIO SmartBrief: "Drug Development Basic Training". I encourage you to check out some of the weekly articles and podcasts at 

I leave you with the passionate words of this year's winner of the Peter Dunnill Award, Professor Mike Hoare from University College London, who concluded in his bioProcessUK presentation on ultra scale-down for enhanced bioprocess discovery: "Design for manufacture; design for lower cost." 

Firstly, Happy New Year! Please help yourself to a slice of cake.

Go UK Bio

The economic and financial crisis that thundered through the world economy in 2008 still rumbles on today. The downgrade of the US debt rating in August 2011, along with the economic chaos that has taken over the European Union in recent months, have done little to lend confidence to the bio/pharmaceutical market. When analyzing data from Pharmaceutical Technology's 2011 annual employment survey, readers' outlooks are positive with regard to job security and business growth for 2012. Approximately 64% of respondents feel that their jobs will be secure in 2012, while 82% believe 2012 will bring improved business conditions or, at the very least, not decline. 

This article was also published in our US sister publication 

The results from our employment survey are in.

The Employment Outlook Brightens

Where does the time go? It is very hard for me to believe that I am already writing for the final issue of the year, looking back over 2011 and planning for 2012. As the Japanese say "otsukaresama deshita", which has no direct English translation but roughly equates to "thank you for your hard work." I use it here because I lived in Tokyo for five years, where usage is ubiquitous and comforting, a sentiment I wish to share with you. 

I thought it would be good practice to read what my predecessor wrote at the end of 2010 to close the year, and what met my eyes led to a distinct feeling of déjàu. Once again, the whole year has been dominated by economic uncertainty and financial upheaval, especially in Europe. As I write this, British Prime Minister David Cameron and German Chancellor Angela Merkel are struggling to come to agreement over how best to stabilise the euro zone. There is no doubt that decisions made by world leaders over the coming weeks will affect all industries in some way, though perhaps to what extent is less predictable. Industry trends have also been echoed this year, with continued focus on tightening supply chain security and curbing counterfeits. Emerging markets continue to be a topic of huge interest, but will growth there be sufficient to protect industry from the economic woes of the West? 

Despite a sense of foreboding, in the meetings and shows I've attended (CPhI in Frankfurt being the latest), the mood has been somewhat more positive. There seems to be a definite sense that things are improving, that business is on the up. Indeed, the results of our annual 

 employment survey in this issue tell a similar tale; though times are tough, respondents are overwhelmingly predicting improved business for 2012. Conversely, our outsourcing specialist, Jim Miller, in the same issue speaks of potential decline for the services market at the hands of a dearth of late-stage candidates in R&D. Confusing times. 

 will continue to provide you with the latest industry trends, innovations and solutions through your preferred media channel, whether on our website, via Twitter or LinkedIn, or simply in our trusted printed magazine. 

I would like to thank you all for your past and continued support, and wish you all the very best for a positive 2012. 

Where does the time go? It is very hard for me to believe that I am already writing for the final issue of the year, looking back over 2011 and planning for 2012.

It’s déjà vu all over again

The middle word in our magazine's title is technology, so I cannot fail to join the increasing numbers of people in all fields of business commenting on the passing of Steve Jobs. I, like many, many others, discovered the news on one of the devices he was so proud of. Personally, I was surprised at how moved I was by the flood of tributes paid to Steve Jobs in the days following his death. I think it was the true scope of how many people all over the world have been affected by the decisions he made. The innovation and ability to pre-empt people's future needs shown by Steve Jobs and his team at Apple have changed even the way we do business; a real inspiration. 

Ever since the iPad was launched, there have been news stories about pharma companies investing in iPads for its sales force, or for scientists to use in its laboratories. And certainly Pharmaceutical Technology Europe will be making use of the new media at our disposal in the coming months. But perhaps the pharma industry would do well to look at Apple's business model and game-changing strategies to make more significant changes. 

You would think working for Apple and job satisfaction go hand in hand... This month, 

 is running its annual employment survey, which gives you a chance to let us know what's happening in your sector and how you feel about it. We will be publishing the results in our December issue as well as online, but this can only happen if you take part! So, please go to 

 where you will be led through questions ranging from the affect of the current economic climate to the reasons you want to leave, or stay at, your current job. There is also a store gift card (not Apple!) up for grabs, if you need even more convincing. 

The middle word in our magazine's title is technology, so I cannot fail to join the increasing numbers of people in all fields of business commenting on the passing of Steve Jobs.

Jobs and Innovation

, I often have the opportunity to visit the sites of a wide variety of companies within the industry. Though differing vastly in the technologies and staff they employ, they all share one thing in common for me: the "you learn something new every day!" factor.  

It is very easy to take for granted the things we use daily, especially in the (over?) developed world where we think nothing of supermarket shelves being (over?) stocked with exotic fruit, bread mountains and rivers of wine from around the globe. But in every instance, there is a company, a process and a horde of employees behind the seemingly simple task of making something "available" and maintaining that all important supply chain. And so it is with the pharma industry. 

On a recent trip to a sterile manufacturing facility in Glasgow, I was once again learning something new. I had not previously considered the processes and scale of the equipment necessary to produce even the simplest of solutions (buffers!) required in the volume and, more importantly, the quality required by the biopharmaceutical industry. The water-for-injection plant was an amazing feat of engineering in itself and the house-size mixing tanks put figures like 10000 litres into real perspective. 

More often than not, the simplicity of the material belies its manufacturing process and it becomes a commodity. Perhaps to such a point, that we stop questioning its origin at all. I think we all agree that quality and patient safety must be at the top of everyone's agenda, but in the face of increasingly fierce competition and a never ending quest by customers for lower costs, perhaps something, somewhere has got to give? 

On a completely different topic, several people have asked me if the crossword on the front cover of our September issue "works" — it does indeed. And so as not to take for granted the sense of reader anticipation in the air, the answers are included below. 

I very much look forward to meeting some of you at CPhI 2011 this month; feel free to stop by at booth number 

1. PSD  6. Generic  10. Isolator  13. TSA  14. Bioconjugate

2. Synthesis  3. Crystallise  4. Precipitation  5. Microdose  7. Cytotoxic  8. Blockbuster  9. Cytostatic  11. MAB  12. HPAPI

As editor of Pharmaceutical Technology Europe, I often have the opportunity to visit the sites of a wide variety of companies within the industry. Though differing vastly in the technologies and staff they employ, they all share one thing in common for me: the "you learn something new every day!" factor.