Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

The future of pharmaceutical R&D may lie in open-source research, with key data being made available to a number of people, including college students and university researchers, in an open and collaborative process. Open-source drug development would leverage an online community of computer users worldwide.

Although the idea of the traditionally reserved and secretive pharma industry adopting such an open R&D process may seem farfetched, a consortium has already been developed to achieve this. The Open Source Drug Discovery (OSDD) Consortium was launched in 2008 and includes more than 3000 members from 74 countries. People can participate in the programme by logging onto the website.

“Most drug discoveries are made in a closed-door environment in which pharmaceutical companies keep drug development information under wraps and limit participation of the academic world,” Samir Brahmachari, Project Director of OSDD, explained in to a 

 from the American Chemical Society (ACS). “The OSDD program aims to address this issue by attempting to attract the youngest and brightest minds around the globe to be part of the drug discovery movement.”

According to ACS, a dozen reports on open-source R&D will be presented at the upcoming ACS meeting.

“I believe this is the way to go about not only drug discovery, but it may be a way of doing science in the future,” said Brahmachari.

Indeed, this view was echoed by participants of an Ernst & Young roundtable, which was published in the firm’s 

 report. During the roundtable, David Norton, Company group Chairman, Pharmaceutical Group, at Johnson & Johnson explained that open-source may be the future of pharma. “Five to 10 years from now, there will be open-source medical research,” he said. “Now that horrifies medical researchers because it raises several issues, such as how to establish clinical validity, but the benefits are compelling.”

“There’s more data out there than we are currently capturing in records,” Kristin Peck, Company Senior Vice President, Strategy and Innovation, at Pfizer added in the roundtable. “There’s a real-world need for real-world data.” 

At the moment, the OSDD is hoping to be able to develop a new drug for tuberculosis and, indeed, the organisation has already provided a comprehensive map of the genome of 

, which causes the disease. However, participants in the Ernst & Young roundtable believe that open-source R&D still has even more to offer in that it could lead to the better health overall.

“Five years from now, we’ll have millions and millions of genomes and associated phenotypic information. And people will routinely monitor their health-related behavior and outcomes  from weight fluctuations to blood pressure and more,” said Norton. “If we can build this huge database  of self-reported patient data, physician observations, lab findings and other objective data  you could, over time, for example, determine common attributes for people who survived 10 years of pancreatic cancer.”

Peck also added: “Because many do not consider this pool of nontraditional data to have validity, it is often ignored. Yet five years from now, this data will probably prove to be just as significant as the traditional-source data that we use today.”

Articles

The future of pharmaceutical R&D may lie in open-source research, with key data being made available to a number of people, including college students and university researchers, in an open and collaborative process.

Pharma's future: open-source R&D

Although the idea of the traditionally reserved and secretive pharma industry adopting such an open R&D process may seem farfetched, a consortium has already been developed to achieve this. The Open Source Drug Discovery (OSDD) Consortium was launched in 2008 and includes more than 3000 people from 74 countries. People can participate in the programme by logging on to the website. 

“Most drug discoveries are made in a closed-door environment in which pharmaceutical companies keep drug development information under wraps and limit participation of the academic world,” Samir Brahmachari, project director of OSDD, explained, according to a 

According to the ACS release, a dozen reports on open-source R&D will be presented at the upcoming ACS meeting.

“I believe this is the way to go about not only drug discovery, but it may be a way of doing science in the future,” said Brahmachari. 

Indeed, this view was echoed in Ernst & Young’s 

 report, which discusses the changing landscape and business of pharmaceuticals. As part of the report, Ernst & Young conducted a roundtable with a number of pharmaceutical experts. During the roundtable, David Norton, company group chairman, Pharmaceutical Group, at Johnson & Johnson explained that open source may be the future of pharma. “Five to 10 years from now, there will be open-source medical research,” he said. “Now that horrifies medical researchers because it raises several issues, such as how to establish clinical validity, but the benefits are compelling.” 

“There’s more data out there than we are currently capturing in records,” Kristin Peck, Company Senior Vice President, Strategy and Innovation, at Pfizer added in the roundtable. “There’s a real-world need for real-world data.”

At the moment, the OSDD is hoping to be able to develop a new drug for tuberculosis and, indeed, the organisation has already provided a comprehensive map of the genome of Mycobacterium tuberculosis, which causes the disease. However, participants in the Ernst & Young roundtable believe that open-source R&D still has even more to offer in that it could lead to  better health overall.

“Five years from now, we’ll have millions and millions of genomes and associated phenotypic information. And people will routinely monitor their health-related behaviour and outcomes—from weight fluctuations to blood pressure and more,” said Norton. “If we can build this huge database—of self-reported patient data, physician observations, lab findings and other objective data—you could, over time, for example, determine common attributes for people who survived 10 years of pancreatic cancer.”

Pharma's Future: Open-Source R&D

GlaxoSmithKline Consumer Healthcare, Cephalon UK, and ProStraken Group have been accused of breaching the Association of the British Pharmaceutical Industry’s (ABPI) 

Code of Practice for the Pharmaceutical Industry

. The code covers the promotion of medicines, including journal and direct-mail advertisements, and the provision of information to patients and the public. 

The companies have breached the code in different ways; however, all three stand in violation of Clause 2 of the code: "bringing discredit upon and reducing confidence in the pharmaceutical industry," according to a 

 released by the Prescription Medicines Code of Practice Authority (PMCPA), which administers the ABPI Code of Practice.


The case against the pharmaceutical giant stems from the company making misleading claims about its smoking cessation aid NiQuitin. The complaint was made by Johnson & Johnson after the company received a mailing promoting the product. The mailing contained the claim, “From day one NiQuitin 25mg Clear Patch delivers more nicotine than any other therapeutic nicotine patch,” which was alleged by Johnson & Johnson to be “ambiguous and misleading,” primarily because of a lack of clarity relating to the measures of speed and the extent of nicotine delivery upon which the claim was based.

In response, the PMCPA ruled that the company was in breach of Clause 2, as well as other clauses relating to:
•	making misleading claims and comparisons
•	using misleading comparisons
•	failing to maintain high standards
•	failing to comply with an undertaking.


Cephalon breached the code by providing free stock of its breakthrough pain treatment, Effentora (a Schedule 2 controlled drug that is subject to ordering/storage and prescribing restrictions) without “sufficient controls.” According to the code, no more than 10 free samples should be provided but in this instance the company supplied 30. The complaint also attached emails that stated Effentora was supplied as an inducement to prescribe and “assist [Cephalon] with moving forward with a formulary application.”

Despite an appeal, Cephalon was ruled as breaching Clause 2, as well as further clauses relating to failing to maintain high standards.


ProStrakan’s breach of the code stemmed from the company making claims about its drug Abstral that were misleading and did not comply with a previous undertaking. In a previous case (case number: AUTH/2207/2/09), the PMCPA had ruled that a “10-minute pain relief claim” of Abstral was in breach of the code as the product only provided pain relief from 15 minutes after administration onward. The most recent case draws from a complaint made by Cephalon. According to the company, a revised promotional campaign for Abstral inferred that the product was actually even faster in onset than 10 minutes by using the advertisement heading "To hell and back in minutes."

The ABPI’s Prescription Medicines Code of Practice Authority (PMCPA) has advertised brief details of all cases in the 

 on Aug. 25, 2010. The full case reports have been published in the PMCPA’s 

GlaxoSmithKline Consumer Healthcare, Cephalon UK Ltd, and ProStraken Group plc have been accused of breaching the Association of the British Pharmaceutical Industry's (ABPI) Code of Practice.

GSK Breaches ABPI Code of Conduct

Members of a UK trade union working at AstraZeneca have voted to strike following cuts in pension benefits. According to a 

 from UK trade union GMB, 70% of voters in a ballot supported the call for strike action. There will now be a meeting to fix dates unless AstraZeneca “come back to the negotiating table with meaningful terms”, said GMB.  

The dispute stems from AstraZeneca’s proposals to change its pension scheme for approximately 2500 staff, based mainly at the company’s Macclesfield (UK) site. In a 

 released prior to the ballot, GMB claimed to have more than 600 members employed at the site. The union also added that the last 4 years have seen huge job losses at the site as well as “radical” changes in working practices. 

“AstraZeneca has in financial terms done extremely well in recent years, last year operating profit rose by a staggering 24% compared to 2008.  The first quarter of this year (2010) shows further growth year on year of 11% and hence our members see no financial need for these swingeing pension cuts,” said the GMB’s July statement. 

According to GMB, talks about AstraZeneca’s pension proposals were held over a 3-month period earlier this year but the company has not moved from its original stance. GMB says it has enlisted the support of unions across Europe. 

AstraZeneca have not yet released a press statement. However, an article from 

 claims that AstraZeneca is reviewing the ballot and has said that about a third of GMB members and less than 2% of its UK employees voted in favour of the strike. 

Members of a UK trade union working at AstraZeneca have voted to strike following cuts in pension benefits.

AstraZeneca workers to strike

 published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalised this year to date (9 and 12, respectively). Although this number will undoubtedly increase by the end of the year, a marked difference is already evident in comparison to 2009, when 38 generic product applications were started. 

Despite many in the industry believing that generics are beginning to dominate with more products going off patent, the figures for 2010 show a different story. Generics clearly dominated 2009, but for 2010 they appear to be lagging markedly behind with only 9 generic product applications started versus 20 for new products. For finalised applications, generics and new products are about even so far with 12 for generics and 11 for new products.

In general, the EMA has reported a reduction in overall positive opinions, with only 28 having been adopted as of July 2010. Companies have a lot of catching up to do if this number is to match the 117 mark reached in 2009, or even the 58 and 66 positive opinions that were adopted in 2007 and 2008, respectively. 

The number of negative opinions is also down from 8 in 2009 to just one so far in 2010. Although this may seem like a positive development, it seems to be part of a larger and more disturbing trend for a lack of marketing authorisation applications as a whole. So far for 2010, only 40 new marketing authorisation applications have been started. Again, this figure will change as the year goes on but if the pace continues throughout the second half of 2010 then the number will lag behind previous years. For 2007, 2008 and 2009, the total number of product applications started was 90, 103 and 95, respectively. 

Looking solely at marketing authorisation applications for new products, there is mixed news. The number of started applications is already 20 for 2010, compared with 35 for the whole of 2009, which isn’t bad when you take into account the drying pipelines of many companies. For finalised applications, however, the story is much more depressing — only 11 have been finalised so far compared with 40 and 49 for 2008 and 2009, respectively.

Overall, the total number of finalised marketing authorisation applications for all products is much lower than 2009, which saw 125 applications finalised. So far, only 30 applications have been finalised in 2010. In comparison, 2007 and 2008 saw the finalisation of 65 and 72 marketing authorisation applications, respectively. The sharp increase in finalised applications in 2009 could mainly be attributed to a huge rise in the number of applications for generic products seen in 2008 (30 applications started) and 2009 (38 applications started), with a huge 51 applications finalised in 2009. 

There’s still five months of the year left before we have a full picture of marketing authorisation application trends for the year. However, the EMA has said it will be providing monthly updates on its website. 

Recent figures published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalised this year to date.

EU generic applications down in 2010

 from UK trade union GMB, 70% of voters in a ballot supported the call for strike action. There will now be a meeting to fix dates unless AstraZeneca can “come back to the negotiating table with meaningful terms,” said GMB.

The dispute stems from AstraZeneca’s proposals to change its pension scheme for approximately 2500 employees, based mainly at the company’s Macclesfield, United Kingdom, site. In a 

 released prior to the ballot, GMB said it had more than 600 members employed at the site. The union also added that the during the past four years, it has seen huge job losses at the site as well as “radical” changes in working practices. 

“AstraZeneca has in financial terms done extremely well in recent years, last year operating profit rose by a staggering 24% compared to 2008. The first quarter of this year (2010) shows further growth year on year of 11% and hence our members see no financial need for these swingeing pension cuts,” said the GMB’s July statement. 

According to GMB, talks about AstraZeneca’s pension proposals were held over a 3-month period earlier this year, but the company has not moved from its original stance. GMB says it has enlisted the support of unions across Europe. 

AstraZeneca has not yet released a press statement. However, an article from 

 claims that AstraZeneca is reviewing the ballot and has said that about a third of GMB members and less than 2% of its UK employees voted in favor of the strike. 