Reactions have run the gamut from the near hysterical to the more soberly measured. Colin Blakemore, professor of neuroscience at the University of Oxford, called the news “a shocking wake-up call.” He added: “We must respond to this signal that one of our most important industries no longer has confidence in the future of British science.” A spokesperson for the Unite trade union said the closure would be “devastating” for the local economy, and Royal Society of Chemistry head Richard Pike said: ‘This rips out a major part of the UK’s scientific infrastructure. Even Prime Minister David Cameron called it “depressing news”.

But generally the UK government has been at pains to point out that the decision to close the Sandwich,Kent-based plant does not reflect disillusionment with UK pharma. Government Business Secretary Vince Cable said: “The company has been clear that this decision was part of its global programme of change and not based on a judgement of the UK as a location for pharmaceutical research.”

Still, the move has to be a bit of an embarrassment for the Cameron administration, given Pfizer head Ian Read, when he was heading the company’s European operations, represented the US on several key UK government advisory committees looking at the industry’s future role in the UK.

Pfizer’s site in Sandwich was opened in 1954 and saw massive expansion in the 1950s and 60s. The site covers 80 acres and employs 2,400 staff. The company has reported that its exit strategy will take 18 to 24 months to complete, as part of its wider plan to focus and sustain R&D.

The UK BioIndustry Association, while expressing its disappointment at the decision, was quick to emphasize that the news “does not change the fundamentals” of the UK as a location for R&D. More immediately critical for Pfizer employees affected by the exit, said Nigel Gaymond, BIA’s Chief Executive, “are the discussions, which Government has committed to, exploring options for continuing research and development activities at the Sandwich facility.” He added: “The Government must now do all in its power to retain these talented and skilled individuals in the UK.”

Of course, Pfizer has confronted closures before — in Ann Arbor, MI, Nagoya, Japan and in France.  In each case some re-purposing of the facilities was achieved in cooperation with local governments — but the employment rolls never really came back. And with Wall Street reacting enthusiastically to the latest closure news, the company is likely to find new areas to cut on the administration side.

Recently, I spoke to R. Arun Kumar about the wider applications of cloud computing. Arun Kumar is Vice President and Head of the Global Life Sciences Business Unit at Infosys, an IT, business consulting and outsourcing services provider.

How is technology helping to tackle the current challenges facing the European pharmaceutical industry?

Technology is helping in a big way. Companies are renewing their focus on improving R&D productivity by investing in better collaboration and analytical tools. Research departments are using next generation sequencing tools and also increasing their collaborating with external partners for research in order to tap new areas of exploration.

In addition, clinical trials are becoming more adaptive by incorporating signal detection technologies, and being more efficient in terms of global supply chain and forecasting. There is an increased focus on digital technology with sales and marketing teams embracing the web and social networking tools to develop better relationships with physicians and patients.

What part is cloud computing playing in this?

The impact of cloud computing is just beginning to be felt in the areas of research, development and healthcare information exchange. The explosion of data from next generation sequencing, growing importance of biologics in the research process, and importance of public–private partnerships (PPPs) to come up with new discoveries is making cloud based computing an increasingly important aspect of R&D.

We are already seeing complex genetic sequences and biomarker data being hosted in the cloud by a few open source bodies, which are then accessed in a secure fashion by individual companies for their research needs. However, there is still a need for more integrated data sharing across research, development, manufacturing, and sales functions to improve trials, increase time to market for drugs, and utilize feedback faster. We’ve seen an increasing trend of pharmaceutical customers exploring use of both public and private clouds for data storage, hosting and access needs.

The main impact to pharmaceutical companies of increased usage of cloud computing is a reduced dependence on their own IT infrastructure. This will provide the ability to move away from CAPEX intensive deployments to an OPEX/pay-as-you-go business model. The main business advantage of cloud computing is the standardization and streamlining of operations, higher reusability, better integration, and stronger collaboration with external entities and the health care ecosystem. However, as the uptake of cloud increases, we can also expect greater focus on aspects related to security, privacy, data protection and IP management when reliance on the cloud grows.

What else can we expect to see affecting pharma in 2011?

One of the biggest changes that 2011 will bring is the increased amount of government intervention in terms of drug approvals, pricing and reimbursements. European pharmaceutical companies are already used to dealing with a single payer system and a higher role for the government. However, they face unfamiliar territory from growing emerging markets, ageing population in mature pharmaceutical markets, and the increased focus on generics.

From a patient perspective, society is showing less trust in drugs alone as the key element of treatment. Customer-centricity will see patients having a higher stake in their own health management decisions and treatment regimes.

2011 will also see the use of telemedicine and remote health monitoring for areas like diabetes, cardiac and sleep disorders. This is due to the fact that it is a popular choice for patients and that it offers obvious cost advantages for all stakeholders.

The facility is operated by Zydus Nycomed, a joint venture between the Swiss drugmaker and the Indian firm Zydus Cadila, which dates back to 1998 when the then incarnation of Nycomed, Byk Gulden, engaged Cadila to manufacture key starting materials for its best-selling gastrointestinal treatment Pantoprazole. Byk Gulden later became Altana Pharma and in 2007 Altana Pharma was acquired by Nycomed. The JV survived — and thrived — and two years ago Nycomed took the decision to transfer the most of the chemical production of Pantoprazole and other branded generic APIs from its facilities in Linz (Austria) and Singen (Germany) to the Mumbai plant, which has now been extended to encompass a third production building.

With the decision resulting in the loss of 200 jobs at the Linz and Singen facilities (and an increase in the Mumbai workforce of 120), it would seem that the drive to cut costs is so vital now that European firms are prepared to go take off-shoring a step further and undertake a fundamental shift in their manufacturing base. The move comes partly as a result of Pantoprazole’s patent expiry in a number of key markets (it expires in the US next year), although the drug still generates sales of up to 30% of the $7–$8 billion PPI market.

But Barthold Piening, Nycomed’s Executive Vice President, Operations, told Pharm Exec Europe that it’s not all about money.  “For chemical/API processing, particularly, it has become more difficult to stay competitive in Europe in terms of cost and available resources, so we were looking for further cost optimization,” he admits. “But we’re not only in India because we want to save on costs. It’s a good location for manufacturing, and there are well-trained, experienced people there.”

Piening maintains the relocation mirrors the shift from west to east in manufacturing efficiency and expertise. Europe, he says, “has to face the reality that India and China has the manufacturing know-how that ten or twenty years ago was more the domain of Europe and the US.”

He adds though that there are areas in which Europe remains more competitive, for example, biologics, and in sophisticated manufacturing processes such as lyophilization. And it’s important to note that Nycomed’s Linz and Singen plants will still be responsible for the production of key Nycomed products such as, for example, roflumilast, the API for Daxas, its new (patented) COPD drug.

Does this suggest that India still has a way to go before European companies can put complete faith in its manufacturing capabilities? I ask Piening whether Nycomed had any supply safety concerns in sourcing its APIs outside Europe. “It’s certainly a topic for consideration,” he says. “We don’t want to be at risk of sourcing only from only one country. In terms of technical risk, though, I am fully convinced it’s safe. But it’s important to minimize our risk exposure, to have a fallback position.”

His faith in his Indian partners, however, is unshakeable. “Even though they are fully professional in the Lean Sigma thinking, they are always looking for process improvement,” Piening says. The Zydus Nycomed plant at Navi Mumbai has yet to receive US and European regulatory approval, but this is not likely to present a problem as Zydus Cadila’s six other Indian plants have received FDA clearance. Nycomed is currently in the last stage of its technical, product and analytical transfers to the Indian plant and full scale manufacturing is likely to commence at the end of this year. “I would say that by spring next year the site will be fully operational and we will be ready to declare our readiness for the FDA audit, with the European audit coming earlier.”

Big in emerging markets

The shift to India is just part of Nycomed’s highly ambitious programme of emerging market expansion, which was outlined to Pharm Exec Europe by Executive Vice President, Commercial Operations, Guido Oelkers, earlier this year. “Basically we want to become Big Pharma in the emerging markets,” Oelkers said. “Over the next five years,” he added, “my hope is that we have a very powerful franchise that places us in the top 15 in China, the top 10 in Mexico, and the top 20 in MENA.”

Since then Nycomed has made its move in China, announcing at the beginning of November a major expansion there with the acquisition of 51.34% of Guangdong Techpool Bio-Pharma Co., Ltd. (Techpool). The Guangdong -based company has built a strong intellectual property position, with 35 patents filed, 17 of which have already been granted.

Are there any plans for a similar manufacturing shift to China, I ask Piening. “There will be more manufacturing activities from Nycomed in the emerging markets,” he confirms. “I’d like to see more activities in India, just as I would in China, as is happening in Brazil.” But, he adds, these “certainly won’t be driven by cost considerations only.”

There’s no question, of course, that pharma is still being hesitant when it comes to actually engaging with social media, regardless of the desire to do so. Faceoff participant Bruce Grant, SVP, Strategic Services, Digitas Health, advises that it’s helpful “for us as marketers to think of social media not as a channel but as a conversation.” But, he adds “a conversation is not a natural instinct for a marketer, it’s learned behavior.” Currently, it seems pharma marketers main hesitancy stems from uncertainty of operating in a world where “marketers are no longer in sole control of the conversation.”

So will the FDA smooth the way with more guidance on social media? Jennifer A. Colapietro, Partner, Pharmaceutical and Life Sciences Advisory, Pricewaterhouse Coopers, doesn’t think so.  FDA hearings are only likely to result in guidelines and perameters and provisions, she says, “but the rubber really hits the road in your individual interpretations, and operationalizing those within your organization.”

So what can pharma do? One thing is to gain a proper understanding of what social media is. “There’s a common misconception that social media is just the triumvirate of Facebook, Twitter and YouTube. That’s not what social media is,” says Colapietro. “There needs to be some awareness and education about what it is, what the risks are and how you can use it.” Tune in here to find out more!

The first of this new Pharma Faceoff series is already generating some positive responses from industry. Steve Woodruff, President of Impactiviti, says on his blog: “Kudos to Pharm Exec for taking it on… let’s face it – video is where it’s at for on-line communications, and this is a great way to hash out some issues and gain needed exposure.”

Watch this space for more Faceoffs to come.

But there remained a niggling doubt that echoes celebrated screenwriter William Goldman’s oft-quoted comment about Hollywood: nobody really knows anything. A scan of the conference participants’ job titles either confirms the healthy buoyancy of the industry’s approach to this revolution in patient, physician and corporate communication, or reflects the fact that everyone has their own conflicting ideas: Director of Social Media, Head of Corporate Internet Presence, Head of Digital Marketing, Lead, New Media Communications and, not forgetting, the good old Director of Corporate Communications.  Still, the very fact that the industry now has some recently re-titled Heads and Directors of Social Media underlines its long-awaited recognition of the importance, or finally its growing fear, of Web 2.0 and what it means for online strategies.

Not surprisingly, the conference saw attitudes to social media’s place in a pharma company vary fairly widely, from “social media is just another communication channel” to “no, it’s not a channel, it’s a platform” (this from speakers in the same company) to “social media shouldn’t be in our job titles, it should be ingrained in all our communication activities” and “there’s no such thing as a social media strategy.” All of which highlighted the concern expressed by more than a few members of the audience: is pharma’s engagement with Web 2.0 still an ‘experiment’ or is it a genuine attempt to spread the social media culture?

Colin Foster, Novartis’ Director of Social Media, told the conference that his role was both to experiment and to spread the culture. “But it soon becomes a question of how you embed social media into the organization,” he said. Novartis has advanced further down this path than some companies. It was one of the first companies to establish an alliance with PatientsLikeMe, an online community for people with ‘life changing conditions’ that has a current membership of around 45,000 patients and which logged over 360,000 posts last year. In 2008, it engaged PatientsLikeMe’s multiple sclerosis (MS) community to boost its registrations for its MS clinical trials. More recently, the company has helped establish an organ transplant community on the site and will use the information gleaned from its discussions in its future research.

But Gillian Tachibana, Merck Serono’s Director of Social Media, seemed to contradict Foster’s stance, saying pharma social media “is not about experimentation. Internally, it’s about education; externally it’s about having a strategy, a vision.” Merck Serono is perhaps more cautious after having had its fingers burnt by one online community it was involved with. Tachibana explained how the company “had a crisis on a message board” when someone made harsh criticisms of a rival company. “We didn’t deal with it too well,” she added. Merck Serono simply shut down the forum, a move that was soon picked up — and criticized — by the press.

As with any discussion of social media, Facebook could not be ignored. But again this was a bone of some contention. The virtues of the site as an important method to build opportunities for dialogue were duly extolled; Facebook, it was noted, has become one of the biggest drivers of traffic to websites; in some cases more so than Google. And it has over 1000 communities for people with chronic illnesses.

But Alex Butler, Communications Manager at Janssen-Cilag UK, reminded us that people on Facebook are there to have fun, not to be sold something, or even ‘educated.’ And with public trust in the industry at an all-time low, is it a good idea for Big Pharma to try and generate ‘friends’ on Facebook? “People don’t want an intimate relationship with a pharma company,” noted Alex. But what pharma does need to do on social networking sites, commented Marianne Gries, VP of Marketing at Merz Pharmaceuticals, is “listen, inform and engage.” Unfortunately, the acronym she uses to convey this message is ‘LIE.’

So, differing opinions reign. But I’ve been to enough pharma conferences in the past five years to know that inconclusiveness is usually the order of the day. I’d probably feel short-changed if I came away with any definite ideas about anything. Still, that doesn’t mean Digital Pharma Europe wasn’t a relevant and potent forum for a very healthy exchange of ideas — indeed it was.  And, in fairness, there was resounding agreement on some inescapable Web 2.0 facts and observations (with thanks to FD Santé):

• A decade ago, product launches didn’t even take account of patients; now they are at the centre of the campaign.
• Younger doctors and medical students comprise a generation that only knows online CME. Now every medical education campaign must include a social media element.
• It is pointless running a symposium unless you are going to broadcast it on the web.
• If we wait for official regulatory guidance on social media, we could be waiting forever, so industry leaders must write it themselves.

All of these topics, and more, we hope to pick up in Pharmaceutical Executive Digest Europe, over the coming weeks and months. Whatever your thoughts are on where online social media sits and how it should be defined within your company, there’s no denying that it’s out there and it’s huge — and it’s not going to go away.

PEE: What do you see as the key regulatory affairs (RA) challenges for 2010?

ZH: Understanding the changing regulatory and health technology environment can help companies to secure regulatory/pricing approval as speedily as possible for new products. Agreement on the EU pharmaceutical package (pharmacovigilance, counterfeits and patient information, and achieving operational excellence in compliance with limited resources available to companies in this economic climate, particularly for SMEs.

What do you see as the TOPRA priorities for your upcoming tenure as president?

I will be delivering an operational plan that helps meet the longer-term strategy of TOPRA. The strategic direction of TOPRA is going to be debated this month and agreed by September 2010. Although the strategy reviewed each year many elements will be enduring for 2­–3 years. Clear themes likely to feature are

• a vision of how to develop as a professional body for RA
• improving education and training for members and regulators
• launching TOPRA publishing, build on providing networking opportunities
• maximising RA membership in developing market
• meeting our financial obligations to members
• improving our offerings and the efficiency of our operations in delivering the many benefits to our broad customer base.

What do you think needs to be done to increase the profile and perceived value of RA in the pharma industry?

We need to consolidate our strength as regulatory professionals in two ways. First, we need to become business leaders who are clear business partners internally within our organisations, whilst educating that a clear commitment to operational excellence in compliance is a competitive advantage. Technical skills traditionally afforded to RA are necessary but no longer sufficient for success in the future. Communication skills and business acumen are key in developing fruitful relations with business colleagues, who need to be clearly given the values of regulatory interventions that grow and protect the business.

Second, we need to build relationships on trust and transparency. Embracing the objectives of regulators and the patient is vital.

Do you think increasing globalization in the pharmaceutical industry will lead to more regulatory harmony, particularly between Europe and the US?

We all hope that increasing harmonization can help improve delivery of innovative medicines to the patient for the future, as an industry we are prepared for this and would like to move faster than perhaps the regulatory processes and legislation will allow. Steady steps in the right direction continue, but there is a great deal more debate to be heard before we get there. Collaboration between the regulators in the US and EU is increasing however the decisions still remain separate based on medical practice and benefit/risk calculations in specific populations.

The role of national competent authorities (NCAs) in Europe will still continue in my view in the next 5­–10 years. Scientific bodies in Europe still need national experts to conduct the review for new medicines. This improves the scientific network in EU also. Although regulating medicines has to do with the free market it also is of public health concern and NCAs are still accountable to local ministers and thus can still make urgent decisions based on national interest. It’s difficult to see pure centralisation of all healthcare professionals in all countries.

Are you optimistic that the EU pharmaceutical package will have a positive effect on anti-counterfeiting and pharmacovigilance measures across Europe?

New legislative proposals are going through the European Commission that I believe will help improve the integrity of the supply chain. Industry has assessed the potential impact of this legislation and although this is still being discussed we are hopeful that the feedback to consultations on these proposals will result in improvements that will help protect patients.

We all need to be abreast of pharmacovigilance changes, and appropriate risk management plans for our products. There is a significant opportunity for colleagues outside of RA and safety to learn and understand these requirements better that help protect patients and improve transparency.  All pharmaceutical companies are inspected on pharmacovigilance as well as other regulatory activities such as good clinical practice and good manufacturing practice. It is increasingly important for marketing and sales colleagues to be aware of these regulatory changes: why they have been put in place, what the implications are for them, and to keep up to date on their training.