Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

This year’s CPhI Worldwide event is set to take place at the Feria de Madrid in Spain, October 9–12, with expectations for more than 30,000 visitors and 2200 exhibitors from 140 countries. Despite the continuing troubled economic times, the show continues to boast growth; 108 new companies are preparing to join the many returning exhibitors, while the number of exhibitors in the ICSE logistics and supply chain zone will double compared with 2011. Indeed, this year will see the highest number of exhibitors compared with any previous year. 

Recently, the organisers of CPhI, UBM, have been introducing a zoning structure to many of their events and this format will be present in Madrid to help facilitate navigation. The zones featured will be:

CPhI Worldwide: APIs; Generic APIs; Custom Manufacturing; Fine Chemicals; Intermediates; Excipients/Formulations; Biopharmaceuticals; General 

ICSE: Logistics and Supply Chain; BioServices; Analytical & Lab Services; Pre Clinical Trials, Clinical Trials Stages 1-4, CRO, Clinical Data Management Zone; Trial Stages; New Exhibitors; North America Zone; General Floor 

In addition, the events will be divided into global pavilions to help visitors quickly locate suppliers from specific regions. The pavilions will feature Argentina, Brazil, China, Egypt, France, India, Ireland, Korea, Morocco, North America, Portugal, Scotland and the UK. Madrid will also see the introduction of pavilions for Russia and Malaysia.

The 2012 event will also see an expansion of the CPhI Innovation Awards, which are being rebranded as the CPhI Pharma Awards for 2012. In addition, the Innovation award category has been expanded to look at showcasing exhibitors with groundbreaking innovations in formulation, drug delivery, chemical manufacturing of APIs and intermediates, and biomanufacturing of biopharmaceuticals and intermediates. You can find out more about the awards 

 teams will be in attendance at the show in Hall 10, Stand A23. We look forward to meeting with you and hearing your thoughts about the show.

CPhI was held in Madrid for the first time in 2009. Did you attend? What did you think of the location? And are you happy that the show is returning to Madrid? Let me know your thoughts in a comment!

Articles

This year's CPhI Worldwide event is set to take place at the Feria de Madrid in Spain, October 9-12, with expectations for more than 30000 visitors and 2200 exhibitors from 140 countries.

Great Expectations for CPhI Worldwide 2012

Johnson & Johnson (J&J) has announced plans to open four innovation centers in California, Boston, London, and China, with the aim of accelerating early innovation and facilitating collaboration and investment opportunities. The company is aiming to have the centers operational within the coming months.

, the areas chosen for the centers are “innovation hotspots.” Each center will serve as a regional hub and will possess science and technology experts, as well as local deal-making capabilities. The centers will be looking to identify promising early stage innovations and to establish collaborations to further explore their development potential for unmet medical needs.

"Today, leading innovation sources have concentrated geographic presence in selected locations around the world," Diego Miralles, MD, head of the California innovation center, said in the J&J statement. "By refocusing our outward facing activities and locating our experts and our deal-making capabilities in those regional hubs we can simplify the deal making and coordination for entrepreneurs who are looking to collaborate and partner with the Johnson & Johnson family of companies."

The centers will provide scientists, entrepreneurs and emerging companies researching early-stage opportunities with access to experts at J&J, who will then facilitate collaboration across J&J’s pharmaceutical, medical device and diagnostics, and consumer businesses. According to the press statement, J&J has a history of accessing early innovation through its Corporate Office of Science and Technology, J&J Development Corporation and RedScript Ventures, as well as other efforts in its business sectors. The new innovation centers will coordinate all early stage efforts into four hubs. Later licensing and acquisition opportunities will continue to be managed by J&J’s Business Development team.

"The innovation centers will help to deepen our relationships with the communities in key innovation hotspots and better support local entrepreneurs," Patrick Verheyen, head of the London innovation center, said in the J&J statement. "Ultimately they will serve to help us more quickly identify and tap into technological advancements that have the potential to benefit the health of people in the future."

Johnson & Johnson has announced plans to open four innovation centers in California, Boston, London, and China, with the aim of accelerating early innovation and facilitating collaboration and investment opportunities.

J&J to Establish Innovation Centers

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities. The fees were described in a 

 from the European Commission, which was released for a public consultation in June 2012. The consultation finished last week and the final paper has not yet been released.

, Greg Perry, EGA Director General, explained, “Taking all the fees into account (annual fees, PSUR, PASS, and referral fees), the generic medicines industry will be paying for the EMA/EU pharmacovigilance system in a disproportionate manner, while the pharmacovigilance workload for generic substances, which are well known substances with a well-established safety profile, is the lowest.”

To more properly assess the proposed fee structure, EGA has suggested that the EC provides a “clear overview” of the costs associated with all of the new pharmacovigilance activities. In 2008, it was estimated that the total annual increase in fees payable to EMA would be about EUR 10.5 million ($13.7 million), but EGA estimated that the actual contributions could be more than ten times this amount. 

EGA has also proposed that for calculating annual fees, Marketing Authorization Holders belonging to the same group of companies and acting under one Pharmacovigilance System Master File should only pay one annual fee per active substance. Otherwise, EGA is concerned that an average-sized generic medicines company with a large portfolio of active substances and marketing authorizations may find itself paying pharmacovigialnce fees of EUR 20 million ($26.1 million).

EMA already requires fees for certain activities, such as reviewing marketing authorization applications, as part of the EMA’s Centralized Procedure. Further fees are being introduced as part of Europe’s pharmacovigilance legislation, which became applicable in July 2012. The legislation requires the EMA to play a greater role in the area of pharmacovigilance. 

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities

Potential European Pharmacovigilance Fees Criticized

	The pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly, but they are – at least Big Pharma is – spending more on so-called inbound social media software and analytics, which lets them listen to what is being said online about brands and unmet needs and match that up marketing strategies.

	A new report from IDC Health Insights, titled “Worldwide Pharmaceutical Social Media Analytics 2012 Vendor Assessment,” found that pharma marketing departments are “starving for new ways to measure market sentiment, competitive analysis and promotional effectiveness” in areas that were previously difficult to gauge, according to Eric Newmark, program director, life sciences, IDC Health Insights and author of the report. “Companies are trying to answer questions like, ‘What are the sentiments being shared by our highest targeted physicians about brands in popular online communities,’ or ‘What is the biggest unmet need among our highest targeted physicians?’”

	Insights gleaned from listening in to social media conversations aren’t being widely integrated at an enterprise level just yet, but pharma is “becoming increasingly interested in integrating this information back into the broader spectrum of CRM and sales and marketing intelligence, so they can start to relate what they’re seeing online back with the actual customer profiles and CRM systems…that gives them something closer to a 360-degree view of what physicians are saying online, and actually tying that back to a [physician] profile,” says Newmark.

	Some companies continue to use third party service providers as a kind of regulatory buffer, in the belief that keeping a social media wiretap at arm’s length protects them from having to report adverse event discussions – discussions which may or may not meet FDA’s criteria for reporting – but source validation, relevancy, and weighting one online conversation against another, is becoming a strong area of focus and attention for pharma, says Newmark. “You don’t want to be misinterpreting what’s out there.”

	So who are the top vendors, according to Newmark’s six months of research and discussions with pharma? The leaders, in no particular order, include Indegene, Cognizant, ListenLogic, Genpact and Semantelli. On the next rung down – major players – Visible Technologies, Genpact and Radian6 made the cut; all have experience working with top pharmas.

	Companies have misjudged the market in the past – Newmark gives an example of a pharma company focusing on the “fast-acting” capabilities of a product, when, come to find out, patients aren’t as concerned about fast-acting as they are about specific side effects – which makes listening software, or monthly reports from service providers, a valuable tool in the marketing arsenal.

The pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly.

Advancing Pharma’s Social Media Listening Analytics

  because of a “misleading” image of a multicolored brain scan that appeared on the company’s website for the diagnostic Positron Emission Tomography (PET) tracer, Amyvid. Amyvid is indicated for PET brain scans to review β-amyloid neuritic plaque density in patients who are being evaluated for Alzheimer’s Disease. 

According to FDA, the use of the colored brain image classifies as misbranding because Amyvid’s product labeling states that Amyvid images must be displayed and reviewed in black and white. Black and white scale “with the maximum intensity of the scales set to the maximum intensity of all the brain pixels” is necessary for accurately reviewing the scans. Amyvid’s product information also includes several black and white example scans to illustrate interpretation. The use of a color image suggests that the scans can be displayed and interpreted in color.

“While many PET images are displayed and reviewed in color, Amyvid scans...must be displayed and reviewed using a black and white scale,” states FDA’s Warning Letter. “Additionally, the [product insert] does not provide instructions for estimating β-amyloid neuritic plaque density using a color scale with Amyvid. Therefore, use of color PET scan image of a brain in Amyvid promotional materials is misleading.”

The image has also been used in other marketing materials, including in the commercial exhibit hall of the American Academy of Neurology annual meeting, which was held in New Orleans, April 23–26, 2012.

Eli Lilly has not yet issued a press statement in response to the Warning Letter. 

Amyvid was approved by FDA in April 2012, but received a complete response letter from FDA in March 2011 because of concerns about how to review and interpret Amyvid scans. In response, Eli Lilly created a specific training program.

PhRMA’s Research and Hope Awards Unveiled

Eli Lilly has received an FDA Warning Letter because of a "misleading" image of a multicolored brain that appeared on the company's website for the diagnostic PET tracer, Amyvid.

Eli Lilly Receives FDA Warning Letter

 plans to eliminate 1100 jobs in its German facilities by the end of 2015 — almost 10% of the company’s 10,900 German positions. Positions will be reduced through voluntary resignation and early retirement programs across all divisions and functions. The company added that it will refrain from making forced redundancies until the end of 2017, with the exception of possible site closures and transfers that are currently under assessment. 

The headcount reduction is being undertaken to ensure that the company remains competitive in the long term. The reduction is part of the company’s “Fit for 2018” program, which calls for production to be focused on core activities that generate high value. More than 100 individual initiatives will be implemented across the different businesses and functions. No outsourcing activities are planned to replace the eliminated positions, with the exception of functions that are already outsourced, such as routine jobs and manual labor. 

Affected areas expected to experience job cuts are support functions, logistics, and the compensation system. For now, Merck explained that it will refrain from moving its financial services, Merck Shared Services Europe GmbH, abroad until at least the end of 2015. In addition, the production of industrial salts in Lehrte and filling operations in Hohenbrunn will be discontinued. Approximately 140 employees currently work at the two sites, and Merck will consider various scenarios in the months ahead.  

Merck also revealed plans to invest at least 250 million Euros at its German sites during the next two years. In particular, the Darmstadt site, the global headquarters of Merck, will be expanded and developed into a state-of-the-art production and research center. 

The measures are part of the company’s global efficiency program, which was announced in February 2012. Earlier job cuts were announced in April when a press statement detailed plans for the closure of sites in Switzerland, including the company’s sites in Geneva and Coinsins. 

As part of the efficiency program, Merck also launched an Entrepreneur Partnership Program earlier this year to facilitate the creation of start-up companies from employees. The first company launched through the program was Prexton Therapeutics, announced in July. The company will employ Merck Serono scientists to continue work around the R&D portfolio in the field of Parkinson’s disease.

Earlier this week, a second company called Quartz Bio was

 through the program. The company will provide biomarker data management and exploratory biomarker analysis services for the pharmaceutical industry.

Merck Serono Announces Final Restructuring Plan

Merck KGaA has announced plans to eliminate 1100 jobs in Germany by the end of 2015&#151;almost 10% of the company's 10,900 German positions.