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2014 Media Plannerwww.PharmTech.com

In 2014, Pharmaceutical Technology Europe marks 25 years of providing objective editorial coverage of bio/pharmaceutical process development, manufacturing, formulation, drug delivery, API synthesis, analytical technology and testing, packaging, IT, outsourcing, and regulatory compliance.

Throughout the year, the editors will mark this milestone with special reviews of the technologies, trends, and advances of the last quarter-century.

The August 2014 issue will feature a retrospective of bio/pharmaceutical developments worldwide in the past 25 years, as well as a look ahead at what may be in store for the next 25 years.

Be a part of this special Commemorative Issue. Advertisers can share their company’s story about advancements in drug development over the last 25 years, their company history, as well as the organisation’s vision for the future.

Ask your representative for details.

Capturing pharma innovation for 25 years

Branding

auDienCe: CirCuLation & reaCh 2014Pharmaceutical Technology Europe has a qualified audience in Europe with 18,000* monthly subscribers; a figure that is qualified biannually by BPA.

*June 2013 BPA Brand Report

aUdience

WHAT IS BPA?

BPA Worldwide is the global industry resource for verified audience data. BPA delivers media audits of unsurpassed rigour, objectivity, accuracy, transparency and timeliness. BPA audits provide solid assurance for advertisers with rich, in-depth information about a magazine’s individual subscribers. All 18,000* subscribers meet strict qualification criteria that ensure direct delivery of your advertising message to your target audience.

AUDITED ELECTRONIC MEDIA PRODUCTS

The BPA Brand Report includes a third-party validation of our online statistics, including our website and e-newsletters.

BUSINESS & INDUSTRY/DISTRIBUTION*

Pharmaceutical/Biopharmaceutical, including manufacturing ��12,081

Drug delivery/medical products and device manufacturing ��1,641

Contract services ��1,146

Ingredients (raw materials, APIs, excipients, chemicals, water) ��1,232

University/Academia/Education ��1,044

Government ��374

Engineering/Facilities/Construction ��482

This year, Pharmaceutical Technology

Europe marks 25 years of editorial

excellence covering drug development

and manufacturing trends and

technologies in Europe, North America,

Latin America, and Asia. The editors will

mark this milestone with special coverage

of the evolving bio/pharmaceutical

market throughout the year.

rita Peters, Editorial Director,

Pharmaceutical Technology Europe

Please refer to your copy of the BPA audit to understand how our audience is represented in Europe by location, business function and market sector.

auDienCe: CirCuLation & reaCh 2014

*June 2013 BPA Brand Report**No figure given on media kit or website***Publisher’s own data – Readership Survey

aUdience

EUROPE’S MOST DESIRABLE INDUSTRY AUDIENCE

Pharmaceutical Technology Europe serves professionals working in pharmaceuticals, biopharmaceuticals, ingredients and raw materials, outsourcing and contract services, formulation development and drug delivery, and more.

The publication is read by scientists, engineers and managers engaged in:***

• Analytical Technology• APIs• Excipients• Cleanrooms and Contamination Control• Contract Manufacturing/Services• Drug Delivery• Formulation Development• Process Development• Packaging (Primary and Secondary)• Regulatory Compliance, QA/QC,

Validation• Security/Anti-Counterfeiting• Supply Chain Management

Publications PublisherAudited

byLast Audit

PrintedCopies

MagazineFrequency

Source


Advanstar Communications

BPA June 2013 18,000*12 issues annually

June 2013 BPA

European Pharmaceutical Manufacturer

Rapid News Communications

BPA June 2013 5,9538 issues annually

Website

Manufacturing ChemistHPCi Media Ltd Not audited Not audited

Not stated on website

11 issues annually

SRDS**

Northern Europe*

1,532

Western Europe*

11,371

Central & Eastern Europe*

1,333

Southern Europe*

395

UK*

3,369

aUdience

Pharmaceutical Technology Europe readers recommend and/or approve a range of products and services:*

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Keeps me current on new and emerging technologies

Differentiating products and services

Purchasing decisions

*Pharmaceutical Technology Europe Readership study, June 2013

aUdience

If they could read just one publication, 76.6% of readers chose Pharmaceutical Technology Europe for the single source for information:*

In the last 12 months, readers have taken the following actions as a result of seeing advertisements in Pharmaceutical Technology Europe:*

Visited a company’s website/sent an email to company

Discussed with someone else in the company

Recommended/ discussed product/service

Contacted company/supplier/representative

No actions taken

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Passed along a tear sheet, photocopy or issue

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BioPharm International

Drug Development & Delivery

Pharmaceutical Manufacturing

American Pharmaceutical Review

Contract Pharma

Pharmaceutical Processing

editorial & Print

eDitoriaL & print aDvertising overvieW 2014.

From materials and formulation, to innovative medicines and equipment, to regulation and standards, to globalisation and outsourcing, pharmaceutical development and manufacturing is complex and challenging. But your marketing strategy remains as simple as ever. With the greatest reach into your market, The Pharmaceutical Technology Group conveys your message directly to your customers.

The Pharmaceutical Technology Group is your global source. From the uk to the uSA, from Western Europe to the Far East, if it’s happening in the bio/pharmaceutical industry, we are there! We have great reader loyalty because we provide the most comprehensive and authoritative coverage in drug development and manufacturing. our subscribers—your customers—turn to Pharmaceutical Technology Europe to learn what’s happening in their region and throughout the world. They listen to us and they’ll listen to you too, when you advertise where your customers are.

PRINT

We have experience working with both traditional and unique advertising styles when it comes to print marketing campaigns. Your account manager’s aim is to develop a creative solution that meets the unique demands of your marketing plan. For a look at the editorial topics covered in 2014, please refer to the editorial calendar. To discuss options in more detail, please contact your account manager.

ADVERTISEMENT PERFORMANCE STUDY

The Readex research study is intended to evaluate the effectiveness of your advertisement using both quantitative and qualitative feedback obtained from a random selection of the Pharmaceutical Technology Europe audience. The Advertisement Performance Study provides real feedback from our readers and a statistical evaluation of your advertisements in terms of perception, attention grabbing ability, believability, information value and actions taken.

In January and August 2014, we will provide an Advertisement Performance Study report, free of charge, to all full-page advertisers.

87.3% of readers find that print advertisements keep them up to date on new and emerging technologies*

PEER-REVIEWED Risk-Based Specifications API SYNTHESIS & MANUFACTURING High-Potency ManufacturingREGULATORY WATCH Medicine Shortages

Controlling Drug Release Through Osmotic Systems

July 2013 Volume 25 Number 7

Advancing Development & Manufacturing

PharmTech.com

August 2013 Volume 25 Number 8

EMERGING MARKETS India and south Korea

PEER-REVIEWED Extractables and Leachables

PHARMACEUTICS Demonstrating Biosimilarity

Sizing Up Big Pharma’s Manufacturing

Investment StrategiesThe pharmaceutical majors target biologics and

emerging markets in their manufacturing expansion activities.


PharmTech.com


editorial & Print

eDitoriaL Coverage: expert insight anD anaLysisPharmaceutical Technology Europe continues its tradition of providing industry-leading information on the technologies, strategies, and regulations crucial to professionals developing and manufacturing pharmaceuticals and biopharmaceuticals.

The editorial mix of peer-reviewed papers, technical articles, technology reports, regulatory and business columns, and expert commentary provide comprehensive coverage of process and formulation development, manufacturing operations, drug delivery, packaging, labelling and distribution.

The contributors—experts from bio/pharmaceutical companies and industry supplier companies, columnists, and the editorial staff—are experts with specialised knowledge and experience in their fields.

editorial FocUsEach issue of PharmaceuticalTechnology Europe addresses a key trend in drug development, includ-ing solid dosage and parenteral manufacturing, analytical testing, biopharmaceutical manufacturing, equipment and manufacturing trends, quality by design, bioavail-ability, API manufacturing, drug formulation, and drug delivery.

Peer-reviewed researchPharmaceutical Technology Europe publishes peer-reviewed papers in the form of data-driven research papers, literature and patent reviews, application and technical notes, and position papers on a broad range of drug development topics. All papers undergo a double-blind peer-review process by Pharmaceutical Technology

Europe‘s Editorial Advisory Board, which represents leading scientists, managers, directors, and consultants.

sPecial FeatUres and ForUmsThrough contributed technical reports, roundtable discussions, and expert interviews, Pharmaceutical Technology Europe addresses current and emerging trends in pharmaceutics, quality and compliance, analytical testing, packaging, as well as vital business and regulatory topics.

API Synthesis & Manufacturing covers active pharmaceutical ingredients, intermediates, fine chemicals, and advances in process R&D.

New analytical instruments, automation and process control systems, information technology tools, laboratory equipment, and manufacturing equipment are profiled in Product Spotlight.

The Troubleshooting feature directs readers through common technical problems and solutions in equipment design and operation, aseptic processing/sterile manufacturing, solid dosage manufacturing, and biopharmaceutical manufacturing.

regUlation and comPlianceLegislation, court decisions, and regulatory changes that shape trends and practices in the global pharmaceutical industry are tracked in the Regulatory Watch column. In the Inside Standards section, major industry associations and standard-

setting bodies address organisation initiatives, new compendial standards and tests, and regulatory trends. The editors summarise recent regulatory action, including warning letters, inspection trends, and recalls in the GMP Report.

news, analYsis, and commentarYService contract providers and users stay current on trends, partnerships, and business activities through the monthly Outsourcing Review column.

Global Market Reports from established and emerging pharmaceutical markets tackle both regulatory initiatives and market trends. Conversation and Community reflects discussions and activities in the online pharmaceutical market. Executive interviews with industry supplier and pharmaceutical developers are featured in Industry Q&A and Pharma Q&A. Reader questions are addressed in Ask the Expert.

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Using model-predictive design to define, predict and control a process is well-established in

many industries, and is beginning to take hold in pharmaceutical process development and manufacturing. Modelling software helps developers to model unit operations and in some cases, an entire continuous process.

Model-predictive design includes a hierarchy of different approaches, explains Bernhardt Trout, PhD, director of the Novartis–Massachusetts Institute of Technology (MIT) Center for Continuous Manufacturing (CCM) and professor in the Department of Chemical Engineering at MIT. The most basic approach is the use of linear univariate models (e.g., parameterised from a linear design of experiments). A more complex approach is multivariate analysis, followed by mechanistic modelling; the ultimate approach is analysis of first principles (e.g., conservation of mass and energy).

The pharmaceutical industry needs to move beyond statistical models, says Fernando Muzzio, PhD, director of the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) and professor in the Department of Chemical and Biochemical Engineering at Rutgers University. “Models based on first principles allow you to achieve a greater level of understanding and thus

extrapolate outside of the area defined by the statistical models,” explains Muzzio, who further discusses modelling tools in an article in this issue (see page 31).

Generating the level of knowledge necessary to build a model, be it statistically or mechanistically based, helps to speed development and mitigate risks during product development, scale-up and commercial manufacture, adds Howard Stamato, associate director in the Portfolio Enabling Technology Group of Drug Product Science and Technology at Bristol-Myers Squibb. He adds that in those cases where the model can be used in closed-loop control, there are significant advantages for both efficiency and quality of the final product.

Much progress has already been made in employing models in the pharmaceutical industry, driven in part by advances in process analytical technology (PAT). “Advances in computing power and analytical methods, including PAT, have broadened what can feasibly be measured and subsequently modelled,” says Stamato. “These advances allow models to be built with reasonable resource commitments and much higher accuracy than previously possible,” he adds. In the solid-dosage drug-product manufacturing arena, modelling work has been performed, for example, in

Jennifer Markarian

Using Model-Predictive Design in Solid-Dosage Manufacturing ProcessesModels and modelling software gain a foothold in solid-dosage manufacturing process design.

Pharmaceutical Technology Europe June 2013 27

April 2013 Volume 25 Number 4

PARENTERAL DRUG MANUFACTURING Sterility Assurance

PEER-REVIEWEDMethod Validation by Design

API SYNTHESIS & MANUFACTURINGAdvancing Flow Chemistry

PAT and Process Control in Solid-Dosage Manufacturing

Moving Toward Closed-Loop Control of Continuous Processing


PharmTech.com

API SyntheSIS & MAnufActurIng

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Heterocyclic compounds play an important role in medicinal chemistry and drug synthesis.

Like any important functional class of compounds, developments that facilitate their production or elucidate their reaction mechanisms are significant for process chemists in the pharmaceutical industry. In two separate developments, researchers at The Scripps Research Institute (TSRI) in La Jolla, California recently reported on the use of zinc sulphinates as reagents for the direct chemical functionalisation of nitrogen-based heterocycles and on reaction-tracking tools to better elucidate copper-catalysed reactions in making triazoles.

A toolkit for synthesising heterocyclesIn the first development, scientists at TSRI developed a set of chemical tools to simplify the synthesis of nitrogen-based heterocycles through more time- and cost-efficient chemical modifications of these compounds. In their work, the researchers pointed out that although advances in transition-metal-mediated cross-coupling have simplified the synthesis of such heterocycles, the carbon–hydrogen functionalisation of medicinally important heterocycles that does not rely on prefunctionalised starting materials was an area requiring further research (1). Although the properties of heterocycles, such as their aqueous solubility and their ability to act as ligands, are desirable for biological applications, these properties also make such heterocycles challenging as substrates for direct chemical functionalisation (1). To address that problem, the researchers used zinc sulphinate salts to transfer alkyl radicals to heterocycles, thereby allowing for the mild (i.e., moderate temperature, 50 °C or less), direct and simple formation of carbon–carbon bonds while reacting in a complementary fashion to other carbon–hydrogen functionalisation methods (i.e., Minisci, borono-Minisci, electrophilic aromatic substitution, transition-metal-mediated carbon–hydrogen insertion and carbon–hydrogen deprotonation) (1). The researchers prepared a toolkit of these reagents and studied their reactivity across a range of heterocycles (natural products, drugs and building blocks) without recourse to protecting-group chemistry. The reagents

could be used in tandem in a single pot in the presence of water and air (1).

“Feedback from companies that have started to use this toolkit indicates that it solves a real problem for them by boosting their chemists’ productivity and by expanding the realm of compounds that they can feasibly generate,” said Phil S. Baran, PhD, a professor in the Department of Chemistry and a member of the Skaggs Institute for Chemical Biology at TSRI who led the study, in a 28 Nov. 2012 TSRI press release. The resistance of nitrogen heterocycles to modification by traditional techniques has slowed drug discovery and has put potential modifications out of reach, notes TSRI.

The genesis behind the toolkit began with the goal for a more a simplified approach. “The ideal for discovery chemists would be a method that works in water, in an open flask, [and] with procedures that are simple enough to be automated,” said Baran. His group’s previous work in synthesising a natural product heterocycle, palau’amine, a toxin made by sea sponges in the Western Pacific that has shown anticancer, antibacterial and antifungal pharmaceutical promise, was a helpful beginning. “As we developed an understanding of how that compound reacts, we recognised that it might help us solve this larger problem that discovery chemists face,” said Baran in the release. In that synthesis, palau’amine was made by a route featuring highly chemoselective transformations, cascade reactions and a transannular cyclisation to produce the trans-5,5 ring junction (2) and led the researchers to examine reagents that would modify heterocycles directly.

Although direct methods exist, they often require extreme temperatures as well as expensive and hazardous reagents. During 2010 and 2011, Baran’s laboratory experimented with several comparatively safe chemical reagents that work in mild conditions to make commonly desired heterocycle modifications, such as the addition of a difluoromethyl group, according to the TSRI 2012 release. One of these new reagents, a zinc dialkylsulphinate salt (DFMS), which was designed to transfer the difluoromethyl group, turned out to work particularly well. “We quickly realised that we might be able to make related

researchers at the Scripps research Institute advance heterocyclic chemistry through developing new reagents and reaction-tracking techniques.

Elucidating Heterocyclic Chemistry for Pharmaceuticals

Patricia Van Arnum

is Executive Editor of

Pharmaceutical Technology

Europe

36 Pharmaceutical Technology Europe JunE 2013 Pharmtech.com

16 Pharmaceutical Technology Europe June 2013 PharmTech.com

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EuropEan RegulaToRy Watch

Pharmaceutical companies applying for marketing approval of their products in Europe are now required to provide

the region’s regulatory authority with documented evidence that they are using a process that consistently produces their medicines at the correct specifications and quality standards. At the moment, companies have the option of providing regulators with the details of a process validation itself or of how they intend to carry one out. However, it is likely that the requirements will become more stringent with details of process validations being demanded not only in applications for marketing authorisations but also during the post-marketing phase.

“Process validation is an evolving landscape with a strategy being used throughout the lifetime of a product,” said Brendan Hughes, an industry participant from Bristol-Myers Squibb at the expert workshop on validation of biopharmaceutical active substances in April at the London headquarters of the European Medicines Agency, the European Union’s central licensing authority.

Data collectionOne of the main driving forces behind this move, which requires drug companies to provide more information on their processes, is an EMA-led policy of gathering as much data possible on the benefits and risks of medicines from multiple sources including their methods of manufacture. Among the new sources of knowledge is data generated by the EU’s new pharmacovigilance legislation that came into effect in July 2012. The aim is to build up an extended database on all authorised medicines, including post-marketing information on possible adverse reactions and manufacturing issues. The database complements an expanded one on GMP—called EudraGMP—containing information yielded by a new legislative requirement on GMP in the production of APIs.

The new legislative initiatives need to be “systematically utilised and further integrated to deliver continuous knowledge generation,” said Peter Arlett, EMA’s head of pharmacovigilance and risk management, and Tomas Salmonson, chair of the committee for medicinal products for human use (CHMP), in a joint article in the agency’s latest annual report published in April. They added that “this concept of continuous knowledge

generation is enabled by a lifecycle approach to data collection and improved scientific and regulatory methods.”

Lifecycle approachWith process validation, EMA wants to use, in particular, a lifecycle system for new technologies being applied in the manufacture of advanced therapies. Last year, after detailed process validation, it approved Glybera, a gene therapy for treatment of the rare inherited disorder lipoprotein lipase, developed by the small Dutch company UiQure. Glybera was the first gene therapy to be authorised by EMA and the Western world. Its production process is likely to be scrupulously monitored after the product’s launch. According to EMA, the authorisation paves “the way for approval of similarly complex medicines in the future, as more gene therapies for rare diseases, personalised medicines and nanomedicines are on their way.”

In a draft guideline on process validation for dosage-form medicines, issued by EMA a year ago and currently being finalised, the agency said that a manufacturing process should be validated before a product is launched on the market. However, with medicines produced by well-established technologies, details of the validation, which can be based on the traditional validation method of using studies on batch production at the pilot stage, do not have to be placed in the application dossier for authorisation. Instead, the data should be held at the manufacturing site to be made available, if necessary, for inspection. With biopharmaceuticals and other “non-standard method” of production as well as specialised products such as modified-release preparation, details of the validation, which should be made with verification data at the production-scale level, should be included in the application dossier.

During the post-authorisation phase, validation is seen in the guideline as a means of monitoring and evaluating the processes in a continuous manner. “It is a science- and risk-based approach to verify and demonstrate that a process operating within the predefined specified parameters consistently produces material that meets all its critical quality attributes (CQAs),” the guideline says.

After a consultation on the draft guideline, one key issue being decided by EMA is the scope of process validation, which comprises an evaluation and verification stage. It was generally agreed that continuous process verification (CPV) should be a key component of the lifecycle monitoring of pharmaceutical manufacturing. “These concepts (with continuous process verification) are new but they are acceptable approaches,” said an official at the UK’s medicines and healthcare products regulatory agency (MHRA).

a manufacturing process should be validated before

a product is launched on the market.

a Lifecycle approach to process Validationa science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

Sean Milmois a freelance writer based in Essex, UK,

[email protected].

contin. on page 30

OUTSOURCING REVIEW

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Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report, tel. 703.383.4903, Twitter@JimPharmSource, [email protected], www.pharmsource.com.

New drug approvals by FDA continued their upward advance in 2012, but CMOs did not

benefit much from the improvement. The data suggest that the market share of dose CMOs may have peaked.

In 2012, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), which approves new small-molecule and biologic therapeutic drugs, approved 101 new drug applications (NDAs). This level was on par with the 102 new drugs approved in 2011 and continues the recovery in NDA approvals that started in 2008 (see Figure 1).

The composition of the new approvals was particularly noteworthy. Of the 101 NDA approvals, 39 were for new molecular entities (NMEs) (i.e., drugs containing an API that was approved for the first time). The NMEs included 10 biologics and 28 small-molecule drugs. This level was the most NME approvals in more than seven years.

There were 62 non-NME drugs approved (i.e., drugs containing a previously approved API). Of those, 47 were approved via the 505(b)(2) route, which provides for a simplified approval process for new formulations of previously approved drugs. The 505(b)(2) process is particularly popular with specialty pharmaceutical and generics-drug companies because it is a lower-cost and lower-risk process for developing new drugs than developing NMEs.

Outsourcing trends remain unchangedWhile the approvals trend grew stronger, the propensity for outsourcing the manufacturing of these new drugs remained flat. Overall, dose manufacturing was outsourced for 42% of the NDAs approved in 2012, which was consistent with the 41% average for the previous six-year period (see Figure 2). Both NMEs and non-NMEs were outsourced at the 42% rate.

The propensity to outsource was largely a function of the nature of the approval and the size of the company getting the approval. Global and

mid-size biopharma companies were more likely to outsource their non-NMEs than their NMEs; the global biopharma companies did not outsource dose manufacturing for any of their biologics approvals, but did outsource some of their small-molecule approvals. Small companies outsourced dose manufacture for most of their new approvals, both NME and non-NME, including 100% of their biologic

approvals. As one would expect, generic-drug companies outsourced few of their new approvals.

A total of 28 different dose CMOs benefited from new product approvals in 2012. Only six had more than one approval, with Catalent (six new approvals) and Patheon (four new approvals) leading the way.

PharmSource analysis of eight years of FDA approvals data suggests that the acceptance of the CMO business model and its penetration of the biopharmaceutical industry have remained relatively unchanged throughout most of the past decade. NME dose-form outsourcing has remained relatively constant for the past seven years as the industry is governed by two basic truths: smaller companies have a strong tendency to outsource while global biopharma companies have a strong preference to keep products in-house.

Outsourcing strategiesAmong global bio/pharma companies, attitudes and strategies regarding contract manufacturing appear to be well entrenched. Out of the 22 global biopharma companies, nine companies—including Abbott/Abbvie, Astellas, Bayer and Novo Nordisk—outsourced none of their new NDA approvals during the 2005–2012 period. On the positive side, four companies have outsourced 50% or more of their

Drug Approval Trends Don’t Extend to CMOsApprovals of new drugs are on an upward swing, but only a few CMOs are benefiting.

OUTSOURCING REVIEW

Among global bio/pharma companies, attitudes and strategies regarding contract manufacturing appear to be well entrenched.


Eric Chiang

is product manager for

texture analyzers at

Brookfield Engineering

Laboratories,

Middleboro, MA, USA, tel:

1.800.628.8139, e_chiang@

brookfieldengineering.com.

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TROUBLESHOOTING

Crushing, fracturing and bending tests quantify hardness.

Measuring Tablet Hardness: A Primer

Solid tablets are perhaps the most commonly used dosage

form for pharmaceuticals. Tablet hardness serves both as a criterion to guide product development and as a quality-control specification. Tablets should not be too hard or too soft. An extremely hard tablet could indicate excessive bonding potential between active ingredients and excipients, which can prevent proper dissolution of the tablet needed for an accurate dosage. By the same token, a softer tablet could be a result of weak bonding and may lead to premature disintegration when ingested by the patient. A soft tablet could also chip or break during processing stages in manufacturing, such as coating and packaging.

Knowing the mechanical properties of a solid-dose tablet can provide valuable information for optimising material constituents and the manufacturing process. The types of binders used, the nature of the active ingredient(s) and the composition of the ingredient(s) in the tablet will affect the hardness of the tablet; the tablet press speed, granulation flow and air in the powder can also potentially affect tablet hardness (1). These factors must be controlled during production and verified after manufacture. As the production-to-market timeline

of pharmaceutical products becomes tighter, it is essential to efficiently and effectively quantify the critical properties that will affect product development and performance.

Methods for measuring the mechanical strength of a tablet include crushing, fracturing and bending tests (2).

Crush testThe crush test is usually performed on a round tablet standing on its rim or for a capsule-like tablet, parallel to the longest axis. This test is sometimes known as a diametrical compression test. The test sample is placed on a base table and compressed against a flat surface cylindrical probe as shown in Figure 1 (CT3 Analyser, Brookfield Engineering). The cylindrical probe surface, which is larger than the test sample, is moved down to crush the tablet at a constant speed, and the force applied to crush the tablet is measured (see Figure 2). The load-force values obtained will depend on the construction and size of the tablet. Figure 3 shows a typical plot of force load (g) vs. time (s) as the test progresses (TexturePro CT software program, Brookfield Engineering). The highest point on the graph, peak load, is the load required by the analyser to break the tablet. This point also indicates the tablet’s maximum

Figure 1: Crush test on tablet (CT3

Analyser, Brookfield Engineering).

Figure 2: Cylinder probe fractures

tablet in crush test (CT3 Analyser,

Brookfield Engineering).



Peer-reviewed

*Adrijana Torbovska is an analyst in the Quality Control

Department of ReplekPharm, Kozle 188, 1000 Skopje, Macedonia,

[email protected]. Suzana Trajkovic-Jolevska,

Phd, is a professor in the Drug Quality Control Department,

Faculty of Pharmacy, Ss Cyril and Methodius University,

Skopje, Macedonia.

* To whom all correspondence should be addressed.

Submitted 9 Nov., 2012; Accepted 5 Dec., 2012.

Methods for Identifying Out-of-TrendResults in Ongoing Stability DataAdrijana Torbovska and Suzana Trajkovic-Jolevska

it is important to distinguish between out-of- specification (OOS) and out-of-trend (OOT) results in stability studies. The authors discuss three methods for identification of OOT results—the regression-control-chart method, the by-time-point method and the slope-control-chart method—and further compare the z-score method and the tolerance interval in OOT analysis. The results highlight the need for issuing a regulatory confirmed guideline for identification of OOT results for ongoing stability data.

The two terms out-of-trend (OOT) and out-of speci-fication (OOS) results are in many cases confused

by pharmaceutical companies and regulatory agencies. OOT results are defined as a stability result that does not follow the expected trend, either in comparison with other stability batches or with respect to previous results collected during a stabil it y study (1). OOT results are not necessarily OOS, but they do not look like a typical data point. Although OOT results are a serious problem, the scientific literature and regulatory guidelines do not fully address this issue.

According to the US Food and Drug Admininstration’s Guidance for Industry: Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production (2), OOT results should be limited and scientifically justified. The guideline, however, does not define the process for identification of OOT results in stability data. The CMC Statistics and Stability Expert Teams of the Pharmaceutical Research and Manufacturers of America made an attempt to address this problem by suggesting several statistical methods for the identification of OOT results (3). The proposed statistical methods were redesigned and analysed for the purposes of this study.

The aim of this study was to make a stat ist ical confirmation of the statistical methods, which will prove their functionality in identification of OOT results in ongoing stability data within a batch or data among batches. In addition, a comparison was made between the z-score method and the tolerance interval (TI) in terms of defining the limits for identification of the present OOT result.

Materials and methodsFor the purpose of this study, data from ongoing stability studies of a final drug product with a shelf life of 36 months were used. The ongoing studies were conducted on 10 batches of Product X. Product X is manufactured in a tablet dosage form and consisted of one active substance with defined strength of 10 mg and packaged in a primary aluminium–polyvinyl chloride (Al–PVC) blister and a secondary package. The ongoing studies were conducted for 36 months in stability chambers at a constant temperature of 25 °C ± 2 °C and relative humidity of 60% ± 5% in accordance with the ICH guideline Q1A(R2) (4).

CiTATiON: When referring to this article, please cite it as A. Torbovska

and S. Trajkovic-Jolevska, “Methods for Identifying Out-of-Trend Results

in Ongoing Stability Data,” Pharmaceutical Technology 37 (6) (2013).

digital media

DigitaL meDia opportunities

Website – www.PharmTech.com

Key advertising benefits: global platform, brand promotion, targeted audience, and timely exposure.

The PharmTech.com website features easy-to-use navigation, a powerful search engine and evergrowing exclusive content. Fresh content provided by industry experts and PharmTech’s global team of editors, as well as easy access to our comprehensive archives make PharmTech.com an essential, bookmarked resource.

WHITEPAPER E-LIBRARY

Key advertising benefits: lead generation, global platform, and brand promotion.

Pharmaceutical Technology’s Whitepaper e-Library hosts papers and technical application notes submitted by the industry’s leading solution providers. our audience has a growing need for technical information about new and existing products, applications, and techniques, so the e-Library has become a popular and well-used resource. A lead-generation tool provides all whitepaper campaigns with a method of producing qualified sales leads. For more information, see PharmTech.com/whitepapers.

87% of readers ratewww.PharmTech.com website as excellent or good*

Website Advertising Options

Interstitial Pop-up banner (640 x 480) Peel Down Leadboard (728 x 90)

box (300 x 250) Rectangle (300 x 100) Sponsored Text


targeted aUdience

CAST™

Custom Audience Segmentation Tool - Right Target. Right Media. Right Now. Meet CAST™ the all new, highly targeted, data driven, Custom Audience Segmentation Tool from Advanstar’s Pharmaceutical Sciencegroup. CAST™ contains the most compre-hensive database in the industry with undu-plicated decision makers from global com-panies involved in the pharmaceutical and scientific industries served by our leading publications and conference brands. With CAST™ we can help you…• understand the size and scope of your

potential target markets.• Create new pathways to potential custom-

ers with our customised products.• Direct your marketing messages to highly

targeted global audiences.• Drive qualified website traffic.• Focus your sales efforts on high quality leads.

WEBCAST

Key advertising benefits: lead generation, global platform, brand promotion, content association, demonstrates innovation and audience engagement.

A Pharmaceutical Technology webcast is a moderated, online panel discussion produced as a live or prerecorded event with various options for on-demand playback. The innova-tive interface displays slides, audio, streaming video, and an array of interactive features, including real time polling, chat, and live Q&A to deliver an interactive experience to prospec-tive customers. our editorial staff works with

you to create a panel discussion/presentation that will attract the most relevant audience while demonstrating your expertise in a chosen field. Beyond the benefits of associat-ing your company with thought leadership, innovation, and high quality content, our web-casts feature a powerful lead generation tool allowing you to retrieve qualified leads from a real-time reporting platform that includes con-tact data, demographics, and other bespoke information from your webcast registrants.

All Pharmaceutical Technology webcasts are supported by a proactive, targeted and inte-grated marketing campaign to leverage the ex-tensive reach of Advanstar’s Life Science brands to provide the best possible audience for future sales and marketing efforts. Webcast: audio with slides + unrestricted audience = €15,000.

SPONSORED SURVEY

Pharmaceutical Technology Europe sponsored web-based surveys are a good way to better understand your clients’ business issues. These survey projects include a written report of find-ings and can provide individual data on each survey respondent’s habits and preferences.

Gain Market Insights: Poll customers and prospects to better understand their needs and preferences for your products and ser-vices. You can measure market share, cus-tomer satisfaction, and brand awareness for your company and your competitors.

Advanstar Advantage: Advanstar’s team of professionals works with your company to produce actionable intelligence through these custom surveys. Whether your company is in need of a quick measure of industry perceptions, or a detailed analysis of products and competitive positions, Advanstar custom surveys can provide the answers you need.

newsletters

pt group neWsLetters

Pharmaceutical Technology Europe weekly newsletter, E-AlertKey advertising benefits: brand promotion, targeted audience, timely exposure and direct delivery.The Pharmaceutical Technology Europe weekly newsletter reaches an average of 11,299* professionals, working in the pharmaceutical and biopharmaceutical industry and delivers high open rates by providing regulatory affairs, feature articles, exclusive industry and corporate news, blogs, and sponsored product/event profiles.

Pharmaceutical Technology’sweekly electronic newsletter, ePTMake an impression on more than 20,995** pharmaceutical manufacturing professionals weekly.

The ePT newsletter delivers feature articles, global regulatory initiatives and guidance, company mergers-acquisitions, critical in-formation on recent contract awards, and general news of interest to a highly desired community of pharmaceutical manufac-turing professionals. Subscribers can keep abreast of key industry topics and players. The e-newsletter also includes information on upcoming industry events and webcasts.

PT Sourcing and Managemente-NewsletterPT Sourcing and Management Monthly, Pharmaceutical Technology’s e-newsletter is the authoritative source on sourcing and management issues within the pharmaceutical’s global manufacturing and supply chain.

Deployed to more than 16,184** subscribers each month, PT Sourcing and Management delivers three feature columns and timely analysis of mergers and acquisitions, agreements and contracts, expansions and more.

Equipment & Processing ReportEquipment & Processing Report focuses on pharmaceutical manufacturing process and technology, providing manufacturing and packaging news, related regulatory issues, and current trends.

Deployed to a list of more than 19,891** subscribers, developed in collaboration with InTERPHEx, each month, Equipment & Processing Report showcases processing equipment, manufacturing processes, and upcoming events.

Whitepaper Alert Pharmaceutical Technology’s Whitepaper Alert is a monthly e-mail containing whitepapers arranged by category (Analytics, Manufacturing, outsourcing, etc.) and a brief description of your whitepaper. In order to download your whitepaper, the reader will click on the description, bringing them to a lead generation form, which they must fill out to receive the entire whitepaper. All whitepapers appearing in the Whitepaper Alert will also be featured in the Whitepaper e-Library on www.PharmTech.com.

*Pharmaceutical Technology Europe BPA Worldwide brand report June 2013.**Pharmaceutical Technology BPA Worldwide brand report June 2013.

PHARMACEUTICAL TECHNOLOGY EUROPE 2014 EDITORIAL CALENDAR

Ad Close: 15 January*

februaryAd Close: 12 February*

march

Focus

The Future of Dosage Forms

Special Features and Forums

Formulation Challenges for Biologics

Peer-Reviewed Technical Notes

Statistical Solutions

Analytical Testing for Biologics

API Synthesis & Manufacturing

Custom Manufacturing Outlook

Product Spotlight

Manufacturing and Equipment

Troubleshooting

Solid Dosage

Regulation and Compliance

Regulatory Watch

Inside Standards

GMP Reports

News, Analysis & Commentary

Drug Development Trends

Outsourcing Review

Global Market Report

Conversation and Community

Industry/Pharma Q&A

Ask the Expert

Bonus Distribution

Informex USA (21-24 January, Miami Beach, florida)

Value-Added Marketing

Readex Advertising Study

Focus

Advances in Analytical Testing


Particle Design/Particle Engineering


Product Quality: Biologics

Mitigating Drug Shortages

Packaging Forum


Global API Supply Chain and DCAT Roundup

Product Spotlight

Automation/Process Control/IT

Troubleshooting

Equipment Design and Operation

Regulation And Compliance

Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert

Bonus Distribution

Pharmapack (12-14 Feb., Paris)

Pittcon (2-6 March, Chicago)

BIO-Europe Spring (10-12 March, Turin Italy)


E-news Profile & Printed Product Release

Focus

Optimising Solid Dosage Manufacturing


Nanotechnology


Investigations/Root Causes

Visual Inspection Techniques

Analytica 2014 Preview


The Next Frontier in Chiral Chemistry

Product Spotlight

Analytical Instruments

Troubleshooting

Biopharmaceutical Manufacturing


Regulatory Watch

Inside Standards,

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert

Bonus Distribution

INTERPHEX (18-20 March, New York)

Analytica (1-4 April, Munich, Germany)

PDA Annual Meeting (7-8 April, San Antonio, Texas)


1/3 Page Product/Service Profile

Ad Close: 11 December*

january

Ad Close: 12 March*

april

Focus

Trends in Biopharmaceutical Manufacturing


Encapsulation Technologies


Process Validation

Combination Products


High-Potency Manufacturing

Product Spotlight


Troubleshooting

Aseptic Processing/ Sterile Manufacturing


Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert



Focus

Quality by Design (QbD) in Lyophilisation


Extractables and Leachables


Quality Metrics

Data Management in Manufacturing


Polymorphism and Crystallisation Cry

Product Spotlight


Troubleshooting

Equipment Design and Operation (INTERPHEX Wrap-up)


Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert

Bonus Distribution

Interpack (8-14 May, Dusseldorf, Germany)


1/4 Page Product Profile (full page advertisers only)

Focus

Advances in Controlled-Release Drug Delivery



Statistical Solutions

Process Analytical Technology (PAT)

Packaging Forum


Catalysis in API Manufacturing

Product Spotlight


Troubleshooting

Aseptic Processing/Sterile Manufacturing


Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert



Ad Close: 16 April*

mayAd Close: 14 May*

june


eDiTOrial SubmiSSiOnS anD DeaDlineS**Pharmaceutical Technology Europe welcomes article pitches and abstracts for regulatory, technical, and peer-reviewed articles throughout the year. Submit your inquiry four months prior to publiation date. Contact Rita Peters, editorial director, ([email protected]) to submit or for futher information.

Focus

Quality by Design (QbD) in API Manufacturing


Orally Inhaled and Nasal Drug Products


Product Quality: Sterile Manufacturing/ Aseptic Processing

Modular/Flexible Manufacturing


Asymmetric Synthesis

Product Spotlight


Troubleshooting

Solid Dosage


Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert

Bonus Distribution

CPhI Worldwide/ICSE/P-Mec (7-9 October, Paris)

TechnoPharm/POWTECH (30 September - 2 October, Nuremberg Germany)

PDA FDA Joint Regulatory Conference (TBD)


1/2 Page CPhI/ICSE/P-Mec Exhibitor Profile

Focus

Equipment and Manufacturing Trends



GMP Regulatory Trends

Equipment Cleaning


Process Intensification/

Continuous Flow Manufacturing

Product Spotlight

Laboratory Equipment

Troubleshooting



Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert

Bonus Distribution

Controlled Release Society (13-16 July, Chicago)


Full Page Product/Service Profile with E-news Profile & Printed Product Release (full page advertisers only)

Special 25th Anniversary Issue

A retrospective of the last 25 years in drug development and a look ahead to the next quarter-century.

Focus

Big Pharma Manufacturing Investment Update


Solubility/Bioavailability Enhancement


Risk Assessment and Mitigation

Securing the Supply Chain/ Anticounterfeiting Technologies



Product Spotlight


Troubleshooting



Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert


Free 25th Anniversary Full Page Profile

Readex Advertising Study

e-News Product/Service Profile

Ad Close: 11 June*

julyAd Close: 16 July*

auguSTAd Close: 13 August*

SepTember


Editorial content may change at the discretion of the editor.*Advertising deadlines may be subject to change.** Receipt of an article or abstract does not guarantee inclusion in a particular issue of the magazine or on www.PharmTech.com


Focus

Quality by Design for Parenteral Drugs


Specialty Dosage Formulation/Delivery


CAPA: Corrective and Preventive Action

Continuous Solid Dosage Manufacturing


Heterocyclic Chemistry in API Manufacturing

Product Spotlight

Aseptic Processing Equipment

Troubleshooting



Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert


Full Page Thought Leader Profile or published white paper

Focus

Single-Use Technologies



Executive Insights: Managing Quality

Next Generation of Pharmaceutical Sciences


API Review and Outlook

Product Spotlight


Troubleshooting

Solid Dosage


Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert


Full Page Corporate Profile

Focus

Bioavailability Enhancements/Solubilisation Strategies


High Potency Drug Formulation


Quality Systems: A Global Perspective

The Future of Personalised Medicine

Packaging Forum


Fluorination Chemistry in API Manufacturing

Product Spotlight


Troubleshooting

Aseptic Processing/Sterile Manufacturing


Regulatory Watch

Inside Standards

GMP Reports



Outsourcing Review



Industry/Pharma Q&A

Ask the Expert

Bonus Distribution

AAPS (2-6 November, San Diego, California)

Lab Innovations (TBD, Birmingham, UK)

CPhI Worldwide/ICSE/P-Mec (7-9 October, Paris)


Free white paper in Online Library and eNewsletter

Ad Close: 10 September*

OcTOberAd Close: 15 October*

nOvemberAd Close: 12 November*

December

1x 3x 6x 9x 12x 24x

full page 7,500 6,955 6,580 6,430 6,130 5,980

2/3 page 6,730 6,060 5,720 5,385 5,050 4,700

1/2 page 5,230 4,710 4,450 4,200 3,925 3,665

1/3 page 4,100 3,700 3,495 3,300 3,080 2,880

1/4 page 3,370 3,030 2,865 2,695 2,530 2,360

Pte groUP ad siZes For all print products. Keep live matter 10 mm from all sides

non-BLeeD BLeeD trim siZe non-BLeeD BLeeD trim siZe

two page spread 368 x 241 400 x 273 394 x 267 1/2 page horizontal 171 x 117 203 x 137 197 x 133

full page 171 x 241 203 x 273 197 x 267 1/3 page vertical 54 x 241 73 x 273 70 x 267

2/3 page 114 x 241 133 x 273 130 x 267 1/3 square 114 x 117 133 x 137 130 x 133

1/2 island 114 x 178 133 x 197 130 x 194 1/4 page 86 x 117 105 x 137 102 x 133

1/2 page vertical 86 x 241 105 x 273 102 x 267

6 months 12 months

super maxi Box 5,040 6,720

maxi Box 4,115 5,430

maxi Box 2,965 3,950

full page 5,245

1/2 page 3,410

1/4 page 2,360

up to 20g

< 5000 (rate per ‘000) 800

> 5000 (rate per ‘000) 690

full Circulation (rate per ‘000) 450

outside Back Cover 1,000

inside front Cover 900

inside Back Cover 700

preferred position 600

Double page spread 12,000

Bellyband** 9,500

tip-on** 9,000

€ euro priCing 2014print

DISPLAY POSITIONS (4 COLOUR) (€)

PREMIUM DISPLAY POSITIONS* (€) SPECIAL DISPLAY POSITIONS* (€)

CLASSIFIED POSITIONS* (€) RECRUITMENT POSITIONS (€) MAGAZINE INSERTS (€)

Rates and sizes correct at time of going to press.*Premium and Special Position charges are in addition to the published print rates for Colour Display Advertising.** Includes production and printing

ad sPecs

1x 3x 6x 9x 12x 24x

full page 10,500 9,737 9,212 9,002 8,582 8,372

2/3 page 9,422 8,484 8,008 7,539 7,070 6,580

1/2 page 7,322 6,594 6,230 5,880 5,495 5,131

1/3 page 5,740 5,180 4,893 4,620 4,312 4,032

1/4 page 4,718 4,242 4,011 3,773 3,542 3,304

Pte groUP ad siZes For all print products. Keep live matter 10 mm from all sides

non-BLeeD BLeeD trim siZe non-BLeeD BLeeD trim siZe

two page spread 368 x 241 400 x 273 394 x 267 1/2 page horizontal 171 x 117 203 x 137 197 x 133

full page 171 x 241 203 x 273 197 x 267 1/3 page vertical 54 x 241 73 x 273 70 x 267

2/3 page 114 x 241 133 x 273 130 x 267 1/3 square 114 x 117 133 x 137 130 x 133

1/2 island 114 x 178 133 x 197 130 x 194 1/4 page 86 x 117 105 x 137 102 x 133

1/2 page vertical 86 x 241 105 x 273 102 x 267

6 months 12 months

super maxi Box 7,056 9,408

maxi Box 5,761 7,602

maxi Box 4,151 5,530

full page 7,343

1/2 page 4,774

1/4 page 3,304

up to 20g

< 5000 (rate per ‘000) 1,120

> 5000 (rate per ‘000) 966

full Circulation (rate per ‘000) 630

outside Back Cover 1,400

inside front Cover 1,260

inside Back Cover 980

preferred position 840

Double page spread 16,800

Bellyband** 13,300

tip-on** 12,600

$ usD priCing 2014print

DISPLAY POSITIONS (4 COLOR) ($)

PREMIUM DISPLAY POSITIONS* ($) SPECIAL DISPLAY POSITIONS* ($)

CLASSIFIED POSITIONS* ($) RECRUITMENT POSITIONS ($) MAGAZINE INSERTS ($)

Rates and sizes correct at time of going to press.*Premium and Special Position charges are in addition to the published print rates for Color Display Advertising.** Includes production and printing

ad sPecs

2014 online RATeSProduct Type 2012 Monthly Rate DetailsWEBSITEHome Page/Other Site Pages MONTHLY

640x480 (Interstitial) $5,500 • €4068 Exclusive728x90 (Leaderboard) $2,600 • €1914 (Up to 5 advertisers rotate)300x250 (Box) $2,600 • €1914 (Up to 5 advertisers rotate)300x100 (Rectangle) $1,600 • €1178 (Up to 5 advertisers rotate)960x45 (Footer) $3,500 • €2579 ExclusiveSponsored Link $700 • €516Page Peel $4,500 • €3316 ExclusivePage Push $4,500 • €3316 Exclusive

Section/Blog/Column Sponsorships Logo $1,250 • €921300x100 $1,250 • €921728x90 $1,500 • €1105300x250 $1,500 • €1105Sponsor Posts (must be part of Blog ad buy) $1,250 • €921

NEWSLETTERePT (4x monthly) rates are per week468x60 $750 • €553 per week160x600 $800 • €590 per weekText - 65 words $800 • €590 per weekButton 220x75 $350 • €258 per weekSourcing and Management (1x monthly) Monthly650x90 (Top position) $2,000 • €1483468x60 $1,500 • €1107160x600 $1,600 • €1180Text - 65 words $1,375 • €1014Button 220x75 $850 • €627300x250 $1,600 • €1180ePR (1x monthly) Monthly468x60 $1,500 • €1107120x240 $1,300 • €959160x600 $1,400 • €1037Text - 65 words $1,375 • €1014Button 220x75 $850 • €627Showcase $750 • €553PTE eAlert (4 x monthly) Per week rates per mailingLeaderboard $1,500 • €1107Skyscraper $1,200 • €885Headline Banner $1,100 • €812Footer Banner $1000 • €741Featured Products/Profile $850 • €627

Lead Generation Whitepaper Alert-(1x Month) MonthlyFeatured WP / WP Library $1,800 • €1328Whitepaper/ WP Library $750 • €553468x60 $1,600 • €1180160x600 $1,600 • €1180eSolution Broadcast $3,500 • €2582 For 5,000 Selects

CUSTOM DIGITAL PRODUCTS Custom Quotes AvailableMicrosite, Newsletter, Digital Magazine

DIGITAL EDITIONButton/Banner Sponsorship (ROS) $1,050 • €775Ad-Jolt $1,050 • €775Ad Gen $1,050 • €775Gatefold $1,575 • €1162Bellyband $1,575 • €1162Insert Cards $1,575 • €1162Tabs $1,575 • €1162Video $1,840 • €1358

WEBCASTLive audio w/ slides, Live video from studio $17,000 • €12542

PODCASTS Minimum 3 $3,800 • €28044 to 7 $6,900 • €50918 to 11 $9,975 • €7360

WEB VIDEOS - “Pharm Tech TV”Sole Sponsored $13,000 • €9591 ExclusiveMulti Sponsored $3,000 • €2213

www.advanstar.com

Advanstar Communications (UK) LtdBridgegate Pavilion, Chester Business Park,Wrexham Road, Chester, CH4 9QH, UKTel: +44 (0)1244 629 300 Fax: +44 (0)1244 659 321

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Michael TraceyPublishertel. 732.346.3027 [email protected]

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Irene OnestoMid-West Sales Managertel. [email protected]

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