Serving the Biopharmaceutical development and...

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Serving the Biopharmaceutical development and manufacturing industry since 1988

BioPharmInternational.com

The Science & Business of Biopharmaceuticals

BioPharm International delivers a return on your advertising investment with high quality sales leads…

Purchase Intelligence Sales Lead Reports: print advertisers receive hard copy and electronic format reports listing individual buyers of their specific equipment or service, including each buyers demographic and contact information.

e-Application Note alert: your application note and description is blasted to BioPharm International’s audience. The electronic form used to request your application note which contains the individual’s name, company, demographic and contact information is sent to you in real time, as a sales lead.

Whitepaper Library: list your white papers on BioPharm International’s website. The electronic form used to request your white papers contains the individual’s name, company, demographic and contact information is sent to you in real time, as a sales lead.

Web site advertising: smart advertising and survey advertising is available for lead generation.

e-Solutions Broadcast (e-blast): the electronic form used to request information on your products and services contains the individual’s name, company, demographic and contact information is sent to you in real time, as a sales lead.

Webcasts: standard online reports include; registrant information, event attendance data & audience interactivity data, Q&A functionality, and audience polling.

Podcasts: sales lead generation links are available.

Branding

BioPharm InternationalBioPharm International integrates the science and business of biopharmaceutical research, development, and manufacturing. The magazine provides peer-reviewed technical solutions to enable business professionals to confront work challenges more effectively.

BioPharm International is the longest-running peer-reviewed publication serving an audited global audience of 30,245** BPA-qualified professionals involved in the development and manufacturing of therapeutics and the management of related business issues. With one of the largest US circulations in the biopharmaceutical market, BioPharm International reaches a large universe of leading biotech companies and pharmaceutical companies with a biotech focus, giving solution providers direct access to the core purchasing power of the biopharmaceutical industry.

The Industry at-a-Glance*

The biotech market is in a stronger growth mode than its traditional pharma counterpart. It has produced more than 200 prescription products, hundreds of diagnostics tools and tests and also has more than 400 candidates in clinical trials.

Biotechnology drugs comprise the fastest-growing sector in drug development, and they are expected to account for more than 50 percent of all new product approvals by 2015 and 71 percent by 2025.

*Source: Michael Harris, “The Billion-Plus Blockbusters: The Top 25 Biotech Drugs.” BioWorld Today, Aug. 27, 2009. http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51907

**Source: June 2009 BPA Statement

BioPharmINTERNATIONAL


FORMULATION

Opalescence in MAbs

A study of the effects of

ionic strength and excipients 36

QUALITY CONTROL

Best Practices

in Deviation ManagementFollow a risk-based approach

to maintain a state of control 48

BIODEFENSE VACCINES

How to Maximize

Funding SuccessAlternative sources that

spin-off companies can tap into 54

REGULATORY BEATThe White House provides

more resources to the FDA 18

PERSPECTIVES ON OUTSOURCING

A systematic approach will

improve supplier selection 22

EXPRESSION SYSTEMSAre new technologies

worth the cost? 26

DISPOSABLES ADVISORA cost model for evaluating

single-use systems 28

BURRILL ON BIOTECHBig biotechs continue

to grow amid crisis 34

Final Word: industry inches Toward a digital Environment 66

april 2009

Volume 22 number 4

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www.biopharminternational.com

Schedule on pp. 16–17




FORMULATION

Best Practices for

Foolproof Formulation

How to maintain product stability

and prevent particulates 32

PROCESS DEVELOPMENT

Fluorescence-Based

Sensing Technology

A probe-free system monitors

accurately at very small scale 50

FROm the editORFDA’s 2010 budget:

The ups and downs 10

ReGULAtORY BeAtFDA spruces up safety and

quality efforts 16

OUtSOURCiNG iNSiGhtS

UK-based CMOs seek

opportunities in new markets 20

the diSPOSABLeS AdViSOR

What end users think about

single-use systems 22

eXPReSSiON SYStemSNew expression systems

compete for attention 26

FiNAL WORdModern bioassays enable

more accurate potency testing 66

GLOBAL NEWS: New Coalition Attacks Supply Chain Risks 12

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June 2009

Volume 22 Number 6



May 2009

Final Word: Why Facility Validation Must be revamped 74

Volume 22 number 5

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PROCESS MONITORING

The Benefits of

Statistical Tools Enhance your control strategy

with robust monitoring methods 26

OPERATIONAL EXCELLENCE

Overall Equipment

Effectiveness How to optimize facility utilization

and improve plant performance 40

QUALITY BY DESIGN

Is QbD the Roadmap

for Future Success?

A discussion of the pros and

cons of QbD implementation 52

OUTSOURCING

Best Practices for

OutsourcingHow to build a successful

CRO–client partnership 60

REGULATORY BEATFederal funding spurs comparative

effectiveness research 18

OUTSOURCING INSIGHTS

Service providers shift their

focus to value and performance 20

COMPLIANCE NOTESUse Lean techniques to improve

manufacturing compliance 24 Schedule on pp. 16–17



CELL LINE ENGINEERING

An Effective Way to

Ensure Consistent

Protein Expression

A proven method for targeted

integration of transgenes 32

PROCESS DEVELOPMENT

Pursuit of the Perfect

Growth Medium Maximize plasmid DNA output

in a high-cell-density culture 40

BIOSIMILARS

Who Will Win the

Biosimilars Debate?

Tug-of-war continues between

generics and innovator industries 46

REGULATORY BEATFDA launches a risk mitigation

program for safe use of opioids 16

PERSPECTIVES ON OUTSOURCING

Pfizer’s strategy for analytical

development and testing 18

COMPLIANCE NOTESLeverage technology to implement

strategic quality management 23

BURRILL ON BIOTECHNew financing and partnering

deals offer hope for an upswing 28

July 2009

FINAL WORD: Three Key Steps for Managing Supply Chains 58

Volume 22 Number 7

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The Bottom Line:

The continued growth of the biopharmaceutical sector will ensure increasing demand and new opportunities for your solutions.

Circulation

Reach 30,245* Subscribers!

BioPharm International delivers a targeted audience of professionals involved in all stages of the development and manufacture of biopharmaceutical therapeutics and diagnostics.**

** Source: Publisher’s Own Data *BPA June 2008 Statement

0 5 10 15 20 25

Materials Management, Purchasing, Procurement 0.9%

Business Advisor 1.9%

Plant Engineering, Facility Design 3.1%

Regulatory Affairs, Clinical Affairs 3.6%

Project Management 5.6%

Lab Management 6.9%

Technology Transfer, Technical Services, Analytical Development, Support 5.8%

Corporate Management 9.0%

Process Development 10.1%

Quality Assurance, Control, Validation 13.5%

Production, Manufacturing 15.2%

Research, Development 24.4%

Primary Job Function*

Biopharmaceutical, Biologics, Biodiagnostic Process Development 6.3%

Biotechnology, Biopharmaceutical Research 9.1%

Research Institutes, Universities, Colleges 8.8%

Contract Research, Analytical Services 4.9%

Biotherapeutic Discovery, Development, Transgenic Therapeutic Productions 1.9%Biodiagnostic Manufacturing 3.1%

Classical Pharmaceutical Manufacturing 25.6%

Biopharmaceutical, Biologics Manufacturing 28.4%

Biopharmaceutical Formulation, Delivery 1.7%

Specialty or Bulk Chemical Manufacturing, Bulk Products and Raw Materials Producers 3.7%Architecture, Engineering, Construction 2.3%Business, Investment, Legal Services 1.9%Government 2.3%

Business and Industry*

Circulation

Top Biotech Companies* # of SubscribersAmgen Inc. 389

Genentech Inc 197

Genzyme 162

Biogen Idec 76

Medimmune Inc 70

Cephalon Inc 63

Gilead Sciences Corp 54

Imclone Systems 51

CSL Ltd 34

Celgene Corp 27

Elan Corp 21

Millenium Pharmaceuticals Inc 20

Chiron Corp (acquired by Novartis) 9

Serono SA 6

Actelion Ltd 6

* Source: Publisher’s Own Data

Top Pharmaceutical Companies* # of SubscribersWyeth 668

Pfizer 587

Merck & Company Inc. 436

Bristol-Myers Squibb 372

GlaxoSmithKline 369

Eli Lilly 328

Schering-Plough 324

Sanofi-Aventis 309

Novartis 268

Astrazeneca 172

Boehringer Ingelheim Pharma 140

Watson Laboratories 104

Teva Pharmaceuticals 100

Sandoz Pharma Group 53

Forest Pharma Co 49

Mylan 38

Tap Pharma 15

Readership

Our Readers Depend on BioPharm International as a Trusted Resource*

In today’s world, biopharmaceutical professionals may only spend a brief amount of time with the publications they receive…this is not the case with BioPharm International readers

1 hour and 9 minutes*…That’s the time that » BioPharm International readers dedicated to reading a typical issue

72% of respondents agree that » BioPharm International delivers information that is useful to them

Going Beyond Our Reader’s Desktop – Our readers share »their copy with an average of 2 colleagues.*

Our readers look to us for comprehensive coverage in the following areas:

Analytical Method Development and Validation

Biochemicals

Biopharmaceutical Development & Scale Up

Business Services & Training

Chemicals

Compliance & Validation

Computer Systems/IT

Contamination Control

Contract Consulting

Controlled Environments

Chromatography

Disposables

Downstream Processing

Engineering

Facility Design & Expansion

Fermentation & Cell Culture

Filtration

Formulation, Fill & Finish

GMPs

Intellectual Property

Laboratory Products & Equipment

Licensing & Partnership

Operations Excellence

Outsourcing

Pharmaceutical Services

Processing Equipment

Manufacturing Methods and Systems

Protein Expression

Quality Control/Quality Assurance

Raw Materials

Regulatory Compliance

Risk Management

Scale Up

Separation/Purification

Stability Testing

Supply Chain Management

Technology Transfer

Transgenics

Upstream Processing

Vaccines

Validation

Source: *2009 Readership Study Conducted by Advanstar Research Services

Readership

The biopharmaceutical industry’s 1st choice*

BioPharm International ranked #1 among the following publications*

BioPharm International . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96.2%

BioProcess International . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41.7%

Genetic Engineering News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17.4%

Contract Pharma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.0%

BioPharm International ranked #1 if respondents could read only one magazine*

BioPharm International . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67.9%

Genetic Engineering News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15.0%

BioProcess International . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.8%

Contract Pharma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.2%

75%* of our readers rated BioPharm International the top publication for being a source of authoritative information they can trust and

rely on, offering in depth coverage of the biopharmaceutical industry.

86%* of our readers say that trade publications are the tool they use most frequently to keep up-to date in their industry.


Electronic Advertising

e-Solution Broadcast: You provide the message; we deliver it to the right audience.* e-Blast

Your customized HTML and text formatted message including live hyperlinks, company logo, designated image, description and contact information delivered to the industry’s most highly desired audience under the brand name of BioPharm International. Your message will be embedded into BioPharm International’s e-solution template and will be deployed to selects you have chosen from our subscriber base.

Biopharminternational.com…Log On!*

BioPharmInternationl.com features an easy-to-use navigation with content available by targeted category, keyword search, or by issue. In addition, easy access to columns such as Jill Wechsler’s Regulatory Beat, the BioPharmNow Podcast Series, Web Seminars, White Paper e-library, and other site features efficiently provide our viewers with the tools they need. All of the above, plus regular fresh content, makes BioPharmInternational.com the most comprehensive industry information source on the web. Enjoy extensive visibility on the site that reaches the universe of leading biotech companies and pharmaceutical companies with a biotech focus.

Drive Qualified Leads from BioPharm’s Whitepaper e-Library*

BioPharm International’s whitepaper e-Library is a feature of BioPharm’s content-rich website, www.BioPharmInternational.com, hosting white pa-pers and technical application notes submitted by the industry’s leading solution providers. Our audience is always looking for technical informa-tion about new and existing products, applications and techniques. This is the ideal place to find them.

BioPharm International’s Science and Business e-Bulletin* Monthly e-Newsletter

BioPharm International’s Science and Business e-Bulletin is delivered monthly to approximately 45,500 industry professionals’ inboxes. This electronic addition complements the in-depth features of our print publication, and provides insights about technology and regulatory issues and the latest company changes.

Feature Sections Include:• News• Deals & Alliances• People Moves

• Products• Conference Calendar & Coverage


Electronic Advertising

e-Application Note Alert*

BioPharm International’s e-Application Note Alert is a monthly e-mail con-taining application notes categorized by technique and a brief description of your application note. Readers will click on your application note de-scription, bringing them to a lead generation form which they must fill out to receive the entire application note.

BioPharm International’s Digital Magazine*

BioPharm International’s digital edition makes it possible for professionals involved in the biopharmaceutical science and business to access credible information from the leading authoritative source across the globe. To complement our print edition, we have introduced the digital edition, which is delivered to approximately 45,000 professionals in the US, Europe and the rest of the world. BioPharm International recognizes the global scale of the issues covered in our print edition and the need to access this information in a timely manner. The digital edition is free for subscribers.

Exclusively Sponsored Webcasts*

BioPharm’s webcast program is a moderated online panel discussion conducted as a live event or pre-recorded for on-demand playback (or both) through an interface that can display slides and audio; streaming video; and an array of interactive features like polling, chat and much more. Our webcast platform does not require any software downloads, making it easy for everyone to access these popular broadcasts.

Exclusively Sponsored Podcasts*

We offer you the opportunity to participate in our podcasts as an exclusive sponsor. BioPharm offers a variety of podcasts to provide our audiences with keen insights on current news, new products, applications and important trends. Our editorial staff works with you to customize programming to attract the most relevant listener base and to demonstrate your connection or expertise with the topic(s). Our sponsored podcast program delivers a unique combination of an easily used media format in high demand, flexible lead generation and multiple points of access from our electronic products to your digital assets.

Find Pharma - Navigating the Pharma Universe*

Introducing FindPharma.com, the new search engine that only brings back results from websites relevant to the pharma industry - handpicked by the editors of BioPharm International. This will give our audience access to critical content they need faster than they would receive from a general search engine. And it offers you a way to reach prospects at the moment they may be searching for information relevant to your products and services.


Purchasing Influence

BioPharm International readers are involved in purchasing, recommending, or influencing the purchase of a wide array of products and services.

Biochemicals, Chemicals, Raw Materials*

ChemicalsContract consulting & pharmaceutical servicesReagentsRaw materialsSolvents, detergents & buffersProteins & peptidesBiochemicals & organic raw materialsAntibodies & antigensMedia & seraEnzymesSpecialty or bulk raw materialsViruses & bacteria

Laboratory Products & Equipment*

Analytical laboratory equipmentLaboratory appliancesBiopharm equipmentGlassware & pipettesMeasuring devicesLiquid handling equipment & pumpsCalibration standardsSafety equipmentCleaning equipment, autoclaves & ovensIncubatorsLyophilizersHomogenizersDNA & RNA analysisNuclear & luminescence

instrumentation/accessoriesCombinational chemistry & Hi-

Throughput screening

Biopharmaceutical Development & Scale Up*

ChromatographyPurificationProcess scale-upCGMP productionDown stream processingFormulationFill and finishLyophilizationCell line construction & developmentDrug deliveryClinical trials, packaging & labelingPharmacokineticsBiodiagnostic process developmentCustom synthesisMicroinjection

Engineering Facilities*

Facilities design & constructionEngineering & facilities servicesUtilities & waste management

Contract Consulting & Pharmaceutical Services*

Analytical methods & validation servicesContract laboratoryContract manufacturingBiopharm development & scale-upContract consultingContract researchDrug discovery & lead optimization

Separation & Purification*

Chromatographic equipmentSeparation & purification productsFilters, membranes & air purifiersCentrifuge productsMagnetic sorting systems & particles

Computer Systems/IT*

Software systems & accessoriesData management softwareDocumentation softwareValidation softwareBioprocess control softwareHardware systems & accessoriesBatch control softwareAutomation & roboticsControlled Environments*

Clean room suppliesHoods & ventilationClean room components & designCleaning validation assaysClean room garmentsAir samplers

Fermentation & Cell Culture*

Cell cultureCell culture equipmentFermentation & cell culture productsFermentationCryogenicsPlant transgenics

Business Training Services & Training*

TrainingConsultingRegulatory consultingGeneral business consultantsClinical researchClinical trials managementLegal servicesFunding & financial servicesLogistics analysis


Supplements

JanuaryGuide to Vaccine Development and Manufacturing: Pandemics and BeyondWith the emergence of the H1N1 swine flu, vaccine produc-tion for pandemic response is once again a hot question. This special supplement will analyze how far we have come in our ability to produce vaccines quickly to new infectious threats, including cell culture production, plant-based sys-tems, virus-like particles, and production tools such as dis-posable and modular systems that can facilitate it all. We’ll also examine questions affecting vaccine production more broadly, including the choice of expression systems, in a field where microbial and yeast hosts continue to hold sway, and the pursuit of more platformed systems for a highly variable range of antigens.

FebruaryGuide to BioterminologyThe BioPharm Guide to BioTerminology is back by popular demand! Unlike other sources, this glossary is specific to biopharmaceutical development, manufacturing, and quality control. It covers all the essential terms and acronyms from fields such as chemistry, microbiology, molecular biology, engineering, facility design, cGMPs, regulatory affairs, and biotech patent law that are missing from general dictionaries or scattered in multiple specialist sources. It’s a must-have resource.

MarchAdvances in Separation & Purification: The Future of Downstream ProcessingAs upstream titers continue to improve, companies need solutions to ensure that cell culture gains are not lost in a downstream bottleneck. This supplement will share data on new strategies and disruptive technologies that can stream-line current processes and facilitate productivity. Examples include contaminant precipitation before column chromatog-raphy, cell flocculation to replace centrifuges in harvesting, replacing dilution steps for better process flow, as well as improvements in traditional unit operations like depth filtra-tion, chromatography, and virus filtration.

AprilGuide to Outsourcing in a Changing Biopharma WorldThe world of biopharma is changing, and in the new world order, outsourcing will be king. Small biotechs have always relied heavily on outsourcing, but today, even Big Pharma is changing its mindset. Gone are the days of the FIPCo, the fully integrated pharmaceutical company, and taking its place is a new model, alternately called the virtually integrat-ed pharmaceutical company (VIPCO), or the fully integrated pharmaceutical network (FIPNet) model. This is the guide to navigating that new world, from outsourcing analytical meth-ods to process development to clinical- and commercial-scale manufacturing.

JuneGuide to Fermentation & Cell Culture: The Keys to Upstream ProductivityEnsuring robust productivity while improving yields are critical

goals in fermentation and cell culture. To help manufacturers achieve these, this supplement will offer the latest on optimal approaches to cell line development and stability, media de-velopment (including chemically defined and animal-origin-component free media), high throughput strategies for cell line selection and process development, process monitoring, and Quality by Design for fermentation and cell culture.

AugustStructure, Comparability, and Biosimilars: A Guide to Protein CharacterizationProtein characterization has always been critical for setting product specifications, determining process controls and release tests, and for establishing comparability after scale-up or site changes. Today, the analysis of protein structure has become even more important, given its key role in the debate over what constitutes “similarity” for biosimilar mol-ecules. This supplement will discuss accepted and emerging methods for mapping, sequencing, secondary and tertiary structure, and post-translational modifications (e.g., glycosy-lation and pegylation), and potency/activity assays, including the strengths and weaknesses of the methods and their use in regulatory filings.

September2010–2011 Industry Directory & Trend ReportThe BioPharm International Industry Directory & Trend Re-port is published in both print and digital editions. In addition to reporting on future industry trends, it is a popular annual resource that offers buyers and sellers a comfortable forum in which to meet to conduct business. Manufacturers and developers looking for products, suppliers, and partners to help them produce new drugs find the service providers they need in this directory. The Industry Directory offers a variety of advertising options to fit your specific marketing budget, including display ads, enhanced listings, strategic logo placement and a special section dedicated to applica-tion notes.

OctoberThe Evolution of Vaccines The dynamic field of vaccines continues to evolve. Long-for-gotten infectious diseases are once again serious prospects for new vaccines, and at the same time, companies con-tinue their hot pursuit of therapeutic vaccines. Adjuvant de-velopment is advancing along with delivery techniques, and manufacturers continue to optimize formulations, stabiliza-tion techniques, characterization methods, and purification strategies. This supplement will examine this evolution and explore the future of vaccine development.

NovemberGuide to Implementing Single-use TechnologiesNow in its fifth year, this supplement will guide readers through the implementation of single-use technologies, from evaluations of specific technologies for various unit opera-tions, to scale-up, validation, and implementation strategies for hybrid plants. We’ll also cover key questions such as lifecycle cost assessments, the analysis of extractables and leachables, disposal strategies, and integration, emphasiz-ing user experiences.

A Two-Column PlatformOptions Without Protein AFacility FitEconomic Drivers Future Technologies



INTERNATIONAL

March 2009

Advances in Separation & Purification:

Purifying High Titers

BioPharmSupplement to:

BioPharmwww.biopharminternational.com

INTERNATIONAL

Guide toOutsourcing

April 2009

Supplement to:



Biochemicals & Organic Raw Materials

Contract Consulting & Pharmaceutical Services


Engineering & Facilities


Information Technology


Manufacturing Systems

Separation & Purification


Largest Directory Dedicated to the Biopharmaceutical Industry

Supplement to:

September 2009

Bio

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Intern

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irectory &

Trend

Rep

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00

9 &

2010

&Industry Directory

Trend Report

BioPharmOctober 2008 The Science & Business of Biopharmaceuticals

INTERNATIONALSupplement to:


Cover Lines?

ADVANSTAR★ COMMUNICATIONS

BioPharmINTERNATIONALSupplement to:

November 2008 www.biopharminternational.com

Supplement to:

BioPharmAccelerated Media Development

Improving Cell Culture Through Metabolomics

Antibody Fragment Production in Microbial Fermentation

Managing Cell Line Instability



INTERNATIONAL

June 2009

Advances in Protein Production

Supplement to:

Regulatory Beat—Monthly

Jill Wechsler is a veteran editor based in Washington, DC, where she keeps a close eye on important developments related to biotechmanufacturing and research. She gathers first-hand information about issues discussed and decisions made on Capitol Hill, at FDA, and at other US government agencies whose policies affect the biopharmaceutical indus-

try. This direct access allows her to report to BioPharm readers every month on significant regulatory decisions, policy developments, and trends.

Outsourcing Insights—Bimonthly (February, April, June, August, October, December)

Jim Miller, president of PharmSource, offers his keen analy-sis of outsourcing trends and strategies for a wide range of biopharmaceutical operations including research, develop-ment, manufacturing, clinical trials, and IT support. He eval-uates the moves of the big players and the small, deciphering the reasons behind the changes and their implications for

outsourcing providers and biopharmaceutical companies alike.

Perspectives on Outsourcing—Bimonthly (January, March, May, July, September, November)

As a complement to Jim Miller’s analysis, this guest column offers a va-riety of viewpoints and practical, hands-on information for handling out-sourcing decision-making and processes such as technology transfer, contract negotiation, conflict resolution, project management, auditing providers, and outsourcing abroad.

The Disposables Advisor—Bimonthly (February, April, June, August, October, December)

As the industry’s adoption of single-use manufacturing tech-nologies increases, users have questions—about validation, cost, environmental impact, regulatory requirements, and more. The Disposables Advisor is here to help! Andrew Sin-clair and Miriam Monge of Biopharm Services UK draw on their experience helping companies implement disposable systems, their ongoing conversations with end-users about their reactions to new technologies, and discussions in the ISPE community of practice for disposables—where Miriam is the European chair—to answer questions, offer guidance, and provide examples of what others have learned from their experiences implementing disposables.

Compliance Notes—Bimonthly (January, March, May, July, September, November)

Conrad Heilman and Joe Villafranca, along with other senior experts from Tunnell Consulting, rely on their extensive in-dustry experience to provide timely compliance advice. Their expert recommendations will help biotech manufacturers avoid unexpected compliance pitfalls and prepare for FDA inspections. They also offer insight into how to apply devel-

oping concepts such as Quality by Design and Design Space, and help readers decipher new guidance documents such as ICH Q10. It’s a col-umn not to be missed.

Downstream Processing Trends—Bimonthly (February, April, June, August, October, December)

In this new column, Eric Langer examines the trends in downstream processing that are revealed from his annual Report and Survey of Biopharmaceutical Manufacturing Ca-pacity and Production and from discussions with people who represent a cross-section of the industry.

Burrill on Biotech—Quarterly (January, April, July, October)

When you want to know how the industry is performing, you turn to Steven Burrill. In this quarterly column, the renowned industry expert and venture capitalist charts the course of the biotechnology industry by drawing on business metrics and the Burrill Biotechnology Indices to provide readers with an ongoing evaluation of the health of this evolving sector.

He assesses the trends in venture capital, M&As, and the overall partner-ing environment, and looks ahead to the future.

Final Word—Monthly

In this guest opinion piece, readers, industry leaders, consultants, and regulators share their views about what is going on in biotech. They tell us what should be done about the things that dismay them, how we can draw inspiration from best, where the industry should head, and the de-tours to be avoided along the way. It’s where the diverse voices in biotech can be heard, for agreement or dissent.

Columns

Editorial Calendar

JanuaryAd Close: December 12 Material Due: December 16

Editorial Theme: Downstream Processing

Monthly Columns:Regulatory Beat »Perspectives on Outsourcing »Final Word »

Bimonthly Columns: Compliance Notes

Quarterly Columns: Burrill on Biotech

Supplement: Guide to Vaccine Development & Manufacturing: Pandemics and Beyond




Special Content: 4th Annual Salary Survey

Podcast Focus: Employment Trends

Newsletter Focus: Employment Trends

Product & Services Spotlight: Disposables

Added Value:Purchase Intelligence »Sales Lead ReportAdvertising cost includes both »print and digital editions

»

FebruaryAd Close: January 9 Material Due: January 13

Editorial Theme: Outsourcing

Monthly Columns:Regulatory Beat »Outsourcing Insights »Final Word »

Bimonthly Columns:Disposables Advisor »Downstream Trends »

Supplement: Guide to Bioterminology

August 2006 www.biopharminternational.com

Supplement to:

ADVANSTAR� COMMUNICATIONS

Podcast Focus: Quality by Design

Newsletter Focus: Quality by Design

Product & Services Spotlight: Separation & Purification

Added Value:Filtration/Purification User Survey »4/C/Release/Web Page Showcase »Advertising cost includes both »print and digital editions

Bonus Distribution:PITTCON Tradeshow Package »

MarchAd Close: February 6 Material Due: February 10

Editorial Theme: Upstream Processing



Supplement: Advances in Separation & Purification: The Future of Downstream Processing

A Two-Column PlatformOptions Without Protein AFacility FitEconomic Drivers Future Technologies



INTERNATIONAL

March 2009

Advances in Separation & Purification:

Purifying High Titers

BioPharmSupplement to:

Podcast Focus: Assessing the realities of the downstream bottleneck

Newsletter Focus: Assessing the realities of the downstream bottleneck

Product & Services Spotlight: Outsourced Services

Added Value:Purchase Intelligence »Sales Lead Report4/C/Release/Web Page Showcase »Advertising cost includes both »print and digital editions

Bonus Distribution:BIO Europe »

AprilAd Close: March 6 Material Due: March 10

Editorial Theme: Quality




Supplement: Guide to Outsourcing in a Changing Biopharma World


INTERNATIONAL

Guide toOutsourcing

April 2009

Supplement to:

Podcast Focus: Current trends in outsourcing

Newsletter Focus: Current trends in outsourcing

Product & Services Spotlight: Fermentation & Cell Culture

Added Value:4/C Release/Web Page Showcase »Advertising cost includes both »print and digital editions

Bonus Distribution:INTERPHEX Tradeshow Package »PDA Annual Meeting »

MayAd Close: April 10 Material Due: April 14



The Science & Business of BiopharmaceuticalsMay 2009

Final Word: Why Facility Validation Must be revamped 74

Volume 22 number 5

Bio

Pharm

Intern

ation

al M

AY 2

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Pro

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esign I O

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PROCESS MONITORING

The Benefits of Statistical Tools Enhance your control strategy with robust monitoring methods 26


Overall Equipment Effectiveness How to optimize facility utilization and improve plant performance 40

QUALITY BY DESIGN

Is QbD the Roadmap for Future Success?A discussion of the pros and cons of QbD implementation 52

OUTSOURCING

Best Practices for OutsourcingHow to build a successful CRO–client partnership 60

REGULATORY BEATFederal funding spurs comparative effectiveness research 18

OUTSOURCING INSIGHTSService providers shift their focus to value and performance 20

COMPLIANCE NOTESUse Lean techniques to improve manufacturing compliance 24

Schedule on pp. 16–17



Podcast Focus: Protein formulation & stability

Newsletter Focus: Protein formulation & stability


Added Value:Purchase Intelligence »Sales Lead Report4/C Release/Web Page Showcase »Advertising cost includes both »print and digital editions

Bonus Distribution:AAPS National Biotech Conference »Tradeshow PackageBIO Annual Meeting »Tradeshow Package

JuneAd Close: May 8 Material Due: May 12

Editorial Theme: Outsourcing



Supplement: Advances in Fermentation & Cell Culture: The Keys to Upstream Productivity

Supplement to:

BioPharmAccelerated Media Development

Improving Cell Culture Through Metabolomics

Antibody Fragment Production in Microbial Fermentation

Managing Cell Line Instability



INTERNATIONAL

June 2009

Advances in Protein Production

Supplement to:

Podcast Focus: Advances in Fermentation & Cell Culture

Newsletter Focus: Advances in Fermentation & Cell Culture


Contract Manufacturing User Survey4/C Release Web Page Showcase »Advertising cost includes both »print and digital editions

Bonus Distribution:DIA Annual Meeting »

JulyAd Close: June 5 Material Due: June 9




CELL LINE ENGINEERING

An Effective Way to Ensure Consistent Protein ExpressionA proven method for targeted integration of transgenes 32

PROCESS DEVELOPMENT

Pursuit of the Perfect Growth Medium Maximize plasmid DNA output in a high-cell-density culture 40

BIOSIMILARS

Who Will Win the Biosimilars Debate? Tug-of-war continues between generics and innovator industries 46

REGULATORY BEATFDA launches a risk mitigation program for safe use of opioids 16

PERSPECTIVES ON OUTSOURCING Pfizer’s strategy for analytical development and testing 18

COMPLIANCE NOTESLeverage technology to implement strategic quality management 23

BURRILL ON BIOTECHNew financing and partnering deals offer hope for an upswing 28

July 2009

FINAL WORD: Three Key Steps for Managing Supply Chains 58

Volume 22 Number 7

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Monthly Columns: Regulatory Beat »Perspectives on Outsourcing »Final Word »



Podcast Focus: Advances in aseptic processing

Newsletter Focus: Advances in aseptic processing



AugustAd Close: July 10 Material Due: July 14


Monthly Columns: Regulatory Beat »Outsourcing Insights »Final Word »

Bimonthly Columns: Disposables Advisor »Downstream Trends »

Supplement: Structure, Comparability, and Biosimilars: A Guide to Protein Characterization

Podcast Focus: Protein Characterization

Newsletter Focus: Protein Characterization


Added Value:Ad Performance Study »4/C Release/Web Page Showcase »Advertising cost includes both »print and digital editions

BioPh

armIn

ternation

alAUGUST

2008

Chrom

atograp

hyISpecification

SettingIDisp

osables

IRegulatory

Volume21

Number

8

DOWNSTREAM PROCESSINGDeveloping EfficientChromatographicSeparationsApply the latest thinking in process modeling to your process, using aQuality-by-Design approach 28

QUALITY SYSTEMSA Better Way to SetSpecifications andProcess Control LimitsPart 3: How to set limits that protectpatients and provide incentives for continuous process improvement 44

GLOBAL NEWSUSP addresses bioassay design and interpretation, including parallelism and product-specific assays 12

REGULATORY BEATFDA‘s new active surveillance system will improve postmarket safety and even future drug development 14

INDIA TODAYThe Indian government’s support is nourishing the growth of biotechnology 18

THE DISPOSABLES ADVISORKey considerations for designing a facility that relies on single-use technologies 22

FINAL WORD: Patients Can Influence Operational Excellence 66

Volume 21 Number 8

INTERNATIONAL

PharmBioThe Science & Business of Biopharmaceuticals


August 2008

SeptemberAd Close: August 7 Material Due: August 11




Supplement: 2010-2011 Annual Buyer’s Guide and Directory



Biochemicals & Organic Raw Materials

Contract Consulting & Pharmaceutical Services


Engineering & Facilities


Information Technology


Manufacturing Systems

Separation & Purification


Largest Directory Dedicated to the Biopharmaceutical Industry

Supplement to:

September 2009

Bio

Pharm

Intern

ation

al

Ind

ustry D

irectory &

Trend

Rep

ort 2

00

9 &

2010

&Industry Directory

Trend Report

Podcast Focus: Supply-chain management

Newsletter Focus: Supply-chain management



Bonus Distribution:PDA/FDA Joint Regulatory »Conference

OctoberAd Close: September 11 Material Due: September 15

Editorial Theme: Outsourcing & Industry Trends

Special Content: Product & Service Innovations*


Bimonthly Columns: Disposables Advisor »Downstream Trends »


Supplement: The Evolution of Vaccines




Podcast Focus: Advances in Vaccine Manufacturing

Newsletter Focus: Advances in Vaccine Manufacturing



NovemberAd Close: October 9 Material Due: October 13


November 2008

INTERVIEW: Balancing the Challenges and Benefits of Disposables 74

QUALITY CONTROL

How to Detect and Control AggregatesFDA perspectives on specifications and effective control strategies 44


Lean Concepts in BioprocessingTranslate the concepts into practical applications and reduce waste 54

GMP COMPLIANCE

Regulatory Challenges of Global Operations A centralized quality control strategy may be the best solution 62

REGULATORY BEATThe FDA weighs the safety of nanomaterials in drugs 18

INDIA TODAYAre Indian CMOs ready for prime time? 22

OUTSOURCING INSIGHTSFactors that will drive demand for mammalian cell culture capacity 26

COMPLIANCE NOTESA better way to frame questions like “build or buy” 30

LEGAL BRIEFSThe top 10 legal priorities for any start-up 40



INTERNATIONAL



Supplement: Guide to Implementing Single-Use Technologies

Cover Lines?

ADVANSTAR★ COMMUNICATIONS

BioPharmINTERNATIONALSupplement to:

November 2008 www.biopharminternational.com

Podcast Focus: Single-use bioprocessing systems

Newsletter Focus: Single-use bioprocessing systems



Bonus Distribution:AAPS Annual Meeting »Tradeshow Package

DecemberAd Close: November 6 Material Due: November 10


Special Content: Corporate Capabilities*

INTERNATIONAL



BioPharm

LEGAL BRIEFS: How Biomarker Regulation is Changing 30

December 2008

QuALITy by dEsIgN

What Does it Take to Create a Design Space?How to use multivariate experiments to define acceptable ranges 37QuALITy by dEsIgN

The Business Case No time for QbD? How to convince management to make it a priority 42

dOwNsTREAm pROcEssINg

Can Membranes Work in Retention Mode? Results from a process developed for a commercial antibody 48

regulatory beatWhat the Obama administration will mean for the industry 18

india todayAs biopharma grows in India, are standards keeping up? 20

perspectives on outsourcingFour factors to consider when outsourcing process development 22

disposables advisorThe risks of supplier dependency must be mitigated early on 27

burrill on biotecHWhat small biotechs must do to weather the credit crunch 34


Bimonthly Columns: The Disposables Advisor

Podcast Focus: Automation / PAT

Newsletter Focus: Automation / PAT


Added Value:Application Notes Page »Advertising cost includes both »print and digital editions

Editorial Calendar

*Full page advertisers receive the adjacent full page, at no charge, for an advertorial article

*Full page advertisers receive the adjacent full page, at no charge, for an advertorial article

2010 BLACK & WHITE RATES - US DOLLARS

1x 3x 6x 12x 18x 24x

Full Page 6,785 6,330 6,155 5,770 5,585 5,450

2/3 Page 5,365 5,060 4,960 4,715 4,580 4,455

1/2 Page 4,945 4,605 4,475 4,205 4,060 3,965

1/3 Page 3,405 3,225 3,155 2,930 2,890 2,855

1/4 Page 2,615 2,480 2,410 2,240 2,240 2,175

2010 FOUR COLOR RATES - US DOLLARS

1x 3x 6x 12x 18x 24x

Full Page 8,855 8,400 8,225 7,840 7,655 7,520

2/3 Page 7,435 7,130 7,030 6,785 6,650 6,525

1/2 Page 7,015 6,675 6,545 6,275 6,130 6,035

1/3 Page 5,475 5,295 5,225 5,000 4,960 4,925

1/4 Page 4,685 4,550 4,480 4,310 4,310 4,245

COLOR CHARGES

Standard 845

Matched 990

Metalic 1,240

Four-Color 2,070

SPECIAL POSITIONS

Cover 2 765

Cover 3 730

Cover 4 1,000

Preferred Position 595

2010 AD MATERIAL REqUIREMENTS 1. Digital data is required for all ad submissions. Preferred format is PDF/X-1a. Note that a standard PDF is not a preferred format, files should be a PDF/X-1a which is a PDF subset specific to printing. Publisher shall have no obligation or liability to Advertiser of any kind (including, without limitation, the obligation to offer Advertiser makegoods or any other form of compensation) if an ad is supplied to Publisher by Advertiser in any format other than our preferred formats. Non-preferred or non-acceptable formats will be charged a $150 processing fee. All files should be built to exact ad space dimensions purchased. For detailed instructions on preparing PDF/X-1a files and submitting ad files to the correct size, go to www.AdsAtAdvanstar.com or contact the production manager.

2. Publisher will not supply a faxed or soft proof for Advertiser-supplied files. Advertiser is solely responsible for preflighting and proofing all advertisements prior to submission to Publisher. If Publisher detects an error before going to press, Publisher will make a reasonable effort to contact Advertiser to give Advertiser an opportunity to correct and resubmit Advertiser’s file before publication.

3. Accepted Method of Delivery: The preferred method of delivering ad files to Advanstar is via a web based ad uploader, www.AdsAtAdvanstar.com. Files can also be submitted on CD-R or DVD-R disc format.

4. Ad Proofs: To insure that Advertiser’s ad is reproduced correctly, a SWOP-certified color proof that has been made from the same file that Advertiser supplies to Publisher must be provided. Publisher cannot provide Advertiser any assurances regarding the accuracy of reproduction of any ad submitted without a SWOP proof. Publisher shall have no obligation or liability to Advertiser of any kind (including, without limitation, the obligation to offer Advertiser makegoods or any other form of compensation) for any ad supplied to Publisher by Advertiser without a SWOP proof.

Send all CD-R or DVD-R files to: Rhonda Rychlak, BioPharm International 131 West 1st Street, Duluth, MN 55802-2065 Phone: 218-740-6372 Fax: 218-740-7224 email: [email protected]

BioPharm International – US Rates

Ad Dimensions Width Depth

Full Page 6–3/4” 9–1/2”

2/3 Page 4–1/2” 9–1/2”

1/2 Page Island 4–1/2” 7”

1/2 Page Horizontal 6–3/4” 4–5/8”

1/2 Page Vertical 3–3/8” 9–1/2”

1/3 Page Square 4–1/2” 4–5/8”

1/3 Page Vertical 2–1/8” 9–1/2”

1/4 Page 3–3/8” 4–5/8”

Publication Width Depth

Trim Size 7–3/4” 10–1/2”

Bleed 8” 10–3/4”

Live Matter 7” 9–3/4”

Spread Size 14–1/2” 9–1/2”

Bleed (Spread) 15–3/4” 10–3/4”

Primers Width Depth

Trim Size 5–1/4” 8–3/8”

Bleed 5–1/2” 8–5/8”

Live Matter 4–1/4” 7–3/8”

Spread Size 10–1/2” 8–3/8”

Bleed (Spread) 11” 8–5/8”

BioPharm International – Euro Rates

2010 AD MATERIAL REqUIREMENTS 1. Digital data is required for all ad submissions. Preferred format is PDF/X-1a. Note that a standard PDF is not a preferred format, files should be a PDF/X-1a which is a PDF subset specific to printing. Publisher shall have no obligation or liability to Advertiser of any kind (including, without limitation, the obligation to offer Advertiser makegoods or any other form of compensation) if an ad is supplied to Publisher by Advertiser in any format other than our preferred formats. Non-preferred or non-acceptable formats will be charged a $150 processing fee. All files should be built to exact ad space dimensions purchased. For detailed instructions on preparing PDF/X-1a files and submitting ad files to the correct size, go to www.AdsAtAdvanstar.com or contact the production manager.

2. Publisher will not supply a faxed or soft proof for Advertiser-supplied files. Advertiser is solely responsible for preflighting and proofing all advertisements prior to submission to Publisher. If Publisher detects an error before going to press, Publisher will make a reasonable effort to contact Advertiser to give Advertiser an opportunity to correct and resubmit Advertiser’s file before publication.

3. Accepted Method of Delivery: The preferred method of delivering ad files to Advanstar is via a web based ad uploader, www.AdsAtAdvanstar.com. Files can also be submitted on CD-R or DVD-R disc format.

4. Ad Proofs: To insure that Advertiser’s ad is reproduced correctly, a SWOP-certified color proof that has been made from the same file that Advertiser supplies to Publisher must be provided. Publisher cannot provide Advertiser any assurances regarding the accuracy of reproduction of any ad submitted without a SWOP proof. Publisher shall have no obligation or liability to Advertiser of any kind (including, without limitation, the obligation to offer Advertiser makegoods or any other form of compensation) for any ad supplied to Publisher by Advertiser without a SWOP proof.

Send all CD-R or DVD-R files to: Rhonda Rychlak, BioPharm International 131 West 1st Street, Duluth, MN 55802-2065 Phone: 218-740-6372 Fax: 218-740-7224 email: [email protected]

2010 BLACK & WHITE RATES - US DOLLARS

1x 3x 6x 12x 18x 24x

Full Page 4,846 4,521 4,396 4,121 3,989 3,893

2/3 Page 3,832 3,614 3,543 3,368 3,271 3,182

1/2 Page 3,532 3,289 3,196 3,004 2,900 2,832

1/3 Page 2,432 2,304 2,254 2,093 2,064 2,039

1/4 Page 1,868 1,771 1,721 1,600 1,600 1,554

2010 FOUR COLOR RATES - US DOLLARS

1x 3x 6x 12x 18x 24x

Full Page 6,325 6,000 5,875 5,600 5,468 5,371

2/3 Page 5,311 5,093 5,021 4,846 4,750 4,661

1/2 Page 5,011 4,768 4,675 4,482 4,379 4,311

1/3 Page 3,911 3,782 3,732 3,571 3,543 3,518

1/4 Page 3,346 3,250 3,200 3,079 3,079 3,032

COLOR CHARGES

Standard 604

Matched 707

Metalic 886

Four-Color 1,479

SPECIAL POSITIONS

Cover 2 546

Cover 3 521

Cover 4 714

Preferred Position 425

Ad Dimensions Width Depth

Full Page 171 mm 241 mm

2/3 Page 114 mm 241mm

1/2 Page Island 114 mm 178 mm

1/2 Page Horizontal 171 mm 117 mm

1/2 Page Vertical 85 mm 241 mm

1/3 Page Square 114 mm 117 mm

1/3 Page Vertical 54 mm 241 mm

1/4 Page 85 mm 117 mm

Publication Width Depth

Trim Size 197 mm 267 mm

Bleed 203 mm 273 mm

Live Matter 178 mm 248 mm

Spread Size 368 mm 241 mm

Bleed (Spread) 400 mm 273 mm

Primers Width Depth

Trim Size 133 mm 212 mm

Bleed 140 mm 219 mm

Live Matter 108 mm 187 mm

Spread Size 267 mm 212 mm

Bleed (Spread) 279 mm 219 mm

Terms and Conditions

The following terms and conditions (the “Standard Terms”) shall be incor-porated by reference into all Insertion Orders (“IO”) submitted to Advan-star Communications Inc. (“Advanstar”) by Advertiser or its advertising agency:

A. Terms: Invoices are rendered on the publication date of each issue of a printed magazine, e-mail newsletter or digital edition of a magazine, and once per month in arrears for website advertising campaigns, and are due upon receipt.

B. Advanstar holds the Advertiser and its advertising agency jointly re-sponsible for paying all duly

authorized advertising inserted in or attached to any magazines, e-news-letters or websites owned or operated by Advanstar. All past due pay-ments may be re-invoiced directly to the Advertiser, who will be held fully responsible for payment.

C. Agency commission: 15% of gross billings on space and premium posi-tions. Production charges are not subject to agency commission. Agency commission will be disallowed on all past due invoices. In the event Ad-vertiser’s account is placed for collection, Advertiser and agency agree to pay Advanstar for all reasonable collection costs and/or attorneys’ fees incurred. Advertiser and agency also agree to pay finance charges on the unpaid account balance at the rate of 1-1/2% per month or the maximum permitted by law.

D. Advanstar will not be bound by any terms, conditions or provisions appearing on IOs or copy instructions which conflict with provisions of these Standard Terms, including, without limitation, sequential liability statements from advertising agencies. In the event of any inconsistency between an IO and/or copy instructions and these Standard Terms, the Standard Terms shall control.

E. Except as otherwise expressly provided in the IO, positioning of ad-vertisements within an Advanstar magazine, e-newsletter, website or on any page is at the sole discretion of Advanstar. Advanstar may redesign or modify the organization, structure and/or look and feel of the magazine, e-newsletter, website or any other advertising product at any time and without notice. Further, Advanstar does not guarantee that access to its website will be uninterrupted or that the website or any ads placed on it will meet the Advertiser’s requirements.

F. Advertiser shall deliver to Advanstar the content, graphic images and other materials for the advertisement in a form and manner to be specified by Advanstar. Advanstar will not be required to publish any advertisement that is not received in accordance with the foregoing and reserves the right, at Advanstar’s sole discretion, to charge Advertiser, at the rate specified in the IO, for inventory held by Advanstar pending receipt of acceptable materials from Advertiser, or to publish in substitution any prior advertise-ment submitted by Advertiser until such time as Advanstar can reasonably begin publication of the advertisement set forth in the IO.

G. Each insertion order for an Advanstar web product shall specify: (a) the type(s) and amount(s) of Inventory to be delivered (e.g. impressions, clicks or other desired actions) (the “Deliverables”); (b) the price(s) for such Deliverables; (c) the maximum amount of money to be spent pursuant to the IO (if applicable), (d) the start and end dates of the campaign, and (e) the identity of and contact information for any third party ad server (“3rd Party Ad Server”), if applicable. Other items that may be included are but are not limited to: reporting requirements such as impressions or other performance criteria; any special advertisement delivery scheduling and/or advertisement placement requirements; and specifications concerning ownership of data collected.

Advanstar will make commercially reasonable efforts to notify Advertiser or its Agency, if applicable, within two (2) business days of receipt of an IO signed by Advertiser if the specified inventory is not available.

Advanstar will use commercially reasonable efforts to comply with the IO including all advertisement placement restrictions, requirements to create

a reasonably balanced delivery schedule, and to provide within the scope of the IO, an advertisement to the Site specified on the IO when such Site is called up by an Internet user. Any exceptions must be approved by Advertiser in writing.

Advanstar will use commercially reasonable efforts to provide Advertiser at least 10 business days prior written notification of any material changes to the Site that would change the target audience or significantly affect the size or placement of the advertisement specified in the affected IO. Should such a modification occur with or without notice, as Advertiser’s sole rem-edy for change or notice, Advertiser may immediately cancel the remainder of the IO without penalty within the 10 day notice period. If Advanstar fails to provide such notification, Advertiser may cancel the remainder of the IO within 30 days of such modification, and in such case shall not be charged for any affected advertisements delivered after such modification.

Advanstar will submit or otherwise make electronically accessible to Ad-vertiser promptly after acceptance of an IO final technical specifications, as agreed upon by the parties. advertisement delivery shall comply with editorial adjacencies guidelines stated on the IO.

Advanstar shall make reporting available as specified in the IO.

Advanstar shall monitor delivery of the advertisements, and shall notify Advertiser either electronically or in writing as soon as possible if Advan-star believes that an under-delivery is likely. In the case of a probable or actual under-delivery, the parties may arrange for makegood consistent with these Terms and Conditions.

In the event that actual Deliverables for any campaign fall below guar-anteed levels, as set forth in the IO, and/or if there is an omission of any advertisement (placement or creative unit), Advertiser and Advanstar will make an effort to agree upon the conditions of a makegood placement either in the IO or at the time of the shortfall.

Permanent or exclusive placements shall run for the specified period of time regardless of over-delivery, unless the IO establishes an impression cap for 3rd Party Ad served activity. Advertiser will not be charged by Advanstar for any additional advertisements above any level guaranteed or capped in the IO.

H. All advertisements are accepted and published by Advanstar on the representation that the agency and/or Advertiser are properly authorized to publish the entire contents and subject matter thereof.

I. All contents of advertisement are subject to Advanstar’s approval. Ad-vanstar reserves the right to reject or cancel any advertisement, IO, URL link, space reservation or position commitment, at any time, for any reason whatsoever even if the advertising has been published previously by Ad-vanstar. In the event of such occurrence, Advanstar shall return to Adver-tiser the amount of the booked value of the advertisement as Advertiser’s sole remedy for any claims of loss or damage arising from such rejection or cancelation.

J. Advertiser hereby grants Advanstar the right and license to use, repro-duce, transmit, and distribute all creative materials supplied by or on behalf of Advertiser, including without limitation, all text, graphics, illustrations and photographs (the “Creative”). Advertiser represents and warrants that: (i) it has all the necessary rights in the Creative; (ii) the Creative does not violate any applicable law or regulation; and (iii) the Creative does not violate or infringe upon any third party right in any manner or contain any material or information that is defamatory, libelous, slanderous, that violates any person’s right of publicity, privacy or personality, or may otherwise result in any tort, injury, damage or harm to any person. Advertiser acknowledges that Advanstar is relying on the foregoing representations and warranties. Advertiser agrees to indemnify, defend and hold Advanstar and its affiliates, and their respective officers, directors and employees, harmless from and against any and all expenses and losses of any kind (including reasonable attorneys’ fees and costs) incurred based upon a breach of any of the foregoing representations and warranties or in connection with any claim

Advanstar Communications Standard Terms and Conditions for Advertising

arising from or related to any advertisement supplied by Advertiser or its agents and run by Advanstar.

K. Advanstar shall not be liable for any omitted, misplaced, or misposi-tioned advertisements.

L. An order for an advertisement in an Advanstar magazine or e-newsletter may be cancelled by Advertiser for any reason up to the issue’s published ad close date (the “Close Date”). Advertiser will be responsible for, and hereby agrees to pay, orders cancelled after the Close Date , regardless of the date of ad placement.

M. An order for an advertisement on any website owned or operated by Advanstar may be cancelled for any reason upon thirty (30) days written notice from the Advertiser.

N. A 1/6 page ad is the minimum rate holder. (WILL VARY PER MAGA-ZINE)

O. In the event Advertiser notifies Advanstar of a request and/or required change of copy (the “Copy Change”) and Advertiser fails to deliver the Copy Change to Advanstar by the Close Date, Advertiser will forfeit such advertisement placement and Advertiser will be responsible to pay for the forfeited advertisement.

P. Advertiser will be shortrated if, within a 12-month period from the date of the first insertion, Advertiser does not use the amount of space upon which its billings has been based. Advertiser will be rebated if, within a 12-month period from the date of the first insertion, Advertiser has used sufficient additional space to warrant a lower rate than that at which it has been billed.

Q. Costs incurred by Advanstar for production work on advertisements will be charged to the Advertiser regardless of whether or not the ad runs. Advertiser will be charged for any file modifications, creative or typography services provided by Advanstar.

R. Advanstar will hold Advertiser’s advertising materials for a maximum of one year from the date of the issue in which the ad last ran. Advanstar will not be held responsible for consequential costs or other damages due to loss or damage of digital ad materials, art, proofs or transparencies.

S. Reader response inquiries are provided as a service. Advanstar dis-claims all liability and responsibility for inaccuracies. Except as otherwise expressly provided in an IO accepted by Advanstar, Advanstar makes no guarantee with respect to usage statistics for any advertisement.

T. Advanstar expressly disclaims any and all warranties, whether express or implied, including, without limitation, any implied warranties of mer-chantability or fitness for a particular purpose with regard to its advertising services, including any and all oral and written information communicated about such services. To the maximum extent permitted by applicable law, in no event shall Advanstar be liable for any consequential, incidental, di-rect, indirect, special, punitive, or other damages whatsoever (including, without limitation, damages for loss of business profits, business interrup-tion, loss of business information, or other pecuniary loss) arising out of this agreement, even if Advanstar has been advised of the possibility of such damages. Because some states/jurisdictions do not allow the exclu-sion or limitation of liability for consequential or incidental damages, the above limitation may not apply to advertiser. In no case, and under no

theory of law, shall Advanstar’s liability for any error exceed the amount due or paid for the advertisement giving rise to aforementioned error. Not-withstanding the foregoing, Advanstar shall have no liability for (i) any failure or delay resulting from conditions beyond Advanstar’s control; or (ii) errors in content or omissions in any creative or advertising materials provided by Advertiser.In the event of a breach by Advertiser, Advanstar may terminate this Agreement immediately without notice or cure period, without liability to Advanstar. Either party may terminate this Agreement for convenience, with or without cause, upon thirty (30) days written notice to the other party. In the event of any termination, Advertiser shall remain liable for any amount due under an IO for advertisements delivered by Advanstar and such obligation to pay shall survive any termination of this Agreement. Un-der no circumstances shall Advanstar be liable for any indirect, incidental, special or consequential damages (including, without limitation, loss of profit or impairment of goodwill) of any Advertiser. Under no circumstances shall Advanstar’s direct or indirect liability to any advertising agency or Ad-vertiser exceed the invoiced cost of the advertisement.

U. Applicable if 3rd Party Server is used. Advanstar will track delivery through its ad server and Advertiser will also track delivery through its pro-prietary or subcontracted 3rd Party Ad Server whose identity is set forth in the IO. Advertiser may not substitute the 3rd Party Ad Server specified in the IO without Advanstar’s prior consent. Advertiser and Advanstar agree to give reciprocal access to relevant and non-proprietary statistics from both ad servers, or if such is not available, provide weekly placement level activity reports to each other. In the event that Advanstar’s ad server mea-surements are higher than those produced by the Advertiser’s 3rd Party Ad Server by more than 10% over the invoice period, Advertiser will facilitate a reconciliation effort between Advanstar and 3rd Party Ad Server.

Where Advertiser utilizes a 3rd Party Ad Server Advanstar will not bonus more than 10% above the Deliverables specified in the IO without prior written consent from the Advertiser. Permanent or exclusive placements shall run for the specified period of time regardless of over-delivery, unless the IO establishes an impression cap for 3rd Party Ad served activity. If a 3rd Party Ad Server is being used and Advertiser notifies Advanstar that the guaranteed or capped levels stated in the IO have been reached, Adv-anstar will use commercially reasonable efforts to suspend delivery.

When applicable, 3rd Party Ad Server tags shall be implemented so that they are functional in all respects.

V. These Standard Terms, together with IOs submitted by Advertiser, (i) shall be governed by and construed in accordance with the laws of the State of New York and the United States, without giving effect to principles of conflicts law; (ii) may be amended only by written agreement executed by an authorized representative of each party; and (iii) constitute the com-plete and entire expression of the agreement between the parties, and shall supersede any and all other agreements regarding the subject matter hereof, whether written or oral, between the parties. Failure by either party to enforce any provision of these Standard Terms shall not be deemed a waiver of future enforcement of that or any other provision. Advertiser may not resell, assign, or transfer any of its rights hereunder.

Section headings are for convenience only and shall not be construed as part of this Agreement.

Terms and Conditions

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