The Library

Welcome to the Library, where you'll find a selection of industry resources including eBooks, Whitepapers, Webinars, Survey Reports, Research Reports and more.

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LIBRARY

The Basics of Biotech 101, 201 & 301

Webinar | Price: Individual Session: $129 | Full Series: $299

This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Download now.

Is Service a Cost? Or Revenue Stream?

Whitepaper | Sponsored by: Watermark Research PartnersWarranties & Service Plans: increase customer confidence & provide a revenue stream to manufacturers.

eBook | Secure File Sharing in a Disaggregated Industry

eBook | Sponsored By: Intralinks | Publisher: October 31

The shift from fully-integrated pharmaceutical companies to the more externalized, networked model of R&D is increasingly prominent. This eBook looks into the need for secure, cloud-based platforms to share files and collaborate. Download today!

Submission, Store, & View Solution

Whitepaper | SPONSORED BY: EMC

Learn how to simplify the search and retrieval of archived submissions and associated correspondence with EMC Documentum Submission Store and View. Learn More.

When Efficacy Isn't Enough: Integrating Product Commercialization Strategy into Clinical and Regulatory Planning

Webinar | Now Available On-Demand | Presented by: PAREXEL

Undertaking commercialization strategy and planning from early stages of development can ensure that considerable R&D investment results in successful market and patient access. Join HERON, a PAREXEL Company, in a timely webinar that addresses best practice commercialization planning. Register to watch now!

Whitepaper | Expert Advice: Designing Systems for Global Content Processes

eBook

Effective content harmonization requires a global system that can balance the needs of both the corporate office and satellite entities and partners. For companies considering content harmonization initiatives, this paper discusses best practices and the efficiency benefits they can expect from deploying a global system. Download now.

Special Report | From Apps to Big Data: Operational Innovations in Life Cycle Management

eBook | SPONSORED BY: Covance

Mobile apps are among a growing collection of tools that life sciences companies use to get closer to patients. Big data flowing from electronic medical records and claims are also enhancing product development. Download this Special Report to learn more.

Understanding Real World Evidence: A Registry Study Perspective

Webinar | Now Available On Demand | Presented by: Medpace

The session addresses best practices for planning and managing a registry, including protocol design, study start-up, site management and data analysis required to reach its objectives. Register to watch now!

Advancing Oncology Drug Development with Patient-Derived Xenografts (PDX)

Webinar | Now Available On Demand | Sponsored by: Champions Oncology

Champions' VP of Corporate Research & Development Neal Goodwin hosts a webinar exploring the utilization of PDX Models in oncology drug development. Register to watch now!

Special Report | The Changing Landscape of Phase IV Research

eBook | Published: September 29, 2014 | Sponsored by: Covance

Industry spending on post-authorization studies belies the rapid changes occurring in Phase IV research, driven by an the demand for evidence of safety and effectiveness. Download this Special Report to learn how Phase IV research continues to transform.

Proceed With Confidence. Understanding Your Molecule's Full Potential During Proof of Concept

Whitepaper | Sponsored by: Covance

Demonstrating your molecule's proof-of-concept (PoC) is an important developmental milestone. If you can show compelling and valid data supporting safety, efficacy and commercial potential, you will feel confident in your decisions to move forward to the next, more costly, developmental phase. Download to learn more.

Proceed With Confidence. Understanding Your Molecule's Full Potential During Proof of Concept

Whitepaper | Sponsored by: Covance | Published: November 3rd

Demonstrating your molecule's proof-of-concept (PoC) is an important developmental milestone. If you can show compelling and valid data supporting safety, efficacy and commercial potential, you will feel confident in your decisions to move forward to the next, more costly, developmental phase. Download today and stay informed.

eBook | Making the Switch from Rx to OTC

eBook | SPONSORED BY: Catalent | Published: November 3, 2014

Switching drugs from prescription to over-the-counter (OTC) status is a marketing strategy that has been growing in popularity over the past few decades. Companies must overcome a number of challenges if they hope to turn the decision to switch into the success of earning shelf space at the pharmacy or gas station. Download this eBook now to learn more!

Leveraging Metabolite Biomarkers for Clinical Trials

Webinar | NOW AVAILABLE ON-DEMAND | Presented by: Metabolon

This webinar will introduce a robust, highly sensitive biomarker development program that leverages the revolutionary metabolomics discovery platform and expands the menu of compounds that can be measured routinely and reliably. Register to Watch Now!

Analyzing Real-World Data for Lifecycle Management

eBook | Sponsored by: Covance | Published on: October 27th

Life used to be simpler for pharma commercialization teams. Once a drug won regulatory approval, the path to sales was relatively clear. Now a drug must prove to payers its value over existing treatments and continue to do so throughout its lifecycle. Download this FierceBiotech Special Report to learn more.

Animal Health Leaders Embrace Biotech R&D

eBook | Published: September 15, 2014 | Sponsored by: Catalent

The presence of biotechs in the animal health industry is growing. Companies working in this industry are using biologic processes to develop large-molecule drugs and vaccines for both livestock and pets, and to improve techniques for research, development, and manufacturing. Download this eBook to learn more about the role biotechs play in the burgeoning animal health industry.

Support Growth & Increase Competitive Edge with Order Processing Automation

Webinar | NOW AVAILABLE ON DEMAND | Presented By: Esker

Join Esker in an upcoming live webinar as we discuss the primary industry challenges, where order processing automation can drive value, and why going "paperless" is such an effective strategy for lean growth. Register to watch now!

Understanding Nutrient Effects on Disease Risk and Prevention with Metabolomics

Webinar | Now Available On-Demand | Presented by: Metabolon

This webinar will outline metabolomic approaches for investigating effects of diet including nutritional ingredients, disease risk and mechanism of disease. Register to watch now!

Biosimilars: A Global Perspective of a New Market Opportunities, Threats and Critical Strategies 2014

Webinar | Now Available On-Demand | Sponsored by: Thompson Reuters

Biosimilars: A Global Perspective of a New Market, presented by BioWorld, will provide webinar participants with a cutting-edge look at the evolving worldwide biosimilars market. Register to watch now!

New Regulatory Compliance – Strategies for Pharma Leaders

Webinar | NOW AVAILABLE ON-DEMAND | Presented by: Model N

Regulatory changes are repeatedly impacting the bottom line for both government and commercial programs. Learn why manufacturers participate in government programs, the obligations associated with such participation, the interconnectivity between various government programs, and the link between commercial pricing and contracting on government pricing. Register To watch now!

Improve the Inclusion & Exclusion Criteria for Your Next Clinical Trial

Webinar | Now Available On-Demand | Presented by: Rho

In this webinar, Dr. Jack Modell will provide suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments. Register to Watch Now!

Cross-Contamination in Drug Manufacturing: The Regulatory Trends

eBook | Published: July 25, 2014 | Presented by: One 2 One

Cross-contamination among production lines is an important issue in drug manufacturing, because it can put both patients and workers at risk of adverse health effects. As the global therapeutics markets grow and drugs become increasingly more potent, authorities in the U.S., Europe and elsewhere are tightening regulations to increase safety and control exposure. Download this eBook to learn more.

Optimizing Formulation Development: New HPMC Capsules Offer Expanded Options for Pharmaceutical Formulations

eBook | Published: July 18, 2014 | Presented by: Capsugel

The evolution of technology in pharmaceutical and medical sciences has extended the range of polymers that are being developed to meet the demand for quality in capsule manufacturing. While they were initially targeted to the producers of vitamins and minerals, these plant-based capsules are now becoming an important option for pharmaceutical manufacturers. Download this eBook to learn more today!

Executive Summary | Veeva 2014 Paperless TMF Survey: An Industry Benchmark

eBook | Published: July 7, 2014 | Sponsored by: Veeva

FierceMarkets and Veeva Systems recently conducted a survey of more than 250 Trial Master File (TMF) owners to explore the impact of growing eTMF adoption as well as the drivers, benefits, and barriers to going paperless. The survey examines the success factors for fully electronic trials and gives an industry-wide view of where organizations fall on the spectrum of paper-based to paperless TMFs. Download this free Executive Summary today!

Expert Guidance on Validating Cloud Systems

Webinar | Now Available On-Demand | Presented by: Veeva

You're invited to join fellow CSV experts for an educational overview of validating cloud systems. Life Sciences companies can safely move to the cloud if you know what changes, what to require of your vendors, and how to implement mitigating controls. Register to watch now!

Next-Generation Orphan Drug Delivery

eBook | Published: May 19, 2014 | Sponsored by: Catalent

According to the National Organization for Rare Disorders (NORD), a disease is rare if it affects fewer than 200,000 Americans. There have been around 6,800 rare diseases defined so far, affecting around 30 million people in the US alone. Big Pharma used to ignore this segment of the market, but now developing orphan drugs to treat these rare diseases is an industry priority. Download this eBook today!

Developing for the Internet of Things: Challenges and Opportunities

Webinar | Now available on-demand | Sponsored by: Kony

Cisco estimates that 50 billion devices and objects will be connected to the Internet by 2020. Will there be a role for developers in this area? And if so, how can developers position themselves in the months ahead on this nascent but potentially explosive opportunity? Register to watch now!

2014 Epocrates Mobile Trends Report: Understanding the Evolving Digital Omnivore

Webinar | Now Available On Demand | Presented by: Epocrates

Since 2012, the Epocrates Mobile Trends Report has tracked the utilization of digital tools among clinicians. Join us to get the first look at the 2014 report, including insights on "Digital Omnivores," task-to-screen engagement trends among key HCP segments, and first-person HCP perspectives on the industry forces fueling digital innovation in the moments of care. Register to watch now!

eBrief | Work Smarter: How Data and Informatics are Reshaping Post-Approval for Pharma

eBook | Published: May 5, 2014 | Sponsored by: Enclarity, a LexisNexis company

With all of pharma’s key markets rethinking reimbursement, the onus is on companies to find ways to deliver the evidence payers want. The rise of new sources of real-world data and the informatics capabilities to derive insights from the figures gives pharma a way to meet these demands. But to make the most of the information, the industry must re-think its practices. Download this eBrief today!

Content Marketing Strategies for Pharma Brand Managers

Webinar | Now available on-demand | Sponsored by: Elsevier

This webinar will bring together pharmaceutical marketing executives and brand managers to discuss effective strategies for managing advertising, public relations, and online communications channels. Speakers will call upon their past experiences - both positive and negative - to provide actionable advice on how to successfully launch and sustain new drug brands. Register Today!

Advancing Research in Skin Biology with Metabolomics

Webinar | NOW AVAILABLE ON-DEMAND | Sponsored by: Metabolon

Accurately assessing perturbations in skin metabolism can provide a proximal snapshot of phenotype and is key to understanding conditions such as acne, eczema, psoriasis and signs of aging. Here we present an overview of how metabolomics can be a powerful tool in skin biology research to improve the development process for therapeutics and skin care products. Register today to watch now!

Jumpstarting Petascale Genomics with Coludera & EMC Isilon

Webinar | Now Available On-Demand | Sponsored by: EMC Isilon and Cloudera

During this webinar we review how distributed computing tools (i.e., the Hadoop ecosystem) can be used to significantly advance the state-of-the-art research such as scaling genome-wide association studies and large-scale data integration of public databases. Register to watch now!

The Future of Animal Health

eBook | Published: March 17, 2014 | Sponsored by: Catalent

The current market for animal drugs and vaccines (not just dogs and cats) is worth $22 billion a year and growing. Add in the huge and growing market for livestock treatments and it's no surprise pharmaceutical companies are angling to find the ideal position in animal health. This FiercePharma eBook will survey the landscape in animal health and the potential growth opportunities for investors and life sciences entrepreneurs. Download this eBook today!

eBrief: Securing Clinical Documents in Cloud-Based Collaborations

eBook | Published: February 18, 2014 | Sponsored by: NextDocs

Big pharma and biotech companies have undergone a series of consolidations, as internal research budgets continue to shrink. With much more at stake, the industry is evolving to embrace more collaborative, future-thinking tools that will not only save sponsors money, but that will also increase efficiency, expedite trials and help identify ineffective drugs sooner. Download this eBrief today!

Targeting cancer treatments: A progress report

eBook | Sponsored by: Catalent

Throughout the history of cancer drug development, researchers have tried to make treatments more specific, reducing the side effects and increasing the efficacy. The next step in this process is the move towards therapies that are not only tailored to each individual, but that also target tumors and nothing else. Download this FierceBiotech eBook to learn more.

New Drugs For Old: Failed Drugs Gaining a Second Chance

eBook | Sponsored by: Catalent

The cost of drugs that fail in clinical trials can be measured by far more than the cash poured into the development process. Now, through drug repositioning some of those investment costs can be recouped by giving drugs a second and often lower-risk chance in a new indication. Download this FierceBiotech ebook to learn key advantages and strategies of drug repositioning.

Picking Winners: Data Mining for Drug Discovery

eBook | Sponsored by: Certara

There are several new initiatives being undertaken in the biopharmaceutical industry aimed at making better use of the vast terabytes of information flowing out of research labs around the world. This ebook discusses the intelligent application of analytics and informatics to enable drug hunters to better understand disease, pharmacological and clinical data. Download it today.

Renal Biomarkers: Driving Drug and Diagnostic Development in Kidney Disease

eBook | Sponsored by: MPI Research

Biomarkers have been used in the diagnosis and monitoring of kidney disease for many years. However, these are most effective in established disease, and by the time they detect injury, the damage may already be done. This ebook discusses the use of biomarkers in identifying susceptibility to kidney disease, using biomarkers to predict outcomes, as well as the limitations of existing biomarkers. Learn more.

eBook | Next-Generation DNA Sequencing in the Clinic

eBook | Sponsored by: EMC Isilon | Published: October 7, 2013

There's no denying the power and promise of next-generation DNA sequencing (NGS) in the healthcare setting. Since 2005, when the first next-gen instruments hit the market, the field has exploded, and not surprisingly, companies have stepped in to fill unmet clinical needs. Here, we profile five businesses taking five different approaches to clinical NGS. Download today.

Bolstering Clinical Trials With Diagnostics

eBook | Sponsored by: Blinded Diagnostics | Published: August 26, 2013

This year has brought a bevy of partnerships between diagnostics makers and drug companies seeking to target experimental drugs to clearly defined patient populations. Download this eBook to learn how personal medicine will develop in today's world and help the patients of tomorrow.

Creating A Scalable Enterprise

eBook | Sponsored by: Windstream | Published: August 19, 2013

As enterprises capture and create data scaling up into petabytes and beyond, it’s not just a matter of adding a few more CPUs and disks. The storage may need to reside physically closer to the processing resources. Learn more today!

Your Peers Expect a VDR. What Are You Using?

eBook | Sponsored by Merrill Datasite | Published: July 22, 2013

While previously companies have kept their important paperwork in physical rooms, virtual data centers have recently become more popular. Download this ebook to learn how VDRs can make viewing classified documents safer and easier.

Collaborations in the Cloud

eBook | Sponsored by Akamai | Published: July 15, 2013

Cloud-based technologies are proving to be useful within the life sciences industry. Download this ebook to learn how pharma and biotech companies are embracing efforts toward accessible and secure information for research collaborations.

Single Use Technology: From Bioprocess Convenience to Drug-Development Driver

eBook | Sponsored by: Catalent | Published: April 29, 2013

In order to accelerate the production of biological molecules, companies have been exploring disposable, single-use systems. Download this ebook to learn the impact and future use of single-use technologies, cost-saving opportunities, and challenges of implementing new drug development processes.

FierceBiotech Special Report | Foundations Fuel Risky Biotech Ventures

eBook | Sponsored by: Catalent | Published: March 25, 2013

Non-profits are taking larger roles in funding clinical trials and research. With their primary goal being finding cures, rather than financial gain, the influx of non-profit research donations may help accelerate cures and advanced research. Download now.

Tablets for Trials: Will Mobile Tech Make Development More Efficient?

eBook | Sponsored by BioClinica | Published: March 18, 2013

With the clinical trial model as flawed as it is, pharma companies are turning to mobile technology as a way to increase success rate and drive down costs. So, what, if anything, can tablets and smartphones do to improve drug development? Download now.

Patient-Centric Drug Formulation Principles: Formulating Drugs for Children and the Elderly

eBook | Sponsored by: Aptalis Pharmaceutical Technologies | Published: March 8, 2013

How are drug developers and doctors tailoring prescriptions to patients? FierceBiotech outlines the principles and strategies for patient-centric drug development. Learn More.

Conversations with World-Class Biotech Innovators

eBook | Sponsored by: Catalent | Published: February 28, 2013

What elevates a researcher to the top of the industry? FierceBiotech profiled five prominent researchers and asked them how they garnered such success. Download for free today.

Special Report: China's Rise Drives Investment in Biotech Drugs

eBook | Sponsored by: Catalent | Published: January 22, 2013

The Chinese government's devotion to biotech has sparked major expansion efforts by some of the country's leading pharmaceutical players, also making it fertile ground for venture capitalists in the U.S. Click here to download the complete report today.

Sterile Manufacturing of Semi- Solids and Liquids

eBook | Sponsored by: DPT Laboratories | Published: October 30, 2012

The role of sterility is a simple one—it is to protect people against infection and contamination. Vital steps and approaches in sterile manufacturing include employee training, process qualification and validation, processes and protocols for cleaning and decontamination, and methods to protect sterility and reduce contamination during processing.  Click here to download this eBook today.

The Right Fix: How Patient- Centric Data is Driving ROI and Revolutionizing the World of Pharmaceutical marketing

eBook | Sponsored by: IMS Health | Published: August 13, 2012

Advances in Anonymous Patient Level Data have empowered pharmaceutical marketers to refine their efforts to reach desired customers, accurately monitor the success of their campaigns, and ultimately generate greater ROI. Click here to download today.

Waiting for Guidelines, Will FDA Take the Reins of Laboratory-Developed Tests?

eBook | Sponsored by Myraqa, Inc. | Published May 21, 2012

A new set of FDA regulations, covering a field the agency has chosen not to supervise in the past, could be a danger on both sides. As many labs, test developers, consultants and FDA lawyers have said, it's the kind of regulation that threatens to stifle innovation with more government red tape. Click here to download.

Supplying Global Clinical Trials: Keys to Avoiding Costly Delays

eBook | Sponsored by: Catalent | Published: April 16, 2012

This FierceBiotech eBook provides expert analysis and industry insights to guide biopharma professionals that face the challenges of meeting strict timelines, selecting contractors and avoiding setbacks during the planning and execution of manufacturing partnerships for global clinical trials.  Download Now.

Trends in Enterprise Content Management in BioPharma

eBook | Sponsored by: OpenText | Published: March 19, 2012

This FierceBiotechIT eBook looks at how ECM has evolved, what the challenges to biopharma are, and how those challenges and obstacles are being met by a variety of ECM approaches. Download now.

Oral Drug Delivery Technologies: Tackling Clinical and Commercial Challenges

eBook | Sponsored by: Catalent | Published: March 12, 2012

This FiercePharma eBook examines Big Pharma's need for technology to give new life to old drugs, and potentially deliver their next breakthrough medicines. This report covers some of the market opportunities, business strategies, and key innovations in the oral drug delivery field. Register Today!

Including China in Drug Development Programs: Opportunities & Challenges

eBook | Sponsored by: Quintiles | Published: February 6, 2012

China’s market growth makes it an attractive target for biopharmaceutical development. FierceBiotech takes an in-depth look at both the opportunities and challenges that come with drug development in the world’s most populous country. Download PDF now.

Academic and Pharma Partnerships: Tapping the Ivory Tower for the Next Blockbuster

eBook | Sponsored by: Merrill Datasite | Published: February 20, 2012

This FiercePharma eBook examines the changing relationship between Big Pharma and academia. Through interviews with both academic and corporate insiders, we gather perspectives from each side and address potential stumbling blocks. While there are pitfalls along the way, there is also great potential if the path can be navigated safely. Download today.

Open R&D: Big Pharma Start Putting Collaboration Plans Into Practice

eBook | Sponsored by: Catalent | Published: December 10, 2012

There's no part of the business more in need of metamorphosis than R&D, and no one more convinced of it than pharma's movers and shakers. To read more on this topic click here to download this eBook today.