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.

If you are interested in submitting items to the Library, please contact our advertising team

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.

Sponsors, CROs and RBM: Getting Aligned for Success

Webinar | Tuesday, April 29 | 11am ET, 8am PT | Presented by: Medpace

Realizing the potential of Risk Based Monitoring (RBM) requires coordination and collaboration across functions within both the Sponsor and CRO organizations. Dr. David Orloff and Dr. Alex Artyomenko will lead a discussion to explore the cross-functional perspectives and process alignment between Sponsor and CRO. Register Today!

Identifying Viable Products with Profit Potential for Drug Development

Whitepaper | Sponsored by: Camargo

For innovative pharmaceutical companies, opportunities for new pharmaceutical products exist within the products, patents, technologies and intellectual properties they already own or control. For these companies, and also for generic companies that are looking for alternative revenue sources to offset losses caused by the generic cliff, the 505(b)(2) pathway offers great potential. Learn more here.

BPM-Based Case Management Approach to Optimizing Clinical Trial Efficiency

Whitepaper | Sponsored by: Pega Systems

This white paper explores how a BPM-based case management approach to clinical trials can optimize your processes and reduce time to market. Download this whitepaper today.

Raising Orphans: How Pharma Companies can Capture Value while Treating Rare Diseases

Whitepaper | Sponsored by: L.E.K. Consulting

In this Executive Insights article, L.E.K. Consulting looks at the changing dynamics of the orphan market and identifies winning strategies designed to capture value within this sector. Learn more and download today.

Encapsulation Technologies for Topical Drug Products

Webinar | Thursday, May 8th | 2pm ET / 11am PT | Presented by: CPL

In this webcast we will focus on various encapsulation technologies and manufacturing techniques, and how they may be used to overcome formulation challenges associated with topical products. Register Today!

Phase IIa proof-of-concept

Webinar | Tuesday, May 13, 11am ET/ 8am PT | Sponsored by: PAREXEL

With clinical trials now so expensive, partly driven by costly drug failures at a late stage, effective and efficient phase IIa trials are becoming more and more important in making early go/no go decisions. Join this live event to hear expert opinions on designing an effective phase IIa proof-of-concept study, what triggers a go/no-go decision at phase IIa and making the most of phase IIa data in dealmaking and collaboration. Register today!

802.11ac in the Enterprise: Technologies and Strategies

Whitepaper | Sponsored by: Meru Networks | PUBLISHED: March 31, 2014

Download the White Paper "802.11ac in the Enterprise: Technologies and Strategies" to learn from industry expert Craig Mathias about the technologies behind 802.11ac, deployment misconceptions and review steps that every organization should take in getting ready for 802.11ac.
Download today!

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!

NFS & Scale Out NAS Best Practices for Next Generation Sequencing

Webinar | Now available on-demand | Sponsored by: EMC Isilon

"Make it go faster!" It's not uncommon to hear this phrase from investigators at Life Science organizations generating and analyzing next generation sequencing (NGS) data. In Part 2 of this 3 part series, join our expert panel as they highlight NFS and NAS guidelines and best practices for NGS mapping and alignment pipelines. Register to watch now!

Strategies for Analgesic Development and the New FDA Guidance for Analgesic Indications

Webinar | Thursday, April 10th, 1pm ET/ 10am PT | Presented by: Rho

CDER recently issued an updated draft guidance for Analgesic Indications. In this webinar, Brett Gordon and Ben Vaughn provide a high-level review of the agency's guidance, offer strategies for analgesic product development and share experiences with PROs and paper vs. tablet collection. Register Today!

How Physicians Are Responding to Healthcare's Inevitable Transformation

Whitepaper | Sponsored by: Healthcare Data Solutions

With Open Payments/Sunshine Act implementation now underway, the Affordable Care Act in effect, and Meaningful Use incentive participation growing, Physicians across the U.S. are feeling the effects of massive transformations in the daily routines of healthcare professionals. Discover how physicians are adapting - download this whitepaper 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!

Metabolomics: Completing the Picture in Systems Biology

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

In Part 2 of this series, we will provide a more detailed understanding of the fundamental nature of metabolomics and a visceral understanding of why it has become such a potent ally in bringing clarity to systems biology efforts. Importantly, an explanation will be provided for why metabolomics has only more recently been exploited. Register to watch now!

Mobile medical apps

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

Valuable process or another regulatory burden? In this webinar, we'll explore how the FDA's new guidance for mobile medical apps is working, and whether regulators are following through with the expectations they have set. Register to watch now!

Re-inventing HPC To Foster Pharmaceutical Research Innovation

Webinar | Now available on-demand | Sponsored by: EMC Isilon and RCH Solutions

Join us in a discussion about a holistic approach to re-invent and deploy state-of-the-art high performance computing in pharmaceutical R&D. We'll highlight a successful re-invention of HPC at Sanofi and explore practical considerations related to cost, diverse HPC workloads and more. Register to watch now!

Clinical Biomarkers: Big Data Challenges and Best Practices

Webinar | PRESENTED BY: Oracle | NOW AVAILABLE ON-DEMAND

The use of biomarkers is creating its own set of "big data" challenges. Join Dr. Jonathan Sheldon and Brett Villagrand of Oracle Health Sciences as they examine why trial sponsors are moving away from heavy investments in siloed, home-grown systems. Register Today!

Clinical Biomarkers Derived from Metabolomics. The Making of an Insulin Resistance Test

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

This webinar will outline challenges involved in identifying risk associations with metabolic disease and introduce metabolomics as a new, practical tool to indentify biomarkers for this purpose. Register today to watch now!

Early phase CNS studies

Webinar | Now Available On Demand | Sponsored by: PAREXEL

Join FierceBiotech as we discuss the use of CNS biomarkers in early clinical trials, CNS imaging technologies in early phase studies and clinical trial design and monitoring. Register to watch now!

Data-driven approach to risk based monitoring

Webinar | Published: Tuesday, March 11th | Presented by: PAREXEL

Join us as we discuss the benefits to adopting a data driven monitoring solution and give some background to industry changes around site monitoring. Learn what you can do every day to support efficient study delivery, and how PAREXEL is running data driven monitoring. Register to watch now!

Begin with the End in mind: Fast-track drug development in Asia

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

This webinar will be an in-depth discussion on "ethnobridging" studies. Join as we discuss how "ethnobridging" studies can speed up drug development, when to incorporate "ethnobridging" studies into the drug development plan, and more. Register to watch today!

Beyond connectivity: Business Innovation with M2M Solutions

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

During this webinar, we will introduce how the adoption of M2M technologies will result in business innovation, and the real customer case will be addressed to validate its deployment. Register today to watch now!

2013 Deal of the Year

Webinar | Now Available On Demand | Presented by: Thomson Reuters

Thomson Reuters Recap analysts have examined hundreds of biopharma deals negotiated in 2013. Join our lively discussion of the five most innovative M&A and Licensing deals from 2013, selected as nominees for the Breakthrough Alliance Award 2013. Register to watch now!

Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)

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

The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are critical components of your new drug application (NDA) submission. This webinar will provide insights and important considerations for developing the ISS and ISE sections of your NDA. Register to watch now!

Customer Experience for Service

Whitepaper | Sponsored by: Oracle | Published: October 16

This Executive Brief explores the role of service and support in creating great customer experiences, the service goals market leaders use related to customer experience and the Oracle approach for empowering new service experiences. Download today!

How to Transform Your Mobile Customer Care Strategy

Whitepaper | Sponsored by: Oracle

It's all about the SCI: the smart, connected interaction. It's not easy - mobility increases the number of variables going into each interaction, requires the preservation of context across channels, but it allows each interaction to naturally evolve. Read this document to learn how to go SCI and naturally connect with your customers.

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.

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!

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.

Mobile medical app regulation

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

The FDA has finally issued new guidance outlining requirements for mobile medical device apps. Are companies altering their app development in response to the new requirements, or can they continue as planned, business as usual? This webinar explores the issue. Register to watch now!

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.

Automate Ontology-Driven Clinical Research to Accelerate Your Time to Market

Webinar | Now Available On-Demand | Sponsored by Remedy Informatics

Subject matter experts from Remedy Informatics will describe an integrated system and innovative biomedical informatics platform that collects, aggregates, maps and harmonizes biospecimen, laboratory, clinical and study data throughout the bench-to-bedside cycle. Register to watch now

Apps in Clinical Trials: How to Improve Site Efficiency and Patient Compliance

Webinar | Now Available On-Demand | Sponsored by: Cenduit

As the FDA demands a more proactive approach to protocol compliance and sites increasingly struggle with patient recruitment and retention, IRT is seeing a shift in the way it is applied in the clinical trial setting. This session will present insights into how sponsors are adding new functionality and applications to IRT to increase site efficiency and patient compliance. Register to watch now!

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.

Clinical trials for targeted cancer drugs

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

Clinical trials of targeted cancer drugs focus on those patients most likely to respond, and show the benefits of the drugs much earlier. Join as we discuss these benefits, the design of clinical trials for targeted cancer drugs, and the impact of targeted drugs on clinical trials in the future. Register to watch now!

Top 5 Ways to Maximize Your Molecule's Value and Reach Your POC Goals

Webinar | Now Available On-Demand | Sponsored by: Covance

Demonstrating your compound's proof-of-concept (PoC) is an important developmental milestone. Join us as we discuss ways to maximize your molecule's value, as well as cover the medicalization of early phase clinical development and risk based drug development. Register to watch now!

Beyond Regulations: Developing a Post-Approval Strategy and Plan to Support a Product Throughout its Lifecycle

Webinar | Now Available On-Demand | Sponsored by Parexel

In this session, we will discuss the market changes driving this demand for evidence, and opportunities for generating and leveraging high-quality late-phase data to optimize product life cycle management. Register to watch now.

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.

Historical Data-Driven Country and Site Selection to Deliver Right Patients Faster

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

Choosing the right country and site for successful patient recruitment is a critical step for entire drug development program. Join us as we address a unique way to leverage informatics insights for optimizing oncology clinical trial site selection based upon consistency of performance and quality indicators across trials. Register to watch now!

Pathway and Network Based Biomarker Identification from 'Omics' Data

Webinar | Now Available On Demand | Presented by: Thomson Reuters

Join Thomson Reuters as they discuss how they effectively mine molecular data in biomarker discovery for precision medicine. Find out how network and pathway information can be used for identification of biomarker signatures and discover how MetaBase content integration works with these approaches. Register to watch now!

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.