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.

Analysis And Control Of Particles In Biopharmaceuticals

Whitepaper | Published: July 2014 | Published by: SGS

A key challenge faced by companies developing and manufacturing biologics is the control of particles in the final formulation. This article describes how to characterize particles, whether they are intrinsic or extrinsic, and how to control particles during the formulation process. Download Today.

Mitigating Phase 2 Development Risks

Whitepaper | Sponsored by: Health Decisions

Phase 2 is the end of the road for many molecules and for others the source of later delays and denials. Learn techniques for mitigating the risks that threaten your development program in the new white paper, Mitigating Phase 2 Development Risks: Design and Operational Strategies and Case Studies for Phase 2 Success. Download the white paper today!

Understanding Nutrient Effects on Disease Risk and Prevention with Metabolomics

Webinar | Tuesday, September 30th, 11am ET / 8am PT | Presented by: Metabolon

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

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.

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!

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!

Support Growth & Increase Competitive Edge with Order Processing Automation

Webinar | Tuesday, October 14th, 2pm ET/ 1pm CT/ 11am PT | 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 Today!

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!

Understanding today's biopharma regulatory climate

Webinar | SPONSORED BY: Appian | NOW AVAILABLE ON-DEMAND

Get the information and guidance you need from our panel of regulatory specialists, compliance professionals and industry experts. Register to watch now!

The Ultimate Sales Tool: 2 in 1 device + Windows + Veeva

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

In a world of increased cost pressures and regulatory compliance, pharmaceutical sales teams need streamlined solutions on a single platform to engage health care providers, collaborate with peers and stay productive. Register today to watch now!

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!

How Parallel Storage Creates Innovation Advantages for Life Sciences

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

Life sciences and research organizations worldwide are generating massive amounts of data. Data-intensive workflows such as these require the sustained performance and virtually unlimited scalability only parallel storage delivers. Join us to discover the power of advanced software storage solutions for life sciences. Register to Watch Now!

Pharma's Post-Approval Uses of Data and Informatics

Webinar | NOW AVAILABLE ON DEMAND | Sponsored by: LexisNexis

Learn how the emergence of an expanding range of data sources and the computing power to aggregate and analyze them could spark a golden age for data-driven decision-making. 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 | Published on: May 5

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 today 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!

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 | Tuesday, June 24th, 1pm ET/ 10am PT | 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!

Phase IIa Proof-Of-Concept

Webinar | Now Available On Demand | 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 to watch now!

Encapsulation Technologies for Topical Drug Products

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

In this FastCast 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 to Watch Now!

Sponsors, CROs and RBM: Getting Aligned for Success

Webinar | Now Available On Demand | 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 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!

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!

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!

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!

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.

Facing Up to the Biosimilar Challenge: Preclinical and Beyond

eBook | Sponsored by: MPI Research | Published: January 22, 2013

Faced with a continuing economic crisis and an aging and increasingly obese population, healthcare providers are seeing where they can cut costs. Generics saved the U.S. healthcare system $192 billion in 2011 alone. To read more on this timely topic, download this eBook 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.

Special Report: Rare Disease and Orphan Disease Drug Development

eBook | Sponsored by: Catalent | Published: November 5, 2012

Drug developers are devoting considerable resources to rare indications and adopting some clever science to bring those orphan diseases home. To read more about the challenges and opportunities associated with bringing drugs for rare diseases to market, click here to download the complete report today.

Moving from Preclinical to Clinical

eBook | Sponsored by: MPI Research | Published: October 15, 2012

In this new eBook from FierceBiotech, learn how the industry has re–emphasized translational medicine to usher molecules from preclinical development to initial human studies. Click here to download this eBook today.

Bioavailability Challenges

eBook | Brought to you by Catalent | Published October 8, 2012

In recent years, researchers and companies have faced increasing challenges in the discovery and development of new drugs. The challenge for Pharma companies has become maximizing the bioavailability of molecules that demonstrate activity, but are often poorly soluble and/or permeable, by selection and careful utilization of the right drug delivery technologies. Click here to download this eBook today.

FierceBiotech Special Report: Armed Antibodies Readied for War on Cancer

eBook | Sponsored by: Catalent | Published: September 29, 2012

For the drug developers looking to bring these products to market, ADCs represent the inevitable marriage of two sometimes hit-or-miss technologies, chemotherapy and antibodies, the next generation of anti-cancer compounds. In this Special Report FierceBiotech explores the potential and the challenges of the burgeoning field of ADCs.

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.