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

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!

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CDER recently issued an updated draft guidance for Analgesic Indications.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!

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!

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!

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!

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.

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.

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.

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.

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!

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.