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