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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WEBINARS

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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!

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!

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CDER recently issued an updated draft guidance for Analgesic Indications.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

Metabolomics: Completing the Picture in Systems Biology

Webinar | Wednesday, April 23, - 11am ET / 8am PT | 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 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!

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!

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!

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!

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!

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.

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!