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.

Key Scientific Considerations and Concepts in Developing a Global Observational Study Protocol

Webinar | Tuesday April 28th | 11am ET / 8am PT | Sponsored by: Parexel

This webinar will summarize the core scientific concepts needed to develop a global observational study protocol that describes or evaluates a therapeutic treatment in patients under conditions of usual care, in terms of clinical, humanistic and economic outcomes for a variety of key stakeholders. Register Today!

Worried about Your Next FDA Meeting? Key Tips to Make It a Success

Webinar | Tuesday, May 12th | 1pm ET / 10am PT | Presented by: Rho

Regulatory authority meetings require strategic preparation to ensure a successful outcome. In this webinar, Lauren Neighbours, Clinical Research Scientist, and Dana Minnick, Regulatory Scientist, discuss how to approach FDA meetings to get the most benefit for your development program. Register Now!

Lessons-learned from Executing Complex Medical Device Trials - Special focus on Cardiovascular Device

Webinar | Wednesday, May 20th | 11am ET / 8am PT | Presented by: Medpace

Medpace uses its vast experience in CV trials as a backdrop to discuss the critical factors for designing and executing studies for complex and high-risk medical devices. Register Now!

Mitigating Risk and Speeding Development with Advanced Capsule Technology

Webinar | Wednesday, June 3rd | 11am ET / 8am PT | Presented by: Capsugel

This webinar will explore capsules' utility in a range of applications, including bioavailability enhancement, modified release, pediatric solutions, & fixed dose combinations. Learn more about how capsules enable rapid advancement of products built on QbD principles and supported by PAT. Register today!

Adherence-Informed Clinical Trials to Achieve and Maintain Maximal Treatment Efficacy

Webinar | Tuesday, June 23 | 11:00am ET / 8:00am PT | Presented By: MWV Healthcare

This webinar will address the impact of medication non-adherence in clinical trials. Accurate adherence measurement is necessary to evaluate a compound's true potential and increase the likelihood of a successful trial outcome. Register today!

mHealth + Patient Engagement: A new connected health model

Webinar | NOW AVAILABLE ON-DEMAND | Presented By: BBK Worldwide

BBK Worldwide hosts a webinar exploring this new connected health model and its impact on clinical research. Join their expert panel, which includes mHealth experts from BBK Worldwide, Oracle and Empatica, and learn key strategies for successful implementation. Registration is free – click here.

Managing Federally Funded Biotechnology Projects: Keys to Successful Execution

Webinar | Sponsored by: Lexem Strategy | NOW AVAILABLE ON-DEMAND

This webinar will demonstrate how government contracts differ in the marketplace. Business cases from the HHS - Biomedical Advanced Research and Development Authority and the DOD will provide a thorough understanding to navigate this landscape of management, legality, contracts, and oversight. Reserve Your Spot Today!

How to Build a TMF Strategy to be Inspection-ready

Webinar | Thursday, April 16th | 2pm ET / 11am PT | Sponsored by: Veeva Systems

Hear how Kythera Biopharmaceuticals reduced their TMF reconciliation time by 40% with their TMF strategy. Sign up for the webinar here.

The TMF Reference Model: It Doesn't Have to be Scary

Webinar | NOW AVAILABLE ON-DEMAND | Presented by: Rho

At first glance, the TMF reference model seems daunting, especially for smaller companies. In this webinar, Kristen Snipes and Missy Lavinder share tips and tricks for making the process manageable based on their own recent experience implementing the model. Register to Watch Now!

Leveraging Cloud to Enable Agility in Regulated Environments

Webinar | Now Available On Demand | Presented by: Veeva

Learn how Natera leverages cloud-based content management systems to simplify collection, management, and secure access of controlled documents - improving operational efficiency, and enabling agility amidst increasing procedural requirements. Register to watch now!

Powering Product Development in Skin Care with Metabolic Profiling

Webinar | NOW AVAILABLE ON-DEMAND | Presented by: Metabolon

Here we describe discovery approaches designed to broadly survey the skin metabolome as well as focused metabolomic assessment of sebum, stratum corneum, skin biopsy, cell culture and reconstructed skin models across a variety of conditions. Further, we share results from recent publications and practical clinical case studies. Register to Watch Now!

Understanding the New FDA Guidance on Data Standards

Webinar | NOW AVAILABLE ON-DEMAND | Presented by: Rho

In December 2014, FDA released the Guidance for Industry "Providing Regulatory Submissions in Electronic Format—Standardized Study Data." This webinar will review the guidance and discuss the implications for Sponsors currently conducting studies and for those starting new studies soon. Register to Watch Now!

Next Generation of Functional Outsourcing Models

Webinar | NOW AVAILABLE ON DEMAND | Presented By: Parexel

This webinar will discuss the evolution of Functional Outsourcing Models from insourcing to functional strategic partnership. Register today!

Thomson Reuters 2014 Deal of the Year

Webinar | Now Available On-Demand | Sponsored by: Thomson Reuters

Join our lively discussion of the five most innovative M&A and Licensing deals from 2014, selected as nominees for the Breakthrough Alliance Award 2014. Thomson Reuters Recap analysts have examined hundreds of biopharma deals negotiated in 2014 and used both subjective and objective criteria to identify the top five contenders in each category. Register to watch now!

Strategies in Pharmacovigilance and Drug Safety

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

This webinar will bring together pharmaceutical executives across a range of functions—from marketing to regulatory affairs to development—to discuss these trends and suggest strategies for thriving in this increasingly vigilant environment. Register to Watch Now!

Formulation Solutions Using Hot Melt Extrusion for Poorly Soluble Drugs

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

BASF SE expert Andreas Gryczke will present fundamental understanding of Role of Polymers using hot melt extrusion technology and Catalent's expert Dr. Sampada B Upadhye will present unique approach to formulation development and strategy for scale-up. Learn How BASF & Catalent can Expedite and Resolve your Challenges with development and manufacturing.

Delivering Next Generation Commercial Capabilities

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

As the life sciences industry evolves, commercial leaders are demanding more innovative and effective customer engagement, but traditional processes limited by legacy technology are holding them back. There is a better way that puts control back in the hands of commercial leaders and eliminates the barriers to coordinated customer engagement. Register to watch now!

Thomson Reuters Recap: 2014 Life Sciences Deal Trends- Year End Review

Webinar | NOW AVAILABLE ON-DEMAND | Presented by: Thomson Reuters

This webinar will provide a detailed analysis of emerging trends in licensing and M&A over the last 12 months, including: Key financial metrics, Most active dealmakers, Trends by therapeutic area, and A showcase of the largest deals signed in 2014. Don't miss out on this exclusive review of the 2014 bio pharmaceutical deals landscape. Register to Watch Now!