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Featured White Paper

4 Tips to identify the right FSP partner

Posted: April 7, 2014
By: Rho World

Functional service provider (FSP) partnerships have been gaining traction in recent years because of their potential for increasing efficiency in outsourcing without compromising quality. Rho World has been supporting sponsors in this model for more than a decade, so they understand the common hurdles and how to avoid them. Learn about seemless integration of biostatistics and statistical programming, CDISC and data standards, clinical data management and regulatory medical writing.

MoFo BioMeter

Posted: April 4, 2013
By: Morrison & Foerster

MoFo BioMeter reports a robust 2013 for biotech licensing deals. Aided by a healthy surge in Q4 transactions, up-front payments for licensing deals for all of 2013 increased more than 60% from 2012, averaging $33.9 million. New in this issue is a survey of 2013 biotech hot spots which shows San Francisco on top followed by the Mid-Atlantic region, New York/New Jersey and San Diego, with Germany the international leader.

The Case for Standards

Posted: March 3, 2014
By: The Global Biological Standards Institute

Recent mainstream media, scientific literature, and even NIH have expressed serious concerns over the state of R&D methodologies in life science research. The Global Biological Standards Institute (GBSI) commissioned a 3rd party organization to assess the quality of these R&D methodologies, and through 60 stakeholder interviews, found that irreproducibility is a pervasive, systemic problem that profoundly affects the entire research community. The Case for Standards in Life Science Research identifies a variety of factors that contribute to this irreproducibility crisis, but overall, most can be traced to the absence of a unifying framework of standards — from systems, processes, and procedures to standardized reference materials. Standards have driven innovation in every field of science and technology from Wi-Fi to building bridges, but there are few broadly implemented standards in the life sciences. The Case for Standards lays out a plan for how a standards framework can transform biological research.

L.E.K. Strategic Hospitals Priorities Study: Hospitals Look to MedTech for New Services and Solutions

Posted: March 10, 2014
By: L.E.K. Consulting

In its fifth annual hospital priorities study, L.E.K. Consulting examines what hospital CEOs and other senior decision makers believe are the major challenges to the MedTech industry and their institutions. As they look to improve profitability and at least maintain patient quality, executives report that hospital systems are initiating four broad measures: consolidating to improve leverage with payers and suppliers; integrating with alternative care facilities to offer a fuller continuum of care; becoming more accountable in order to take advantage of emerging reimbursement models; and centralizing and coordinating supply chains. While the final measure may frighten some MedTech executives, it presents opportunities for companies that can reposition themselves to offer broader solutions to hospital systems. The fifth annual L.E.K. Hospital Priorities Study explores how MedTech companies can thrive in this new environment.

The Future Policy Landscape for Emerging Biotechnology Companies: A Guide to Promising Policies Shaping the Future of the Biotech Industry

Posted: December 31, 2013
By: Biotechnology Industry Organization

Innovative biotech companies at all stages of the development process are working toward next generation technologies to heal, fuel, and feed the world. Many research-intensive companies rely on private investment to support their groundbreaking R&D. Because of the long research process intrinsic to scientific advancement, growing innovators operate without product revenue and thus cannot use the sale of one product to finance the development of another. The investment dollars that fund the decade-long, billion-dollar biotech pipeline are supporting the next generation of breakthrough technologies. BIO’s whitepaper, The Future Policy Landscape for Emerging Biotechnology Companies: A Guide to Promising Policies Shaping the Future of the Biotech Industry, highlights key legislation that could impact the sector in the future.

4 Key Considerations for Digital Signatures in the Life Sciences Industry

Posted: January 23, 2014

As life sciences professionals move toward automation in order to improve operational efficiency, they must consider a secure and compliant solution for obtaining signatures. Without one, they are forced to revert to paper each time the need for a signature arises, creating process delays and hindering efficiency and collaboration. In this white paper, you'll gain four key insights that will help set you on the right path toward a proper digital signature solution for your organization.

Managing the Complexities of Global Pharmaceutical Sourcing

Posted: December 31, 2013
By: DPT Labs

With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve. With appropriate resources and systems in place to manage these issues, CDMOs such as DPT Laboratories offer a turnkey approach to control costs, avoid disruptions and ensure quality across the supply chain.

How to Build an Investor Base for a Biotech Company

Posted: December 31, 2013
By: Rx Communications Group, LLC

This presentation answers all your questions about building a meaningful investor base as a start-up Biotech company and ensuring that your company lays the groundwork for future financings. We answer all the questions you were afraid to ask. Find out the most significant steps to take as you launch your company and target potential investors, as well as a tutorial on how to begin to communicate your message to Wall Street. Rx Communications Group, LLC Providing award-winning communications counsel to the life science and healthcare industries for more than a decade.

GWP® – The Standard: Science Based Weighing

Posted: January 7, 2014
By: Mettler Toledo

Recent changes to USP weighing chapters 41 and 1251 include revisions to acceptance limits and test weight selection criteria, clarification on repeatability and accuracy tests, and balance checks based on process risk rather than a daily check. These updates have made weighing compliance a current concern for many pharmaceutical companies. This white paper explains the benefits of a user-friendly, risk-based GWP® (Good Weighing Practice™) testing approach. It covers the factors which affect measurement uncertainty, the impact for pharmaceutical companies, and how risks can be mitigated and SOPs can be updated in order to ensure compliance with latest guidelines. GWP® is a global standard that can be applied to new or existing weighing equipment from any manufacturer in any industry or workplace. It was developed as a standardized scientific methodology for secure selection, calibration and operation of weighing equipment.

A Primer: Solving the Unique Problems of Orphan Drug Communications Programs

Posted: January 7, 2014
By: LaVoie Group

This paper outlines the considerations that must be taken into account when planning orphan disease drug communication programs and the best practice approaches to implementing them successfully through pre-approval, approval and post-approval phases.

A Guide to Successful Western Blotting

Posted: December 31, 2013
By: Cell Signaling Technology

The western blot technique is a powerful tool to elucidate the complex signaling events that underlie biological processes and disease. This paper highlights critical steps in the western blot protocol and demonstrates how protocol changes can affect the final outcome of your blot.

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