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Featured White Paper

Proceed With Confidence. Understanding Your Molecule's Full Potential During Proof of Concept

Posted on October 28, 2014
By: Covance

Demonstrating your molecule's proof-of-concept (PoC) is an important developmental milestone. If you can show compelling and valid data supporting safety, efficacy and commercial potential, you will feel confident in your decision to move forward to the next , more costly, development phase.

Building Bridges To Innovation - The BioCentury China Healthcare Summit 2014 Report

Posted on November 19, 2014
By: McKinsey & Company

Commissioned for the BioCentury China Healthcare Summit 2014 (Nov. 12-13, Shanghai), this exclusive report from McKinsey & Company examines the trends shaping China's healthcare system, scenarios for how the market will evolve and the implications for industry players from both commercial and innovation perspectives. The report also discusses key success factors for industry players to drive growth in China, including how to balance portfolios with both mature and innovative products.

Anticipating success: Meeting the inherent challenges of complex drug substances

Posted on October 8, 2014
By: Vetter Pharma International GmbH

Realizing the full potential of a novel injectable drug compound is no small task. In the months and years that lead from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can slow development to a halt, often at key stages. A careful, systematic approach to identifying where and why these roadblocks can occur is fundamental to staying on course. Just as important is a robust, repeatable process design focused on retaining the stability of a compound as it moves through clinical development. The early-stage data captured during this period can play a valuable role in an efficient transition from lab to clinic to market.

How to Proactively Avoid the Common Pitfalls of Biologics Development

Posted on August 7, 2014
By: Covance

When developing a biologic, great science does not always translate into a great product. Doing the rights studies, the right way, is paramount to realizing the product's potential. Knowing which studies to conduct, when to conduct them and interpreting the data in the context of the product's development, can make the difference between success and failure. Download this article to learn more about the common pitfalls in biologics development and three ways to proactively avoid them.

Insights and Perspectives Series
Immuno-Oncology: Breakthrough But Not Unbounded

Posted on September 8, 2014
By: Triangle Insights

Immuno-oncology is among the most highly anticipated areas of innovation in the pharmaceutical industry. Extraordinary commercial expectations for these agents have driven large-scale realignment of portfolio investments in the sector's largest companies and they sit at the core of some of the most significant mergers and acquisitions ever considered. At the same time, even breakthroughs have boundaries. In fact, the emergence of such a transformative technology will likely accelerate change to the commercial system in which that technology is applied. There are seven factors that should be watched closely by leaders responsible for setting immuno-oncology strategies. This paper provides a review of the emerging immuno-oncology therapies, describes factors that support the extremely high expectations for these agents, and then identifies and explores the seven factors that will define the ultimate size of the commercial opportunity.

Taking a Value-Based Approach to Portfolio Strategy and Planning

Posted on August 26, 2014
By: Campbell Alliance

Traditional strategic planning processes are often blindsided by changing market realities. This article examines how a value-based approach to strategic portfolio planning can be used to identify the threats to current commercialization efforts in addition to identifying where the real opportunities exist relative to prior assumptions.

Key Account Management Strategies for Biotech, Med Device & Pharma

Posted on: July 23, 2014
By: Healthcare Data Solutions

A one-size-fits-all approach to new customers won't work in today's dynamic healthcare landscape. Companies that want to thrive must move away from the buyer-seller model and head toward key account management.

In this free whitepaper, you'll discover:

Why Key Account Management is crucial in healthcare
How to overcome common barriers to KAM
Skills that every Key Account Manager needs
New rules and new tools for marketing & sales

2014 Dealmakers' Intentions Study

Posted: June 30, 2014
By: Campbell Alliance

Now in its sixth year, the Campbell Alliance Dealmakers’ Intentions Study is the only forward-looking measure of dealmaking activity in the pharmaceutical and biotech industries.  While there are many quality sources of information that look historically at past deal trends, this survey offers a prospective view of the partnering and licensing landscape for the year ahead.

In the first quarter of 2014, Campbell Alliance surveyed 99 licensing professionals, capturing expectations for deal activity, supply and demand for assets at different stages of development, and approaches to valuation. The results of that survey provide a forward-looking view into what dealmakers anticipate will happen in licensing and acquisitions over the upcoming year. The results of the 2014 Dealmakers’ Intentions Study suggest a narrowing of the discount rate, coupled with a strong IPO market, contributing to tempered optimism for M&A/licensing deal activity looking forward into the second half of 2014. The market for dealmaking appears to be softening, and, as such, both buyers and sellers are likely going to need to modify their approach given the potential headwinds.

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.

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.

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.

Biologics Inflection Point: Managing Risk From Biosimilar Competition

Posted: April 23, 2014
By: L.E.K. Consulting

In this Executive Insights, L.E.K. Consulting argues that the future success of blockbuster branded biologics hinges on the response of three key stakeholder groups who will play a role in biosimilar adoption—prescribers, patients and payers. Examining these stakeholders in detail, the authors explore a subset of strategies for engagement which underpin an enhanced ability to compete and win in this new and challenging market landscape.

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.

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