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Featured White Paper

The Paradox of Antibiotics Pricing

Posted on January 27, 2015
By: L.E.K.

Experts agree: antibiotic-resistant bacteria is a growing threat but the pipeline for novel antibiotics has virtually dried up. What's holding back new treatments to combat these infections? Jonathan Kfoury offers solutions to unleash a new wave of antibiotic development by fixing a broken pricing and reimbursement model in L.E.K.'s Executive Insights.

Toward Clarity on Transparency: An evolution in thinking – and action – about sharing patient-level clinical trial data

Posted on: March 2, 2015

This paper summarizes discussion with life sciences leaders at the fourth installment of the Clinical Trial Data Transparency Forum. Topics include: why sharing data is a good idea, the challenges and risks that come with it, the mindset change that is required, and best practices from participants representing some of the leading organizations in life sciences today.

Deploying an Analytics Foundation for Clinical Research

Posted on: March 2, 2015

Life sciences companies face ever-increasing regulation, global competition, higher market expectations and rising clinical complexity and costs. The good news is that by using advanced analytics to harness their clinical trial data, they're producing insights that lower trial costs and accelerate the revenue potential of new products. This white paper outlines the capabilities and potential of the SAS® Life Science Analytics Framework -- and how it can benefit an organization’s clinical trial and overall business.

Meeting the Challenges in Designing and Conducting Phase III Trials for Rheumatoid Arthritis Biosimilars

Posted: January 27, 2015
By: Inventiv Health Clinical

The clinical considerations for trials in Rheumatoid Arthritis present enough unique challenges that both the US FDA and the European Medicines Agency published guidance specific to the therapy area. This complexity and the ongoing scrutiny around the development of biosimilars, clearly shows the need for more in-depth consideration and discussion. Learn more about meeting the challenges in study design and patient recruitment that sponsors are encountering as they break new ground in studying RA biosimilars.

Choose a Path: A Value-Based Approach to Market-Entry Strategy

Posted on January 21, 2015
By Campbell Alliance

Commercialization by smaller companies is becoming more feasible as the industry shifts toward specialty and orphan drugs that require a focused sales force and relatively small scale infrastructure. As a result, for development stage companies with an asset in the pipeline, the decisions to be made around the right way forward are more important than ever. In some cases, a go-it-alone strategy will be the right fit for an organization, while in other cases, strategic partnerships are the only viable option. This decision involves not only strategic questions regarding the identity of the company and its core competencies, but also multiple value drivers that are easy to overlook. The decision can also be influenced by natural biases that may distract management from choosing the path that creates the most value for shareholders. This article outlines some of the major considerations development stage companies should keep in mind as they go forward with a market-entry strategy. By taking a value-based approach, companies will be positioned to ensure their business plans contribute to a product's success and a better return on investment.

Firepower Index and Growth Gap Report — Firepower Fireworks

Posted on January 20, 2015
By: Ernst & Young LLP

EY's 2015 report on biopharma M&A, Firepower Index and Growth Gap Report — Firepower Fireworks looks back on biopharma deal activity for 2014 as deal volume surged to over US$200b for the first time in over a decade. Big pharmas – largely absent in 2012-13 – reemerged as important dealmakers in 2014, alongside specialty pharmas. This report also explores "growth gaps": despite big pharma's 2014 deal activity, which should have improved revenue growth, many big pharmas continue to face significant revenue shortfalls and must further reinvigorate their deal-making strategies to help close those gaps. Read also EY's outlook for the 2015 biopharma deal climate – are there more fireworks ahead?

'Walking the talk' in patient-centric pharma

Posted on December 16, 2014
By: Heidrick and Struggles

As governments, payers, and healthcare providers rapidly move toward a health system that focuses on outcomes rather than products and services, pharmaceutical companies are feeling their way toward a new business model: patient-centricity. This shift of emphasis from products to patients represents a radical departure for the pharma industry, upending a half-century-old business model based on blockbuster drugs, incremental innovation, and physician preferences. Continuing pressure on the old model and the business benefits of adopting the new model will accelerate the drive toward patient-centricity, but new strategies and new organizational structures will not be enough. Top leaders will not only have to develop innovative patient-centered models, they will also need to achieve enterprise-wide culture change and introduce the new leadership competencies patient-centricity requires.

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.

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.

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.

Traceability with Microgram Weights

Posted on December 11, 2014
By: Mettler Toledo

Advances in nanotechnology and biotechnology are driving the need for traceable small-force measurement in the sub-milligram measurement range. To meet this demand, reproducible microgram weights issued with a calibration certificate have created critical traceability to the International Prototype Kilogram (IPK) and thus to the International System of Units (SI). The key factors for design and development of microgram weights - material, shape, handling and robust production processes - are explained. The UK National Measurement Office (NMO) describes the challenges and procedures involved in becoming the first accredited microgram weight calibration laboratory in the world. Calibration methods and stability of microgram weights over the mid-term are discussed.

Cutting Costs, Saving Time: Improving Life Sciences Operations with Digital Signatures

Posted on December 15, 2014
By: CoSign by ARX

Read this eBook to discover how 10 real-world life sciences organizations are reducing process times, cutting costs and supporting compliance with digital signatures. You'll also find a checklist of what to look for when evaluating a digital signature solution that will meet the rigorous demands of an FDA-regulated environment while delivering optimal business flexibility.

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.

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.