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Featured White Paper

A Multi-Stakeholder Vision for Patient-Centered Measurement in New Payment and Delivery Models

Posted on: August 13, 2015
By: Avalere Health

In light of concerns over the rising costs of healthcare, many policymakers and healthcare stakeholders have shown increased interest in reforms that contain costs while improving quality. As new payment and delivery models have proliferated, patientcenteredness has emerged as a key component of high-value care to ensure that patient perspectives inform the decision-making processes of healthcare stakeholders, and that all activities are anchored in the aim to improve outcomes for patients. This shift has led to the search for patient-reported outcomes (PRO) measures that assess the extent to which our healthcare system is keeping the patient at the center. Avalere brought together leaders from the patient, payer, health information technology, product developer, provider, and research communities to prioritize the development and implementation of PRO measures in new payment and delivery models.

Duchenne Muscular Dystrophy

Posted on November 16, 2015
Sponsored by: Santhera Pharmaceuticals

The Duchenne Muscular Dystrophy (DMD) report will highlight BioCentury’s coverage of clinical and regulatory events in DMD, in addition to outlining the current state of the DMD drug development pipeline, partnering, and financial environments. The report will conclude with case studies on some of the key players in the space.

Building Bridges to Innovation - The BioCentury China Healthcare Summit 2015 Report

Posted on November 2, 2015
By: McKinsey & Company

Commissioned for the 2nd BioCentury China Healthcare Summit (Oct. 20-21, 2015, Shanghai), this exclusive report from our Insights Partner, McKinsey & Co., discusses recent trends impacting the short- and long-term potential of the China pharmaceuticals market. The report explores root causes of the market slow-down observed in 2015, and assesses China's latest policy developments meant to better support innovation. In the report, McKinsey also launches the China Drug Innovation Index (CDII), the first holistic assessment of China's innovation ecosystem to be tracked annually.

Ethical, Scientific and Commercial Perspectives on Gene Editing

Posted on: October 16, 2015
Sponsored by: Biogen

Gene editing has made rapid advances in the last few years, with the advent of zinc-finger nucleases (ZFNs), TALENs, and most recently, CRISPR — techniques that offer the potential to pinpoint and repair genetic mutations. The advances have triggered the foundation of several companies with gene editing platforms, while many other companies — notably in the chimeric antigen receptor (CAR) T cell field — have incorporated gene editing strategies for building their own toolkits and therapies. The excitement centers on the promise of gene editing to allow not only major improvements in tools available to biologists, such as highly specific cell-based or animal models of disease, but also radical advances in therapies for genetic diseases in which repair of the underlying mutation could treat the disease at its root. But the rapid pace of development in the field has also led to a debate in the field about whether, how and when the technology should be used in human germline cells or embryos. While gene editing could be used to eliminate devastating diseases, some believe that tinkering with the genome crosses a moral boundary.

Understanding the Research Focus of Federally-Funded CER in the U.S.

Posted on October 12, 2015
By: Avalere Health

Using the EBM Navigator®, Avalere Health reviewed comparative effectiveness research (CER) projects funded by the Agency for Healthcare Research and Quality (AHRQ) and the Patient-Centered Outcomes Research Institute (PCORI) to identify key implications regarding complementary or duplicative research between the two organizations as well as any potential research gaps left unaddressed thus far. Investigate how these two key federally-funded CER entities in the U.S. are directing their funds.

Results: The Future of Pharmaceutical and Healthcare Marketing. Chapter 3: The Promise of Big Data

Posted on September 1, 2015

With the right analytical tools to uncover deep insights from vast amounts of both structured and unstructured data, life sciences has an unprecedented opportunity to profoundly influence health management and marketing. But is the industry moving too slowly to capitalize on the benefits of big data? In "The Promise of Big Data," a chapter excerpted from the book Results: The Future of Pharmaceutical and Healthcare Marketing, the author explores key areas where life sciences can use big data to improve outcomes, deliver timely new treatments and optimize marketing.

Second Quarter 2015 Deal Highlights

Posted on August 24, 2015
By: Merrill Corporation

2Q15 saw the second fewest partnerships (167) compared with any quarter in the past four years. Despite the downturn in overall deals, the average cash and equity upfront payments for 2Q15 deals was $50 million, on the higher end of quarterly averages seen in deals from 2011 to 2014. Learn about partnership activity and upfront payment through 1H 2015.

Dealmakers' Intentions 2015

Posted on: July 16, 2015
By: Campbell Alliance

Following the best year in history for life sciences dealmaking, the seventh annual Dealmakers' Intentions 2015 examines what the immediate future holds by surveying dealmakers throughout the industry on their intentions for the rest of the year. Providing a unique perspective on the future of licensing and acquisitions, Campbell Alliance's Dealmakers' Intentions study of licensing decision makers captures expectations for deal activity, supply and demand for assets at different stages of development, and approaches to valuation.

The Journey Toward Launch Excellence: Harnessing the Power of Experience and Insights

Posted on: July 16, 2015
By: Campbell Alliance

This article examines the importance of the journey toward launch excellence and shows why many companies today are investing in developing the right launch processes and capabilities. The article also examines why knowledge transfer is critical in ensuring the success of a launch, given external pressures, and it details the considerations necessary for developing a robust and continuously evolving launch excellence capability.

Making Real World Evidence Real

Posted on: August 1, 2015

Life sciences companies are being asked by regulators, payers, providers and patients to prove therapies measure up to their real-world promise. Transforming HEOR data into real-world evidence gives a clear picture of product safety and effectiveness, economics and value in actual use. This paper discusses how using advanced analytics technology will help bridge the data-to-evidence gap, allowing integration and management of diverse data sources; fit-for-purpose analytical applications; scalable, high-performance computing power; and the option to move to the cloud.

Record 2014 BioMeter Shows Strong Year for Biotech

Posted on: May 12, 2015
By: Morrison & Foerster

The full-year 2014 BioMeter confirms it was a banner year for biotechnology. The average BioMeter value for the entire year across all transactions reporting up-front payments and stage of development was $58.7 million, up dramatically from $33.9 million in 2013, and the highest MoFo has observed for a full year since they started reviewing data going back to 2006. Increases were at all stages of development..

Beyond Pills: Designing a Winning Drug Delivery Strategy for the New Era of Biologics

Posted on: April 1, 2015
By: L.E.K. Consulting

What does drug delivery 2.0 look like? In the new era of biologics, companies will need to innovate delivery methods and improve the patient experience to increase sales and market share. But how? L.E.K.'s Max Cambras, Sue St. Sure and Nurry Hong outline a three-step process that can help in our Executive Insights.

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.