White Papers

Analytics – It’s The Journey Not The Destination That Matters

A New Market Access Modus Operandi For US Pharma – Are You Ready?

FREE Whitepaper- Global Data: The Next Frontier In Healthcare Data

Benefits and Barriers of Payer-Manufacturer Post-Marketing Study Collaborations

Consumer Access to Specialty Medications

NPC – Consumer Access to Specialty Medications.

Has Orphan Drug Pricing Reached A Breaking Point?

Free White Paper! Learn more about Clinical Trials in Russia

Since 1990, the number of clinical trials performed in Russia has grown rapidly, from 292 in 2002 to 563 in 2007. Russia’s large population and centralized health care system are two aspects of its environment that make Russia so conducive to clinical trials. Pharm-Olam’s “Clinical Trials in Russia, The Promise and the Approach ” Whitepaper details how to tap into the potential the Russian market has to offer.

Whitepaper – Updating Systematic Reviews

Assessment Of A Method To Detect Signals For Updating Systematic Reviews

Whitepaper – Updating Systematic Reviews

Assessment Of A Method To Detect Signals For Updating Systematic Reviews

The Pharmacist: Tomorrow’s Stakeholder

With well-defined barriers to physician access, the pharma industry is looking towards the pharmacist as a key stakeholder. To help define the interaction that pharma and the pharmacist could have, the latest eyeforpharma whitepaper outlines which companies are leading this new form of customer engagement. (Source: eyeforpharma, 2013). Download your free copy of The Pharmacist, Tomorrow’s Stakeholder here.

How Much Do You Know About Defensive Pricing?

Counter Brand Revenue Erosion from Generics through Defensive Pricing Strategies

Guide to Payer Research in EU5 and US

CONSULT Publications.

The role, identity and connectivity of the payer is shifting in the face of global cost containment that is seeing all major pharma markets globally adopt new healthcare infrastructures geared around delivering economically efficient longer term positive outcomes. Clinicians and traditional payers combine within these emerging networks designed to assess cost-effectiveness at the national, regional and local level, presenting new engagement challenges and evidence requirements for the pharma industry.

Gain valuable insight into the EU5 and US country specific market trends; governmental regulation and formulary committee decision making processes; pricing and reimbursement regulations; why payers are vital to your research; helpful hints and recruitment considerations.

Download the white paper. Registration is required.

FTC vs Actavis. Aftermath of the Verdict.

From DATAMONITOR Healthcare.

Recently, the US Supreme Court delivered a verdict regarding the legality of reverse payment, or ‘pay-for-delay’ settlements, in which a would-be generic manufacturer accepts payment from the patent holder in order to delay the market launch of a generic drug. This White Paper explores how the ruling will impact the dynamics of generic drug market entry.

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Ensuring Optimal Medical Affairs Performance: Delivering Measurable Value

There is still a significant benefit in understanding which Medical Affairs activities are the most effective in gathering insights of strategic value. Companies looking for ideas on how to assess the impact of their Medical Affairs programes and conversations, and how to manage change within the organization, will find effective answers in this extensive report.

Download the paper. Requires registration.

Bringing Clinical and Commercial Together

Through their Clinical, Commercial and Consulting Divisions, inVentiv Health is uniquely placed to bring together science and strategy in generated evidence. Their clients rely on them to ensure that their clinical initiatives align with overall commercial goals through effective planning, evidence generation and communication strategies.

This white paper describes how the global pharmaceutical industry is increasingly seeing the need to combine their clinical and commercial objectives into a single strategy, to drive the creation of improved evidence and value propositions for their products and brands. Read more here.

Application of Item Response Theory in Validating the Morisky Medication Adherence Scale in Patients with Hypertension

Prepared by Shaloo Gupta, MS and Amir Goren, PhD, August, 2013. From Kantar Health.

Medication adherence for those with chronic conditions is generally poor, often around 50%. A recent Cochrane review suggested that improving adherence may have a greater impact on overall health than any treatment itself. Adherence can be assessed in several ways, and each method has its pros and cons. Indirect methods, such as self-report easures, offer the benefit of being inexpensive and easy to administer, and they account for patients’ assessment of actual medication use (compared with, for example, claims data), but at the cost of greater error and subjectivity.

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Real World Data: Sources and Applications

The new market access environment is value-driven. With shrinking health budgets – the drug budget is being more heavily scrutinised than ever before. To guarantee access, payers and HTA agencies need to know exactly what medicines will do in the ‘real world’ – EVEN with orphan drugs where small patient populations make evidence hard to come by. That's why eyeforpharma have commissioned the exclusive whitepaper Real World Data: Sources & Applications.

Do Lilly, Aetna and More Understand ACO Engagement for Specialty Rx?

The ACO: a new stakeholder in the landscape

The ACO: a new stakeholder in the landscape

This whitepaper analyses how big pharma must adapt its stakeholder engagement strategy to reflect the new landscape created by this emerging player. It also provides unique insights from AETNA, Orange Health, Eli Lilly, the Association of Community Cancer Centers, Arizona Care Network and Independent Physician’s ACO of Chicago.

Focus Reimbursement Strategy to Demonstrate Full Value Story

Demonstrating product value is now a top priority of drug manufacturers if they hope to gain optimal formulary positions. This means incorporating many players early in drug development to foresee and plan for all possible access obstacles.

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A Guide to Understanding Knowledge Translation

EPI-Q's whitepaper illustrates Knowledge Translation as a critical mechanism for identifying barriers,influencing behavior change, and improving the delivery of evidence-based care in end users. Read more

SAS For Marketing Strategy and Planning

Innovation in the Biopharmaceutical Pipeline: A Multidimensional View

From Analysys Group

The U.S. innovative biopharmaceutical industry leads the world in the development of new medicines: over the past decade some 300 new prescription medicines have been approved for use by the U.S. Food and Drug Administration (FDA). Together, these innovations have contributed to a range of new treatments resulting in improvements in the length and quality of life and reduced disease burden for individuals and society. However, the need for innovative new therapies for some of the most costly and challenging diseases and conditions has never been greater.

This study presents data on two types of potential new treatments in the research and development pipeline:
  • New medicines in development, or new molecular entities (NMEs) - data for which are referred to in this report as new “products”; and
  • New molecule-indication combinations in development (which may be NMEs or new indications for medicines previously approved by the FDA) – data for these unique molecule-indication combinations are referred to in this report as “projects.”

  • Download the white paper here.

Unleashing value: The changing payment landscape for the US pharmaceutical industry

Lessons from Avastin

In the third-quarter of 2010 (3Q10), a US regulatory advisory committee voted twelve to one to rescind Roche/Genentech’s Avastin’s conditional approval on the basis of (tumor) progression - free survival (PFS) to treat advanced breast cancer. This decision followed a review of trial data in which Avastin, in combination with chemotherapy, reliably did not increase overall survival (OS), as compared to chemotherapy only, above chance levels across four new and old studies (bloomberg.com, 7/21/10; pharmalot.com, 2/24/11). In terms of safety, based on clinical trial data across solid tumor types (N = 10,217 patients, randomized in 16 trials), fatal adverse events with Avastin occurred at a rate that was nearly 1% greater absolutely (2.5% vs 1.7%), as compared to chemotherapy alone (Ranpura, etal., 2011). The most common causes of fatal adverse events were hemorrhage (23.5%), neutropenia (12.2%), and gastrointestinal tract perforation (7.1%), and were observed independent of tumor type. On this basis, presumably, the US regulators questioned the efficacy : safety of the biologic in the population with advanced breast cancer.

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Groundwork for Methods Guide To Compare Medical Tests

From the Comparative Effectiveness News, Jan., 2010.

A SET OF WHITE PAPERS published in the September 22, 2009, issue of Medical Decision Making will serve as the groundwork for an Agency for Healthcare Research and Quality (AHRQ) Work Group charged with creating a new methods guide to focus on comparisons of diagnostic and prognostic tests for the Effective Health Care (EHC) Program. The new methods guide is scheduled to be released in draft form during the first part of 2010.

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