Quintiles White Papers Feed

Reinventing Biopharma

Wed, 01 Feb 2012 17:07:14 -0500

The biopharmaceutical industry today is facing a multifaceted “value challenge.” Download the PDF

Expected Growth of Industry-Sponsored Clinical Trials in the Middle East Benchmarked on other Global Regions

Wed, 01 Feb 2012 06:01:22 -0500

The evolving business model in the biopharmaceutical industry depends on increased productivity in clinical trials. This demands lower-cost, faster and more effective clinical trial processes. Download the PDF

FSPs: Ranging from Tactical to Strategic Models

Wed, 04 Jan 2012 10:57:09 -0500

Biopharma companies can choose from a range of outsourcing models as they seek to respond effectively to the ever-changing conditions in the New Health. Download the PDF

Strategic Alliances

Mon, 05 Dec 2011 15:24:16 -0500

Strategic alliances with specialized external partners allow companies to increase agility and the efficiency of processes, variablize resources and raise the number of promising drug candidates in their pipeline. Download the PDF

An Integrated Approach to Biosimilar Development & Commercialization

Thu, 29 Sep 2011 00:00:00 -0500

As the market for biosimilar products continues to grow, many biopharmaceutical companies trying to enter the space are struggling to overcome the unique challenges that developing such products presents. Download the PDF

Partnering to Maximize Rewards in Pharmerging Markets

Thu, 15 Sep 2011 18:36:17 -0500

In the past few years so-called “pharmerging” markets have been heralded as the hottest growth area for biopharmaceutical drugs. With large populations, growing disposable income and unmet medical needs, these markets have seen doubledigit growth rates in pharmaceutical spending. Download the PDF

The New Health

Tue, 23 Aug 2011 10:07:54 -0500

In 2010, Quintiles advanced the concept of the New Health, our perspective on the fast-morphing biopharma landscape, where the rules are changing on all fronts. Download the PDF

Methods Matter

Mon, 18 Jul 2011 07:41:22 -0500

As healthcare decision making becomes more complex, stakeholders are demanding real-world evidence tailored to their own individual needs. Download the PDF

Reinventing Biopharma

Mon, 11 Jul 2011 11:42:31 -0500

It’s not easy being a life sciences firm today. Companies in the sector have seen rising research and development (R&D) costs, in exchange for flat, or even diminishing, innovation returns. Download the PDF

The Molecular Biomarker Revolution in Non-Small Cell Lung Cancer

Thu, 23 Jun 2011 14:33:45 -0500

In this new white paper Quintiles’ experts Christopher Ung, Jason Hill, Carrie Lee and Harish Dave review some of the most promising molecular pathways and targeted approaches for NSCLC, the critical role of diagnostics, and strategies to detect and address the emergence of resistance. Download the PDF

The New Health Report 2011

Tue, 24 May 2011 00:00:00 -0500

Download a PDF of the full 2011 New Health Report. Download the PDF

CardioCheck

Tue, 10 May 2011 12:19:07 -0500

Quintiles' CardioCheck program is designed to provide rapid insight into potential cardiotoxic influences of pharmaceutical compounds. Download the PDF

The Art of Compliance

Thu, 21 Apr 2011 16:36:35 -0500

The Art of Compliance is more than just meeting regulatory requirements for a new drug, biologic or medical device. It is the ability to elevate compliance beyond execution to achieve strategic advantage. Its insight-based solutions facilitate quick and appropriate response to repidly changing conditions. Download the PDF

Asia

Tue, 08 Mar 2011 19:00:00 -0500

This paper examines new development models as Western companies seek to develop and register their products in Asia, while emerging Asian companies seek new capabilities to globalize products.

Clinical Endpoint Committees - Summary

Sun, 06 Mar 2011 09:56:34 -0500

What are regulatory boards looking for in clinical endpoint committees? Read our executive summary on the current best practice across the industry.

Clinical Endpoint Committees

Tue, 22 Feb 2011 09:04:10 -0500

As regulatory boards are expecting more from clinical endpoint committees, what guidance can you follow? This white paper sets forth current best practice for CECs.

The New Health Alliance

Mon, 10 Jan 2011 12:00:00 -0500

Biopharmaceutical companies must explore alternative strategic alliances that meet the needs of the New Health and produce medicines that demonstrate value to the entire constellation of stakeholders. Download the PDF

Japanese Cardiac Safety Requirements

Mon, 06 Dec 2010 09:58:00 -0500

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) recently implemented ICH Guideline E14, an important regulatory concern for companies aiming to market their drugs in that country. Download the PDF

Identifying Multiple Routes

Mon, 29 Nov 2010 17:57:30 -0500

As seen in Drug Discovery & Development. New research on the PI3K pathway is leading to a better understanding of its role in cancers. Download the PDF

2010 Executive Vision Forum Insight Report

Thu, 18 Nov 2010 11:43:48 -0500

The 2010 forum presented a venue for executives and key opinion leaders to discuss and debate the converging forces now reshaping the industry.

Oncology Drug Development and Value-Based Medicine

Fri, 05 Nov 2010 14:57:57 -0500

This report demonstrates the need to converge clinical and commercial imperatives earlier within the drug development process to meet a future demand for value-based medical practices. Download the PDF

Pharmacobiomics and Infectious Disease: Progress and Opportunities

Tue, 02 Nov 2010 08:35:43 -0500

Pharmacobiomics and Infectious Disease: Progress Opportunities. After decades of work mapping the human genome, we are beginning to reap real benefits. Download the PDF

From Biomarkers to Diagnostics - The Road to Success

Mon, 18 Oct 2010 10:43:12 -0500

In the second installment of a two-part series, Eric Groves, Jason Hill and Christopher Ung walk through the challenges associated with drug-diagnostic co-development, addressing potential pitfalls and areas of opportunity. Download the PDF

Advancing Clinical Research in Alzheimer's Disease

Mon, 18 Oct 2010 10:13:05 -0500

This report from Quintiles’ own Alzheimer’s experts gives you an inside look at the news from ICAD 2010. Download the PDF

Is a REMS Request from FDA More Likely for Drugs & Biologics Indicated for Pediatric Use?

Fri, 08 Oct 2010 08:15:13 -0500

Is a REMS Request From FDA More Likely For Drugs and Biologics Indicated for Pediatric Use?

Using Real-Time Data to Drive Better Decisions, Faster

Thu, 30 Sep 2010 12:57:35 -0500

This white paper examines the advantages afforded by access to real-time data during the course of a clinical trial. Download the PDF

Advancing Oncology Care Through Innovative Treatment Approaches

Wed, 22 Sep 2010 08:19:57 -0500

In this new white paper, Quintiles’ oncology experts Harish Dave and Eric Groves summarize the new findings and promising results presented at the June ASCO 2010 meeting. Download the PDF

Navigating Future Challenges in Alzheimer's Disease Trials

Tue, 21 Sep 2010 13:54:12 -0500

Quintiles’ own Alzheimer’s experts, Amir Kalali, Roza Hayduk and Lynne Hughes, sum up the insights and discoveries that could lead to the next breakthrough for Alzheimer’s disease.

Mapping the Future in Oncology Drug Development

Fri, 27 Aug 2010 10:32:39 -0500

Industry veterans Harish Dave and Eric Groves summarize key findings of Quintiles’ ASCO Ancillary Event, Mapping the Future in Oncology Drug Development

New York State's New PACeR Clinical Data Network

Thu, 05 Aug 2010 16:44:28 -0500

This briefing describes how the PACeR initiative has connected hospitals, physicians, patients' homes and pharmaceutical scientists to provide valuable insights into current, real-world medical practices. Download the PDF

A Blueprint for Clinical / Commercial Convergence

Thu, 05 Aug 2010 10:34:12 -0500

The development model for bio pharmaceutical companies must shift from two divergent paths to one that combines these two resources with market access strategy, information and capabilities. Download the PDF

Managing Pharmacovigilance as a Business

Wed, 28 Jul 2010 14:38:56 -0500

The three steps required to develop a strategic approach to global capacity management.

White Paper

Wed, 14 Jul 2010 12:00:00 -0500

Für ein patientenzentriertes Kommerzialisierungsmodell in der Pharmawelt Download the PDF

Challenges in Conducting Trials in Alzheimer's Disease

Fri, 21 May 2010 09:39:29 -0500

This paper examines the opportunities for conducting clinical trials in Alzheimer's disease in low and middle income countries.

EMA’s Guidance on New Antidiabetic Drug Development

Wed, 12 May 2010 14:33:05 -0500

Assessing the EMA’s Guidance on New Antidiabetic Drug Development In January 2010, the European Medicines Agency (EMA) issued a draft guideline on antidiabetic drug development

The New Health

Thu, 22 Apr 2010 14:09:43 -0500

Quintiles examines the complex challenges and opportunities facing the biopharmaceutical industry and how companies must manage risk, demonstrate greater value and improve patient outcomes. Download the PDF

PMRG Spring 2010 Insight Brief

Mon, 12 Apr 2010 13:45:48 -0500

Insight brief from PMRG Spring conference Download the PDF

FDA Requirements for Clinical Studies in Pediatric Patients

Thu, 01 Apr 2010 15:26:38 -0500

FDA Requirements for Clinical Studies in Pediatric Patients FDA rules around pediatric drug trials have been tightening, to ensure more targeted data on drug efficacy Download the PDF

Integration of Molecular Biomarkers into Clinical Development

Mon, 29 Mar 2010 11:14:02 -0500

Examining the challenges and opportunities in co-developing a biomarker and drug, this is the first white paper in a new series focusing on oncology. Download the PDF

Data-Driven Patient Recruitment

Tue, 23 Mar 2010 09:11:24 -0500

Under pressure to deliver more evidence faster, drug developers are constantly searching for more patients for clinical trials.

Realizing the Promise of Asia-Pacific

Tue, 16 Mar 2010 12:00:00 -0500

Long seen as merely an outsourcing destination, the Asia-Pacific region is evolving into a center of biopharmaceutical innovation. Download the PDF

Regulations for Clinical Studies in Pediatric Patients in the European Union

Wed, 10 Mar 2010 14:36:34 -0500

After the United States issued pediatric drug study requirements, the European Union (EU) passed a regulation that created major changes to clinical studies for pediatric Download the PDF

Key Trends in Multiple Myeloma Treatment

Fri, 26 Feb 2010 11:30:43 -0500

An overview of the latest studies into novel drug combinations and new therapies in early stage testing in multiple myeloma. Download the PDF

Biomarker Trends in Breast Cancer Research

Wed, 24 Feb 2010 16:30:43 -0500

Dr. Hill discusses the implications and questions that will drive future R&D efforts to develop targeted breast cancer therapies. Download the PDF

Data Driven Patient Recruitment

Tue, 23 Feb 2010 10:08:58 -0500

Quintiles examines the extraordinary opportunity for the biopharmaceutical industry as electronic health data paves the way for a more efficient, scalable way to recruit patients for clinical trials. Download the PDF

New Voices, New Opportunities

Fri, 19 Feb 2010 09:53:07 -0500

Biopharmaceutical companies must learn to navigate the increasingly tricky waters of commercializing products by adjusting to the needs of a new set of stakeholders. Download the PDF

New FDA Guidance on Antidiabetic Therapies

Fri, 11 Dec 2009 06:00:00 -0500

Understanding the FDA Guidance on Assessing Cardiovascular Risks for new Antidiabetic Therapies. Learn what FDA cardiac safety requirements may mean for your development program.

Chasing Influenza

Mon, 30 Nov 2009 06:00:00 -0500

The rise in influenza strains like H1N1 — and the demand for new vaccines — signals a new era in vaccines. Learn how flu vaccines have evolved and where they’re headed. Download the PDF

Shaping Clinical Transformation

Wed, 18 Nov 2009 00:02:11 -0500

A summary of key insights exchanged between pharma executives at the inaugural Quintiles Consulting Executive Vision Forum. Download the PDF

PMRG 2009 Insight Brief

Tue, 17 Nov 2009 16:31:33 -0500

Insights from PMRG 2009 Fall Conference Download the PDF

Rewarding Innovation and Value

Tue, 06 Oct 2009 12:44:04 -0500

The impact of comparative effectiveness research on the future of drug development. Download the PDF

The Future of Data Management

Wed, 17 Jun 2009 12:56:40 -0500

The New Face of Clinical Data Management Download the PDF

Rebalancing Risk to Transform R&D

Wed, 03 Jun 2009 10:32:40 -0500

A strategic approach to re-balancing the main components of biopharma company risk: portfolio, operational and resource. Download the PDF

The Value of CROs

Tue, 31 Mar 2009 16:45:30 -0500

Contract Research Organizations (CROs) are making an increasingly valuable contribution to healthcare by conducting the clinical trials that help determine which investigational medicines advance toward regulatory approval. Download the PDF

The New Face of Clinical Data Management

Tue, 31 Mar 2009 16:41:54 -0500

Discusses the new face of clinical data management in today's biopharmaceutical industry. Download the PDF

Reinventing the Clinical Trial

Tue, 31 Mar 2009 16:38:19 -0500

As a new era of drug discovery unfolds, reinventing the clinical trial is essential to medical advancement. Download the PDF

The Globalization of Clinical Trials

Tue, 31 Mar 2009 16:31:31 -0500

Today, the globalization of clinical trials is accelerating, driven by scientific and economic needs to reach more patients. Download the PDF

Championing the Clinical Trial

Tue, 31 Mar 2009 16:06:10 -0500

Quintiles’ ethical standards and review procedures ensure patient safety remains the top priority for all clinical trials. The company is also leading the way for data transparency, so drug trial sponsors have instant access to information about the conduct and status of trials. Download the PDF

Advancing Drug Development Through Pharmacogenomics

Tue, 31 Mar 2009 15:57:08 -0500

Pharmacogenomics (PG x) is the study of how such genetic differences influence drug therapy. The goal is to use a person’s DNA profile to predict how the individual will respond to a medicine. The ability to predict drug response holds enormous promise to advance the drug development process and to improve drug safety and effectiveness in medical practice. Download the PDF

White Paper: EDC Past, Present and Future

Wed, 25 Mar 2009 16:30:40 -0500

Quintiles has run EDC at more than 19,000 trial sites worldwide, covering more than 310,000 subjects. Download the PDF

Monitoring for Quality

Thu, 22 May 2008 11:14:34 -0500

Scott Cooley, Executive Director, Phase IIIb/IV Product Management, Quintiles, discusses innovative and traditional resources in a risk-based monitoring program. Download the PDF