Quintiles Hear From the Experts Feed

Devising OTC strategies for devices

Mon, 14 May 2012 17:06:02 -0400

Registering an OTC product as a medical device can provide a faster and more cost-effective way of entering the European market, according to Quintiles’ Dr Peter Lassoff. Download the PDF

Podcast: Addressing Compliance Challenges

Fri, 20 Apr 2012 05:33:15 -0400

Bob Rhoades and Marie McDonald, from Consulting at Quintiles, discuss some of the top reasons biopharmaceutical companies fail to make progress on the compliance maturity curve.

Robust Audit Programs

Fri, 20 Apr 2012 05:15:38 -0400

Good internal audit programs and auditing practices enable an organization to evaluate the effectiveness of its Quality Management System, and promote continuous improvement. Download the PDF

US Biosimilar Guidelines

Tue, 10 Apr 2012 15:20:31 -0400

In March 2010, section 351(a) of the Public Health Service Act was amended to create an abbreviated pathway for the approval of biosimilars or interchangeable biologic products. Download the PDF

Podcast: Dispatch from CALBIO 2012

Fri, 09 Mar 2012 10:01:57 -0400

Adrian McKemey, Ph.D., Practice Leader, Product Development and Commercialization, Consulting at Quintiles, discusses a panel he moderated at CALBIO 2012.

Centralised Endpoint Adjudication in Cardiovascular Outcome Studies

Wed, 29 Feb 2012 12:52:48 -0400

This paper provides a succinct overview of Clinical Endpoint Committees, their role in the independent adjudication of suspected cardiovascular events during clinical trials, and the need for their employment in clinical development programs for new antidiabetic drugs for Type 2 Diabetes Mellitus. Download the PDF

Cardiovascular Safety Watch - Part 2: Regulatory Landscape for Off-Target Blood Pressure Assessment

Wed, 29 Feb 2012 12:44:39 -0400

This column provides further discussion related to a potential future regulatory landscape for the assessment of off-target drug-induced blood pressure responses, based on feedback from additional cardiovascular safety conferences. Download the PDF

Cardiovascular Safety Watch - DIA Cardiac and Cardiovascular Safety Conferences

Wed, 29 Feb 2012 12:35:10 -0400

This column reviews the 2nd DIA Cardiac Safety Conference in Japan (held September 5th and 6th in Tokyo), and previews the 5th DIA European Cardiovascular Safety Conference, held on November 3rd and 4th in Barcelona. Download the PDF

Cardiovascular Safety Watch - Regulatory Landscape for Off-Target Blood Pressure Assessment

Wed, 29 Feb 2012 12:24:31 -0400

This column discusses a potential future regulatory landscape for the assessment of off-target drug-induced blood pressure responses, and the challenges of deciding which parameter(s) to focus upon, and how to determine thresholds of regulatory concern. Download the PDF

Cardiovascular Safety Watch - DIA/FDA Conference on Cardiovascular Safety in Drug Development

Wed, 29 Feb 2012 12:10:16 -0400

This column provides a report of the DIA/FDA conference entitled “Cardiovascular Safety in Drug Development: State-of-the-Art Assessments,” held in Washington DC on 14-15th April 2011. Download the PDF

Cardiovascular Safety Watch - Assessments for New Oncologic Agents

Wed, 29 Feb 2012 10:01:18 -0400

This column discusses cardiovascular safety assessments for new oncologic agents, and illustrates how benefit-risk balances differ in different circumstances. Download the PDF

Cardiovascular Safety Watch - Introduction to Cardiac Safety Research Consortium

Wed, 29 Feb 2012 09:35:08 -0400

This column provides an introduction to the Cardiac Safety Research Consortium (CSRC) and a review of its 2010 Annual Meeting and accompanying Pediatric Drug and Devices Cardiovascular Safety Think Tank, in December 2010 at the FDA Headquarters (Silver Spring, Maryland). Download the PDF

New and existing pharmacotherapeutic options for persistent asthma and COPD

Thu, 23 Feb 2012 08:29:18 -0400

Asthma and COPD are chronic inflammatory airway disorders with systemic manifestations. The two diseases have different airway inflammation, features of airway remodelling with subsequent pathophysiology and clinical presentation. Download the PDF

Pharmaceutical Executive: The Power of Observation

Mon, 30 Jan 2012 18:06:15 -0400

Observational studies present a compelling real-world corollary to the classic randomized clinical trial. Download this article to learn how you can build your evidence portfolio. Download the PDF

Registries for Evaluating Patient Outcomes: A User's Guide

Mon, 30 Jan 2012 17:40:39 -0400

Outcome leads the development of best practices for designing and implementing patient registries for real-world observational research. Download the Agency for Healthcare Research & Quality (AHRQ) 2nd edition of Registries for Evaluating Patient Outcomes. Download the PDF

The Power of Observation

Thu, 26 Jan 2012 07:33:26 -0400

As the name implies, in observational studies one 'observes.' The choice of therapy is determined by the patient and her physician rather than protocol, and, Download the PDF

Making Observational Studies Count

Thu, 26 Jan 2012 07:28:27 -0400

There is substantial interest in using observational epidemiologic research in combination with randomized clinical trials (RCTs) and meta-analyses to support decisionmaking by regulators, payers, and Download the PDF

Patient Registries for Understanding the Natural History of Diseases

Thu, 26 Jan 2012 07:20:15 -0400

Understanding the natural history of a disease - its characteristics. management. and outcomes with or without treatment - is critical for developing new therapies. identifying Download the PDF

GRACE Principles: Recognizing High-Quality Observational Studies of Comparative Effectiveness

Thu, 26 Jan 2012 07:15:05 -0400

Comparative effectiveness (CE) has been defined as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, Download the PDF

The Contribution of Early-phase Clinical Data to a Drug’s Integrated Cardiac Safety Portfolio

Mon, 16 Jan 2012 12:00:00 -0400

This article examines the financial and time benefits to incorporating intensive ECG and QT/QTc monitoring in early-phase clinical studies.

Optimising Patient-Centric Services

Mon, 19 Dec 2011 12:23:14 -0400

The cost of avoidable hospitalisations and disease progression in the United States has reached the unprecedented level of some $290bn per year; in turn these Download the PDF

Regulatory Implications of Technology Platforms for Patient-Centric Services

Mon, 19 Dec 2011 12:14:28 -0400

The rise in healthcare costs has outpaced Gross Domestic Product (GDP) growth since the 1970s. Contributing factors are avoidable hospitalizations and disease progression that add Download the PDF

Why Do I Need Regulatory Affairs Certification (RAC)?

Mon, 19 Dec 2011 12:07:38 -0400

Regulatory Affairs Certification (RAC) is the badge that proves the person carrying it has done the legwork to speak authoritatively in matters that are vital Download the PDF

Harish Dave Discusses ASH 2011

Thu, 08 Dec 2011 14:16:12 -0400

Harish Dave discusses the American Society of Hematology annual meeting.

The Contribution of Early-phase Clinical Data to a Drug’s Integrated Cardiac Safety Portfolio

Tue, 06 Dec 2011 15:08:43 -0400

This article examines the financial and time benefits to incorporating intensive ECG and QT/QTc monitoring in early-phase clinical studies. Download the PDF

Leveraging Compliance for Sustainable Business Advantage

Wed, 16 Nov 2011 15:57:34 -0400

Article from Update Magazine, a publication of FDLI. “Leveraging Compliance for Sustainable Business Advantage” by Robert A. Rhoades, VP, Quality & Compliance Consulting Download the PDF

Commentary: The Real-world Convergence of Comparative Effectiveness Research and Risk-Benefit Assessment

Thu, 10 Nov 2011 14:39:56 -0400

Concerns about safety, value, and outcomes are driving demand for more robust evidence about biopharmaceuticals and other medical interventions. Download the PDF

Podcast: Global Biosimilars Outlook

Tue, 11 Oct 2011 11:50:16 -0400

Dr. Amar Kureishi, Regional Chief Medical Officer, Asia-Pacific, Quintiles, discusses the main drivers behind the growth of biosimilars, and offers suggestions for biopharmaceutical companies looking to enter the space.

Podcast: Real-time Data and Patient Safety

Fri, 30 Sep 2011 06:02:01 -0400

Andrew Garrett, Global Head of Biostatistics, Medical Writing and Regulatory Affairs for Quintiles, discusses how real-time collection of clinical research data can accelerate development timelines and better ensure patient safety.

Podcast: Strategic Considerations for Biosimilar Development & Commercialization

Fri, 30 Sep 2011 05:11:50 -0400

Deepa Dahal, Principal Consultant, Consulting at Quintiles, and Dr. Nigel Rulewski, Vice President of Global Strategic Drug Development, emphasize an integrated approach to biosimilar development and commercialization.

How Informative is Your Segmentation?

Thu, 15 Sep 2011 12:25:09 -0400

Article published by Quintiles' Pieter Sheth-Voss in the Winter 2010 issue of Market Research magazine was recently awarded the David K. Hardin Memorial Award for 2011. Download the PDF

Editor’s Commentary

Thu, 25 Aug 2011 09:07:57 -0400

Rick Turner's editor's commentary from the July 2011 issue of the Drug Information Journal. Download the PDF

Editor’s Commentary

Thu, 25 Aug 2011 09:02:36 -0400

Rick Turner's editor's commentary from the May 2011 issue of the Drug Information Journal. Download the PDF

Editor’s Commentary

Thu, 25 Aug 2011 08:52:24 -0400

Rick Turner's editor's commentary from the Drug Information Journal. Download the PDF

Editor’s Commentary

Thu, 25 Aug 2011 08:42:21 -0400

Rick Turner's editor's commentary from the Drug Information Journal. Download the PDF

Podcast: Late Phase Research Strategies

Mon, 08 Aug 2011 12:39:38 -0400

Louise Parmenter, Ph.D., Senior Director, Late Phase Strategic Planning for Quintiles, discusses late phase research methods and their implications for drug development.

Clinical Trial Educators

Wed, 06 Jul 2011 10:12:44 -0400

Stewart Rosen discusses the role of Clinical Trial Educators in Enrollment and Retention.

Global Clinical Trials: Effective Implementation and Management

Tue, 28 Jun 2011 10:39:04 -0400

Seventeen Quintiles experts from around the world collaborated to produce these key chapters in “Global Clinical Trials: Effective Implementation and Management.” Download the PDF

Podcast: Vaccine Trials - Little Margin for Error

Mon, 13 Jun 2011 09:56:21 -0400

Clinical studies for flu vaccines are some of the most challenging to execute.

CDRH's Proposed Changes to the Premarket Notification [510k]

Fri, 27 May 2011 16:31:42 -0400

On January 19, 2011, the FDA unveiled a plan to improve the 510(k) program, involving 25 actions the agency intends to implement during 2011, including new guidance and enhanced staf training. Download the PDF

The Effect of Comparative Effectiveness Research on Drug Development Innovation

Fri, 20 May 2011 13:35:11 -0400

In healthcare the drug development process is in dire need of transformation, and Comparative Effectiveness Research (CER) is helping to fundamentally change drug development by forcing biopharmaceutical manufacturers to view drug innovation from a holistic, 360 degree perspective. Download the PDF

Podcast: Key FSP stakeholders - roles, relationships and impacts

Mon, 16 May 2011 11:27:27 -0400

Fred Cooley, Senior Director, Clinical Operations, North America Field Monitoring Group, describes key stakeholders in Functional Service Provider Relationships.

Podcast: The Benefits and Drawbacks of Functional Service Provider Arrangements (FSPs)

Mon, 16 May 2011 11:23:31 -0400

Ian Birks, Vice President, Integration, Resourcing, Metrics & Reporting, discusses the benefits and drawbacks of Functional Service Provider Arrangements (FSPs)

Dr. Frank Massam

Fri, 13 May 2011 22:01:05 -0400

Dr. Frank Massam discusses the significance of Quintiles' partnership with Population Genetics Technologies Ltd.

New Healthcare Architecture to Maximize Vaccine Coverage Rates

Tue, 19 Apr 2011 12:48:05 -0400

Jason Baumgartner discusses the steps required to create a complete healthcare architecture the shift among biopharma toward preventive medicine.

Hybrid Sales Solutions

Tue, 19 Apr 2011 11:19:12 -0400

Joseph Chirillo, Senior Vice President, Commercialization, Strategic and Risk-Based Business, discusses the different challenges of reaching physicians in densely and sparsely populated areas.

Quintiles Joins the I-SPY 2 Breast Cancer Trial

Thu, 14 Apr 2011 08:00:00 -0400

The I-SPY 2 clinical trial involves 800 patients with advanced breast cancer, and employs innovative adaptive trial design and genetic and biological markers from individual patients’ tumors to screen multiple investigational therapies simultaneously.

Podcast: Process Driven Compliance

Thu, 31 Mar 2011 14:14:17 -0400

Bob Rhoades, Practice Leader for Quality Systems with Consulting at Quintiles, explains the need for a process-driven approach to regulatory compliance.

Podcast: Observational Research through Online Patient Communities

Sat, 26 Mar 2011 17:34:51 -0400

Elisa Cascade, Vice President of MediGuard, discusess how observational research can be conducted with the rich real-world outcomes data available through online patient communities.

Podcast: MediGuard's Membership Milestone

Fri, 25 Mar 2011 16:10:43 -0400

Hugo Stephenson, President of MediGuard, dicusses the 2.5 million member milestone.

Podcast: Strategic Drug Development in Asia

Tue, 08 Mar 2011 19:00:00 -0400

Dr. Amar Kureishi, Regional Chief Medical Officer, Asia, Quintiles, explains the drivers behind biopharma's need to establish new models for working in Asia.

The Current Regulatory Landscape for Cardiac and Cardiovascular Safety Assessments - Part II

Thu, 24 Feb 2011 11:06:04 -0400

Last month, in Part I of this two-part series, we provided an overview of the history of formalized cardiac safety assessment, a brief discussion of Download the PDF

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

Wed, 23 Feb 2011 12:29:06 -0400

The F ood and Drug Administration Amendments Act of 2007 (FDAAA) authorized the US Food and Drug Administration (FDA) to require that a Risk Evaluation Download the PDF

The Current Regulatory Landscape for Cardiac & Cardiovascular Safety Assessments: Part I

Tue, 22 Feb 2011 14:01:16 -0400

The history of formalized cardiac safety assessment, and the dedicated study used to investigate a drug’s propensity to increase the length of the QT interval. Download the PDF

The US Approval Pathway for Biosimilar Products

Tue, 22 Feb 2011 13:51:36 -0400

The Public Health Service Act allows biosimilars in the US. The law incorporates a specific subsection dealing with biosimilars entitled the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Download the PDF

Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs

Tue, 22 Feb 2011 13:13:55 -0400

Bioequivalence studies play a crucial role in drug development as companies pursue line extensions, make manufacturing changes, develop generic drugs and seek US Food and Drug Administration (FDA) approval via the abbreviated drug approval pathway known as 505(b). Download the PDF

Key Aspects of Pharmaceutical Due Diligence Intellectual Property Assessment—Part II

Sun, 20 Feb 2011 09:56:28 -0400

We provide overviews regarding the role of the regulatory professional, patent attorney (PA) and chemistry, manufacturing and controls (CMC) professional for the IP assessment. In addition, a case study is presented to tie together the concepts discussed in Parts I and II. Download the PDF

Key Aspects of Pharmaceutical Due Diligence Intellectual Property Assessment—Part I

Sun, 20 Feb 2011 09:46:46 -0400

This article reviews regulatory legislation enacted to provide additional marketing exclusivity in addition to patent protection. Download the PDF

Diabetes and Biomarkers

Tue, 15 Feb 2011 13:58:22 -0400

The landscape is changing. Where do biomarkers fit in? Discover the current implications and challenges with biomarkers in the development of your diabetes portfolio in this peer reviewed commentary. Download the PDF

The Patient is Waiting - Quality's Quiet Impact on the Public Trust - Risky Business, Chapter 8

Wed, 02 Feb 2011 14:50:18 -0400

Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter eight carefully steps into the controversies surrounding the public’s expectations about the affordability, effectiveness and safety of prescription drugs. Download the PDF

Money and Morals - Management Responsibility in the Pharmaceutical Industry - Risky Business, Chapter 6

Wed, 02 Feb 2011 14:26:26 -0400

Chapter Six Excerpt from Risky Business: Managing the Quality of America’s Medicines by Robert A. Rhoades Download the PDF

25 Years of Regulation - and Still Failing - Risky Business, Chapter 4

Wed, 02 Feb 2011 13:54:35 -0400

Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter four identifies two simple principles needed for the improvement of quality management in pharmaceuticals today: managing consistency and maintaining responsiveness. Download the PDF

Pharmaceutical Quality Control - Taking Comfort in Numbers - Risky Business, Chapter 3

Wed, 02 Feb 2011 13:43:20 -0400

Chapter Three Excerpt from Risky Business: Managing the Quality of America’s Medicines by Robert A. Rhoades Download the PDF

Strange Bedfellows - Science, Business, Politics, and the Law - Risky Business, Chapter 2

Wed, 02 Feb 2011 13:27:36 -0400

Chapter Two Excerpt from Risky Business: Managing the Quality of America’s Medicines by Robert A. Rhoades Download the PDF

Deploying Clinical Trial Educators to Increase Clinical Trial Recruitment

Tue, 01 Feb 2011 11:16:58 -0400

In the February 2011 issue of the ACRP Monitor experts from Quintiles explain the importance of Clinical Trial Educators (CTEs) and their role in clinical Download the PDF

Podcast: Market Segmentation

Thu, 27 Jan 2011 09:04:49 -0400

Ismael Carreras, Ph.D., senior research director, market intelligence at Quintiles, details some new approaches to market segmentation for the biopharmaceutical industry.

Podcast: The New Health Alliance

Mon, 10 Jan 2011 12:00:00 -0400

Michael Arlotto, Ph.D., Senior Vice President of Corporate Development with Quintiles, discusses the requisite elements for an alternative approach to biopharmaceutical partnerships.

EU Regulations for Clinical Studies in Pediatric Patients

Fri, 24 Dec 2010 07:28:14 -0400

In 2006, the European Council (EC) and the European Parliament adopted a regulation that created major changes in the way clinical studies in pediatric patients Download the PDF

Z-Score for Benchmarking Reader Competence in a Central ECG Laboratory

Fri, 17 Dec 2010 11:03:50 -0400

To ensure consistent quality in TQT studies, the Z-Score method offers an easy, reliable and robust method of defining ECG reader competence. Published by Annals Download the PDF

Cardiovascular Safety Watch

Fri, 17 Dec 2010 10:50:03 -0400

Dr. Rick Turner's inaugural cardiac safety column in Journal for Clinical Studies discusses the automation of ECG interval readings. Download the PDF

Integrated Cardiovascular Safety

Fri, 17 Dec 2010 10:46:13 -0400

Reviews a three-component risk exclusion model for assessing investigational drugs: clinical science, regulatory science and statistical science. Published by Applied Clinical Trials (ACT) magazine. Download the PDF

Cardiovascular Safety Watch

Fri, 17 Dec 2010 10:42:13 -0400

Can non-clinical investigations predict the degree of proarrhythmic liability in clinical trials? Download the PDF

Cardiovascular Safety Watch

Fri, 17 Dec 2010 10:38:43 -0400

A review of FDA advisory committees' recommendations on cardiac safety risks associated with rosiglitazone, a drug for treating Type 2 diabetes. Download the PDF

Cardiovascular Safety Watch

Fri, 17 Dec 2010 10:34:01 -0400

Following advisory committees' recommendations concerning rosiglitazone, the FDA did not withdraw the drug but did require a risk evaluation and mitigation strategy. Download the PDF

The Science of Cardiac Safety

Fri, 17 Dec 2010 10:27:38 -0400

Makes the case for a centralized approach to Phase III ECG data collection to ensure quality and integrity — while still realizing cost savings. Published Download the PDF

Exclusive Report From Scientific American

Tue, 09 Nov 2010 08:55:28 -0400

In-depth insights on every angle of the changing health landscape - brought to you by Quintiles Get the report today.

Healthcare's Future Tools

Mon, 08 Nov 2010 11:22:22 -0400

Beyond Genomics. The knowledge gained in mapping the genome is producing more tools and new ways of understanding how the human body works. See what's in store in this exclusive report.

Podcast: Clinical Development of Cancer Drugs in China

Mon, 18 Oct 2010 11:34:18 -0400

Hear exclusive interviews with Quintiles's experts, Christopher Ung, Patty James and Harish Dave on their recent participation at the 13th Annual Chinese Society of Clinical Oncology

Podcast: Biopharma Needs Value Focused Commercial Model

Thu, 30 Sep 2010 15:46:24 -0400

Jim Featherstone, Vice President within the Consulting group at Quintiles, talks to Outsourcing-Pharma about some of the challenges of commercializing a new drug product

Podcast: Cardiac Safety in Clinical Research

Fri, 24 Sep 2010 10:19:57 -0400

J.Rick Turner, Ph.D., Senior Scientific Director, Cardiac Safety Services at Quintiles, discusses the importance of cardiovascular assessments in clinical development.

Jeffrey Cummings, M.D.

Tue, 21 Sep 2010 15:11:50 -0400

Jeffrey Cummings, MD Professor of Neurotherapeutics and Drug Development Cleveland Clinic Lerner College of Medicine Director, Cleveland Clinic Lou Ruvo Center for Brain Health Jeffrey

Podcast: Clinical / Commercial Convergence

Thu, 26 Aug 2010 14:49:57 -0400

John Doyle explains the concept of clinical / commercial convergence.

Dr. Michael Shi

Wed, 04 Aug 2010 10:04:08 -0400

Dr. Michael Shi, President, United States Chinese Anti-Cancer Alliance (USCACA), Senior Director, Oncology Biomarkers, Novartis

Podcast: Data, Patients and Payers are the Keys to New Health Success

Tue, 13 Jul 2010 09:21:26 -0400

Jay Norman, President of the Consulting group at Quintiles, talks to Outsourcing-Pharma about the constellation of stakeholders in the New Health landscape.

Communication Strategies for Risk Minimization

Mon, 12 Jul 2010 08:24:56 -0400

In the US, the Food and Drug Administration (FDA) approves pharmaceutical products based upon the results of adequate, wellcontrolled clinical studies demonstrating that each product Download the PDF

Generic Drug Approvals in the US Prior to the Hatch-Waxman Act

Mon, 12 Jul 2010 08:19:54 -0400

It is a common misconception that the Hatch-Waxman Act of 1984 created the generic drug approval process in the US. A recent article claimed there were Download the PDF

The Pros and Cons of Using Virtual Data Rooms for Due Diligence

Thu, 08 Jul 2010 08:46:54 -0400

Pharmaceutical and biotech companies, strategic partnering divisions of contract research organizations (CROs) and investment firms are entering into alliances and joint ventures at an ever-increasing Download the PDF

Establishing a US Sales Force Through a Strategic Alliance

Thu, 08 Jul 2010 08:40:58 -0400

In October 2007, ProStrakan Group plc, a fast-growing European-based specialty pharmaceutical company, announced its intention to establish its first US sales force through a strategic Download the PDF

The Evolution of Oncologic Drug Development

Thu, 08 Jul 2010 08:33:55 -0400

Despite a doubling in the number of candidates in the cancer drug pipeline from 1990 through 2006, the overall US approval rate for cancer drugs Download the PDF

FDA Requirements for Clinical Studies in Pediatric Patients

Wed, 07 Jul 2010 14:22:47 -0400

Differences in the physiology of adults and children can produce significant differences in the way they respond to drugs and vaccines. Without adequate data on pediatric Download the PDF

On the Origin of the Animal Rule

Wed, 07 Jul 2010 14:16:02 -0400

New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible Download the PDF

Key Challenges to US Topical Ocular Drug Development

Wed, 07 Jul 2010 14:08:36 -0400

This article examines five key facets of the topical ocular drug industry to highlight key challenges associated with ocular drug development. An understanding of ophthalmology Download the PDF

Follow-on Biologics in the EU & US

Wed, 07 Jul 2010 14:03:04 -0400

Follow-on biologic (FOB) is the generally accepted terminology, although “biogeneric” is often favored by the generic drug industry. European and Canadian regulatory agencies refer to Download the PDF

CMC, Preclinical and Clinical Considerations for Biosimilars and Follow-on Biologics

Wed, 07 Jul 2010 13:54:28 -0400

This article summarizes some of the issues pertaining to biosimilars in Europe that are also likely to impact eventual FOB approval testing in the US. Download the PDF

Doctors and Sales Reps

Wed, 07 Jul 2010 09:57:45 -0400

Pharmaceutical companies are faced with a difficult question, should they invest in an inhouse sales force to market their product or does it make sense

Mapping the Future in Oncology Drug Development

Thu, 03 Jun 2010 21:06:45 -0400

Gate #33 for Quintiles Transportation from McCormick Place to the W Hotel, Lakeshore. Buses start at 5pm. Download the PDF

Applications of Modeling and Simulation in Cardiac Safety Studies

Thu, 27 May 2010 15:35:28 -0400

Applications of Modeling and Simulation is discussed by Giridhar S. Tirucherai PhD, Director, Clinical PK-PD at Quintiles in the April issue of DIA Global Forum.

Assessing Cardiac Safety Throughout Clinical Development

Thu, 27 May 2010 15:32:09 -0400

Assessing Cardiac Safety Throughout Clinical Development and the ramifications for an integrated cardiac safety program is discussed by Rick Turner, Senior Scientific Director at Quintiles in the April issue of DIA Global Forum. Download the PDF

Philip Scheltens, MD

Thu, 20 May 2010 10:00:24 -0400

Prof. Dr. Philip Scheltens, VU Medical Center, Amsterdam Dr Philip Scheltens studied at the VU University Amsterdam, Netherlands

Eric Siemers, MD

Thu, 20 May 2010 09:25:02 -0400

Eric Siemers, MD Medical Director, Alzheimer’s Disease Eli Lilly Eric Siemers, M.D. is Medical Director of the Alzheimer’s Disease Team at Eli Lilly

Amir Kalali, MD

Thu, 20 May 2010 09:04:06 -0400

Amir Kalali, MD Vice President, Medical and Scientific Services CNS Global Therapeutic Team Leader, Quintiles Amir Kalali, MD, is Vice President, Medical and Scientific Services,

Paul Aisen, MD

Mon, 17 May 2010 16:11:40 -0400

Paul Aisen, MD Professor of Neurosciences Director, Alzheimer’s Disease Cooperative Study, University of California, San Diego Paul Aisen is Professor of Neurosciences at the University

Regulatory Landscapes for Future Antidiabetic Drug Development

Wed, 12 May 2010 15:36:59 -0400

In the March 2010 Journal for Clinical Studies, Dr. Erica Caveney and Dr. Rick Turner analyze the EMA Guidance on diabetes drugs and cardiovascular risk. Download the PDF

Podcast: Clinical Data Standards

Tue, 11 May 2010 08:35:27 -0400

Paula Brown Stafford, Executive Vice President of Integrated Clinical Services, Quintiles, and Chair-elect of CDISC, the Clinical Data Interchange Standards Consortium, explains the importance of data standards in clinical trial execution and how improvements in data collection can better ensure patient safety.

Navigating Future Challenges in Alzheimer's Disease Trials

Mon, 10 May 2010 13:04:28 -0400

Learn more about this exciting program

Podcast: Transformational Change

Tue, 04 May 2010 09:18:05 -0400

Chip Gillooly, Global Vice President of Corporate Development at Quintiles, explains the need for wide-sweeping transformational change within the biopharmaceutical industry.

Introduction to the Due Diligence Process

Tue, 27 Apr 2010 10:37:01 -0400

Introduction to the Due Diligence Process is the essential reference for regulatory professionals and pharmaceutical executives involved in the process of due diligence for product-based

New HIPAA Regulations and Their Impact on Clinical Research

Tue, 20 Apr 2010 13:27:14 -0400

In this article in Update magazine from FDLI, Quintiles' Judy Beach explains recent HIPAA changes and the potential impact on clinical research. Download the PDF

Michael King Jolly, PharmD

Tue, 20 Apr 2010 08:19:26 -0400

Michael King Jolly, Pharm.D, is Senior Vice President of Quintiles Capital, where he leads virtual drug development

John F. Smyth, MD

Tue, 20 Apr 2010 08:12:32 -0400

John F. Smyth, MD Emeritus Professor of Medical Oncology Assistant Principle, University of Edinburgh Edinburgh, UK John Smyth trained in medical oncology at the Royal

Denis Lacombe, MD, MSC

Tue, 20 Apr 2010 08:03:47 -0400

Denis Lacombe, MD, MSC European Organisation for Research and Treatment of Cancer Scientific Director In 1988 Dr. Lacombe graduated as MD from the University of

Daniel Haller, MD

Tue, 20 Apr 2010 07:54:03 -0400

Daniel Haller, MD Professor of Medicine Deenie Greitzer Professor of Gastrointestinal Oncology Abramson Cancer Center at the University of Pennsylvania Daniel Haller is currently Professor

Richard B. Gaynor, MD

Tue, 20 Apr 2010 07:50:39 -0400

Richard B. Gaynor, MD Vice President for Clinical Development and Medical Affairs Oncology Business Unit Eli Lilly and Company

Podcast: Biopharma's Commercialization Challenges

Mon, 19 Apr 2010 09:29:41 -0400

Michael Ackermann, Ph.D., Vice President of Global Commercial Strategy and Alliance, Global Commercial Solutions at Quintiles, discusses the factors that are leading to a radical shift in how biopharmaceutical products are developed and commercialized.

Mapping the Future in Oncology Drug Development

Mon, 29 Mar 2010 12:21:45 -0400

A world-renowned, multidisciplinary panel of experts to investigate challenges in, and propose strategies to enhance, oncology drug development. Download the PDF

Publications

Fri, 26 Mar 2010 08:29:04 -0400

Quintiles' experts contribute regularly to academic journals and other medical or trade publications.

CVCT Forum: Preparing Data for the DSMB

Tue, 23 Feb 2010 14:41:48 -0400

Data Cleaning Issues — Preparing the Data for the DSMB How you prepare data for monitoring boards can help streamline your cardiovascular approval or delay Download the PDF

Podcast: Data Driven Patient Recruitment

Tue, 23 Feb 2010 10:38:40 -0400

Dr. Christopher Cabell discusses the extraordinary opportunity for the biopharmaceutical industry to better use data for patient recruitment.

Journal for Clinical Studies

Fri, 19 Feb 2010 11:00:10 -0400

In the January 2010 Journal for Clinical Studies, Dr. Erica Caveney and Dr. Rick Turner analyze the FDA Guidance on diabetes drugs and cardiovascular risk. Download the PDF

Interpreting the Interval

Thu, 10 Dec 2009 15:16:08 -0400

Dr. Rick Turner’s recent article looks at the design, methodology, analysis and interpretation of the ICH Guideline E14 thorough QT/QTc study. Download the PDF

Podcast: New Realities Require New Approach

Tue, 01 Dec 2009 14:34:07 -0400

Dr. Uwe Maennl, Vice President and Global Head of Lifecycle Safety, explains why taking a lifecycle approach to safety is a business imperative.

Pharmacovigilance across the Lifecycle

Mon, 30 Nov 2009 00:00:00 -0400

Uwe Maennl, Vice President and Global Head of Lifecycle Safety discusses the benefits of an integrated lifecycle safety approach and provides practical guidance on evolving Download the PDF

Late Phase Patient Reported Outcomes

Wed, 04 Nov 2009 15:32:12 -0400

Applied Clinical Trials October 2009 Download the PDF

Late Phase Studies: An Early Priority

Wed, 04 Nov 2009 15:29:13 -0400

Next Generation Pharmaceutical, Q4 2009 Download the PDF

Sound responses to the changing late-phase game

Wed, 04 Nov 2009 15:25:29 -0400

Next Generation Pharmaceutical, Q3 2009 Download the PDF

Enhancing a Culture of Safety in the Life Sciences Sector

Tue, 06 Oct 2009 12:51:38 -0400

Axel Olsen stresses that stakeholder collaboration is the key to improving drug safety. Download the PDF

Comparative Effectiveness Research as a Drug Development Tool

Tue, 01 Sep 2009 08:04:02 -0400

A Q&A with John Doyle sheds light on the complex issue of comparative effectiveness research, and its strategic importance in successful and efficient biopharmaceutical development. Download the PDF

Podcast: Changing the Face of Cancer Research

Mon, 31 Aug 2009 12:13:18 -0400

Christopher Ung, Vice President, Strategic Business & Operations, Oncology, Quintiles, explains how advances in biomarker technology are ushering in a new era of cancer therapy development. Download the PDF

Podcast: Changing the Face of Cancer Research

Mon, 31 Aug 2009 12:13:18 -0400

Claire Huguet

Wed, 08 Jul 2009 10:18:34 -0400

Dr. Claire Huguet, an expert in clinical laboratory operations and biomarkers, brings more than 20 years of experience to Quintiles Central Laboratories.

The Future of Data Management

Tue, 30 Jun 2009 11:12:59 -0400

Paula Brown Stafford, MPH EVP, Integrated Clinical Services

Early phase strategies

Mon, 15 Jun 2009 14:49:48 -0400

Web cast about Early Phase Strategies.

Charting a New Course by Catalyzing Transformation

Tue, 09 Jun 2009 10:54:05 -0400

Adrian McKemey, Quintiles Consulting Product Development and Commercialization Practice Leader, and Michael Arlotto, Senior Vice President Corporate Development Quintiles, discuss how organizations are transforming their clinical organizations to more effectively deliver safer drugs.

Building Bridges

Tue, 02 Jun 2009 15:09:57 -0400

Pharmaceutical companies are recognizing that a preferred provider relationship with a central lab service provider can bridge processes across projects and enable a consistent platform across an entire drug program. Download the PDF

Placing Patients First

Tue, 26 May 2009 21:05:39 -0400

Regaining and restoring the public's trust in the pharmaceutical industry is of the utmost importance. Download the PDF

Anatomy of a Managed Partnership

Tue, 26 May 2009 20:55:45 -0400

Partnering affords pharma the opportunity to bolster development pipelines without taking on additional risk or adding to fixed costs. Download the PDF

Making Headway in Shifting Winds by Maximizing Value

Fri, 01 May 2009 10:57:45 -0400

Three experts discuss how personalized medicine and more targeted therapies are causing organizations to change their commercial organizations.

Setting Sail for Success by Optimizing Productivity

Wed, 01 Apr 2009 11:06:10 -0400

Quintiles Consulting Market Intelligence (Eidetics) Practice Leader James Kirk and our process optimization expert Principal Consultant Mike Hagan discuss how you can optimize productivity in your organization.

Robert A. Pearlstein

Wed, 25 Mar 2009 15:24:43 -0400

Bob is a co-founder of Eidetics, and has over two decades of experience assessing commercial opportunities and creating product strategies for biopharma and medical device clients worldwide.

George A. Mabry

Wed, 25 Mar 2009 15:21:43 -0400

George joined Eidetics in 1989 after a successful career in consumer and industrial products marketing and strategic planning. He previously held product management positions at General Foods and senior marketing management positions at Teradyne.

James C. Kirk

Wed, 25 Mar 2009 15:19:01 -0400

Jim joined Eidetics in 1988 from senior management positions in consumer and industrial product marketing, strategy, and development positions at Ocean Spray Cranberries and Gillette Company. Previously at Ocean Spray, Jim successfully spearheaded the company’s new Ingredient Division.

Frederick M. Gale, MD, FACS

Wed, 25 Mar 2009 15:15:30 -0400

A co-founder of Eidetics, Frederick brings over 20 years of experience in strategic research and consulting support for the pharmaceutical, biotech, and medical device industries.

Geoff Garabedian

Wed, 25 Mar 2009 15:08:35 -0400

As Practice Leader for Regulatory and Quality in the U.S., Geoff combines a strong management consulting background with specific experience in the regulatory and compliance arena, including design and implementation of large-scale process, organization and technology transformations.

Deepa Desai, BHMS

Wed, 25 Mar 2009 14:58:43 -0400

Deepa Desai, B.H.M.S., is the senior manager and head of laboratory operations for Quintiles ECG services in India.

Mandar Dasture, M. Pharm, PMP

Wed, 25 Mar 2009 14:55:42 -0400

Mandar Dasture, M. Pharm, PMP is responsible for supervising project management staff across all Quintiles ECG locations.

Jason Parker, BEng.

Wed, 25 Mar 2009 14:53:30 -0400

Jason Parker, BEng., is Senior Director of Technology for Quintiles.

Dhiraj Narula, MD

Wed, 25 Mar 2009 14:45:23 -0400

Dhiraj Narula, MD, joined Quintiles ECG Services in 2004 as medical director. A board certified cardiologist and electrophysiologist, he is a member of the Royal College of Physicians in the United Kingdom and a Fellow of the American College of Cardiology.

John Doyle, Dr.P.H., MPH

Wed, 25 Mar 2009 14:29:30 -0400

John Doyle, Dr.P.H., MPH, is Senior Vice President and Practice Leader, Commercial and Market Access Strategy, Consulting at Quintiles.

Adrian McKemey, Ph.D.

Wed, 25 Mar 2009 13:52:40 -0400

Adrian leads the Product Development and Commercialization consulting practice at Quintiles Global Consulting.

Jim Featherstone, Ph.D.

Wed, 25 Mar 2009 13:27:40 -0400

Jim joined Quintiles Consulting from Wood Mackenzie, a leading business intelligence and strategy consulting services company based in the UK, where he was the Global Head of Consulting for the Pharmaceuticals and Biotechnology practice.

Matthew Eberhart

Wed, 25 Mar 2009 13:11:24 -0400

Matt is a proven business-building executive with a strong track record of implementing successful business development initiatives for consulting healthcare companies in both North America and Europe.

Jay Norman

Tue, 24 Mar 2009 17:05:58 -0400

President – Quintiles Consulting Jay brings 25 years of experience in the consulting industry and a strong track record of growth, most recently with Diamond Management and Technology Consultants, where he served as President and Chief Operating Officer.

Evidence-Based Development and Smarter Sourcing

Mon, 09 Mar 2009 11:22:16 -0400

Jay Norman, president of Quintiles Consulting, discusses the changing landscape of drug development and suggests that better, evidence-based decisions, combined with smart sourcing strategies, will differentiate the future winners. Download the PDF

Overcoming Global Challenges

Mon, 02 Mar 2009 11:42:26 -0400

Learn about strategies to overcome globalization challenges from John Doyle, Market Access Practice Leader, and Geoff Garabedian, Regulatory and Quality Systems Practice Leader in podcast brought to you by PharmaVoice.

Podcast: A New Gold Standard

Thu, 01 May 2008 14:58:56 -0400

John Doyle discusses the concept of a health economic balance sheet and the need for evidence-based pricing for biopharmaceutical valuation. Download the PDF

International Society of CNS Drug Development Depression Rating Scale Standardization Team

Fri, 01 Apr 2005 11:27:02 -0400

A recently published review of studies evaluating the Hamilton Rating Scale for Depression posed the question: Has the Gold Standard become a lead weight?

Letter to T. Thompson Dept Health & Human Services

Fri, 30 Mar 2001 13:43:35 -0400

It is the corporate policy of Quintiles, its affiliates and subsidiaries to protect the confidentiality of individually identifiable health information. Quintiles has been involved in performing health-related research for many years and has always regarded the protection of patient privacy and confidentiality as a fundamental principle of medical ethics. Quintiles believes that the privacy rule represents a necessary step toward establishing national standards to support the efficiency and security of the health information infrastructure, and thereby allow progress toward the goals of improving health care quality and reducing administrative costs as envisioned in the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Download the PDF