June 2016

Letter from the Editor

June 1, 2016

Scurvy + Science In May 1747, the HMS Salisbury of Britain’s Royal Navy fleet was patrolling the English Channel at a time when scurvy is thought to have killed more British seamen than French and Spanish arms. According to the Association of Clinical Research Professionals (ACRP), aboard this ship, surgeon mate James Lind, a pioneer […]

UpFront

June 1, 2016

Industry at Large Sanofi Genzyme Donates Corporate Archives To Harvard Business School Sanofi Genzyme is donating materials to create an extensive archival collection, spanning the more than three decades since the company’s founding in 1981, to the Historical Collections of Harvard Business School (HBS) Baker Library. Materials in the Genzyme Archive, as permitted by the […]

Innovator’s Corner

June 1, 2016

 A “Universal” Flu Vaccine in the Works Tim Alefantis, Ph.D., Sanofi Pasteur’s R&D lead on the second-generation vaccine program, and Sam Lee, Ph.D., project strategy for Sanofi Pasteur’s pandemic and new influenza vaccines, talk about the company’s work to develop a broadly effective influenza vaccine. Influenza is a serious disease that can lead to hospitalization […]

mHealth

June 1, 2016

Baxter Strives to Improve Health of Women and Children in India via Mobile App Trending now:  Pharma continues to support patients through mobile services. Baxter and the Baxter International Foundation, in conjunction with Bangalore’s Health Department and World Vision India, has launched a mobile health application that allows community health workers to better monitor the […]

Pharma Trax

June 1, 2016

Surge in Biosimilars to Drive Significant Change in Health System Costs Trending now:  Sustainable competitive markets and support for innovation, clinical education, and incentives are needed to deliver full value. Greater acceptance of biosimilar medicines in a growing number of therapy areas and an active pipeline of 56 new products in clinical development are expected […]

What’s New

June 1, 2016

SBP and GSK Create Center for Translational Neuroscience  Trending now: Academic-industry alliance seeks to find and validate new targets for drug development. Sanford Burnham Prebys Medical Discovery Institute (SBP), a fundamental and translational research institute, and GlaxoSmithKline (GSK), a global pharmaceutical company, have created the SBP-GSK Center for Translational Neuroscience. The new center, located on […]

Tools of the Trade

June 1, 2016

Ogilvy CommonHealth Worldwide Launches the Ogilvy CommonHealth Marketing Cloud Trending Now:  New service redefines data-driven marketing services for the life-sciences industry. Ogilvy CommonHealth Worldwide, the health behavior change specialists of Ogilvy & Mather, and a WPP company, has launched the Ogilvy CommonHealth Marketing Cloud platform, a first of its kind, data-driven offering to help marketers […]

The Calendar

June 1, 2016

Coming Attractions The inaugural Rational Combinations 360° — June 23 – 24, 2016 Park Lane Hotel, New York, NY — is the only event addressing business aspects, novel clinical trial designs, and scientific developments for combination immunotherapies. With promising cancer immunotherapies in the clinic and an encouraging pipeline of new targets being developed, additional discoveries […]

Talent Pool

June 1, 2016

Pharma pool Bob Chib Cassie Hogenkamp Astellas Announces Key Leadership Appointments Astellas has named Bob Chib and Cassie Hogenkamp to key leadership roles within its corporate development function to advance the strategic capabilities of Astellas’ Americas operations and further strengthen the company’s focus on patient needs. Mr. Chib is serving as executive director, corporate strategy, […]

Last Word

June 1, 2016

Patient-Centricity: More than a Catch Phrase John McCarthy, VP of Global Commercial Excellence at AstraZeneca, talks about why putting patients first should be a core focus of the biopharma industry. PV: How is AstraZeneca addressing the trend of patient-centricity? McCarthy: Patient-centricity can be a way of thinking about how patients’ needs are being addressed while […]

The Changing Clinical Landscape

June 1, 2016

Clinical operations — the department that manages the operational aspects of clinical studies — is facing increased challenges: compressed timelines; increased competition for sites and patients; more complex study protocols; increased regulatory expectations; and new technologies and industry standards. Clinical operations is transitioning to align with innovative methodologies for faster and more efficient study start […]

Data Analytics Create Better Commercial Strategies

June 1, 2016

The pharmaceutical industry is not immune to the glut of data being generated by medical records, social media, and connected medical devices. It cannot ignore the possibilities that these big data sets can bring to the commercial strategy table. The time is now to embrace the myriad amounts of critical information available and translate them […]

Mobile Technology Increases Patient Engagement

June 1, 2016

More than 60% of smartphone users used their mobile device to search for information about a health condition, according to Pew Research Center. The analysts at eMarketer have forecast that pharma digital ad spending will rise to $2.55 billion by 2019. This growing evolution in digital applications to monitor and improve health sets the foundation […]

2016 DIA Preview

June 1, 2016

This year’s annual meeting of the Drug Information Association is expected to draw more than 7,000 attendees for the largest global interdisciplinary gathering of life-sciences professionals. DIA 2016 is packed with more than 175 educational offerings over 22 tracks on today’s hottest topics, and more than 450 companies will be exhibiting. This year’s meeting will […]

CNS Research Challenges

June 1, 2016

Neurological disorders consist of more than 600 conditions, impacting an estimated 50 million Americans every year. Although some are well known, many are rare disorders that affect a small number of patients who currently have access to few, if any, effective treatments. Research in the CNS area has been cyclical. Now there is an upward […]

China: An Emerging Pharmaceutical Super Power

June 1, 2016

Over the past 25 years, China has been on an extraordinary economic trajectory. Economic and political reforms that were implemented in the latter part of the last century have transformed the country. “The result is the emergence of a new economic and political super power with global GDP performance second only to that of the […]

SHOWCASE FEATURE: Clinical Trial Solutions: Serving the Clinical Trial Ecosystem

June 1, 2016

With drug development costs topping $2 billion, R&D spending at an all time high, and as the global market for clinical trials continues to grow and diversify, there is increasing pressure on the industry to bring drugs, biologics, and devices to market with increased speed and greater efficiency. Helping to drive much-needed changes in a […]

Inside the Central Laboratory Model For Clinical Trials Diagnostic Testing

June 1, 2016

Central laboratories — charged with providing harmonized clinical diagnostic testing and a consolidated database for clinical trial sponsors — continue to evolve against the backdrop of an increasingly complex clinical trial environment. Today the industry balances the demands of complicated laboratory testing requirements, budget restrictions, and geographical challenges while maintaining a constant focus on the […]

Are You Ready for Risk-Based Monitoring? Conditions for RBM Readiness

June 1, 2016

Choosing your first risk-based monitoring (RBM) program is a big decision. As RBM continues to gain traction in many clinical programs across our industry, it is important to know how to evaluate when RBM is the best choice for your development program. Service providers have been confronted by various challenges in implementing RBM programs, ranging […]

More Than Child’s Play: Uncovering the Role of Video Games in Patient Education

June 1, 2016

Over the past few decades, advances in technology and creative talent from programmers, artists, and writers have spawned a new generation of video games and those who play them, contributing to a $22.4 billion market. Many people assume video games are for entertainment only, but that assumption disregards the massive educational potential that scientific research […]

How Bring Your Own Device and Other Innovations Are Improving Patient Engagement

June 1, 2016

Improving how patients participate in clinical trials is an essential challenge for the industry. The past few years have seen an encouraging shift of attention to the various ways we can improve patient engagement in research programs. In the past, patient engagement focused on how we recruit subjects for clinical trials, and small interventions that […]

Patient-Centricity Key to Rare Disease Trial Success

June 1, 2016

Patient-centricity has become a buzzword in the clinical development world. But for rare disease trials, “putting patients first” isn’t just an ideal, it’s an essential element to the success of such studies. The challenges of recruiting and retaining sufficient patient numbers to power a study to show value to both regulators and payers are substantial. […]

Shared Investigator Platform Making Life Easier For Clinical Investigators

June 1, 2016

Life sciences companies are under continual pressure to reduce clinical trial costs and the time it takes to bring a new therapy to market. Clinical trial challenges include subject retention, medical adherence, and managing the huge volume of administrative documents and tasks required of investigative sites. The administrative work necessary for startup and management represents […]

Clinical Performance Management

June 1, 2016

Today, global biopharma and medical device companies lament their inability to effectively harness the wealth of data they generate to help guide their thinking and inform decisions.  The result is that organizations require valuable resources to spend enormous amounts of time preparing reports that often contain outdated and incomplete data  across global geographies. Global trial […]

Thoughtful Technology to Reduce Burden For Clinical Trial Sites and Patients

June 1, 2016

The concept of patient-centricity in research is about offering patients a better clinical trial experience. As such, there are a variety of ways to enhance the engagement of the patient. These include empowering other key stakeholders — sponsors, CROs, and sites — with better tools to improve the interactions with their patients.  Every patient’s needs […]

An Industry Call to Action: A Convergence Model Driven By Real World Intelligence

June 1, 2016

As payers escalate measures to contain costs, providers adjust to new models such as the Affordable Care Act, and patients assume more financial responsibilities for their care, manufacturers are being forced to generate more complex and comprehensive bodies of real world evidence (RWE) about drugs’ effectiveness and value. Given the industry’s R&D productivity challenge and […]

Industry Trends for Life-Science Talent

June 1, 2016

What workforce trends can the life-sciences industry expect to see through the end of 2016?  Developments that were set in motion in the past two years will continue to disrupt the market, broadening the life-sciences workforce spectrum, and change how top talent wants to be engaged. Workforce Engagement Challenges Mergers & Acquisitions. The trend of […]

How Uber’s Tech Model Is Driving Improvements in Clinical Trial Payments

June 1, 2016

In Tom Goodwin’s oft-quoted article in TechCrunch last year, he says: “Uber, the world’s largest taxi company, owns no vehicles. Facebook, the world’s most popular media owner, creates no content. Alibaba, the most valuable retailer, has no inventory. And Airbnb, the world’s largest accommodation provider, owns no real estate. Something interesting is happening.” The “Ubers” […]

Biomarkers Supporting Clinical Trials: A Quality Driven & Integrated Approach to Advancing Drug Development

June 1, 2016

The pharmaceutical industry faces major challenges; patent expiry, generic competition, weak pipelines, spiralling R&D costs, high attrition rates, and falling drug approval rates. In response, the drug development landscape is set for major changes in the coming five to 10 years. Most pharmaceutical companies, and smaller biotech companies, have already embraced a biomarker approach to […]

Assessing SaaS Vendors in Clinical Research: Best Practices to Ensure Compliance

June 1, 2016

As the adoption of digital technology such as cloud-based data capture and management into clinical research has increased, the scope and complexity of conducting – and, therefore, preparing for – regulatory audits have become more complex. This trend, coupled with the expansion of trials across time zones and languages, has made it more critical than […]

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