PharmaVOICE - 
June 2016
Purchase Issue

PV0616_Cover

In Every Issue
Letter from the Editor
Scurvy + Science In May 1747, the HMS Salisbury of [...]
By

Taren Grom, Editor

UpFront
Industry at Large Sanofi Genzyme Donates Corporate Archives To Harvard [...]
By

PharmaVOICE Staff

Innovator’s Corner
 A “Universal” Flu Vaccine in the Works Tim Alefantis, Ph.D., [...]
By

Tim Alefantis, Ph.D., Sanofi Pasteur and Sam Lee, Ph.D., Project Strategy for Sanofi Pasteur

mHealth
Baxter Strives to Improve Health of Women and Children in [...]
By

PharmaVOICE Staff

Pharma Trax
Surge in Biosimilars to Drive Significant Change in Health System [...]
By

PharmaVOICE Staff

What’s New
SBP and GSK Create Center for Translational Neuroscience  Trending now: [...]
By

PharmaVOICE Staff

Tools of the Trade
Ogilvy CommonHealth Worldwide Launches the Ogilvy CommonHealth Marketing Cloud Trending [...]
By

PharmaVOICE Staff

The Calendar
Coming Attractions The inaugural Rational Combinations 360° — June 23 [...]
By

PharmaVOICE Staff

Talent Pool
Pharma pool Bob Chib Cassie Hogenkamp Astellas Announces Key Leadership [...]
By

PharmaVOICE Staff

Last Word
Patient-Centricity: More than a Catch Phrase John McCarthy, VP of [...]
By

John McCarthy, VP of Global Commercial Excellence, Astrazeneca

On The Cover

The Changing Clinical Landscape
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 [...]
By

Denise Myshko and Taren Grom

Features

Data Analytics Create Better Commercial Strategies
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 [...]
By

PharmaVOICE Staff

Mobile Technology Increases Patient Engagement
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 .55 billion by 2019. This growing evolution in digital applications to monitor and improve health sets the foundation [...]
By

Robin Robinson

2016 DIA Preview
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 [...]
By

PharmaVOICE Staff

CNS Research Challenges
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 [...]
By

Denise Myshko

China: An Emerging Pharmaceutical Super Power
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 [...]
By

Kim Ribbink

SHOWCASE FEATURE: Clinical Trial Solutions: Serving the Clinical Trial Ecosystem
With drug development costs topping 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 [...]
By

Taren Grom, Editor

Inside the Central Laboratory Model For Clinical Trials Diagnostic Testing
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 [...]
By

Mark Engelhart, Chief Commerical Officer and Jerry Boxall, Managing Director, ACM Europe and Asia, ACM Global Laboratories

Are You Ready for Risk-Based Monitoring? Conditions for RBM Readiness
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 [...]
By

Cheryle Evans, Senior VP, Clinical and Medical Operations, Advanced Clinical

More Than Child’s Play: Uncovering the Role of Video Games in Patient Education
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 .4 billion market. Many people assume video games are for entertainment only, but that assumption disregards the massive educational potential that scientific research [...]
By

Allison R. Musante, Copywriter and Editor in the Life Sciences, Artcraft Health

How Bring Your Own Device and Other Innovations Are Improving Patient Engagement
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 [...]
By

Adam Butler, Senior VP, Strategic Development, Bracket

Patient-Centricity Key to Rare Disease Trial Success
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. [...]
By

Scott Gray, CEO, Clincierge

Shared Investigator Platform Making Life Easier For Clinical Investigators
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 [...]
By

Bhaskar Sambasivan, VP, Global Markets Leader, Life Sciences and Beenu Kapoor, Senior Director, Cognizant Business Consulting, Cognizant

Clinical Performance Management
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 [...]
By

Larry Florin, Clinical Leader, Life Sciences R&D Practice, Cognizant

Thoughtful Technology to Reduce Burden For Clinical Trial Sites and Patients
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 [...]
By

Kevin T. Williams, MBA/MS, VP, Corporate Development, DrugDev

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

Ramita Tandon, Executive VP Commercialisation and Outcomes, ICON plc

Industry Trends for Life-Science Talent
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 [...]
By

Kevin D. Duffy, Global VP, Life Sciences Vertical, Kelly Outsourcing and Consulting Group and Mark Lanfear, VP & Global Practice Leader, Life Science Solutions, Kelly Outsourcing and Consulting Group

How Uber’s Tech Model Is Driving Improvements in Clinical Trial Payments
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” [...]
By

April Mulroney, Managing Director, Payments, Medidata Solutions

Biomarkers Supporting Clinical Trials: A Quality Driven & Integrated Approach to Advancing Drug Development
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 [...]
By

Paul Travis, BSC MSC, Executive Director, Global Laboratory Business Strategy and Development, Medpace

Assessing SaaS Vendors in Clinical Research: Best Practices to Ensure Compliance
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 [...]
By

Anu Virkar, VP, Quality and Compliance, Merge, an IBM Company, eClinical Division

Cancer Immunotherapy and Other Advanced Therapies: Opportunity and Challenges Combine to Bring Tomorrow’s Treatments to Patients
The immunotherapy field holds great promise.  Many of these therapies represent a “breakthrough“ in cancer treatment, as well as other diseases and disorders, and may revolutionize the way we treat various illnesses. As an example, immunotherapy treatments for oncology can be delivered using a variety of techniques and classes of agents, including: Monoclonal antibodies (mAbs) [...]
By

Etienne Drouet, VP, Strategic Development, SynteractHCR

Healthcare Needs A Hero
Hero is a big word. The image it brings to mind is someone who saves the day or who stands up for what is right. The bar is set pretty high for what makes a hero today. The pharma industry is full of heroes. They don’t walk around wearing capes or rappel down the face [...]
By

Patrick Lindsay, President, United BioSource Corp.

Complexity and Specialization: An Inevitable Dance
For decades, general practitioners successfully managed the healthcare needs of entire families. From treating the common cold to addressing urgent injuries, from delivering babies to providing geriatric care, the family doctor was there to see us through all walks and phases of life. Today, although many of us reflect on that period in time with [...]
By

Donal A. Deieso, PH.D., Chairman and CEO, WIRB-Copernicus Group

Speak Out
Reframing the adherence challenge Jennifer Sigaud, MD of Atlantis Healthcare, US, says it’s time to think differently IN my 20+ year career, there have been tremendous advancements in the world of healthcare, including new and better medications. Yet one problem continues to plague marketers, HCPs and other healthcare stakeholders: treatment adherence. It’s the albatross of [...]
By

Jennifer Siguad, MD of Atlantis Healthcare, US, says it's time to think differently.

Preparing for the Silver Tsunami
The Intersection of Healthcare and Technology With more than 10,000 people a day turning 65 in the United States — equating to more than 2 billion seniors by 2050 — the healthcare industry needs to prepare to meet the demands of this older population. Patient care and technology are converging, and together they have the [...]
By

Tunstall Panel Discussion

FEEDBACK