PharmaVOICE - 
June 2017
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Letter from the Editor
Trial transformation IBM Watson, Microsoft, Oracle, GE are among the [...]

Taren Grom, Editor

Allergan Encourages Those with Migraine to Share Experiences Through Art [...]

PharmaVOICE Staff

Innovator’s Corner
Regenerative Medicine Research Tackles Hearing Loss Chris Loose, Ph.D., Co-founder [...]

Chris Loose, Ph.D., Co-founder and Chief Scientific Officer, Frequency Therapeutics

J&J Company Buys 3D Printing Technology to Create Bone-healing Implants [...]

PharmaVOICE Staff

Last Word
Bringing Patients’ Voices to Drug Development Sudip Parikh, Senior VP [...]

Sudip Parikh, Senior VP and Managing Director, DIA Americas

On The Cover

The Clinical Trials Technology Ecosystem
Data are — and will continue to be — the linchpin for clinical trials. In the future, fewer data points will come from the traditional investigator-led EDC data entry process. Emerging technologies offer an incredible potential in transforming drug development. The ability to pool real-world data evidence information from payers, from insurance companies, EMR integration, [...]

Denise Myshko


Marketing Mashup: Client and Agency Do’s and Don’ts
A true partnership is a rare find, and when a pharma client and an ad agency develop one, magical things happen. Much like any relationship, these partnerships take chemistry, communication, transparency, trust, and commitment. Also, setting expectations clearly and up front helps smooth the partnership road. PharmaVOICE interviewed five client-agency “couples,” each with their own [...]

Robin Robinson

City Centers of Excellence
There is no disputing that the top two centers of R&D excellence in the country are San Francisco and Cambridge, Mass. However, there is much friendly debate between the two locations on which hub actually takes first place. While Bloomberg Business recently ranked Massachusetts No. 1 for innovation, San Francisco was ranked a close second. [...]

Robin Robinson

Malaria Research Update
Despite the successful deployment of multiple interventions against malaria, there were an estimated 212 million cases of malaria and an estimated 429,000 malaria deaths worldwide in 2015, according to the most recent figures from the World Health Organization. Malaria is a mosquito-borne disease caused by a parasite. People with malaria often experience fever, chills, and [...]

Denise Myshko

Supply and Demand: Getting Rare Disease Treatments to Patients
Collectively, about 7,000 different types of rare diseases affect around 350 million patients globally. A disease is considered rare if it affects fewer than 200,000 people in the United States or one in 2,000 people in Europe, but the burden such diseases place on patients, communities, and healthcare systems is vast. Today, a growing number [...]

Kim Ribbink

SHOWCASE FEATURE: Clinical Trial Solutions: Redefining the Clinical Trial Solution Landscape
Clinical trial solutions bring together technology, product, and services to automate and better manage the clinical trial process. In addition to helping to reduce time and cost, clinical trial solutions are also vital for improving data management and in integrating data from different trials for clearer analysis. Clinical trial solutions typically include electronic data capture [...]

PharmaVOICE Staff

Moving Down the Digital Path: The Next Evolution in Clinical Trials Testing
The continued emergence of personalized medicine alongside the need for more consistent and less variable tissue analysis and interpretation has led to an increased reliance on central laboratories to perform anatomic pathology testing and services in support of clinical studies. This demand, coupled with a growing shortage of pathologists worldwide, has also placed considerable pressure [...]

Robert A. Carlson, M.D., VP, Medical Affairs, ACM Global Laboratories

Responding to Increased FDA Focus on Data Integrity
As clinical trials grow in complexity and new technologies emerge for capturing clinical data, the need to improve sustainability of data integrity throughout study conduct has heightened. Over the past five years, the volume of data integrity-related CGMP violations have grown in prevalence. In fact, the number of issued warning letters has more than tripled [...]

Don Zinn, Practice Director, Validation Services, Advanced Clinical

Can CRA Empowerment Make Clinical Trials More Successful?
A high clinical research associate (CRA) turnover rate — exceeding 25% annually — coupled with an often checklist-driven monitoring style can lead to a toxic environment for site staff. This impersonal atmosphere can lead to a negative feedback loop, in which CRAs become disengaged with the job and cause frustrated investigators to de-prioritize a trial. [...]

John Boland, VP of Product Development, Atlantic Research Group

Choosing the Right EDC/DM Partner: Critical Considerations for Small-toMedium-Sized Life Sciences Organizations
Whether you are a start-up pharmaceutical or biotech company, a medical devices innovator, or an established organization you want to be equipped with the best possible solution for your study. For small- to medium-sized organizations finding an eClinical partner that is not only competitive but the correct fit is crucial to both program and organizational [...]

Andrew Schachter, Founder and CEO, Axiom Real-Time Metrics

Improved Patient-Centricity Means Improved Patient Diversity Too
Increasing the diversity of patients enrolled in clinical trials of new medicines has become a growing theme for improving the clinical trial process. There is broad recognition that research participants need to be representative of the patient population who will ultimately use the product. Responses to medications can vary according to a variety of factors, [...]

Scott Gray, CEO, Clincierge

Accelerating the Shift to Digital in Life Sciences
An unprecedented wave of value is about to explode for pharmaceuticals companies and medical device makers that embrace digital approaches to doing business. Digital mastery will result in renewed opportunities for life sciences companies to forge deeper connections in the currently fragmented industry, collaborate more fully with value chain participants and drive better health outcomes [...]

Bhaskar Sambasivan, Senior VP & Global Markets Leader, Cognizant Life Sciences

eConsent: Reducing Uncertainty to Retain Patients
Imagine you’re applying for a new bank account. A bank associate guides you through forms, pointing at where your signature belongs. He’s got good intentions and wants to help, but speaks quickly with jargon and acronyms. You leave feeling cautiously optimistic, as you still have questions. Weeks later, you discover hidden fees — and wind [...]

Eric Delente, President, Patient Solutions, DrugDev

21st Century Trials Demand 21st Century Technology
The pharmaceutical industry can pride itself on its use of state-of-the art technology in drug discovery using such advances as robotics, molecular modeling, and powerful computational software. Oddly, though, the industry has been slow to take advantage of technology to support clinical operations. Consequently, clinical trial systems are notoriously inefficient as they depend on many [...]

Chris Hall, Director, eCOA Product & Clinical Science Consulting, ERT and Brion Regan, Product Manager, Trial Oversight, ERT

Transforming Trials: Reducing Cost and Risk
The total sponsor cost per new drug compound approved in the United States now exceeds .5 billion, including nearly .5 billion for clinical development — an astounding 145% jump in just 15 years, according to the Tufts Center for the Study of Drug Development1. With just 7% of first-in-human drugs gaining FDA approval in the [...]

Dr. Phil Birch, VP, Strategic Alliance Management, ICON

Talent Acquisition with 20/20 Vision
Is your talent strategy in focus for the year 2020?   The global life science industry faces significant challenges due to geo-political unrest, evolving regulatory controls, the aging workforce, and heightened public awareness around the cost of drugs and overall healthcare expenditures. Simultaneously, demographic shifts, lifestyle changes, and technological advancements are creating opportunities for accelerated [...]

Kevin Duffy, Global VP, Global Solutions, Life Science & Healthcare, KellyOCG

EEG Meets Cloud Computing
A 2011 report from the Tufts Center for the Study of Drug Development suggests that CNS trials are far more complex and costly for pharmaceutical companies to develop than other medicines. Compounds for CNS drugs spend about 8.1 years in clinical testing and 1.9 years in the regulatory process. It can take up to 18 [...]

Simon Griffin, CEO, Lifelines Neurodiagnostic Systems, Inc.

The Evolution of Clinical Data Management Through Cloud Computing
Rapid advances in technology are fundamentally changing the role of the data manager. Don’t worry: robots aren’t taking over. But, cloud computing is transforming the way we conduct clinical trials, and massive computing power is enabling analytics and machine learning to become a more integral part of data management. At its core, cloud computing enables [...]

Mike Capone, Chief Operating Officer, Medidata

Providing Meaningful Outcomes for Rare Disease Patients and Clinical Developers
Successful rare disease studies demand different approaches on a number of levels. Early access studies for patients who are living with life altering of rare diseases call for differences regarding study design, regulatory considerations, patient support in study conduct, and an eye to early phase translational medicine techniques to provide successful patient-centric study outcomes. Fast [...]

Richard Scheyer, VP, Medical Affairs, Medpace

Speak Out
Are Early Phase Clinical Trials and Electronic Data Capture Still an Unlikely Pair? At a time when technology is well and truly embedded within people’s everyday lives, the adoption of modern technology within clinical research has been an obvious step forward for the industry. Fifteen years ago, Electronic Data Capture (EDC) in clinical research was [...]

Dr. George Atiee, Vice President and Medical Director, Worldwide Clinical Trials Early Phase Services Unit