PharmaVOICE - 
June 2015
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In Every Issue
Letter from the Editor
In the rare disease community there is saying: Alone we [...]
By Taren Grom, Editor
UpFront
Genentech Supports New STEM Initiative Genentech has launched Futurelab, a [...]
By PharmaVOICE Staff
Innovator’s Corner
The 3D Human Body Frank Sculli, Co-founder and CEO of [...]
By Frank Sculli, Co-founder and CEO of BioDigital
The Network
IBM Partners For Advanced Health Data Collection Trending Now: Apps [...]
By PharmaVOICE Staff
What’s New
Medicines360 is Driven to Empower Women Trending now:  New nonprofit [...]
By PharmaVOICE Staff
Tools of the Trade
N-of-One Launches App Sequencing Data Trending Now: As the life-sciences [...]
By PharmaVOICE Staff
Pharma Trax
Uptake of Digital Records Not sufficient to Drive Better Care [...]
By PharmaVOICE Staff
The Calendar
Coming Attractions The annual BIO International Convention, June 15-18, 2015, [...]
By PharmaVOICE Staff
Talent Pool
Biopharma Pool David Allsop Amicus Therapeutics Appoints Senior VP, International [...]
By PharmaVOICE Staff
Last Word
Pharma’s Health Mission Novo Nordisk North America President Jesper Hoiland [...]
By Jesper Hollad, President North America, Novo Nordisk

On The Cover

Rare Diseases: Research, Development, and Commercialization
In the past few years, significant progress has been made in rare diseases; in 2014, orphan drugs constituted 17 of the 41 new molecular entities approved by the Food and Drug Administration. An average of 140 drugs have been designated as orphan drugs by the FDA each year over the past decade, compared with 64 [...]
By Denise Myshko

Features

Patient Engagement: Not Just For Physicians Anymore
When Pfizer wanted to engage with people living with chronic pain, it used an online crowdsourcing model and social media campaign that connected thousands of people, from patients and caregivers, to nurses and doctors. In what was the first initiative of its kind by a pharmaceutical company, Pfizer collaborated with patient advocacy groups to launch [...]
By Robin Robinson
Wearables in Clinical Trials
Wearables are emerging as a solution for creating a more nimble and efficient clinical trial process, from recruiting patients to collecting real-world patient data. While the movement is still in its infancy and there are several challenges and hurdles to overcome before wearables become commonplace in the industry, there are demonstrable benefits of using wearables [...]
By Robin Robinson
The Importance of CROs For Oncology Trials
Oncology trials are different from trials in other therapeutic areas. They are often more complex, involve adaptive design, and can include biomarker and companion diagnostics. They require CROs with therapeutic experience and the knowledge and skills to address these more complex studies. Cancer is not a single disease, says Andrew Zupnick, Ph.D., senior director, oncology [...]
By Denise Myshko
2015 DIA Preview
The DIA Annual Meeting brings together key thought leaders and innovators from industry, academia, government and regulatory agencies, health, patient, and philanthropic organizations from around the globe and across all disciplines involved in the discovery, development, and life-cycle management of medical products. This year’s meeting includes 76 forums, 117 sessions, 12 innovation theater presentations, 21 [...]
By PharmaVOICE Staff
C-Suite: Digital Agencies
Digital Agencies  C-suite executives from some of the industry’s leading digital agencies provide their insights on where the greatest opportunities for innovation lie to improve digital marketing, the greatest challenges involved with digital media, and best practices for reaching stakeholders with key messages using digital media. Brendan Gallagher Executive VP, Experience Strategy & Innovation Digitas [...]
By PharmaVOICE Staff
Poland: Eastern Europe’s Leading Light
With a population of 38 million people and a healthy, growing economy, Poland is an attractive market for the pharma industry. This is bolstered by the fact that Poland is a member of the European Union, providing it with stability and a predictable regulatory environment. Poland underwent many political and economic changes in 1989, when [...]
By Kim Ribbink
SHOWCASE FEATURE: Clinical Solutions: Clinical Services Market Poised For Growth
According to a recent report from JZ Med, the global clinical trial service market is expected to reach more than billion by 2020, up from .4 billion at present, representing a CAGR of 9% between 2015 and 2020. By 2020 the average clinical trial outsourcing penetration will likely reach around 72%. In other words, [...]
By PharmaVOICE Staff
Endpoint-Based Protocol Development: An Outcomes-Based Approach to Clinical Trial Testing
A shift toward more targeted therapeutics, combined with the need to meet specific endpoints in clinical trials, has placed a significant emphasis on esoteric laboratory tests within the test menus employed in clinical trials. Biopharmaceutical companies and clinical research organizations have long relied on central laboratories for maintaining a full continuum of testing capabilities where [...]
By Mark Engelhart, Chief Commercial Officer, ACM Global Central Laboratory
Patient or Partner? Building An Innovative Relationship for the Future
The healthcare industry has struggled with many changes in the last 10 years, including the inevitable patent cliff, the emergence of patient advocacy, increased regulatory and healthcare reform, and the rising cost of doing business. However, even in this age of rapid innovation and adaptability, most of us within our industry seem to be slow [...]
By Marc Sirockman, Executive VP General Manager, Artcraft Health
Implementing Interactive Response Technology in A Software-As-A-Service Model
Historically, the software used in clinical trials has taken the form of either a fully installed customized solution, or a hybrid customized and configurable solution. The implementation of such systems has been time-consuming with costly infrastructure, and because minimizing IT delivery times remains crucial for clinical trials, CROs and research Sponsors have the opportunity to [...]
By Jamey McCarty, Director, IRT Services, Chiltern
Clinical Trial Transformation Through Digital Clinical and Code Halos
What is “Digital Clinical?” As Morpheus tells Neo in the film The Matrix, “No one can be told what the Matrix is. You have to see it for yourself.” Today we sometimes find ourselves immersed in our own real-life version of the Matrix, as our personal data accumulates on computer servers somewhere in the mysterious [...]
By Larry Florin, Clinical Leader, Life Sciences R&D Practice, Cognizant
The Importance of A Beautiful Technology Experience
Do you remember when the first Apple iPod was released? The advertisements on television showed beautiful images of rotating color behind a clean silhouette dancing to the sounds coming from the earbuds. It was bold, fresh, and exciting. It was fun. We were not confused by technical specs. We were not overwhelmed by configuration options. [...]
By Ibraheem (IBS) Mahmood, President and CEO, DrugDev
How Do iComply? A Look at Regulatory Topics Surrounding the use of Mhealth Technology in Clinical Trials
The U.S. National Institutes of Health (NIH) Consensus Group has defined mHealth as “the use of mobile and wireless devices to improve health outcomes, health care services and health research.” The mHealth landscape is expanding with over 97,000 apps (mobile applications) as of 2013. Yet the vast majority of these apps have not been through [...]
By Philip Coran, Senior Director of Quality & Regulatory Affairs, Medidata Solutions
Extracting Maximum Value From Electronic Data Capture
Electronic data capture (EDC) has been employed for clinical trial data for many years and is encouraged by the FDA because it provides significant benefits to sponsors, investigators, and patients, including more accurate data that can be more easily shared and monitored, increased compliance with regulatory requirements, and lower overall costs. With the storage of [...]
By Zaher El-Assi, President, Merge eClinical
Which Patients Are Really at Risk For Becoming Non-Adherent?
If you’re targeting only the most obvious patients with your medication adherence programs, you’re missing out on a big opportunity. Quite often, outreach programs focus on individuals hovering around the 80% threshold for proportion of days covered (PDC). It makes sense. Why not use your resources to help those just below 80% to become adherent, [...]
By Craig Schilling, Pharm.D., VP Patient Programs, Optum
Seeing the Big Picture With Visual Data Analytics
Pharmaceutical and biotechnology companies are facing a gigantic increase in data — not just in volume, but in complexity. The number of clinical trials in the National Institute of Health’s registry has jumped from 5,635 in 2000 to 183,991 in 2015 — an increase of more than 30 times. The data landscape has evolved to [...]
By Greg Moody, Executive Director, Life Science Analytics, PerkinElmer Informatics
All Monitoring is Risk Based
Drug developers must introduce innovation across the entire life cycle of product development to more effectively bring new therapies to markets. The innovations will be recognized by the use of smarter and faster methods for discovery of new drug entities and companion diagnostics, use of flexible trial designs, implementation of an end-to-end clinical trial platform, [...]
By Michael Brooks, Senior VP and Head Product Registration, Americas, PRA Health Sciences
Five Tips for Expediting Clinical Trial Recruitment and Enhancing Patient Retention
According to the National Institutes of Health (NIH), more than 80% of clinical trials in the United States fail to meet their patient recruitment timelines. These delays increase costs, deplete resources, and prolong the time to market introduction. Patient recruitment is challenging as it involves multiple stakeholders, including patients, healthcare providers (HCPs), office staff, sponsors, [...]
By Lou Shapiro, Senior VP, Tunstall Healthcare Group
Everything You Wanted to Know About Pharmacovigilance But Have Been Afraid to Ask
From the time humans begin taking an investigational new drug, pharmacovigilance measures play a critical role in every phase of a product’s lifecycle. However, understanding pharmacovigilance requirements can be daunting even for seasoned industry pros. This overview will answer all the questions you ever wanted to know about pharmacovigilance, but were afraid to ask. What [...]
By Veronique Basch, Pharm.D., Executive Director, Global Pharmacovigilance, United BioSource Corp.
MHRA Guidelines on TMFs: Where Are We One Year Later?
On April 2014, the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) updated its definition of a critical GCP inspection finding to include trial master files (TMFs) that were “not readily available or accessible.” The agency asserted the change was partly driven by the fact that more than one-third of TMF inspections are delayed due [...]
By Jennifer Goldsmith, VP of Vault, Veeva Systems
Managing the Scientific and Ethical Complexities of Medical Innovation
Today, advances in science and medicine are occurring at an unprecedented pace. These exciting changes broaden the ethical implications of medical innovation and expand the need to protect clinical research subjects. Often, Institutional Review Boards (IRBs) find themselves on the frontline of these emerging issues, and must embrace their role as both arbiter and guide. [...]
By Lindsay McNair, MD, MPH, MSB, Chief Medical Officer, WIRB-Copernicus Group
Maximizing Portfolio Value By Smart Partnering: This is Not Your Father’s Oldsmobile
Portfolio value is traditionally associated with innovation value; i.e., intellectual property, market attractiveness, potential clinical utility, and other product-centric attributes. Less commonly considered is the differentiation afforded by the partnering process employed during clinical development. Maximizing portfolio value by considering a wider audience of stakeholders in key outsourcing decisions thus becomes an exercise as valuable [...]
By Michael Murphy, M.D., Ph.D., Chief Medical Scientific Officer, Worldwide Clinical Trials Inc.
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