June 2015

Letter from the Editor

June 1, 2015

In the rare disease community there is saying: Alone we are rare, together we are strong. Wendy White, senior VP, for rare diseases, at Dohmen Life Science Services, a board member of Global Genes,  and the president of the Heathcare Businesswomen’s Association (HBA), shared her personal rare disease story at the HBA’s recent Woman of […]

UpFront

June 1, 2015

Genentech Supports New STEM Initiative Genentech has launched Futurelab, a collaborative program with the South San Francisco Unified School District to support science, technology, engineering and mathematics education. Futurelab builds on Genentech’s long-standing commitment to science education and seeks to make a difference in the lives of local students, empower teachers, and inspire employees. Through […]

Innovator’s Corner

June 1, 2015

The 3D Human Body Frank Sculli, Co-founder and CEO of BioDigital, talks about his company’s 3D technology that can produce a virtual model of the human body to help everyone better understand health and disease concepts. The amount and complexity of health information continues to grow, but the way that it’s communicated has remained the […]

The Network

June 1, 2015

IBM Partners For Advanced Health Data Collection Trending Now: Apps and partnerships extend medical reach and research. IBM has established a Watson Health Cloud that will provide a secure and open platform for physicians, researchers, insurers, and companies focused on health and wellness solutions. Extending the company’s exclusive Watson cognitive computing platform, IBM is entering […]

What’s New

June 1, 2015

Medicines360 is Driven to Empower Women Trending now:  New nonprofit pharma company changing access to medicine. San Francisco-based Medicines360.org is a nonprofit pharma company that is doing things differently from traditional pharma companies. Its mission is to help remove barriers and improve access to healthcare in the public sector. Dedicated to women’s health, Medicines360 is […]

Tools of the Trade

June 1, 2015

N-of-One Launches App Sequencing Data Trending Now: As the life-sciences business continues to diversify across borders and new channels, the need for easily accessible and accurate HCO, HCP, and affiliation information has never been greater. N-of-One has launched Variant Interpreter, a cloud-based app that allows oncologists and researchers to access relevant biological and clinical knowledge […]

Pharma Trax

June 1, 2015

Uptake of Digital Records Not sufficient to Drive Better Care Trending now: Despite increased use of electronic medical records, fewer U.S. doctors believe it improves health outcomes. Most U.S. doctors are more proficient using electronic medical records (EMR) than they were two years ago, but fewer believe that EMR has improved treatment decisions, reduced medical […]

The Calendar

June 1, 2015

Coming Attractions The annual BIO International Convention, June 15-18, 2015, in Philadelphia covers the wide spectrum of life-sciences innovations and application areas. Drug discovery, biomanufacturing, genomics, biofuels, nanotechnology,  and cell therapy are just a few of the industries represented at the conference. According to BIO, the top five reasons for attending are: partnering within the […]

Talent Pool

June 1, 2015

Biopharma Pool David Allsop Amicus Therapeutics Appoints Senior VP, International Amicus Therapeutics, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, has appointed David Allsop as senior VP, international. He is responsible for Amicus’ international organizational build out, and is leading international commercial and market access activities for migalastat monotherapy for […]

Last Word

June 1, 2015

Pharma’s Health Mission Novo Nordisk North America President Jesper Hoiland talks about the responsibility pharmaceutical companies have to society and the larger impact they can have on health and the environment. PV: Why should pharmaceutical companies ­become involved in social issues? Hoiland: We have a social responsibility. We have knowledge and the insight to do […]

Rare Diseases: Research, Development, and Commercialization

June 1, 2015

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 […]

Patient Engagement: Not Just For Physicians Anymore

June 1, 2015

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 […]

Wearables in Clinical Trials

June 1, 2015

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 […]

The Importance of CROs For Oncology Trials

June 1, 2015

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 […]

2015 DIA Preview

June 1, 2015

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 […]

C-Suite: Digital Agencies

June 1, 2015

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 […]

Poland: Eastern Europe’s Leading Light

June 1, 2015

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 […]

SHOWCASE FEATURE: Clinical Solutions: Clinical Services Market Poised For Growth

June 1, 2015

According to a recent report from JZ Med, the global clinical trial service market is expected to reach more than $64 billion by 2020, up from $38.4 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, […]

Endpoint-Based Protocol Development: An Outcomes-Based Approach to Clinical Trial Testing

June 1, 2015

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 […]

Patient or Partner? Building An Innovative Relationship for the Future

June 1, 2015

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 […]

Implementing Interactive Response Technology in A Software-As-A-Service Model

June 1, 2015

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 […]

Clinical Trial Transformation Through Digital Clinical and Code Halos

June 1, 2015

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 […]

The Importance of A Beautiful Technology Experience

June 1, 2015

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. […]

How Do iComply? A Look at Regulatory Topics Surrounding the use of Mhealth Technology in Clinical Trials

June 1, 2015

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 […]

Extracting Maximum Value From Electronic Data Capture

June 1, 2015

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 […]

Which Patients Are Really at Risk For Becoming Non-Adherent?

June 1, 2015

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, […]

Seeing the Big Picture With Visual Data Analytics

June 1, 2015

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 […]

All Monitoring is Risk Based

June 1, 2015

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, […]

Five Tips for Expediting Clinical Trial Recruitment and Enhancing Patient Retention

June 1, 2015

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, […]

Everything You Wanted to Know About Pharmacovigilance But Have Been Afraid to Ask

June 1, 2015

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 […]

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