June 2018

Letter from the Editor

June 1, 2018

Transforming for the Future By definition transformation means a thorough or dramatic change in form or appearance. Our thought leaders in this month’s cover story believe such a reshaping is necessary for the industry to have success in the future as biopharma companies must meet the business challenges of a more complex operating, regulatory, and […]

Upfront

June 1, 2018

Bayer Unites with Advocacy Groups to Raise Awareness about Colorectal Cancer Bayer has announced another year of its partnership with patient advocacy organizations Colorectal Cancer Alliance and Fight Colorectal Cancer. Bayer is touring with the alliance on the national Big Colon Tour in 2018 to bring a giant inflatable exhibit to 50 events nationwide to […]

HealthTech

June 1, 2018

Caffeine-Containing Biocompatible Gels for Drug Delivery Trend Watch: Gels and AR advances create new methods of disease treatment, monitoring and diagnosis Researchers at MIT may use caffeine to jump start their day, but they are also working on using it as a catalyst for a biocompatible polymer gel to enable drug delivery. Caffeine is more […]

Innovator’s Corner

June 1, 2018

A New Way to Deliver Proteins Paul Wotton, Ph.D., CEO of Sigilon Therapeutics, discusses his company’s approach for delivering cells that avoid immune detection. Encapsulated cell therapy is an emerging area of biopharmaceutical research that aims to unleash the therapeutic potential of cells to treat serious diseases without the need for immunosuppression. While implanted cells […]

Last Word

June 1, 2018

Sanofi Pasteur’s Approach to Vaccine Deployment Dr. Joël Calmet, Senior Director of Communications at Sanofi-Pasteur, discusses the company’s efforts to bring vaccines to underserved patient populations. PV: Why is patient access to vaccines in disadvantaged countries still a challenge? Calmet: Despite continuous progress in vaccine development for life-threatening diseases, ensuring access to these medicines for […]

Transformation: Is the Industry Ready?

June 1, 2018

Although the pharma industry scored pretty low on a McKinsey scale of digital maturity, there is evidence that it is moving — perhaps only incrementally — toward a digital transformation that can streamline processes, generate collaboration, and coordinate data collection. The pharma sector, not surprisingly, is also lagging behind other industries in digital performance. According […]

Client-Agency Relationships 101

June 1, 2018

We could write a book — and many have — on all of the necessary ingredients to create a successful partnership in the life-sciences space of client-agency relationships. But instead, we’ve asked our thought leaders to focus on three vital issues: what is needed to build and maintain strong relationships with their pharma clients; the […]

SHOWCASE: Clinical Trial Solutions: Digital Technology Changing the Face of Clinical Trials

June 1, 2018

Greater investment in R&D and a growing number of clinical trials combined with accelerated demand for automated solutions are contributing to a rapidly expanding contract research organization (CRO) market and changing the face of clinical trials. According to some estimates, the CRO market will reach $59.42 billion by 2020, growing at a CAGR of 9.8% […]

The Future of Blockchain in Clinical Research

June 1, 2018

Imagine this: a group of pre-identified, pre-screened patients are remotely enrolled in a clinical trial, their private health records accessed and validated instantaneously upon consent. The investigative product is traced from inception to consumption by each individual patient; ensuring quality is documented and maintained. Then using remote patient authenticated mobile and wearable devices, validated patient […]

The Transformational Power of Sharing

June 1, 2018

Decades of progress in information technology reveal, however, that as individuals and in the collective, we constantly struggle to find balance between the benefits of sharing and our desire to keep control. The mainframe computer was cheered as it enabled a corporation to share information that had previously been locked in metal file cabinets lining […]

Build a Road, Not a Roadblock — What Sites Want Sponsors To Know

June 1, 2018

Their message is loud and clear — technology has the potential to be a site’s best friend, but it’s often a roadblock instead. That’s just one of the many insights learned from the sites who participated in a thoughtful panel discussion focused on how they feel about the past, present, and future of clinical technology. […]

Moving Beyond Risk-based Monitoring: Improving Quality and Performance with Real-time Management

June 1, 2018

Risk-based monitoring (RBM) in clinical trials has long been touted as a more proactive way to reduce risk and improve data quality. But the current generation of risk monitoring tools and processes lack the transparency and integration needed to support a level of proactive risk-based management necessary to drive real-time cost and quality benefits. Part […]

RWE Continues to Shape the Future Clinical Research Landscape

June 1, 2018

The increasing availability of big data is creating a shift in the clinical research landscape — from trial planning to late-phase — allowing for clinical research professionals to make intelligent, strategic decisions based on real-world evidence (RWE), which is derived from the aggregation and analysis of real-world data (RWD). In addition, RWE is being used […]

Transforming the Life-Science and Healthcare Workforce

June 1, 2018

In today’s rapidly changing market, organizations and workforce experts alike are trying to determine how the future of work will transform. However, most professionals operate from the perspective of their individual scope of responsibility, which often leads to narrow perspectives that may solve one aspect of the challenge — yet create another problem. Based on […]

Community-Based Clinical Trials — The New “Virtual”

June 1, 2018

Long recruitment timelines and under-performing sites are the most frequently discussed topics in the clinical trials sector. With actual recruitment timelines double the planned expectations, at least 39% of sites under-enroll and 11% of sites fail to enroll a single patient1, new technological advances are often heralded as holding the answer to these problems. In […]

When Patients Control Their Data, Clinical Researchers Win

June 1, 2018

From a young age, we learn to share, but when it comes to the collection and management of clinical research data, the opposite is more often true. Then why is the question still being asked whether patient data should be shared and accessible by patients themselves? The journey towards betterment is complicated and doesn’t happen […]

Is Your eClinical System a Mixed Tape or a Playlist?

June 1, 2018

Just a decade ago, the most advanced option for listening to music at home was a large stereo system made up of a jumble of separate components, all with specific functions, from a half-dozen brands. Not only were these stereo systems bulky they were also expensive, complex to set up and run, only able to […]

AI and the Cloud: Changing the Clinical Trial Experience

June 1, 2018

It doesn’t take a crystal ball to see that there are a number of exciting life-science industry trends that will profoundly influence clinical trial solutions in the years to come. Chief among them are: Patient engagement and patient centricity will be king, driving digital transformation with IoT and AI. Robotic Process Automation (RPA) will change […]

Pediatric Drug Development: Regulatory Updates to Know

June 1, 2018

All applications for marketing authorization for new medicines must include the results of studies in children as described in the pediatric plan, unless the medicine is exempt because of a deferral or waiver. Pediatric legislation internationally has led to better medicines for children, but gaps still exist that regulatory agencies want to close. How will […]

Rare Disease Studies: Patient-Focused Approaches

June 1, 2018

The National Organization for Rare Disorders (NORD) indicates that there are approximately 7,000 medical conditions that qualify for a rare disease designation. In the United States, this is defined as an affected population with a prevalence of fewer than 200,000 patients. Because there is a great unmet need for novel therapies to address these rare […]

R&D Leaders On Leadership

June 1, 2018

What makes for a great leader? Many books and articles exist to try to tease out the qualities and behaviors that make good leaders great. Many of these detail that leaders inspire employees, position their companies for innovation and change, and they have integrity and the courage to lead. A McKinsey survey in 2015 of […]

GoBoldly: A Reputation-Enhancing Effort

June 1, 2018

We’ve all seen the commercials. They feature patients living with serious diseases and the researchers working to develop innovative therapies. These ads focus on the science and the breakthroughs being made in medicine. They end with what looks like a genetic analysis giving way to the words America’s Biopharmaceutical Companies. The commercials aim to showcase […]

Regenerative Medicine: The Dawn of a New Age of Biology

June 1, 2018

Regenerative medicine could completely shake up the way diseases are treated. According to Reportlinker, the regenerative medicine market will reach an estimated $50.55 billion by 2025 thanks to the rapid growth of stem cell and gene therapy in developed markets. Scott Bruder, M.D., Ph.D., founder and CEO of Bruder Consulting and Venture Group, describes regenerative […]

Red Zone: Personalized Medicine Requires Personalized Measurement

June 1, 2018

CNS is the second largest area of pharmaceutical research, but the success rate has been low and approvals rare. In CNS drug development, it is common for investigational therapies to show promising effects in earlier trials, only to fail in the final stages of testing. Some of the reasons can be attributed to the technical […]

Speak Out

June 1, 2018

Understanding The Why Applying health psychology to deliver effective patient support As a health and clinical psychologist, I’ve spent the last ten years helping the healthcare industry address the self-management needs of patients living with long-term conditions. For the most part, this work has involved collaborating with pharma to support patients to take their medication […]

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