February 2018

Letter from the Editor

February 1, 2018

Weird Science Digital therapeutics are a hot commodity. As reported in this month’s cover story, software programs are part of a new class of therapeutics — digital medicines — that can lead to changes in behavior and provide clinical benefit. But digital therapeutics go beyond behavior modification programs; they are digital tools that have been […]

Upfront

February 1, 2018

Documentary Film Shines Light on Physical and Emotional Impact of COPD A new documentary film — Clear the Air: Opening Up About COPD — presents the stories of three people living with chronic obstructive pulmonary disease (COPD). The film was created by Emmy-nominated director Abbey LeVine in collaboration with Boehringer Ingelheim Pharmaceuticals. The film chronicles […]

Innovator’s Corner

February 1, 2018

Using Stem Cells to Treat Frailty Longeveron’s Chief Science Officer and Co-Founder Dr. Joshua Hare talks about the company’s cell-based therapies for age-related diseases. Breakthroughs in stem cell research could potentially lead to new treatment options for chronic diseases and injuries affecting various organ systems. Research is being conducted with stem cells in diabetes, Alzheimer’s, […]

HealthTech

February 1, 2018

Draper R&D Uses Technology to Solve Unmet Healthcare Needs Trend Watch: Health technology is providing quicker, safer solutions for disease management and care. Draper, a nonprofit research and development company focused on advanced technological solutions, has designed the first pediatric heart valve that’s designed to grow with a child. Currently, there are no heart valve […]

Last Word

February 1, 2018

Connecting Silos Through System Integration Monica Kennedy, Director of Regulatory Operations at Halozyme, discusses how technology can be leveraged to address inefficiencies in organizations. PV: What do think has led to operational silos and created inefficiencies? Kennedy: Technology is one factor, but it alone is not responsible for operational silos; it’s the lack of process-enabling […]

The Convergence of Medicine and Technology

February 1, 2018

Imagine instead of a pill, a doctor prescribes a game for a child with attention deficit disorder. Or imagine patients dealing with substance abuse being prescribed assessments they can do via a mobile device to track progress. These software programs are part of a new class of therapeutics — digital medicines — that can lead […]

Behavioral Economics

February 1, 2018

Have you ever made a decision — health or otherwise — and on reflection, you couldn’t be sure what drove you to make it? That’s called being human. It’s that characteristic — making decisions based on emotions or gut instinct rather than logic — that is at the heart of behavioral economics. To successfully influence […]

Patient-Centric Trial Recruitment

February 1, 2018

Social media, mobile, and other technologies are making patient and physician outreach easier and more cost-effective and analytical tools are enhancing performance measurement, but patient recruitment for clinical trials continues to be a challenge. This is especially true for trials involving rare diseases and oncology. For a rare disease, there is a smaller number of […]

SHOWCASE: Outsourcing: The Growth and Expansion of Outsourcing

February 1, 2018

Outsourcing in the pharma industry continues to increase, with many companies spending $50 million or more a year on outsourcing services. A survey from Outsourcing-Pharma.com found that 44% of pharmaceutical companies expected to outsource more business in 2017 than the previous year, and only 11% of pharma companies and suppliers expected more business to be […]

The Digital Pill

February 1, 2018

Ten years ago, the smartphone united two existing technologies — the telephone and Internet — to revolutionize global communication. Today, we are experiencing a revolution in healthcare, with powerful medicine and innovative technology coming together to transform the way we treat patients and manage diseases. On November 13, 2017, the U.S. Food and Drug Administration […]

Blockchain Technology

February 1, 2018

Blockchain can be a challenging concept to get your head around, and it’s difficult to embrace something you can’t understand. That may be why the pharma industry lags behind others in its adoption of the immutable ledger. In fact, a recent survey aimed at assessing blockchain adoption, conducted by Ipsos and sponsored by the Institute […]

SHOWCASE: Rare Disease: Building Relationships and Value with Rare Diseases

February 1, 2018

There is growing commitment across the industry to improve the lives of the 350 million people living with a rare disease across the globe. Since 2013, 60% of the drugs approved by the FDA under the Breakthrough Therapy Designation program have been indicated for rare diseases. Nevertheless, only 5% of rare diseases have an approved […]

Rare Disease Research Operational Risk: Supporting New Clinical Sites

February 1, 2018

Over the last decade, the number of drugs gaining FDA approval for new indications per year has nearly quadrupled, growing from seven new or expanded approvals in 2007 up to 21 in 2017. As more rare diseases are identified and rare disease research expands to new indications, it must also expand to reach remote clinical […]

Critical Steps for Guiding Your Orphan Drug to FDA Approval

February 1, 2018

The Orphan Drug Act was passed in 1983 to stimulate the development of treatments for rare diseases by providing incentives for drug developers, including seven-year marketing exclusivity and tax credits for clinical trial costs. While the program has been effective in driving increased clinical development in the rare disease space, many orphan drugs still struggle […]

How Well Do You Really Know Your Patients?

February 1, 2018

Why an outsourcing evolution builds better patient relationships Global Genes reports that therapy adherence in the rare disease space can vary from only 58% to 65%, a troubling statistic for our industry, and most importantly, the patients we serve. Manufacturers must be wondering, how well do we really know our patients and what they need? […]

The Value of Online Support Groups in Rare Disease Communities – and the Role Pharma Marketers Can Play

February 1, 2018

Online support groups for patients and caregivers living with rare diseases have grown tremendously in number and size over the past 10 years. Often closed to the general public, these semi-private groups are usually started by one or two motivated individuals, then extend throughout the world to include others living with the same condition. The […]

Commercialization Strategies in Rare Diseases

February 1, 2018

Agency Partners Simply Can’t Fake It. Over the course of my career working in pharmaceutical advertising, one of the most common refrains I’ve heard through the years from eager agency folks is: “We need to get into oncology or rare diseases.” I have to admit that it’s a declaration that always makes me laugh a […]

A Patient-Focused Approach to Rare Diseases – Connecting with Multiple Stakeholders

February 1, 2018

In order to successfully commercialize a rare disease product, manufacturers must consider the needs of multiple stakeholders. Adding to the challenge, each stakeholder may have unique needs. This creates increased complexity when marketing a therapy in the rare disease space, but also offers multiple opportunities to engage, connect, and build relationships at a level that […]

Tackling Regulatory Challenges in a Tighter Global Marketplace

February 1, 2018

When it comes to pharmaceutical regulations, change is constant. Regulatory authorities have become more cautious with product approvals, there are increased demands for more comprehensive data, digital is creating new opportunities and challenges, and globalization of the industry means companies must navigate different requirements. According to PwC, over the next decade the industry can expect […]

Gender Parity

February 1, 2018

A recent McKinsey report reveals that women remain underrepresented at every level in corporate America, despite earning more college degrees than men for 30 years and counting. There is a pressing need to do more, and most organizations realize this: McKinsey reports that company commitment to gender diversity is at an all-time high for the […]

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