PharmaVOICE - 
February 2018
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In Every Issue
Letter from the Editor
Weird Science Digital therapeutics are a hot commodity. As reported [...]
By

Taren Grom, Editor

Upfront
Documentary Film Shines Light on Physical and Emotional Impact of [...]
By

PharmaVOICE Staff

Innovator’s Corner
Using Stem Cells to Treat Frailty Longeveron’s Chief Science Officer [...]
By

Dr. Joshua Hare, Chief Science Officer and Co-Founder, Longeveron

HealthTech
Draper R&D Uses Technology to Solve Unmet Healthcare Needs Trend [...]
By

PharmaVOICE Staff

Last Word
Connecting Silos Through System Integration Monica Kennedy, Director of Regulatory [...]
By

Monica Kennedy, Director of Regulatory Operations, Halozyme

On The Cover

The Convergence of Medicine and Technology
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 [...]
By

Denise Myshko

Features

Behavioral Economics
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 [...]
By

Robin Robinson

Patient-Centric Trial Recruitment
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 [...]
By

Denise Myshko

SHOWCASE: Outsourcing: The Growth and Expansion of Outsourcing
Outsourcing in the pharma industry continues to increase, with many companies spending 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 [...]
By

PharmaVOICE Staff

The Digital Pill
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 [...]
By

Sofija Jovic, Ph.D., MBA, Clinical Psychologist and Executive Leader, MedAvante-ProPhase, a WIRB-Copernicus Group Company

Blockchain Technology
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 [...]
By

Robin Robinson

SHOWCASE: Rare Disease: Building Relationships and Value with Rare Diseases
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 [...]
By

PharmaVOICE Staff

Rare Disease Research Operational Risk: Supporting New Clinical Sites
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 [...]
By

Cheryle Evans, Senior VP of Clinical & Medical Operations, Advanced Clinical

Critical Steps for Guiding Your Orphan Drug to FDA Approval
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 [...]
By

Clareece West, VP/General Manager, Cardinal Health Regulatory Sciences

How Well Do You Really Know Your Patients?
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? [...]
By

Linda Newberry-Ferguson, Senior VP, Clinical Navigation, Dohmen Life Science Service

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

Laurie Bartolomeo, Executive VP, Creative Director, Dudnyk

Commercialization Strategies in Rare Diseases
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 [...]
By

David M. Paragamian, Managing Director, Razorfish Health

A Patient-Focused Approach to Rare Diseases – Connecting with Multiple Stakeholders
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 [...]
By

David Schneider, Senior Director, Strategic Account Management, RxCrossroads (a McKesson company)

Tackling Regulatory Challenges in a Tighter Global Marketplace
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 [...]
By
Gender Parity
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 [...]
By

Taren Grom, Editor

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