Lisa Banket
Cofounding Partner/Publisher
Taren Grom
Cofounding Partner/Editor-in-Chief
Heather Hummel
Project Coordinator
Dan Limbach
Producer, Webcast Network
Denise Myshko
Managing Editor
Kim Ribbink
Features Editor
Robin Robinson
Senior Editor
Marah Walsh
Cofounding Partner/New Business Development

PharmaVOICE Editors' Blog

Wednesday, September 17, 2014

New White Paper - Proactive Pharmacovigilance: A New Model for the 21st Century

by Sciformix

21st century technologies will create significant opportunities and challenges for all health care stakeholders. Pharmacovigilance too is in transition, with new sources of medical information and methods for its analysis that will transform today's largely reactive system into proactive benefit-risk management for all medication users.

Key topics:
  • Why do we need a new PV model?
  • What might effective PV look like in 2038?
  • What are some new data sources?
  • How can I improve clinical decision making?
  • How do we achieve broad accessibility of appropriate information?
  • What are the cost-benefit considerations?

Download now

PharmaVOICE Webcast Network
provided by Sciformix

Monday, September 8, 2014

White Paper: The Link Between Your Cold Chain and Your Bottom Line

White Paper

Specialty Solutions
3PL Services

One of the most critical, yet overlooked, aspects of product success is safe, successful distribution. And for a growing number of pharmaceuticals and biologics, that involves refrigerated, or cold chain, distribution. A problem with your cold chain can quickly become a problem with your bottom line. In this white paper, you'll learn why the cold chain is so vital for healthcare, as well as the risks and costs of improper shipping, the need for accurate documentation, and methods for protecting your products.

Download Now

Provided by: Cardinal Health

Tuesday, September 2, 2014

White Paper: Tips for Content That Drives Qualified Web Traffic for Healthcare Marketers

The socialization of the internet has made writing for and reaching a targeted audience not just possible, but necessary. While in the past you may have been successful with taking a broad approach to reaching patients and prospective clients, today users’ desires for more specific targeting and personalization require a more laser-like focus.

Effective web content is the new “Holy Grail” in internet marketing. But knowing this and producing it are two different things. Download the white paper to find out more.

Download now

White Paper: Navigating the Landscape of Compassionate Use

Siren Interactive

This white paper summarizes insights on compassionate use developed at Siren Interactive’s workshop,
Critical Issues in Patient Advocacy Engagement & Collaboration: How Do We Find Common Ground?, at
the World Orphan Drug Congress in April 2014. Participants included representatives from the industry
in commercialization and patient advocacy roles, rare disease patient advocacy group (PAG) leaders, and
patient opinion leaders (POLs). 

Special thanks are due to our moderator Wendy White, founder and CEO
of Siren Interactive, and panelists:
  • Barbara Wuebbels, vice president of patient advocacy and medical affairs
  • at Audentes Therapeutics
  • Pat Furlong, founding president and CEO of Parent Project Muscular Dystrophy
  • Ben Lenail, co-founder and business strategy officer of ALD Connect
  • Julie Raskin, executive director of Congenital Hyperinsulinism International
  • Carrie Burke, director of alliance development at Shire Pharmaceuticals
  • Nicole Boice, founder and president of Global Genes/Rare Project

Siren Interactive

September Digital Edition is now available

Digital Edition

The September issue of PharmaVOICE is now available in a digital edition.

Thursday, August 28, 2014

Webinar: Expedited Programs for Drug Development

with PharmaVOICE

Leveraging Expedited Programs for the Development of Drugs and Biologics for Serious Conditions and Rare Diseases

October 8, 2014 @ 1PM EDT
Reserve your spot now

a PharmaVOICE Webinar
in partnership with Cardinal Health
FDA is committed to advancing the development of therapies for the treatment of serious conditions and rare (orphan) diseases.  As part of this commitment, FDA provides expedited pathways to decrease the development and review time for new drugs and biologics that address unmet medical needs.  In addition to these expedited pathways, which are fast track, priority review, and accelerated approval, FDA recently introduced the new breakthrough therapy designation.

This new designation will allow for more intensive guidance from FDA throughout the development process. This presentation will examine each of FDA’s four expedited programs and their impact on recently approved products indicated for serious conditions and rare diseases.

Includes a live Q&A session, and post-webinar OnDemand access for all who register.

Key Takeaways:
  • FDA regulations, legal acts, and guidances governing expedited programs for serious conditions and rare diseases 
  • The concepts of serious condition, available therapy, unmet medical need, and rare disease
  • Understand and distinguish the differences between FDA’s four expedited development programs - fast track, breakthrough therapy, priority review designations, and accelerated approval pathway
  • The qualifying criteria and features of each expedited program, as well as what is required for requesting a specified designation
  • The impact of expedited programs on recent New Drug Application (NDA) and Biologic License Application (BLA) approvals
  • How to leverage expedited programs to support the development of pharmaceuticals indicated for serious conditions and rare diseases
Who Should Attend:
  • Professionals who wish to broaden their understanding of drug development in the pharmaceutical or biotechnology industry, including:
  • Regulatory Affairs Directors/Managers
  • Research and Development Directors/Managers
  • Clinical Research Associates
  • Medical Writers
  • Quality and Manufacturing Director/Managers
  • Quality Assurance Directors/Managers
  • Project Managers
Reserve your spot now

PharmaVOICE is partnering with Cardinal Health Regulatory Sciences

Tuesday, August 26, 2014

Happy 20th Anniversary SCDM!

Clinical Data Management

Join SCDM in Las Vegas Sept 28th – Oct 1st for exclusive networking and educational experiences. Do you want to be part of the discussion on CDASH, SDTM and ADaM?

Visit for the full event program.

Monday, August 25, 2014

David Ormesher: Difference Maker – a Red Jacket Honoree

David Ormesher

As one of our inaugural Red Jacket winners, David Ormesher, CEO of closerlook, inc., is someone others will continue to say created some big shoes to fill.

“You have to touch the heart to move the mind”

David has been a visionary in business, leading his digital marketing agency into a driving force in the use of analytics and digital initiatives to help pharma brands build valuable relationships with their customers.

He is an active philanthropist, serving as a leader, mentor, and board member of many organizations outside of his business, including:
Lurie Children’s Hospital Foundation
Innovation Board of XPRIZE Foundation
Lyric Opera of Chicago
i.c.stars, an innovative business and leadership training program for inner city youth

David is also the founder of Bigger Future, a social-enterprise building the capacity of high-potential entrepreneurs in Rwanda.

Learn more about David’s approach to volunteering and philanthropy, his future vision for the life-sciences industry and his advice to the next generation of leaders in his full profile:

Friday, August 22, 2014

Upcoming Webinar: 10 Killer Applications for Digital Signatures in the Life Sciences Enterprise

Wednesday – October 1, 2014 / 01:00 pm EST/10am PT – Free Attendance
Sponsored by CoSign by ARX

Life sciences enterprises of all sizes are using digital signatures in a variety of ways across their business operation. They’re using this technology with their core quality management systems (QMS) and electronic document management systems (EDMS), as well as within various departments such as FDA-regulated clinical operations, manufacturing, field sales and service, research and discovery, and in non-FDA regulated back office applications.

Join us as we take a closer look at each of the 10 killer applications for digital signatures within a life sciences enterprise and uncover the tangible benefits that thousands of these enterprises are already enjoying. We’ll explore a number of real-world use cases involving these applications. Whether you’ve already deployed digital signatures within some of your departments or you’re still at the consideration stage, this webinar will be worth your while.

Topics include:
  • Defining standard digital signatures and their global acceptance in regulated applications
  • Considerations in using digital signatures for closed system applications throughout an enterprise for corporate governance
  • Strategies for deploying digital signatures in open systems for the front and middle office: collaboration and secure document exchange

Key Takeaways Include:
  • Discover new ways digital signatures can be used in the life sciences enterprise
  • Discover the value of digital signature automation for specific business processes
  • Learn the unique considerations for digital signatures in both closed and open systems from end-user case studies

Who Should Attend:
  • QA & Compliance
  • IT
  • COO
  • CIO
  • Department heads within: clinical operations, manufacturing, product management and project management

Friday, August 15, 2014

Connected Health: Big Business and Big Impact on Healthcare

is the connected consumer
Technology connects patients and healthcare
The future of healthcare, according to many experts, will be a connected, or integrated, model that encompasses a number of different technologies, including apps, EMR, telehealth, mHealth, wearable devices, etc.

We're steadily moving toward that future.  If you take a look around you will see that connected health is already becoming a growing part of many of our lives.  Technologies continue to improve and provide a more seamless interface between patients, healthcare providers, payers, and health information technology companies.  Whether looking up health information online, using an app to manage a health condition or having a real-time video call with a doctor, connected health enables people  to be more proactive in managing their health while helping to provide them with more efficient health care.

Research  of U.S. broadband households by Parks Associates has found :
  • Over 50% with access to online services such as prescription refills, real-time video calls with a doctor, or appointments use these services
  • 27% have used a provider or insurer website, averaging about 2.5 visits per year
  • 25% have used a health app, with usage averaging almost four times per year
  • 13% are interested in virtual tools to manage medications, and 15% are interested in post-surgery virtual monitoring
According to Harry Wang, Director, Health & Mobile Product Research, Parks Associates, "2014 will be a pivotal year for consumer-centric healthcare solutions and services. The healthcare technology market is benefiting from a favorable policy environment, a groundswell of consumer interest, a brisk innovation cycle, and a growing eagerness among payers and providers for effective consumer/patient engagement."
Connected health will continue to rapidly expand and touch more of our lives in more ways in just a few years.

Harry Wang also states, "The tech industry is in a stage of intense experimentation and innovation as companies try to find successful strategies to transform the health industry."
Additional research by Parks Associates finds:
  • The number of U.S. households using video consultations for their care needs will increase to 22.6 million in 2018.
  • By 2018, almost 135 million healthcare consumers will benefit from care practices following the accountable care principles. Among them, almost 20 million will be eligible to participate in a physician/hospital-led care program responsible for coordinating all their health needs and  managing multiple chronic conditions.
  • The connected health and wellness solution market will generate almost $8 billion in revenue in 2018 from selling hardware, software/apps, and wellness services.
  • The market for senior-focused independent living solutions will grow 11% annually on average for the next five years, generating $1.4 billion in service revenues in 2018.
To learn more about the best strategies to engage consumers and create a healthcare experience with technology that is enjoyable, convenient, and friction-free, consider attending Parks Associates  upcoming ConnectedHealth Summit: Engaging Consumers, September 4 - 5, 2014, in San Diego.

The event will examine strategies to drive increased adoption and usage of connected health solutions and services while reducing wasteful healthcare spending and improving care quality.  Keynote speakers will be Ascension Health, Humana Wellness, Kaiser Permanente, Qualcomm Life, and Walgreens.

If you would like to read more about Connected Health, PharmaVOICE  published a special March 2014 issue focusing solely on the topic.  You can access it here.

September 4-5, 2014 San Diego