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

Friday, October 17, 2014

OnDemand Available: 10 Killer Applications for Digital Signatures in the Life Sciences Enterprise

Originally Recorded:
Wednesday – October 1, 2014 / 01:00 pm EST/10am PT – Free Attendance

(if you registered previously, use the same email address)

Includes live polls and a Q & A session.


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 View:
  • QA & Compliance
  • IT
  • COO
  • CIO
  • Department heads within: clinical operations, manufacturing, product management and project management
(if you registered previously, use the same email address)

Thursday, October 9, 2014

Key Takeaways from BigDiP (Big Data in Pharma)

Now that BigDip is over, it’s time to share some of the key insights shared during the conference. Some of the top thought leaders in the industry shared their insights with the attendees. If you attended, please add your takeaways in the comments below. If you were not able to attend, enjoy this recap and feel free to participate in the discussion as well.

* * * * * * * * * * * * * * *
  • Review current publications concerning your products or drugs in development to understand how comparative groups are being assigned today.
  • List any gaps that may exist in current research that could be addressed via observational data research provided the right data elements are collected.
  • Consider the value of closing these gaps via a registry environment only if the right data are not collected at the right times in the right patients for the right products.
 -          Billy Franks - Astellas

* * * * * * * * * * * * * * *

Complex Business Problems Drive Analytics Innovation.  Enable Disruptive Information by following these three principles:

  • Shared: The biggest difference in practical analytics may not be in how we analyze or interpret results but rather how that information is shared and consumed by all of us. 
  • Enabled:  Data/analytic portals and interactive analytic tools available to business leaders, analysts and scientists alike. 
  • Transparent: Information isn’t sequestered in static reports/memos and data isn’t hidden in disjointed data warehouses but rather is open and accessible to everyone.
 -          Christian Nimsch - SAS

* * * * * * * * * * * * * * *
  • Get Parallel - The difference between a lot of data and big data is parallel processing. Via Netezza, sharded SQL, Hadoop, Apache Spark, etc. If you are not yet in an environment where you can do parallel processing, you will soon run out of capacity.
  • Get to the Decision - If you can apply your analytics where you make the most decisions, you will generate the most value.
 - Greg Hayworth, Humana

* * * * * * * * * * * * * * *
  • In healthcare analytics a focus on causal conclusion is key.
  • Maximize the use of the longitudinal data structure healthcare records provide.
  • Three keys that will unlock the potential of healthcare database networks: size, depth, and speed.

 - Sebastian Schneeweiss – Harvard Medical School
* * * * * * * * * * * * * * *
  • Evaluate how quickly you are getting answers to critical questions.
  • Look at the bottlenecks in data processing and ask how well your system can scale if data volumes go up by a factor of ten or 100.
  • Honestly assess what the total cost of your system and its upkeep are, and ask if it has become unwieldy.
 -          Brian Bradbury - Amgen

 * * * * ** * * * * * * * * * * * * * *
  • Think of patient data as the new resource that will power drug discovery in the next decade. Are your systems ready?
  • Everyone should at least have pilots on how to manage large patient data. Genomic datasets are expected to grow beyond 100,000 patients, but current systems are not ready to handle even a few thousand patients.
  • Push the edge on data analytics and facilitate the combination of knowledge across disciplines (chemistry, biology, genetics, statistics etc.).
 -          Francesca Milletti - Roche

* * * * * * * * * * * * * * *
  • No development of any RWE BIG DATA platform is complete without the ability to provide an end- to -end view of the patient journey.
  • Think about, conceptualize and address “confounding by indication” & “ selection bias” every time real world BIG Data platforms are being developed and analyzed.
  • BIG Data stacking in R&D spans different methodologies that need to be coordinated simultaneously for any reliable analytic exercise.
 -          Usman Iqbal - AstraZeneca

* * * * * * * * * * * * * * *
  • Decide beforehand what are the questions that you plan to ask of the data. This will determine how you should store your data as the performance of the storage schema is impacted by the users queries.
  • Context is crucial - in many cases a single sensor may not suffice. Use multiple sensors to complete the picture
  • Data is dirty and outliers may skew your results. Ensure that you have a set of rules in place that will enable you to differentiate between "good" and "bad" data.
 -          Yadid Ayzenberg - MIT

* * * * * * * * * * * * * * *
  • To assure meaningful patient centered outcomes, plan for patient input through all stages of measures development, including concept elicitation, determination of item language and relevance, and testing.
  • Consider differences in patient preferences in the design and logistics of clinical trials based on condition, severity, demographics, and other patient level variables.
  • The potential utility of wearables is promising but requires a carefully considered engagement experience to enhance collection of meaningful data.
 -          Emil Chiauzzi – Patients Like Me

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

Wednesday, September 10, 2014

BigDip (Big Data in Pharma) Starts 9/16

SAS attends and presents at conference

Join SAS for two big events on Big Data

Workshop: Seeing is Believing: Data Visualization for Drug Development and Life Sciences Commercial Operations
9/16 9:00m PT

Session: Analytics Provide the Cure for Big Data Overload
9/18 9:30am PT

Hope to see you there!

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.