Unveiling the New Artcraft Health Website

Artcraft Health recently updated its website, to better serve the interests of its clientele in the life sciences industry, including pharma, biotech, and medical device companies.

Here’s a quick company overview—They are an award-winning, full-service health education agency specializing in the creation and development of compelling solutions that are aligned with their clients’ strategic imperatives. They work with clients to develop strategies and tactics to overcome health literacy barriers and promote effective, innovative outcomes that drive results.

The website houses each strategic division, while showcasing Artcraft’s leadership team, innovative work, and solutions ranging from professional to motion media, awards, client experience, and testimonials. The website also gives an insight into their internal solutions and services, from the clinical trials division through mature brand extension. Their blog is filled with informative posts covering the latest trends in healthcare education such as patient engagement, risk-based contracts, and gamification.

“The Artcraft Health website showcases the talents and expertise of our team,” says Marc Sirockman, Executive Vice President and General Manager at Artcraft Health. “The look and feel depicts everything that the company stands for. It’s innovative, informative, and all-encompassing of our core principles and values.”

Experience the new website today.  Please visit www.artcrafthealth.com.

Pharma Social Media Strategy Guidebook - by Telerx

Social media presents new opportunities for patients to manage their health – empowering them to seek direct access to information about medical conditions, treatment options and patient communities. Are you prepared to support them?

Download the guidebook today to uncover a best practice approach to social participation and strategy development.

http://www.pharmalinx.com/Telerx_PharmaSocialMedia/

Overview:

The increased adoption of social media is impacting every industry, but maybe none more than the healthcare industry. Patients and healthcare providers (HCPs) are looking to social media for information and support regarding their health and the health of their patients. Social media offers you an opportunity to interact with patients, caregivers and HCPs on topics for which you have unique and valuable insights. These interactions can improve outcomes, open new opportunities, and increase loyalty.

What is this new Patch Pump? Webinar Dec 2

Subcutaneous Delivery by Patch Pump – A New Route for Proven Parenterals

Tuesday – December 2, 2014 / 01:00 pm EST/10am PT – Free Attendance

Register now
http://bit.ly/sc-webinar

Certificate of Attendance provided on request

Traditional delivery of parenteral drugs comes with an associated burden of cost, discomfort and inconvenience. Through the conversion of iv therapy to subcutaneous drug administration, made possible by novel patch pump technology, a new paradigm of "anytime, anywhere" drug delivery, has emerged. Drs. Muntendam, Pitt and Nguyen will introduce the enabling technology and the opportunities it presents to improve heart failure outcomes and outpatient parenteral antibiotic therapy (OPAT) treatment alternatives.

Key Take Aways:

• Unique pump technology enables convenient and comfortable subcutaneous administration of parenteral drug by patient or caregiver.
• Anytime, anywhere administration of parenteral drugs improves medical outcomes and reduces the burden to patient and payor.
• Subcutaneous delivery of furosemide introduces new heart failure treatment options that reduce the reliance on inpatient and emergency room care.
• Subcutaneous delivery of antibiotics enables effective antibiotic therapy without the need of PICC lines or infusion services.

Who Should Attend:

Managers and above in...

• Infectious disease drug research and development
• Cardiovascular drug and device research and development
• Business development
• Strategy
• Medical Directors of health plans, hospitals, accountable care organizations, large family practices
• Pharma Directors

OnDemand Webinar: Handling Missing Data in Analgesic Clinical Trials

Handling Missing Data in Analgesic Clinical Trials; Dropouts, Regulatory Strategies and Practical Implications

View the recorded webinar today

Speaker: Neil Singla, MD, Owner, Managing Member, Lotus Clinical Research

When it comes to subject dropouts, an ounce of prevention is worth a pound of cure. Subject and study staff education can reduce dropout rates. The lecture will focus on educational paradigms designed to reduce dropouts and their efficacy. Regardless of technique, dropouts cannot be eliminated. When dropouts occur, they need to be statistically accounted for utilizing accepted imputation methods. In the recently released FDA draft analgesic guidance, a significant amount discussion was devoted to the appropriate statistical handling of missing data. Dr. Singla will provide a primer on accepted imputation techniques for acute and chronic analgesic studies.

View OnDemand: http://bit.ly/lotusreg14

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

View OnDemand Archive

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

Includes live polls and a Q & A session.

Overview:

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

View OnDemand Archive

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

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

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

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

provided by Sciformix

BigDip (Big Data in Pharma) Starts 9/16

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
http://big-datapharma.com/agenda/workshops

Session: Analytics Provide the Cure for Big Data Overload
9/18 9:30am PT
http://big-datapharma.com/agenda/Day-two

Hope to see you there!

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

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

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

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). 

Download now

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

September Digital Edition is now available

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

http://www.pharmavoice.com/content/digitaledition.html?pg=1

Webinar: Expedited Programs for Drug Development

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

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

Happy 20th Anniversary SCDM!

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  www.scdm2014.org for the full event program.

David Ormesher: Difference Maker – a Red Jacket Honoree

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:
http://bit.ly/1thD4vd

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

Register Now

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

Register Now

Connected Health: Big Business and Big Impact on Healthcare

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.

An Ounce of Prevention, a Pound of Cure: Social Media Risks and Benefits for the Pharmaceutical Industry - White Paper

Drug makers are just beginning to realize how social networks can improve business results. But what seems like a spoon full of sugar is often a tough pill to swallow when you consider regulatory requirements from agencies like the FDA for use of these networks. Read this paper to gain an understanding of what the regulatory landscape of the pharmaceuticals industry looks like, and what concerns you should be aware of from a legal perspective.

Download this free white paper now - Click Here

Provided by: Actiance

New Podcast and White Paper on the Pain Market

Podcast: Pharma Attempts to Ease the Pain

Thought Leader: Michael Fronstin, General Manager, Health Outcomes, Forecasting and Epidemiology, Kantar Health

In this episode, Mr. Fronstin illustrates the size and scope of the pain market, addresses current unmet needs, outlines promising new Mechanisms of Action, and covers the implications for the pharma industry.

Michael Fronstin

Play podcast

Download transcript of podcast

White Paper: The Pain Market and the Promise of New Mechanisms of Action

This white paper explores the current drug development landscape of the pain market and the most promising mechanisms of action in development. It identifies the pain conditions new drugs most commonly targeted for development focus on. Lastly, it covers the commercial implications for manufacturers.

Download white paper

Red Jacket Award Winners - PharmaVOICE 100

The Inaugural Red Jacket Awards

In celebration of 10 years of the PharmaVOICE 100, we are proud to launch the Red Jacket Award. This honor recognizes individuals who have been nominated multiple times by their colleagues and peers as inspirational leaders.

Throughout their careers, they have demonstrated a commitment to furthering the life-sciences industry through leadership, innovation, motivation, mentorship, and philanthropy.

Their entrepreneurialism and managerial styles have allowed their employees and companies to not just thrive but leave a lasting impact on their various sectors of the life-sciences and healthcare industries.

They are committed to the careers and professional goals of their employees and colleagues.

This year’s Red Jacket Award honorees demonstrate that success is not just based on hard work and a healthy bottom line; their legacy extends to improving the healthcare environment for patients and caregivers now and into the future.

These inspirational individuals have also significantly given back in service to domestic or international philanthropic associations and communities dedicated to social change.

Join us in congratulating this year’s Red Jacket Award honorees.

See the list.