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.

E-publication: Optimizing the Customer Experience Through Multi-social Marketing

Customer Experience Roadmap

The marketing environment for life sciences companies demands that treatments improve patient health outcomes, deliver value to healthcare providers (HCPs), and enhance business effectiveness and results. Additionally, the ways customers (i.e., HCPs, patients, and caregivers) obtain information has changed dramatically, and they seek information customized to their needs. This white paper provides an overview of multi-social marketing and describes how to create immersive customer experiences that engage customers and drive results.

Download this free e-publication now - Click Here

PharmaVOICE 100 - 2014 Edition

PharmaVOICE 100 - The 10th Year

It is with great pleasure that we announce this year's PharmaVOICE 100. It marks the 10th year of showcasing 100 of the most inspiring people in the life sciences.

From its humble beginnings on the back of a napkin during a delayed flight, the PharmaVOICE 100 has given the people in our industry a voice in selecting their peers, colleagues, and mentors for this honor. We hope you enjoy this feature for another 10 years.

Our industry is stronger because of these amazing people. Thank you to everyone who has nominated, has been nominated, and has earned this award.

Browse through our July/August issue and see how many people you know. Let their stories inspire you.