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Utah's New, Independent Life Science Association
March 2013
 Note From the President

On February 28, the BioUtah team was joined by 150-plus Utah life science leaders at our inaugural open house at the new flagship building of the Utah Science Technology and Research Initiative (USTAR) at the University of Utah. This extraordinary facility, which houses some of the nation’s most dynamic groundbreaking research, was a fitting location for a celebration of Utah’s life science community and its bright future.

 

The event was held in concert with some of our most valued friends and strategic partners, USTAR and the Governor’s Office of Economic Development (GOED). USTAR was represented by its chairman, Dr. Dinesh Patel and by executive director and event host Ted McAleer, GOED by the State of Utah’s Life Science Cluster Director, Dr. Suzanne Winters.

 

At this first open house, BioUtah and our partners laid out the broad strokes of our shared vision of expanding Utah’s place as a magnet for transformative ideas, people, capital and companies for the life sciences. It will require the determined efforts of a tightknit, growing community to refine and execute this vision. This is where you come in. We invite you to learn what we’re doing, participate in our events, and get engaged on one or more of our core action committees:

 

·         Public Policy/Advocacy

·         Funding/Investment

·         Communications

·         Talent/Leadership Development & Acquisition

·         Industry, Education & Government Collaboration

·         Utah Life Science Vision

 

We look forward to working together!

 

Kimball

 

Kimball Thomson

President & CEO

BioUtah

 

BioUtah Perspective: An Interview with Greg Jones, PhD, Associate Director, SCI Institute
By Kimball Thomson



Greg Jones

Dr. Greg Jones has compressed multiple careers into a few short decades, and experienced success in the spheres of education, industry and government. At the University of Utah, Jones has twice served as associate director of the renowned Scientific Computing and Imaging Institute (SCI), and as executive director of the Moran Eye Center. He has founded innovative companies, including Visual Influence and VisTrails, and serves on numerous company and community boards. In government, he served as State Science Advisor in Gov. Jon M. Huntsman’s administration. At SCI, Jones currently manages several strategic research centers and leads major funding and strategic partnership initiatives.  For his multifaceted service to Utah’s scientific community, Jones was awarded the 2007 Medal for Science and Technology by Gov. Huntsman.

Recently BioUtah took advantage of the opportunity to sit down with this affable, respected mainstay of Utah’s life science community for a wide-ranging discussion about SCI, national collaborations and Utah’s potential to become a major life science player. 

BioUtah:     Could we talk about what you've built here at the SCI Institute?

Greg Jones:     
SCI is between 150 and 200 people now. In 2000 we were 35 people, so we have grown significantly—and as anybody that's grown with the company from small to larger, the dynamic of the group changes as it gets closer to 200 compared to 40.

BioUtah:    How have you had to change your leadership style as you have grown?

GJ:     
The changes to keep moving forward can be trying; it is difficult. They're not trivial changes the leadership has to go through. We are not a very hierarchical group and I like to think of us as a very successful research environment that recruits and attracts high-powered faculty and staff and students. And we build a structure with those faculty students and staff where they can have a lot of freedom in finding great collaborations. Administratively and infrastructure-wise with our computer systems and just the way we think of research, we make a really fertile environment for them to collaborate and look at new ways of doing science.

READ MORE....

University of Utah's 2013 Translational Medicine Symposium Highlights Path to Market for Life Science Products
 
By Peter Knauer
Chief Operating Officer, BioUtah
 
The University of Utah's Entrepreneurial Faculty Scholars recently held the 2013 Translational Medicine Symposium. The symposium illuminates the entrepreneurial pathway, providing students, researchers and professors with a comprehensive roadmap for bringing an innovative life science product to market.
 
The all-day event is staged annually by Glenn Prestwich, Presidential Professor, Director of the Center for Therapeutic Biomaterials and Special Presidential Assistant for Faculty Entrepreneurism at the University of Utah. Topics range from intellectual property management to pre-clinical/clinical development and commercial reimbursement strategies. This holistic approach gives innovators a solid understanding of the expertise and resources they will need to successfully navigate the many obstacles that confront them.
 
READ MORE...
 
 

Creating, Staffing and Managing an Inspection War Room
By Walt Murray
Director of Quality and Compliance Services, MasterControl Inc.


Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

When I served in the military there was a term used that is still pretty familiar today: “sound general quarters!”  When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time.  All commands during general quarters came from the war room behind the bridge of the vessel.  
Many companies in the life science sector hear their own version of “sound general quarters!” from FDA and anxiously await the ultimate examination:  An inspection visit by the FDA.  One of the key components of hosting such an inspection is the preparation and use of a “war room” during the visit.  It can be referred to as the primary line of defense in the success of such a visit.  
This strategic office should be devoted and organized to provide the necessary objective evidence requested during such an inspection.  One of the key observations the inspector will make is the timeliness of the turnaround of a request. A speedy response is always favorably acknowledged and a well-organized war room makes that possible.

War Room Components
Three war room components should be easily accessible during the inspection: desktop documentation; records of data and recorded information; and pre-selected auditees and their backups.
Making these items quickly available requires some pre-planning. Choose a war room location in an office area that is not in the traffic mainstream.  It should be in close proximity to the room hosting the inspection.  All electronic venues should be available, including email, cell phone and a reliable devoted printer (e-documentation).  Be cognizant of the nature of documents to be made available in terms of sign-offs for review and approvals of documents and records.  Conducting a dry run for war room readiness would be very prudent.
Pre-selected auditees should be “processed” through the war room before entering the “inspection arena.”  Coaching in the war room before entering an inspection interview will be very effective in setting the appropriate tone for the auditee.  Also, if last minute plans for availability change, then the war room can regroup, preparing the backup auditees before the inspector’s interview.
The strategic person in the war room should have certain items at their finge tips at the start of the inspection:

  • A quality system manual and/or site master plan
  • An organization chart showing the relationship of quality and regulatory management
  • Key SOPs that manage quality and compliance system:  CAPA, record control, internal audits, change control , master batch or actual batch records and associated process flow diagrams
  • Permissions for file access, or person(s) who can access critical information when “on-deck”
This inspection moment for a company should be called a call to “general quarters” but the war room should be prepared under the motto “Semper Paratus,” meaning always ready.  When the call to duty comes, everyone should know their positions.  All will await the orders from the war room while the company continues to navigate its business affairs.  No one should be lackadaisical until the order comes to “stand-down” from the war room.  


Walt Murray has performed and hosted many audits in his 30-year career.  He is a veteran of the U.S. Coast Guard and has obtained certified Lead and Six Sigma Black Belt statuses during his tenure in the quality management field.  He currently consults for MasterControl, based in Salt Lake City, Utah. One can learn more by accessing the website at www.mastercontrol.com
USANA Health Sciences' China Subsidiary BabyCare Ltd., Receives Approval For Three Additional Direct Selling Licenses In Mainland China

SALT LAKE CITY, Feb. 25, 2013 /PRNewswire via COMTEX/ -- USANA Health Sciences Inc. USNA -1.11% , a global nutritional company, announced today that its China subsidiary BabyCare Ltd. received official government approval from the Ministry of Commerce People's Republic of China (MOFCOM) to expand direct selling activities in three additional provinces/municipalities within the People's Republic of China. The provinces/municipalities include Jiangsu, Shanxi and Tianjin.

 These three additional licenses granted to USANA's wholly owned subsidiary, BabyCare Ltd., add to the company's existing direct selling license in the municipality of Beijing. This announcement of MOFCOM granting three additional provincial/municipality direct sales licenses shows the good standing of USANA's China operations doing business as BabyCare Ltd.


Survey: New Tax Drives Up Medical Device Prices

MATT PILON

 

More than 40 percent of medical device companies expect to increase prices in response to an industry tax that took effect last month, according to a survey by a Texas-based consulting firm.

The survey of 3,509 medical device industry professionals around the world by the Emergo Group found that the 2.3-percent tax will bring about both tax increases and efforts to lower production costs.

Nearly 42 percent of respondents said their companies would pass along some or all of the increased costs to customers. Those in the next largest segment – 36 percent – said they could not disclose that information. And 31 percent said they would work to lower their own production costs without cutting staff, while 11 percent said they expect to reduce employment.

READ MORE...

Outlook for the medical device industry in 2013

The 2013 Medical Device Industry Survey was conducted in January 2013, with a total of 3,509 respondents. Only one response per person was allowed. Survey questions were emailed to an in-house list maintained by Emergo Group. A publicly available online link to the survey also solicited responses from industry via social media channels.

Due to the nature of our business, QA/RA professionals make up a much higher percentage of respondents than they would otherwise represent in the industry. Some results should be interpreted bearing this in mind.

Click here to download the PDF of the survey.

READ MORE...

 

Dear Mr. Adams, there are things we don't talk about in the natural products industry…

Friday, February 22, 2013

by Mike Adams, the Health Ranger
Editor of NaturalNews.com

(NaturalNews) "Dear Mr. Adams, there are things we don't talk about in the natural products industry..." Such began a message sent to me by the founder of a nutritional products company. It was sent in reaction to my posting of my "organic China fraud" article that questioned the legitimacy of organic certification for foods and superfoods grown in China.

This article has sent shockwaves through the natural products industry, an industry that has its own "dirty little secrets" that no one dare talk about.

For over a decade, I passionately promoted this industry, advocating superfoods like chlorella and spirulina, all while companies selling the products raked in hundreds of millions dollars in profit off the publicity we helped generate here at Natural News. I helped educate tens of millions of people about superfoods, micro-algae, nutritional supplements and natural cures, and all the while, I never made a single dollar on this editorial promotion of the industry. (And I was happy with that. This was never about profit.)

READ MORE...

 

FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events

Today the U.S. Food and Drug Administration is seeking input from industry and the public on the effects of extreme weather and natural disasters on the production and supply of medical devices. The FDA will use the information to identify steps that the agency, manufacturers, and the public can take to prepare for such events.

Extreme weather and natural disasters can interrupt the manufacturing and distribution of medical devices and affect their safety, quality and availability. For example, flooding and fire can damage facilities where sterile products are stored; electricity outages or lack of access to filtered water can stop or slow down medical device production; or large storms can disrupt the shipping and distribution of medical devices or the materials and components used to make them.

The FDA will collect input during a meeting of the Device Good Manufacturing Practice Advisory Committee on April 11, 2013 and through a public docket announced today in the Federal Register. The docket will remain open until May 10, 2013.
 
 

Wireless in healthcare: 7 critical questions that every CTO needs to consider

Eric B. Abbott and Tormod Larsen / February 20, 2013

In the last decade, the use and application of wireless technologies in healthcare has grown exponentially. Analysts at Gartner predict that the annual market for wireless solutions in healthcare will reach $1.7 billion by 2014. Additionally, an estimated 500 million users are expected to use wireless health and wellness applications by 2015. The meteoric growth of mHealth – the use of mobile communication technology to deliver healthcare services – is stark testimony to the value of employing wireless in healthcare.

Wireless in healthcare is driving a high degree of disruptive innovation, supplanting and replacing traditional methods for the delivery of healthcare services. Key underlying trends include real-time and virtual access to enterprise clinical systems via web-based portals, wireless point of care (both workflows and process), outreach and extension of clinical operations (i.e., remote medication compliance), wireless medical imaging (via DICOM and ePACS), the medical home (i.e., in-situ care and primary triage) and (chronic) disease and wellness management.

READ MORE...

 

House bill would exempt emergency medical devices from Obamacare tax

A bill in the U.S. House of Representatives would exempt medical devices used by emergency responders from a 2.3% sales tax imposed by the Affordable Care Act.

Medical device tax

Legislation sponsored by Rep. Michael Turner (R-Ohio) would exempt emergency medical devices from the 2.3% sales tax on medtech products that went into effect last month.

The measure has attracted meager support compared with a bid to repeal the tax outright, sponsored by Rep. Erik Paulsen (R-Minn.). Turner's bill has 3 co-sponsors: Rep Ken Calvert (R-Calif.), Michael Grimm (R-N.Y.) and Walter Jones Jr. (R-N.C.). Paulsen's repeal bill has 187 co-sponsors.

READ MORE...

How Digital Technology Can Personalize Health Care

Ralph Snyderman, M.D.

Digital technology has transformed virtually all aspects of how we live, and now it's ready to revolutionize health care. In The Creative Destruction of Medicine, Dr. Eric Topal makes a convincing argument that the digital revolution will deconstruct how health care is delivered. For example, hand-held digital devices will provide precise diagnostic information virtually anywhere and transmit it instantaneously wherever needed. Smart phones and e-tablets will give individuals access to applications allowing them to understand and manage their health or disease. Inefficient, inconvenient, and expensive physician office or hospital visits will be far less necessary as distant monitoring goes online. The power of digital technology in health care is clear, but what hasn't been described is how such devices can be used to facilitate the creation of a better health care system.

A major flaw in health care today is that it's focused on treatment of disease events after they develop rather than on preventing them. This approach is partly responsible for the massive increase in preventable chronic diseases. Digitalizing today's "fix what's broken" approach to health care would be akin to adding GPS to a horse and buggy. While improved technologies can enhance the effectiveness of treating disease events, the real opportunity lies in using them to create a new approach to care that enables individuals to improve their health, diminish their chance to develop preventable diseases, and minimize the consequences of diseases if they occur. A more rational model of care is within our grasp, and digitalization can make it far more effective. This approach is termed personalized health care.

READ MORE...

BioUtah: Growing Utah's Robust Life Sciences Industry

Feature Story

Kimball Thomson, CEO of BioUtah, likes to say, "We are punching below our weight class." He's using a boxing phase to emphasize that Utah's life sciences industry is bigger than most people realize, and that the industry hasn't advocated for itself and made its presence felt locally and nationally as much as it should. 

"Most people are surprised to hear we are a $14.6 billion industry, employing 63,000 people in the state and generating $3.5 billion in personal income every year," says BioUtah COO Peter Knauer. "This is one of the reasons BioUtah was formed and we fully intend to speak in a far stronger voice for the state." 

READ MORE...

 

Study: FDA Enforcement Growing for Medical Device Companies

FEBRUARY 11, 2013
 BY   
Editor & Publisher, eDataIntegrityReport.com

Turns out that some paranoid people have a reason to, well, be paranoid.

Researchers from the London Business School issued a report last year finding that many people at work who thought they were being talked about were probably right.

Maybe some in the medical device industry can be forgiven for thinking the FDA has come down harder on them in recent years.  A new study kind of backs their “paranoia,” too.

FDA efforts since 2009 to strengthen key policies has resulted in more medical device enforcement that will have a “long-lasting” effect on the industry, says an independent study from Greenleaf Health’s enforcement and compliance team. It was overseen by former FDA Associate Commissioner for Regulatory Affairs, Michael Chappell.

READ MORE...


Premarket review process for some medical devices raises safety concerns

February 09, 2013  -- Before a medical device can be marketed and sold in the United States, the Food and Drug Administration (FDA) must review the device and make a determination about its safety and effectiveness. Once the FDA is satisfied with the safety and effectiveness of a medical device, it will clear the device for marketing to the public. Unfortunately, in an attempt to obtain speedy clearance to market from the FDA, some manufactures misrepresent the characteristics and/or intended uses of devices resulting in the sale and use of unsafe and ineffective medical devices, often resulting in serious pain, suffering and even death to the recipients of those medical devices.

Food and Drug Administration (FDA), Institute of Medicine (IOM) and Government Accountability Office (GAO) critical of 510(k) process

Citing its findings that from 2005-2009 three out of four recalled high risk medical devices had been cleared by the FDA under the 510(k) process, the Institute of Medicine (IOM) has called for eliminating the 510(k) process. Echoing the IOM's findings, the Government Accountability Office (GAO) found that 83 percent of roughly 700 medical devices recalled every year are Class II medical devices that received premarket approval under the 510(k) process, concluding that theFDA should enhance its oversight of recalls.
 
 

Asia emerging as a hub for global pharma industry: A global life sciences cluster report

 

Singapore
Thursday, February 07, 2013, 18:00 Hrs  [IST]
 

The pharmaceutical multinationals are reinforcing their presence in Asia, according to Jones Lang LaSalle's - a professional services and investment management firm of annual revenue of $3.9 billion with operations in 70 countries - latest global life science  cluster report. The report says widening patient pools and increasing consumer demand in emerging markets is driving the growth of sales offices, manufacturing operations as well as research and development facilities around Asia.

"Beyond the cost of developing new drugs and treatments, facility and real estate costs are among the highest expenses for life sciences companies and such firms are optimising their real estate and location strategies to capture market opportunity in Asia," said David Wilton, Asia Pacific regional director for Industrial and Logistics at Jones Lang LaSalle. "It is also apparent that the industry is becoming more strategic with regards to site selection, choosing locations with rich industry resources, capital and a higher propensity for discovery and innovation.”

READ MORE...


Utah Represented at the World's Top Arab Health Trade Show in Dubai

by Jeff Wangsgard, Fellow, Governor’s Office of Economic Development

02/07/2013 | 259 views | 0 0 comments | 3 3 recommendations | email to a friend | print
New World Trade Center Utah Logo
 Last week, Franz Kolb, Director – Middle East, from the International Trade and Diplomacy Office of the Governor’s Office of Economic Development as well as several Utah companies, attended and exhibited at the annual Arab Health trade show in Dubai, United Arab Emirates.

The Arab Health 2013 show is the largest medical device and health science trade show in the Middle East and one of the largest in the world. The four day event had over 83,000 visitors from 142 countries and over 3,500 exhibiting companies showcasing the very latest medical breakthroughs and technological developments in healthcare. The medical health industry in the Middle East exceeded $80 billion in 2011.
 

GOP, Dems call for repeal of $30 billion medical device tax

By Pete Kasperowicz 02/07/13 11:11 AM ET

A bipartisan group of 180 House members — consisting of about 40 percent of the House — has reintroduced a bill to end the 2.3 percent tax on medical devices that was imposed under President Obama's healthcare law.

That tax took effect at the start of 2013, and is expected to raise a few billion dollars a year in tax receipts for the government, and $30 billion over 10 years. But opponents of the tax say it will hinder innovation and job creation in the medical device industry.

READ MORE...

 

No. of life science start-ups receiving VC money for first time in 2012 was lowest since 1995

February 7, 2013 10:52 am by  | 0 Comments

decline, fall

Life science venture capital activity may have picked up in the last quarter of 2012, but it still wasn’t enough to overwhelm the dismal showing in the first half of the year.

A new Pricewaterhouse Coopers Money Tree Report found that the number of life science start-ups that received venture capital for the first time in 2012 was the lowest since 1995. Only 135 start-ups got first-time VC money last year.

Those companies attracted only $664 million, a 44 percent drop from 2011. The average deal was $4.9 million, compared with $6.3 million in 2011.

READ MORE...


Life Sciences Venture Capital Funding Drops 14% During 2012, According To The MoneyTree Report

Number of Life Sciences Companies Receiving VC for the First-time in 2012 Reaches Lowest Level Since 1995

PwC logo. (PRNewsFoto/PwC)
 

NEW YORK, Feb. 7, 2013 /PRNewswire/ -- US venture capital (VC) funding in the life sciences sector, which includes the Biotechnology and Medical Device industries, dropped 14 percent in dollars and 7 percent in deals during 2012 according to a new PwC US report, "Double-digit dip" that includes data from the MoneyTree™ Report from PricewaterhouseCoopers LLP and the National Venture Capital Association based on data provided by Thomson Reuters.  Venture capitalists invested a total of $6.6 billion in 779 Life Sciences deals during the year, compared with $7.7 billion in 836 deals during 2011. The number of Life Sciences companies receiving VC funding for the first time reached the lowest level since 1995 with only 135 companies receiving funding in 2012.

Compared to the prior quarter, Life Sciences venture funding rose 11 percent in Q4 2012 to $1.9 billion. Deal volume also increased, rising 12 percent to 187 deals compared to the prior quarter.

For all sectors, VCs invested $26.5 billion in 3,698 deals in 2012, a 10 percent drop in dollars and 6 percent decline in deals from the prior year. Venture investors funneled $26.5 billion into 3,698 deals during 2012. While total investments saw a decline for the year, Deal volume in Q4 2012 rose 5 percent compared to the prior quarter.  However, dollars invested did decline 3 percent over the same time period to $6.4 billion in 968 deals.

READ MORE...


Guide to Medical Device Process Validation

Go step-by-step through the most complex, challenging process validation compliance problems.

FEBRUARY 6, 2013

Last year, when the FDA clarified its guidance on process validation for drugmakers, medical device companies were left in the dark. The CDRH did not sign on to a new guidance, leaving in place only the old and confusing guidance that dates back years.

However, time has not stood still on the manufacturing floor: New and more complex manufacturing processes emerge every year, greater outsourcing leaves devicemakers relying more on third-party manufacturers, and international standards continue evloving. Devicemakers need to be sure their process validation systems have kept pace with reality.

READ MORE...


Merit Medical Partners With Verite Mobile Tools and Strategies to Create an Innovative Medical Device Conversion App

February 06, 2013 09:00 ET

SALT LAKE CITY, UT--(Marketwire - Feb 6, 2013) - Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, and Vérité, a digital communications agency, announced the release of a cutting-edge iPhone App, Merit Convert, available on the App Store now. This revolutionary app quickly calculates important unit conversions and includes medical device-centric conversion modules such as an Artificial Aging Calculator, Needle Gauge Calculator and Work Week Calendar. 

The key strategy behind Merit Medical's Convert app is to be a leading resource in the medical device industry and produce an app that can be used by clients, partners, and the public. The app is successfully driving new visitors to the Merit OEM site located athttp://www.meritoem.com/conversion-app/. Since its initial deployment in the App Store, the Merit Convert app has received a 5 star rating and accolades for the time saving French size converter feature and innovative artificial aging calculator.

READ MORE...


MDMA Praises Introduction of Bipartisan Medical Device Repeal Legislation

02/06/2013

 WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today regarding introduction in the U.S. House of Representatives of  H.R. 523, the “Protect Medical Innovation Act:”

“MDMA thanks Congressman Paulsen and Congressman Kind for their continued leadership on this crucial issue for medical innovation and patient care, and we remain fully committed to repealing the device tax. There is no question that the device tax is destroying jobs, eliminating investments in research and development and shelving plans for new medical technologies, all to the detriment of patients.

“The broad, bipartisan support for repealing the medical device tax speaks volumes to the recognition by Members of Congress that the United States needs to maintain our global leadership position in this high tech, manufacturing-based industry.

“America's workers and patients have too much on the line for us to let up on our call to repeal the medical device tax, and MDMA and our members are more committed than ever to get the job done."

 

Why the medical-device tax repeal won’t be easier this time around

February 5, 2013, 4:00 PM

Boston Scientific
Rotablator Rotational Atherectomy System.

Efforts to repeal a tax on medical devices are back on the table, House Majority Leader Eric Cantor said Tuesday. But will scrapping the 2.3% excise tax be any easier this time around?

Probably not, though it isn’t stopping Cantor from trying. The Virginia Republican has been trying to repeal the tax — part of President Barack Obama’s health-care law — since at least last year, as part of the fiscal-cliff talks. Now he’s resurrecting the idea under the banner of a new Republican push on health care, education and other areas.

READ MORE...

 

Social Good Venture Meets Venture Capital at Utah Conference

Social Good Network, an online fundraiser business for nonprofits, heads down to Salt Lake City to present for the Wayne Brown Institute's 29th Annual Investor's Choice Conference.

Feb. 5, 2013 - BOISE, ID (February 5, 2013
In the 29-year history of the Investor’s Choice® Venture Capital Conference, Bradley Bertoch has never seen a presenting startup the likes of Social Good Network.

“This is new territory for the conference.  We’ve had hundreds of startups present their ideas to investors, from cleantech to life sciences, but never one with a mission to ‘make money and do good,’” said Bertoch, president and CEO of the Wayne Brown Institute, which organizes the annual event to be held this year on Thursday, February 7, at the Zermatt Resort and Spa in Midway, Utah.
 
Biopharmaceutical Industry Facing Hiring Difficulties and R&D Talent Gap, Finds PwC Health Research Institute Report

New era of collaborative R&D drives demand for new breed of scientist and bigger role for HR

Mon, 4 Feb, 2013
 
NEW YORK, Feb. 4, 2013 /PRNewswire/ -- A talent gap in the scientific workforce has biopharmaceutical companies searching outside for fresh skills and alternate approaches to R&D staffing, according to PwC's Health Research Institute (HRI) in a new report published today.  New R&D organizational models based on partnerships, alliances and even crowd sourcing are changing talent needs, challenging traditional talent management strategies and redefining the role of human resources (HR) in R&D productivity.
 
 HRI's report, New Chemistry: Getting the biopharmaceutical talent formula right takes an in-depth look at the changing R&D model and what it means to workforce design.  Pharmaceutical companies have long relied on a highly educated workforce of scientists and researchers to replenish their product pipelines.  In response to a host of challenges to its business model, the industry has right sized its workforce and is changing how it conducts R&D.  Demand for productivity is as high as ever, from a workforce with fewer resources and new expectations of performance based on improved health outcomes and/or lower costs.
 
 
The Lifesaving Promise Of The Pharmaceutical Drug Pipeline
OP/ED  |  Sally Pipes, Contributor 2/04/2013 

 

There was a time not long ago when patients suffering from rare diseases had little hope of finding a medicine that could cure their ills. But in the 30 years since Congress passed the Orphan Drug Act, research into “orphan drugs” — defined as those treating diseases that affect fewer than 200,000 people — has become increasingly common.

All told, orphan diseases afflict about 25 million people in the United States. But before 1983, there were just 38 orphan drugs approved for use in the United States.

READ MORE...

March 12
Commercialization Interchange / A Roundtable to Improve Execution in Technology Commercialization
Marriott University Park Hotel
3/12/2013 - 3/15/2013
All Day

Commercialization Interchange / A Roundtable to Improve Execution in Technology CommercializationNext event: March 12-15, 2013

Register

Technology Venture Development and the Technology Commercialization Office at the University of Utah host this innovative roundtable conference to share best practices among a small group of universities and companies to take university technologies to market. This small group shares ideas, processes, approaches and perspectives on what it takes to successfully inspire, promote, protect, license and market exciting new technologies.

Themes
  • Forming commercialization ecosystems
  • Managing academic administration
  • Structuring technology commercialization
  • Engaging faculty for disclosure, mentoring
  • Fostering student entrepreneurship
  • Responding to multiple constituencies
  • Securing and managing intellectual property
  • Licensing, art and science
  • Facilitating startups
Hands-on experience

Commercialization Interchange participants get a hands-on experience on the final day, when they will form groups to use what they have learned to address challenges in their own organizations. Possible challenges include intellectual property, culture, administration, faculty relations or student programs. This is a great opportunity to address important questions or concerns with other professionals facing the same challenges.

contact
April 24
2013 Utah Genius Awards
Little America Hotel
11:00 a.m. - 12:00 p.m. Honoree Showcase
12:00 p.m. - 1:30 p.m.  Awards Luncheon
4/24/2013

 

Honoring Utah’s
Top 20 Patentees
Top 20 Trademark Registrants
Top 20 Companies by Patents Issued
 
HONORING
Fred Lampropoulos
Chairman & CEO 
Merit Medical Systems, Inc.
Lifetime Achievement Award

Keynote Speaker
Lane Beattie

President & CEO
Salt Lake Chamber
of Commerce
 
Online registration at: www.utahgenius.com

April  22
BIO International Convention
4/22/2013 - 4/25/2013
All Day
The Global Event for Biotechnology Welcomes You


Thousands of companies from around the world and all industry segments will be at BIO, ready to build strategic partnerships. Attend the Global Event for Biotechnology and you will reap the benefits of an efficient four days!  You will find connections, partnering and innovation everywhere at BIO. 16,000+ leaders from 65 countries come to this global gathering. We invite you to join!

BIO covers the wide spectrum of life science innovations and application areas. Drug discovery, biomanufacturing, genomics, biofuels, nanotechnology, and cell therapy are just a few of the industries represented at the BIO International Convention.

 >> View the snapshot of the 2013 BIO International Convention

We have a free service, myBIO Personal Event Planner - search using keywords to find what interests you at BIO.

The key elements of the event are education, networking, BIO Business Forum partnering and the 2,000 companies showcasing the latest technologies, products and services in the BIO Exhibition.  

1 OF 3 BIO ATTENDEES COMES FROM OUTSIDE THE U.S.

The BIO International Convention brings together life science leaders and policy makers from around the globe. You will find leaders with new perspectives and make vital connections at the many networking events. 

We have a wealth of information and services for our international attendees. Visit our international visitors section.

MEET YOUR NEXT BUSINESS PARTNER

At BIO, you will meet a full range of executives as more than 65% of attendees are either Managers, Directors, C-Level or Executive Management. BIO represents companies of all sizes, 40% of attendees are from companies with more than 500 employees and 27% are from companies with fewer than 20 employees.

The BIO Business Forum and the BIO One-on-One Partnering™ system make it easy to find your potential matches and set up face-to-face private meetings.

Attend BIO to experience a global event that ensures you accomplish your business objectives.


April 29
WEBCAST Public Workshop - Accessible Medical Device Labeling in a Standard Content and Format
WEBCAST-FDA White Oak Campus
4/29/2013 - 4/30/2013
All Day

The purpose of the workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling.

Day 1

  • Morning introductions and expectations followed by main address
  • Summary of surveys from health care professionals and National Family Caregivers Association on medical device labeling
  • CRADA with Kwikpoint and the development of a visual language
  • CDER-measures of success with electronic submission of drug labeling
  • Development of a standard content and format
  • The use of a shortened or quick guide version of labeling

Day 2

  • Clinical perspectives panel to discuss medical device labeling. Including: ER physician, staff nurse, caregiver, patient, home health professional
  • Regulatory perspectives panel. Including: analyst, pre-market staff, industry representative
  • Results from a pilot conducted for the electronic submission of labeling
  • Medical device labeling repository and ways of accessing labeling.
Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by close of business on April 5, 2013. If you wish to view this Workshop by Webcast you must also register by close of business on April 5, 2013.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

Public Comment

If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by April 12, 2013. All requests to make oral presentations must be received by the close of registration on April 5, 2013, at 5:00 p.m.. If selected for presentation, any presentation materials must be emailed to the Mary Weick-Brady no later than April 19, 2013.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Joyce Raines, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5709, FAX: 301-847-8142, email: joyce.raines@fda.hhs.gov.

For questions regarding workshop content please contact:

Mary Weick-Brady, MSN, RN, 
Center for Devices and Radiological Health 
Food and Drug Administration 
WO66 Room 5426 
Phone:301-796-6089 
FAX: 301-847-8510 
email: Mary.Brady@fda.hhs.gov.

May 14
The Biocompatibility and Performance of Medical Devices Symposium
Hilton Minneapolis
5/14/2013 - 5/16/2013
All Day

The Biocompatibility and Performance of Medical Devices Symposium is the medical device manufacturers’ leading event for science and education, specifically designed for professionals in research and development, quality assurance, regulatory affairs, product engineering and other device-related positions. You'll find expertise for every medical specialty:

Anesthesiology and pulmonary medicine, Cardiovascular, Dental, Ear/Nose/Throat, General medical devices and equipment, Neurology and spine, Obstetrics and gynecology, Oncology, Ophthalmology, Orthobiologics, Orthopedics and bone healing, Surgery, Tissue engineering, Wound healing …and more!

featuring speakers from:

Biocompatibles UK Ltd
Ecolab
Medtronic, Inc.
NAMSA
SGS
Shanghai Biomaterials Research & Testing Center
U.S. Food and Drug Administration
Wake Forest Insitute for Regenerative Medicine

Early bird pricing (through April 22, 2013) $1,800 

Standard pricing (begins April 23) $2,000

 register now

June 04
MPO Summit 2013
The Grand America Hotel

6/4/2013 - 6/6/2013
All Day

 The MPO Summit Salt Lake City, held at the Grand America hotel, will tap into the state’s innovative and growing medical device market. Utah’s life-sciences industry boasts more than 26,800 employees, making it a leader among Western states for life-science businesses per capita and second for overall industry growth. Companies such as C.R. Bard, Becton Dickinson, Boston Scientific, Edwards Lifesciences, Fresenius, ICU Medical and Merit Medical are just a few of the medical device firms already doing business in Utah.

The MPO Summit Salt Lake City will include sessions on supply chain issues, product development, supplier management, industry trends, logistics, quality & risk management, outsourcing strategies, sourcing decisions, product commercialization, and much more.

A detailed agenda is coming soon.  

November 21, 2013
SAVE THE DATE
BioUtah’s Annual Utah Life Science Summit
Grand America Hotel, Salt Lake City, UT

www.bioutah.org
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