| 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
· Talent/Leadership Development & Acquisition
· Industry, Education & Government Collaboration
· Utah Life Science Vision
We look forward to working together!
President & CEO
BioUtah Perspective: An Interview with Greg Jones, PhD, Associate Director, SCI Institute
By Kimball Thomson
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.
|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.
|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:
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.
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”
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
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.
|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.
|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.)
|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.
|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.
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.
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.
How Digital Technology Can Personalize Health Care
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.
BioUtah: Growing Utah's Robust Life Sciences Industry
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."
|Study: FDA Enforcement Growing for Medical Device Companies
FEBRUARY 11, 2013
BY MICHAEL CAUSEY 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.
|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
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.”
|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 | 3 | |
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.
|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 Arundhati Parmar | 0 Comments
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.
|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
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.
|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.
|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.
|MDMA Praises Introduction of Bipartisan Medical Device Repeal Legislation
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
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.
|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.