Don’t miss Montreal’s InVivo Career Fair, September 2008
“With over 500 jobs to be filled, once again the 2007 Career Fair attracted many companies and participants. This shows the dynamism of our sector and potential for people growth.”
- Mr. Carl Viel
General Manager, Montréal InVivo
Contact: Dr. Andrew Gregory at 1-877-751-9415 for details.
ALBERTA
BIO 2008 International Convention
San Diego: June 17 - 20, 2008
Alberta will once again have a strong presence at the BIO International Convention. It is the largest global biotech exhibition with more than 2,200 exhibitors this year, and over 60 international pavilions. This year’s convention will take place in San Diego, CA from June 17 - 20, 2008. The Alberta pavilion has only one booth space still available! If you are a BioAlberta member company interested in exhibiting, contact Aggie Mikulski - Marketing Manager.
ONTARIO
BioFinance 2008
May 6 - 8, 2008
BioFinance 2008 is the Canadian Life Science industry’s leading investor conference. The meeting brings together key industry players to consider investment opportunities and issues affecting companies in biotechnology, medical devices, diagnostics and research tools. Participants include senior life science executives, institutional and venture capital investors, industry analysts, corporate finance executives and experts from the scientific and medical communities in Canada, the United States, Europe and Asia.
Official website: http://www.biofinance.ca
ACETECH Symposium in Ontario
May 29 - 30, 2008
This is the one time of the year when you, the CEO, should take the time to invest in yourself as a leader.
For this 2 day CEO retreat in Ontario, ACETECH brings a lineup of leaders of world-class companies dedicated to sharing the lessons they’ve learned while building their companies. You’ll hear how each met the challenges of the day…many of the same challenges you face every day…and how they faced these issues on the path to success.
The program is designed to provide an interactive environment of CEO networking, learning and sharing with each other. It’s quite an experience! The succession of presentations, breakout sessions to address specific issues in focused groups and even war stories will stay with you for a long time to come.
The ACETECH Symposium in Ontario is about CEO growth, performance and leadership. Join us for this exclusive symposium in Ontario and meet the movers and shakers in your industry who can help you take your company to the next level.
The program for the Annual ACETECH Symposium in Ontario in May 2008 will be available on this site in December 2007. Subscribe online to receive regular updates and invitations to other ACETECH networking events and workshops in Ontario.
For more information or to register visit http://www.acetech.org/.
QUEBEC
Festival Eurêka
Eureka! Festival
June 13 - 15, 2008
On the Quays of the Old Port of Montreal
Official website: http://www.festivaleureka.ca
Come celebrate science and technology on June 13, 14, and 15 in Old Montreal. The Eureka! Festival, initiated by the regional Conférence of the elected officials of Montreal (CRÉ) and organized by the Montreal Science Centers, invites everyone to discover the creativity, wealth and diversity of the Montreal scientific scene.
Fascinating research, innovative technology, intriguing shows, inspiring scientists, hair-raising exhibits, astonishing demonstrations - the second edition of Eureka! has all this and more in store for you!
For further information, contact:
Catherine Jolin
Project Manager, Farming Activities - Montreal Science Centers
Tel: (514) 283-5688
E-mail: cjolin@vieuxportdemontreal.com
Marianne Groulx
Project Manager, Farming Activities - Montreal Science Centers
Tel: (514) 496-6738
E-mail: magroulx@vieuxportdemontreal.com
Mathieu Latour
Development Officer - Economy and Knowledge - regional Conference of the elected officials of Montreal
Tel: (514) 842-2400 p 2664
E-mail: mlatour@credemontreal.qc.ca
The IXth World Conference on Clinical Pharmacology and Therapeutics (CPT2008)
July 27 - August 1, 2008
Québec City Convention Centre
900, boul René-Lévesque East, Quebec City Canada
Official website: http://www.cpt2008.org
CPT 2008 will bring together recognized international experts, in all areas of clinical pharmacology, clinical pharmacy, basic pharmacology, toxicology and pharmacoepidemiology to support better health outcomes and rational use of drugs. The exciting program will appeal to attendees whose interests range from the molecular to community health. New sciences of pharmacogenomics and proteomics will be well represented. The program will allow open discussions on the advances of drug research and utilization. The celebration of 400 years of Québec City history will provide an outstanding backdrop to sizzling science. It’s the first time since 1983 that CPT is held in North America. Do not miss this one!
Tel: +1 (613) 993-0414
Fax: +1 (613) 993-7250
E-mail: cpt2008@nrc-cnrc.gc.ca
NOVA SCOTIA
BioNova’s Celebration of Research Excellence
April 24, 2008
Halifax Marriott Harbourfront
In addition to the announcement of this year’s SABC winners, a member of Nova Scotia’s life sciences community will be honoured with BioNova’s Research Excellence Award for his or her outstanding contributions to the development of the life sciences industry in the province. This year’s Celebration is sponsored by Dalhousie University.
For more information or to purchase tickets, contact 902-421-5705.
BioPort Atlantic 2008
October 8-9, 2008
Cunard Centre, Halifax
Hosted by BioNova, BioPort Atlantic is the annual signature event for Atlantic Canada’s life sciences industry. To find out more about BioPort Atlantic, visit http://www.bionova.ca/bioport/.
Canada’s National Biotechnology Week
Coast-to-coast, September 19-26, 2008
Join BIOTECanada and partners in a celebration of the imagination and capacity of Canadian biotech innovators from discovery to commercialized product. To find out about NBW and the events taking place across the country, visit http://www.imagenenation.ca.
PHILADELPHIA
Oncology Drug Development World 2008
June 24-27, 2008
Courtyard Philadelphia
Downtown, Philadelphia, USA
The World’s leading Oncology Strategy Summit, developing best practice in international drug safety and pharmacovigilance strategy. This unique meeting will address the critical strategic, scientific and regulatory issues in the development of targeted oncology therapeutics. This important meeting is for Early to late stage development managers and directors working on oncology products.
Official website: http://www.healthnetworkcommunications.com
E-mail: jphillips@healthnetworkcommunications.com
Tel: +44 (0) 207 608 7039
Contact: Julie Phillips
ATLANTA
Introducing BioPharm America™ 2008
Atlanta, GA
September 9-10, 2008
The North American counterpart to EBD’s partnering conferences BIO-Europe and BIO-Europe Spring®
As part of the EBD family of events, BioPharm America builds on a unique and proven model to facilitate partnering opportunities. BioPharm America will bring together international decision-makers from the biotechnology industry, as well as from major pharmaceutical corporations and the financial sector.
- EBD Group’s state-of-the-art partnering system enables delegates to set up meetings with potential partners
- Company presentations by small and large biotech and pharma firms as well as young, innovative start-ups
- Panels and workshops providing analyses and opinions of renowned industry leaders
- Sponsor exhibition to showcase products, services and technologies
- Excellent networking opportunities during lunches and exclusive evening receptions
Official website: http://www.biopharmamerica.com
Registration and information contact:
Elaine Bundy
EBD Group
Tel: +1 (760) 930 0500
Fax: +1 (760) 930 0520
E-Mail: ebundy@ebdgroup.com
LONDON, UK
16th Annual BioPartnering Europe
October 12-14, 2008
London, United Kingdom
Register online at: http://www.techvision.com/bpe/registration/
Early registration is now open for the 16th Annual BioPartnering Europe conference, which will take place at the QEII Conference Centre in London, England.
Why You Can’t Miss BioPartnering Europe
- 1300+ attendees from more than 650 companies
- 140 company presentations by innovative, cutting-edge life science companies
- 1-to-1 meeting scheduling through biopartnering.com
- 12 panel sessions and interactive workshops by industry leaders
- Outstanding networking opportunities with senior executives and decision makers
This year they have created a new set of options for presenting and non-presenting companies, offering you the opportunity to create a customized and tailored package. Presenting company packages are limited and will fill quickly, so apply early for your best chance to be accepted.
For more details, contact Lila Taylor at ltaylor@techvision.com.
Key features of biopartnering.com include:
- 1-to-1 meeting scheduling
- Personal, company, and product profiles
- Onsite SMS messaging of new meeting scheduling
- Stay updated to additions to the program
“Obstacles are those frightful things you see when you take your eyes off your goal.”
–Henry Ford,
July 30, 1863 – April 7, 1947
American founder of the Ford Motor Company
and father of modern assembly lines
used in mass production.
“You must be the change you wish to see in the world.”
–Mahatma Gandhi
October 2, 1869 - January 30, 1948
A major political and spiritual leader of India
who pioneered non-violent resistance,
and led India to independence and inspired
movements for civil rights and
freedom across the world.
“Do not wait to strike till the iron is hot; but make it hot by striking.”
–William Butler Yeats,
June 13, 1865 - January 28, 1939
Irish poet and dramatist, and
one of the foremost figures
of 20th-century literature.
Find Out Exactly Where Your Time Goes
If you think you are too busy to figure out exactly where your time goes, then you are precisely the person who should compile a detailed time log.
So, for at least three days or, better yet, for a week, keep close track of how you spend your days - how many total minutes on important and unimportant phone calls? How many minutes studying papers or restudying papers you have already read? How much time socializing, planning, daydreaming, being interrupted, and making significant headway?
Then, figure out where you are wasting your time in relation to your priorities. Being too busy to come to grips with time management is like putting off getting your roof repaired because it is the rainy season.
Make Your Wardrobe Work For You
We have all had days when we’ve looked into our closets in the morning and, while it was full to the bursting, felt like there was nothing to wear. We hate those days, yet instead of fixing the problem and creating a cohesive wardrobe, we just keep buying more and more clothes without any sort of plan, in the hopes that something will end up working.
Often we acquire our clothes haphazardly - a sale item or an impulse buy here, a Christmas gift there - without much thought as to how they fit our image, or even if they match each other. In fact, you have probably seen folks who have expanded their wardrobe only to hobble themselves by wearing a plaid shirt with a striped tie, or to go overboard with jewelry that clatters and clangs when they walk. In other words, unless you know how to put it all together, you can improve your wardrobe but still project a poor image. So make sure your colors, patterns, and accessories are complementary, not clashing.
Most of us have at least one or two outfits that make us feel especially good when we are wearing them. We tend to save those for special occasions. However, why not try to increase that number to three, four, or more such outfits and, thus, try to make a particularly good impression every day? At the same time, clean out your closet of older clothing you never wear.
If you are vague about what you look best in, consult a friend or co-worker whose taste you admire, or go to a wardrobe consultant. They often spot things that you would look good in but probably would not consider trying on.
A wardrobe consultant may sound like a costly luxury. However, many times their advice is free if you buy clothes from them, and some will even shop for you at an hourly rate, which can save you a lot of time. Combine that time-savings with greater selection and the likelihood of a superb fit, and it all may add up to a terrific value.
Here’s to more personal insight,
Tony Alessandra, PhD
Dr Tony Alessandra is a lecturer and author.
http://www.alessandra.com
How to Carry a PC in Your Pocket
by Scott Dunn, PCWorld
With a USB keychain drive and a little forethought, you can carry a personalized computer everywhere and leave your laptop at home.
A notebook PC is a handy thing to have, but lugging one around everywhere you go can be downright inconvenient. Fortunately, there’s a solution that fits right in your pocket: The ubiquitous USB flash drive, often called a keychain or thumb drive.
With the right device and software, you can plug your flash drive into a computer at an Internet cafe, hotel business center, or elsewhere, and have all the tools and files you need to do your work–complete with your own personal launch menu. Sure, you can use online applications like Google Docs or Zoho Office, but a flash drive lets you carry a much wider variety of the applications, utilities, and other fun doodads you’ve come to depend on.
Here’s everything you need, from hardware to software and beyond, to get going in the world of pocket computing.
Harness the Right Hardware
To get the most out of portable computing, you need a good flash drive. Here are some things to consider:
Take a drive on the reading edge
The faster your flash drive, the more smoothly programs will run. When shopping for a drive, look at the specs and try to find one with a read rate of 15 mbps (megabits per second; in megabytes, 1.9 MBps) or faster. If you already have a flash drive, you can test its speed with a free utility like HDTach for Windows.
Look for high-speed USB
A USB 2.0 flash drive will perform much better than USB 1.x. Make sure the drive you buy specifies USB 2.0 or “high-speed USB.”
U3 or not U3?
Some flash drives (notably those from SanDisk) are labeled “U3,” meaning they use a proprietary format to create applications for USB drives. Such drives usually come with a built-in pop-up program launcher called LaunchPad and a few programs, or they at least link to a Web page for downloading and installing free and for-pay U3 applications. SanDisk claims that only U3-compatible programs will run on such a drive, but I had no problem running U3 and non-U3 programs side by side on the same memory stick. (However, don’t expect your non-U3 apps to show up on the U3 launch menu.)
With so many portable applications available from a variety of free sources these days, you don’t necessarily have to get a U3-equipped drive. If you do have one, you can either take advantage of the LaunchPad feature and its various apps, or you can find utilities for removing U3 LaunchPad software from SanDisk drives and from non-SanDisk drives. And if you change your mind about such removal, SanDisk has a free tool for getting it back.
To continue reading, visit PCWorld.
Source: PCWorld © 2008
UPCOMING SEMINARS
Rx&D Code Awareness Seminars
Toronto: October 30, 2008
Montreal: April 29 and November 4, 2008
Download the course brochure
Drug Safety: Pharmacovigilance
Toronto: May 6, 2008
Download the course brochure
The Marketing of Pharmaceutical Products (System 100)
Montreal: May 6-9, 2008
Download the course brochure
NEW FOR 2008!
Information Security in Your Sales Rep’s Home Office
Montreal: May 15, 2008
Download the course brochure
See full seminar details below
The Changing Relationship between the Pharmacist and Pharma
Montreal: May 14, 2008
Toronto: May 22, 2008
Download the course brochure
See full seminar details below
A Practical Forecasting Workshop for the Pharmaceutical Industry (System 700)
Toronto: May 14-15, 2008
Montreal: May 28-29, 2008
Download the course brochure
Essentials of Public Payer Reimbursement
The Essentials of Public Payer Reimbursement seminar is coming in May 2008. For more information, please contact Andrew Gregory at (877) 751-9415, or by e-mail, andrew@pharmahorizons.com
Clinical Trial Applications
Toronto: May 15, 2008
Montreal: May 13, 2008
Download the course brochure
The PAAB Code: Strategies, Tools and Techniques to Speed Approval of Your Submission
Toronto: May 14 and November 19, 2008
Montreal: May 22 and November 12, 2008
Download the course brochure
Effective Decision-Making in Early Drug Development Trials
Toronto: May 27 and October 21, 2008
Montreal: May 29 and October 28, 2008
Download the course brochure
Fundamentals of Pharmaceutical Product Labeling
Montreal: May 29, 2008 (NEW DATE)
Download the course brochure
Segmentation and Targeting: SIMULATION-BASED TRAINING
Toronto: May 29, 2008
Download the course brochure
CHE: Changing Physician Behaviour
Toronto:June 3, 2008 and November 25, 2008
Montreal: June 12, 2008
Download the course brochure
Fundamentals of Regulatory Affairs
Toronto: June 4-5, 2008
Montreal: June 18-19, 2008
Download the course brochure
Principles and Practice of Pharmaceutical Marketing Research (System 300)
Montreal: June 10-11, 2008
Toronto: October 15-16, 2008
Download the course brochure
Senior Sales Management: Simulation-Based Training
Montreal: June 16-17, 2008
Toronto: September 8-9, 2008
Download the course brochure
Optimizing District Performance: Simulation-Based Training
Montreal: June 18-20, 2008
Toronto: September 10-12, 2008
Download the course brochure
SEMINAR DETAILS
Coaching for Improved Sales Performance
Montreal: May 7, 2008
Download the course brochure
About the Seminar
Sales managers in the pharmaceutical industry face a variety of challenges in the routine execution of their leadership roles. For example, managers demonstrate leadership when they deal effectively with unproductive and negative behaviours that potentially impact the performance of their teams.
Employees who fail to meet performance expectations typically treat others carelessly, complain and criticize others inappropriately, and spread discord within the sales team. Effective sales managers must move quickly and skilfully to maintain and grow harmonious and productive working relationships.
This highly-interactive session provides participants with models and proven techniques for eliminating performance-blocking behaviours. Through realistic pharmaceutical case studies, participants will explore practical strategies for approaching and managing difficult coaching situations.
During the one-day session participants will:
- Identify the requirements for well-designed objectives and standards in the development of effective performance.
- Examine the role and strength of “values” in the resolution of unproductive behaviours.
- Explore three techniques for delivering interpersonal feedback that reinforce desirable behaviours and eliminate negative behaviours.
- Identify challenges faced by managers when dealing with difficult coaching situations.
- Explore and implement models for resolving difficult situations.
Who Should Attend:
Pharmaceutical Sales Managers, VPs of Sales and Marketing
Learn to:
- Establish clear performance expectations and standards
- Deliver effective performance feedback.
- Create a motivating environment that reduces potential performance problems.
- Deal productively with misdirected frustrations and negative “attitudes”.
- Demonstrate clear leadership in challenging coaching situations.
Information Security in Your Sales Rep’s Home Office
Montreal: May 15, 2008
Download the course brochure
About the Seminar
Now you can reduce your company’s risk of data breach and ID theft in the home office environment. This great mini seminar is ideal for regional and national sales meetings and is packed with 2 ½ hours of practical, often overlooked tips.
Seminar topics include:
ID theft, paper and electronic file management, securing home networks and portable devices, securely storing electronic data, and password management.
Speaker Coaching: Influencing Speaker Performance
Montreal: November 20, 2008
Toronto: November 13, 2008
Download the course brochure
About the Seminar
This practical interactive workshop presents a sophisticated platform, based on physician behaviour change research, to influence your speaker and generate success in CHE. By combining and applying theories from psychology and adult education, the participant will build knowledge and skill to influence CHE outcomes.
Would you like to feel more confident in your ability to influence the speaker? Do you want to save time & reduce frustration with your CHE efforts? Do you want to identify the 4 disciplines that contribute to successful CHE outcomes and how you can influence them? Do you question whether the CHE events in which you’re involved are as “successful” as possible?
If you answered ‘Yes” to these questions, you don’t want to miss this new seminar by Jill Donohue.
The Changing Relationship between the Pharmacist and Pharma
Montreal: May 14, 2008
Toronto: May 22, 2008
Download the course brochure
About the Seminar
Did you know that some pharmacists can now prescribe?
Learn how new legislation and health care policy is altering the role of pharmacists in health care delivery across Canada.
This course is designed to provide a solid background in understanding pharmacists, their evolving role in health care delivery, and how to maximize sales to this increasingly important target group.
Who Should Attend:
Sales managers and directors Product and brand managers Marketing managers and directors Business development managers and directors. Special price available for Teams! Enroll 2 & the 3rd participant pays half the regular price. Get your entire group involved and lower your training costs.
Pharma Looks to Outside Talent
by Andrew Jack in London
Drug companies are stepping up recruitment of specialists from outside their own ranks as they attempt to adapt to tougher market conditions, say senior industry executives and headhunters.
Last year, at least one chief executive, one head of pharmaceutical operations and three chief financial officers with careers outside the industry were appointed to leading companies in the search for new skills.
Executive search firms are also reporting rising demand for their services, as companies seek ways to draw in fresh experience from other sectors and to reduce costs.
Jacques Bouwens, head of the European healthcare practice at Russell Reynolds, the recruitment company, said there was growing recognition of the need for “hybrid” hirings from outside pharmaceuticals, including marketing, supply-chain work and communications.
From a survey of 25 leading industry executives his company recently conducted, highlighting the need for more external recruitment, it identified a focus on cost as the top strategic priority for the next five to ten years.
In considering the skills that future top executives needed, most believed governments were the most important growing influence over the sector, while doctors’, regulators’ and investors’ power was waning.
The company’s mandates to find pharmaceutical executives have risen sharply in the past five years, with the greatest jump in demand for senior human resource executives, followed by finance, manufacturing and supplychain, and legal and communications specialists.
James Cornelius, formerly head of Guidant, the medical devices company, was ratified last spring as chief executive of US-based Bristol-Myers Squibb, where he had been interim chief after a shake-up triggered by a court-appointed monitor.
Most of the spate of newly appointed chief executives from rival pharmaceutical companies in recent months have been hired internally, but the next level in the hierarchy has been more open to outsiders.
Peter Kellogg, the new head of finance at Merck, previously worked in the sector at Amgen and Biogen, but before then was based at PepsiCo. Frank D’Amelio at Pfizer formerly worked at Alcatel-Lucent, while AstraZeneca hired Simon Lowth from Scottish Power.
Joe Jimenez, who now runs pharmaceutical operations at Novartis of Switzerland, briefly ran its consumer health division but only joined last year from Heinz in Europe.
Peter Levin, head of the North American life sciences practice at Egon Zehnder International, said: “There is a clear drive to hire people with different experiences, particularly at the executive levels.”
© The Financial Times Limited 2008
TV drug ads should list FDA hotline, lawmakers say
The information would allow consumers to report serious side effects from prescription medication.
By Ben DuBose, Staff Writer for the Los Angeles Times
WASHINGTON — Citing a new Consumer Reports poll, two members of Congress urged the Food and Drug Administration on Wednesday to mandate that all television advertising for prescription drugs include information for consumers to report serious side effects to the agency.
The poll found that 16% of respondents who had taken a prescription drug had experienced a side effect serious enough to send them to the doctor or hospital, but only 35% were aware that such side effects could be reported to the FDA.
The FDA “is failing to serve its most vital supervisory responsibility,” said Rep. Rosa DeLauro (D-Conn.), who chairs a House subcommittee with oversight of the agency. “The more we know about serious drug side effects, the more we can do.”
Through a program known as MedWatch, the FDA is responsible for tracking side effects from prescription and over-the-counter medication. It uses the reports to detect problems with drugs. But agency officials estimate they learn about fewer than 1 in 10 drug reactions.
The poll results reflected that statistic, with 7% of respondents naming the FDA as a place where they would report a serious drug side effect.
Consumers Union, the nonprofit organization that publishes Consumer Reports, sent the FDA a petition with more than 55,000 signatures requesting that a toll-free number and website address be included in television drug advertisements to make it easier for people to report side effects.
“We have received the petition and are in the process of reviewing it at this time,” said FDA spokeswoman Rita Chappelle.
In FDA-related legislation passed last year, Congress required that contact information for the agency be included in all print drug ads and called for an FDA study to be completed by the end of last month to assess whether a similar requirement was needed for television ads. Chappelle said the study was still in progress.
In the poll, television was identified as the medium where consumers were most likely to be exposed to a prescription drug ad. Of respondents who had recently seen at least one such ad, 98% said they had seen it on television; 59% said they had seen it in print.
BenDuBose may be reached at ben.dubose@latimes.com.
© Los Angeles Times
Schering plans $1B cutback as Vytorin, Zetia fall
10% layoffs, plant closings due
by George E Jordan and Susan Todd, Star-Ledger Staff
Faced with a crushing blow to its top-selling medicines, drugmaker Schering-Plough announced in early April more than $1 billion in spending cuts, including plans to lay off 10 percent of its work force and shut manufacturing plants over the next two years.
Fred Hassan, chairman and chief executive of the Kenilworth-based company, used tough language to describe the cuts that he said were precipitated by calls at the American College of Cardiology meeting in Chicago to halt the widespread use of the cholesterol tablets Vytorin and Zetia.
“No area will be exempt,” Hassan said. “Hard new realities are requiring the hard new actions.”
Rosemarie Yancosek, a spokeswoman for Schering-Plough, could not offer a timetable for the approximately 5,500 global layoffs. Neither could she identify which facilities around the globe would be closed or would eliminate jobs.
Schering-Plough has 8,000 employees in New Jersey and another 47,000 workers scattered around the world, she said. It also operates 60 manufacturing plants, including production lines in New Jersey.
“We are going to be taking down the cost basis for the entire company,” Hassan said in a teleconference with Wall Street analysts last night.
The company had already been in the throes of making layoffs and $500,000 in cuts since its $14.4 billion acquisition last year of Organon BioSciences, which gave Schering-Plough a stable of potential new drugs.
The lion’s share of the layoffs and plant closings announced will occur by 2010, while the rest would happen by 2012, Schering-Plough said in a news release.
The recommendation to curtail use of the drug by an ACC panel, and in an editorial in the New England Journal of Medicine, was prompted by a study released partially in January that found Vytorin worked no better than Zocor — a generic drug five times less expensive — at reducing blockages that cause heart attacks. The drugs’ safety was not questioned.
The full study results were released at the ACC meeting.
George E. Jordan may be reached at gjordan@starledger.com or (973) 392-1801.
Susan Todd may be reached at stodd@starledger.com or (973) 392-4125.
© 2008 The Star Ledger and © 2008 NJ.com
Bill Gates Encourages New Health Ideas
by Donna Gordon Blankinship, Associated Press Writer
If you have an unorthodox, unproven idea that can prevent HIV infection or help protect against infectious diseases, one of the richest men in the world wants to hear from you.
The Bill & Melinda Gates Foundation has set aside $100 million to encourage innovation in global health research, offering grants to those with innovative ideas on four topics: Tuberculosis, HIV, infectious diseases and drug resistance.
The foundation’s new Grand Challenges Explorations program plans to give $100,000 each to about 60 projects in the first round of what is expected to be a five-year program.
Proposal applications are short — only about two pages long — and preliminary data is not required for the applications due at the end of May.
Of course, each applicant will need to be a scientist and have a lab in which to do the work, foundation officials said. But there won’t be many more restrictions.
Foundation officials say it’s one of the most open-ended requests for proposals they’ve ever issued, but it fits well with the organization’s quest to be innovative.
“We push ourselves to be as creative as we can,” said Martha Choe, who is slated to become the foundation’s new chief administrative officer.
The foundation has no plans to open the door to unorthodox ideas for its other focus areas — global development, libraries, education and support for children and families in the Pacific Northwest — although unsolicited grant requests arrive in the mail daily.
The world’s largest philanthropy, which was established by Bill Gates, the co-founder of Microsoft Corp., paid out 1,322 grants totaling more than $2 billion in 2007, compared to 1,283 grants totaling more than $1.54 billion in 2006.
The Grand Challenges Explorations program is an outgrowth of an effort launched by the foundation in 2003 to help foster innovation in global health discovery.
The foundation is already spending about $450 million to support 40 bigger projects focused on preventing infectious diseases, creating drugs or delivery systems that limit resistance, creating new ways to prevent or cure HIV infection, and understanding latent TB infection.
The smaller grants announced will focus on the same research areas. The foundation expects to make several requests for proposals each year, officials said.
Gates Foundation official website: http://www.gatesfoundation.org
Justices Shield Medical Devices From Lawsuits
By Linda Greenhouse
WASHINGTON — Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled in February.
The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.
In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.
The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.
The case before the court concerned only medical devices that had gone through the pre-market approval process specified by the Medical Device Amendments of 1976. Most devices now available reached the market through a different process, under which the F.D.A. found them to be “substantially equivalent” to those marketed before the 1976 law took effect.
The Supreme Court ruled in 1996 that this less rigorous approval process does not pre-empt state damage suits against the manufacturers of “grandfathered” devices.
Devices subject to the pre-market approval process, and thus affected by the court’s opinion, tend to be more technologically advanced, expensive and, in some instances, risky.
Examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees.
It was not immediately clear how many of the thousands of lawsuits against medical device manufacturers would be affected, though some pending cases will almost certainly be nullified.
The decision, for example, does not foreclose lawsuits claiming that a device was made improperly, in violation of F.D.A. specifications. Cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them.
A jury, looking only at the injured plaintiff, will tend to weigh only the dangers of a device and “is not concerned with its benefits,” Justice Scalia said, adding, “the patients who reaped those benefits are not represented in court.”
Barnaby Feder contributed reporting from New York and Gardiner Harris from Washington.
© New York Times
Co-Payments Go Way Up for Drugs With High Prices
By Gina Kolata
Health insurance companies are rapidly adopting a new pricing system for very expensive drugs, asking patients to pay hundreds and even thousands of dollars for prescriptions for medications that may save their lives or slow the progress of serious diseases.
With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug’s actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month.
The system means that the burden of expensive health care can now affect insured people, too.
No one knows how many patients are affected, but hundreds of drugs are priced this new way. They are used to treat diseases that may be fairly common, including multiple sclerosis, rheumatoid arthritis, hemophilia, hepatitis C and some cancers. There are no cheaper equivalents for these drugs, so patients are forced to pay the price or do without.
Insurers say the new system keeps everyone’s premiums down at a time when some of the most innovative and promising new treatments for conditions like cancer and rheumatoid arthritis and multiple sclerosis can cost $100,000 and more a year.
But the result is that patients may have to spend more for a drug than they pay for their mortgages, more, in some cases, than their monthly incomes.
Read more: New York Times Article
© New York Times
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News from PAAB
Learn the regulations and guidelines that embody the pharmaceutical industry’s commitment to the highest standard of professional conduct. Pharmahorizons is the authorized training partners of the PAAB and Rx&D.
PAAB will be holding national open workshops on May 14, 2008 in Toronto and on May 22 in Montreal.
Title: PAAB Code: Strategies, Tools and Techniques to Speed Approval of Your Submission
For more information, click here.
News from Montreal InVivo
Montreal is Canada’s largest life science cluster. Each month, Pharmahorizons will showcase news, trends and events in the greater Montreal area.
Montréal InVivo Life Sciences Career Fair
Don’t miss this annual career fair targetted specifically for Quebec’s Life Sciences industry!
For employers interested in attending this event (sponsoring, renting a booth, adverstising), contact Andrew Gregory at 1-877-751-9415 for details.
Atrium announces the sale of its Active Ingredients and Specialty Chemicals
Atrium Innovations Inc. (Quebec City) announced that, as a result of the strategic re-evaluation process announced on December 18, 2007, it has entered into a definitive agreement to sell its Active Ingredients and Specialty Chemicals division to AXA Private Equity for US$155 million in cash, subject to working capital adjustments. Total proceeds from the sale, including excess cash in the business, are expected to be US$165 million, subject to working capital adjustments. The parties expect the transaction to be completed by mid May. Following the transaction, the main office of the Active Ingredients and Specialty Chemicals division will remain in Quebec City under the leadership of Charles Boulanger, President of the Active Ingredients and Specialty Chemicals division, and its existing management team.
http://www.atrium-innov.com
http://www.axaprivateequity.com
NTMir Announces First Canadian Research Grant to McGill for Genome Sequencing
NTM Info & Research (NTMir), a Miami, Florida based not-for-profit organization, announced that its first international research grant has been awarded to the Research Institute of the McGill University Health Center to provide funding for “The Complete Genome Sequence of Mycobacterium avium intracellulare.” NTMir is headed by Montreal native and former resident Philip Leitman. The McGill grant is the third study funded by NTMir in its innovative research initiative, Rapid Information Pilot Studies (RIPS™). The RIPS™ program provides guidance about pressing issues regarding pulmonary NTM host vulnerability, sources of infection, and clinical treatment issues.
http://www.mcgill.ca
MedMira an Approved Supplier to the Pan American Health Organization
MedMira Inc., (Halifax), a global market leader in premium rapid diagnostic solutions, announced that it is now an approved supplier to the Pan American Health Organization (PAHO) and has received an initial purchase order for rapid HIV tests from the Ministry of Health in Belize. The PAHO, headquartered in Washington, D.C., with 35 member states, is an international public health agency working with Latin America and Caribbean countries on priority health issues such as HIV. It also serves as the regional office for the World Health Organization (WHO) in the Americas.
http://www.medmira.com
Alethia Biotherapeutics
Alethia Biotherapeutics (Montreal) announces that it has secured C$2.4 M in financing from BDC Venture Capital and GO Capital Fund. This investment will allow Alethia to initiate the pre-clinical development of therapeutic monoclonal antibodies for the treatment and prevention of severe bone loss, ovarian cancer, and metastatic breast cancer, indications for which there are currently few therapeutic options.
http://www.alethiabio.com
Heart Health, Inc.
Heart Health, Inc. (Montreal) announced that the Company is currently researching similar products to receive approval of its Heart Health Monitor (HHM). Selection of a similar product, known as “Predicate Device,” will enable the Company to proceed in filing its 510(k) to the FDA, which will allow Heart Health to begin marketing the HHM to the public.
http://www.hearthealthmonitor.com/index.html
Supratek Pharma Inc.
Supratek Pharma Inc. (Montreal) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SP1049C for the treatment of gastric cancer.
http://www.supratek.com
© Life Sciences News Briefs 2008
E-mail: Leduc.Louise@ic.gc.ca
NB’s New Plan Includes e-Health Projects
FREDERICTON – New Brunswick announced that more than $154 million will be invested in new and enhanced health services over the next four years as part of a new Provincial Health Plan. A major thrust of the plan includes continued development of the province’s e-health strategy, including the One Patient One Record electronic health record.
Read more
© Canadian Healthcare Technology
Dalhousie University’s Brain Repair Centre and the Harvard Medical School’s New Partnership
Dalhousie University’s Brain Repair Centre and the Center for Neuroregeneration Research at McLean Hospital and Harvard Medical School have entered into a partnership that will lead to more comprehensive research, education, and clinical care programs for each of the institutions. The partnership will explore and facilitate new patient care strategies by contributing to the development and application of advanced clinical services, such as robotic surgery, neural transplantation, and deep brain stimulations. It will also seek opportunities for commercial developments with application to the life sciences, which will include the creation of new technologies and adapting existing ones for better use. An exchange program will also be instituted, encouraging professional development between the two centres.
Dalhousie University researchers and DeNovaMed Inc. Founders Receive $816,000 Grant
Dalhousie University researchers and DeNovaMed Inc. founders received an $816,000 grant from the Canadian Institutes of Health Research to support the design, synthesis, and commercialization of the first new class of antibiotics introduced to the health care system in over 30 years. Heading this milestone discovery are Dr. Donald Weaver, Dr. David Byers and Dr. Christopher McMaster.
Atlantic Canada Opportunities Agency (ACOA) Contributes nearly $500,000 to First Angel Network
The Atlantic Canada Opportunities Agency (ACOA) is contributing nearly $500,000 to Nova Scotia’s First Angel Network. The non-profit organization, which links investors to entrepreneurs, will use the non-repayable funds for “growth and permanency.” The funds are projected to be spent over the next three years to help grow the membership so membership revenue will support the Network.
Ross Finlay and Brian Lowe of IVT launched First Angel Network in 2005 with about 40 investors. Together, they have invested $2.7 million in eight companies, including Origin BioMed Limited. According to Ross, that money has leveraged a minimum of another $10 million for the companies.
Read More
Source: BIONOVA
NB reorganizes, will create 2 health authorities
FREDERICTON – New Brunswick has announced it will consolidate its eight Regional Health Authorities into two authorities, a transition that is scheduled for completion by Sept. 1. As well, the province has created a new public sector company to more effectively implement and manage selected, non-clinical services that are currently carried out by the health authorities.
Read more
© Canadian Healthcare Technology
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Growth expected for Canadian pharmaceutical market for 2007
The Canadian pharmaceutical market is expected to grow 6% to 6.5% for 2007 to $19 billion in drug store and hospital sales, according to IMS Health. Last year’s market growth was slower than the 8.4% average rate achieved from 2002 to 2006.
In 2007, growth in the generics and innovative sectors was 20.1% and 3.3%, respectively. Excluding biotechnology products, the growth of innovative therapies was only 1.6%. According to IMS Health, this disparity in growth between the two sectors is primarily the result of the large number of patent expirations experienced during the year. In addition to the strong growth experienced in the generics sector, sales of biotechnology products are up 17.2%.
Biotechnology therapies represent 10% of total pharmaceutical sales in Canada, but are responsible for approximately 24% of the market’s overall growth last year. Also contributing to more moderate pharmaceutical market growth overall is the low number of new products last year. New medicines (new molecular entities and line extensions) launched in Canada in 2007 account for less than 0.3% of total drug store and hospital sales this year as their sales continue to be affected by market-access delays.
Source: BioBusiness
News from Toronto’s BioPharma Community
St. Michael’s hospital joins robotic revolution
TORONTO – St. Michael’s Hospital, a major teaching hospital in Toronto’s downtown core, has become the city’s first medical centre to acquire a surgical robotic system. As a result, hospital surgeon Ken Pace now has four arms, instead of two, when working on his patients. What’s more, those arms – and many fingers – can enter the smallest of places through tiny incisions.
Read more
© Canadian Healthcare Technology
Handheld Palm devices benefit the autistic
TORONTO – Palm Canada has announced a Palm Foundation cash grant and the donation of 100 Palm handhelds and accessories to kick-start a new e-Learning program at the Geneva Centre for Autism, based in Toronto. The resources are being used for training and technical-support costs associated with transferring paper-based visual cues and reminders onto Palm handheld devices.
Read more
© Canadian Healthcare Technology
Toolkit for small, rural and northern hospitals
TORONTO – The Ontario Hospital Association (OHA) has launched a Pandemic Planning Toolkit designed specifically for the province’s small, rural, and northern hospitals. The Toolkit was developed by the association in response to the unique issues and challenges faced by these hospitals in developing emergency response plans specific to an influenza pandemic.
Read more
© Canadian Healthcare Technology
News from the OCRI Life Sciences
Ontario pharma, research industries get boost
Job and research funds among latest Ontario government initiatives
The Ontario government has launched several initiatives to support the province’s science and technology sectors. The $150-million Next Generation Jobs Fund is designed to encourage research-based pharmaceutical companies to invest in Ontario.
The money is designed to create jobs in the biopharmaceutical research community by enabling companies to apply for grants, loans, forgivable interest loans and funds for building infrastructure, research and training. The biopharmaceutical industry currently employs more than 9,000 Ontarians and makes up 31 of Canada’s top 100 corporate R&D investors. For its part, the $115-million Ontario Research Fund plans to help Ontario’s top researchers develop new ideas and turn these ideas into products and services that can be marketed to the world. Government funding will be matched by 107 partners including industry.
Other recent Ontario initiatives include: Launching the $160-million Ideas-to-Market strategy that supports emerging companies, which includes the Ontario Venture Capital Fund; providing a 21% capital tax rate cut for all businesses retroactive to January 1, 2007, on the way to full elimination in 2010; and announcing in the 2007 Fall Economic Statement an additional $50 million in strategic investment to further strengthen Ontario’s environment for scientific research that will lead to new discoveries, higher quality of life and new jobs.
http://www.ontario.ca/innovation/
Source: BioBusiness
CSL Behring Canada awarded supply contracts by Canadian Blood Services and Hema-Quebec
CSL Behring Canada, Inc. (Ottawa) announced that Canadian Blood Services, and Hema-Quebec, have each awarded the company contracts to supply Helixate(R) FS (Antihemophilic Factor [Recombinant]), Humate(R) P (Antihemophilic factor / von Willebrand Factor Complex [Human], Dried, Pasteurized), Privigen (Immune Globulin Intravenous [Human]), Vivaglobin(R) (Immune Globulin Subcutaneous [Human]) and other plasma-derived products. These products are used for the treatment of conditions such as hemophilia, von Willebrand Disease, primary immunodeficiency as well as other serious conditions.
http://www.CSLBehring.com
Life Sciences News Briefs © 2008
E-mail: Leduc.Louise@ic.gc.ca
Canadian Agency for Drugs and Technologies in Health (CADTH) Revises Guidelines and Procedures Documents
The Common Drug Review routinely reviews and revises its Submission Guidelines for Manufacturers and the Procedure for CDR as part of ongoing efforts to ensure that they are as current and clear as possible. Listed below are revisions to the two documents.
- Changes to the CDR Submission Guidelines for Manufacturers
- Changes to the Procedure for CDR
CADTH is a national body that provides Canada’s federal, provincial and territorial health care decision makers with credible, impartial advice and evidence-based information about the effectiveness and efficiency of drugs and other health technologies.
For details contact:
Canadian Agency for Drugs and Technologies in Health
600-865 Carling Avenue, Ottawa ON K1S 5S8
Telephone: (613) 226-2553
Source: CADTH Update 47
Government of Canada Announces Funding to Improve Surveillance of Chronic Disease Risk Factors Among Canadian Youth
OTTAWA –The Public Health Agency of Canada today released the Healthy Settings for Young People in Canada report, which examines smoking, alcohol and drug use, physical activity/body image, eating patterns, emotional health and injuries in children and youth aged 11 to 15.
Read more
Source: Public Health Agency of Canada
http://www.phac-aspc.gc.ca
Ottawa: Bed Crunch: Scores of Hospital Beds Occupied by People Who Can’t Find Other Care
Recently, 178 beds in Ottawa hospitals were being occupied by people who didn’t need to be there but couldn’t find home care or long-term care.
So many hospital beds in Ottawa are being used to care for people who should be in long-term care or at home that it’s the equivalent of closing the Montfort Hospital, health officials say.
It’s the most serious problem facing hospitals across Ontario, says Tom Closson, the new president of the Ontario Hospital Association, far worse than a lack of money, and the crisis is deepening.
Mr. Closson said 2,800 hospital beds - or 18 per cent of all beds in the province - are occupied by patients who can’t find home or long-term care. On any given day, he said, about 800 emergency room patients in Ontario - “the equivalent of three medium-sized hospitals” - wait in hallways for admission beds that are not available.
In the Ottawa region during the first week of March, 178 patients were stuck in hospitals because there was nowhere else to send them.
While the problem is not new, it has become so serious in the last 18 months it is threatening the ability of hospitals to care for patients, Mr. Closson said.
“The single greatest risk to access lies in the huge number of patients waiting in hospitals for more appropriate care at home or in another place,” he said. “This is what we hear from our members more than anything else as being the big issue.”
Queensway-Carleton president Tom Schonberg agreed.
“In Ottawa, we have identified this as our No. 1 issue. The situation is absolutely critical because it puts pressure on all of the system right now,” he said.
He has identified four major challenges facing the province’s 157 hospital corporations:
1. Underfunding that sees Ontario hospitals getting $100 less per person a year than the Canadian average.
2. Underfunding for hospital renovations that are estimated at $8 billion. With governments strapped for cash, it is imperative to have more public-private partnerships to build new hospitals, Mr. Closson said.
3. A move to electronic health records that could revolutionize patient care and save lives. Mr. Closson said digitizing paper records would cost $4.5 billion over eight years. It could be done and would be money well-spent, he says.
4. Beefing up community health services to take pressure off hospitals, which are reeling from patient overload.
At the Queensway-Carleton, where 30 per cent of beds are occupied by patients who have no medical reason to be there, but can’t be discharged for lack of alternative beds, 22 elective surgeries have been cancelled in the past four weeks as a result, Mr. Schonberg said.
“It is particularly frustrating for us at Queensway-Carleton because we have built new facilities, but are not able to utilize the full capacity of our operating rooms because we have no beds.”
Dr. Robert Cushman, chief executive of the Champlain Local Health Integration Network, which oversees medical services in Eastern Ontario, acknowledges that the bed shortage now trumps other problems in Ontario hospitals. It has such a corrosive effect on the entire system that solutions have to be found quickly, he said.
“It impedes our hospitals from being the acute-care centres they were designed to be,” Dr. Cushman said.
© Ottawa Citizen 2008
News from BioAlberta
BioAlberta is the central voice and the organizing hub for the bio-industry in Alberta.
Saskatchewan moves ahead with physician IT
REGINA – Health Minister Don McMorris and Saskatchewan Medical Association (SMA) President Dr. Joe Pfeifer have signed an agreement whereby the provincial government and SMA will each commit $2 million annually to assist physicians with computerizing their patients’ medical records. When fully implemented in 2014-15, the government’s contribution will be $7.26 million per year, with a total program cost of $10.37 million.
Read more
© Canadian Healthcare Technology
CV Technologies Returns To Profitability: Announces Net Earnings Of $6.8 Million For First Quarter, Fiscal 2008
EDMONTON, ALBERTA – CV Technologies Inc. (TSX:CVQ) reported fiscal 2008 first quarter sales of $21.3 million, down 5.9% from sales of $22.6 million in the same period last year. Net earnings were a record $6.8 million ($0.06 per share, diluted) in the first quarter ended December 31, 2007, an improvement of $10.4 million from a net loss of $3.6 million (loss of $0.03 per share, diluted) in the quarter ended December 31, 2006.
Sales in Canada were $20.9 million in the first quarter of fiscal 2008 compared to $22.2 million in the comparable quarter of fiscal 2007, while U.S. sales were unchanged quarter over quarter at $0.4 million, and U.S. losses before tax were $0.2 million for the current quarter compared to $11.9 million in the same quarter of the prior year.
“While the cold and flu season began much later than usual, producing some decline in our quarterly revenue year over year, our results were very strong overall, with net earnings reflecting one of our best quarters ever, good cash flow and a solid balance sheet,” said Dr. Jacqueline Shan, President, CEO and Chief Scientific Officer. “This performance underscores our success in refocusing our attention on achieving growth in Canada, our primary market. We continue our U.S. strategy of concentrating on existing customers and managing expenditures to ensure they are aligned with sales levels. Management believes we are on track to meet our growth and profitability goals for fiscal 2008. We believe the long-term prospects for our Company remain excellent.”
Read more
Source: BioAlberta
British Columbia Life Sciences Sector Leads the Way in Securing Federal Research Funding
British Columbia Life Sciences Sector Leads the Way in Securing Federal Research Funding — Four New Centres of Excellence for Commercialization Established in BC
Vancouver, BC – British Columbia’s life sciences research community has once again demonstrated its stature as a true national leader in the commercialization of innovation by proving to be the most successful sector and cluster in Canada at securing recent federal funding.
The announcement by the The Honourable Jim Prentice, Minister of Industry saw $163 million invested towards establishing 11 new Centres of Excellence for Commercialization and Research (CECRs) across the country, with a total of four of those being in British Columbia.
The successful BC Centres of Excellence for Commercialization are:
- The Centre for Drug Research and Development (CDRD)
- CECR in the Prevention of Epidemic Organ Failure (PROOF)
- The Prostate Centre’s Translational Research Initiative for Accelerated Discovery and Development (PC-TRIADD)
- Advanced Applied Physics Solutions, Inc. (AAPS)
All told, BC projects garnered a total of $59.8 million or approximately 37% of the national total, equaling that of Ontario and exceeding any other province.
Read more
Source: BC Life Sciences
Bio-energy Grant Helps Turn Waste to Wealth
Edmonton — A new wood waste gasification facility, featuring cutting-edge German technology, has been approved for $5 million in government funding under the province’s bio-energy strategy. The $70-million project will divert forestry and municipal wood waste from land fills in the Edmonton region to create a new value-added opportunity from forestry biomass.
“Bio-energy, particularly from forestry waste, is a textbook example of a value-added opportunity,” said Mel Knight, Minister of Energy. “These grants will increase investment in the bio-energy marketplace and help unlock other ways that Alberta can get more out of all its resources.”
The facility, a project of Expander Energy, will develop a commercial scale prototype of the Choren Carbo-V technology outside of Edmonton. A thermo-chemical process using heat and pressure will provide the capability to produce a synthetic bio-diesel fuel from wood waste materials. Carbon capture and sequestration are also key components of this proposal.
“These types of projects provide Alberta’s forest industry with a unique opportunity to diversify by harnessing the potential of bio-energy,” added Sustainable Resource Development Minister Ted Morton.
The funding was allocated through the Biorefining Commercialization and Market Development Program and the Bio-energy Infrastructure Development Program. Both grant programs are part of the Alberta government’s $239-million Nine-Point Bio-energy Plan designed to encourage the growth of a clean, renewable fuel industry in Alberta.
The grants also support product development, market research, and feasibility studies to assist bio-refiners in adopting new technologies and meeting market requirements.
More information on Alberta’s bio-energy industry and the grant programs is available on the Alberta Energy website under the Our Business section.
Developing Alberta’s bio-energy portfolio is part of Premier Ed Stelmach’s plan to secure Alberta’s future by building communities, greening our growth and creating opportunity.
Contact: Sean Beardow
Alberta Energy Communications
780-422-3786
Source: Government of Alberta
Edmonton’s UAB Researchers Discover Gene That Blocks HIV
Stephen Barr, a molecular virologist in the Department of Medical Microbiology and Immunology at Edmonton’s University of Alberta, says his team has identified a gene called TRIM22 that can block HIV infection in a cell culture by preventing the assembly of the virus. This means the virus cannot get out of the cell and spread. The team is trying to determine why TRIM22 does not work in people infected with HIV and if there is a way to turn it on. The research could lead to the design of new drugs, or vaccines that can halt the person-to-person transmission of HIV and the spread of the virus in the body, thereby blocking the onset of AIDS. The findings are published in the Public Library of Science Pathogens.
Read more
Source: BIOTECanada
Thailand to Keep Generic Drugs Scheme: Minister
Thailand’s new health minister said today he would keep the country’s controversial generic drugs program but stopped short of saying whether the new government would expand the scheme. The army-backed government in Thailand already overrode patents for popular heart drug Plavix and two key AIDS medicines — Kaletra and Efavirenz — and was planning to expand the program to include cancer drugs.
Source: Pharmalive.com
More Americans Are Using More Prescription Drugs
ST. LOUIS–(BUSINESS WIRE)- More U.S. adults are taking prescription drugs than ever before, fueling $12 billion in additional spending during 2006 alone. The number of people with at least one prescription increased from 67% to 74% between 2000 and 2006, according to a new Geographic Variation in Prescription Utilization study by pharmacy benefit manager Express Scripts. The number of prescriptions per person rose to 14.3 from 10.8 in 2000 - a 32 percent jump.
The study correlates the climb in increased spending for antidiabetic and antihypertensive prescription drugs with rising obesity rates. The top five states (West Virginia, Kentucky, Alabama, Mississippi, Louisiana and Arkansas) in the study’s ranking of per capita spending increases for drug classes linked to obesity were also the states with the top five obesity rates, according to the U.S. Centers for Disease Control and Prevention.
“The $12 billion in additional spending in 2006 would have been much greater had the nation not increased its use of lower cost generic drugs from 40% to 58% over the intervening years,” explains Emily Cox, senior director of research for Express Scripts. “In fact, greater use of generic drugs still has significant potential for managing prescription drug costs. The key will be using an advanced understanding of the consumer to get more people to choose generics.”
Conducted within the commercially insured market, the study evaluated overall prescription drug use, analyzing commonly prescribed therapy classes to highlight national and state-by-state trends. Medications from four of the seven therapy classes evaluated are frequently used to treat conditions associated with obesity and related chronic conditions such as high cholesterol, diabetes and high blood pressure. These four therapy classes include antihyperlipidemics, antidiabetics, antihypertensives and gastrointestinal (GI) medications. Also studied were analgesics/anti-inflammatories, antidepressants and estrogen.
The state-by-state analysis found that overall usage and rates of increase varied significantly across geographic regions with the South experiencing the highest utilization and greatest increase in use.
Source: BusinessWire
Drug Ads to Get More FDA Scrutiny
By Julie Schmit, USA TODAY
The Food and Drug Administration’s current budget for reviewing consumer drug advertisements is larger than in the previous five years combined.
But whether that level of funding will be sustained and continue to come from taxpayers - or will be raised from drugmakers through new user fees - is likely to be battled out in Congress as it addresses future FDA funding.
The FDA received $6.1 million for the current fiscal year to check the fairness and accuracy of consumer drug ads. That’s up from $2.2 million the previous year and $1 million the year before.
The FDA says it plans to hire more people so it can review more ads. It has 13 workers devoted to policing direct-to-consumer ad materials. Six are primary reviewers. Last year, the FDA received 12,616 drug ad materials directed to consumers.
The FDA has long been so overwhelmed by drug industry ad materials that only a “small portion” is reviewed, the Government Accountability Office said in a 2006 report. The FDA often didn’t declare consumer ads false or misleading until after ad campaigns were over, the GAO said.
The boost in 2008 funds came after Congress approved user fees for drug ad reviews, but the program wasn’t launched amid funding issues and opposition from some lawmakers, including Rep. Rosa DeLauro, D-Conn., who chairs a subcommittee overseeing FDA funds.
President Bush seeks to resurrect the fees. The proposed 2009 budget he sent to Congress this month calls for $14 million from fees to fund 27 FDA positions devoted to the consumer-ad-review program. In exchange, the FDA would review TV drug ads within 45 days of getting them from drugmakers - which is faster than many reviews occur now - and before the ads are seen by millions of viewers.
The drugmakers’ trade association, Pharmaceutical Research and Manufacturers of America, supports user fees. Timely FDA review would help drugmakers meet marketing goals and lessen the risk of running ads later cited by the FDA for false or misleading content.
The FDA can recommend changes in an ad it considers misleading. Drugmakers can be fined if they run ads without changes.
The FDA already collects user fees for reviews of new human and animal drugs and medical devices. In Bush’s proposed budget, a quarter of the FDA’s funds would come from fees paid by industries the FDA regulates.
DeLauro is likely to continue to be a staunch opponent. “I believe Congress should provide a direct appropriation in order to minimize industry influence in the FDA,” she says.
Source: USA Today
Paying Patients Test British Health Care System
By SARAH LYALL
LONDON - Created 60 years ago as a cornerstone of the British welfare state, the National Health Service is devoted to the principle of free medical care for everyone. But recently it has been wrestling with a problem its founders never anticipated: how to handle patients with complex illnesses who want to pay for parts of their treatment while receiving the rest free from the health service.
Although the government is reluctant to discuss the issue, hopscotching back and forth between private and public care has long been standard here for those who can afford it. But a few recent cases have exposed fundamental contradictions between policy and practice in the system, and tested its founding philosophy to its very limits.
One such case was Debbie Hirst’s. Her breast cancer had metastasized, and the health service would not provide her with Avastin, a drug that is widely used in the United States and Europe to keep such cancers at bay. So, with her oncologist’s support, she decided last year to try to pay the $120,000 cost herself, while continuing with the rest of her publicly financed treatment.
By December, she had raised $20,000 and was preparing to sell her house to raise more. But then the government, which had tacitly allowed such arrangements before, put its foot down. Mrs. Hirst heard the news from her doctor.
“He looked at me and said: ‘I’m so sorry, Debbie. I’ve had my wrists slapped from the people upstairs, and I can no longer offer you that service,’ ” Mrs. Hirst said in an interview.
“I said, ‘Where does that leave me?’ He said, ‘If you pay for Avastin, you’ll have to pay for everything’ ” - in other words, for all her cancer treatment, far more than she could afford.
Officials said that allowing Mrs. Hirst and others like her to pay for extra drugs to supplement government care would violate the philosophy of the health service by giving richer patients an unfair advantage over poorer ones.
Patients “cannot, in one episode of treatment, be treated on the N.H.S. and then allowed, as part of the same episode and the same treatment, to pay money for more drugs,” the health secretary, Alan Johnson, told Parliament.
“That way lies the end of the founding principles of the N.H.S.,” Mr. Johnson said.
Read the full report from the New york Times
FDA Plans Regulators in China
The Associated Press
WASHINGTON — The Food and Drug Administration announced plans Friday to place regulators in China, pending approval from the Chinese government.
The agency said the State Department had approved a plan to establish eight full-time, permanent FDA positions at U.S. diplomatic posts in China. The FDA also plans to hire five Chinese employees to work with the FDA at the U.S. Embassy in Beijing and the U.S. consulates in Shanghai and Guangzhou.
“Our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs and medical devices in the global market,” said Murray M. Lumpkin, the FDA’s deputy commissioner for international and special programs.
Over the past year, U.S. regulators have recalled a number of contaminated products, including toothpaste, pet food and the blood thinner heparin, made in China.
FDA Commissioner Andrew von Eschenbach said last month that the FDA must make major changes to keep up with complex global markets that mean more and more U.S. food and medicine is produced abroad.
© 2008 The Associated Press
Read the full report from the Associated Press
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News from PAAB
Learn the regulations and guidelines that embody the pharmaceutical industry’s commitment to the highest standard of professional conduct. Pharmahorizons is the authorized training partners of the PAAB and Rx&D.
PAAB will be holding national open workshops on May 14, 2008 in Toronto and on May 22 in Montreal.
Title: PAAB Code: Strategies, Tools and Techniques to Speed Approval of Your Submission
For more information, click here.
News from Montreal InVivo
Montreal is Canada’s largest life science cluster. Each month, Pharmahorizons will showcase news, trends and events in the greater Montreal area.
Montréal InVivo Life Sciences Career Fair
Don’t miss this annual career fair targetted specifically for Quebec’s Life Sciences industry!
For employers interested in attending this event (sponsoring, renting a booth, adverstising), contact Andrew Gregory at 1-877-751-9415 for details.
Whether you want to host a booth or find your ideal job, this career fair will keep you in touch with the life sciences community. Free for candidates, no registration required. Just show up and don’t forget to bring your CV’s.
Atrium refocuses its operations on the health and nutrition sector
Atrium Innovations Inc. (Quebec City) disclosed its annual financial results and also reconfirmed the strategic refocusing of its business operations. Atrium intends to concentrate its operations uniquely in the health and nutrition sector and, consequently, has decided to divest its Active Ingredients & Specialty Chemicals Division. This decision, which was made in the best interest of both divisions, follows a strategic re-evaluation process of the AI & SC Division initiated by the Company on December 18, 2007. It became clear that focusing on one sector would be the best option for Atrium to optimize its future development and profitability.
http://www.atrium-innov.com
Why some carriers don’t get sick
A Canada-U.S. research team has solved a major genetic mystery: How a protein in some people’s DNA guards them against killer immune diseases such as HIV. In an advance online edition of Nature Medicine, the scientists explain how the protein, FOX03a, shields against viral attacks and how the discovery will help in the development of a HIV vaccine. “HIV infection is characterised by the slow demise of T-cells, in particular central memory cells, which can mediate lifelong protection against viruses,” said lead researcher Rafick-Pierre Sékaly, a Université de Montréal professor and a researcher at the Centre Hospitalier de l’Université de Montréal and the French Institut national de la santé et de la recherche médicale (Inserm). “Our group has found how the key protein, FOX03a, is vital to the survival of central memory cells that are defective in HIV-infected individuals even if they are treated,” added Dr. Sékaly www.chumontreal.qc.ca
Source: Life Sciences News Briefs © 2008, prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Louise Leduc Tel: (613) 954-4715; E-mail: Leduc.Louise@ic.gc.ca).
Jewish General launches surgical robotics program
MONTREAL - Surgeons at Montreal’s Jewish General Hospital (JGH) have entered into the new age of cutting-edge surgery with the arrival of its first da Vinci surgical robot, taking the JGH to the forefront of treating prostate and gynaecological cancers.
Robotic surgery allows for unprecedented surgical precision, translating into shorter operation times, less blood loss, and a decrease in possible complications.
“It has become increasingly evident that prostatectomies performed with robotic technology lead to a significant decrease in incidence of sexual dysfunction and incontinence improving the daily lives of our patients,” said Dr. Jacques Corcos (pictured), Director of the Robotics Program and Chief of the Department of Urology at the Jewish General Hospital.
“This knowledge is based on current research being conducted at the JGH, and is part of a larger design, a Robotics Program in affiliation with all six of Quebec’s universities.”
There are approximately 700 surgical robots in use throughout the world, 500 located in the United States alone, where all JGH surgeons received their training and where 70% of prostatectomies are conducted using a surgeon-assisted robot.
There are few surgical robots in Canada - in London, Ont., in Vancouver, Edmonton, and now in Montreal. The latest generation is quite distinguished from existing models, with the addition of a high-definition monitor which allows for exceptional vision and a fourth arm, enabling the physician to carry out precise surgical movements with ease.
Under the direction of Dr. Jacques Corcos, the JGH Robotics Program will allow for surgical advances in urological and gynaecological cancers, and other specialties including digestive and cardiac surgeries.
Working in collaboration with surgeons in Canada, the United States and Europe are Dr. Maurice Anidjar specializing in urology, Dr. Walter H. Gotlieb and Dr. Susie Lau specializing in gynaecological cancers, Dr. Togas Tulandi, specializing in infertility, Dr. Jacob Garzon and Dr. Shannon Fraser specializing in surgeries of the digestive system, and Dr. Yves Langlois specializing in cardiac surgery.
Their collaboration with national and international robotic centres enables the population of Quebec to benefit from otherwise costly medical treatment.
According to Henri Elbaz, Executive Director of the JGH, “The arrival of the da Vinci system marks our latest success in making the Jewish General Hospital a focal point for the best medical technology and the most up-to-date facilities in the province.”
Source: Canadian Healthcare Technology
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News from IMS Health
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Generics Capture 65% of U.S. Market as Costs Rise
Presidential Candidates Support Rise of Generics and Products from Canada
By Catherine Larkin
(Bloomberg) — Two-thirds of prescriptions filled in the U.S., the most ever, are cheap copies of brand names made by generic-drug companies.
Generics accounted for 65 percent of the U.S. market last year, up from 63 percent in 2006, according to data released today at the Generic Pharmaceutical Association’s annual industry meeting in Boca Raton, Florida. Costlier brand-name drugs made up about 80 percent of dollars spent on prescriptions in each year.
The figures, compiled by the research firm IMS Health Inc., show generic drugmakers are capitalizing on expiring patents and efforts by insurers to rein in health-care costs. The companies seek further gains this year as drugs with $20 billion in annual sales lose patent protection and the presidential candidates promise to make generic drugs more widely available.
“We’re poised to do very well,” said Kathleen Jaeger, president of the Arlington, Virginia-based Generic Pharmaceutical Association, in an interview yesterday. “All the candidates believe that generics are part of the answer.”
Drugs facing generic competition for the first time this year include Merck & Co.’s osteoporosis treatment Fosamax and Johnson & Johnson’s antipsychotic therapy Risperdal. Generic-drug companies are permitted under a 1984 U.S. law to apply for approval to copy conventional medicines, made through chemical synthesis, once patents expire or are ruled invalid.
Executives from the world’s biggest sellers of generic drugs — including Israel’s Teva Pharmaceutical Industries Ltd., the Sandoz unit of Swiss drugmaker Novartis AG, and U.S.-based Mylan Inc. — gather each year to discuss strategies for success in the competitive, low-margin business.
Health-Care Overhaul
This year’s topics include proposals by presidential candidates and lawmakers to overhaul the U.S. health-care system and to create a pathway for copies of medicines made through biotechnology. Costs for medical services have risen faster than wages and White House hopefuls from both parties have vowed to slow health-care inflation.
Paul Bisaro, chief executive officer of Watson Pharmaceuticals Inc., said changes in health-care policy may not benefit his company and other generic drugmakers unless they play an active role to ensure the new rules aren’t manipulated by brand-name companies with more lobbying power in Washington.
“We have to be careful with health-care reform,” Bisaro of Corona, California-based Watson said yesterday in an interview. “Well-meaning, well-intentioned efforts could be very damaging to our industry.”
Democratic presidential candidate Hillary Clinton co- sponsored legislation last year that would for the first time allow the U.S. Food and Drug Administration to approve copies of biotechnology drugs that have been on the market at least 12 years.
Delayed Competition
Generic companies have called for revisions to the proposal, saying 12 years is too long to delay competition for drugs that can cost as much as $200,000 a year. Americans now spend $40 billion annually on medicines made from living cells, including Amgen Inc.’s anemia treatment Epogen.
Generic drugmakers also want the FDA to be able to consider on a case-by-case basis when clinical trials are needed to approve a copy of a biotechnology drug and when the copy can be substituted for the brand product at a pharmacy.
“We must achieve a balance of affordability, access and innovation,” said Senator Charles Schumer, a New York Democrat and longtime advocate of generics, in a taped speech today at the industry conference. “We need a clean approval pathway that is driven by science and allows FDA discretion based on that science.”
Presidential Candidates
Clinton, a New York senator, has said that if elected president she would increase funding for the FDA’s Office of Generic Drugs to speed reviews of new medicines and eliminate “loopholes” in U.S. law that allow brand-name companies to block generic products from entering the market.
Generic companies say they don’t want to start paying regulators to handle their drug applications, as proposed by President George W. Bush this month in his budget, unless quicker reviews are guaranteed.
Clinton’s Democratic rival Barack Obama, a senator from Illinois, has said he also would prevent brand-name companies from blocking copies and would encourage wider use of generics in U.S. health programs, including Medicare for the elderly and Medicaid for the poor, to lower costs.
Obama and Senator John McCain of Arizona, the leading Republican candidate for president, want to allow Americans to buy drugs from Canada and other countries if the medicines are shown to be safe and less expensive. McCain also has said he wants to improve the approval process for generic drugs and biotechnology medicines.
To contact the reporter on this story: Catherine Larkin in Boca Raton, Florida, at clarkin4@bloomberg.net.
News from Toronto’s BioPharma Community
Bioniche Receives Fast Track Designation For Bladder Cancer Therapy
Bioniche Life Sciences Inc. (Belleville), a research-based, technology-driven Canadian biopharmaceutical company, announced that it has received notice from the U.S. Food and Drug Administration (FDA) that its therapy for first-line non-muscle-invasive bladder cancer meets the criteria for Fast Track designation. A Phase III clinical trial comparing a formulation of the Company’s Mycobacterial Cell Wall-DNA Complex (MCC) - Urocidin(TM) - to the current standard therapy in patients with non-muscle-invasive bladder cancer at high risk of recurrence or progression. This clinical trial, scheduled to begin later in 2008, aims to demonstrate non-inferior efficacy with respect to disease-free survival and fewer toxicities than the current therapy. This is the second Phase III trial of the Company to receive Fast Track designation: Bioniche’s registration trial of Urocidin for bladder cancer patients that have failed current therapies was designated as Fast Track in April, 2006. That first “Refractory” Phase III trial is ongoing at leading bladder cancer centres across Canada and the United States.
http://www.bioniche.com/
Bradmer Phase II results published in newly diagnosed glioblastoma
Bradmer Pharmaceuticals Inc., (Toronto) a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, announced that Phase II data on the Company’s Neuradiab product candidate as a treatment for newly diagnosed glioblastoma multiforme (GBM) were published in the journal, Neuro-Oncology. This report summarizes the most recent clinical results utilizing patient-specific dosing of Neuradiab (I-131 mAb81c6) as an adjunctive therapy to oral chemotherapy, surgery and external beam radiation in patients with newly diagnosed GBM. The study, conducted at Duke University Medical Center evaluating the efficacy and toxicity of Neuradiab as an adjunct to standard of care therapy in a 21 patient trial, demonstrated a 42 percent increase in overall survival compared to a historical control of the current standard of care. The article titled, “A pilot study: 131I-Antitenascin monoclonal antibody 81c6 to deliver a 44-Gy resection cavity boost”, written by David A. Reardon and Michael R. Zalutsky as lead authors, will be published in the April 2008 edition of Neuro-Oncology.
http://www.bradmerpharma.com/
Computerized system promotes hand-washing in hospitals
TORONTO - Researchers at the Toronto Rehabilitation Institute (Toronto Rehab) are developing state-of-the-art technology that will help caregivers reduce hospital-acquired infection rates and provide safer patient care.
Each year in Canada, about 8,000 patients - or approximately 22 people a day - die from hospital-acquired infections. It is estimated that as many as half of these deaths are attributable to inadequate hand cleansing on the part of healthcare workers.
“Blaming the spread of infections in hospitals on healthcare workers is not really fair,” says Dr. Geoff Fernie (pictured), Toronto Rehab’s Vice President of Research. “Healthcare professionals typically work in very busy clinical environments with multiple competing demands for their time and attention. It is very difficult for them to remember to clean their hands each and every time they have contact with a patient.”
While everyone can improve their hygiene habits, according to Dr. Fernie, a healthcare worker would need to disinfect his/her hands 100 to 150 times per eight hour shift to achieve 100 per cent compliance. That is approximately once every five minutes and, during especially busy times, the need to disinfect could be as high as 70 times per hour. That works out to the equivalent of once per minute.
“We need to help caregivers remember to cleanse their hands at critical junctures in their daily care routine,” adds Dr. Fernie. “Our new hand hygiene technology will help healthcare professionals improve the consistency of their hand cleansing practices and support them in maintaining a safe and healthy environment for their patients and themselves.”
All workers in patient care environments would be outfitted with a small sensor attached to their identification lanyard. This sensor is part of an overhead electronic monitoring system that reminds healthcare staff by way of an auditory signal (a beep) to cleanse their hands, if they have not already done so, when they approach or leave different patients.
A portable alcohol gel dispenser that is attached to their waist or a static alcohol gel dispenser mounted to a wall - both equipped with sensors - can detect whether or not hands have been washed prior to and after individual patient/caregiver contact. The system also records the time of entry and exit of each designated patient area and the number of times hands are disinfected to obtain an overall record of hand cleansing compliance.
A few hospitals in Europe and the United States have implemented successful hand hygiene programs and report increases in hand cleansing frequency and decreases in certain types of hospital infections. However, achieving better staff hand hygiene practices does not happen overnight and is difficult to sustain.
“There are many factors that influence the development of hospital-acquired infections. While it is well established that the most effective way to stop the spread of infections in hospitals is hand hygiene using an alcohol hand gel, good hand hygiene must be used in combination with other measures, such as better hospital design, adequate cleaning and disinfection of the hospital environment and medical equipment, effective use of aseptic technique and appropriate use of personal protection gear such as masks, gowns, gloves, and face shields, and optimal antibiotic management.” says Dr. McGeer.
Under proposed new standards for infection prevention and control developed by the Canadian Council on Health Services Accreditation in March 2007, hospitals will be required to monitor infection rates and participate in hand hygiene initiatives to maintain their accreditation.
“We’ve been successful in obtaining the research funding required to get us to this stage in the development process. What we need now is significant investment to accelerate development, refine the product and get it into the hands of those who are in a position to save thousands of lives each year,” says Dr. Fernie.
Dr. Fernie predicts that the system will be on the market in the next two years.
Source: Canadian Healthcare Technology
The Future of the Pharmaceutical Industry in Canada
By Ronnie Miller, President and CEO, Hoffmann-La Roche Ltd, Chair Rx&D
The Canadian pharmaceutical industry today, “is like a roller coaster,” declared Ronnie Miller to the 137 members and guests who attended the January, 2008 OPMA dinner meeting. The industry “is going faster and higher and dropping further and faster than ever before,” he said.
To illustrate the roller coaster analogy, Mr. Miller summarized a recent article he had read, which listed the six key factors that keep a pharmaceutical CEO up at night:
- Share price.
- Pipeline vulnerability.
- Health economic assessments.
- The ability to sustain attacks from generic companies on intellectual property.
- Job cuts and restructuring.
- Relationships with Government.
He pointed out that in Canada there is an extremely rigorous approach to health economic assessments. Also, job security is no longer a given. In Canada, alone, the industry lost 2,500 jobs in 2007.
Read the full presentation on OPMA’s website
News from the OCRI Life Sciences
Liponex and ImaSight Announce Definitive Combination Agreement
Liponex Inc. (Ottawa), and ImaSight Inc., (Gatineau) a commercial-stage medical device company marketing an innovative, cost effective digital radiology solution, announced that they have entered into a definitive agreement to combine their respective businesses. This transaction has been approved by the boards of directors of both companies.
http://www.imasight.com
http://www.liponex.ca
Feds invest $118M in public-private S&T partnerships
In December, the Canadian government pledged $118 million over three years for six National Research Council (NRC) technology cluster initiatives. As part of this announcement, the NRC National Institute for Nanotechnology (NINT) will receive $36 million over the next three years.
The investment will support the government’s priority areas: hydrogen and fuel cell technologies in Vancouver, nanotechnology in Edmonton, plants for health and wellness in Saskatoon, biomedical technologies in Winnipeg, photonics in Ottawa, and aluminium transformation in the Saguenay - Lac-Saint-Jean region.
Technology clusters are broadly based community partnerships between industry, academia and all levels of government, focused on building a competitive advantage for Canada through research and innovation. These S&T partnerships position communities to attract talent, investment and economic activity.
Bed crunch: Scores of Ottawa hospital beds occupied by people who can’t find other care
Recently,178 beds in Ottawa hospitals were being occupied by people who didn’t need to be there but couldn’t find home care or long-term care.
So many hospital beds in Ottawa are being used to care for people who should be in long-term care or at home that it’s the equivalent of closing the Montfort Hospital, health officials say.
It’s the most serious problem facing hospitals across Ontario, says Tom Closson, the new president of the On