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GE Healthcare designs Innovation Village for life science businesses to be launched in Cardiff

A "hothouse" for growing hi-tech life science companies is being unveiled in Cardiff on Monday.
GE Healthcare is setting up an innovation village at its base to help develop businesses and new ideas.
The first phase will have labs and space for 12 small firms but 50 have expressed an interest since the idea was first announced last month.
Life sciences – developing new drugs and health technologies – is one of the fastest-growing sectors in Wales.
There is a life sciences hub already established in Cardiff for businesses and health organisations to work together under one roof.
 Wales is also the only country in the world to have a designated £100m fund to attract life science companies to relocate here.
The campus at Atlantic Wharf is backed by £367,000 of Welsh government and EU funding – aimed at encouraging businesses to collaborate.
GE Healthcare will provide advice on turning ideas into products and to market them across the world.
Life sciences encompass a wide range of companies from pharmaceuticals to diagnostics and even e-health. It brings together experts in a broad selection of disciplines.
It is already very important to the Welsh economy and has the potential to make a real difference.
The sector employs 11,000 people in Wales in 350 companies, with a combined turnover of £2bn. The jobs tend to be relatively high skilled and better paid but the economic impact goes beyond that.
The Welsh government is supportive of the sector and recognises it has the potential to help lift the wider economy, especially if new technologies or products are developed here.
Until now and across the economy Wales has not had a good record in terms of the numbers of patents given to products developed here. It hopes the growing Welsh life sciences sector will help to change that.
Economy Minister Edwina Hart said it was a "tremendous opportunity" for growing businesses.
Kieran Murphy, president and chief executive GE Healthcare Life Sciences, said: "We can both support their development with our expertise and scale, and potentially access promising new technologies that could complement our own."

Iran to open Amir-al-Momenin Burn Center, largest in Middle East

An Iranian medical official announced on Wednesday that the largest burn center in the Middle East will be inaugurated later this year in Shiraz, south of Iran.
President of Shiraz University of Medical Sciences Mohammad Hadi Imaniyeh told the Tasnim News Agency that Amir-al-Momenin Burn Center, with an area of 28,000 square meters and a capacity of 1000 patients, will be launched in late August, adding that the center will be the largest of its kind in the Middle East region.
The project to construct the seven-floor sub-specialty hospital was started in 2005. It is under construction using funds from charities and the Health Ministry, he added.
Amir-al-Momenin Burn Center will include special rooms for patients with infectious and noninfectious diseases, ICU, reconstructive surgery, and plastic surgery as well as children and women's burn wards, Imanieh explained.
A burn center is a hospital specializing in the treatment of burns. These centers are often used for the treatment and recovery of patients with severe burns.

Bryn Mawr Hospital’s $200 million modernisation project approved

Bryn Mawr Hospital (BMH) in Bryn Mawr, Pa., part of Main Line Health, has received tentative sketch plan approval from for a $200 million campus master plan to modernize the hospital campus.
The modernization project will include a new five-story, 203,000-square-foot patient pavilion, as well as renovations to the labor/delivery and maternity units. Once completed in 2018, the hospital will be equipped with all private patient rooms, modern facilities, and advanced technology.
The building will be built in the center of the campus, taking the place of the Clothier Building and Medical Office Building South. A parallel project to the $200 million modernization project is the construction of a new 100,000-square-foot medical office building (MOB) by a private, national developer for multispecialty clinician offices. The MOB project also involves two levels to be added to the Bryn Mawr Avenue parking garage.
RTKL is designing the patient pavilion and existing department renovations, and HSC Builders & Construction Managers is managing the building construction. Stantec Consulting Services Inc., is serving as the overall project manager.

 

Vaccination drive by health services integration essential to avert 1.5 million child deaths yearly

One fifth of the world's children still do not receive routine vaccinations that could prevent 1.5 million deaths a year from preventable diseases, the World Health Organisation has said.
Many nations, including the United States, have had serious measles outbreaks in the past year, threatening to undermine efforts to eliminate the viral disease by the end of 2015, one of the WHO's global vaccination targets.
"It is critical that the global community now makes a collective and cohesive effort to put progress towards our six targets back on track," Dr Flavia Bustreo, WHO assistant director-general for family, women's and children's health, said in a statement ahead of the agency's World Immunization Week.
The WHO said five of the six vaccination targets set for end-2015 had not yet been met – 90 percent immunization coverage for diphtheria, tetanus and whooping cough, the eradication of polio, and the elimination of measles, rubella, and tetanus among newborns and pregnant mothers worldwide.
The only target that has been met is getting poor and middle income countries to use one or more under-used vaccines, such as those against cholera, the agency said.
Half of all children do not receive the rubella vaccine and 16 percent of all children are not being vaccinated against measles, according to the WHO. Polio remains endemic in three countries – Afghanistan, Nigeria and Pakistan.
In 2012, nearly 22 million children, many of them in the world's poorest countries, did not receive the required three doses of vaccines containing diphtheria, tetanus and pertussis, known as DTP3, the WHO said.
The drive to increase global vaccination levels began in the mid-1970s and vaccination levels rose from five percent to more than 80 percent by 2013, particularly in Latin American countries. But progress has stalled in recent years, WHO said.
More needs to be done to integrate vaccination programs with other health services, particularly during postnatal care for mothers and babies, WHO says.
The organization is due to hold a meeting in May of 34 countries where coverage with three doses of DTP3 is less than 80 percent with a view to boosting their use of the vaccine.

Global medical device makers form APACMed, Asia’s first industry trade club

Some of the biggest medical device makers, including GE Healthcare, Abbott, Johnson & Johnson and Boston Scientific , are banding together to form the first industry trade group in Asia.
The Asia Pacific Medical Technology Association, or APACMed, which is expected to be announced on Friday, hopes that by working together in the historically fragmented region, governments and regulators will take the group’s interests more seriously.
The broad constituent base, which the group hopes will include local companies in addition to multinational device makers, “will make the government and regulators and policy makers look at us a little bit differently,” APACMed ceo Fredrik Nyberg tells us. All of the founding APACMed members are western companies but the leadership is talking with a number of companies in Japan, Korea, China and Singapore, as well as an Indian industry association, he adds.
Among the key issues to address, he explains, are new regulations in China for medical device clinical trials that were issued last year and could stall the time it takes to get products to market by 12 to 24 months.
Though there have been medical device industry groups in the U.S. and Europe for decades, Asia is a newer and more fragmented market. And so, Nyberg says that senior industry leaders have been talking for the last year or two about the importance of working together and forming an industry group to more effectively affect change in regulations, treatment guidelines, laws and ethics.
“What we’re seeing is we’re at a bit of an inflection point in Asia Pacific in terms of healthcare,” says Nyberg, who has worked in the industry across Asia for some 25 years. More and more people in Asia want – and are able to afford – better healthcare but supply is not keeping up, he notes.
In some markets, the challenge is in establishing better medical infrastructure like hospital beds and an adequate number of doctors. But in others, the issue is how to train medical professionals on the latest technologies or to get reimbursed for innovative products, according to APACMed chairman Vladimir Makatsaria.
“At the end of the day, healthcare is an extremely important part of our economy and part of our society,” says Makatsaria, who also leads the medical device business in the Asia-Pacific region for Johnson & Johnson. “Healthcare is facing a major challenge moving forward globally but in Asia even more so.”

FDA dratfs guide on use of foreign trial data in medical device approvals

The U.S. Food and Drug Administration (FDA) recently released draft guidance on accepting foreign clinical trials in support of premarket submissions for medical devices.
The draft guidance communicates considerations that sponsors of device submissions should take into account when initiating, or relying on previously collected data from, an outside the United States (OUS) clinical study to support an investigational device exemption (IDE), premarket notification [510(k)], de novo petition, humanitarian device exemption (HDE), or premarket approval (PMA) application, according to a prior notice by the FDA.
"The guidance describes special considerations that apply when using such data, including applicability to populations within the United States and study design issues and provides recommendations to assist sponsors in ensuring their data are adequate under applicable FDA standards to support approval or clearance of the device in the United States," the summary in the Federal Register states.
The draft guidance titled, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States [PDF], seeks to clarify FDA's use of an increasing number of clinical studies conducted outside the U.S. and used by sponsors and device manufacturers for premarket submissions and investigational device exemptions.
"The number of IDE applications and submissions for marketing authorization supported by OUS clinical trials has increased in recent years and will likely continue to increase in the future," the guidance explains. "This increasing globalization of clinical trials presents challenges to both US and foreign regulators. Among the challenges are resource constraints that impact the number of foreign clinical site inspections and unnecessary duplication of clinical studies and administrative burdens."
Under Section 1123 of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, clinical data from foreign studies should be accepted by the FDA provided that such studies comply with U.S. federal standards on good clinical practices (GCPs). The draft guidance seeks to clarify the processes by which the FDA applies those standards.
According to a Regulatory Affairs Professional Society (RAPS) article, OUS studies can also be accepted by the FDA if they meet local standards of the country where those studies are conducted, provided such local standards must be shown by a company to be either equal to or greater than U.S. requirements for human protection under the 1983 version of the Declaration of Helsinki.
Any OUS data used to support device premarket applications, including 187 510(k)s, premarket approvals (PMAs), and de novos should constitute "valid scientific evidence," the FDA stated in the guidance. The document defines it as evidence from "well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use."
The new guidance could facilitate the movement of medical devices along the regulatory pipeline, Vicki Anastasi, VP and global head of medical device and diagnostics research at contract resource organization (CRO) Icon, told Outsourcing-Pharma.com
"Assuming that collected data are scientifically valid and compliant, the clarity provided by this guidance could shorten the clinical trial cycle time, expedite data collection, and move more products in the global market faster," Anastasi said. "This increase in efficiency would certainly be bolstered if these trials also employ smart strategies such as adaptive design, risk based monitoring, and early collection of health economic data."
The FDA is accepting written and electronic comments on the draft guidance until July 20, 2015.

 

Medical device maker ReShape Medical secure $12 million from Oxford Finance, SVB

Oxford Finance and Silicon Valley Bank announced the closing of a $12 million senior secured term loan agreement with ReShape Medical, Inc. ReShape Medical specializes in a dual-intragastric balloon for weight loss, ReShape Integrated Dual Balloon System, which is used as an aid in the treatment of obese patients.  Proceeds of the loan will be used for marketing  purposes and for future product enhancements.
"Oxford is pleased to provide capital to ReShape Medical for the commercialization of its product," said Christopher A. Herr, managing director for Oxford Finance. "The company is anticipating FDA approval of the ReShape Dual Balloon, which would be among the first non-surgical weight loss devices available in the United States."
"Increasing our clients' probability of success is our primary objective in working with companies like ReShape Medical that are bringing important medical advancements to the healthcare market," said Brett Maver, director for Silicon Valley Bank in San Diego, California. "We are happy to help the ReShape Medical team move its business forward quickly as the company grows."
"We are very pleased to be working with the SVB and Oxford teams," said Rick Thompson, ReShape Medical president and CEO.  "This financing enhances our ability to move forward while awaiting the FDA decision and preparing for an equity financing round to fund commercialization of our product."
Oxford Finance is a specialty finance firm providing senior secured loans to public and private life sciences and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to its clients, enabling these companies to maximize their equity by leveraging their assets. In recent years, Oxford has originated over $2 billion in loans, with lines of credit ranging from $500 thousand to $75 million. Oxford is headquartered in Alexandria, Virginia, with additional offices in California, Massachusetts and North Carolina.
For more than 30 years, Silicon Valley Bank (SVB) has helped innovative companies and their investors move bold ideas forward. SVB provides targeted financial services and expertise through its offices in innovation centers around the world. With commercial, international and private banking services, SVB helps address the unique needs of innovators.
ReShape Medical is a medical device company focused on the development and commercialization of its dual intragastric balloon for weight loss.

Excela Health begins $14 million ICU upgrade at Westmoreland Hospital

Excela Health has begun fundraising in the community to offset the cost of rehabilitating Westmoreland Hospital’s intensive care unit, its first upgrade since 1980.
The $14 million project will expand the 32-bed unit throughout the hospital’s sixth floor, moving the short-stay surgical unit to the first floor from the sixth, spokeswoman Robin Jennings said.
Private baths for each room, designated family space and smart-room communications that include patient education and entertainment capabilities are planned.
“This really was a design that was intended to bring out the best components of what this work environment should be,” Jennings said.
The work is expected to last up to 18 months. Preliminary work on the project is underway as Excela Health moves ahead with community fundraising for the project.
The Westmoreland Hospital Foundation has committed $1 million to the project, and every Excela trustee has pledged financial support along with the medical staff and some employees. The hospital auxiliary pledged $100,000.
Dr. Peter Safar, the late University of Pittsburgh anesthesiologist, is credited with opening the first integrated, fully staffed critical care unit in the country at Baltimore City Hospital in 1958. Each of Excela’s three hospitals are more than 100 years old.

Lisa Banks, AstraZeneca Wins ‘customer Innovator Award’ at Eye Pharma Philadelphia Awards

Philadelphia, PE – Lisa Banks was deservedly recognized for her work in driving customer-focused innovation at the inaugural eyeforpharma Philadelphia Awards.
The eyeforpharma Philadelphia Awards reflect eyeforpharma’s mission is to make the pharmaceutical industry more open and valued by celebrating those who drive innovation that put the customer before profits. In a largely traditional industry, mindsets can be hard to change with innovators facing significant resistance by those who still believe in the status quo. The ‘Customer Innovator Award’ aims to put the spotlight on those with the courage to step forward, in order to encourage others to do the same.
Lisa Banks led the development of AstraZeneca’s ground-breaking mHealth app, Me & MyCOPD which used a patient-centric design approach to create a service that responded to user needs. Lisa  and her team were able to deliver an app that was intuitive to a population not overwhelmingly digitally savvy, to collect patient insights and improve the ability of the provider to deliver care.
The program measured improved outcomes in clinical visitations and patient adherence by giving health care professionals real-time visibility over health progress and integrating reminder systems for upcoming appointments.
Jessica Kuzmick at Bayer praised Lisa’s recent work both as an individual and as a team leader, saying, “I loved the teamwork internally and externally exhibited in identifying patient needs and in developing this patient adherence program. This is a ground-up initiative, but the innovative spirit is evident throughout. Truly digital health solutions are in their infancy, yet it looks like you got this one off to a fast start. Congratulations! This is an innovation the patients will truly benefit by.”
The winning projects were selected from about 80 initiatives from North America and were announced last night at the inaugural eyeforpharma Philadelphia Awards ceremony, determined by a diverse judging panel of senior industry experts, and patient advocates.
***ENDS***

AstraZeneca’s Joe Shields in the running for Lifetime Achivement Award

From EMMY-award winning filmmaker to – global digital strategist for a top-10 pharmaceutical company, AstraZeneca’s Joe Shields has forged an interesting path. He now faces 3 other contenders for the Lifetime Achievement Award at eyeforpharma’s inaugural Philadelphia Awards on April 7th. But has he done enough to take the prize?

The Philadelphia Awards are designed to recognize those in healthcare who focus and prioritize their work for the benefit of patients. Alongside Joe, Diego Miralles of Janssen, Ray Chepesiuk of PAAB and Matt Portch of Pfizer have been nominated by their peers. Shields is a leader in the design of many of AstraZeneca’s customer-centric marketing programs. He is also one of the architects of AstraZeneca’s new capabilities in Customer Experience, with an increased focus on delivering the company’s innovative science, products and services to patients.

Since the success of eyeforpharma’s first awards ceremony, held in Barcelona last year we are witnessing a new type of competition. Competition which drives, rather than pure company performance, more patient-focused work from an industry with a battered reputation.

The winner of the 2014 Lifetime Achievement Award, Patrick Cashman of Lundbeck, claimed, “It is so important that the pharmaceutical industry continue to focus on the patient journey and specifically the challenges faced by patients and their loved ones. This valuable recognition will encourage others to renew their efforts to serve patient needs.”

An all-inclusive list of eyeforpharma’s Philadelphia Awards 2015 can be found online here: http://www.eyeforpharma.com/philadelphia/awards-index.php

For more information please contact the eyeforpharma Awards Manager, Jenna Gottscho on jenna@eyeforpharma.com or visit www.eyeforpharma.com/philadelphia/awards

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