Allegheny General Hospital Cardiovascular Institute Becomes Exclusive Pittsburgh Site for Study of Novel Coronary Artery Disease Device

Pittsburgh, PA (PRWEB) May 20, 2013

Interventional cardiologist Tony Farah, MD, and his colleagues at the Allegheny General Hospital (AGH) Cardiovascular Institute have helped pioneer many breakthroughs in the treatment of coronary artery disease (CAD) over the past three decades, from new disease-fighting medications to life-saving procedures such as balloon angioplasty and coronary artery stent implantation.

Today, AGH officials announced that the hospital will once again play a prominent role in the study of a novel, first-of-its kind investigational device for CAD that many believe could be the next revolution in the treatment of a disease that strikes more than one million people annually in the United States, claims nearly 500,000 lives each year and is the leading cause of death for both men and women.

Under Dr. Farahs direction, AGH has been selected to join the ABSORB III clinical trial, a multi-center international study exploring a unique bioresorbable vascular scaffold (BVS), a small mesh tube that is designed to open a blocked artery and then fully dissolve over time, leaving the vessel free of a permanent metallic implant.

The FDA-approved study of the drug-eluting AbsorbTM BVS, made by healthcare company Abbott, is expected to enroll approximately 2,250 patients over the next 12 months, up to 200 of who could enter the trial at AGH.

Across every discipline in the treatment of cardiovascular disease, physicians at Allegheny General Hospital continue to set new standards of patient care through pioneering research and clinical ingenuity. The ABSORB study is just the latest example of the innovation that has been a hallmark of our cardiovascular program, said Dr. Farah, the hospitals principal investigator in the ABSORB III clinical trial.

Coronary artery disease is a condition in which one or more arteries that supply blood to the heart become narrowed, putting patients at risk of a heart attack and cardiac death. Similar to conventional metallic stents, the Absorb device is designed to open a blocked heart vessel and restore blood flow to the heart.

Unlike metallic stents, however, which are permanently implanted into the blood vessel, Abbotts Absorb is a uniquely engineered, temporary scaffold that provides support to the vessel until the artery can stay open on its own. Made of polylactide, a naturally dissolvable material that is commonly used in medical implants (such as dissolving sutures), the device dissolves into the blood vessel after its work has been done.

According to Dr. Farah, the potential advantages of a bioresorbable scaffold device are significant when it comes to the long-term management of CAD patients.

With the standardization of balloon angioplasty and stent implantation and the vast experience that we have accumulated in the use of these techniques, it has become apparent that the most effective and safe means of restoring natural blood vessel function in the setting of coronary disease is ultimately a treatment that leaves nothing behind in the vessel which was the original idea of angioplasty. The Absorb device moves us in the direction of that goal, Dr. Farah said.

Balloon angioplasty is a procedure in which a balloon tipped catheter is used to open an area of arterial blockage. The catheter is delivered into the artery through the skin via a small incision in the groin or arm.

Deployed in a similar fashion, stents evolved to help prevent a complication of angioplasty in which the previously opened lesion in the artery gradually re-narrows from continuing plaque build-up a condition called restenosis. To further improve stent performance, the technology was more recently advanced to include drug-eluting devices coated with medications designed to further inhibit the growth of plaque at the treatment site.

For all their effectiveness at improving the outcomes of many patients with CAD, the risks of conventional, permanently placed stents are not insignificant, Dr. Farah said.

Patients receiving stents typically require prolonged use of blood thinning medications to prevent blood clots from forming within the device, which may cause sudden heart attacks. Stented lesions are also still prone to restenosis, particularly among one of the largest subsets of patients at risk for CAD diabetics.

And for patients with advanced coronary disease, the presence of stents in multiple vessels has the potential to limit future heart surgery options, if needed.

Because of these concerns, there has always been a desire to find a better way to accomplish the pivotal short term function of stents, without the long-term complications, Dr. Farah said.

International studies to date of the Absorb device have been extremely encouraging and the start of the ABSORB III U.S. clinical trial follows the recent commercial launch of Absorb in Europe and parts of Latin America, Asia and India.

Absorb III is a prospective, randomized study that will compare Abbotts drug-eluting Absorb BVS devise to the companys XIENCETM family of drug eluting metallic stents. Both devices deliver everolimus, an anti-proliferative drug that has been shown to inhibit in-stent plaque growth in coronary vessels.

The primary endpoint of the trial is target lesion failure, a combined measure of safety and efficacy, at one year. In addition, a subset of patients within the trial will be evaluated for novel endpoints such as vasomotion, a measure of how much natural motion returns to the vessel as Absorb dissolves into the arterial tissue.

Dr. Farah said many patients with CAD who are good candidates for stent placement will be eligible for enrollment in the study. Those with questions about the clinical trial can contact Joe Carothers at 412-359-4156.

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Utah Assistant Attorney General, Documentary Star Among Patient Advocate Fellows at DIA 2013 49th Annual Meeting

Horsham, Pa. (PRWEB) June 06, 2013

Utah Assistant Attorney General and spinal muscular atrophy survivor Steve Mikita and five other inspiring patient advocates will share stories of their tireless efforts to insert the patient voice at each step of the drug development process at the DIA 2013 49th Annual Meeting in Boston this month. The news media are invited to listen to the compelling stories of these patients and patient advocates on June 24 at 10:15 a.m. at the Boston Convention & Exhibition Center.

In addition to Mikita, who has lived decades beyond his life expectancy of age 2, the panel of patient advocates includes Karen Ball, whose work has led to the discovery of the genetic mutation of her daughters disease, Sturge-Weber syndrome, and Donna Appell, whose race on behalf of her daughter to find a treatment for Hermansky-Pudlak syndrome has been chronicled in the documentary Rare. All of the panelists were selected for the DIA Patient Advocate Fellowship Program for their determined efforts to accelerate drug development and access.

The work of patient advocates is vital in discovering and developing therapies, and their stories reflect their utmost determination and resilienceeven when faced with roadblocks when trying to develop the right drug, said Susan Cantrell, director of DIA North America. DIA brings these incredible individuals to our meeting to stimulate collaboration, promote dialogue and share best practices with the premier professionals that can benefit from their work and help advance their goals.

Steve Mikita

Paralyzed since before he even reached age 2 from a rare neuromuscular disease that had not a single treatment available, Steve Mikita knew he would never be able to run and jump like the other boys. Yet he knew what his father told him: He could exercise his mind. Throughout his life, this disease has never stopped the assistant attorney general, Duke University graduate and author from working on behalf of every person struggling with a rare disease.

Mikita is a patient representative for the federal Clinical Trials Transformation Initiative, a public-private partnership that brings together thought leaders and decision-makers who are dedicated to increasing the quality and efficiency of clinical trials. He promotes including patient insight throughout all phases of drug development and approval.

Mikita said his quality of life and the quality of life of others with rare diseases is being diminished because the pharmaceutical industry is looking for low-hanging fruit. He added, My disease is up in the top branches. I am up here saying, Hey, talk to me up here.

Donna and Ashley Appell

Donna Appells daughter, Ashley, was diagnosed with Hermansky-Pudlak syndrome (HPS) as an infant. The life expectancy for people with the extremely rare genetic disease is around age 30, and Ashley is now 26 years old.

Donna Appell, a resident of Oyster Bay, N.Y., has traveled so many times to Puerto Rico to identify and recruit patients with HPS for a clinical trial that shes acquired a nickname, Big Applebecause of her strong New York accent and larger-than-life personality. Her recruitment efforts eventually led to a clinical trial by the National Institutes of Health on the effect of pirfenidone on pulmonary fibrosis, an often fatal symptom of HPS. The study showed the drug to be ineffective, but Appell is not giving up.

I will not stay still, she said.

Appells race to find a treatment for her daughter is chronicled in the documentary Rare, which will be screened at DIAs annual meeting.

Karen Ball

When Karen Ball, of Mount Freedom, N.J., got the call in May 2013 with the results from a clinical researcher studying Sturge-Weber syndrome (SWS), her life, her daughters lifelike the lives of thousands of SWS patients and familieswas changed forever.

Her daughter, Kaelin, was diagnosed with SWS at birth. To raise awareness of SWS and associated port-wine birthmark conditions, Ball started the Sturge-Weber Foundation in 1987. The foundation work led to her support for the development of a clinical trial on SWS with the Kennedy Krieger Institute; she supplied the study with patient data and tissue samples.

Twenty-six years after Kaelin was diagnosed, Balls years of tireless work came to fruition: The clinical trial detected the genetic mutation that can result in SWS. Researchers have heralded Ball for her contributions, saying their work resulted in part from her efforts. This July, the foundation will meet with researchers to discuss next steps in developing a therapy for SWS.

Debra Madden

Debra Madden, of Newtown, Conn., was diagnosed with stage 3 Hodgkins lymphoma in 1987, at age 22. She remembers, as a terrified young patient, looking up information on her diagnosis and finding it described as a uniformly fatal diseaseshocking and dated words that inspired her to begin her career as a medical writer, focusing on making complex scientific information more accessible and understandable for patients and their families.

Twenty years later, Madden had more devastating news. She was diagnosed with stage 2 breast cancer, likely a result of her radiation therapy for Hodgkins decades earlier. But this time, there was Anns Place, a source of support and resources for people living with cancer that got her through surgery and well on the way to recovery. Following her chemotherapy, Madden immediately began serving as a peer mentor for newly diagnosed cancer patients.

Her experience fighting and surviving both cancers is the foundation of her daily work on behalf of other patients as a medical writer leading grant review panels for national research efforts. As a grant reviewer, Madden has tirelessly worked her way up, serving as a U.S. Food and Drug Administration (FDA) patient representative, a key member of the Patient-Centered Outcomes Research Institutes new Advisory Panel on Assessment of Diagnosis, Prevention, and Treatment Options, a reviewer for the U.S. Department of Defense Breast Cancer Research Program and a patient representative for several ongoing initiatives with the Clinical Trials Transformation Initiative. With clinical trial development and the grant review process, Madden is a recognized force as the voice of patients nationwide.

Maddens work has placed patients at the table where research and policy decisions intersect.

My transition as an advocate continues to evolve, and there remains so much more to be done, she said. And our workas research advocates, scientists, investigators, and clinicianswont be done unless or until we find the answers.

Teresa Barnes

Pulmonary fibrosis has devastated Teresa Barnes family. Within 10 years, the disease killed her father, her three uncles and her auntall of whom went from good health to death in just a few years or even weeks. Barnes, a former broadcast journalist from Memphis, Tenn., knows she and her toddler daughter, Eme, could be nextand is in a race against time to find a cure. With a family history of pulmonary fibrosis on both sides, Eme has a 68 percent chance of developing the disease.

Barnes dove into accelerating research for pulmonary fibrosisan area she knows all too well. With an extreme genetic risk to develop the disease, Barnes family has been part of genetic research for 12 years. She co-founded the Coalition for Pulmonary Fibrosis, and, along with Appell, recruited patients for the first clinical trial testing a therapy for the disease. The drug was proven ineffective, but it did slow the diseases progression for a minority of the patients. Barnes testified before an FDA panel to support approval of the drug as the only hope pulmonary fibrosis patients and their families had for a treatment.

Belcorp USA General Manager Recognized as One of the Top 20 Most Influential Women in the Direct Selling Industry

San Francisco, CA (PRWEB) November 20, 2012

Direct Selling News recently ranked Belcorp USA General Manager, Mona Ameli, among the top 20 most influential women in the direct selling industry. This group of women were selected based on their leadership roles in companies that achieved the DSN Global 100 list and their abilities to guide the industry and foster growth through passionate vision and commitment.

One of the dominant forces driving Amelis achievements as head of the U.S. subsidiary of Belcorp, a Latin-based international direct selling giant, is her ardent support of womens empowerment and social and economic advancement. When prioritizing economic strategies for growth for Belcorp USA, she ranks gender and cultural diversity as the surest way to build a prosperous and sustainable future for its employees, distributors, and customers, as well as the community and economy of the San Francisco Bay area they call home. Belcorp USA is the only worlds top 10 direct selling company in the San Francisco Bay area.

There is no room for cultural or gender gaps at Belcorp USA. Some 75% of managerial positions are filled by women, in stark contrast to the gender gap still occupying most of corporate America. That is, in part, why Direct Selling News recently ranked Ameli among the top 20 most influential women in the direct selling industry.

Inviting diversity, in both gender and culture, into top level management teams not only expands opportunities for individuals, but also escalates corporate return on equity 53% on average, McKinsey Global Institute found among companies with the most diverse executive teams. Simply put, research backs what Belcorp knew and has practiced all along.

Diversityits our strength here at Belcorp USA. It is our point of differentiation, Mona Ameli, General Manager, says. Ameli twice immigrated to new lands, first from her native Iran as a young child and then again as a young adult from France to the United States.

As a woman of Middle Eastern origin, Amelis immigration allowed her to break free from gender limitations and restrictions. These personal experiences help guide Ameli in the fostering of an inclusive corporate environment that empowers women to fully engage in the new-world economy through diversity of culture and gender. While reduced availability might informally preclude women or mothers from reaching their full potential at other companies, Ameli says, I dont see it that way. These female managers deal with many of the same availability challenges as our distributors in the field the women we work for many are single mothers or work two jobs or care for an aging parent.

Secretary of State Hillary Rodham Clinton made the economic case for The Participation Age and closing the gender gap at an international event in Belcorp USAs backyard in September 2011. The conclusion of international dialogue: Economic growth can only be realized through the empowerment of women and girls to fully participate in the global economy.

Close the gender gap, Ameli says, and its not just women who benefit. She sites a Goldman Sachs report stating Americas gross domestic product would increase 9% if barriers to female participation in the labor force were reduced.

Belcorps diverse and inclusive nature make it increasingly versatile, adaptive, and competitive as an employer in the San Francisco Bay area and as a direct selling career opportunity. Since January, Belcorp USAs employee base grew 40% in marketing, sales and finance. Ameli expects an additional 10% boost in sales and marketing before years end. The companys direct selling distributor base exploded some 180% since late 2010.

Im so glad we have a corporate environment that reflects the same inclusive values we advocate for in the direct selling industry. That harmony that Belcorp has created between the employee side and distributor side is appealing. It is seamless and genuine. Theres not a dichotomy between the two, Ameli says.

The essence of Belcorp USAs mission is empowering women and enhancing their opportunities. Often that is accomplished through direct selling careers and corporate employment, but Belcorp Foundation partners with San Franciscos First Graduate and Womens Initiative to advance the dreams of low-income and college-ready women who need assistance. Scholarships, job shadowing, internships, and entrepreneurial training help these women bridge the gap from where they are to where they want to be.

For Ameli, advancing opportunities for women and girls is a priority both professionally and personally. Through her successes and accolades she hopes to instill self-belief in young women and girls who come from different parts of the world, who may have an accent, a different look or way of dressing. Because of that, they might think theres no room for them. But I say there is room. I hope more companies will see diversity at all levels as one our countrys most amazing assets that can drive us to the top while we touch lives and positively impact our communities and society all around.

About Belcorp USA

Belcorp International, Ltd. is a private, multi-brand, international corporation with over 45 years of experience in developing and selling prestige beauty products in skin care, fragrance, makeup, body care and hair care through a network of more than 938,000 Independent Distributors across the Americas. It is the 10th largest direct selling company in the world conducting business in 16 countries. Established in 2005, Belcorp USA is a wholly-owned subsidiary that sells beauty products in the United States under the L'Bel brand, which are available both online and through a large network of Independent Beauty Advisors nationwide. Products can be purchased online at http://www.lbelusa.com or by calling 800.922.LBEL(5235).

Sources:

Asia-Pacific Economic Cooperation (APEC) High-Level Policy Dialogue on Women and the Economy, September 2011, San Francisco, CA Secretary of State Hillary Rodham Clinton

Goldman Sachs, increase of Americas GDP by 9% (multiple online sources including Forbes.com)

McKinsey Global Institute, 2012, Is There a Payoff From Top-team Diversity? By: Thomas Barta, Makus Kleiner, Tilo Neumann