Professional Documents
Culture Documents
CIBR Advocate 7
CIBR Advocate 7
CIBR Advocate 7
Paul Tuma diagnosed with lung cancer utilizing ty, University of California, San Die-
Regional Vice President go, and the University of Pennsylva-
Nuance Communications, Inc.
Nuance Healthcare Division
In this Issue nia.
…………………………
CIBR
1029 Vermont Avenue, NW, Suite 505
Medical Technology Event—Page 1 NIH-FDA Meeting—Page 5 Upcoming Events—Page 7
Washington, DC 20005 Photos and Feedback—Page 2-3 Fibroid Relief—Page 6 New Members—Page 8
Email: rcruea@imagingcoaliion.org
Radiation Exposure Initiative—Page 4 NIH Hearing—Page 7
Ph: 202.347.5872 Fax: 202.347.5876
July 2010 Page 2
Former Democratic Leader Dick Gephardt Representative Jim Gerlach (R-PA) stops Former Democratic Leader Dick
is shown how MR-guided Focused Ultra- by the Siemens Healthcare PET display. Gephardt with CIBR President, Renée
sound is used to treat fibroids. Cruea.
―It was a pleasure to
have had the opportunity
to participate in the first-
ever Congressional Med-
ical Technology Exhibi-
tion on June 24th, 2010.
Medical innovation is key
to both economic growth
and improved treatment
and cures. The federal
government has an im-
portant role to play in CIBR members at the Fuji 3D Digital CIBR Chair Dr. Bill Bradley at the GE dis- Congressional staff view the Fuji 3D
Mammography display. play with Dr. Don Rucker of Siemens. Digital Mammography display.
developing policies to
promote and facilitate
medical innovation. Medical Technology Exhibit Feedback
I’m sure that enabling
―The exhibition was a unique and challenging opportunity to explain to Congressional representatives and their staff who we are
Members of Congress
and what we do in radiology. This event was a novel way to deliver our message.‖
and their staff to see -R. Nick Bryan, MD, PhD, Chair of Radiology, University of Pennsylvania School of Medicine
firsthand such an impres-
sive display of medical ―The opportunity for CIBR to show its face as collectively representing health advocacy and medical innovation was powerful. It
technology vividly under- was also an opportunity for radiology physician leaders and imaging device personnel to confront both common and divergent
scored the value of medi- goals in the current environment.‖
cal innovation and the -Carolyn C. Meltzer, MD, Chair of Radiology, Emory University School of Medicine
imperative to foster it.‖
"It was a pleasure for Fujifilm to participate in this inaugural event. We were excited by the enthusiasm of Members of Congress
-Former Democratic and their staff as they participated in the demonstration of our 3D Digital Mammography technology and look forward to attending
Leader Dick Gephardt, future events."
President & CEO, -Andrew F. Vandergrift, National Marketing Manager, FUJIFILM Medical Systems, USA
Gephardt Government ―Toshiba was pleased to participate in this important event representing CT. Toshiba, along with many others in the industry, is
Affairs committed to continuing to develop advanced low dose CT technology to improve patient safety without sacrificing diagnostic
quality. Recent innovations in CT technology are dramatically reducing radiation dose for patients, making CT imaging safer than
ever before.‖
-Rich Mather, PhD, Toshiba Medical Research Institute
―The introduction of electronic Decision Support, as it applies to clinician ordering of high-tech radiology exams, will enable the
automated use of appropriateness criteria resulting in improved clinical outcomes for patients at a lower overall cost. This event
was an incredible opportunity to show this type of IT to legislative staff and Members of Congress.‖
-Paul Tuma, Nuance Communications, Inc., Nuance Healthcare Division
―It was an absolute delight to spend time with you all and to see the incredible gains that technology and people deliver to improve
lives and outcomes. It was particularly fantastic to see Dr. Seltzer (Massachusetts’ own!) and to talk with all of the partners who
work together on behalf of your organization and the people who you serve, including the patients.‖
-Diego M. Sanchez, Health Legislative Assistant to Congressman Barney Frank (D-MA)
July 2010 Page 4
On June 2 the Coalition for Imaging What mechanisms for the sup- In addition, CIBR suggested that the
and Bioengineering Research port of regulatory science re- NIH-FDA Joint Leadership Council,
(CIBR) attended the first Stakehold- search would be most effective working through the NIH, the Bi-
ers Meeting held by the National and efficient in addressing omarkers Consortium, and academ-
Institutes of Health (NIH) and Food pressing priority areas in the ia, undertake a focused and coordi-
and Drug Administration (FDA) Joint translational pipeline? nated research effort to illuminate
Leadership Council. The Council’s the process elements of a biomarker
primary goal is to ensure that regula- What are the priority issues that regulatory pathway and create a
tory considerations form an integral currently need to be addressed, framework that will encourage bi- ―CIBR and ARR will
component of biomedical research e.g. clinical trial design, end- omarker development, validation, continue submitting
planning, and that the latest science point selection and qualifica- approval and dissemination. In con- testimony to the
is integrated into the regulatory re- tion, bioinformatics needs, to cert with this effort, FDA would de- NIH, FDA, and
view process. Chaired by Dr. Fran- inform on the regulatory review velop appropriate regulations that other appropriate
cis Collins, NIH Director, and Dr. process? recognize the science, logistics and agencies with the
Margaret Hamburg, FDA Commis- economics relevant to biomarkers. aim of raising the
sioner, the Council consists of six In response to the first question, The combined result would be the profile of medical
other senior representatives from CIBR recommended elevating the establishment of a scientific and imaging to benefit
each of the two agencies. urgency of developing a regulatory regulatory pathway for the develop- patient care.‖
pathway to accelerate the rapid and ment and commercialization of bi-
The purpose of the meeting was to efficient clinical translation of diag- omarkers, analogous to the pathway -Keith Kerneklian,
elicit public comments on how the nostic and therapeutic biomarkers. for generic drugs and the pathway Legislative & Advo-
NIH and FDA could better collabo- CIBR testified that the NIH and FDA for ―biosimilars‖ recently authorized cacy Manager,
rate to accelerate technologies to can effectively promote promising in the amendments to the Public CIBR
prevent, diagnose, and treat diseas- new diagnostic and therapeutic tech- Health Service Act signed by Presi-
es. Consequently, the Joint Leader- nological advances through coordi- dent Obama earlier this year.
ship Council posed the following nated research and regulatory ef-
questions for comments: forts that bridge the gap between Furthermore, the Academy of Radi-
discoveries and medical products. ology Research (ARR) submitted
written comments to the second
question, focusing on the need to
manage and reduce the amount of
ionizing radiation that patients re-
ceive from diagnostic imaging. ARR
believes that a coordinated program
of research and regulatory develop-
ment would have a significant im-
pact on decreasing radiation expo-
sure for the benefit of patients and
the United States healthcare sys-
tem.
One of CIBR’s newest patient advocacy members, Fibroid Relief, is dedicated to supporting women suffering from
uterine fibroids who seek non-invasive treatment alternatives. Fibroid Relief is committed to raising awareness about
the benefits of Focused Ultrasound and will work tirelessly to promote patient access through educational and advo-
cacy activities. Fibroid Relief’s vision is to put the power of choice in the hands of uterine fibroid sufferers.
Medical imaging is essential to treating uterine fibroids. Therefore, since its founding in 2008, Fibroid Relief has
aimed to educate women about the availability of MR-guided Focused Ultrasound treatments for uterine fibroids. To
―I appreciate the opportunity date, 6,000 women worldwide have received this non-invasive treatment option.
to join CIBR just at the right
time! The Medical Technol- Uterine fibroids are common, non-cancerous tumors of the uterus consisting of smooth muscle cells and connective
ogy Exhibit was a great tissue. At least 25 percent of women in the United States have symptoms of uterine fibroids. In fact, about 70 percent
experience to be able to of Caucasian women and more than 80 percent of African-American women have developed fibroids by the time they
provide a patient advocate are 50 years old. Many fibroids go undetected until they become symptomatic.
perspective. Getting our
collective voices heard by Fibroid Relief has touched and improved the lives of thousands of women through its educational and advocacy ac-
Members of Congress is tivities. As Tina Krall, executive director, observes, ―we’re here to raise awareness of the benefits of focused ultra-
never an easy task so when sound and to promote patient access. Our aim is to give women access to information that empowers them to make
these opportunities present sound health decisions.‖
themselves, it makes our
work easier.‖ Hailed as a breakthrough technology, MR-guided Focused Ultrasound integrates the visualization capabilities of
magnetic resonance imaging with the intense energy that is created when multiple waves of high frequency ultra-
-Tina Krall, sound are directed to a treatment site. Highly precise, it can target treatment sites as small as a grain of rice, about
Executive Director, one millimeter in diameter.
Fibroid Relief
The technology is currently approved in Europe and elsewhere for the treatment of uterine fibroids, adenomyosis and
bone metastases. In the U.S., it is approved as a therapy for uterine fibroids. Worldwide, there are 45 treatment cen-
ters using the new technology and 65 research sites investigating its use in other non-invasive procedures, in the
precise delivery of drugs and as an alternative to radiation therapy.
In addition to Fibroid Relief, the Focused Ultrasound Surgery Foundation (FUSF) provides research and fellowship
funding and engages in numerous outreach activities. Its most visible and comprehensive program, the
2nd International Symposium on MR-guided Focused Ultrasound, will be held from October 17-20, 2010 in the Wash-
ington, D.C. area. The meeting will spotlight the latest developments in pre-clinical, clinical and translational research
addressing a wide range of life-threatening and debilitating illnesses, including brain, breast, prostate, bone, pancre-
atic and liver tumors and conditions such as epilepsy, stroke, chronic pain, Parkinson's disease and essential tremor.
Information about the FUSF and the symposium can be found at www.fusfoundation.org.
July 2010 Page 7