Report: Twin Cities Area Continues To Be A Medical Device Hot Spot.

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From Minnesota, the Minneapolis Star Tribune (4/10, Moore) reports that "the Twin Cities' cluster of medical device and life-sciences companies slipped a notch in 2012, but the area continues its stronghold as a medical device hot spot, according a recently released report." The report, put together by the firm Jones Lang LaSalle, did not specify why Minneapolis-St. Paul went from eighth to ninth place. Instead, it measured "employment in high-tech research and in the hospital/medical fields, the number of life sciences establishments, and the prevalence of National Institutes of Health (NIH) and venture capital funding." The Star Tribune points out that biotechnology and pharmaceutical companies are considered under the life-sciences category in the report, as well as medical device companies. While the Twin Cities has the latter (Medtronic, St. Jude Medical), it lacks the former.

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

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iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

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Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044 Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

Aggressive Tactics Used To Market High-Tech Medical Devices Examined.

On the front of its Science Times section, the New York Times (3/26, D1, Rabin, Subscription Publication) reports in an investigatory piece, "Internal company e-mails, provided to The New York Times...offer a glimpse into the aggressive tactics used to market high-tech medical devices and raise questions about the quality of training provided to doctors before they use new equipment on patients." For example, according to the Times, "the Food and Drug Administration allowed the sale of the da Vinci [Surgical] system in 2000 under a controversial process called 'premarket notification,' often used to bring medical devices to market without the rigorous trials of safety and efficacy typically required of new drugs." But, "when devices are brought to market this way, the FDA 'cannot require training programs as a condition of clearance,' said Synim Rivers, an agency spokeswoman."


Subscribe to the DIA Daily.View archives.
iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044
Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

 

What Lies Ahead for 2013?

DIA's first annual What Lies Ahead? report, provides expert insight into the year ahead for pharmaceuticals, biotechnology, and the product development of medical devices.

With thought leaders from industry and academia asked to choose the trends they foresee shaping the world of medical product development in 2013 most agreed that the number one trend for this year will be “new models of innovation.” Based on the report, it is highly anticipated that industry will focus on collaboration and partnerships which are becoming the new norm for therapeutic research and development as companies look to capitalize on innovations outside their own walls. The report points to shrinking industry R&D budgets as being a motivator for such partnerships. The desire to reduce the time to market for urgently needed medicines and to avoid needlessly exposing patients to previously failed approaches were highlighted as strong motivators as well.

Susan Cantrell, Director, North America at DIA said, “We are excited to provide insights into where the industry is heading each year and what may continue to grow in importance over the next few years. These projections of the future landscape can be valuable to companies as they strategize to successfully meet the ever-changing needs of the marketplace.”

The study shows expectations of 2013 are that of the continued strengthening of consumer/patient empowerment (2^nd most expected trend), a focus on unmet medical needs as the driver for innovations, and growing regulatory cooperation and convergence across multiple regions.

“While this study is specific to North America, and the United States in particular, as the global forum for therapeutic innovation and regulatory science we anticipate it being useful on a worldwide scale,” said Cantrell.

Therapeutic Innovation & Regulatory Science in 2013

1. New Models of Innovation.

2. The Continued Rise of Patient/Consumer Empowerment: the Importance of Patient/Consumer Engagement.

3. Learning How to Utilize Big Data.

4. Achieving Market Access is the New Goal, and Value Is a Key Driver.

5. Regulatory Cooperation and Convergence.

6. Personalized Medicine/Tailored Therapies and Companion Diagnostics.

7. An Explosion of Mobile Health Applications.

8. Continued Importance of Global Markets.*

9. Clinical Trial Data Transparency.*

10. Growing Ability to Make Meaningful Benefit–Risk Assessments.*

11. Laser Focus on Unmet Medical Needs.*

*Trends 8-11 each received the same number of votes for inclusion in the “Top 10” trends.

12. The Era of Data Standardization Is Here.

To obtain a copy of the study or to interview a respondent, please contact Eric Rosen at Eric.Rosen@diahome.org or at +1.215.290-9153.
- See more at: http://www.diahome.org/en/News-and-Publications/Newsroom/What-Lies-Ahead-in-2013.aspx?_id=DDD6EB0B232743E691EF5C3AE65D9F42&_z=z#sthash.MK9eJL9M.dpuf

FDA / CDRH 2013 Strategic Priorities released

Link to: CDRH 2013 Strategic Priorities

The Center for Devices and Radiological Health's (CDRH, the Center) 2013 Strategic Priorities continue and expand upon the work we first started three years ago to reset the direction of the Center towards smart regulation – protecting public health by assuring that devices that enter and remain on the U.S. market are safe and effective, and promoting public health by facilitating device innovation. However, the structure of this year's Strategic Priorities has been re-organized to align with CDRH's Vision, which, along with our Mission and Shared Values, immediately follow this Introduction. You will note that our Vision begins with the word Patients. We intentionally began our Vision with this word because what is at the heart of what we do and what we truly are about is saving the lives, improving the health and enhancing the quality of life of patients and those who one day will or would have been patients.

Although we have re-aligned our Strategic Priorities to support the achievement of our Vision, you will see that the objectives of our 2010-2012 Strategic Priorities² (such as fully implementing a total product life cycle approach) are encompassed within our 2013 plan. In addition, we have kept our earlier Strategic Priority of Strengthening Our Workforce and Workplace in the 2013 plan, consistent with the Center's Shared Value of Our People. A vibrant workforce and workplace are essential to achieving our Mission and Vision.

The primary purpose of CDRH's 2013 Strategic Priorities is to inform the public of some of the most important actions we are committing to implement this year to better understand the direction the Center is heading in and what to expect from us this year. It is not intended as a comprehensive blueprint of every action the Center may take in the coming months.

Lastly, in July 2012, Congress enacted the Food and Drug Administration Safety and Improvement Act (FDASIA)³, which includes reauthorization of the medical device user fee program⁴ and other device-related provisions. We consider implementation of FDASIA to be a top priority for CDRH. Therefore, as a well understood priority, we will implement or begin to implement all of the device-related provisions of FDASIA this year. However, because the FDA has provided a separate mechanism to inform the public of its efforts to implement FDASIA, we have generally not included actions specifically directed at implementing FDASIA in our 2013 Strategic Priorities.

Link to: CDRH 2013 Strategic Priorities

Department of Health and Human Services - FDA - Medical Devices; Custom Devices; Request for Comments

[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Notices]
[Page 69488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28042]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1045]


Medical Devices; Custom Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration Safety and Innovation Act 
(FDASIA), which was signed into law on July 9, 2012, amended the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Food and Drug 
Administration (FDA) is in the process of developing an implementation 
strategy and policy for the custom device exemption criteria in the 
FD&C Act amended by FDASIA. FDA is seeking information on appropriate 
uses of the custom device exemption.

DATES: Submit either electronic or written comments by January 18, 
2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville MD 20852.

FOR FURTHER INFORMATION CONTACT: Bryan Benesch, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3424, Silver Spring, MD 20993-0002, 301-796-5506.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 520(b) of the FD&C Act (21 U.S.C. 360j(b), as amended by 
section 617 of FDASIA (Pub. L. 112-144), sets forth the requirements 
that must be met in order for a device to qualify for a custom device 
exemption (Ref. 1). Section 520(b) of the FD&C Act exempts ``custom 
devices'' from performance standard or premarket approval requirements 
under sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e), 
if these devices meet the enumerated statutory requirements, including, 
among others, the following for each device: (1) Is ``created or 
modified in order to comply with the order of an individual physician 
or dentist (or any other specially qualified person designated under 
regulations promulgated by the Secretary after an opportunity for an 
oral hearing)''; (2) must not be ``generally available in the United 
States in finished form through labeling or advertising by the 
manufacturer, importer, or distributor for commercial distribution''; 
(3) must be for the purpose of treating a ``unique pathology or 
physiological condition that no other device is domestically available 
to treat''; and (4) must be manufactured for the ``special needs of 
such physician or dentist (or other specially qualified person so 
designated) in the course of the professional practice of the physician 
or dentist (or other specially qualified person so designated)'' or by 
an individual patient named in such order.
    In addition to these new requirements for establishing a custom 
device, manufacturers will have limitations for use of a custom device 
only for the purpose of treating a ``sufficiently rare condition, such 
that conducting clinical investigations on such device would be 
impracticable'' and production of the device must be limited to no more 
than five units per year of a particular device type. Lastly, 
manufacturers will be required to submit an annual report explaining 
their use of the custom device exemption under section 617 of FDASIA.
    FDA is seeking information on and examples of appropriate uses of 
the custom device exemption identified in section 520(b) of the FD&C 
Act. FDA encourages all stakeholders, including patients, physicians, 
dentists, and manufacturers, to submit comments on the appropriate use 
of this statutory provision.
    FDA is particularly interested in receiving information relating 
to:
    1. Input from patients, manufacturers, dentists, or physicians on 
where use of the custom device exemption is appropriate.
    2. Specific instances where manufacturers, dentists, or physicians 
have used, would have liked to use, or plan to use the custom device 
exemption for treatment of a sufficiently rare condition.
    3. Product areas other than orthopedic and dental devices where the 
custom device exemption may be useful.
    4. The type of information manufacturers intend to require a 
physician, dentist, or other qualified person to submit to them when 
ordering a custom device.
    5. How often a custom device is ordered due to unusual anatomical 
features of the individual physician/dentist, or due to a unique need 
in the physician's/dentist's practice not shared by health 
professionals of the same specialty (i.e., a special need of a 
physician or dentist).
    This notice provides the first opportunity for the public to 
comment on these issues. The public will have a second opportunity to 
provide input when the Agency announces the availability of a draft 
guidance document and a draft regulation for implementing section 
520(b) of the FD&C Act.

II. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and are 
available electronically at http://www.regulations.gov.
    1. The Food and Drug Administration Safety and Innovation Act, 
available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm.

    Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28042 Filed 11-16-12; 8:45 am]
BILLING CODE 4160-01-P

Recycle, reduce, reuse: Americans’ heart devices reimplanted safely in India, from MedCity News

NEW YORK (Reuters Health) - U.S. patients' used heart devices can be safely implanted in seriously ill heart disease patients in the developing world, a study out Monday suggests.

"These devices did work well. They delivered appropriate shocks and saved lives," said lead researcher Dr. Behzad B. Pavri, of Thomas Jefferson University Hospital in Philadelphia.
The devices, known as implantable cardioverter defibrillators (ICDs), automatically deliver potentially life-saving electrical shocks to the heart in people at high risk of cardiac arrest. But in the developing world, few people have the money to afford the cost - about $5,000 in the U.S. for pacemakers, and four times that for ICDs.

A few studies have already shown that it's possible to reuse pacemakers, devices that use electrical pulses to the heart to keep a normal heartbeat.

for complete article: Recycle, reduce, reuse: Americans’ heart devices reimplanted safely in India

DIA2012 - 49th Annual Meeting, June 24-28, Philadelphia

Wendy Kovitz 4 Days. 22 Tracks. 500+ Exhibitors. 7,500+ Attendees. Join more than 7,500 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products to unlock the innovation needed to expand global access to effective and affordable patient care. Register Online or Download Registration Form by May 18 to be Included on the Advance Attendee List! DIA 2012 Mobile Apps Now Available on Android, iPhone, iPad, and Mobile Web! During the months leading up to the DIA 2012 Annual Meeting, everyone, whether registered or not, can access the most up-to-date event content including: Important announcements about new speakers, sessions, and networking opportunities Event preview materials List of exhibiting companies And more! Download. Android. Download. iPhone & iPad Download. Mobile Web Stay Informed...Opt In and update your email preferences. STAY CONNECTED » My DIA » About Membership » Get Involved » Follow DIA       DIA 2012 Annual Meeting Highlights: 22 Tracks featuring 270+ Educational Opportunities, including: Standards for Patients: Collaborations to Innovate Therapy Development A Challenge for the Industry: What Will it Take for a Sponsor to Use EHRs With a Regulated Research Protocol? Discussion with Former Center for Devices and Radiological Health (CDRH) Management Collaborative Partnerships in Drug Development: An Executive Roundtable Discussion Partnering for Impact in Global Health Implementation of the Physician Payments Sunshine Act: Now What? Meta-collaborations: A Call to Action DIA 2012 Executive Session: Pioneering Partnerships India Regulatory Town Hall List of Special Topics NEW TRACK! White Paper Showcase featuring: Philips Respironics: Value of Actigraphy in Clinical Trials Cape Code Clinical Research, Inc.: Enabling Remote Monitoring in Clinical Trials for Sponsors and Sites DAC Patient Recruitment Services: The Unique Relationship Between Global Patient Recruitment and Translation Management Quintiles: The New Health Report 2012: Rethinking the Risk Equation in Biopharmaceutical Development and Delivery Microsystems: Raising the Bar for Regulatory Submission Document Quality- A Collaborative, Transitional Approach Kelly Services Inc.: Free Agency is Here- Exploring Workforce Impact on Clinical Outsourcing Aptiv Solutions: Implementation of Adaptive Clinical Trials 20+ Tutorials Innovative Theater Presentations 500+ Exhibiting Companies 6 months FREE access to all audio-synchronized presentations   Program Overview   Register Online

Nearly 300 Medical Device, Healthcare Professionals Attend First National Conference on Value-driven Engineering, from PR Newswire

press release

April 25, 2012, 3:02 p.m. EDT

AKRON, Ohio, April 25, 2012 /PRNewswire via COMTEX/ -- Researchers, health care engineers and medical device experts gathered this week for the inaugural National Conference on Value-driven Engineering to Improve Medical Innovation for U.S. Global Competitiveness assembled by the Austen BioInnovation Institute in Akron (ABIA) and sponsored by the Ewing Marion Kauffman Foundation. Experts from some of the nation's leading biomedical device engineering companies and research institutions advised the U.S. healthcare device industry to accelerate innovation by changing their approach to research and development.

For nearly a year, members of a national steering committee, led by ABIA, have promoted Value-driven Engineering as a strategy for medical device development that embraces simplicity while advancing quality and improved, patient-centered care as a way to promote innovation, value and efficiency across the healthcare system. The process marries American creativity and innovation that aims to advance U.S. medical device development past the trends of other countries like China, India and Brazil who are focused on frugal and reverse engineering.

Different from frugal engineering, which focuses on reduced manufacturing costs, Value-driven Engineering focuses on improved clinical utility and reduced complexity to the end user, as well as value and cost efficiency across the entire healthcare continuum. The Value-driven Engineering approach is critical to the U.S. medical device sector's ability to remain a global leader, said Dr. Frank Douglas, president and CEO of ABIA, a unique collaboration of leading Akron institutions.

"We must, as an industry, adopt new approaches to understand 'value' and how it should be measured to accelerate innovation and improve patient care," Dr. Douglas, who chairs the Value-driven Engineering national initiative, said. "This conference attracted top medical researchers and engineering talent. It is another valuable step down the path of widespread acceptance of Value-driven Engineering principles in the biomedical device industry."

During the two-day conference, attendees heard from:

Dr. Thomas Fogarty, Fogarty Institute for Innovation: "Value Collaboration between Physicians and Engineers"

Dr. Robert E. Litan, Ewing Marion Kauffman Foundation: "The Importance of Harnessing Bid Data with Respect to Defining the Value Equation"

Mike Hess, Medtronic Inc.: "What Value-driven Engineering Means to the Medical Device Industry"

Dr. William J. Heetderks, National Institutes of Health: "The Role of Federal Funding Agencies in the Adoption of Value-driven Engineering"

Dr. DeVon W. Griffin, NASA Glenn Research Center: "NASA's Need for Less Complex Medical Devices"

Megan Moynahan, U.S. Food and Drug Administration: "Regulatory Innovation Pathway"

Dr. Marc S. Penn, FACC, Summa Health System: "Clinical Utility to the Clinician"

Stephen P. Welby, U.S. Department of Defense: "DOD's Value Engineering Initiative"

One of the conference's highlights was presentation by students of real-world Value-driven Engineering project, including:

A team of students from Johns Hopkins University Center for Bioengineering Innovation and Design, who won the conference grand prize for case studies, created an ultraportable, easy-to-use fetal heart rate monitor. Every year, approximately 1 million stillbirths occur and nearly 99% of these newborn deaths are in developing countries. One major cause is the lack of monitoring of the baby's status during labor. The student team's battery-powered device uses a portable microphone with a modified attachment and a smartphone to display fetal rates prior to delivery. Though Doppler monitoring devices have been proven to be more effective, they are not widely available due to their prohibitively high cost.

A team studying at Virginia Commonwealth University, who helped develop an easy to assemble operating room table. The affordable, easy-to-use table will improve healthcare in surgical rooms around the globe.

A lower-cost, high-value and quality medical device developed in collaboration with Johns Hopkins School of Medicine that can save the lives of babies with an ailment called Hypoxic-Ischemic Encephalopathy (HIE), an asphyxial event which occurs in three of 1,000 live births and causes death to 10% to 60% of affected infants. The device essentially is a "pot-to-pot" method, where a larger clay pot lined with nearly 5 cm of sand contains a smaller pot, in which a patient will be placed for therapeutic cooling. The experimental results indicate that the "Cooling Cure" is more efficient at cooling than the existing technology. In addition, the clay pot device costs $100 to build, which is less than 1% of the cost of the state-of-the-art device.

The conference was organized by the members of the National Value-driven Engineering for U.S. Global Competitiveness Steering Committee, which includes Harvard-Massachusetts Institute of Technology's Dr. Martha Gray; Johns Hopkins University's Dr. Soumyadipta Acharya, Dr. A. Jay Khanna and Dr. Youseph Yazdi; Medtronic's Mike Hess; Orthopaedic Research Laboratories' Dr. A. Seth Greenwald and Jonathan F.I. Greenwald; The University of Akron's Dr. Ali Dhinojwala; and ABIA's Dr. Brian L. Davis and Dr. Stephen D. Fening, the 2012 conference chair.

Please visit www.abiakron.org/vde for details.

About the Austen BioInnovation Institute in Akron

Based in Akron, Ohio, the Austen BioInnovation Institute in Akron--a unique collaboration of Akron Children's Hospital, Akron General Health System, Northeast Ohio Medical University, Summa Health System, The University of Akron and The John S. and James L. Knight Foundation--is focused on patient-centered innovation and commercialization at the intersection of biomaterials and medicine. To learn more about the Austen BioInnovation Institute in Akron, please visit www.abiakron.org .

Media Contact:Scott Rainone, 330-572-7581 (o), srainone@abiakron.org

SOURCE Austen BioInnovation Institute in Akron

Copyright (C) 2012 PR Newswire. All rights reserved

Students build wiki of medical devices designed for low-income countries, MedicalExpress.com

Students build wiki of medical devices designed for low-income countries

April 24, 2012 By Nicole Casal Moore

A human powered nebulizer could provide breathing treatments to asthma patients in parts of the world without reliable electricity. The device, developed at Marquette University, is one of the more than 100 technologies University of Michigan students have cataloged in a new wiki of medical devices for resource-limited settings. Credit: courtesy of Marquette University.

(Medical Xpress) -- In parts of the world without reliable electricity, a pedal-powered nebulizer could provide life-saving asthma treatments. Small wax-filled sleeping bags could keep premature infants warm. A salad spinner centrifuge for blood samples could help clinicians diagnose anemia.

 

University of Michigan researchers have cataloged more than 100 such technologies in a new wiki of medical devices designed for resource-limited settings. The Global Health Medical Device Compendium, an open-source inventory, is hosted by the popular appropriate technology wiki Appropedia. It is expected to serve as an important communication vehicle for end users, non-governmental organizations, researchers and others to help advance such technologies.

Developing nations import roughly 90 percent of their medical technologies from higher-income countries. But systems tested in controlled settings in high tech hospitals often don't work as intended in places where continuous electricity, replacement parts, clean water, and appropriate training aren't always accessible.

In the new database, each device's entry outlines the problem the technology aims to solve and includes links to related peer-reviewed studies. Visitors can search by disease, device status, and the region where the device has been tested or targeted. They can comment on a device's usefulness. And, because the database is a wiki, they can update information and add technologies.

"We've created an active, dynamic compendium of devices specifically designed for resource-limited settings. It will help people see what is possible and what is in the pipeline," said Kathleen Sienko, an assistant professor of mechanical and biomedical engineering who spearheaded the project.

Rachel Strauss (left) and Megan Bland, master's students in biomedical engineering developed an inexpensive, low-tech child car seat for use in developing nations where car seats are not mandated or even commonly used. The car seat one of the more than 100 technologies University of Michigan students have cataloged in a new wiki of medical devices for resource-limited settings. Credit: Marcin Szczepanski

The endeavor began in 2010 in Sienko's Design for Global Health engineering course. When she found that a suitable textbook for the course did not exist, she turned the students into global health researchers. Over the course of the semester, they examined 600 health-related technologies and even traveled to Nicaragua to observe medical care there. During the past two years, other students have whittled down this information and cataloged it. Design science doctoral student Amir Sabet, who took Sienko's class, led the Appropedia project.

more... http://medicalxpress.com/news/2012-04-students-wiki-medical-devices-low-income.html
More information: The new database can be found at http://www.apprope … h_Compendium

Pharma, Medical Devices, Regulatory issues in China - learning opportunities at DIA2012

 

DIA 2012 Collaborate to Innovate 48th Annual Meeting
June 24-28, 2012
Philadelphia, PA
Pennsylvania Convention Center

Regulatory Roundtable on Biosimilars

This forum will explore the challenges of biosimilars in light of the recent policy developments in the US, EU, and Asia. Participants will hear from a roundtable of authorities on how to address biosimilars and the opportunities for the future.

Tracks: Track 08 - Regulatory Affairs and Submissions                                           

Day: Monday, Jun, 25

Time: 1:30PM - 3:00PM

 

Challenges and Opportunities for Drug Development in China

This session will provide enriched discussions on the current status and unique challenges for drug development in China, the increasing role of China in global development of drug products, and opportunities for China's SFDA and pharmaceutical industry to improve, succeed, and excel. This session is hosted by Sino-American Pharmaceutical Professionals Association (SAPA).

Tracks: Track 08 - Regulatory Affairs and Submissions                                           
Day: Monday, Jun, 25

Time: 1:30PM - 3:00PM 

 

Pharma R&D in Asia: Opportunities, Models, and Challenges

The center of the global pharmaceutical industry is shifting. Part of that shift is also the outsourcing of pharma R&D to Asia by various means and models. This symposium will highlight that strategic move in general but also discuss a clinical CRO alliance model and, furthermore, zoom into the Chinese clinical CRO business.

Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies

Day: Monday, Jun, 25

Time: 3:30PM - 5:00PM 

Optimizing Performance in Outsourced Projects in China and Other Asian Countries

Outsourcing and participation in clinical trials in China and other Asian countries have expanded dramatically in recent years. Many global companies now have ongoing or newly initiated collaboration with their local subsidiaries or selected CRO in the Asia-Pacific region. Along with the apparent advantages and fast-paced development, the global and local project teams often face various unforeseen challenges that may result from the cultural differences leading to misalignment and frustration on both sides. In the sponsor-CRO collaboration, these variances include different expectations and project management practices ranging from project planning, risk management, and communication. This session will discuss the key differences and challenges of project management practice through case studies, and identify better ways to optimize the project performance internally within the matrix environment or when collaborating with a CRO.

Tracks: Track 02 - Project/Portfolio Management and Strategic Planning

Day: Tuesday, Jun, 26

Time: 10:00AM - 11:30AM 

 

SFDA Town Hall

Representatives from the State Food and Drug Administration, P.R. China will provide updates on initiatives, guidances, and regulations in their country, and the audience will have an opportunity to address the esteemed panel.

Tracks: Track 17 - Global Regulatory

Day: Tuesday, Jun, 26

Time: 1:30PM - 3:00PM 

 

Current Advancement of Regulatory Reform for Medical Devices in Asia Pacific and Its Strategic Impact

The symposium will discuss the current advancement of regulatory pathway, the reform of related regulations, and the impact on industry. The harmonization effort initiated by Global Harmonization Task Force (GHTF), Asian Harmonization Working Party (AHWP), and the Regional Harmonization Steering Committee of APEC Life Science Forum will be discussed. Experience will be shared from industrial and regulatory perspectives.

Tracks: Track 09 - Medical Diagnostics and Devices

Day: Wednesday, Jun, 27

Time: 10:00AM - 11:30AM 

 

#40: Understanding and Navigating the Regulatory System in China

This tutorial will provide an overview of the regulatory system in China, including the agencies and institutions at the central government and provincial levels, as well as their roles and responsibilities. Various regulations for product registration, clinical trials, and safety reporting will be presented, and the regulatory pathways and strategic considerations for clinical trial and marketing applications will be discussed. A step-by-step roadmap of how to navigate the regulatory system in China for clinical trial approval and product registration will also be discussed. This discussion will include key points to consider, strategies, and tactics.

Credits: IACET

Tracks: Track 08 - Regulatory Affairs and Submissions

Day: Sunday, Jun, 24

Time: 9:00AM - 5:00PM

 

Discussion with Former Center for Devices and Radiological Health (CDRH) Management, DIA2012

Discussion with Former Center for Devices and Radiological Health (CDRH) Management

Monday, June 25, 2012
3:30 pm- 5:00PM ET

Join this moderated panel discussion with former CDRH Directors and Management. This interactive session will focus on the evolving face of medical devices, the interface between drugs and devices, new challenges and opportunities, and the changing regulatory landscape.

Chair

Daniel G. Schultz, MD
Senior Vice President, Medical Devices & Combination Products, Greenleaf Health, LLC

Speakers

David W. Feigal, JR, MD, MPH
Partner
NDA Partners, LLC

Donna-Bea Tillman, PhD
Senior Consultant
Biologics Consulting Group

Timothy Alan Ulatowski, MS
Director, Medical Devices
Becker & Associates Consulting, Inc.
United States

UNC’s Emerging Company Showcase highlights new healthcare technologies, from MedCityNews

Innovation is brewing in Chapel Hill, North Carolina.
The University of North Carolina at Chapel Hill held its annual Emerging Company Showcase this week, an event that gives companies spun out of the university the chance to strut their stuff in an eight minute presentation before an audience of researchers, entrepreneurs and potential investors or partners.

This year’s showcase featured a total of 14 companies; eight companies in the scientific track, which encompassed technologies that have applications in healthcare or scientific work. Many of the companies have received support from Carolina KickStart, a UNC program funded by the North Carolina Translational and Clinical Sciences (TraCS) Institute. Carolina KickStart’s role is to provide support UNC faculty members who are looking to commercialize new biomedical technologies. Here are the scientific companies that presented at the event.

Augment Medical: Augment Medical aims to improve the ability of disabled patients to use the nurse call system. The Joint Commission, a hospital certification and accreditation body, has called for the hospitals to make the nurse call system accessible to all patients regardless of cognitive or physical ability by the third quarter of 2012. On Augment’s system, raising an eyebrow is all it takes to activate a facial sensor that triggers a call to the nurse. Future versions will have eye-tracking capabilities that bring the calling function to a tablet computer. The company was founded by graduate students in the joint departments of biomedical engineering at North Carolina State University and UNC. “We want to be the standard of care for The Joint Commission,” said Timothy Martin, Augment’s president and co-founder. The company last year was awarded a $7,000 grant from NC TraCS. The company is looking to raise $750,000 from investors or strategic partners.

GeneCentric Diagnostics: Taking a personalized medicine approach to cancer treatment, GeneCentric is developing new diagnostics to match a drug to individual patients in order to maximize the efficacy of cancer treatments and reduce adverse events. GeneCentric’s initial focus is nonsmall cell lung cancer, or NSCLC. The company’s diagnostic tests for the subtype of NSCLC, which is important because some currently approved drugs as well as drugs still in development work differently depending on the subtype. “We wouldn’t know which drug would work if we didn’t have the right diagnostic,” said Myla Lai-Goldman, CEO and co-founder. The company is based on research from Dr. Neil Hayes and Chuck Perou of UNC.GeneCentric raised $250,000 from Hatteras Venture Partners last year.

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FDA Finalizes Benefit-Risk Determination Methodology for Certain Medical Devices

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FDA Finalizes Benefit-Risk Determination Methodology for Certain Medical DevicesIn an attempt to improve the predictability, consistency and transparency of the medical device review process, the U.S. Food and Drug Administration (FDA) released final guidance describing the principal factors the agency will consider when making benefit-risk determinations during the premarket approval and de novo classification processes, respectively.
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Related Event:  Clinical Data Quality Summit  |  April 24-25 | PhiladelphiaThe Clinical Quality Data Summit is a mix of plenary and breakout sessions with specific tracks on various clinical quality data interest areas. You will learn ways to utilize new tools and technologies and how to partner with different research professionals to operate more efficiently and contain costs. Case studies, a Q&A, and tabletop exhibits round out the summit.
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