Session Highlights at EuroMeeting2013 - 4-6 March in Amsterdam

Session Highlights at the EuroMeeting 2013 Among the packed conference programme of the EuroMeeting are a few sessions, that you definitely don't want to miss. Hot topics, presentations delivered by high level speakers, and the opportunity to discuss current issues with fellow professionals and our special presenters. Opening Plenary: Public/Private Partnerships – Working Together in the Interest of Patients 4 March | 14:00-17:15Public-private partnerships (PPP) are collaborative relationships that transcend national boundaries. Each partnership brings together at least a corporation or an industry association and intergovernmental organisations to achieve a shared health-creating goal on the basis of a mutually agreed division of tasks. The positive aspects and concerns of these initiatives will be discussed. Moderator: Steffen Thirstrup, Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority, Denmark Panelists: Jan Geissler, Director, EUPATI, Belgium Kemal Malik, Head of Global Development, Member of the Bayer HealthCare Executive Committee and Chief Medical Officer, Bayer HealthCare Pharmaceuticals, Germany Pat O’Mahony, Chief Executive, Irish Medicines Board, Ireland Luca Pani, Director General, Italian Medicines Agency (AIFA), Italy Andrzej Rys, Director of Health Systems and Products, European Commission, EU Harpreet Singh, Managing/CSO, Immamics Biotechnologies, Germany Sessions 1803/1804: GCP Hot Topics 5 March | 14:00-17:30 Session Chairs Gabriele Schwarz, Head, GCP Inspection Services, German Federal Institute for Drugs and Medical Devices (BfArM), Germany Beat Widler, Senior Partner, Widler & Schiemann, Switzerland The GCP Hot Topics Sessions that in recent editions of the EuroMeeting have been bringing together regulators, industry, CRO and academia professionals who want to get first hand information on newest trends, has by now become a EuroMeeting tradition. In 2013 the impact of changes and evolutions in technology on the conduct and quality management of clinical trials determine the programme of the GCP Hot Topic session. The focus will be on electronic health records (EHRs) when used as source documents or direct input source into clinical trial databases. As a second topic the session will deal with the challenges presented to sponsors and CROs when clinical trial activities are outsourced. This topic is not new but becomes increasingly a root cause of major and critical inspection findings. The program will be completed by the presentation of the White Paper on protocol violations that has been authored by the GCP SIAC. As in other years the roster of international speakers will involve senior representatives from health authorities, industry and CROs. The audience is invited to actively participate in the panel discussions by bringing examples or challenging statements. Delegates can anonymously submit topic-related questions or cases they would like to be discussed by the panel in advance to the session chairs via the DIA. Session 1805: EMA Roundtable – Scientific Committees United in Diversity 6 March | 9:00-10:30 Session Chair: Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU This roundtable will discuss how the EU Scientific Committees come together and interact at the European Medicines Agency to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public health, while being enriched by the EU’s many different cultures and traditions. Session 1207: Regulatory Town Hall Meeting 6 March | 14:00-15:30 Session Co-Chairs: Guido Rasi, Executive Director, European Medicines Agency, EU and Christa Wirthumer-Hoche, Member CMDh, Deputy Head, Austrian Medicines and Medical Devices Agency (AGES), Austria. At the Town Hall Meeting attendees can put burning questions to experts about these topics: • Latest views on legislative changes • Implementation of the new pharmacovigilance legislation • Transparency • Drug shortages • Decision making • New approaches to licensing Download the full Conference Programme and read about these, and the 110+ other sessions, the exhibition and other activities the EuroMeeting has to offer. If you have any specific questions, please feel free to contact us. Make the most of your EuroMeeting Experience - register for a Pre-Conference Tutorial Monday, 4 March | 09:00-12:30 Read more... Download Advance Programme Register now Exhibiting Opportunities at the 25th Annual EuroMeeting Showcase your company’s products or services to key decision makers The exhibition hall is one of the busiest places at the meeting and provides a unique opportunity to interact with professionals from more than 50 countries working in pharma, devices, government, academia, healthcare delivery and other related occupations, together with representatives from patient organisations and much more. Apply for your Exhibition space today! More information... Download Application Form.... Exhibitor Prospectus Marketing & Hosting Information

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FDA To Play Role In Medical-Device Research Consortium.

 

The AP (12/4) reports that the Food and Drug Administration announced Monday that it will "collaborate with medical device manufacturers on a public-private partnership." The FDA "says it hopes to offer guidance" to the Medical Device Innovation Consortium (MDIC), which was "created by LifeScience Alley, a Minnesota-based industry group" to streamline the "design and testing of medical devices." The AP suggests that the agency's decision to play a role in the new consortium is a response to "criticism from industry and Capitol Hill" about its "overly burdensome review process."

        Reuters (12/4, Kelly) adds that the goal of the nonprofit MDIC is to improve the methods used during the medical-device development process so more products can reach the market faster. Industry members involved in the MDIC include representatives from Abiomed, Becton Dickinson, Boston Scientific, Cyberonics and Medtronic. Reuters quotes FDA Commissioner Dr. Margaret Hamburg as saying, during a press teleconference, that the MDIC "is going to represent a model that will be watched carefully, will be replicated. I know there will be real advances and new approaches that will emerge from it."

        The Minneapolis Star Tribune (12/4, Walsh) adds that Dr. Hamburg noted that many companies "don't have the research budgets to find more effective ways of testing their products." She said the MDIC would "pull information and ideas from industry, government and academia" to ensure "we're applying the best science to the task and bringing together the best minds." The consortium will be "governed by a national board of directors, including industry executives and government leaders."

        According to CQ (12/4, Adams, Subscription Publication), the "partnership will be funded largely by device companies, although the FDA and the Centers for Medicare and Medicaid Services may contribute funding later." Dr. Hamburg called the consortium the "first public-private partnership of its kind in the medical device area" and cited "interest from a wide variety of groups, including members of Congress, for the agency's ability to move forward with the initiative." The MDIC will "invest in projects" that could reduce the time and costs involved in medical-device development. The alliance has not yet decided on "specific projects" to fund but they could "include investments in research to improve computer models or other tools that can test the effects of potential devices." The MDIC is planning to hold its "initial meeting in the first quarter of 2013."

        Modern Healthcare (12/4, Daly, Subscription Publication) adds that the FDA's "support for the initiative may extend to its staff collaborating on partnership-supported research." The FDA's Center for Devices and Radiological Health Director Dr. Jeffrey Shuren said, "By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost."

        The Minneapolis-St. Paul (MN) Business Journal (12/4, Grayson, Subscription Publication) reports that the MDIC "will be led on an interim basis" by Maura Donovan, who recently served as "vice president of therapy research and development" at Fridley, Minnesota-based Medtronic Inc.

        Medscape (12/4, Lowes) says that in addition to the FDA, the CMS and the medical device firms, the MDIC's founding members include LifeScience Alley, the Pew Charitable Trust and the National Organization for Rare Disorders. HealthDay (12/4, Preidt) also covers the new public-private partnership.

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Bristol-Myers Squibb Forms the International Immuno-Oncology Network - from The Burrill Report

VINAY SINGH

The Burrill Report

“The public-private partnerships formed through the collaboration will leverage the intellectual capabilities of an extensive global network.”

Bristol-Myers Squibb has created a new International Immuno-Oncology Network, a collaboration between industry, universities, and research centers from around the world aimed at furthering the scientific understanding of immuno-oncology, or the human immune system’s potential to fight cancer.

In addition to Bristol-Myers Squibb, the collaboration consists of ten academic or cancer-research institutions from around the world including The Netherlands Cancer Institute, Dana-Farber Cancer Institute, The Royal Marsden NHS Foundation Trust, the Institute of Cancer Research, and Johns Hopkins Kimmel Cancer Center.

Collaborations between academia, private research institutions, and Big Pharma has become increasingly common as pharmaceutical companies continue to look outside their own walls to acquire promising new early-stage treatments and try to lessen both the risks and costs of developing such drugs.
http://www.burrillreport.com/article-bristol_myers_squibb_forms_the_international_immuno_oncology_network.html

CDRH Seeks To Expand Public-Private Medical Device Epidemiology Network

FDA hopes the MDEpiNet post-market surveillance program will be fully functional by the end of the year. A May public meeting is planned to catalyze the effort.

CDRH Seeks To Expand Public-Private Medical Device Epidemiology Network Article preview from "The Gray Sheet"- April 9, 2012
FDA plans to reach out to the public at a meeting this May to expand its nascent public-private Medical Device Epidemiology Network and discuss models for the network to improve device surveillance.
The network, also known as MDEpiNet, has an “overall mission to bridge the gaps that we currently have in the evidence for medical devices,” said Danica Marinac-Dabic, director of CDRH’s Division of Epidemiology in the Office of Biometrics and Surveillance, in an interview.

http://www.medicaldevicestoday.com/2012/04/cdrh-seeks-to-expand-public-private-medical-device-epidemiology-network.html