Medgadget.com, a leading medical blog, has announced they are opening up nominations for the 2008 Medical Blog Awards. MedGadget is branded as an internet journal of emerging medical technologies. They have been a media partner on various Q1 events including the upcoming 2009 Health Care New Media Conference. To nominate Q1 Productions or to view who is in the running click here.
The National Institute for Health and Clinical Excellence (NICE) is a leader in medical technology assessment. Assessing the clinical, financial and efficacy of genetic tests, NICE is valuable to hospitals, payers and healthcare consumers. NICE works to supply healthcare providers with evidence-based data and reports that have a significant effect on overall valuation and use of new tests.
Members in Congress have started proposing that the United States adopt the methods of NICE due to high costs, according to the story “British Balance Gain Against the Cost of the Latest Drugs”, released by The New York Times on December 2, 2008. This article states that, “skyrocketing prices for drugs and medical devices have led a growing number of countries to ask the hardest of questions: How much is life worth? For many, NICE has the answer.” NICE is already influencing policies in Austria, Brazil, Colombia and Thailand, according to top health officials. Even middle-income countries, such as Eastern Europe and all over Asia, have been made aware of NICE and are considering setting up similar programs. In Britain, drug and device makers have quietly started to drop prices in order to gain NICE’s approval. ( To Read Full Article Click Here).
At Q1 Productions’ European IVD Regulatory and Reimbursement Conference scheduled for February 16-17, 2009, Sarah Garner, Associate Director, Research and Development for NICE will be speaking. She is planned to provide an explanation of the company’s process in determining a rating in addition to how their findings are communicated to insurance providers and hospitals.
What do you think about the United States adopting NICE’s methods of assessment?
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As the role IVD’s play in pharmaceutical R&D increases, companies are discovering the benefits of developing strategic partnerships for their various therapies.
Has your company partnered with a separately manufactured therapy to gather evidence in clinical studies? Was this clinical evidence beneficial for your use in regulatory approvals or post-marketing studies?
Has your company partnered with a separately manufactured therapy to commercialize a test in conjunction with a therapy? Where did marketing and sales support come from?
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CHICAGO–(BUSINESS WIRE)–On Nov. 21, 2008, Invitrogen Corp. and Applied Biosystems Inc. completed their previously announced merger to form a new company named Life Technologies Corp. In a press release dated Aug. 4, 2008, Fitch assigned the following ratings to the merged entity:
–Issuer Default Rating (IDR) ‘BBB-’;
–Senior convertible notes ‘BBB-’;
–Senior secured credit facilities ‘BBB-’.
The Rating Outlook is Stable.
Life Technologies’ ratings are supported by the company’s strong cash flows, leading market position, diversified customer base and low capital expenditure needs. The company benefits from the recurring nature of its revenue stream (over 70% of total revenues are from consumables and services), strong customer loyalty, and the nature of its end markets (tied to general health care spending and biological research). Key ratings concerns center on integration risks post-merger as well as the high levels of debt and leverage expected. Fitch’s ratings incorporate the expectation that the company will reduce debt over the next one to two years to a level more appropriate for the rating category (under 3.0 times (x)).
Fitch believes the complementary nature of the successor companies’ product lines will enable the realization of revenue synergies post-merger. Life Technologies will be able to offer more bundled product solutions, including complementary instruments and reagents, which are increasingly important to life science researchers and applied markets customers. In addition, Fitch believes the company will have the opportunity to leverage existing customer channels (such as Invitrogen’s Supply Centers) and complementary research & development projects to drive revenue growth. Facility rationalization, overhead reduction, and consolidation of marketing activities, among other activities, should lead to the realization of cost synergies as well. In addition, Fitch believes there is significant growth potential for the life sciences tools industry in general as well as the company’s targeted market segments in particular (such as next-generation DNA sequencing).
Fitch’s rating definitions and the terms of use of such ratings are available on the agency’s public site, www.fitchratings.com. Published ratings, criteria and methodologies are available from this site, at all times. Fitch’s code of conduct, confidentiality, conflicts of interest, affiliate firewall, compliance and other relevant policies and procedures are also available from the ‘Code of Conduct’ section of this site.
Contacts
Fitch Ratings, Chicago
Lauren Coste, 312-606-2320
Mike Zbinovec, 312-368-3164
or
Media Relations:
Cindy Stoller, 212-908-0526, New York
Email: cindy.stoller@fitchratings.com
The increased availability of point-of-care facilities has aided in the development of a generation of empowered patient consumers. With current innovations such as rapid test centers at local Wal-Marts and Flu shots in airport booths, individual medical data is made available instantaneously. With patients gaining more power than ever and recent trends pointing towards a decentralization health care, what does this mean for the IVD industry?
At our recent IVD Conference Mr. Harry Glorikian, Founder and Managing Partner for Scientia Advisors, 
addressed this topic with his keynote presentation entitled: State of The Union: The In Vitro Diagnostic Industry. Scientia Advisors is an international management and strategy consulting firm concentrating in biotechnology and life science. With over 20 years of experience in the health care industry, Mr. Glorikian projects an overall optimistic outlook on the affect of personalized medicine on the IVD industry. The Scientia Advisors website hosts a number of presentations focusing on the benefits of a decentralized health system http://www.scientiaadv.com/data.cfm.
At Q1 Productions we are interested in hearing from other industry leaders on this topic. How do you perceive the decentralization will affect the diagnostic industry? What changes do you foresee for your commercialization strategy in the next 10 years?
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At our recent In Vitro Diagnostic Regulatory & Reimbursement Conference, health policy and economics were central topics of discussion. With today’s wavering economy and shifting of the administration there is heightened concern over changes to the current health care system. Recent activity in congress coupled with anticipation over President Elect Barack Obama’s new plan has led to much speculation.
Q1 Productions would like to hear what the leaders in the In Vitro Diagnostic Sector think. How do you foresee the new administration will affect health policy specifically? If the current system moves towards universal health care would cost pressures decrease IVD profit margin?
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BRISBANE, Calif.–(BUSINESS WIRE)–XDx, a molecular diagnostic company, today announced that Pierre Cassigneul, president and chief executive officer, is scheduled to present at the 2008 In Vitro Diagnostic Regulatory and Reimbursement Conference on November 18, 2008 at 9 a.m. (ET) at the Hyatt Regency Baltimore.
Cassigneul will present a keynote lecture, entitled “XDx’s Innovative Reimbursement Strategy,” that will highlight AlloMap® Molecular Expression Testing. AlloMap is a noninvasive, multi-gene molecular diagnostics blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing, in conjunction with standard clinical assessment.
In August, AlloMap received market clearance from the U.S. Food and Drug Administration (FDA), making XDx the first U.S. molecular diagnostics company to obtain FDA clearance of an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) for use in transplant management.
“AlloMap clearance provides physicians with a non-invasive test to assist in the management of potential organ rejection of heart transplant patients,” said Cassigneul. “We look forward to participating in the In Vitro Diagnostic Regulatory and Reimbursement Conference, and sharing our best practices with other members of the healthcare community.”
About XDx
Based in Brisbane, California, XDx is a molecular diagnostics company focused on the discovery, development and commercialization of noninvasive gene expression-based tests for the monitoring of transplant rejection and autoimmune diseases. The company has developed a proprietary new method for noninvasively monitoring immune system activity by measuring gene expression in a patient’s peripheral blood. This work is the basis for AlloMap Molecular Expression Testing, which provides transplant physicians with a new tool to aid in the identification of the probability of acute cellular rejection for postcardiac transplant patient management.
Some of the AlloMap Molecular Expression Technology developed and implemented by XDx in heart transplant patient management may be applicable to other diseases that involve transplant rejection and the immune system. XDx’s noninvasive technology offers the potential to decrease healthcare costs and significantly improve the quality of life for patients with a variety of life-threatening or life-altering immune-mediated diseases.
About the In Vitro Diagnostic Regulatory & Reimbursement Conference
The In Vitro Diagnostic Regulatory & Reimbursement Conference is a comprehensive and multidisciplinary forum where leaders in the global health community will discuss health economics and its role in the value of diagnostics. This forum will focus on regulatory, market access and reimbursement strategies for innovative products. The In Vitro Diagnostic Regulatory & Reimbursement Conference will be held on November 17-18, 2008 at the Hyatt Regency Baltimore. For more information, visit www.q1productions.com.
For information on XDx contact:
Pure Communications
Sheryl Seapy, 949-608-0841
For information regarding this program contact:
Paul Hernandez,
Group Marketing Manager
Q1 Productions
312.602.9684
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