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THIS ISSUE:
-Bayer PHT Awards Program 2013
-Important Health Care Provider Communication: GSK


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Bayer health care is supporting a world wide intiative for research in PHT.
Australian and NZ PHT researchers below the age of 40 are encouraged to apply with applications closing on November 20, 2012.

Grants with a total of 
400,000 will be made over two seperate categories. Please see the offical grant release (below) or website for more details.


Pulmonary Hypertension Awards Program 2012

Mission Statement

Bayer is a committed and dedicated partner to health care professionals and patients in pulmonary hypertension.
Through the Pulmonary Hypertension Awards Program, Bayer aims to support young researchers from around the world to further the scientific understanding of disease with the ultimate aim of improving patient’s lives.
Finalists will not only receive an educational grant, but will also be mentored by one of the global expert panel, who will provide invaluable experience and insights throughout the research program.
As a committed and dedicated partner to health care professionals and patients in pulmonary hypertension (PH), Bayer is delighted to sponsor the Bayer Pulmonary Hypertension Awards Program again in 2013.


Objectives

Through the Pulmonary Hypertension Awards Program, and with the support of globally renowned experts in the field of PH, Bayer aims to support young researchers to further the scientific understanding of disease with the ultimate aim of improving patient’s lives. The Pulmonary Hypertension Awards Program is a global* initiative that encourages young researchers from around the world to apply.

Expert panel

The Pulmonary Hypertension Awards Program is supported by four leading experts in the field of PH who will draw up the shortlist and select the finalists.
Each finalist will be mentored by one of the expert panel throughout the research program. This mentoring system will allow the finalists to benefit from the invaluable experience and insights of these global experts to inform and guide their research.

Entrant categories

For 2013, the following two categories will be available for applicants:

PhD program

  • The proposal must be to investigate a relevant question in PH, utilizing any methodology (ie in vitro, pre-clinical or clinical), irrespective of the PH subtype
  • Applicants must be supported by a university and be less than 40 years old
  • The proposal must be able to be completed within 3 years
  • The proposal must not be drug-related or promotional in nature
Research program
  • The proposal must be to investigate a clinically relevant question in PH, utilizing any methodology (ie in vitro, pre-clinical or clinical), irrespective of the PH subtype
  • Applicants must be less than 40 years old
  • The proposal must be able to be completed within 2 years
  • The proposal must not be drug-related or promotional in nature

Educational grants

Two finalists will be selected from each category to receive the following educational grants:

PhD program

  • Total educational grant of €120,000 over three years*
  • The finalists will be mentored by one of the expert panel over the course of the three years
Research program
  • Total educational grant of €80,000 over two years*
  • The finalists will be mentored by one of the expert panel over the course of the two years
The grant will be paid out to the finalist´s institution in the name of the finalist. A sponsorship contract will therefore be entered between Bayer and the institution.

Application selection process

  • Interested researchers should register themselves at the Bayer PH Award Homepage.
  • Applications should be submitted via the application page of this website between September 3, 2012 and November 20, 2012
  • The proposals received will be reviewed by the panel of global PH experts who will shortlist a maximum of 10 proposals for each category by January 15, 2013
  • Applicants of the shortlisted proposals will be asked to present their proposal at the 8th Bayer International PH Symposium where the four finalists (2 per category) will be identified
  • The selected finalists will be asked to present updates on their research at key PH events
 
* If awarded, U.S. applicants will have their proposal and subsequent grant subject to fair market evaluation.  The grant award delineated in the program represents the maximum amount of support that can be provided
 
Please note that Bayer is not involved in this selection process.

 



 Important Communication to Health Care Professionals.

 

The following important communication letter was recently distributed by GSK.

 
Level 4, 436 Johnston Street 

Abbotsford Victoria 3067 

PO Box 18095 Melbourne Vic 8003 

Australia 

Tel: +61 03 9721 6000 

Fax: +61 03 8761 2451 

www.gsk.com.au 

27 July 2012 
 

 

Direct Healthcare Professional Communication 

VOLIBRIS ® (ambrisentan) must not be used in patients with Idiopathic Pulmonary Fibrosis (IPF). 
 

Dear Healthcare Professional: 
 

Summary 
 

* Ambrisentan must not be used in patients with idiopathic pulmonary fibrosis (IPF). 

 

* A clinical study in patients with IPF has shown higher rates of respiratory hospitalizations, mortality events, and decreases in respiratory function in the ambrisentan group versus placebo. 

 

* Patients with IPF who may have already been on treatment with ambrisentan should be assessed carefully and alternative therapies should be considered. 

 

* The Product Information will be updated to amend the Precautions statement to a Contraindication 

 

* The Therapeutic Goods Administration (TGA) has been consulted on this matter. 
 

Further information on the safety concern 

Ambrisentan is a selective endothelin A receptor antagonist indicated for the treatment of patients with pulmonary arterial hypertension (PAH, WHO Group 1), classified as WHO functional class II, III and IV to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. 

A study (ARTEMIS_IPF) in patients with IPF was conducted but was terminated early when it was determined that the primary efficacy endpoint could not be met. 

In this study, patients were randomized to ambrisentan or placebo in a 2:1 ratio. A total of 492 patients (ambrisentan N=329, placebo N=163) were included, 11% of which had secondary pulmonary hypertension. Ninety events (27%) of IPF progression (including AUS/ABT/0015/12 respiratory hospitalizations) or death were observed in the ambrisentan group compared to 28 events (17%) in the placebo group. 
 

Evaluation of the primary endpoint components indicated that there were higher rates of respiratory hospitalizations, mortality events, and decreases in respiratory function in the ambrisentan group versus placebo.
 

In view of the available data from this study, and in consultation with the TGA, please remember that ambrisentan must not be used for the treatment of IPF. Ambrisentan should only be used in patients with Pulmonary Arterial Hypertension (WHO Group 1) as per the approved Product Information. 

The product information for Volibris will be updated to amend the Precautions statement to a Contraindication for the use in patients with idiopathic pulmonary fibrosis (IPF). This Contraindication also includes patients with pulmonary hypertension secondary to IPF (WHO Group 3). 
 

Call for reporting 

Any suspected adverse reaction to Volibris should be reported to the TGA in accordance with the national spontaneous reporting system rules. In addition, we encourage these reactions to also be reported to GSK Medical Information on 1800 033 109. 
 

Communication Information 

Should you have any questions or require additional information please contact GSK Medical Information on 1800 033 109. 

 

Yours sincerely, 

 

Dr Andrew Yeates 

Country Medical Director 

GSK Australia 

PP Dr John Bower, 

Associate Director, Medical 

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