Biopharmaceutical launches data sharing venture

reported by Pharmatimes.com As of the 1st January 2014 the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) and the Pharmaceutical Research Manufacturers of America’s (PhRMA) joint agreement on the sharing of clinical-trial data came into effect.

Under the newly established ‘Principles for Responsible Clinical Trial Data Sharing’, it is now possible for researchers to request access to patient-level data, clinical-trial protocols and clinical-study reports for any new medication approved in the US and the European Union after 1st January 2014.

This new venture highlights the biopharmaceutical sectors commitment to data-sharing as it will dramatically expand the volume of information from clinical trials available to qualified researchers as well as patients and members of the public.

To read more about this new industry principle click here 

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Alzheimer’s drug enters major clinical trial

As reported on CareIndustryNews.co.uk. A commonly prescribed diabetes drug may reverse the symptoms of Alzheimer’s so has now entered into a major clinical trial.

The initial research, which was funded by the Alzheimer’s Society, claims the drug liraglutide may be able to reverse some of the damage caused in the later stages of the disease, such as memory loss and the build up of plaques on the brain.

Liraglutide is currently used by diabetes sufferers to help  stimulate insulin, but research has shown it also has the ability to pass through the blood brain barrier and have a protective effect on brain cells.

The Alzheimer Society’s Drug Discovery programme repurposes existing drugs for use in dementia treatment. Early research showed the potential in early stage Alzheimer’s leading to a major clinical trial, led by the Imperial College of London. With the recruitment of patients beginning in the next few weeks and if successful liraglutide will be the first new dementia treatment in ten years!

To read this article in full click here

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  Clinical Trials jobs at CK Clinical

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Head of Statistics – UK

Priya Mukherjee at CK Clinical is currently recruiting for a Head of Statistics to work in a leading clinical trials unit for a top university in the UK.


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h3 style=”padding-top: 25px;”>Responsibilities:

As Head of Statistics you will have responsibility for:

  • Running the SMG to the highest standards
  • Interacting with key researchers and pharmaceutical companies worldwide
  • Fostering the continued academic development of the group
  • Helping to ensure the DTU’s continued success by delivering high quality statistical support in a timely manner

 

Further responsibilities of this Head of Statistics role will include to:

  • Provide oversight of all SMG activities and play a key role in the design, monitoring, analysis, and reporting of clinical trials in accordance with DTU Standard Operating Procedures (SOPs) and study-specific Statistical Analysis Plans (SAPs)
  • Ensure SMG activities are regulatory compliant and in accordance with ICH GCP requirements, using template procedures for timely production of SAPs and trial reports and ensuring appropriate quality control schemes are in place
  • Critique and interpret the statistical content of trial data, abstracts, posters and manuscripts from both internal and external sources and provide advisory reports where required
  • Prioritize SMG tasks and be responsible for ensuring that they are delivered on time and to the highest quality
  • Play a key role in developing research projects, securing funding, and participating in bid defence meetings
  • Provide backup for Senior Statisticians where necessary
  • Participate in seminars and workshops showcasing the work of the DTU
  • Contribute to the wider academic life and work of the DTU and the University through, for example, editing journals, refereeing papers, external examining and involvement in professional bodies.
  • Contribute to institutional and national policy making especially in relation to medical statistics.
  • Foster constructive collaborative relationships with senior University personnel, key stakeholders including commercial sponsors of DTU research and academic collaborators.
  • Attend external meetings on behalf of DTU, where there is a need for a Statistical Advisor to be present and provide reports of such meetings where appropriate
  • Provide high-level statistical advice to other DTU staff on how best to design, analyse and interpret their studies
  • Contribute to other relevant aspects of the work of the DTU, including assisting other DTU sections as necessary with the development of documentation or materials relating to the integrity of trial data
  • Develop the research activities of the DTU and the University by maintaining an expert reputation in own subject area independently and/or in collaboration with others and identifying new areas of research
  • Engage in external academic activities in accordance with the DTU’s research strategy at a national and international level
  • Publish original research in appropriate journals or other media, as appropriate
  • Lead funding bids which develop and sustain research support for the diabetes and/or statistics area and advance the reputation of the DTU and the University

 

Qualifications, skills and experience:

To be considered for this Head of Statistics position, you will have the following qualifications, skills and experience:

  • A higher degree PhD in the area of medical statistics or epidemiology (OR Equivalent)
  • Proven clinical trials analytic experience with an excellent knowledge of all aspects of trials methodologies
  • Thorough understanding of statistical methods, especially randomisation methodology, advanced multivariate modelling, generalized mixed modelling and advanced survival analysis methodologies
  • Proven ability to lead a team, and to plan and manage multiple project workloads within deadlines
  • Proven staff management skills and ability to develop junior staff
  • Extensive experience in using statistical packages with good working knowledge of SAS and R
  • Good communication skills in oral and written English and attention to detail
  • Expertise in medical statistics oversee all aspects of SMG output, including production of statistical analysis plans, randomisation methodology, advanced multivariate modelling, generalized mixed modelling and advanced survival analysis methodologies.
  • The ability to lead a team of statisticians and programmers, to prioritize tasks, and to manage resources to ensure tight deadlines and DTU contractual commitments are met

 

 

Priya Mukherjee - Statistics Recruitment

Please contact Priya for more details.

How to apply:

Click here to apply online now.

For more information regarding this Head of Statistics role, please contact Priya Mukherjee at CK Clinical on 0207 470 5670 or email pmukherjee@ckclinical.co.uk.

 

 

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Bayer Healthcare and Covance announce a long term partnership

Pharmatimes reported that Bayer HealthCare has announced a long-term strategic partnership for clinical drug development with US-based provider CovanceBayer and Covance will work on clinical drug development, including research and development related to Phase II-IV clinical studies and central laboratory services.

Bayer Healthcare  aims to better leverage Covance’s broad range of experience and services across the R&D portfolio to attain best in class operational delivery, efficiency and quality while also delivering significant financial benefits to both organizations.

John Watson, president, strategic partnering, and chief commercial officer at Covance said “We are extremely proud to have established an enduring relationship with Bayer HealthCare built on trust and proven performance that is now elevating to a strategic partnership,”

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Clinical Research Nurses – Salford

Russell Oakley at CK Clinical is recruiting for 2 + Clinical Research Nurses to support a high profile two-year study relating to respiratory diseases run by a global pharmaceutical company. This role is based in Salford.

The Job:

As a Clinical Research Nurse you will work in small teams supporting pharmacies and primary practices taking part in the study. This will involve liaison with community pharmacies, doctors, nurses, practice staff and other healthcare professionals in preparation to join the study and the provision of respiratory patient review for practices.

These positions will be an equivalent grade to grades 5 or 6 within the NHS and benefits include 38 days holiday per annum, pension and medical insurance (optional).

Qualifications and skills:

The successful candidate for this Clinical Research Nurse role must have:

  • A registered nurse qualification recognised in the UK.
  • A diploma in respiratory care would be an advantage but experience in clinical trials is key for this role due to the nature of the position.
  • You will comply with and maintain Good Clinical Practice throughout the study, performing study visits with patient volunteers, gaining consent and reviewing patients as per protocol.
  • The successful candidates will be keen to contribute proactively to the project’s success and will demonstrate advanced team working and networking skills and the ability to develop effective working relationships.
  • You must be able to work independently from home, travelling in the Salford region as required.
  • You must be in possession of a driving licence and your own car (with business insurance use).

How to apply:

Apply online now:

For more information or to apply for this role please contact Russell Oakley on 0114 283 9956 or email Salford@ckclinical.co.uk.  Please quote reference CL24110 in all correspondence.

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Hepatitis C vaccine clinical trials show promising results

As reported by the BBC News, researchers at Oxford University have stated that the initial clinical trials of a new hepatitis C vaccine have shown promising results. Hepatitis C is notoriously difficult to treat as the virus changes it’s appearance all the time – this is makes it difficult to find something to target. However, researchers have stated in Science Translational Medicine, that a trial on 41 patients has had good results. It is believed that this is because the vaccine targets the core of the virus, and not the surface markings which change over time.   About the clinical trials The Phase 1 trial was conducted on 41 healthy patients with the aim of determining whether it would be safe to run future clinical trials. Results indicated a strong immune response which lasted for approximately one year.  Talking of the results, Prof Klenerman stated: “The immune responses we’ve seen are exciting and we are beginning the next stage of trials. While we are hopeful, it could be a long road to any vaccine that protects people against hepatitis C.” Click here to search our clinical research jobs now.

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Senior Data Manager Job in UK

Priya Mukherjee at CK Clinical is currently recruiting for a Senior Clinical Data Manager to join a niche clinical trials company based in the UK.

The role:

As Senior Data Manager, you will be expected to contribute significantly to the EDC and project management aspects of Data Management, including management, development and review of EDC databases, both from an internal and external vendor perspective. In addition, you will be the Data Management lead on a number of projects, having the ability to work as part of the project team as well as on your own initiative.

The ideal candidate:

Priya is looking for candidates who have implemented and worked with a number of Electronic Data Capture (EDC) systems and providers and must be able to demonstrate experience gained within EDC Data Management. You will have a broad knowledge of the Pharmaceutical Industry, associated regulations and a full understanding of the role of the Contract Research Organisation (CRO) in Clinical Research.

Experience of leading complex Oncology studies is also highly desirable and you must have managed the EDC Data Management aspects of a number of large and complex studies simultaneously, using your excellent management and communication skills across all disciplines and at all levels to ensure success.

Interested applicants will have a flexible approach to their work, be self-motivated, have excellent organisational skills and be able to motivate and direct others within a project team environment. Good problem solving and decision making skills are essential, as is the ability to help facilitate the development of EDC Data Management skills in Data Managers and Data Associates.

How to apply:

For more information or to apply for this Senior Data Manager position, please contact Priya Mukherjee at CK Clinical on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk. Please quote reference CL23017 in all correspondence.

Not quite what you’re looking for? Click here to search our current Data Manager jobs in the UK and EU now.

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Biomarkers to See Huge Growth by 2017

Clinical development is the largest growing section of the global biomarkers market, which is expected to reach $34 billion by 2017, reports pharmatimes.com.

Annual growth of over a quarter leading up to 2017 is expected in biomarker applications in clinical drug development, though the high costs of the trials hampers the overall market growth, which means smaller businesses aren’t involving themselves in the sector. Despite this, the biomarker applications sector is growing quickly, particularly as 90% of drugs fail in clinical trials.

Biomarkers allow detection of reasons drugs may fail, such as toxicity, in early stage trials which allows for significant savings in the long term. Oncology and cardiology are expected to be the two areas in which biomarkers are most extensively used as drugs fail in clinical trials more often for these therapy types. They can also be used to assess patient’s susceptibility to illness, such as the risk of a stable patient suffering coronary issues, for example a stroke.

Looking for a job in the biomarker or clinical industries? Start your search here, today!

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GSK Breast Cancer Trial Scaled Back

Inpharm.com has reported that GlaxoSmithKline is to scale back a phase III clinical trial looking into potential breast cancer treatments.

The trial, which has been running since 2007, is evaluating the effectiveness of the breast cancer drug Tyverb in four different combinations, following surgery. The patients in the trial receive either Tyverb, Roche’s established drug Herceptin, Herceptin followed by Tyverb or both drugs.

An interim report has indicated that the patients only receiving Tyverb are not demonstrating any improvement compared to Herceptin, so that arm of the trial has been discontinued. Those who are halting their treatment are to discuss other options with trial physicians. 8,400 patients are taking part in the study, and the remaining three trials are to continue as normal.

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ICON and BMS Further Partnership

ICON, already global clinical development partner to Bristol Myers-Squibb, have added to the agreement by announcing a preferred provider agreement with BMS in early-phase studies, reports inpharm.com.

The agreement includes full service clinical pharmacology and exploratory clinical studies, based in Manchester in the UK and elsewhere around the world. ICON will also be responsible for all the scientific support services during the trials, such as biostatistics and clinical monitoring, amongst a variety of others.

Dr Mario Rocci, president of ICON Development Solutions, is looking forward to “demonstrating the same values and efficiencies to BMS’s early phase clinical programmes” as they do with phase II-IV studies. Under this new agreement, ICON expects to be able to report “significant cost savings and productivity” by putting it’s global network to use.

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