Disappointment as NICE turns down Roche’s breast cancer drug

Pharmatimes reported that NICE have turned down Roche’s Avastin for patients with advanced breast cancer in a draft because of uncertainties over the drug’s survival and costing’s. Roche however say this drug could make a real difference to cancer patients.

NICE said despite clinical evidence showing that the drug is able to increase progression-free survival by just under three months compared with capecitabine alone, its effect on overall survival is less clear.. NICE’s appraisal committee concluded that they could not recommend the treatment as an effective use of NHS resources

Basel-based Roche said the draft guidance wasn’t the final recommendation from NICE  in this setting and that it will respond to the draft guidance as per NICE’s process.

Roche said “Avastin in combination with [chemotherapy drug] capecitabine is an important treatment option for women with breast cancer….In a subgroup analysis of women treated with a taxane when their disease was at an early stage, progression-free survival more than doubled from 4.2 months to 8.7 months compared to those treated capecitabine alone.”

Pharmatimes reported that this news will certainly disappoint   thousands of patients suffering from the condition, who will no doubt be hoping that additional evidence will be submitted during the current consultation period to overturn the decision.

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Amgen and AstraZeneca agree a $50M deal

As reported by FierceBiotech, Amgen has struck a $50 million deal to work with AstraZeneca to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio.

AstraZeneca will pay Amgen for access to these 5 antibodies and the companies will share both costs and profits. Amgen will note the sales and take a percentage of the royalties on the antibodies but the companies will share the profits equally beyond that.

This collaboration is designed to strengthen each company where it needed help the most and to develop these antibodies effectively.

Kevin Sharer, Chairman and CEO at Amgen said “We are very excited at the prospect of collaborating with a well-respected organization like AstraZeneca to advance our inflammation pipeline. We believe this collaboration has the potential to bring more therapies to patients sooner, across more geographic areas”

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Sanofi launches the 1st iPhone monitor for Diabetes

Fierce Pharma has reported that Sanofi have launched the first blood-sugar monitor that connects to the iPhone and the iPod Touch.

The product is called the iBGStar, it is a break through new approach for people with diabetes who take insulin as it can help them manage their glucose levels. The iBGStar (which is only an inch long) connects to the iPhone or iPod Touch and delivers results via a free diabetes manager app that tracks and graphs blood-sugar levels, and can collect relevant information about carb consumption, exercise and insulin doses. Patients can see interactive reports and email a report to their doctors.

Dr Andrew Hockey, medical director for Sanofi, said: “It harnesses the power of the latest technology to empower people with diabetes to manage their condition on a day-to-day basis.”

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Clinical Administrator (Named Patient Admin Coordinator) – Berkshire

Russell Oakley at CK Clinical is currently recruiting for a Named Patient Administrative Coordinator to join a global manufacturer of pharmaceuticals to join their oncology clinical research team in Berkshire

Role:

This Named Patient Administrative Coordinator role is to provide full administrative support to the department to make more effective and efficient use of their time. This role will be starting ideally in the beginning of May 2012, the length of contract will be 12 to 18 months (to be reviewed)

 

Responsibilities:

The successful candidate for this Named Patient Administrative Coordinator role will have the following responsibilities:

  • Manage information flow internal & external including gathering, processing and distributing data as necessary
  • Plan and organise meetings internal and external, co-ordinating all necessary arrangements
  • Maintain records for the team including sickness, holidays and training
  • Act as a focal point co-ordinating activities through effective diary management and checking e-mail in managers absence. Handling and resolving internal and external queries
  • Provide administrative support to a department which includes initiating, composing, typing and editing correspondence, memos, reports, taking and transcribing minutes, compiling presentations, producing reports, etc
  • Recommend improvements to processes or procedures within the department and own role

Leadership, team work and decision making expectations:

As a Named Patient Administrative Coordinator you will be expected to: 

  • Contribute as a full team member, supporting others and sharing information and ideas
  • Liaise with other teams or departments regarding the resolution of issues or problems
  • Identify own training/development needs within the team
  • Work on own initiative
  • Decide relevant contact who can deal with non routine problems
  • Prioritise own workload on a daily basis
  • Escalate significant or complex problems
  • Recommend improvements to processes or procedures within own role
  • Accept/decline meetings on behalf of  manager and/or team
  • Organise meetings and deal with all associated administration

Skills and Experience required:

The ideal candidate for this Named Patient Administrative Coordinator role will have the following skills and experience:

  • English and Mathematics essential (GCSE level or equivalent)
  • Minimum 2 years’ experience of working within an office environment, to include budgetary monitoring duties
  • Computer literate in MS Office
  • Good communication skills
  • Able to work in a team
  • Attention to details
  • Excellent experience in excel spread sheet
  • Process driven
  • Customer focused
  • Ideally seeking someone who has previously worked within either:
  • Regulatory affairs or drug safety.  Someone who has maybe been a CTA, Scientific Assistant or Drug Safety Business Assistant.
  • Experience in study or drug safety administration would be an advantage.
  • Excellent filing and archiving skills/ experience.
  • Good organisational Skills – used to putting a system together for filing relevant information.
  • Good English skills as well as they may occasionally be required to write letters.

How to apply:

Apply online now:

For more information or to apply for this a Named Patient Administrative Coordinator role please contact Russell Oakley on +44 (0) 114 283 9956 or email roakley@ckclinical.co.uk. Please quote reference CL24026 in all correspondence.

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Our Latest Clinical Jobs in This Week – 30.3.2012

Here is a list of the latest clinical jobs in the UK and Europe that we have had in this week.

Please click on the links below to find out more and apply online.

Contact Us:

If you are looking for a new clinical job, or are looking to expand your team, please contact us directly on +44 (0)1438 743 047 or email info@ckclinical.co.uk.

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Pfizer Forges Partnerships in Cambridge

Business Weekly reported that Pfizers R&D model at the Cambridge UK Life Sciences Cluster is already a success. Regenerative medicine is based at the Granta Park Science Park in Cambridge.

Pfizer is currently forging ahead making partnerships with small UK Biotech companies that are boosting the innovation pipeline and promise to accelerate the pace of new medicine discovery.

Pfizer – Neusentis (Pfizer’s new research unit) held a networking event last week at Granta Park during Cambridge Awards Week called Partnering with Neusentis, an entrepreneurial Pfizer research unit at the forefront of the new pharma R&D model. Influential people from the life sciences and VC communities attended and were said to be pleased with the initiative.

Dr Ruth McKernan who is a senior vice president at Pfizer and chief scientific officer at Neusentis was pleased with the reaction to the initiative. She said told Business Weekly that “the Cambridge hotspot is proving to be fertile territory for the new and highly focused R&D model that Pfizer is pioneering” She also said that half a dozen potential collaborations had been identified in the last week alone in Cambridge and that small businesses in the sector were often a major source of innovation in their own right.

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Clinical Manager Job in Home Counties

Jim Gleeson at CK Clinical is currently recruiting for a Clinical Manager to join an international pharmaceutical company at their site based in the Home Counties.

As Clinical Manager, you will have responsibility for all aspects of study management for assigned global studies from the concept and planning stage through to close-out. This will include resource allocation, documentation development, vendor selection and management, supplies management and CSR review.

To be considered for this Clinical Manager position, you will have the following skills and experience:
– Clinical project management experience on an EU or global basis, from start-up to close-out
– Urology trial experience would be advantageous
– The ideal candidate will also have had experience of trial monitoring
– Thorough understanding of ICH-GCP requirements
– Ability to travel up to 25%

How to apply:

Click here to apply online now.

For more information regarding this Clinical Manager position, please contact Jim Gleeson at CK Clinical on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL23976 in all correspondence.

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Boehringer Ingelheim expands its biopharmaceutical development and manufacturing capabilities

Ingelheim Boehringer New’s Centre released a press statement announcing that it has expanded its biopharmaceutical development and manufacturing capabilities at its cell culture and microbial sites in Biberach, Germany and in Vienna, Austria

The press statement said that 17 million Euros has been invested which has meant  the expansion of Boehringer Ingelheim’s current GMP (good manufacturing practice) cell banking, process science, cell line development and quality laboratories, all equipped with the latest technologies.   These expansions will enhance state-of-the art cell line development with the proprietary BI-HEX® high expression system and microbial strain as well as process development services for the contract manufacturing business.

The expansion has been taylor-suited to fully meet our customer demands in cell culture and microbial process science, especially for our rapidly expanding pre-clinical project portfolio with biotech companies”, commented Dr. Dorothee Ambrosius, Senior Vice President Biopharmaceuticals Global Process Science at Boehringer Ingelheim.

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Clinical Study Programmer Job in Hertfordshire

Priya Mukherjee at CK Clinical is currently recruiting for a Clinical Study Programmer to join a successful pharmaceutical company based in Hertfordshire.

Clinical Study Programmer Job Description

As Clinical Study Programmer, you will work and be involved in supporting global data handling activities by providing study databases and reporting tools for clinical data review, and the transformation of study data for analysis across a range of therapeutic areas.

As Clinical Study Programmer, your main responsibilities will include:

  • Creation and maintenance of clinical trial databases and related objects for the  collection of patient data for clinical trials
  • Program derivations and conditions to control access to forms and fields
  • Review of data quality check specifications and programming data quality checks during the course of clinical studies
  • Development of programs for extracting and transforming patient data into the appropriate data model to support reporting and analysis activities
  • Customizes standard report templates to produce study-specific reports for data cleaning and Medical Data Review
  • Supports study closeout activities
  • Adherence to global standards and project related standards
  • Co-operate with local and international study teams to achieve efficient solutions
  • Contributes to the timelines for programming deliverables at the study level
  • Responsible for deliverables for one or more studies
  • Manages the handover and provides support to service providers on study-level tasks
  • Reviews and monitors study-level tasks performed by the service provider as needed
  • Provides technical mentoring
  • Effectively coordinates workload and communicates status of work

As Clinical Study Programmer you will have the following qualifications, skills and experience:

  • Educated to degree level (or equivalent) in a scientific or relevant technical degree
  • Experience with handling biomedical data and relational databases.
  • Strong planning and organizational skills and the ability to manage multiple priorities, tasks or goals, developing and committing to realistic estimates and plans to complete required tasks.
  • Familiar with programming language including SQL, PL/SQL, C# or SAS
  • Proven experience of working in Clinical Data Management, Clinical Study Database Setup, edit check programming, data extraction, transformation or reporting.

 

How to apply:

For more information or to apply for this Clinical Study Programmer position, please contact Priya Mukherjee at CK Clinical on +44 (0)1438 743 047 or email pmukherjee@ckclinical.co.uk.

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Eli Lilly invests Cork Ireland site making 200 jobs

Eli Lilly in Ireland released a statement reporting that the Minister for Jobs, Enterprise and Innovation Richard Bruton TD announced that Eli Lilly and Company, a global leader biopharmaceuticals, is to invest €330 million in a brand-new facility at its Kinsale campus.

The investment will lead to the creation of 200 new jobs at the facility, as well as a further 300 construction jobs which will be created as part of the building works. This will bring Eli Lilly’s total employment in Ireland up to almost 1,000.

The investment will expand the Kinsale site’s existing biopharmaceutical mission with the establishment of an additional world-class commercialisation and manufacturing facility.

The planned 240,000-square-foot biopharmaceutical commercialisation and manufacturing facility will further enhance the company’s ability to bring treatments for illnesses such as cancer and diabetes to patients worldwide

“This investment is an endorsement of the Lilly Kinsale site’s success in developing a biopharmaceutical business in recent years and demonstrates our ability to rise to that challenge. This is in no small part due to the site’s excellent performance record, the talent of the workforce, and the support from IDA Ireland,” said Ed Canary, general manager of the Kinsale site.

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