FDA Efforts in Advancing Development of Gene Therapy

Posted by Brian Wile on May 24, 2019 9:25:52 AM

With Dr. Marks’ (Director, Center for Biologics Evaluation and Research), recent perspective on FDA’s Effort to Advance the Development of Gene Therapy, he thoughtfully highlights the recent successes of approved gene therapies, highlights the expert resourcing within FDA, CBER and NIH being applied towards this therapeutic specialization and details the innovative programs and committees (Novel and Exceptional Technology and Research Advisory Committee (NExTRAC), Regenerative Medicine Advanced Therapy (RMAT) designation and the INTERACT program) being instituted and enacted by the FDA.  In addition, he highlights the critical issue facing success of this scientific endeavor, is quality manufacturing capacity but attentively details FDA action of awarding grants dedicated to industry stakeholders for the advancement of manufacturing technologies.

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Tags: FDA, Results, Drug Development, Cellular Response, Development, DNA, Gene Therapy

Join Eurofins at the 2019 BIO Annual International Convention

Posted by Jesse Gehris on May 10, 2019 9:00:00 AM

Eurofins BioPharma Services will be attending the 2019 BIO International Convention in Philadelphia, June 3-6, to celebrate the globally important innovations in biotech that start with one: one meeting, one theory, one trial, one breakthrough. Join Eurofins BioPharma Services at Booth 2949 to consider how the largest wholly-owned network of BioPharma dedicated laboratories in the world can assist in your clinical trial research!

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Tags: Central Laboratory, Quality, Results, Clinical Trial, BioPharma

Brexit Status Update - April 11, 2019

Posted by Sandra Hageman on Apr 11, 2019 11:28:33 AM

 

Update - April 11th, 2019

 

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Tags: Central Laboratory, Clinical Trial, Brexit

Brexit - What's Next?

Posted by Sandra Hageman on Mar 29, 2019 9:28:23 AM

 

Update - March 29th, 2019

Last week, the United Kingdom (UK) and European Union (EU) reached an agreement on a postponement of the Brexit after ample discussions. As a result, the Brexit will not occur on Friday, March 29, 2019 as originally planned.

Actually today, March 29th, 2019, on the day the UK was due to leave the EU, MPs will have a third vote on the Withdrawal Agreement - the legally binding document that sets out the terms of the UK's departure from the EU. This includes a settlement, details of a transition period for after the UK leaves and protections for citizens' rights. It also includes the controversial backstop, or the insurance policy that aims to prevent a hard border returning to the island of Ireland.

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Tags: Central Laboratory, Clinical Trial, Brexit

Join Us at ProcureCon PHARMA in Frankfurt, Germany March 19-20, 2019

Posted by Sandra Hageman on Mar 11, 2019 11:14:46 AM

 

Transforming Pharma Procurement. Together.

Eurofins BioPharma Services looks forward to meeting you at the ProcureCon PHARMA meeting in Frankfurt, Germany from March 19-20, 2019.

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Tags: Central Laboratory, Clinical Trial, BioPharma, Leadership, Pharma Procurement

Eurofins Celebrates International Women's Day

Posted by Jesse Gehris on Mar 8, 2019 10:30:11 AM

Today, on March 8th, 2019, Eurofins Central Laboratory, a member of Eurofins BioPharma Services, celebrates International Women's Day (IWD).

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Tags: Central Laboratory, Quality, Results, Peace, Development, BioPharma, Leadership, International Women's Day

Newly Expanded Shanghai Facility

Posted by Jesse Gehris on Feb 26, 2019 11:52:02 AM

In 2017, China became the world's second-largest national pharmaceutical market, due to its aging population and rising medical needs. In its ongoing commitment to adapt to emerging trends in the pharmaceutical industry, Eurofins Central Laboratory,  a member of Eurofins BioPharma Services, has expanded its facility in Shanghai, China.

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Tags: Central Laboratory, Clinical Trial, Development, Science Education, Shanghai

How To: Brexit-Proof Your Study

Posted by Sandra Hageman on Feb 12, 2019 10:18:32 AM

What is Brexit?

The deadline for the United Kingdom to withdraw from the European Union, known as Brexit, is quickly approaching. The formal date will be March 29, 2019. In June 2016, Britain held a national referendum on their European Union membership, and having to choose between remain and leave, the British voted to leave by 52%. After 18 months of negotiating a divorce plan on trade, security and migration matters with European Union, the deal was rejected by the British Parliament just 10 weeks before Britain is scheduled to leave the EU.

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Tags: Central Laboratory, Clinical Trial, Brexit

Happy Chinese New Year 2019!

Posted by Sandra Hageman on Feb 5, 2019 11:09:26 AM

新年快乐

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Tags: Quality, Peace, Development, BioPharma, Chinese New Year, Year of the Pig

National Go Red Day

Posted by Jesse Gehris on Feb 1, 2019 12:30:00 PM

Today, at all four of our wholly-owned central laboratory testing facilities (United States, Netherlands, China, and Singapore), we at Eurofins Central Laboratory, a division of Eurofins BioPharma Services, wear red with the American Heart Association to aide in uniting the world from continent to continent in effort of bringing awareness to our friends, families, and colleagues suffering from cardiovascular-related diseases (CVD). Diseases under this remit include, but are not limited to, defects at birth, heart rhythm complications, and abnormal blood vessel conditions.

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Tags: Quality, Results, Development, American Heart Month, Heart Disease, Healthy Lifestyle