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.
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!
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.
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.
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.
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.
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.