The year 2011 may be seen as one in which regenerative medicine entered its adolescence. Public attention — from investors to desperate patients — finally turned toward this nascent industry with something other than skepticism or unrealistic expectations. The FDA’s approval of Dendreon’s Provenge cellular immunotherapy switched on the spotlight, and cell therapy companies suddenly faced a barrage of questions about cost, manufacturing issues, product development, and patient access. US Policy: In May 2011, US representatives Brian Bilbray…
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Top 10 Regenerative Medicine Stories of 2011
Geron Ends Stem Cell Programs in November: Big hope for a spinal cord injury trial, big loss for a field — the most discussed news of the year. Despite the company’s official comment citing a “purely business decision,†many professionals think that a “lack of impressive preliminary results†also played a role. The company is now seeking a partner to take over that trial. The effect on the cell therapy industry remains to be seen — but for…
Opportunities in Regenerative Medicine
Capitol Hill fly-in days (see the last page of this issue) … A focus of Google Ventures (www.google.com/ventures) … A favored new investment arena for GE’s CEO Jeffrey Immelt, the recently named head of President Obama’s economic recovery advisory panel, and Life Technologies’ Greg Lucier … Hardly a day skipped without a major news publication covering some exciting aspect of the science … The provocative cover of Wired magazine’s (www.wired.com/magazine) November 2010 issue … It all sounds like the stuff…
Enzyvant to build regenerative med plant in NC to support Rethymic
Enzyvant says the construction of a regenerative medicine facility in Morrisville, North Carolina will bolster its size, flexibility, and capability to support its commercial needs. Financial details of the expansion remain under wraps, but regenerative medicine focused firm Enzyvant says the development of a 25,972 square-foot facility will begin this summer and take around two and a half years to complete. The plant is located within the Research Triangle Park area and is being co-developed by and operated with Sumitomo…
Accelerated Pathways for Authorization of Medicines in Europe and the United States
Before a medicinal product can be considered suitable for patients, it must go through laborious testing and cost-effectiveness analysis. In addition, all medicinal products must be authorized before they can be sold on the market and thus made available to patients (1). This is the case in the European Union (EU) and European Economic Area (EEA) countries as well as in the United States (US). Every year, a number of medicines receive marketing authorization. In their wake, however, several thousand…
Enzyvant hit with CRL due to regenerative therapy manufacturing concerns
The US FDA has cited manufacturing concerns in a complete response letter (CRL) rejecting Enzyvant’s regenerative tissue therapy RVT-802. RVT-802 is a tissue-based therapy in development for congenital athymia. While the candidate has been granted Breakthrough Therapy designation, Rare Pediatric Disease designation, Orphan Drug designation, and Regenerative Medicine Advanced Therapy (RMAT), the US Food and Drug Administration (FDA) has rejected the therapy due to manufacturing concerns. Roivance Sciences subsidiary Enzyvant received the CRL this week and while there were no…
BioLife eyes up M&A in ‘fragmented’ regenerative med supply space
The cell and gene therapy tool supplier space is ripe for consolidation says BioLife Solutions, which is evaluating several acquisition targets. For the third quarter 2018, regenerative medicine consumables and tools firm BioLife reported sales of its biopreservation media product of $5.3 million (€4.7 million), up 79% year-on-year. With the firm also turning a profit of $1.2 million for the period, CEO Michael Rice spoke about the scaling-up opportunities to take advantage of the continued demand from the cell and…
BioTime spinning out regenerative med firm AgeX
BioTime has received US$43 million (€37 million) from Juvenescence for a stake in AgeX and plans to spin the cell therapy subsidiary out in September. In April 2017, Californian late-stage biotech BioTime formed the subsidiary AgeX therapeutics to focus on its human aging candidates derived from regenerative stem cells. Earlier this year, fellow aging-focused firm Juvenescence made a $5 million investment in the subsidiary, and this week has upped its stake by 14.4 million shares paying BioTime $21.6 million in…
Cell Therapy Will Transform the Future of Medicine
The third annual IBC Cell Therapy Bioprocessing conference was held in Bethesda, MD, on 21–22 October 2013. It brought pioneers in the development of cell-based therapies together with companies that have enabling technologies, such as bioreactors, cell culture media, and advanced monitoring software. After the conference, I discussed the highlights and key themes coming out of the event with Dr. Phil Vanek, general manager of cell bioprocessing at GE Healthcare Life Sciences in Westborough, MA. Also an instructor for advanced…
Moving Cell Purification Methods from Bench to Bedside
The technological innovations and improvements to cell purification and other cellular analysis-based processes have dramatically increased sample throughput rates resulting in an improved ability to treat cancer, autoimmune diseases, and a range of applications in regenerative medicine.