Not much time is left before we close 2016 and enter the new year. As we wrap up the final few weeks of this year, we want to take the time-as we do every year-to reflect on the year that is ending.
2016 has been, for many reasons, a year of growth, excitement and surprises — globally for the cell and gene therapy field, it will be remembered for numerous breakthroughs both scientifically as well as clinically, alongside a reinvigorated federal interest in regenerative medicine and immunotherapy.
At Akron, 2016 brought all of that, alongside innovation – in discovery, manufacturing and our involvement in national and international consortia advancing the therapeutic possibilities of regenerative medicine.
Here, we want to reflect on some of Akron’s highlight from this past year:
- In the first quarter, Akron announced acceptance of a Drug Master File for Interleukin-2 by the FDA, and invites all parties interested in referencing it in their regulatory submissions to submit a request.
- At the beginning of the year, Sen. Tommy Baldwin presented The Advancing Standards in Regenerative Medicine Act, which calls for the establishment of a Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. Akron is part of the task force behind this SBC, efforts regarding which are still ongoing.
- Our industry-leading product portfolio expanded by the introduction of innovative new products: we reformulated recombinant Eryothropoietin which now has enhanced stability and activity, and launched a 5% HSA solution.
- Our research efforts resulted in the publication of a number of manuscripts. A highlight is a review on liposome systems for drug delivery, Pharmaceutical Liposomal Drug Delivery: A Review of nEW Delivery Systems and a look at the regulatory landscape, which was published in Drug Delivery.
- Akron was awarded an SBIR Phase II grant by the Department of Defense for our leading innovations in the space of DMSO-free cryopreservation.
- Akron has always maintained leading presence at International Conferences and symposia. 2016 was no different: Akron was featured at ISCT, ISSCR, TERMIS, CAR-TCR to name a few.
As 2016 draws to a close, we look forward to 2017 and wish everyone happy holidays.
Our blog will resume in two weeks, on January 1st – we hope to see you usher in the new year with us.