"We Have To Do Better."
The overall success rate for a new drug from Phase I to FDA approval is barely 9%. New drugs must get past Phase III, and developers will have to do better than the 9% success rate for drugs that enter the clinic, say R&D pharma chiefs. (Source: The world’s biggest R&D spenders, FierceBiotech).
Stem cell and cell therapy show great promise promoting healing and regeneration of diseased or injured tissues. Many degenerative conditions have no effective treatment option and represent a significant burden on health care systems. Stem cells are a remarkably fast growing life science sector and clinical evidence of their effectiveness is mounting. Large pharma growth for conventional drugs may be much slower than had been expected, with fewer new drugs in the pipeline than ever before. Appetite for new treatments and more-personalized medicines is fueling investment within the regenerative medicine sector.
Understanding the technology and innovation of stem cell therapies is crucial to navigating and overcoming the challenges to commercialization. Stem cells are living entities, and cannot be synthesized or defined by a chemical formulation, like small-molecule-based drugs. Autologous treatments offer a shorter route to market, but allogeneic treatments present the potential for administration to a much wider patient population.
Work together with Akron to develop and optimize your strategy. Address quality assurance, tissue source, manufacturing, preclinical testing, regulatory submission, cold chain transport, and clinical trial design.
Accelerate Commercial Timelines and Reduce Unexpected and Costly Delays
The potential of stem cell therapy is huge, but the safety of these treatments has yet to be fully proven. Although significant preclinical safety testing reduces associated risks, clinical data are ultimately required. In addition to being safe, treatments must be effective. The size and duration of clinical trials to guide cell therapies toward commercialization is a key challenge. In addition, stem cell therapies are viewed by many as too expensive. Akron can maximize the clinical potential and cost-effectiveness of your cell-based product through tools and technologies that enable stable and consistent manufacture and delivery to a wide spread patient population.
Optimize Stem Cell Therapy for Clinical Trials
Akron is passionate about advancing treatments that deliver advanced cell therapies to fill unmet health care needs. Critical to biotechnology industries developing stem cell based therapies are the requirements and timelines to enter clinical evaluation. Below is an overview of the stages and time requirements for setting up a clinical trial from regulatory dossier preparation to first patient treated:
Regulatory Strategy to Clinical Trial Initiation