Regenerative medicine: learning from past examples.

Regenerative medicine products have characteristically shown great therapeutic potential, but limited market success. Learning from the past attempts at capturing value is critical for new and emerging regenerative medicine therapies to define and evolve their business models as new therapies emerge and others mature. We propose a framework that analyzes technological developments along with alternative business models and illustrates how to use both strategically to map value capture by companies in regenerative medicine. We analyze how to balance flexibility of the supply chain and clarity in the regulatory pathway for each business model and propose the possible pathways of evolution between business models. We also drive analogies between cell-based therapies and other healthcare products such as biologicals and medical devices and suggest how to strategically evolve from these areas into the cell therapy space.

Lessons from innovation in drug-device combination products.

Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon.

Nanostructured multilayer coatings combining chitosan with bioactive glass nanoparticles.

There is an increasing interest in conceiving biomimetic coatings and films for a variety of biomedical applications. Biodegradable multilayer coatings combining a polycation (chitosan) and an anionic element (bioactive glass nanoparticles) were developed by sequential deposition. Quartz crystal microbalance showed that this methodology may be used to produce tunable and viscoelastic nanostructured multilayers upon increasing the number of layer-by-layer cycles. The hypothesis of this concept, which was also verified in this work, is that such robust coatings, inspired by the ordered and tough brick-and-mortar structure of nacre, could also induce the formation of apatite upon immersion in simulated body fluid with ion concentrations similar to those in human plasma. The proposed method could be also employed in the coatings of substrates with complex geometries, including scaffolds for bone tissue engineering applications, and thus constitutes a new technological solution to improve osteoconductivity of a variety of implants for orthopedic applications.

Development of bioactive and biodegradable chitosan-based injectable systems containing bioactive glass nanoparticles.

There is increasing interest in the development of new tissue engineering strategies to deliver cells and bioactive agents encapsulated in a biodegradable matrix through minimally invasive procedures. The present work proposes to combine chitosan-beta-glycerophosphate salt formulations with bioactive glass nanoparticles in order to conceive novel injectable thermo-responsive hydrogels for orthopaedic reconstructive and regenerative medicine applications. The initial rheological properties and the gelation points of the developed organic-inorganic in situ thermosetting systems were revealed to be adequate for intracorporal injection. In vitro bioactivity tests, using incubation protocols in simulated body fluid (SBF), allowed the observation of bone-like apatite formation in the hydrogel formulations containing bioactive nanoparticles. The density of the apatite formed increased with increasing bioactive glass content and soaking time in SBF. These results indicate that the stimuli-responsive hydrogels could potentially be used as temporary injectable scaffolds in bone tissue engineering applications.