Francis Lamberti, Ph.D. Email & Phone Number

Cary, Nc, Us

Rockville, Md, Us

I am responsible for providing original and engaging content to Dentine.org the go-to information source for dental professionals and consumers.

I am providing scientific and manufacturing support to MxBiodevices LLC, a near virtual venture in the last stages of product development. MxBiodevices is positioned to begin a pivotal clinical study of an an injectable hydrogel which provides a wound healing template for tissue repair of chronic wounds such as diabetic foot ulcers.I am also developing a portfolio of the next generation products including new formulations and customized product delivery systems.

Biomedical Device Consulting LLC provides fractional product, process & assay development management services to life science companies focused on regenerative medicine and tissue engineering.

Alachua, Fl, Us

Launching a product prematurely is much much worse than launching a product late or it's really hard to fix a leaking boat once you have left the dock.Responsible for developing new products for unmet clinical needs using regenerative medical technologies. Responsible for providing technical matter expertise to manufacturing and process development teams charged with improving product performance. Responsible for finding new technologies capable of providing significant reductions in the cost of manufactured goods.

It is always more expensive to do it again, rather than do it right the first time.Responsible for cross-functional team charged with developing novel bone filler materials based on nanOss (a nanocrystalline hydroxyapatite osteoconductive ceramic) and a freeze-dried formulation of a collagen based hydrogel carrier. Responsible for cross-functional team charged with developing cross-linked collagen based carrier containing osteoconductive ceramics as a new generation of ready-to-use bone void fillers indicated for use in spine and orthopedic surgery.

Even the best product will not perform well in a clinical trial with low enrollment rates.I developed methods of freeze-drying an injectable wound healing template to increase product shelf life and enable new product opportunities. I invented a novel method to prepare cross-linked collagen based wound healing templates to create a potential new family of products while expanding intellectual property portfolio of the company.I initiated grant writing efforts leading to non-dilutive funding totaling over $2M from NIH grants to demonstrate new product feasibility in preclinical animal studies. and support clinical trials conducted with a strategic corporate partner. This experience taught me that the success of a clinical trial depends on the enrollment rate as much as the product efficacy.

If what you're doing isn't working change what you are doing. I developed a scalable manufacturing process for a novel collagen based hydrogel designed to provide an injectable wound healing template to promote tissue repair of chronic wounds such as diabetic foot ulcers.Following process transfer I continued to provide technical expertise & support to manufacturing teams charged with producing materials for clinical trials.I developed new product formulations reducing the cost of goods by three-fold and improving shelf stability.

Build and maintain your network of experts and mentors.I provided technical expertise to medical device start-ups engaged in developing novel cell-based therapies and sought to out-license a novel encapsulation technology.

Ground breaking innovative medical device technologies such as cell based therapeutics require early involvement, monitoring and on-going engagement with regulatory agencies.I managed the technology transfer of a novel photochemical cell encapsulation process from an academic lab to a scalable, pilot manufacturing process. This transfer included the development of functional quality assurance methods for incoming organ explants as well as developing final product release specification for a cell-based bio-artificial pancreas. This work enabled successful pre-clinical large animal model studies which demonstrated both the proof of concept and commercial feasibility of a bio-artificial pancreas.An FDA guidance on the use of living xenograft tissue implants required a re-boot of company to pivot from developing a xenograft based bioartificial pancreas to using islets isolated from human donors.

True innovation requires collaboration -- not management.I created a novel cell encapsulation process capable of surrounding living cells with an ultrathin hydrogel coating to provide immuno-isolation of implanted tissue grafts for a bio-artificial pancreas to cure diabetes. This work was published as an issued US patent. I directed cross-functional team responsible for reducing pilot scale manufacturing costs by 75% by improving the isolation and yield of viable, functional insulin secreting cells from harvested porcine (pig) pancreas tissue. This work resulted in 2 issued US Patents and enables a commercially viable process for isolating primary tissue cells of interest from organ explants.

A good idea is not enough to make a great product.I was part of an early product development team charged with commercializing technology spun out from MIT. The concept was to use immobilized heparinase as a means of removing heparin from circulating blood following cardiopulmonary bypass surgery. I manufactured prototypes and developed functional quality control assays for a novel immobilized enzyme bioreactor designed for use as a medical device. These studies required the company to pivot from developing a medical device to developing diagnostics.

Ph.D, Applied Chemistry Chemical Engineering

Bachelor Of Science (Bsc), Biochemistry

Education record