Cellular and Gene Therapy Products

Restoring health.

From treating inherited and progressive diseases to restoring loss of function, the landscape of cell and gene therapy is rapidly evolving, offering new possibilities for the treatment of a wide range of clinical indications. Current approved therapies have shown their effectiveness for treating blindness, cancer, neurological disorders, and sickle cell disease among others. In this rapidly evolving field, a preclinical safety and toxicology package is determined on a case-by-case basis. At KreaMedica, we can help you determine the needs of your preclinical package and execute the preclinical program necessary to support your advancement into the clinic.

Unique Challenges within Cellular and Gene Therapy Products.

Standard animal models may be irrelevant for the cellular or gene therapy product that needs to be tested.
“Non-standard” species, such as genetically modified rodents, or the use of an analogous product for the animal model might be suitable alternatives for obtaining meaningful results that can be extrapolated to humans.
Safety and toxicity evaluations are not standard and should be defined depending on the stage of differentiation and origin of a cell therapy product or of the genetic characteristics of a gene therapy product.
Delivery of Cellular and Gene Therapy products often involves a complex route of administration or the use of a delivery device system or scaffold.
Undifferentiated or incompletely differentiated cells pose a safety concern in stem-cell-derived therapies that should be evaluated.

KreaMedica’s Solutions

At KreaMedica, we can help you design and outsource in vitro and in vivo pilot studies to define product functionality and determine an animal species’ biological relevance.
We collaborate with you to design a preclinical program to identify and characterize local and systemic toxicities, whether acute or delayed and evaluate the reversibility of these effects.
Following the 3Rs, we incorporate pharmacological endpoints within the design of your toxicology program to evaluate safety parameters, reduce animal use, and maximize your budget.
We can help you design a study to evaluate the safety of delivery devices or scaffolds associated with the therapeutic product.
We help you define and incorporate biomarker readouts that will guide your dosing schedule by characterizing gene therapy products’ presence, persistence, and clearance profile.

Truth in Numbers

110+

Development Programs

70+

Sponsors Who Trust Us

73+

Years Combined
Industry Experience

Testimonials

Don’t take our word for it.

James L. Ellis, Ph.D.
Nocion Therapeutics, Inc., Chief Scientific Officer

They provided valuable insights and recommendations while seamlessly integrating into our team.

I have had the pleasure of working with KreaMedica on several programs. They proactively identified and addressed issues and provided regular updates to ensure everyone was on the same page. Their attention to detail and willingness to take ownership of the project’s success makes them invaluable partners. They are great to work with, and I would highly recommend them to anyone looking for a drug development partner.

Brian Jones
Respirion Pharmaceuticals, Chief Operating Officer

KreaMedica was an essential complement to our virtual team.

They supplemented and filled in gaps in our internal network and worked well with our advisors. They truly wanted to contribute to and be part of the project’s success. I highly recommend Claude, Poulomee, and Rudi as reliable partners for planning and executing toxicological and bioanalytical projects.

Ron Wolff
RK Wolff Safety Consulting Inc., Principal

The combination of all their perspectives made a tremendous difference.

I have worked with KreaMedica for many years, and I must credit them for the team’s talent, professionalism, and chemistry. That doesn’t happen by accident. As a consultant, I rely on them as the first line to monitor studies and provide proactive solutions when required.

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