Area of Focus

Areas of Focus

 

Drug Discovery

Clinical trials for Investigational New Drugs (IND) are perhaps the biggest cost associated with drug development. And yet, up to 90% of all INDs fail at some phase in clinical trials. This is mainly attributable to the fact that most IND research and development is done in animal models and cell culture. The translation of efficacy, clinical safety and toxicology data to humans is not assured.

The REPROCELL Group has ready access to live human tissues through our extensive clinical networks, in addition to human iPSC-derived 3D cell model systems to create custom assays that can provide predictive human data to de-risk your drug discovery programs. No other company has this unique combination of expertise and capabilities.

Disease Focus

For every human disease, there are perhaps multiple pharmacological targets explored in drug development. Furthermore, there are many approaches to drug screening and validation that involve human cell culture and animal models. Human iPSC-derived disease models, 3D tissue models and classical pharmacological testing are all capabilities (services or tools) offered by REPROCELL. The disease focus category pages on the REPROCELL website are an attempt to summarize the key products or services related to these specific diseases. They are areas in which REPROCELL has knowledge and experience through contract research projects or product development.

Regenerative Medicine

A strong area of future growth in health care is predicted to be regenerative medicine. Already cell therapy has been used for years to treat certain human diseases. Furthermore, many somatic stem cell therapies are currently in clinical trials worldwide. It is also predicted that induced pluripotent stem cells (iPSC) will be a key cell resource in the future to support a variety of approaches to regenerative medicine. With a pedigree of commercializing and researching stem cells, REPROCELL is positioned to be a key player in regenerative medicine.

The REPROCELL Medical business unit, newly formed in 2017, is leading the effort toward patient care and commercial support of the emerging regenerative medicine market. To meet the evolving market needs of regulatory compliant and higher grade materials, REPROCELL is developing a suite of GMP-compliant and clinical grade products and services. And, through a partnership with Steminent Biotherapeutics (Taiwan), REPROCELL has acquired the rights to begin clinical trials in Japan for the treatment of a rare form of neurodegenerative disease, using an enriched preparation of human mesenchymal stem cells (Stemchymal®) supplied by Steminent. These efforts by REPROCELL represent a shift in corporate strategy toward precision medicine and therapies to support the emerging regenerative medicine commercial and medical market.

Stem Cell Research

Human stem cells have become widely used for both studying fundamental molecular processes of developmental biology, as well as developing new therapies for previously intractable diseases. The manipulation of stem cells in vitro enable disease modeling and new possibilities for drug development. Most research with human stem cells has shifted toward the use of induced pluripotent stem cells (iPSCs) for moral and ethical reasons, and regulatory restrictions. The creation of iPSC has developed rapidly with many alternative technologies, most involving expression vectors or viral delivery. Although effective, these technologies are increasingly problematic as the basic research shifts to translational research and clinical applications. REPROCELL iPSC reprogramming technology is based on RNA delivery and consequently much more clinically relevant than others.

Biomarker Research

Biomarkers are playing an increasingly important role in drug development and diagnostics. Medical practice will increasingly require new biomarkers to help stratify patients into personalized treatments. However, biomarker identification requires the use of human clinical samples that have been vetted for disease state and collected ethically in accordance with regulatory guidelines and proper oversight. REPROCELL has the products, the network and services that can assist you in biomarker research and development.

Personalized Medicine

Sometimes known as Precision Medicine, this medical model utilizes patient stratification to tailor treatments for more effective therapy. Stratification can be based on patient personal genetics, life-style, or characteristics of the disease tissue itself.

REPROCELL's Biopta contract research services can employ precision-cut tissue sections, arraying primary tumor samples into multi-well plates for testing against a panel of drugs, drug combinations or various concentrations. Other assay configurations are also be possible, depending on the disease and target tissue.