Innovation

Innovation

Finding creative means to help our clients achieve their goals

Triskel often works with first-in-class products that present new scientific, regulatory and legal issues and has first-hand drug development and regulatory expertise in areas as diverse as biosimilars, advanced cell and gene therapies and transgenic products.
For example, Triskel was instrumental in the development and CTD submission of the first ever human cell line-derived medicinal product approved by the EMA in 1998 and of the first biosimilar/follow-on protein approved both by the EMA and FDA in 2006.
Triskel's ground-breaking projects with innovative products for which no appropriate regulatory guidance existed has led directly to the development of regulatory and legal frameworks for several new EU guidelines.
Regardless of the nature of the molecule, Triskel provides customised, strategic services responsive to our clients' goals. Our "learning/confirming" approach to drug development is designed to offer timely, cost-effective and efficient strategies to steer a molecule from discovery to the market.

First in human cell line-derived medicinal products

In 1996, the first MAA filed by Triskel through the EU centralised procedure was for a fully human mAb produced by Epstein-Barr virus-transformed human B-lymphocyte cells. This mAb also represented the first ever human cell line-derived medicinal product to be approved in the EU.

First in biosimilars

Triskel has been at the forefront in instigating dialogue between clients and regulatory authorities in the area of "Biosimilars/Follow-on Biologics" and has been instrumental in the successful registration of three biosimilar recombinant proteins in both the EU and North America.
Our early interactions in 1998 with the FDA and EMA in parallel with the development of our clients' "generic" recombinant proteins led directly to the creation of a concept paper entitled "Development of a Committee for Proprietary Medicinal products (CPMP) Guideline on Comparability of Biotechnology-derived Products" in 1998 and laid the framework for the EU guidelines on "Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance: Quality issues" and "Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance: Non-clinical and clinical issues".

First in cell therapy medicinal products

In the absence of an appropriate regulatory framework for cell therapies, Triskel initiated dialogue with EU authorities in the context of a development project for an autologous cancer vaccine. This collaboration resulted in the publication in 2001 of the "Points to Consider on the Manufacture and Quality Control of Human Somatic Cell Therapy Medicinal Products", which led to the adopted "Guideline on human cell-based medicinal products".
Since then, Triskel has assisted clients with the successful commercialisation of two autologous human cell therapy medicinal products.

First in transgenic plant-derived active substances

In the absence of an appropriate scientific and regulatory framework for the development of transgenic plant-derived biological medicinal products, and in the context of a project for such a product, Triskel collaborated with the EMA's Biotech Working Party to develop specific scientific guidance. This collaboration resulted in the publication in 2006 of the "Guideline on the quality of biological active substances produced by stable transgene expression in higher plants".

Unique Learning/Confirming approach

Triskel's rational drug development is divided into two stages:
  • Learning: Very early in development of the molecule, we integrate pharmacokinetic/pharmacodynamic and population modeling methods to thoroughly and efficiently identify the dose response relationships and their source of variability both for efficacy and for safety. Thus, we can establish activity, indications, target population, efficacy and dosage parameters quickly and efficiently.
  • Confirming: Having obtained hard data on the product, we can design efficient Phase III studies needed to demonstrate positive benefit /risk ratios and to convincingly support product claims and regulatory approval.

 

The ultimate benefit of this two step approach is that the time to market is decreased while the scientific integrity of the file is strengthened. More importantly, risk is reduced as expensive failures at the Phase III level are avoided.