In 2007 the European Commission passed Regulation 1394/2007/EC regulating Advanced Therapy Medicinal Products (ATMPs). This act recognised the scientific progress in the various fields encompassed by the legislation and the need for more comprehensive legislation than existed previously.
The types of products classed as ATMPs include somatic cell therapies, gene transfer products, tissue engineered agents and combination products of medical devices with cellular or tissue material. In USA these products are also subject to specific legislation and regulations but not under one umbrella as now exists in EU.
Gene and cell therapy products are in development for, usually, serious conditions and Kinesys has experience in a number of these areas. Kinesys has worked on several ATMPs, including one approved in 2017 for a gastrointestinal condition. Not surprisingly, few scientists or business professionals have yet gained extensive experience in the novel and developing ATMP fields. Those who work in the area tend to be experts in one type of product only.
At Kinesys, we have harnessed our interest and experience in working on novel and innovative products, and our profound understanding of many of the scientific and development challenges, to accumulate a growing knowledge and experience of the various types of ATMPs.
We have, worked on one of the first cell therapy products to be approved by EMA, an adult stem cell agent for a severe gastrointestinal condition. Our cell therapy experience also extends to prostate cancer and a novel artificial liver product. We have advised extensively on combination cell-device products even, especially in the areas of orthopaedics and urology.
The company’s Principals and Advisory Board have always had a keen interest in cutting edge products, having worked on many novel biologicals such as antibodies, fusion proteins, antibodies linked to cytotoxic agents, and others, in a variety of indications from cancer to arthritis to hormonal deficiencies. The experience gained from these projects is of course often relevant to the issues faced when developing an ATMP.
Kinesys can advise on early and late stage development of ATMPs, including timing and execution of ATMP classification and certification at EMA. The knowledge we have accumulated over more than 20 years allows us to assist with CMC, nonclinical and clinical aspects of development, as well as commercialization and pricing strategies.
Our experience with ATMPs and other novel products, our knowledge of regulatory agency expectations, and our agency connections are key factors that ensure a high quality and high value service for our ATMP clients.