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.
Where are we now?
To date, no gene therapies have secured a marketing authorisation in either region. As of summer 2010 only one cell therapy product had been approved in the EU, and none in USA. Tissue engineered and combination products have been developed and marketed in Europe for multiple indications under national regulatory frameworks, which ranged from a complete lack of regulation to regulation under tissue banking rules.
Many of these will now be regulated under the new EU legislation. Gene and cell therapy products are in development for, usually, serious conditions and Kinesys has experience in a number of these areas. 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. In addition, this is an area which is still in flux: for those TEP-containing products that are not covered by the ATMP regulations nor the Medical Devices Directive (as revised in 2007/47/EC), the European Commission is due to develop new requirements for products that include non-viable human tissue as an ancillary substance in combination with a medical device in the context of the forthcoming recast.
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, for example, worked on one of the first cell therapy products to succeed in entering phase 3 clinical trials, an adult stem cell agent for a severe gastrointestinal condition. Our cell therapy experience also extends to prostate cancer. We have advised extensively on combination cell-device products even before the recent legislation was enacted, especially in the areas of orthopaedics and urology.
The company’s Principals and Expert Panel 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.