Wissenschaftlicher Kongress am Samstag, 27. Oktober 2018 in Köln

Dr Gerry Kenna

Dr Gerry Kenna PhD BSc Hons, Pharmaceutical Director at Safer Medicines Trust, Kingsbridge, UK; and independent Drug Safety Consultant, Macclesfield, UK

About Dr Gerry Kenna

Dr Gerry Kenna is the Pharmaceutical Director of Safer Medicines Trust. He is also an independent Drug Safety Consultant and a leading figure in the field of human drug induced liver injury. Following his initial scientific training in biochemistry, at the Universities of Leeds (BSc Hons) and London (PhD), Dr Kenna established and led academic research teams which, for 19 years, studied the mechanisms by which medicines and other chemicals may damage cells of the liver. He then moved to industry (at Zeneca, Syngenta and AstraZeneca), where for 14 years he used his expertise to support human safety assessment of new medicines and agrochemicals. During this time, he also led research teams which developed improved human safety testing methods. These used human tissues and did not require use of animals. Dr Kenna is committed to ensuring that such human-relevant approaches are used routinely, by scientists in industry and in regulatory agencies, to aid the invention and development of safe new medicines.

Overcoming obstacles to human relevant science

Abstract

Developing safe and effective new drugs is an extremely inefficient process. Very few of the compounds evaluated in clinical trials are successful. A frequent cause of failed drug development is human toxicity. This occurs even though extensive safety studies in animals, which are mandated by regulatory guidelines, are undertaken before drugs are progressed into clinical trials. Furthermore, many licensed drugs that are introduced into widespread clinical use are found to cause unexpected human toxicities, which are termed “Adverse Drug Reactions” (ADRs). ADRs are the leading cause of withdrawal from use of licensed drugs and also may lead to cautionary labelling, which restricts the use of many potential valuable new medicines. Scientists have been tackling the problem posed by drug toxicity and ADRs by investigating underlying mechanisms and then using the resulting information to develop human-relevant in silico and in vitro test methods. The value of this approach will be illustrated for drug-induced liver injury (DILI), which is one of the most common human toxicities caused by drugs. Promising progress has been made in developing methods that enable identification of drugs that may cause DILI and other clinically concerning ADRs. However, as yet these methods have not gained widespread scientific and regulatory acceptance. Key bottlenecks which will need to be addressed and surmounted before this can be achieved will be discussed, and a potential way to accelerate the process will be proposed.