Peter Watts

Pete joined Bibra on 24th October 1977. With 45 years of experience in desk-based toxicology, his interests include the pragmatic application of risk assessment methodology to mammalian toxicity data sets, to derive robust conclusions on any health risks posed by exposure to chemicals. Pete's primary goal is to ensure that bibra provides a chemical hazard and risk assessment service that is robust, transparent, independent and scientifically defensible, in a cost-effective, timely manner. Pete routinely generates health risk assessments relating to extractables and leachables, in line with ISO 10993, 18562, and 21726 guidance. The propensity of containers, closures and processing equipment to leach chemicals is investigated in Extractables studies using standard solvents, while Leachables studies explore the extent of actual migration into the intended contents. Pete's focus in this area is on pharmaceuticals, medical devices and e-cigarettes or other ENDS/ENDD (including CBD products). Pete gives regular presentations on these topics. Pete's group also advises on appropriate SCTs and QTs, helping the analytical experts to set AETs. His group also carry out screening assesments of Extractables study results, identifying compounds that are health-critical for monitoring in Leachables studies. US PQRI recommendations and publications are a key element of such activities. Supporting the Medical Devices sector accounts for a considerable portion of bibra's working time. Pete's team are experienced in the generation of ISO 10993 biocompatibility evaluation reports (BERs); typical activities include proposals for biological evaluation plans (BEPs), interpreting biocompatibility and chemical characterisation studies, writing endpoint study waivers e.g. Via literature reviews, and chemical equivalence cases, as well as generation of toxicological risk assessments (TRAs) following 10993-17 principles. Pete is also heavily involved in the health risk assessment of pharmaceutical impurities. In generics, these may be novel or occur in concentrations higher than those approved for existing products, thus requiring Qualification. Bibra can assess the potential genotoxicity of "unavoidable"​ impurities, via the application of a range of techniques/approaches, such as literature searching, "read-across", in silico SAR/QSAR analyses, expert reports and modification of TTC defaults. Bibra runs Leadscope, Toxtree and OECD Toolbox, and commissions DEREK analyses from expert partners. ICH M7 plays a key role in mutagen classification and cancer risk assessments.