Ron Lawrence provides up-to-date CMC (Chemistry, Manufacturing & Controls) consulting services to the biotechnology and pharmaceutical industries via his consultancy (RML Pharma Consulting Ltd ) and is proficient in all CMC activities required for the development of new chemical entities.
Ron has a strong and successful background in synthetic organic chemistry. After completing his PhD in Australia, he continued postdoctoral studies in the UK working with the Medical Research Council and Imperial College in London before joining GlaxoWellcome/GSK. For 13 years, he worked in process development where he developed scalable manufacturing processes to support GMP manufacturing campaigns for GSK new chemical entities. Ron has also authored numerous papers and patents is this field.
He has a proven track record of success and has broad knowledge of what is required to develop new drugs from the early, pre-candidate selection phase right through to manufacture.
In recent years, he has specialised in the global outsourcing of API development & manufacture to contract manufacturers. Whilst at GSK, he was responsible for the scientific management of these projects at contract, which included the focus and the pace of all of the technical aspects, as well as ensuring that the internal project team's requirements for quality, quantity, timelines and budget were successfully achieved.
In terms of behavioural competencies, Ron's assets are his strong leadership and communication styles, his ability to communicate clearly and effectively at all levels of an organisation. He also has a demonstrated sense of urgency, this is a highly competitive industry and focusing these skills on the customer's needs is paramount to his success.
Ron has expertise in the following key areas:
- Outsourced API Manufacture (cGMP & non cGMP, including intermediates, analytical markers, impurities)
- Analytical Chemistry (method development, validation, API release)
- Project Management (manage outsourced project at contract, interface with the internal project teams to successfully deliver the CMC objectives)
- Route Selection and Development (process development/optimisation, new route work)
- Physicochemical Studies (Salts and polymorphs, crystallisation development)
- Risk Management (risks identified and mitigation strategies implemented)
- Regulatory Submissions (CMC sections compiled and reviewed)
- Due Diligence (review CMC data package ahead of inlicencing/outlicencing)
Specialising in the development of early phase assets, Ron can provide you with a tailored development approach that will facilitate you achieving your next milestone without incurring delay or unnecessary costs.