Material management

Jozsef Repasi explains the importance of chemistry services in drug development.

What are the main challenges currently facing those charged with sourcing chemicals for use in pharmaceutical drug development?
Jozsef Repasi. Over the last couple of years the requirements of customers of CROs have changed substantially. They are putting increasing pressure on service providers to improve prices and reduce lead times. Therefore, sourcing of starting materials has become a critical part of the activities of CROs. In early discovery phase, the chemical suppliers are providing excellent and very rapid service, supplying starting materials from stock within a couple of days. However, sourcing of the same chemicals for late preclinical and early clinical work can be a major challenge. As a result of the ongoing economic crisis European trading companies have reduced their stock levels substantially, so most of the materials have to be sourced from Indian and Chinese suppliers. There are good and reliable Asian suppliers, but materials from the same source are often offered by a number of companies. Unfortunately, the originally agreed lead times are frequently not met.

Nowadays, the buyers of CROs are working under extreme time pressure as their work has substantial impact on the success of the company and its reputation. In order to secure the timely supply and good quality of the critical starting materials it is sometimes necessary to dual source materials in order to minimise the risk of late delivery or quality problems.

It is vital that pharmaceutical compounds, and the processes and procedures that surround them, are compliant with all relevant legislation. How can companies ensure this is the case?
JR. As Ubichem is a small company, with approximately 100 employees it is more efficient for us to use external experts to guarantee that we are compliant with all the relevant regulations. The external experts are responsible for providing information about any changes on a monthly basis and our colleagues are evaluating the changes and preparing plans to allow us to meet them. We also have an in-house system regarding internal monitoring and distribution of the legislation. Our colleagues responsible for the regulatory compliance regularly participate in training and conferences to keep their knowledge up to date, but they are also highly motivated and continuously developing themselves through self-education.

What should pharmaceutical companies look for when searching for a chemistry partner to help accelerate their drug discovery and early development programmes?
JR. In my experience, the priorities of large and medium size pharmaceutical companies are very different when looking for service providers, and this has a fundamental impact on the success of the cooperation. Large pharmaceutical companies frequently base the decision on the size and FTE rate of the service provider. One should wonder if it's possible to develop a CRO of a few thousand people which functions efficiently in a few years. It could be argued that a company needs years of organisational development to achieve this. European and American service providers were established after years of such development, so, on the whole, they are able to provide fast, good quality and reliable service. In early discovery, cheap service en masse can be sufficient for large pharmaceutical companies, but as the drug development progresses, flexibility and honest communication in timely fashion will get higher priority. The on-time service of the chemical supplier will greatly influence the work of other service providers. A delay in toxicology or clinical phase can cost an order of magnitude more for the pharmaceutical company than the price to manufacture the drug substance. As a result, some pharmaceutical companies use different supplier evaluation methods in different phases of development, that is, reliability, trust, price, spee, and flexibility are weighted differently in each phase.

How did Ubichem's Pharma Services Division come to be recognised as a Centre of Excellence for global chemistry services?
JR. Ubichem Research, which provides our pharma services, was created in Hungary in 1996. Since then continued investment in people and facilities means that we now offer a comprehensive range of chemistry services to support the development programmes of our pharmaceutical and biotech partners around the world. An experienced team, with particular expertise in heterocyclic and organometallic chemistry, ensure that we minimise the risks associated with the scale-up of medicinal chemistry routes. Our passion for chemistry is matched by a pragmatic approach to innovation enabling us to create new opportunities and add value to our clients' projects. This, coupled with reliability and excellent problem-solving skills, makes Ubichem a preferred partner for many pharmaceutical and biotech companies.

Jozsef Repasi is Managing Director at Ubichem Research Ltd. and Director of Ubichem Plc. He has held his Managing Director position since the creation of the company in 1996. Répási earned a masters degree in Science, specialising in Pharmaceutical Chemistry at ELTE, in 1986 and has more than 20 years experience in pharmaceutical reserach and development.