API Development - Changing demands and requirements in the design and implementation of work programs associated with both non-clinical and clinical phase development of novel APIs is one of the key topics to be covered in the BOS Forum on Sept. 20 at the Royal College of Physicians in London. This event follows the BOS cmc Forum held this year in June in Copenhagen and provides complimentary information to cover the entire life cycle activities of API development.

Saltigo , a wholly owned subsidiary of the specialty chemicals group Lanxess, is a "Silver Sponsor" of both these events. It uses the platform to proactively showcase itself and its API development and manufacturing services to a large number of both established big pharmaceutical companies as well as a much wider range of smaller Biotech companies.

Tony Jones, head of Marketing & Sales in Saltigo's Pharma business line, explains, "forums such as the BOS event in London provide Saltigo with a tremendous amount of valuable information regarding the ever changing dynamics of the Pharmaceutical industry. From attending the presentations by industry experts to the many one-on-one-meetings with our customers and other attendees, we are able to get a much better understanding of the future services these organizations will require to achieve their own business objectives.

With a better understanding of our customer's needs, we can continue to evolve, expand and development our own service offering to ensure that both current and future service market requirements can be professionally provided by Saltigo."

Strategic investments totaling several million euros, over the last three years, by Saltigo has enabled it to expand its customer base both geographically and to develop a more balanced product portfolio covering projects in each phase of development /commercialization. In the same time period the pharmaceutical industry has experienced an unprecedented level of change with consolidation through the mergers and acquisitions of several major pharmaceutical companies, offset by continued growth in the number of emerging pharmaceutical companies.

Jones adds, "over the past three years the industry has changed dramatically and we have had to monitor these changes and decide how best to position Saltigo on a market basis or more importantly, on a customer by customer basis.

Customizing our services to help our customers overcome their specific project challenges has been a key aspect of our success and one that also brings with it tremendous demands on the flexibility of our organization. Hence, good communication is a key factor for success and as a result our entire project teams now work much more closely with our customers and everyone has a much clearer understanding of the importance of meeting timelines in full (OTIF) and the commercial requirements of each project in its own particular market area.

Each project has different needs and has to be approached with this in mind. A clear specification of the needs of the project is essential for appropriate planning and successful execution of the project goals."

Dr. Christoph Schaffrath, one of Saltigo's Pharma business managers, further highlighted this diversity in his summary of Saltigo's meetings during the BOS cmc Forum held earlier this year in Copenhagen.

"Throughout the event I was able to talk with representatives from many different organizations and for more established Pharma companies these the discussions were in general geared towards Saltigo achieving clearly defined manufacturing activities for certain novel API projects. However, for some of the smaller organizations the discussions were on a more consultative basis in which Saltigo's own advice on project development plans should be structured and how we could assist more actively in regulatory matters."

In summary, Jones concluded "in our three years of sponsorship of the BOS events we have seen a great deal of change in the needs of our customers. One common theme which runs throughout this period is the increased focus on predicting future cost of goods much earlier in product development activities. In the past, the potential efficacy of a novel drug was often the primary driving force behind the early clinical development of potential new API's.

Now, the funding of these early activities requires more closely monitoring cost issues both in terms of achieving key milestones and long term cost of goods. More and more we are be asked to provide innovative solutions to develop process chemistry to meet necessary price points for development of the final drug product.

On this aspect, Saltigo has a considerable depth of experience and proven track record for cost improvement throughout all of its businesses. This is a fact which is positively received by both our customers and equally important their financial investors." 

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